GE Portrait Hub01, User Manual

Page: 30 / 198

Safety and intended use
WARNING
PATIENT INJURY. To avoid patient injury, always check the
compatibility of the SpO
2
measurement components prior
to use. Incompatible components can result in degraded
performance, device malfunction, and patient injury.
WARNING
PATIENT SAFETY. A pulse oximeter should not be used as
an apnea monitor. A pulse oximeter should be considered
an early warning device. As a trend toward patient
deoxygenation is indicated, blood samples should be analyzed
by a laboratory CO-oximeter to completely understand the
patient’s condition.
Cautions
Alarm cautions
CAUTION
MISSED ALARMS. Use care when setting parameter alarm
limits to the maximum permitted limits as this may
compromise the alarm system and lead to missed alarms.
CAUTION
MISSED EVENTS. Exercise care when changing the alarm
priority of the SpO
2
low alarm to be lower than Medium
as this is not compliant with ISO 80601-1-61:2017 clause
208.6.1.2.101 and may lead to missed events.
System cautions
CAUTION
EQUIPMENT DAMAGE, PATIENT INJURY. Always store the
Hub and sensor batteries in the charger while not in use.
Equipment that is not properly placed in the charger may fall
and harm the patient or result in damage to the equipment
itself.
CAUTION
EQUIPMENT DAMAGE, PATIENT INJURY. To avoid the risk of
injury, always check that the Hub, Wearable SpO
2
and RR
Parameters, and accessories are safely attached. Equipment
that is not properly attached may fall and harm the patient or
result in damage to the equipment itself.
Operation cautions
CAUTION
ALLERGIC REACTION. Periodically check the patient to make
sure that they have not developed any allergic reaction to
the system components. If any unusual reaction develops,
discontinue the measurement and remove the system
component(s).
CAUTION
PATIENT DISCOMFORT. To avoid a stressful environment and
patient discomfort caused by audible alarms, check that the
Hub is not in close proximity to the patient's ear and change
its location if needed.
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Portrait ™ Mobile Monitoring Solution
5815148-01