Directions for Use
Onyx
®
II Model 9550 Finger Pulse Oximeter
Indications for Use
The NONIN Onyx
®
II Model 9550 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in
measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO
2
) and pulse rate. It is intended for
spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 – 2.5 cm)
thick. The index finger is the recommended site.
Precautions for Use
Contraindications
• Do not use the Onyx II in an MRI environment, in an explosive atmosphere, or on infant or neonatal patients.
Warnings
• The Onyx II is intended only as an adjunct in patient assessment. It must be used in conjunction with other methods
of assessing clinical signs and symptoms.
• General operation of the Onyx II may be affected by the use of an electrosurgical unit (ESU).
• The use of accessories other than those specified in these instructions may result in increased emission and/or
decreased immunity of this device.
• The Onyx II 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.
Cautions
• Federal law (USA) restricts this device to sale by or on the order of a physician.
• The Onyx II is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin.
Significant levels of dysfunctional hemoglobin may affect measurement accuracy.
• This equipment complies with International Standard EN 60601-1-2:2001 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.
• Portable and mobile RF communications equipment can affect medical electrical equipment.
• In some circumstances, the Onyx II may interpret motion as good pulse quality. Minimize patient motion as much as
possible.
• The presence of a defibrillator may interfere with the performance of this device.
• Fluctuating or very bright light, moisture, blood pressure cuffs, infusion lines, venous pulsations, insufficient pulse
signals, anemia, arterial catheters, nail polish, and/or artificial nails may degrade the device’s performance.
• The Onyx II has no audible alarms and is intended only for spot-checking.
• Cardiogreen and other intravascular dyes may affect the accuracy of the SpO
2
measurement.
• A flexible circuit connects the Onyx II’s two halves. Do not twist or pull the flexible circuit or overextend the device’s
spring.
• Batteries may leak or explode if used or disposed of improperly.
• 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 governing ordinances and recycling instructions regarding disposal or recycling of the device and device
components, including batteries.
• Do not immerse the Onyx II in liquid or use caustic or abrasive cleaning agents on the Onyx II.
• The Onyx II is a precision electronic instrument and must be repaired by trained NONIN personnel only.
Symbols
Symbol Definition of Symbol
ATTENTION: See Instructions for Use
CE Marking indicating conformance to EC Directive No. 93 42/EEC
concerning medical devices
Type BF Applied Part (patient isolation from electrical shock)
Not for Continuous Monitoring (no alarm for SpO
2
)
SN
Serial Number
Battery Orientation
UL Mark for Canada and the United States with respect to electric shock, fire, and
mechanical hazards only in accordance with UL 60601-1 and CAN/CSA C22.2 No.
601.1.
Indicates separate collection for electrical and electronic equipment (WEEE).
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11
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