1
Indications for Use
Indications for Use
Nonin
®
Models 8500 and 8500M Handheld Pulse Oximeters are 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. Models 8500 and 8500M are intended for continuous monitoring and/or spot-
checking of patients when attended by a healthcare professional.
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.
Inspect the sensor application site at least every 6 to 8 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).
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, 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.