1
Indications for Use
Indications for Use
The Nonin
®
Model 7500FO Pulse Oximeter is a portable, tabletop device indicated for use in
simultaneously measuring, displaying, and recording functional oxygen saturation of arterial
hemoglobin (SpO
2
) and pulse rate of adult, pediatric and infant patients in an Magnetic
Resonance (MR) environment while operating on battery power alone. Testing was performed in
MR conditional environments at 1.5T and 3T. It is intended for spot checking and/or continuous
monitoring of patients who are well or poorly perfused.
Warnings
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.
The battery charger cannot be used in the MR environment.
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.
Inspect the sensor application site at least every 4 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.
Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU).
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.
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.
Do not use this device in or around water or any other liquid, with or without AC power.
As with all medical equipment, carefully route patient cables and connections to reduce the possibility of entanglement,
strangulation, or injury to the patient.
Use this device only with power adapters supplied by Nonin Medical.
This device turns off after approximately 30 minutes when in low battery mode.
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 battery pack must be installed at all times while the device is operating—even when operating on AC power. Do
NOT use the device without batteries.
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.
To comply with relevant product safety standards, ensure that all alarm volumes are set appropriately and are audible in
all situations. Do not cover or otherwise obstruct any speaker openings.