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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) 

 

 

 

 

 

 

Содержание PRO-Diary

Страница 1: ...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...

Страница 2: ...ions of EC Council Directives 93 42 EEC Annex VII An EC declaration of Conformity will be provided upon request US FDA status Manufacturer Australian Sponsor Please note that the sponsor should be con...

Страница 3: ...perational 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 contact with liq...

Страница 4: ...2 7 Check for Software Updates 10 3 Charging the PRO 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 U...

Страница 5: ...ns 30 7 Downloading Results 31 8 Viewing Results 32 8 1 Filtering by Questionnaire 32 8 2 Transposing the Results Table 33 8 3 Filtering by Scheduled Requested 33 8 4 Exporting Motion Logging Data 33...

Страница 6: ...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 PRO Diary system comprises of One or more PRO Dia...

Страница 7: ...ed Skills Training Knowledge 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 ho...

Страница 8: ...NOT been tested with any MAC OS 2 2 Software Registration To access the PRO Diary software download it is necessary to first register the software with CamNtech Please visit www camntech com register...

Страница 9: ...dules 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 See Sec...

Страница 10: ...10 2 7 Check for Software Updates...

Страница 11: ...11 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 12: ...12 3 3 Charging Several Diaries from a USB Hub 7 Port USB hub for charging Order code 05 312...

Страница 13: ...13 4 Creating and Editing Questionnaires 4 1 Basic Concepts...

Страница 14: ...14 4 2 Questions Multiple Choice...

Страница 15: ...15 Visual Analogue Enter a Number...

Страница 16: ...16 Enter a Time Just a Message...

Страница 17: ...17 List Free Text...

Страница 18: ...18 Likert Scale 4 3 Questionnaires 4 4 Schedules...

Страница 19: ...19 Day Designation Time Type of Entry Motion Logging 4 5 Locked and Unlocked Items...

Страница 20: ...20 4 6 Creating a New Question Database 4 7 Diary Menu Customisation...

Страница 21: ...21 4 8 Conditional Questionnaire Sequences Quick Summary Simple example to omit some questions depending on a previous answer...

Страница 22: ...22...

Страница 23: ...23 Bigger example to present a nested set of options...

Страница 24: ...24...

Страница 25: ...25...

Страница 26: ...26 Random Ordering Example...

Страница 27: ...27 5 Setting up a Diary 5 1 User Name 5 2 Schedule 5 3 Question Size 5 4 Menu Customisation...

Страница 28: ...28 5 5 Enable Keylock 5 6 Enable Demo Beeps...

Страница 29: ...29 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...

Страница 30: ...laceable 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 Either CamN...

Страница 31: ...31 7 Downloading Results...

Страница 32: ...32 8 Viewing Results 8 1 Filtering by Questionnaire...

Страница 33: ...33 8 2 Transposing the Results Table 8 3 Filtering by Scheduled Requested 8 4 Exporting Motion Logging Data 8 5 Other Exports Data Analysis...

Страница 34: ...34 9 Tutorial 9 1 Create a Schedule...

Страница 35: ...35...

Страница 36: ...36 9 2 Waking Up...

Страница 37: ...37...

Страница 38: ...38...

Страница 39: ...39 9 3 Going to Bed o o o...

Страница 40: ...40 9 4 Afternoon Tiredness 9 5 Using the Schedule...

Страница 41: ...41 9 6 Downloading Results...

Страница 42: ...42 9 7 Demonstrating a Timed Questionnaire o o o o o o...

Страница 43: ...43 10 Frequently Asked Questions...

Страница 44: ...44 11 Additional Documents...

Страница 45: ...45 12 Safety and Handling Information 12 1 De contamination 12 2 Battery 12 3 Water Ingress 12 4 Disposal...

Страница 46: ...align with FDA submission HS 1 1 15a 1 1 15b 03 03 14 Updated FDA clearance status HS 1 1 15b 1 2 1 10 02 15 Minor updates to match software changes TE 1 2 1 1 5 7 07 02 19 Updates to regulatory info...

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