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Sleep Diary User Guide 1.5.7a 31/12/2019

Page 1

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)

Содержание Sleep Diary

Страница 1: ...Guide 1 5 7a 31 12 2019 Page 1 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 Me...

Страница 2: ...ll 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 U...

Страница 3: ...at 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 co...

Страница 4: ...oftware Updates 11 3 Charging 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 4 P...

Страница 5: ...Sleep Diary User Guide 1 5 7a 31 12 2019 Page 5 10 1 Decontamination 34 10 2 Battery 34 10 3 Water Ingress 34 10 4 Disposal at End of Life 34...

Страница 6: ...e 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...

Страница 7: ...ed 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 D...

Страница 8: ...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...

Страница 9: ...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 sta...

Страница 10: ...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 nu...

Страница 11: ...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...

Страница 12: ...Sleep Diary User Guide 1 5 7a 31 12 2019 Page 12 3 Charging the PRO Diary Battery 3 1 Charging the Diary from the PC 3 2 Charging the Diary using the Mains Power Supply...

Страница 13: ...Sleep Diary User Guide 1 5 7a 31 12 2019 Page 13 3 3 Charging Multiple Diaries using a USB Hub 7 Port USB hub for charging Order code 05 312...

Страница 14: ...d 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...

Страница 15: ...me 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 U...

Страница 16: ...puts 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 re...

Страница 17: ...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...

Страница 18: ...Sleep Diary User Guide 1 5 7a 31 12 2019 Page 18 The newly downloaded recording will be automatically saved to your chosen Results database and the recordings list will show the new recording...

Страница 19: ...ding 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 da...

Страница 20: ...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 questi...

Страница 21: ...d in the subsequent analysis The form will switch to the following Click the OK button to confirm the options and continue loading the recording for analysis The Sessions Check window will not show ag...

Страница 22: ...3 Deleting Recordings Click on a recording to select it or drag the mouse cursor to select multiple recordings in the recordings list and then click the Delete button The selected recordings will be...

Страница 23: ...as the start of the week Results for each element are provided as a Mean Standard Deviation and Range lowest highest The application also highlights discrepancies between the subjective data from the...

Страница 24: ...the day for alertness 6 1 Changing Views There are two views in the analysis window Sleep and Alertness You can switch between the two by clicking on the corresponding menu item in the Views section o...

Страница 25: ...by clicking the Included in Report menu item in either analysis view 6 3 Exporting Results Data Exports are provided for the sleep analysis results and for the internal data used to produce the resul...

Страница 26: ...sults Table lets you to view the raw unanalysed questionnaire and question answer data and also provides functions for exporting raw the Diary data and motion activity data To open the Results Table c...

Страница 27: ...n such as a spreadsheet application You can export the raw motion activity data by clicking the Motion Logging Results button You can open the exported Mtn file in an external application such as CamN...

Страница 28: ...ase An example of this is when managing several users each of who have several recordings A group can be created for each user and their corresponding recordings can be assigned to their group The gro...

Страница 29: ...on enter a group name in the textbox and click the OK button The new group will be added the groups list Recordings can now be assigned to the group by dragging a single recording or selecting and dra...

Страница 30: ...Sleep Diary User Guide 1 5 7a 31 12 2019 Page 30 The contents of a group can be viewed by clicking on a group in the groups list to select it and then clicking the Open button...

Страница 31: ...usual by clicking on a recording to select it and then clicking the Open button Recordings can be removed from a group by clicking on a recording to select it and then clicking the Delete button Note...

Страница 32: ...a questionnaire which will 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 e...

Страница 33: ...l the document below is provided and can be found from the windows Start Menu once the Diary software is installed Sleep Diary Quick Guide This provides a single page guide for using the Sleep Diary Y...

Страница 34: ...Sleep Diary User Guide 1 5 7a 31 12 2019 Page 34 10 Safety and Handling Information 10 1 Decontamination 10 2 Battery 10 3 Water Ingress 10 4 Disposal at End of Life...

Страница 35: ...Sleep Diary User Guide 1 5 7a 31 12 2019 Page 35...

Страница 36: ...tions to match latest version of software DW 1 2 3 1 5 7 07 02 19 Updates to regulatory information C0462 re write of software installation section updated cleaning advice added reference to vibrating...

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