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Indications for Use
Indications for Use
The SenSmart H500 System, is intended for noninvasive measuring of
functional oxygen saturation of arterial hemoglobin (%SpO
carboxyhemoglobin saturation (%COHb), methemoglobin saturation
(%MetHb), and cerebral or somatic hemoglobin oxygen saturation (%rSO2).
This device is not meant for sole use in clinical decision making; it must be used
in conjunction with additional methods of assessing clinical signs and
symptoms.
• For %SpO2 and pulse rate, the SenSmart H500 System is intended for
spot-checking and/or continuous monitoring of adult, pediatric, infant, and
neonate patients who are well or poorly perfused, during both motion and
non-motion conditions in professional healthcare facilities, mobile, and
EMS settings.
• For %rSO2, the SenSmart H500 System is intended for spot-checking
and/or continuous monitoring of adult, pediatric, infant, and neonate
patients in professional healthcare facilities, mobile, and EMS settings.
• For %COHb and %MetHb, the SenSmart H500 System is intended for
spot-checking, multiple spot-checks to observe change, and/or continuous
monitoring of adult and pediatric patients in professional healthcare
facilities, mobile, and EMS settings.
Warnings
Display and signal processor cannot be used outside of carrying case.
This device is intended only as an adjunct device in patient assessment. It should not be
used as the sole basis for diagnosis or therapy decisions. It must be used in conjunction
with other methods of assessing clinical signs and symptoms.
Oximetry functions are disabled after critical battery is reached.
Device is not defibrillation proof per IEC 60601-1.
Use only Nonin-branded signal processors, sensors, power supplies and accessories,
otherwise patient injury can result. These sensors are manufactured to meet the accuracy
specifications for this device. Using other manufacturers' sensors can result in improper
oximeter performance.
Inspect the sensor application site in accordance with the sensor instructions for use to
ensure correct sensor alignment and skin integrity. Patient sensitivity to the sensor may
vary due to medical status or skin condition.
Avoid excessive pressure to the sensor application site as this may cause damage to the
skin beneath the sensor.
), pulse rate,
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