1
Indications for Use
Indications for Use
The Nonin Model 3150, WristOx
2
™
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 of adult and pediatric patients. It is intended for spot-checking and/or
data collection and recording of patients during both no motion and motion conditions, and for
patients who are well or poorly perfused. The intended use environments are sleep and
pulmonary rehab labs, surgical recovery, critical care, emergency room, long-term care, home
use, 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 60601-1:1988/A2:1995 clause 17h.
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.
Carefully route patient cables and connections to reduce the possibility of patient entanglement or strangulation.
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.
This device is a precision electronic instrument and must be repaired by qualified technical professionals. Field
repair of this device is not possible. Except to replace batteries, do not attempt to open the case or repair the
electronics. Opening the case may damage the device and void the warranty.
The USB cable must be unplugged from the device before replacing batteries.
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.
This equipment complies with International IEC 60601-1-2:2007 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.
To Next Page
Loading...
Need help?
General
