Nonin Onyx II 9560 Instruction Manual

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Instructions for Use—English

• 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

• excessive motion

• 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

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Onyx® II Model 9560 Finger Pulse Oximeter

Indications for Use

The Nonin Onyx II Model 9560 Finger Pulse Oximeter is a small, lightweight, portable, wireless device indicated for
use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO
patients who are well or poorly perfused. 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 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.

Warnings

• Use the Model 9560 within its designated range (approximately 328 feet/100 meters, spherical radius, line of sight when
connected to a class I device, from patient module to the display). Moving outside this range may cause missing, lost, and/
or inaccurate data.

• 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 SpO
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).

• The use of accessories other than those specified in these instructions 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.

• 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 the lanyard should become wrapped around your neck.

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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:

measurement. Verify that nothing is

2

) and pulse rate of

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.

• In some circumstances, the device will 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 into the device.

• Do not use caustic or abrasive cleaning agents, or any cleaning products 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 health
care 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)
[phone] (US and Canada)

Fax: [phone]
[phone] (Europe)

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

www.nonin.com

MPS, Medical Product Service GmbH
Borngasse 20

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

D-35619 Braunfels, Germany

© 2012 Nonin Medical, Inc.
6742-001-04

Declaration of Conformity with FCC and Canadian Ministry of Health Rules for

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Electromagnetic Compatibility

• Nonin Medical, Inc., of 13700 1st Avenue North, Plymouth, Minnesota, 55441, declares under its sole
responsibility that Model 9560, to which this declaration relates, comply with part 15 of the FCC Rules. Operation
is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired operation.

• Ministry of Health (Canada), Safety Code 6: standards include a substantial safety margin designed to ensure
the safety of all persons, regardless of age and health. The exposure standard for wireless mobile phones
employs a unit of measurement known as the Specific Absorption Rate, or SAR. The SAR limit set by the FCC
is 1.6W/kg.

Federal Communications Commission (FCC) Notice

This equipment has been tested and found to comply with the limits for a class B digital device, pursuant to part 15
of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses, and can radiate radio frequency energy. If not installed
and used in accordance with the instructions, it may cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on. The user is encouraged to try to correct the
interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the distance between the equipment and the receiver.

• Connect the equipment to an outlet on a circuit different from the outlet where the receiver is connected.

• Consult the dealer or an experienced radio/TV technician for assistance.

• RF Exposure: For body worn operation, to maintain compliance with FCC RF exposure guidelines, use only
accessories that contain no metallic components and provide a separation distance of 15 mm (0.6 inches) to the
body. Use of other accessories may violate FCC RF exposure guidelines and should be avoided.

• The Model 9560 is designed and manufactured not to exceed the emission limits for exposure to radio frequency
(RF) energy set by the United States FCC. These limits are part of comprehensive guidelines and establish
permitted levels of RF energy for the general population. The guidelines are based on the safety standards
previously set by both U.S. and international standards bodies. This EUT has been shown to be capable of
compliance for localized specific absorption rate (SAR) for uncontrolled environment/general population
exposure limits specified in ANSI/IEEE Std. C95.1-2005 and has been tested in accordance with the
measurement procedures specified in FCC/OET Bulletin 65 Supplement C (2001) and IEEE Std. 1528-2003.

• The FCC requires the user to be notified that any changes or modifications to this device that are not expressly
approved by Nonin Medical, Inc. may void the user’s authority to operate the equipment.

A Guide to Symbols

Symbol Definition of Symbol

Follow Instructions for Use.

Consult Instructions for Use

Caution!

Type BF Applied Part (patient isolation from electrical shock)

UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical
hazards only in accordance with IEC 60601-1, UL 60601-1 and CAN/CSA-C22.2 No. 601.1.

CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices

Radio Equipment Class Identifier

Serial Number

Battery Orientation

Non-ionizing electromagnetic radiation. Equipment includes RF transmitters. Interference may
occur in the vicinity of equipment marked with this symbol.

Indicates separate collection for electrical and electronic equipment (WEEE).

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Symbol Definition of Symbol

R

A

B

C

Remote Alarms; Not for Continuous Monitoring.

Protected against vertically falling water drops when enclosure is tilted up to 15 degrees and

IP32

ingress of solid foreign objects greater than or equal to 2.5 mm (0.1 in.) in diameter per
IEC 60529.

Bluetooth

Indoor use (France only)

Continua Certified™ signifies that this product has been tested and proven to be interoperable
with other products that carry the “Continua Certified” symbol.

RoHS Compliant (China)

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Installing Batteries

pin

BDA

Ver

NOTE: Where applicable, an additional label bearing your country radio communications license information will

appear on the side of your device. This is not a serial number or device identifier.

Two 1.5 volt AAA-size batteries power the Model 9560 for approximately 600 spot checks. Nonin recommends using
alkaline batteries (included with each new Model 9560). 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 Model 9560 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 re­secure the battery tray. Do not force it into place; it fits only when properly positioned.

5. Visually inspect to ensure that the battery cover is properly placed.

6. Insert your finger in the device to verify operation. See the Activating the Onyx II 9560 and Verifying Operation
section for more information.

Personal Identification Number

Bluetooth Device Address

Versi on

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