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PRO-Diary User Guide 1.2.1 10/02/15

Page

Document Revision History

Issue
From

Issue

Date

Description

Initiator

1.1.14

1.1.15

04/12/13

Added Australian Sponsor Details

1.1.15

1.1.15a

10/12/13

Updated indications for use to align with FDA submission

1.1.15a

1.1.15b

03/03/14

Updated FDA clearance status

1.1.15b

1.2.1

10/02/15

Minor updates to match software changes

Summary of Contents for PRO-Diary Motion

Page 1: ...iary 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 Devi...

Page 2: ...s 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...

Page 3: ...ates 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 a...

Page 4: ...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 4 Creating and Editing Questionnaires 12 4...

Page 5: ...ewing 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...

Page 6: ...y 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 P...

Page 7: ...edge 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 G...

Page 8: ...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...

Page 9: ...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 clos...

Page 10: ...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 wi...

Page 11: ...stop the diary charging until normal operation is resumed If you any issues related to charging or battery life we recommend using a mains power supply for charging to avoid this issue 3 2 Charging th...

Page 12: ...ncepts It may be useful to clarify the terminology used in programming the Diary The diary presents the user with questions either at specific times or when the wearer requests it and logs their answe...

Page 13: ...stions There are eight types of questions Multiple choice Visual analogue Enter a number Enter a time Just a message List Free Text Likert Scale All types include a main question message but a selecti...

Page 14: ...is longer than that it will be repeatedly scrolled through but this is not ideal Enter a Number For example What is your weight in kilograms with the answer 53 displayed below and a range up to 120 Th...

Page 15: ...th the displayed time to an accuracy of 1 minute in 24 hours Dragging off the beginning or the end of the 24 hours results in the time wrapping round The Diary automatically starts with the current ti...

Page 16: ...r question type but may be invaluable if you really need to capture any possible answer to a single question The Diary will present the question along with a compressed alphabet To select a letter pla...

Page 17: ...in list The questions can be placed directly where they are wanted in the sequence or re ordered later by dragging them up or down the list To remove a question simply drag it back onto the available...

Page 18: ...at a chosen epoch interval of between 1 and 60 seconds The resulting data can be used to monitor sleep or daytime activity profiles and analysed using the CamNtech MotionWare software package The Moti...

Page 19: ...gging questions to and from the available list The questions will always be asked one after the other from the top to the bottom They can be re ordered by dragging them up or down the list However it...

Page 20: ...its right including the answers Yes and No from that question Both of these answers have arrows leading from them to the next question in the main list This means that giving either answer will lead...

Page 21: ...is present here You can always see the exact sequence by selecting a question to reveal the answers Bigger example to present a nested set of options You may wish to allow the user to select from a la...

Page 22: ...tion will be shown With questions entered for the top level and each of the categories above the questionnaire design window looks like this As can be seen there are no arrows within the list because...

Page 23: ...if these were always shown We now need to ensure that the user will jump to the correct following question after their category question Otherwise they will simply step down the list and be asked all...

Page 24: ...an choose between 22 different options based on a logical set of categories rather than having to scroll through a long single list Obviously the better choice will depend on your application but the...

Page 25: ...es will be available or prompted for at what times once the Diary is set up All the available schedules in the current question database are listed Additional schedules can be created or edited using...

Page 26: ...when they are wearing it If this option is enabled then a function is created at the right hand end of the system information menu to artificially begin a beeping questionnaire When you activate this...

Page 27: ...to explore or change options and will never actually activate anything so you can operate it freely without fear of changing anything Once you are happy with the option or answer displayed select it b...

Page 28: ...e your volunteers to use this mode sparingly but it is a better alternative to leaving the Diary behind somewhere where it may be forgotten when going to a meeting or similar 6 6 Not Waterproof Anybod...

Page 29: ...e To download data connect the Diary to the PC and click on Download Results The data will be downloaded to the current results database and a popup window will confirm when the download is finished T...

Page 30: ...milar to the image below This is a table of all the answers the Diary recorded The contents of the table can be changed using the filtering functions described below and the data can then be exported...

Page 31: ...ile or optionally in an Actiwatch compatible format for analysis with your existing sleep software The latter format will not save some details of the file data particularly only marking questionnaire...

Page 32: ...y epoch motion logging Subjective sleep information collected at lights out and getting up times An extra mid afternoon questionnaire to assess sleepiness You can omit the motion logging if you do not...

Page 33: ...s controlling the motion logging of the PRO Diary device and in this example is set to record Actiwatch compatible counts on a 15 second epoch This means that a single number will be recorded every 15...

Page 34: ...w Questionnaire This will create an empty new questionnaire as shown below First change the questionnaire name to Morning as in the red circle This is not just the name shown when editing but also the...

Page 35: ...you to see how well the question and answers fit on the screen of the PRO Diary You can move your mouse across the selection bar below the display of the Diary to show different answers If the previe...

Page 36: ...n click on Add new entry The questionnaire and Every day options should already be set by default and you should set the other options Firstly choose On request which will not set an alarm for the use...

Page 37: ...ep at any point today in the question textbox near the top of the window Make sure Multiple Choice is selected Click the third mark down to the left of the list of answers to open three boxes for answ...

Page 38: ...shing with the user doing a particular activity at a precise time Alternatively you can schedule it for a fixed time using the option above The user can in either case choose to delay the prompt by a...

Page 39: ...also added the afternoon entry as suggested then the Diary will beep at you to begin that questionnaire When wearing the Diary you can check the time at any point simply by holding your finger over th...

Page 40: ...est using a spare device already set up with a single questionnaire on request and selecting the Enable Demo Beeps option during setup You can then show them How to turn on the device by holding their...

Page 41: ...ll take more or less of the wearer s time than this Will too many answers fill up the memory No the answers to questions do not take up a significant part of the memory Short epoch motion data will ta...

Page 42: ...the document below is provided and can be found from the windows Start Menu once the Diary software is installed Templates for Cue Cards Depending on your users you may consider printing out and lamin...

Page 43: ...ater exposure to water 12 4 Disposal Waste Electrical Electronic Equipment WEEE The EU requires under the Waste Electrical and Electronic Equipment Directive 2002 96 EC that manufacturers and or distr...

Page 44: ...ate Description Initiator 1 1 14 1 1 15 04 12 13 Added Australian Sponsor Details HS 1 1 15 1 1 15a 10 12 13 Updated indications for use to align with FDA submission HS 1 1 15a 1 1 15b 03 03 14 Update...

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