Nonin Onyx II 9550 Instructions For Use Manual

Instructions for Use—English
Onyx
Indications for Use
The Nonin
measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO
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.
Warnings
• 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.
• Inspect the sensor application site at least every 4 hours to ensure correct sensor alignment and skin integrity. Patient
sensitivity to the sensor may vary due to medical status or skin condition.
• Avoid excessive pressure to the sensor application site as this may cause damage to the skin beneath the sensor.
• 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 lanyard should become wrapped around your neck.
• Before changing batteries, make sure the device is off and is not applied to a digit.
• Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the ME system, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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 may 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 onto the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning agent containing ammonium chloride.
• This device is a precision electronic instrument and must be repaired by Nonin Technical Service. Field repair of the device
is not possible. Do not attempt to open the case or repair the electronics. Opening the case may damage the device and
void the warranty.
• 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 or sensor.
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441, USA
+1 (763) 553-9968 (outside US and Canada)
+31 (0)13 - 79 99 040 (Europe)
(800) 356-8874 (US and Canada)
II Model 9550 Finger Pulse Oximeter
®
®
Onyx II Model 9550 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in
Fax: +1 (763) 553-7807
+31 (0)13 - 79 99 042 (Europe)
E-mail: info@nonin.com
infointl@nonin.com (Europe)
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 patients
2
measurement. Verify that nothing is
2
• cardiogreen and other intravascular
dyes
• carboxyhemoglobin
• methemoglobin
• dysfunctional hemoglobin
• artificial nails or fingernail polish
• residue (e.g., dried blood, dirt, grease,
oil) in the light path
5104-001-08
© 2019 Nonin Medical, Inc.