• 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
• residue (e.g., dried blood, dirt, grease, oil)
in the light path
Instructions for Use—English
Onyx® Vantage 9590 Finger Pulse Oximeter
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
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 SpO
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.
• Before changing batteries, make sure the device is off and is not applied to a digit.
!
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.
2
) and pulse rate of patients who are well or poorly
2
measurement. Verify that nothing is hindering the
2
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
+1 (763) 553-9968 (outside US and Canada)
+
31 (0)13 - 79 99 040
(800) 356-8874 (US and Canada)
• 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 or isopropyl alcohol.
• 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.
• 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.
• When using the device in the home, avoid exposing the device to lint and dust.
Authorized Representative in the European
Community
QTY
Quantity
01230123
CE Marking indicating conformance to
EC Directive No. 93/42/EEC concerning
medical devices.
Manufacturer
Country of manufacture
Type BF Applied Part (patient isolation from
electrical shock)
Date of manufacture
Not for continuous monitoring
(no alarm for SpO
2
)
IP32
Protected against vertically falling water drops
when enclosure is tilted up to 15 degrees and
ingress of solid foreign objects greater than or
equal to 2.5 mm (0.1 in.) diameter per IEC 60529.
Battery orientation
Indicates separate collection for electrical
and electronic equipment (WEEE).
Storage/shipping temperature range
UL Mark for Canada and the United States
with respect to electric shock, fire, and
mechanical hazards only in accordance
with:
• ANSI/AAMI ES60601-1:2005/(R)2012
and CAN/CSA-C22.2 No. 60601-1:14
• ISO 80601-2-61:2011
Non-ionizing electromagnetic radiation.
Equipment includes RF transmitters; interference
may occur in the vicinity of equipment marked
with this symbol.
RoHS compliant (China)
Federal law (USA) restricts this device to sale by
or on the order of a licensed practitioner.
A
B
C
REF
EC
REP
QTY
US
Installing Batteries
Two 1.5 volt AAA-size batteries power the 9590 for about 6,000 spot checks or 36 hours of operation. Nonin recommends
using alkaline batteries (included with each new device). 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.
WARNING: Before changing batteries, make sure the device is off and is not applied to a digit.
NOTE: Rechargeable batteries may be used; however, they require more frequent replacement.
1. Hold the 9590 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 re-secure the
battery tray (figure C). Do not force it into place; it fits only when properly positioned.
5. Insert your finger into the device to verify operation. See the Activating the Onyx Vantage 9590 and Verifying Operation
section for more information.
2
Page 3
Activating the Onyx Vantage 9590 and Verifying Operation
!
Pulse Quality
Indicator
%SpO
2
The device contains numeric Light-Emitting Diodes (LEDs) that display oxygen saturation and pulse rate. A tricolor LED
display (pulse quality indicator, shown at left) provides a visual indication of the pulse signal quality, while blinking at the
corresponding pulse rate. This display changes colors to alert you to 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.
Activate the 9590 by inserting the patient’s finger into the device. The device detects the inserted finger and automatically
illuminates the displays. Correct positioning of the device on the finger is critical for accurate measurements.
NOTE: While on the finger, do not press the device against any surface and do not squeeze or hold it together. The internal
spring provides the correct pressure; additional pressure may cause inaccurate readings.
1. Insert the patient’s finger, nail side up, into the 9590 until the fingertip touches the built-in stop guide.
2. Make sure the finger is lying flat (not on its side) and is centered within the device. For best results, keep the device at
the patient’s heart or chest level.
3. If the device does not turn on, remove the finger and wait a few seconds before reinserting it.
When a finger is inserted, the device performs a brief startup sequence. Verify that all LEDs illuminate during the startup
sequence. If any LED is not lit, do not use the 9590; contact Nonin Technical Service for repair or replacement.
