Nonin Onyx Vantage 9590 Instructions For Use Manual

Instructions for Use

Onyx Vantage 9590 Finger Pulse Oximeter
®
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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 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).
• 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:
• 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
• 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
+1 (763) 553-9968 (outside US and Canada)
+46 650 401500 (Europe)
800-356-8874 (US and Canada)
• finger is outside recommended size
range
• poor pulse quality
• venous pulsations
• anemia or low hemoglobin
concentrations
Fax: +1 (763) 553-7807 /
EC REP
+46 650 401514 (Europe)
E-mail: info@nonin.com /
infointl@nonin.se (Europe)
Nonin and Onyx are registered trademarks of Nonin Medical, Inc.
U.S. Patents 5,490,523; 5,792,052
www.nonin.com
) and pulse rate of patients, who are
2
measurement. Verify that nothing is
2
measurement.
2
• cardiogreen and other intravascular
dyes
• carboxyhemoglobin
• methemoglobin
• dysfunctional hemoglobin
• artificial nails or fingernail polish
MPS, Medical Product Service GmbH
Borngasse 20
D-35619 Braunfels, Germany
© 2011 Nonin Medical, Inc.
8208-001-02