Nonin Onyx II 9550 User manual

5104-001-08
© 2019 Nonin Medical, Inc.
MPS, Medical Product Service GmbH
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
EC
REP
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441, USA
[phone] (outside US and Canada)
+31 (0)13 - 79 99 040 (Europe)
[phone] (US and Canada)
Fax: [phone]
+31 (0)13 - 79 99 042 (Europe)
E-mail: [email protected]
[email protected] (Europe)
nonin.com
Instructions for Use—English
Onyx®II Model 9550 Finger Pulse Oximeter
Indications for Use
The Nonin®Onyx II Model 9550 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 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 SpO2measurement. Verify that nothing is
hindering the pulse measurement before relying on the SpO2measurement.
• 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:
• 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.
II
• 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

2
• 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.
Symbols
Symbol Definition
!
Caution!
Follow Instructions for Use
EC
REP
Authorized Representative in the European Community
CE Marking indicating conformance to EC Directive No. 93/42/EEC concerning medical devices
Type BF Applied Part (patient isolation from electrical shock)
Not for Continuous Monitoring (no alarm for SpO2)
SN Serial Number
Battery Orientation
C
L
A
S
S
I
F
I
E
D
US
CUL
UL Mark for Canada and the United States with respect to electric shock, fire, and mechanical
hazards only in accordance with UL 60601-1 and CAN/CSA-C22.2 No. 60601-1.
Indicates separate collection for electrical and electronic equipment (WEEE).
Non-ionizing electromagnetic radiation. Equipment includes RF transmitters. Interference may occur
in the vicinity of equipment marked with this symbol.
IP33 Protected against spraying water and against access to hazardous parts with a tool, per IEC 60529.
RoHS compliant (China)
Manufacturer
US
Country of manufacture
Date of manufacture
REFREF
Catalogue number
QTY
QTY
Quantity
Storage/shipping temperature range
Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.

3
Installing Batteries
Two 1.5 volt AAA-size batteries power the 9550 for about 10,000 spot checks or 63 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 9550 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 the 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 II 9550 and Verifying Operation
section for more information.
Activating the Onyx II 9550 and Verifying Operation
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 9550 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 9550 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 9550
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 9550; 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.
ABC
II
Pulse Quality
Indicator

4
A minus sign (-) appears in the left-most digit of the %SpO2display when the device senses the finger has been
removed. The last measured SpO2and pulse rate values display for 10 seconds while the device automatically turns
off. The device 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 9550 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 OxitestPlus7 by Datrend Systems, Inc. can be used to verify operation of the pulse oximeter.
Using the Lanyard and Carrying Case
WARNING: Certain activities my 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 and carrying case are provided for convenience. The device will function with or without the lanyard.
If lanyard use is desired, thread the lanyard as shown below.
Onyx II 9550 Care, Maintenance, and Cleaning
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 9550 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 9550 more than 90°, and do not twist or pull on the device when cleaning.
Cleaning the Onyx II 9550
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 into the device.
• Do not use caustic or abrasive cleaning agents, or any cleaning agent containing ammonium chloride.
1. To clean, wipe the surfaces with a soft cloth dampened with 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.
!

5
Equipment Response Time
If the signal from the sensor in inadequate, the last measured SpO2and pulse rate values freeze for 10 seconds and
are then replaced with dashes.
Example: SpO2Exponential Averaging
SpO2decreases 0.75% per second; pulse rate = 75 BPM
The response of the 4-beat average is 1.5 seconds.
Testing Summary
SpO2accuracy and low perfusion testing was conducted by Nonin Medical, Incorporated as described below.
SpO2Accuracy Testing
At an independent research laboratory, SpO2accuracy 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 (SpO2) of the device is compared to arterial hemoglobin oxygen
(SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the device is in
comparison to the co-oximeter samples measured over the SpO2range of 70 – 100%. Accuracy data is calculated
using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61 and ISO 9919, Standard Specification
for Pulse Oximeters for Accuracy.
Low Perfusion Testing
This test uses an SpO2Simulator to provide a simulated pulse rate, with adjustable amplitude settings of various
SpO2levels. The device must maintain accuracy in accordance with ISO 80601-2-61 and ISO 9919 for pulse rate
and SpO2at the lowest obtainable pulse amplitude (0.3% modulation).
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 (SpO2) from this color
difference by measuring the ratio of absorbed red and infrared light as volume fluctuates with each pulse.
SpO2Values Average Latency
Standard/Fast Averages SpO24 beat exponential 2 beats
Pulse Rate Values Response Latency
Standard/Fast Averages Pulse Rate 4 beat exponential 2 beats
Equipment Delays Delay
Display Update Delay 1.5 seconds

6
Specifications
Oxygen Saturation Display Range: 0% to 100% SpO2
Pulse Rate Display Range: 18 to 321 beats per minute (BPM)
Declared Accuracy:
The table below shows Arms values measured using the Onyx II 9550 in a clinical study in non-motion conditions.
SpO2Low Perfusion Accuracy (Arms*): 70 to 100% ±2 digits
Pulse Rate Declared Accuracy Range (Arms*): 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy Range (Arms*): 40 to 240 BPM ±3 digits
Measurement Wavelengths and Output Power**:
Red: 660 nanometers @ 0.8 mW maximum average
Infrared: 910 nanometers @ 1.2 mW maximum average
Temperature:
Operating: -5 °C to 40 °C (23 °F to 104 °F)
Storage/Transportation: -40 °C to 70 °C (-40 °F to 158 °F)
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 95% non-condensing
Storage/Transportation: 10% to 95% non-condensing
Altitude:
Operating: Up to 12,192 meters (40,000 feet)
Hyperbaric Pressure: Up to 4 atmospheres
Battery Life:
Operating: Approximately 10,000 spot checks, or 63 hours of continuous
operation using new alkaline batteries.
Storage: 48 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: IP33
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.
*± 1 Arms represents approximately 68% of measurements at zero bias.
**This information is especially useful for clinicians performing photodynamic therapy.
This graph shows plots of the error (SpO2– SaO2) by SaO2
using the 9550 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.
Accuracy Summary by Decade
Decade Oxygen Saturation (Arms)
70 – 80% ±2
80 – 90% ±2
90 – 100% ±2
70 – 100% ±2

7
Manufacturer’s Declaration
Refer to the following tables for specific information regarding this device’s compliance to IEC 60601-1-2.
Essential Performance
Essential performance of the 9550 is defined as SpO2accuracy and pulse rate accuracy or an indication of abnormal operation.
Accuracies may be affected as a result of exposure to electromagnetic disturbances that are outside of the environments listed in the
Indications For Use. If issues are experienced, move the Nonin system away from the source of electromagnetic disturbances.
Warranty
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of 4 years from the date of purchase, each Onyx II
9550 exclusive of the batteries, spring, carrying case, lanyard, and lanyard lock.
Nonin shall repair or replace any Onyx II 9550 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 II 9550 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 II 9550 found to be within specifications.
Onyx is a precision electronic instrument and must be repaired by trained Nonin personnel only. Any sign or evidence of opening the
Onyx II 9550, field service by non-Nonin personnel, tampering, or any kind of misuse of the Onyx II 9550, 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
Military/Safe-to-Fly Information
Nonin Medical’s Onyx II 9550 has completed aeromedical test and evaluation by the U.S. Department of Army and has received a “Safe-
to-Fly” recommendation from the Department of the Air Force. The Onyx II 9550 carries a NATO Stock Number or National Stock
Number (NSN).
For additional information, contact regulato[email protected].
WARNING: 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.
Table 1: Electromagnetic Emissions
This device is intended for use in the electromagnetic environment specified in the Indications for Use section. The user of this device
should ensure that it is used in such an environment.
Emissions Test Compliance
RF Emissions
CISPR 11 Group 1, Class B
Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441, USA
[phone] (USA and Canada)
[phone] (outside USA and Canada)
Fax: [phone]
E-mail: [email protected]
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: [email protected]

8
Table 2: Electromagnetic Immunity
Immunity Test Compliance
Electrostatic Discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
Power Frequency (50/60 Hz) Magnetic Field
IEC 61000-4-8 30 A/m
Radiated RF
IEC 61000-4-3
80 MHz – 2.7 GHz 10 V/m
380 – 390 MHz 27 V/m
430 – 470 MHz 28 V/m
704 – 787 MHz 9 V/m
800 – 960 MHz 28 V/m
1.7 – 1.99 GHz 28 V/m
2.4 – 2.57 GHz 28 V/m
5.1 – 5.8 GHz 9 V/m
Table 3: Not Applicable
Harmonic Emissions (IEC 61000-3-2), Voltage Flicker Emissions (IEC 61000-3-3), Electrical Fast Transients (IEC 61000-4-4), Surge (IEC
61000-4-5), Voltage dips (IEC 61000-4-11), Conducted Immunity (IEC 61000-4-6)
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.