Related Manuals for CamNtech PRO-Diary Motion
Summary of Contents for CamNtech PRO-Diary Motion
- 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 Device (EU) PRO-Diary User Guide 1.2.1 10/02/15 Page 1...
- Page 2 (European Union) Medical Device Directive 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.
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Page 3: Important Safety Information
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 (R only) in the USA... -
Page 4: Table Of Contents
Contents IMPORTANT SAFETY INFORMATION ......................3 WARNINGS ..............................3 Safety Classification Information: ........................ 3 Device and Packaging Symbols and Markings: ..................3 Contents ................................4 Introduction to the PRO-Diary System ....................6 An Overview of the PRO-Diary System ....................6 Intended Use ............................ - Page 5 Menu Customisation .......................... 25 Enable Keylock ..........................26 Enable Demo Beeps.......................... 26 Using the Diary ............................27 Waking it up ............................27 Using Menus and Answering Questions .................... 27 Answering a Scheduled Questionnaire ....................27 Requesting a Questionnaire ......................27 Silent Mode ............................
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Page 6: Introduction To The Pro-Diary System
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 device is intended to monitor limb or body movements during daily living and sleep. -
Page 7: Intended Use
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. -
Page 8: Installing The Pro-Diary Software
2 Installing the PRO-Diary Software 2.1 System Requirements The PRO-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: ... -
Page 9: Users Upgrading From An Earlier Version Of The Software
Microsoft. Select ‘Continue Anyway’ (Please note that this is NOT a problem and just means that the CamNtech version of the driver software has not been assessed by Microsoft. In fact the actual drivers are Microsoft approved). -
Page 10: Using The Software For The First Time
2.5 Using the software for the first time Double clicking on the PRO-Diary icon on the desktop will start the software. This will display the main menu as shown below. Each option is introduced in a section of this guide. EDIT QUESTIONNAIRES Create or edit questions, questionnaires and schedules. -
Page 11: Charging The Pro-Diary Battery
2. Plug the USB cable from the Diary directly into the USB socket on the mains power supply adaptor. 3. The Diary will be automatically charged. CamNtech can supply a suitable mains power supply if required – please contact your local distributor. 3.3 Charging Several Diaries from a USB Hub A USB extension hub may be more convenient to charge several PRO-Diary devices at once without requiring a PC to be connected. -
Page 12: Creating And Editing Questionnaires
4 Creating and Editing Questionnaires The Diary is set up using a combination of questions, questionnaires, and schedules. It is easiest to familiarise yourself with these by exploring the examples included with the PC software. After clicking on ‘Edit Questionnaires’ in the main menu, you will be presented with the quick view window, as shown in the example below. -
Page 13: Questions
A ‘schedule’ is a list of schedule entries, each with a time and day, that tell the diary to do something at that time. These may prompt the user, or simply make available a user-requested questionnaire during a given period. They may also apply to ‘every Tuesday’... -
Page 14: Visual Analogue
Visual Analogue For example: “How difficult is it to touch your toes?”, with the text “Easy” at the left hand end of the slider bar and “Hard” at the right hand end. The user positions the slider directly wherever they feel is appropriate between the two ends. -
Page 15: Enter A Time
Enter a Time For example: “What time did you wake up this morning?”, with a time of “07:07” displayed. This functions similarly to ‘Enter a number’, except as the user drags the slider the displayed time changes. They can move it until they are happy with the displayed time, to an accuracy of 1 minute in 24 hours. -
Page 16: List
List For example: “What activity are you doing right now?” with a list of 20-30 activity types to select from. The Diary will display the question along with part of the list and a scrollbar to indicate the user can scroll up or down the list by dragging their finger on the slider. -
Page 17: Likert Scale
Likert Scale For example: “How much do you like fruit?” with a scale of five answers. This allows the user to select from a numerical scale, whilst also attaching a small text description to each level. The text is displayed above the selected number scale similarly to a multiple choice question, but with the addition of the highlighted number display below. -
Page 18: Day Designation
“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. -
Page 19: Creating A New Question Database
4.6 Creating a New Question Database When you want to begin work on your own set of questions and schedules, you can create a new database file to contain these. This way it will not be cluttered up by the examples or any questions you have previously created for a different purpose. -
Page 20: Simple Example (To Omit Some Questions Depending On A Previous Answer)
Simple example (to omit some questions depending on a previous answer) In the first example, we show how to make a part of the questionnaire optional, depending on the answer to a question. First, drag all the questions you want into the questionnaire. -
Page 21: Bigger Example (To Present A Nested Set Of Options)
As you can see, there are now changes in the arrows to show the new question sequence. The arrow from the ‘Yes’ answer still leads to the immediately following question, but the arrow from ‘No’ now leads to the new target question. So the user will move to a different next question depending on their answer at this point. - Page 22 Driving Public transport Walking Cycling Other Eating Breakfast Lunch Dinner Other (small meal) Other (large meal) Other Physically active Inactive The category can then be chosen with a single ‘top-level’ question. The answer to this then determines which category question will be shown.
- Page 23 Drag the ‘Work’ answer onto the work activity question Drag the ‘Home/Leisure’ answer onto the home/leisure question Drag the ‘Travelling’ answer onto the travelling question Drag the ‘Eating’ answer onto the eating question Drag the ‘Other’ answer onto the ‘other activity’ question The window should now look as below, showing each answer leading to a different one of the questions below.
