Nonin Onyx II 9560 Instructions For Use Manual

Instructions for Use—English
Onyx
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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 SpO
• 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.
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,
arterial catheter or infusion line(s) (IVs)
• excessive light, such as sunlight or
direct home lighting
• excessive motion
• moisture in the 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 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
+1 (763) 553-9968 (outside US and Canada)
+46 650 401500 (Europe)
(800) 356-8874 (US and Canada)
II Model 9560 Finger Pulse Oximeter
®
Fax: +1 (763) 553-7807
+46 650 401514 (Europe)
E-mail: info@nonin.com
infointl@nonin.se (Europe)
www.nonin.com
measurement.
2
• improperly applied device
• finger is outside recommended size
range
• poor pulse quality
• venous pulsations
• anemia or low hemoglobin
concentrations
MPS, Medical Product Service GmbH
EC REP
Borngasse 20
D-35619 Braunfels, Germany
Nonin and Onyx are registered trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052
) and pulse rate of
2
measurement. Verify that nothing is
2
• cardiogreen and other intravascular
dyes
• carboxyhemoglobin
• methemoglobin
• dysfunctional hemoglobin
• artificial nails or fingernail polish
© 2012 Nonin Medical, Inc.
6742-001-04