CamNtech Sleep Diary User manual

Sleep Diary User Guide 1.5.7a 31/12/2019
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SLEEP DIARY
User Guide
Document Reference: 30181
Version: 1.5.7a
Date of current version: 31/12/19
Original Author: David Walker
The PRO-Diary and PRO-Diary V are Class I Medical Devices (EU)

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PRO-Diary and PRO-Diary V Regulatory Information
Medical Device Directive (European Union)
The PRO-Diary and PRO-Diary V are Class I Medical Devices 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
Manor Farm
Fenstanton
Cambridgeshire
PE28 9JD, 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.

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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
Section 10.1.
Safety Classification Information:
PRO-Diary is INTERNALLY POWERED EQUIPMENT.
PRO-Diary mode of operation is CONTINUOUS OPERATION.
PRO-Diary 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 10

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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 Sleep Diary System...............................................................................................6
1.1 An Overview of the Sleep Diary.......................................................................................................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 Use..............................................................................................................7
1.6 Inspection Before Use......................................................................................................................7
1.7 Service Life.......................................................................................................................................8
1.8 Modifications.....................................................................................................................................8
1.9 Adverse (Serious) Events.................................................................................................................8
2Installing the Sleep Diary Software......................................................................................................9
2.1 System Requirements......................................................................................................................9
2.2 Software Registration.......................................................................................................................9
2.3 Software Installation Menu...............................................................................................................9
2.4 Installing the USB Drivers ................................................................................................................9
2.5 Using the software for the first time................................................................................................10
2.6 Check for Software Updates ..........................................................................................................11
3Charging the PRO-Diary Battery........................................................................................................12
3.1 Charging the Diary from the PC.....................................................................................................12
3.2 Charging the Diary using the Mains Power Supply........................................................................12
3.3 Charging Multiple Diaries using a USB Hub..................................................................................13
4PRO-Diary Setup/Download................................................................................................................14
4.1 Introduction.....................................................................................................................................14
4.2 Creating a Results Database .........................................................................................................14
4.3 Running the Setup..........................................................................................................................15
4.4 Using the Diary...............................................................................................................................16
4.5 Downloading a Recording..............................................................................................................16
5Opening Recordings for Analysis......................................................................................................19
5.1 Open Recordings............................................................................................................................19
5.2 Checking Recordings .....................................................................................................................19
5.3 Deleting Recordings.......................................................................................................................22
6Analysis Window..................................................................................................................................23
6.1 Changing Views..............................................................................................................................24
6.2 Printing & PDF creation..................................................................................................................24
6.3 Exporting Results/Data...................................................................................................................25
6.4 Viewing Raw Diary Data.................................................................................................................26
6.5 Editing Patient Information.............................................................................................................27
7Miscellaneous.......................................................................................................................................28
7.1 Groups............................................................................................................................................28
8Frequently Asked Questions..............................................................................................................32
What limits the recording life?................................................................................................................32
Will too many answers fill up the memory? ...........................................................................................32
Will the data be lost if the battery runs flat?...........................................................................................32
9Additional Documents.........................................................................................................................33
Sleep Diary Quick Guide........................................................................................................................33
10 Safety and Handling Information....................................................................................................34

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10.1 Decontamination.............................................................................................................................34
10.2 Battery ............................................................................................................................................34
10.3 Water Ingress.................................................................................................................................34
10.4 Disposal at End of Life ...................................................................................................................34

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1 Introduction to the Sleep Diary System
1.1 An Overview of the Sleep Diary
The Sleep Diary system uses a PRO-Diary worn on the wrist which
prompts the wearer with standard questions for sleep and alertness
monitoring. The results are collated and presented in a standard report
by the included PC software. The overall system combines wrist-worn
actigraphy with an electronic diary, presenting the subjective and
objective data in a single easy to use report.
The PRO-Diary incorporates a tri-axial accelerometer to allow objective
actigraphy data to be collected while the device is worn. The PRO-
Diary has a direct USB connection for setting up, downloading and
charging the battery. See Section 0 for details of battery charging and
expected life.
The PRO-Diary has a clear, high contrast OLED screen. 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 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 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 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 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.
1.6 Inspection Before Use
The PRO-Diary (including strap) shall be inspected for signs of
damage or wear before each use. Do not use the device if the
inspection reveals any damage.

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Contact CamNtech UK or your local representative if you suspect your
PRO-Diary device(s) may have sustained damage.
1.7 Service Life The recommended service life of the PRO-Diary devices is 5 (five)
years.
1.8 Modifications DO NOT ATTEMPT TO MODIFY THE PRO-DIARY IN ANY WAY.
Doing so may affect device safety and/or performance, and will nullify
any remaining device warranty.
1.9 Adverse (Serious) Events
Any and all serious/adverse events which result in patient harm MUST
be reported to CamNtech and your national Competent Authority.
Refer to guidance provided by your local legal authority for information
on reporting procedures and timescales.

