Nonin Onyx II User manual

© 2016 Nonin Medical, Inc.
7750-101-06
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
nonin.com
[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)
Instructions for Use
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.
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.
• Cardiogreen and other intravascular dyes may affect the accuracy of the SpO2measurement.
• Clean the device before applying it to a new 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 or sensor.
• 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.
Symbols
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.
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
Symbol Definition Symbol Definition
Consult Instructions for Use
EC
REP
Authorized Representative in
the European Community
Follow Instructions for Use
Federal law (USA) restricts this
device to sale by or on the order
of a licensed practitioner.
!
Caution!
IP33
Protected against spraying
water and against access to
hazardous parts with a tool, per
IEC 60529.
Type BF Applied Part (patient
isolation from electrical shock)
Not for Continuous Monitoring
(no alarm for SpO2)RoHS Compliant (China)
SN Serial Number Manufacturer
Battery Orientation
US
Country of manufacture
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. 601.1.
Date of manufacture
REF
REF
Catalogue number
QTYQTY
Quantity
Non-ionizing electromagnetic
radiation. Equipment includes
RF transmitters. Interference
may occur in the vicinity of
equipment marked with this
symbol.
Storage/shipping temperature
range
Indicates separate collection for
electrical and electronic
equipment (WEEE).
NOTE: Rechargeable batteries may be used; however, they require more frequent replacement.
1. Hold the 9550 as shown in figure A. To release the 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 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 Customer Support 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 %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
7 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 new 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 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 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.
BC
A
II
Pulse
Quality
Indicator
!
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 Delay Delay
Display Update Delay 1.5 seconds

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 [email protected]
Testing Summary
SpO
2
accuracy 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.
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 A
rms
values measured using the Onyx II 9550 in a clinical study in non-motion conditions.
SpO2Low Perfusion Accuracy 70 to 100% ±2 digits
Pulse Rate Declared Accuracy Range (Arms*): 20 to 250 BPM ±3 digits
Low Perfusion Pulse Rate Declared Accuracy
Range (A
rms
*): 40 to 240 ±3 digits
Measurement Wavelengths and Output Power**:
Red:
Infrared:
660 nanometers @ 0.8 mW maximum average
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 40,000 feet / 12,192 meters
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.
Warranty
NONIN MEDICAL, INCORPORATED, (Nonin) warrants to the purchaser, for a period of 7 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 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 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 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, field service by non-Nonin personnel, tampering, or any kind of misuse of the
Onyx, 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
This graph shows plots of the error (SpO2– SaO2) by SaO2using 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
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]
Manufacturer’s Declaration
Refer to the following tables for specific information regarding this device’s compliance to IEC 60601-1-2.
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.
For transmitters rated at a maximum output power not listed above, the recommended separation distance
din 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.
Table 1: Electromagnetic Emissions
Emissions Test Compliance 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.
RF Emissions
CISPR 11 Group 1
This 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.
RF Emissions
CISPR 11 Class B
This 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 domestic
purposes.
Harmonic Emissions
IEC 61000-3-2 N/A
Voltage Fluctuations/Flicker
Emissions
IEC 61000-3-3
N/A
Table 2: Electromagnetic Immunity
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.
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, relative humidity should
be at least 30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines N/A
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode N/A
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interruptions, and
voltage variations on
power supply input
lines
IEC 61000-4-11
±5% UT(>95% dip in UT) for
0.5 cycle
±40% UT(60% dip in UT) for
5 cycles
±70% UT(30% dip in UT) for
25 cycles
<5% UT(>95% dip in UT) for
5 sec.
N/A
Mains power quality should be that of a
typical commercial or hospital
environment.
Power Frequency (50/
60 Hz) Magnetic Field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
NOTE: UTis the AC mains voltage before application of the test level.
Table 3: Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
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
3 Vrms
150 kHz to 80 MHz N/A
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz 3 V/m 80 MHz to 800 MHz
800 MHz to 2.5 GHz
Radiated RF per
ISO 9919 clause 36
and ISO 80601-2-61
clause 202.6.2.3
20 V/m
80 MHz to 2.5 GHz 20 V/m
where Pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a
, should
be less than the compliance level in each frequency
range.
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.
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
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
d1.17P=
d1.17P=
d2.33P=
d1.17P=
d1.17P=
d2.33P=