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Nonin 8500M Manual

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Indications for Use
Indications for Use
Nonin
®
Model 8500 Handheld 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 in hospitals, ambulatory, home and EMS environments. Model 8500 is intended for
continuous monitoring and/or spot-checking of patients when attended by a healthcare professional.
Warnings
Do not use in an explosive atmosphere or in the presence of flammable anesthetics or gasses.
Do not use this device in an MR environment.
This device is not defibrillation proof per IEC 60601-1.
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.
Inspect the sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity. Patient
sensitivity to the sensor may vary due to medical status or skin condition.
Oximeter readings of this device may be affected by the use of an electrosurgical unit (ESU).
To avoid patient injury, 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 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.
As with all medical equipment, carefully route patient cabling to reduce the possibility of entanglement, strangulation, or
injury to the patient.
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 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.
The device turns off after approximately 10 minutes when at critically low battery capacity.
Before changing the batteries, make sure the device is off and the sensor is not applied to a digit.
Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the ME system, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
… 7 …


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