Indications For Use; Warnings - Nonin CO-Pilot H500 Operator's Manual

Indications for Use

Indications for Use
The Nonin Medical CO-Pilot™ Wireless Handheld Multi-Parameter System
(Model H500), is intended for noninvasive measuring of functional oxygen
saturation of arterial hemoglobin (%SpO
saturation (%COHb), methemoglobin saturation (%MetHb), and cerebral or
somatic hemoglobin oxygen saturation (%rSO2). This device is not meant for
the sole use of clinical decision making; it must be used in conjunction with
additional methods of assessing clinical signs and symptoms.
• For %SpO2 and pulse rate, the CO-Pilot System is intended for spot-
checking and/or measuring during clinician assessment 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 CO-Pilot System is intended for spot-checking and/or
measuring during clinician assessment of adult, pediatric, infant, and
neonate patients in professional healthcare facilities, mobile, and EMS
settings.
• For %COHb and %MetHb, the CO-Pilot System is intended for spot-
checking, multiple spot-checks to observe change, and/or measuring
during clinician assessment of adult and pediatric patients in professional
healthcare facilities, mobile, and EMS settings.
Refer to the applicable sensor Instructions for Use (IFU) for sensor indications
for use and accuracy claims.

Warnings

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.
This device is only defibrillation proof when used with Nonin-specified cables and
accessories. To avoid patient injury, only use Nonin-specified cables and accessories (see
Accessories).
Use only Nonin-branded signal processors, sensors, 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.
), pulse rate, carboxyhemoglobin
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