Corsano CardioWatch 287-2, Инструкция по эксплуатации

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As of 2022-11-17
Ι Revision status: 12
32
12 CLINICAL PERFORMANCE
Definition Unit Range Acquisition
Time Update
interval Accuracy *
Heart Rate* Number of
beats of the
heart per
minute beats/minute
(bpm) 30-220 5-10 sec 1 sec HR is ±4 bpm
MAD, ±5%
MARD (at rest)
RR Interval Elapsed time
between two
consecutive
heart beats msec 300-2000
ms 5-10 sec 1 sec RR Interval
±50 ms MAD,
±5% MARD (at
rest)
Heart Rate
Variability Beat to beat
(RR interval)
variations msec 0-200 ms 5-10 sec 1 sec HRV ±10 ms
MAD, ±5%
MARD (at rest)
Respiration
Rate Number of
breaths
(inhalation -
exhalation
cycles) per
minute breaths/minute
(brpm) 5-45 brpm 20-30 sec 1 sec Respiration
Rate ±1 bprm
MAD, ±5%
MARD (at rest)
Sleep Stages Detection of
specific sleep
stages & sleep
HR awake, light
sleep, deep
sleep, REM sleep stage upon end of
the entire
sleep event
1 min Sleep Stage
±10 % MAD
Sleep Score Sleep
performance
and sleep
consistency
with equal
weight % 0-100% 10 sec 1 sec Sleep Score
±5 % MAD
SpO2* Functional
oxygen
saturation % saturation 70-100% 1 min 1 sec ±4% RMSE
(excl. motion
and low
perfusion)
Body
Temperature Temperature of
the body at the
measurement
site Degree
Celsius 35-45°C 30 min 1 min +/- 0.3°C
*NOTES:
MAD=Mean absolute difference, MARD=Mean absolute relative difference, RMSE=Root Mean
Square Error
Because the CardioWatch287-2 measurements are statistically distributed, only about two
‐
thirds of
the measurements can be expected to fall within Arms of the value measured by a co-oximeter.
SpO2 is calculated on a 30 second period and updated every second.
Heart rate and SpO2 measurements cannot be considered as current data because of the
synchronization delay. The synchronization usually takes less than 1 minute to the APP but may take
more than 10 minutes to appear in the Cloud.
Heart rate and SpO2 alarms may be delayed and are not intended for high acuity conditions like ICUs
or severe pathologies.
Heart rate and SpO2 are not normalized. They are measured with quality factor. When the values are
potentially incorrect, they are not displayed. In this case, gaps may appear in the plots.
Heart rate and SpO2 was clinically validated on adults with informed consent. Functional testers
cannot be used to assess accuracy. Modified Bland Altmann plots can be provided to healthcare