Heart and Respiration Rate Monitoring System powered by EarlySense
Centrella® Smart+ Bed with Heart and Respiration Rate Monitoring System powered by EarlySense Instructions for Use 87
(193587 REV 10)
INTRODUCTION
The HR and RR Monitoring System powered by EarlySense is designed to provide a Contact-Free
Continuous Monitoring Solution (CFCM) of heart and respiration rate with the use of the HR/RR
Monitoring sensor. The touchscreen shows numerical heart and respiration rates as well as graphical
data of trends of these parameters. The system sounds an alarm to notify the caregiver when the HR or
RR averaged over time, passes above or below the user defined limits or thresholds.
The sensor is placed between the mattress and the bed at the head end. The data provided by the
system is intended to aid in the evaluation process of a patient’s clinical status and should be
interpreted by a Healthcare Practitioner only.
The system begins to monitor the patient’s HR and RR within two to four minutes after the patient is
quietly lying still. The measured data is continuously saved and can be viewed on the touchscreen. To
NOTES:
• The HR/RR Monitoring sensor must be replaced after three years of continuous use to make
sure the system operates correctly. A notification will show on the GCI when it is time to
replace the sensor.
• The HR and RR Monitoring System powered by EarlySense has not been studied on any
specific patient group, nor has it been studied as a diagnostic tool for any specific disease or
medical condition. It is meant as an adjunctive tool only for measuring respiration and heart
rate.
• The HR/RR Monitoring sensor is rated for continuous operation.
• It has been determined that the HR and RR Monitoring System by EarlySense has no
performance, the loss of that would result in unacceptable risk.
• The HR/RR Monitoring sensor is rated IPX4, splash proof.
• If the number is gray, the sensor can not read the HR or RR to measure. The last
measured result will show on the screen in gray.
• When the patient is out of the bed “--” will show for the measurement.
• The system can detect a heart rate that is greater than 1.8 times of the respiration rate.
• The total system accuracy including undetected signals is 90% for respiration rate and for
heart rate.
• A Bed Exit Alert will have priority over a heart rate or respiration rate alarm. You must address
the Bed Exit Alert before the heart rate or respiration rate alarm will show on the touchscreen.
• The HR and RR Monitoring System powered by EarlySense® can interface with existing nurse
call system found in the facility, though the actual connection to the nurse call system
requires the support of your facility-authorized maintenance persons.
• Heart and respiration rate values are most likely to show when the patient is centered (left to
right) and the angle of the bed’s head section is as low as clinically appropriate.
• There must be AC power to the bed for the HR/RR Monitoring System powered by EarlySense
to operate.
• For Preventive Maintenance for the HR/RR Monitoring System powered by EarlySense, see
“Preventive Maintenance” on page 130.
• For Environmental Conditions for Use for the HR/RR Monitoring System powered by
EarlySense, see “Environmental Conditions for Use” on page 134.
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