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Indications for Use
Indications for Use
®
The Nonin WristOx
, Model 3150 Pulse Oximeter is a small, wrist-worn device indicated for
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use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin
(%SpO
) and pulse rate. It is intended for spot-checking and/or data collection and recording of
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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.
Warnings
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.
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 4 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
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.
This equipment complies with International IEC 60601-1-2 for electromagnetic compatibility for medical electrical
equipment and/or systems. This standard is designed to provide reasonable protection against harmful
interference in a typical medical installation. However, because of the proliferation of radio-frequency
transmitting equipment and other sources of electrical noise in healthcare and other environments, it is possible
that high levels of such interference due to close proximity or strength of a source might disrupt the performance
of this device. Medical electrical equipment needs special precautions regarding EMC, and all equipment must
be installed and put into service according to the EMC information specified in this manual.
Only use Nonin-branded sensors with a length of 1 meter or less. Accuracy may degrade if sensor cable is over
1 meter in length. Using the sensor cable adapter does not affect accuracy.
®
pulse oximeter sensors. These sensors are
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