GE Portrait Hub01, User Manual

Page: 29 / 198

Safety and intended use
WARNING EQUIPMENT DAMAGE, UNEXPECTED PERFORMANCE. Do not
use any automated cleaning or disinfection processes for
the Portrait Mobile Monitoring Solution system components.
Incorrect cleaning may result in damage to the equipment
and unexpected performance, such as loss of monitoring.
WARNING
LEAKAGE CURRENT. To avoid the risk of unacceptable leakage
current that could result in risk to the patient or user, always
clean the sensor-battery interface.
Respiration warnings
WARNING
APNEA EVENTS. The device may not detect all episodes of
inadequate breathing, nor does it distinguish between central,
obstructive, and mixed apnea events. Therefore, do not use it
as an apnea monitor.
WARNING
LOSS OF MONITORING. To avoid the risk of loss of monitoring
due to dry respiration electrode gel, periodically check the
patient and the respiration patch.
WARNING
PATIENT SAFETY. Implantable Minute Ventilation Rate
Responsive Pacemakers may react with the respiration
sensor and cause the pacemaker to execute pacing with the
maximum programmed rate. Before pairing the sensor and
Hub, always check that the patient does not have this type of
pacemaker. Failing to do so may compromise patient safety.
WARNING
UNEXPECTED SYSTEM PERFORMANCE. Movement artifact may
affect the accuracy of the respiration measurement. To avoid
inaccurate readings, instruct the patient about the effect of
movement on the measurement and ensure that the sensor
patch is properly attached to the patient.
SpO
2
warnings
WARNING
INACCURATE READINGS. Make sure that there are no
light-emitting devices close to the SpO
2
sensor because they
might interfere with the measurement and cause inaccurate
readings.
WARNING
PATIENT SAFETY. Pulse rate measurement is based on the
optical detection of a peripheral flow pulse and therefore does
not detect certain arrhythmias. The pulse oximeter should
not be used as a replacement or substitute for ECG-based
arrhythmia analysis. Otherwise, there is a risk of compromised
patient safety.
WARNING
PATIENT DISCOMFORT. Prolonged monitoring can cause
patient discomfort, such as skin reaction, pressure points or
elevated temperature of the SpO
2
sensor. To avoid patient
discomfort, periodically check the patient and change the
sensor location.
5815148-01
Portrait ™ Mobile Monitoring Solution
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