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1.2  Intended Purpose 

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 addition to the traditional written patient diary in 
conjunction with activity monitoring.

  

NOTE: the

 

device software should not be used directly for diagnostic or 

therapeutic decision making. 

 

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. 

 

1.4  Required 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 hospital 
environment. 
 

1.5  General Description of Operation 

The PRO-Diary Motion provides patient diary functionality by means of PC 
software based questionnaire configuration and upload to the device. The device 
will automatically prompt the subject for input at pre-defined intervals or, 
depending upon configuration, upon user request. The responses to the 
questions are recorded to internal non-volatile memory and the date may then be 
downloaded using the PC software. The resulting data may be exported for 
further analysis in third party software packages. 
 
The PRO-Diary Motion contains a miniature accelerometer to allow 
measurement and recording of physical movement of the wrist which provides a 
close correlation to whole body movement. The data are sampled at 50Hz and 
p

rocessed into ‘epochs’ of user selectable length. These data are stored into an 

internal non-volatile memory and then downloaded for analysis at the end of the 
study period.  Activity data recorded by the PRO-Diary may be analysed off-line 
using the MotionWare Software Package.  
 
 
 
 

 

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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