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CamNtech PRO-Diary Instruction Manual

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The PRO-Diary User Guide
FOR PRO-DIARY, MOTION AND 'V' MODELS
Document Reference:
Version:
Date of current version:
Author:
The PRO-Diary is a Class I Medical Device (EU)
30119
1.5.7
07/02/2019
Tom Evans
1

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Summary of Contents for CamNtech PRO-Diary

  • Page 1 The PRO-Diary User Guide FOR PRO-DIARY, MOTION AND ‘V’ MODELS Document Reference: 30119 Version: 1.5.7 Date of current version: 07/02/2019 Author: Tom Evans The PRO-Diary is a Class I Medical Device (EU)
  • 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.

  • 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

    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 Purpose ..........................7 Contraindications ..........................7 Required Skills, Training & Knowledge of Intended Users..............7 General Description of Operation ......................
  • Page 5 Random Ordering Example ........................26 Setting up a Diary ........................... 27 User Name ............................27 Schedule ............................27 Question Size ............................ 27 Menu Customisation .......................... 27 Enable Keylock ..........................28 Enable Demo Beeps.......................... 28 Using the Diary ............................29 Waking up the Diary .......................... 29 Using Menus and Answering Questions ....................

  • Page 6: Introduction To The Pro-Diary System

    The PRO-Diary system consists of a wrist-worn electronic patient diary and associated PC software which can record the user’s answers to questions during daily living in a very flexible and easy to use way. The PRO-Diary incorporates a tri-axial accelerometer to allow objective actigraphy data to be collected while the device is worn.

  • Page 7: Intended Purpose

    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.

  • Page 8: Installing The Pro-Diary Software

    2 Installing the PRO-Diary Software 2.1 System Requirements The PRO-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 PRO-Diary software: ...

  • Page 9: Running The Software For The First Time

    EDIT QUESTIONNAIRES Create or edit questions, questionnaires and schedules. See Section 4 SET-UP A DIARY Apply the questionnaire to the PRO-Diary with various use options. See Section 5 DOWNLOAD RESULTS Read the stored answers and activity data from the PRO-Diary.

  • Page 10: Check For Software Updates

    2.7 Check for Software Updates...

  • Page 11: Charging The Pro-Diary Battery

    3 Charging the PRO-Diary Battery 3.1 Charging the Diary from the PC 3.2 Charging the Diary using the Mains Power Supply...

  • Page 12: Charging Several Diaries From A Usb Hub

    3.3 Charging Several Diaries from a USB Hub 7-Port USB hub for charging. Order code 05-312...

  • Page 13: Creating And Editing Questionnaires

    4 Creating and Editing Questionnaires 4.1 Basic Concepts...

  • Page 14: Questions

    4.2 Questions         Multiple Choice...

  • Page 15: Visual Analogue

    Visual Analogue Enter a Number...

  • Page 16: Enter A Time

    Enter a Time Just a Message...

  • Page 17: List

    List Free Text...

  • Page 18: Likert Scale

    Likert Scale 4.3 Questionnaires 4.4 Schedules...

  • Page 19: Day Designation

    Day Designation      Time/Type of Entry Motion Logging 4.5 Locked and Unlocked Items...

  • Page 20: Creating A New Question Database

    4.6 Creating a New Question Database 4.7 Diary Menu Customisation...

  • Page 21: Conditional Questionnaire Sequences

    4.8 Conditional Questionnaire Sequences Quick Summary           Simple example (to omit some questions depending on a previous answer)

  • Page 23: Bigger Example (To Present A Nested Set Of Options)

    Bigger example (to present a nested set of options)          ...
  • Page 24            ...
  • Page 25     ...

  • Page 26: Random Ordering Example

    Random Ordering Example...

  • Page 27: Setting Up A Diary

    5 Setting up a Diary 5.1 User Name 5.2 Schedule 5.3 Question Size 5.4 Menu Customisation...

  • Page 28: Enable Keylock

    5.5 Enable Keylock 5.6 Enable Demo Beeps...

  • Page 29: Using The Diary

    6 Using the Diary 6.1 Waking up the Diary 6.2 Using Menus and Answering Questions 6.3 Answering a Scheduled Questionnaire 6.4 Requesting a Questionnaire...

  • Page 30: Silent Mode

    6.6 Not Waterproof 6.7 Wearing & Strap options The PRO-Diary is designed to be worn on the wrist with replaceable fabric straps or washable plastic straps available from CamNtech. It uses standard sprung watch pins for the attachment so you can obtain alternative straps from any watch supplier.

  • Page 31: Downloading Results

    7 Downloading Results...

  • Page 32: Viewing Results

    8 Viewing Results 8.1 Filtering by Questionnaire...

  • Page 33: Transposing The Results Table

    8.2 Transposing the Results Table 8.3 Filtering by Scheduled/Requested 8.4 Exporting Motion Logging Data 8.5 Other Exports/Data Analysis...

  • Page 34: Tutorial

    9 Tutorial    9.1 Create a Schedule...

  • Page 36: Waking Up

    9.2 Waking Up...

  • Page 39: Going To Bed

    9.3 Going to Bed                ...

  • Page 40: Afternoon Tiredness

    9.4 Afternoon Tiredness 9.5 Using the Schedule...

  • Page 41: Downloading Results

        9.6 Downloading Results...

  • Page 42: Demonstrating A Timed Questionnaire

    9.7 Demonstrating a Timed Questionnaire     ...

  • Page 43: Frequently Asked Questions

    10 Frequently Asked Questions...

  • Page 44: Additional Documents

    11 Additional Documents...

  • Page 45: Safety And Handling Information

    12 Safety and Handling Information 12.1 De-contamination     12.2 Battery   12.3 Water Ingress  12.4 Disposal    ...
  • Page 46 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 1.2.1 1.5.7 07/02/19...

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