Sleep Diary User Guide 1.5.7a 31/12/2019
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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 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 Use
The PRO-Diary 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 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 processed 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.
1.6 Inspection Before Use
The PRO-Diary (including strap) shall be inspected for signs of
damage or wear before each use. Do not use the device if the
inspection reveals any damage.