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2 Installing the Sleep Diary Software
2.1 System Requirements
The Sleep 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 Sleep Diary
software:
Windows®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
SVGA graphics (1280 x 1024) recommended.
In general, a faster processor will provide superior performance.
The software has NOT been tested with any variant of Apple MacOS
and is not intended to be installed on devices running this operating
system.
2.2 Software Registration
To access the Sleep 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
Download the installer (.msi) from the CamNtech website:
www.camntech.com/downloads
Double click on the downloaded .msi to run the installer then follow the
installation process.
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).
Note that the software requires the Microsoft .NET Framework 4 to
operate –this will be automatically installed if not present.
2.4 Installing the USB Drivers
Upon connecting the PRO-Diary device to your computer for the first
time, Windows®will automatically search on-line to locate and install
the latest drivers. No user intervention is required and the PRO-Diary

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should remain connected until the process is complete. An internet
connection is required to install the drivers automatically.
If the drivers cannot be loaded automatically, you should visit our web
site drivers area: http://www.camntech.com/support/drivers.
Using the software for the first time
Double clicking on the Sleep Diary icon on the desktop will start the
software.
You will be prompted to enter a serial number when you first run the
application. Enter your serial number and click the OK button to apply
it.
The main menu will be shown as below.
Setup a PRO-Diary ready to be used for
data collection
New Recording
Download the data from a previously set up
PRO-Diary
Download Recording
View and analyse downloaded recordings
Previous Results
Access the application settings
Options Menu

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2.6 Check for Software Updates
The Sleep Diary software will check for software updates once per day
when it is run. It is also possible to manually check for software
updates then automatically download and install them.
To manually check for updates, click the ‘Help’ menu and then select
‘Check for updates’.
If a newer version is available, a prompt similar to the following will be
shown:
Click ‘Yes’ to download the new version or click ‘No’ to ignore the
update message.
Your CamNtech login details will be required to allow the software to
connect and download the update. If these have not been previously
entered, the following prompt will be shown:
Enter your Username and Password obtained from CamNtech when
the software was registered (see Section 2.2 above). Click ‘Save &
Close’ and your details will now be stored in the software. The
download will begin:
When the download has completed, click the Exit & Run Update
button to close the application and initiate the installer. The software
update will then be installed.

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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 Multiple Diaries using a USB Hub
7-Port USB hub for charging. Order code 05-312

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4 PRO-Diary Setup/Download
4.1 Introduction A Sleep Diary recording consists of questionnaires and motion logging.
The questionnaires have been carefully designed and tested by an
independent party and cover sleep, alertness and mood. The
questionnaires are completed at various times of the day. The
scheduling of the questionnaires is as follows:
Questionnaire
Type
Time
Bed Time
On user request
Every evening
(18:00-04:00)
Woke Up
On user request
Every morning
(04:30-15:00)
Mood, Alertness &
Sleepiness
Automatic
All Day
4.2 Creating a Results Database
A results database has to be created to store your downloaded
recordings. Click the Options Menu to open it and the click the
Settings menu item to open the settings window:
Click on the Database option to show the database settings.

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Click the Create New Results Database… button to open the file save
dialog box. Select a save folder, enter a filename and save to create
the database.
You can now close the settings window.
4.3 Running the Setup
Connect a PRO-Diary to the computer using the USB cable provided
by CamNtech. Please note: using your own USB cable may cause
connectivity issues due to the type/size of the connector.
Click on the New Recording option on the main menu to show the
Recording Setup window:

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Enter a User ID in the User ID box –this will be used to identify the
recording when it has been downloaded.
The Diary can either be set up for Sleep Only (Bed Time + Woke Up
questionnaires) or for Sleep & Alertness (Bed Time, Woke Up and
Mood, Alertness & Sleepiness questionnaires). Select your desired
setup type by clicking the corresponding option box.
The Diary can be configured with a screen lock to prevent unintentional
inputs. To enable this on the Diary, ensure the Enable Key Lock
option is checked:
Click the Set up Diary button to send the setup to the Diary:
Once complete, remove the Diary from the computer.
It is now ready to be used.
4.4 Using the Diary The Diary should now be worn by the subject to collect movement and
question data over a number of days. Brief instructions for this are
provided in the Sleep Diary Quick Guide which should be handed to
the subject along with the Diary. Please note: the PRO-Diary is NOT
waterproof.
4.5 Downloading a Recording
Connect a previously set-up Diary to the computer using a USB cable.
Click on the Download Recording option on the main menu.

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The application will immediately begin downloading the recording from
the Diary:
Once complete, a completion dialog box will be shown which contains
options to shut down the Diary, or leave it running to continue to
capture data. Select the Shutdown option in this case:
The Diary can be disconnected from the computer.

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The newly downloaded recording will be automatically saved to your
chosen Results database and the recordings list will show the new
recording:

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5 Opening Recordings for Analysis
5.1 Open Recordings
To open a recording, click on its entry in the recordings list and the
click the Open button. You can also double-click on the entry itself:
5.2 Checking Recordings
The first time a recording is opened a recording check window will be
shown.
The Sessions Check window allows you verify each of the
questionnaire answer sessions which have taken place throughout the
recording.
The list of items contains each day in which at least one attempt at
answering a Woke Up questionnaire was performed. This is to account
for instances where the user may have chosen to answer multiple
times, for example if the user was interrupted during one attempt and
decided to attempt the questionnaire again at a later time during that
day.

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The software automatically analyses each attempt and picks the best
attempt for days where there is more than one attempt.
The software flags any days where the best questionnaire attempt for
that day looks to be incomplete. This is shown in the Questionnaire
Status column.
The software also flags any days where there appears to be a large
amount of empty motion data. This is shown in the Activity Status
column.
To choose a different questionnaire attempt for a day, double-click on
the day entry in the list. Then in the window which is shown, click on
the column heading for the day you would like to use. The attempt
which will be used will have its entire column highlighted in green. Click
the OK button to confirm the selection: