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Indications for Use
Indications for Use
®
The Nonin
Model 9847 Pulse Oximeter and Carbon Dioxide Detector is indicated for use in measuring
and displaying functional oxygen saturation of arterial hemoglobin (SpO
carbon dioxide (CO
) changes in the airway of intubated patients. These functions may be used
2
separately or simultaneously.
Pulse Oximeter Intended Use
The pulse oximeter is intended to be used for noninvasively monitoring oxygen saturation and pulse rate
for adult, pediatric, and neonatal patients in hospital, ambulatory, and Emergency Medical Services
(EMS) environments. The pulse oximeter may be used for spot checking and/or continuous monitoring
when attended by a healthcare professional.
Carbon Dioxide Detector Intended Use
The CO
detector is a mainstream device intended to be used for semi-quantitative detection of CO
2
levels in intubated patients during patient transport, and for short-term hospital use (e.g., emergency
rooms or crash carts), and where gaseous anesthetic is not present. The CO
initially confirm proper placement of the endotracheal tube and to provide continued confirmation of
correct endotracheal tube placement and patient respiration status. The CO
prolonged CO
monitoring. The CO
2
The CO
detector is not intended for use in patients younger than 3 years old and weighing less than
2
10 kg (22 lb).
Contraindication: Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gasses.
Warnings
Do not use this device in an MR environment.
Do not use the Model 9847 CO
the dead space introduced by the airway adapter tube.
This device is not defibrillation proof per IEC 60601-1.
This device is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods of
assessing clinical signs and symptoms.
Do not use the Model 9847 CO
from the person performing resuscitation will cause inaccurate readings.
The Model 9847 CO
detector cannot distinguish between oropharyngeal tube placement and endotracheal tube
2
placement if the airway is patent. Standard clinical assessment must be used.
Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU).
Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor.
Verify all alarm settings and limits during system startup to ensure that they are set as intended.
A hazard can exist if different presets are used on multiple 9847 monitors in one care area.
detector is not intended for long-term monitoring of end-tidal CO
2
detector for patients younger than 3 years old and weighing less than 10 kg (22 lb) due to
2
detector during mouth-to-tube ventilation. The presence of CO
2
), pulse rate, and approximate
2
detector may be used to
2
detector is not intended for
2
in the exhaled breath
2
2
.
2
1
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