Indications For Use; Contraindications; Warnings - Nonin Avant 9600 Operator's Manual

Indications for Use

Indications for Use
® ®
The Nonin Avant 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use
in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial
hemoglobin (SpO ) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals,
2
medical facilities, home care, and subacute environments. It may also be used in patient
transport, sleep laboratories, and EMS environments. The Avant 9600 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.
This device is not defibrillation proof per IEC 60601-1.
Do not use this device in an explosive atmosphere.

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 sensors 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.
The device must be able to measure the pulse properly to obtain an accurate SpO
nothing is hindering the pulse measurement before relying on the SpO
Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
General operation of this device may be affected by the use of an electrosurgical unit (ESU).
The use of accessories 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 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.
To avoid patient injury, use only Nonin-branded PureLight
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.
measurement. Verify that
2
measurement.
2
®
pulse oximeter sensors. These sensors are
1