Directions for Use
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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
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).
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• The use of accessories other than those specified in these instructions may result in increased emission and/or
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decreased immunity of this device.
• The Onyx II must be able to measure the pulse properly to obtain an accurate SpO
is hindering the pulse measurement before relying on the SpO
measurement.
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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
• 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
0123
CE Marking indicating conformance to EC Directive No. 93 42/EEC
concerning medical devices
Type BF Applied Part (patient isolation from electrical shock)
) and pulse rate. It is intended for
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measurement. Verify that nothing
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measurement.
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)
2
SN
Not for Continuous Monitoring (no alarm for SpO
Serial Number
Battery Orientation
I
S
F
I
E
A
D
L
C
U
C
L
U
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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Perfusion Indicator
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Activating the Onyx II and Verifying Operation
The Onyx II contains numeric LEDs that display blood oxygen saturation and pulse rate. A tricolor LED display provides
a visual indication of the pulse signal quality, while blinking at the corresponding pulse rate. This display changes colors
to alert you to changes in pulse quality that may affect the readings: green indicates a good pulse signal, yellow indicates
a marginal pulse signal, and red indicates an inadequate pulse signal.
Activate the Onyx II by inserting the patient’s index finger into the unit. The Onyx II detects the inserted finger and
automatically illuminates the displays. Correct positioning of the light emitter and photodetector on the finger is critical
for accurate measurements. All emitted light must pass through the fingertip.
While on the finger, do not press the Onyx II against any surface and do not squeeze or hold it together. The internal
spring provides the correct pressure; additional pressure may cause inaccurate readings.
1. Insert the patient’s finger, nail side up, into the Onyx II until the fingertip touches the built-in stop guide.
2. Make sure the finger is lying flat (not on its side) and is centered within the device. For best results, keep the Onyx II
at the patient’s heart or chest level.
3. If the device does not turn on, remove the finger and wait a few seconds before reinserting it.
When a finger is inserted, the Onyx II performs a brief startup sequence. Verify that all LEDs illuminate during the startup
sequence. If any LED is not lit, do not use the Onyx II; contact NONIN Customer Support for repair or replacement. After
the startup sequence, the Onyx II begins sensing the pulse (indicated by the blinking pulse quality display). Allow the
device to stabilize, observing about 4 seconds of continuous green-colored pulse quality before relying on the displayed
values. It is common for the displayed values to fluctuate slightly over a period of several seconds. If the pulse quality
display blinks yellow or red, try another finger.
A minus sign (-) appears in the left-most digit of the %SpO
removed. The last measured SpO
device will automatically shut off (to conserve battery life) approximately 10 seconds after the finger is removed, or after
a 2-minute period of inadequate pulse signals.
Installing Batteries
Two 1.5 volt AAA-size batteries power the Onyx II for about 2,500 spot checks or 21 hours of operation. NONIN
recommends using alkaline batteries (included with each new Onyx II). When batteries are low, the numeric displays
flash once per second. Replace low batteries as soon as possible, using the instructions below.
Note: Rechargeable batteries may be used; however, they require more frequent replacement.
1. Hold the Onyx II as shown at left, pressing upward and then pulling outward slightly with the thumb to release the
device’s battery tray.
2. Remove the battery tray and the old batteries, disposing of the batteries properly.
3. Insert two new 1.5 volt AAA-size batteries. Follow the polarity markings (+ and -) as illustrated. Proper positioning of
the batteries is essential for operation.
4. Carefully guide the battery tray back onto the Onyx II, pressing downward and pushing inward slightly to re-secure
the battery tray. Do not force it into place; it fits only when properly positioned.
and pulse rate values freeze for 10 seconds, and then the displays go blank. The
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display when the Onyx II senses that the finger has been
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Using the Lanyard and Carrying Case
A lanyard and carrying case are provided for convenience. The Onyx II will function with or without these accessories.
• If lanyard use is desired, thread the lanyard as shown below.
Onyx II Care, Maintenance, and Cleaning
The advanced digital circuitry within the Onyx II requires no calibration or periodic maintenance other than battery
replacement. Field repair of the Onyx II circuitry is not possible. Do not attempt to open the Onyx II case or repair the
electronics. Opening the case will damage the Onyx II and void the warranty. Do not open the Onyx II more than 90°,
and do not twist or pull on the device when cleaning.
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Cleaning the Inner Surfaces of the Onyx II
1. Wipe the surfaces with a soft cloth dampened with a mild detergent or isopropyl alcohol solution. If low-level
disinfection is required, a cloth dampened with 10% bleach / 90% water solution may also be used. Do not use
undiluted bleach or any cleaning solution other than those recommended here, as permanent damage could result.
2. Dry with a soft cloth, or allow to air dry.
3. Ensure that all surfaces are completely dry.
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