After the startup sequence, the device begins sensing the pulse (indicated by the blinking pulse quality indicator). Allow the
device to stabilize and observe about 4 seconds of continuous green-colored pulse quality before relying on the displayed
values. Continually verify operation. It is common for the displayed values to fluctuate slightly over a period of several
seconds. If the pulse quality indicator blinks yellow or red, try another finger.
A minus sign (-) appears in the left-most digit of the %SpO
The last measured SpO
and pulse rate values display for 10 seconds while the device automatically turns off. The device
2
will automatically shut off (to conserve battery life) approximately 10 seconds after the finger is removed, or after a 2-minute
period of inadequate pulse signals.
If the 9590 does not turn on or if it shuts off unexpectedly:
• Verify batteries are correctly inserted. Note: If batteries are installed backwards, the unit will not function.
• The batteries are depleted. Replace batteries.
If the problem persists, remove the batteries and contact Nonin Technical Service.
The Oxitest
Plus7
by Datrend Systems, Inc. can be used to verify operation of the pulse oximeter.
2
display when the device senses the finger has been removed.
Using the Lanyard
WARNING: Certain activities may pose a risk of injury, including strangulation, if lanyard should become
wrapped around your neck.
CAUTION: 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 lanyard is provided for convenience. The device will function with or without the lanyard.
If lanyard use is desired, thread the lanyard as shown below.
The advanced digital circuitry within the device requires no calibration or periodic maintenance other than battery
replacement. The device’s expected service life is 5 years. Field repair of the 9590 circuitry is not possible. Do not attempt
to open the case or repair the electronics. Opening the case will damage the device and void the warranty. Do not open the
9590 more than 90°, and do not twist or pull on the device when cleaning.
Cleaning the Onyx Vantage 9590
• 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. To clean, wipe the 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 surfaces are completely dry.
Equipment Response Time
If the signal from the sensor is inadequate, the last measured SpO2 and pulse rate values
freeze for 10 seconds and are then replaced with dashes.
Example: SpO
SpO
decreases 0.75% per second; pulse rate = 75 BPM
2
The response of the 4-beat average is 1.5 seconds.
Exponential Averaging
2
Testing Summary
SpO2 accuracy and low perfusion testing was conducted by Nonin Medical, Inc. as described below.
SpO2 Accuracy Testing
At an independent research laboratory, SpO2 accuracy testing is conducted during induced hypoxia studies on healthy, male
and female, non-smoking, light-to-dark-skinned subjects that are aged 18 years and older. The measured arterial hemoglobin
saturation value (SpO
samples with a laboratory co-oximeter. The accuracy of the device is in comparison to the co-oximeter samples measured
over the SpO
ISO 80601-2-61 and ISO 9919, Standard Specification for Pulse Oximeters for Accuracy.
range of 70–100%. Accuracy data is calculated using the root-mean-squared (A
2
Low Perfusion Testing
This test uses an SpO2 Simulator to provide a simulated pulse rate, with adjustable amplitude settings of various SpO2 levels.
The device must maintain accuracy in accordance with ISO 80601-2-61 and ISO 9919 for pulse rate and SpO
obtainable pulse amplitude (0.3% modulation).
Performance in Motion
Motion artifact simulation introduced by a pulse oximeter tester determines whether the oximeter meets the criteria of
ISO 80601-2-61 and ISO 9919 for pulse rate during simulated movement, tremor, and spike motions.
Contact regulatory@nonin.com for more information regarding motion testing.
Principles of Operation
Pulse oximetry is a non-invasive method that passes red and infrared light through perfused tissue and detects the fluctuating
signals caused by arterial pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse
oximeter determines functional oxygen saturation of arterial hemoglobin (SpO
ratio of absorbed red and infrared light as volume fluctuates with each pulse.
