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Indications for Use
Indications for Use
The Nonin
®
Model 2500 Pulse Oximeter is indicated for use in measuring and displaying
functional oxygen saturation of arterial hemoglobin (SpO
2
) and pulse rate for adult, pediatric, and
neonatal patients. The device is intended for continuous monitoring and/or spot-checking of
patients during both motion and no-motion conditions, and for patients who are well or poorly
perfused.
Contraindications
Do not use this device in an MR environment.
Explosion Hazard
: Do not use in an explosive atmosphere or in the presence of flammable anesthetics or
gasses.
This device is not defibrillation proof per IEC 60601-1.
Warnings
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.
Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU).
Inspect the sensor application site at least every 6 to 8 hours to ensure correct sensor alignment and skin
integrity. Patient sensitivity to sensors and/or double-backed adhesive strips may vary due to medical status or
skin condition.
Use only with Nonin-branded PureLight
®
pulse oximeter sensors. These sensors are manufactured to meet the
accuracy specifications for Nonin Pulse Oximeters. Using other manufacturers’ sensors may cause improper
pulse oximeter performance. Using other manufacturers’ sensors can result in improper pulse oximeter
performance.
Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace
the sensor.
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or
strangulation.
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, cables, and power supplies other than those specified in the Parts and
Accessories List may result in increased electromagnetic emission and/or decreased immunity of this device.
This device must be able to measure the pulse properly to obtain an accurate SpO
2
measurement. Verify that
nothing is hindering the pulse measurement before relying on the SpO
2
measurement.
Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
Discontinue use of adhesive tape strips if the patient exhibits an allergic reaction to the adhesive material.
Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the
sensor.