CamNtech PRO-Diary User manual

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The PRO-Diary User Guide
FOR PRO-DIARY, MOTION AND ‘V’ MODELS
Document Reference: 30119
Version: 1.5.7
Date of current version: 07/02/2019
Author: Tom Evans
The PRO-Diary is a Class I Medical Device (EU)

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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
.
Manufacturer:
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

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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 Purpose................................................................................................................................7
1.3 Contraindications.................................................................................................................................7
1.4 Required Skills, Training & Knowledge of Intended Users...................................................................7
1.5 General Description of Operation ........................................................................................................7
2Installing the PRO-Diary Software...........................................................................................................8
2.1 System Requirements.........................................................................................................................8
2.2 Software Registration..........................................................................................................................8
2.3 Software Installation Menu ..................................................................................................................8
2.4 Installing the USB Drivers....................................................................................................................8
2.5 Running the software for the first time.................................................................................................9
2.6 Software Serial Number ......................................................................................................................9
2.7 Check for Software Updates..............................................................................................................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........................................................................................12
4Creating and Editing Questionnaires....................................................................................................13
4.1 Basic Concepts .................................................................................................................................13
4.2 Questions..........................................................................................................................................14
Multiple Choice.........................................................................................................................................14
Visual Analogue .......................................................................................................................................15
Enter a Number........................................................................................................................................15
Enter a Time.............................................................................................................................................16
Just a Message........................................................................................................................................16
List ...................................................................................................................................................17
Free Text..................................................................................................................................................17
Likert Scale ..............................................................................................................................................18
4.3 Questionnaires..................................................................................................................................18
4.4 Schedules .........................................................................................................................................18
Day Designation.......................................................................................................................................19
Time/Type of Entry...................................................................................................................................19
Motion Logging.........................................................................................................................................19
4.5 Locked and Unlocked Items ..............................................................................................................19
4.6 Creating a New Question Database ..................................................................................................20
4.7 Diary Menu Customisation.................................................................................................................20
4.8 Conditional Questionnaire Sequences...............................................................................................21
Quick Summary........................................................................................................................................21
Simple example (to omit some questions depending on a previous answer) ............................................21
Bigger example (to present a nested set of options).................................................................................23

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Random Ordering Example......................................................................................................................26
5Setting up a Diary...................................................................................................................................27
5.1 User Name........................................................................................................................................27
5.2 Schedule...........................................................................................................................................27
5.3 Question Size....................................................................................................................................27
5.4 Menu Customisation..........................................................................................................................27
5.5 Enable Keylock..................................................................................................................................28
5.6 Enable Demo Beeps..........................................................................................................................28
6Using the Diary.......................................................................................................................................29
6.1 Waking up the Diary..........................................................................................................................29
6.2 Using Menus and Answering Questions............................................................................................29
6.3 Answering a Scheduled Questionnaire..............................................................................................29
6.4 Requesting a Questionnaire..............................................................................................................29
6.5 Silent Mode .......................................................................................................................................30
6.6 Not Waterproof..................................................................................................................................30
6.7 Wearing & Strap options....................................................................................................................30
7Downloading Results.............................................................................................................................31
8Viewing Results......................................................................................................................................32
8.1 Filtering by Questionnaire..................................................................................................................32
8.2 Transposing the Results Table..........................................................................................................33
8.3 Filtering by Scheduled/Requested.....................................................................................................33
8.4 Exporting Motion Logging Data .........................................................................................................33
8.5 Other Exports/Data Analysis..............................................................................................................33
9Tutorial....................................................................................................................................................34
9.1 Create a Schedule.............................................................................................................................34
9.2 Waking Up.........................................................................................................................................36
9.3 Going to Bed .....................................................................................................................................39
9.4 Afternoon Tiredness..........................................................................................................................40
9.5 Using the Schedule...........................................................................................................................40
9.6 Downloading Results.........................................................................................................................41
9.7 Demonstrating a Timed Questionnaire ..............................................................................................42
10 Frequently Asked Questions..............................................................................................................43
11 Additional Documents........................................................................................................................44
12 Safety and Handling Information.......................................................................................................45
12.1 De-contamination..............................................................................................................................45
12.2 Battery...............................................................................................................................................45
12.3 Water Ingress....................................................................................................................................45
12.4 Disposal ............................................................................................................................................45

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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 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.
‘Select’ Key
‘Function’ Key
Slider Control
OLED Display
USB Port

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1.2 Intended Purpose
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.
NOTE: the device software should not be used directly for diagnostic or
therapeutic decision making.
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 Operation
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 provided via download (A USB stick can optionally be
provided at extra cost). The installer contains 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®7, 8 or 10, 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.
The software has NOT been tested with any MAC OS.
2.2 Software Registration
To access the PRO-Diary software download, it is necessary to first register the
software with CamNtech. Please visit www.camntech.com/register to register
your software using the reference number provided with your equipment. You will
then be provided with a username and password allowing log-in and download of
the software at any time during the two year warranty period.
Note that CamNtech standard software licensing allows up to 3 users to register
and use one copy of the software.
You will also be provided with a software serial number that will be required to
activate the software following installation.
The software will continue to be fully functional beyond the warranty period but
updates will no longer be provided.
2.3 Software Installation Menu
2.4 Installing the USB Drivers

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2.5 Running the software for the first time
2.6 Software Serial Number
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
Type your serial
number here.
Then click ‘OK’
to activate.

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2.7 Check for Software Updates

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3 Charging the PRO-Diary Battery
3.1 Charging the Diary from the PC
3.2 Charging the Diary using the Mains Power Supply

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3.3 Charging Several Diaries from a USB Hub
7-Port USB hub for charging. Order code 05-312

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4 Creating and Editing Questionnaires
4.1 Basic Concepts

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4.2 Questions








Multiple Choice

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Visual Analogue
Enter a Number

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Enter a Time
Just a Message

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List
Free Text

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Likert Scale
4.3 Questionnaires
4.4 Schedules

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Day Designation





Time/Type of Entry
Motion Logging
4.5 Locked and Unlocked Items

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4.6 Creating a New Question Database
4.7 Diary Menu Customisation