) of the device is compared to arterial hemoglobin oxygen (SaO2) value, determined from blood
2
value) for all subjects, per
rms
at the lowest
2
) from this color difference by measuring the
2
4
Page 5
Specifications
Accuracy Summary by Decade – Finger and ThumbAccuracy Summary by Decade – Toe
DecadeOxygen Saturation (A
rms
)DecadeOxygen Saturation (A
rms
)
70 – 80%±270 – 80%±2
80 – 90%±280 – 90%±3
90 – 100%±290 – 100%±3
70 – 100%±270 – 100%±3
This graph shows plots of the error (SpO2 – SaO2)
by SaO
2
using the 9590 with a linear regression fit
and upper 95% and lower 95% limits of agreement.
Each sample data point is identified by subject
from a clinical study in non-motion conditions.
This graph shows plots of the error (SpO2 – SaO2)
by SaO
2
using the 9590 with a linear regression fit
and upper 95% and lower 95% limits of agreement.
Each sample data point is identified by subject from
a clinical study using toes in non-motion conditions.
Oxygen Saturation Display Range:0% to 100% SpO
Pulse Rate Display Range:18 to 321 beats per minute (BPM)
Declared Accuracy:
The tables below show A
values measured using the Onyx Vantage 9590 in a clinical study in non-motion conditions.
rms
NOTE: If your national regulatory authority recognizes accuracy in motion, please contact regulatory@nonin.com for accuracy data.
2
Low Perfusion Accuracy (A
SpO
2
Pulse Rate Declared Accuracy Range (A
Low Perfusion Pulse Rate Declared Accuracy Range (A
*)70 to 100% ±2 digits
rms
*):20 to 250 BPM ±3 digits
rms
*):40 to 240 BPM ±3 digits
rms
Measurement Wavelengths and Output Power**:
Red:660 nanometers @ 0.8 mW maximum average
Infrared:910 nanometers @ 1.2 mW maximum average
Temperature:
Operating:23 °F to 104 °F / -5 °C to 40 °C
Storage/Transportation:-40 °F to 158 °F / -40 °C to 70 °C
Time (from storage) for monitor to be ready for its intended use: 3 minutes to warm from -40 °C to -5 °C
5 minutes to cool from 70 °C to 40 °C
Humidity:
Operating:10% to 90% non-condensing
Storage/Transportation:10% to 95% non-condensing
*± 1 A
represents approximately 68% of measurements at zero bias.
rms
**This information is especially useful for clinicians performing photodynamic therapy.
5
Page 6
Altitude:
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441-5443 USA
(800) 356-8874 (USA and Canada)
+1 (763) 553-9968 (outside USA and Canada)
Fax +1 (763) 553-7807
E-mail: technicalservice@nonin.com
Nonin Medical B.V.
Prins Hendriklaan 26
1075 BD Amsterdam, Netherlands
+31 (0)13 - 79 99 040 (Europe)
Fax: +31 (0)13 - 79 99 042
E-mail: technicalserviceintl@nonin.com
Operating:Up to 13,123 feet / 4,000 meters
Hyperbaric Pressure:Up to 4 atmospheres
Battery Life:
Operating:Approximately 6,000 spot checks or 36 hours of continuous operation
using new alkaline batteries.
Storage:12 months
Classifications per ANSI/AAMI ES60601-1 / CAN/CSA-C22.2 No. 60601-1:
Degree of Protection: Type BF-Applied Part
Enclosure Degree of Ingress Protection:IP32
Mode of Operation:Continuous
This product complies with ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing.
This device is not made with natural rubber latex.
Warranty
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of 4 years from the date of
purchase, each Onyx Vantage 9590 exclusive of the batteries, spring, lanyard, and lanyard lock.
Nonin shall repair or replace any Onyx Vantage 9590 found to be defective in accordance with this warranty, free of
charge, for which Nonin has been notified by the purchaser by serial number that there is a defect, provided notification
occurs within the applicable warranty period. This warranty shall be the sole and exclusive remedy by the purchaser
hereunder for any Onyx Vantage 9590 delivered to the purchaser which is found to be defective in any manner whether
such remedies be in contract, tort or by law.