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Page 24: Random Ordering Example
Select each of the category questions in turn, and drag each of their ‘- Drag here to redirect all answers –’ to below the bottom of the questionnaire. You should now see: Note that this completed set shows both a set of arrows down the left from the first question, and a set down the right leading from each of the category questions to the common following point below (which happens to be the end of this questionnaire). -
Page 25: Setting Up A Diary
5 Setting up a Diary Selecting the option to ‘Set up a Diary’ from the main menu will result in a window similar to that shown below. This shows the various setup options available. These options will be affected by the currently opened question database –... -
Page 26: Enable Keylock
5.5 Enable Keylock The Diary may be carried in the pocket as an alternative to being wrist worn. In this case you must enable this keylock to prevent accidental data entry. This will require the wearer to smoothly run their finger across the slider before accessing the Diary. -
Page 27: Using The Diary
6 Using the Diary The Diary is designed to be as simple and intuitive to use as possible. This section guides you through basic use in case of any difficulty. We recommend that you demonstrate the use of the Diary in front of each volunteer before a trial, and then ask them to work through your questionnaire on it whilst you are available to answer any questions. -
Page 28: Silent Mode
CamNtech. It uses standard sprung watch pins for the attachment so you can obtain alternative straps from any watch supplier. Either CamNtech or your watch supplier will also be able to assist if you are not confident inserting the spring loaded pins yourself. -
Page 29: Downloading Results
7 Downloading Results After the end of a trial with the Diary, the results can be downloaded to your PC for analysis. For convenience, results are stored in a database file, so that you can keep many downloads together in one file. You can then also create a new file when you want to group together another series of downloads. -
Page 30: Viewing Results
8 Viewing Results When the ‘Open Result View’ option on the main menu is clicked, the software will display a list of all the downloaded data in the currently selected result database. If you want to look in a different result database, use ‘File -> Open Result Database…’... -
Page 31: Transposing The Results Table
However, there are many different methods to proceed with that analysis. If you need more assistance with your data analysis please contact CamNtech to discuss this; we may be able to make some arrangement to assist you. -
Page 32: Tutorial
9 Tutorial The PRO-Diary motion is designed to provide a flexible package combining accurately logged subjective results with epoch-by-epoch actigraphy data. This allows a uniquely integrated approach to data collection for sleep and lifestyle monitoring, but inevitably makes the system slightly more complex to configure. - Page 33 The software will display a blank new schedule. You should then edit the schedule as shown below: The red circle highlights the schedule name – this is fairly self-explanatory and allows you to refer to several schedules within the question database. It must be set to something meaningful before saving the schedule, but is not otherwise important.
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Page 34: Waking Up
9.2 Waking Up Next, we will create a questionnaire for the user to complete after they wake up. This both collects subjective data at the start of the day, and additionally places a mark in the resulting actigraphy data which makes analysis easier (in exactly the same way as the marker button on simpler actigraphy devices). - Page 35 Configure the parts circled in red above: 1. Type in the question “Did you sleep well?” 2. Ensure the “Multiple Choice” question type is selected 3. Select the fourth mark down on the left to enable four answer boxes to the right 4.
- Page 36 Next, we will add the “Morning” questionnaire to the schedule, so that it will be available for the user to select in the morning. Return to the schedule window, or double-click the schedule in the Questionnaire Management window if you had already saved it.
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Page 37: Going To Bed
9.3 Going to Bed Next, we need another questionnaire for the user to complete just before they go to sleep. Again, this both collects subjective data, and additionally places a mark in the resulting actigraphy data. The steps required are as follows. Screenshots will be similar to the “Waking Up”... -
Page 38: Afternoon Tiredness
You should use the “Save” button to save this schedule, and can now close the Questionnaire Management window entirely. Connect a PRO-Diary Motion to the PC, and click on the “Set up a Diary” button to configure it: PRO-Diary User Guide 1.2.1 10/02/15... -
Page 39: Downloading Results
Enter the User name as you wish, and ensure the Sleep monitor schedule you have created is selected. You need not select any of the other options – consult the normal PRO-Diary Guide to Getting Started for more information. Then click on “Set up Diary”;... -
Page 40: Demonstrating A Timed Questionnaire
From this window, you can choose to save the motion data for use in the MotionWare analysis software (as a Motion format file), 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 times to a per-epoch resolution, and having no method of marking data periods “missing”... -
Page 41: Frequently Asked Questions
No. Plug the device into a USB port to recharge for an hour or so, and try to download again. If you still have difficulty recovering data, contact CamNtech before doing anything else with the Diary. We will do our best to recover data even from badly damaged devices. -
Page 42: Additional Documents
11 Additional Documents Subsections of this user manual are provided for quick reference from the PRO- Diary software. In addition, 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 laminating these credit-card sized guides to give out with the Diary. -
Page 43: Safety And Handling Information
CamNtech has registered with an approved producer compliance scheme (PCS) in accordance with the requirements of the WEEE Directive. CamNtech will provide free recycling for all of its WEEE products when returned to CNT. CamNtech WEEE products will be designed with recycling, reuse and waste management as a consideration. - Page 44 Document Revision History Issue Issue Date Description Initiator From 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 PRO-Diary User Guide 1.2.1 10/02/15 Page 44...
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