Nonin Onyx Vantage 9590 Instruction Manual

EC

REP

Instructions for Use

%SpO

2

!

• do not apply the pulse oximeter on the
same arm as a blood pressure cuff,
arterial catheter or infusion line(s) (IVs)

• excessive light, such as sunlight or
direct home lighting

• moisture in the device

• improperly applied device

• finger is outside recommended size
range

• poor pulse quality

• venous pulsations

• anemia or low hemoglobin
concentrations

• cardiogreen and other intravascular
dyes

• carboxyhemoglobin

• methemoglobin

• dysfunctional hemoglobin

• artificial nails or fingernail polish

0123

Onyx® Vantage 9590 Finger Pulse Oximeter

Indications for Use

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 (%SpO
well or poorly perfused, during both motion and non-motion conditions. It is intended for spot-checking of adult and
pediatric patients on fingers, including the thumb, that are between 0.3 – 1.0 inch (0.8 – 2.5 cm) thick. Alternatively, the
Onyx Vantage 9590 may be placed on a toe of a patient during non-motion conditions. The device’s intended use
environments include hospitals, clinics, long-term care facilities, skilled nursing facilities, emergency medical services, and
home healthcare services.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.

Contraindications

• Do not use the device in an MR environment, in an explosive atmosphere, or on infant or neonatal patients.

• This device is not defibrillation proof per IEC 60601-1 clause 8.5.5.

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.

• 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.

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:

) and pulse rate of patients, who are

2

• 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.

• This device has motion tolerant software that minimizes the likelihood of motion artifact; however, the device may still interpret
motion as good pulse quality.

• 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 or isopropyl alcohol.

• 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.

• Portable and mobile RF communications equipment can affect medical electrical equipment.

• 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.

Nonin Medical, Inc.

13700 1st Avenue North

Plymouth, Minnesota 55441-5443, USA

[phone] (outside US and Canada)
[phone] (Europe)
800-356-8874 (US and Canada)

Fax: [phone] /
[phone] (Europe)

E-mail: [e-mail] /
[e-mail] (Europe)

www.nonin.com

MPS, Medical Product Service GmbH

Nonin and Onyx are registered trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052

Borngasse 20
D-35619 Braunfels, Germany

© 2011 Nonin Medical, Inc.
8208-001-02

Symbols

!

EC

REP

0123

A

B

C

Symbol Description

Caution!

Follow Instructions for Use

Authorized Representative in the European Community

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 SpO2)

SN

IP32

Installing Batteries

Two 1.5 volt AAA-size batteries power the 9590 for about 6,000 spot checks or 36 hours of operation. Nonin recommends
using alkaline batteries (included with each new device). When batteries are low, the numeric displays flash once per
second. Remove batteries if the device will be stored for more than 30 days. 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 9590 as shown in figure A. To release the device’s battery tray, press upward and then pull outward slightly
with the thumb.

2. Remove the old batteries from the battery tray. Dispose of the batteries properly.

3. Insert two new 1.5 volt AAA-size batteries. Follow the polarity markings (+ and -) as illustrated in figure B. Proper

positioning of the batteries is essential for operation.

4. Carefully guide the battery tray back onto the device. Press downward and then push inward slightly to re-secure the
battery tray (figure C). Do not force it into place; it fits only when properly positioned.

5. Insert your finger into the device to verify operation. See the Activating the Onyx Vantage 9590 and Verifying
Operation section for more information.

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).

Protected against vertically falling water drops when enclosure is tilted up to 15 degrees and ingress of
solid foreign objects greater than or equal to 2.5 mm (0.1 in.) diameter per IEC 60529.

RoHS compliant (China)

Latex Free

2

Activating the Onyx Vantage 9590 and Verifying Operation

!

%SpO

2

Pulse Quality

Indicator

The device contains numeric Light-Emitting Diodes (LEDs) that display oxygen saturation and pulse rate. A tricolor LED
display (pulse quality indicator, shown at left) 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.

• Red indicates an inadequate pulse signal.

Activate the 9590 by inserting the patient’s finger into the device. The device detects the inserted finger and automatically
illuminates the displays. Correct positioning of the device on the finger is critical for accurate measurements.

NOTE: While on the finger, do not press the device 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 9590 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 device 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 device performs a brief startup sequence. Verify that all LEDs illuminate during the startup
sequence. If any LED is not lit, do not use the 9590; contact Nonin Customer Support for repair or replacement. After the
startup sequence, the device begins sensing the pulse (indicated by the blinking pulse quality indicator). Allow the device
to stabilize and observe 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 indicator
blinks yellow or red, try another finger.

A minus sign (-) appears in the left-most digit of the %SpO
The last measured SpO

and pulse rate values display for 10 seconds while the device automatically turns off. The device

2

will automatically shut off (to conserve battery life) approximately 10 seconds after the finger is removed, or after a 2­minute period of inadequate pulse signals.

display when the device senses the finger has been removed.

2

Using the Lanyard

WARNING: Certain activities may pose a risk of injury, including strangulation, if lanyard should become
wrapped around your neck.

A lanyard is provided for convenience. The device will function with or without the lanyard.

If lanyard use is desired, thread the lanyard as shown below.

CAUTION: 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.

3