This warranty excludes cost of delivery to and from Nonin. All repaired units shall be received by the purchaser at
Nonin’s place of business. Nonin reserves the right to charge a fee for a warranty repair request on any Onyx Vantage
9590 found to be within specifications.
Onyx Vantage 9590 is a precision electronic instrument and must be repaired by trained Nonin personnel only. Any
sign or evidence of opening the Onyx Vantage 9590, field service by non-Nonin personnel, tampering, or any kind of
misuse of the Onyx Vantage 9590, shall void the warranty. All non-warranty work shall be done at Nonin’s standard
rates and charges in effect at the time of delivery to Nonin.
nonin.com
6
Page 7
Manufacturer’s Declaration
Refer to the following tables for specific information regarding this device’s compliance to IEC 60601-1-2.
This device is intended for use in the electromagnetic environment specified below.
The customer and/or user of this device should ensure that it is used in such an environment.
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker
Emissions
IEC 61000-3-3
Group 1This device uses RF energy only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
Class BThis device is suitable for use in all establishments, including domestic and those directly
connected to the public low-voltage power supply network that supplies buildings used for
N/A
domestic purposes.
N/A
Table 2: Electromagnetic Immunity
Immunity Test
IEC 60601
Test Level
This device is intended for use in the electromagnetic environment specified below.
The customer and/or user of this device should ensure that it is used in such an environment.
Electrostatic Discharge
(ESD)
±8 kV contact
±15 kV air
IEC 61000-4-2
Electrical Fast Transient/
Burst
±2 kV for power supply lines
±1 kV for input/output lines
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions, and voltage
variations on power supply
input lines
IEC 61000-4-11
Power Frequency (50/60 Hz)
±1 kV differential mode
±2 kV common mode
±5% U
(>95% dip in UT) for 0.5 cycle
T
±40% U
±70% U
<5% U
(60% dip in UT) for 5 cycles
T
(30% dip in UT) for 25 cycles
T
(>95% dip in UT) for 5 sec.
T
30 A/m30 A/mPower frequency magnetic fields should be at
Magnetic Field
IEC 61000-4-8
NOTE: UT is the AC mains voltage before application of the test level.
Compliance
Level
±8 kV contact
±15 kV air
Electromagnetic Environment—Guidance
Floors should be wood, concrete, or ceramic tile.
If floors are covered with synthetic material,
relative humidity should be at least 30%.
N/AMains power quality should be that of a typical
commercial or hospital environment.
N/AMains power quality should be that of a typical
commercial or hospital environment.
N/AMains power quality should be that of a typical
commercial or hospital environment.
levels characteristic of a typical location in a
typical commercial or hospital environment.
7
Page 8
Table 3: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
d1.17 P=
d1.17 P=
80 MHz to 800 MHz
d2.33 P=
800 MHz to 2.7 GHz
d1.17 P=
d1.17 P=
d2.33 P=
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment—Guidance
This device is intended for use in the electromagnetic environment specified below.
The customer and/or user of this device should ensure that it is used in such an environment.
Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the
recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended Separation Distance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Radiated RF per
ISO 9919 clause 36
and ISO 80601-2-61
clause 202.6.2.3
3 V
rms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.7 GHz
20 V/m
80 MHz to 2.7 GHz
N/A
3 V/m
20 V/m
where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey
each frequency range.
a
, should be less than the compliance level in
b
Interference may occur in the vicinity of equipment marked with the following
symbol:
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the
applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
NOTES:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects, and people.
The following table details the recommended separation distances between portable and mobile RF communications equipment and this
device.
Table 4: Recommended Separation Distances
This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Users of this device
can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication
equipment (transmitters) and the device as recommended below, according to maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter
Rated Maximum Output
Power of Transmitter
150 kHz to 80 MHz80 MHz to 800 MHz
800 MHz to 2.7 GHz
W
0.010.120.120.23
0.10.370.370.74
11.21.22.3
103.73.77.4
100121223
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTES:
• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects, and people.
8
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