Product Manual

1
Indications for Use
Indications for Use
The Nonin WristOx
2
®
, Model 3150
Pulse Oximeter is a small, wrist-worn device indicated for
use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin
(%SpO
2
) and pulse rate. It is intended for spot-checking and/or data collection and recording of
adult and pediatric patients, during both no motion and motion conditions, and for patients who
are well or poorly perfused. The intended use environments are hospitals, medical facilities,
ambulatory, subacute, and sleep study environments, and mobile units.
Contraindications
Do not use this device in a Magnetic Resonance (MR) environment or in the presence of flammable anesthetics
or gases.
This device is not defibrillation proof per IEC 60601-1.
Warnings
This device is intended only as an adjunct device in patient assessment. It must be used in conjunction with
other methods of assessing clinical signs and symptoms.
Check the pulse oximeter sensor application site every 6-8 hours to determine the positioning of the sensor
and the circulation and skin sensitivity of the patient. Patient sensitivity varies depending on medical status or
skin condition.
Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
Carefully route patient cables and connections to reduce the possibility of patient entanglement, strangulation, or
injury to the patient.
To avoid patient injury, use only Nonin-branded PureLight
®
pulse oximeter sensors. These sensors are
manufactured to meet the accuracy specifications for Nonin pulse oximeters. Using other manufacturers’
sensors can result in improper pulse oximeter performance.
To prevent improper performance and/or patient injury, verify compatibility of the monitor, sensor(s), and
accessories before use.
No modifications to this device are allowed as it may affect device performance.
The USB cable must be unplugged from the device before replacing batteries.
Before changing the batteries, make sure the device is off and the sensor is not applied to a digit.
This device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is
necessary, the device should be observed carefully to verify normal operation.
The use of accessories, sensors, and cables other than those listed in this manual may result in increased
electromagnetic emission and/or decreased immunity of this device.
Do not use the device when alarms are required.
Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace
the sensor.