Nonin 9590 Instructions For Use page 4

Indications for Use/Intended Use/Intended Purpose
®
The Nonin Onyx Vantage 9590 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying
functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for
spot-checking of adult and pediatric patients on digits (fingers, thumb, toes) that are between 0.3 – 1.0 inch (0.8 – 2.5 cm) thick. The device's
intended use environments include hospitals, clinics, long-term care facilities, skilled nursing facilities, emergency medical services, and
home healthcare services.
CAUTION: Regulatory authorities outside the U.S. recognize the use of this device in motion conditions.
Warnings
• Do not use the device in an MR environment, in an explosive atmosphere, or on neonatal patients.
• This device is not defibrillation proof per IEC 60601-1.
• 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.
• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
• 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.
• The device must be able to measure the pulse properly to obtain an accurate SpO2 measurement. Verify that nothing is hindering the
pulse measurement before relying on the SpO2 measurement.
• Operation of this device below the minimum amplitude of 0.3% modulation may cause inaccurate results.
• General operation of the device may be affected by the use of an electrosurgical unit (ESU).
• 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.
• Keep the oximeter away from young children. Small items such as the battery door, battery, and lanyard are choking hazards.
• Certain activities may pose a risk of injury, including strangulation, if lanyard should become wrapped around your neck.
• Before changing batteries, make sure the device is off and 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.
Cautions
• This device has no audible alarms and is intended only for spot-checking.
• This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may
degrade pulse oximeter performance or affect the accuracy of the measurement include the following:
• Do not apply the pulse oximeter on the
same arm as a blood pressure cuff, arteri-
al catheter or infusion line(s) (IVs)
• Excessive motion
• Excessive light, such as sunlight or direct
home lighting
• Moisture in the device
• Improperly applied device
• The device may not work when circulation is reduced. Warm or rub the finger, or re-position the device.
• This device's display will go blank after 30 seconds of no readings or poor readings.
• In some circumstances, the device may interpret motion as good pulse quality. Minimize patient motion as much as possible.
• Clean the device before applying it to a patient.
• Do not sterilize, autoclave, or immerse this device in liquid. Do not pour or spray any liquids onto the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning agent containing ammonium chloride.
• This device is a precision electronic instrument and must be repaired by Nonin Technical Service. Field repair of the device is not possible.
Do not attempt to open the case or repair the electronics. Opening the case may damage the device and void the warranty.
• A flexible circuit connects the two halves. Do not twist or pull the flexible circuit or overextend the device's spring. Do not hang the lanyard
from the device's flexible circuit.
• A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor.
• This equipment complies with IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or systems. This
standard is designed to provide reasonable protection against harmful interference in a typical medical installation. However, because
of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in healthcare and other environments,
it is possible that high levels of such interference due to close proximity or strength of a source might disrupt the performance of this device.
Medical electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into service according
to the EMC information specified in this manual.
• Batteries may leak or explode if used or disposed of improperly. Remove batteries if the device will be stored for more than 30 days.
Do not use different types of batteries at the same time. Do not mix fully charged and partially charged batteries at the same time.
These actions may cause the batteries to leak.
• Follow local, state, and national governing ordinances and recycling instructions regarding disposal or recycling of the device and
device components, including batteries.
• In compliance with the European Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, do not dispose of this
product as unsorted municipal waste. This device contains WEEE materials; please contact your distributor regarding take-back or
recycling of the device. If you are unsure how to reach your distributor, please call Nonin for your distributor's contact information.
• When using the device in the home, avoid exposing the device to lint and dust.
Adverse Event Statement
Users and/or patients should report adverse events involving their Nonin device to Nonin Medical, Inc. and the competent authority of the
EU Member State in which the user and/or patient is established, if applicable.
P/N 114847-000-02 11/2022
©2022 Nonin Medical, Inc. All trademarks are the property of Nonin Medical, Inc. unless otherwise noted.
• Finger is outside recommended size range
• Poor pulse quality
• Venous pulsations
• Anemia or low hemoglobin concentrations
• Cardiogreen and other intravascular dyes
• Carboxyhemoglobin
13700 1st Avenue North, Plymouth, MN 55441-5443 USA
• Methemoglobin
• Dysfunctional hemoglobin
• Artificial nails or fingernail polish
• Residue (e.g., dried blood, dirt, grease,
oil) in the light path
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