NONIN 9590 Finger Oximeter Instruction Manual

NONIN 9590 Finger Oximeter

Thank you for trusting Nonin with your patients’ healthcare needs. We sincerely appreciate your business. Please read your Operator’s Manual carefully and direct any further questions to a Nonin Technical Service representative. If you would like to order products or check the status of a current order, please contact Customer Service.

Product Information

The Nonin Model 9590 is a pulse oximeter that allows for the management of patients’ medical conditions by providing fast, accurate, real-time, noninvasive oxygen measurement. It is designed to meet patients’ medical needs and comply with ISO 10993 standards. The device comes with a 4-year warranty and is not made from natural rubber latex.

For more detailed information, you can refer to the user manual and the symbol glossary available on the Nonin website.

Instructions for Use: Translations of the IFU can be found using this QR code.

****https://www.nonin.com/support/9590

Intended Use

Indications for Use/Intended Use/Intended Purpose
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 (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on digits (fingers, thumb, toes) that are 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: Regulatory authorities outside the U.S. recognize the use of this device in motion conditions.

Warnings

• Do not use the device in an MR environment, in an explosive atmosphere, or on 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 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.
• 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)
  • Finger is outside recommended size range
  • Methemoglobin
  • Poor pulse quality
  • Dysfunctional hemoglobin
  • Excessive motion
  • Venous pulsations
  • Artificial nails or fingernail polish
  • Excessive light, such as sunlight or direct home lighting • Anemia or low hemoglobin concentrations
  • Residue (e.g., dried blood, dirt, grease, oil) in the light path
  • Moisture in the device
  • Cardiogreen and other intravascular dyes
  • Improperly applied device
  • Carboxyhemoglobin
• 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.
• 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.
• 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.
• When using the device in the home, avoid exposing the device to lint and dust.

Clinical Benefits

Nonin pulse oximeters allow for the management of patients’ medical conditions by providing fast, accurate, real-time, noninvasive oxygen measurement in order to meet patients’ medical needs.

To use the Nonin Onyx® Vantage 9590 fingertip pulse oximeter, please follow the simple instructions below.

1. Insert two AAA batteries. Follow the polarity markings (+ and -) as illustrated in the figure below.

2. Insert patient’s finger, nail side up, into the 9590 until the fingertip touches the built-in stop guide. Ensure the finger is lying flat and is centered within the device.

3. The device detects the inserted finger and automatically illuminates the display. The display changes colors to alert you of 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
     If the 9590 does not turn on or if it shuts off unexpectedly:

   • Remove the finger and wait a few seconds before reinserting.

   • Verify batteries are correctly inserted.

   • If it still does not turn on, the batteries are depleted and must be replaced.

Specifications

• Additional specifications available in the Operator’s Manual that can be located using the QR Code.
  • Oxygen saturation measured from 0%-100% SpO2
  • Pulse rate measured from 18bpm-321bpm
  • The device must maintain accuracy in accordance with ISO 80601-2-61 and ISO 9919 for pulse rate and SpO2 at the lowest obtainable pulse amplitude (0.3% modulation).
• Measurement Wavelengths and Output Power:
  • Red: 660 nanometers @ 0.8 mW maximum average
  • Infrared: 910 nanometers @ 1.2 mW maximum average

Cleaning the Onxy Vantage 9590

CAUTIONS:

• 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.

1. Wipe surfaces with a soft cloth dampened with mild detergent or a 10% bleach solution (household bleach [5.25% sodium hypochlorite]). Do not use undiluted bleach or any cleaning solution other than those recommended here, as permanent damage could result.
2. Dry with a soft cloth or allow to air dry. Ensure that all solutions are complete dry.

Warranty

The device warranty is 4 years. nonin.com/warranty

Symbol Glossary
nonin.com/symbols

Compliance
This product complies with ISO 10993. Not made from natural rubber latex.

Adverse Event Statement
Users and/or patients should report adverse events involving their Nonin device to Nonin Medical, Inc. and the competent authority of the EU Member State in which the user and/or patient is established, if applicable.

Contact Customer Service or Technical Service

Toll Free: 800.356.8874 (U.S. and Canada only)
Phone: +1 763.553.9968
Email: [email protected]

Nonin Medical Inc.
13700 1st Avenue North
Plymouth, MN 55441-5443, USA

Nonin B.V.
Doctor Paul Janssenweg 150
5026 RH Tilburg, Netherlands

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13700 1st Avenue North, Plymouth, MN 55441-5443 USA nonin.com

References

• Pulse and Regional Oximeters, Capnographs, Sensors | Nonin
• Symbol Guide - Nonin
• Warranty - Nonin
• Onyx Vantage 9590 - Nonin

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