Sleep Diary User Guide
32Pages

Sleep Diary User Guide 30181 1.2.2 27/01/2017 David Walker Document Reference: Version: Date of current version: Author: The PRO-Diary is a Class I Medical Device (EU) Page 1 Sleep Diary - User Guide v1.2.3

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 Australian Sponsor: Please note that the sponsor should be contacted ONLY to report adverse events - all sales and support issues...

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 9. 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 (RX only) in the USA Device and Packaging Symbols and Markings: Potential hazard - refer to the warnings in the instructions for use (i.e. this user guide). General Warning...

Sleep Diary - User Guide v1.2.3

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...

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...

2 Installing the Sleep Diary Software 2.1 System Requirements The Sleep 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 Vista, 7, 8 or 10 operating systems. One free USB port A CD-ROM or DVD drive for software installation In general, a faster processor will provide superior performance. Software Installation Menu Place the CD-ROM into the drive; Windows will offer to run the installation program and you should select...

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. New Recording Setup a PRO-Diary ready to be used for data collection Download Recording Download the data from a previously set up PRO-Diary Previous Results View and analyse downloaded recordings Options Menu Access the application settings Sleep Diary – User Guide v1.2.3

3 Charging the PRO-Diary Battery The PRO-Diary contains a lithium polymer rechargeable battery. The life of the battery is very dependent on usage of the unit – more frequent and longer interactions will be more demanding. However it should be at least 14 days in normal Sleep Diary use. Before the Diary can be used, the user must ensure that it is fully charged. You may charge it directly from the PC, from a mains power supply or from a separate USB hub. It will typically take around 3-4 hours for the PRO-Diary to be fully charged. Charging the Diary from the PC Connect the Diary to a free...

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: 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. Sleep Diary

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. 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. Sleep Diary – User Guide v1.2.3

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...