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Testing Summary
SpO
accuracy and low perfusion testing was conducted by Nonin Medical, Incorporated as described below.
2
SpO
Accuracy Testing
2
At an independent research laboratory, SpO
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
oxygen (SaO
) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the
2
device is in comparison to the co-oximeter samples measured over the SpO
data is calculated using the root-mean-squared (A
ISO 9919, Standard Specification for Pulse Oximeters for Accuracy.
Low Perfusion Testing
This test uses an SpO
Simulator to provide a simulated pulse rate, with adjustable amplitude settings of
2
various SpO
levels. The device must maintain accuracy in accordance with ISO 80601-2-61 and ISO 9919
2
for pulse rate and SpO
at the lowest obtainable pulse amplitude (0.3% modulation).
2
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
) from this color difference by measuring the ratio of absorbed red and infrared light as
2
volume fluctuates with each pulse.
Specifications
Oxygen Saturation Display Range:
Pulse Rate Display Range:
Declared Accuracy:
The table below shows A
values measured using the Onyx II 9550 in a clinical study in non-motion conditions.
rms
Accuracy Summary by Decade
Decade
Oxygen Saturation (A
70 – 80%
±2
80 – 90%
±2
90 – 100%
±2
70 – 100%
±2
This graph shows plots of the error (SpO
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.
SpO
Low Perfusion Accuracy
2
Pulse Rate Declared Accuracy Range (A
rms
Low Perfusion Pulse Rate Declared Accuracy
Range (A
*):
rms
Measurement Wavelengths and Output Power**:
Red:
Infrared:
Temperature:
Operating
Storage/Transportation:
Time (from storage) for monitor to be ready for
its intended use:
Humidity:
Operating:
Storage/Transportation:
Altitude:
Operating
Hyperbaric Pressure:
Battery Life:
Operating
Storage:
Classifications per ANSI/AAMI ES60601-1 / CAN/CSA-C22.2 No. 60601-1:
Degree of Protection:
Enclosure Degree of Ingress Protection:
Mode of Operation:
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 A
represents approximately 68% of measurements at zero bias.
rms
**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 Medical, Inc.
13700 1st Avenue North
Plymouth, Minnesota 55441, 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
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 regulatory@nonin.com
accuracy testing is conducted during induced hypoxia studies
2
) of the device is compared to arterial hemoglobin
2
range of 70-100%. Accuracy
2
value) for all subjects, per ISO 80601-2-61 and
rms
0% to 100% SpO
2
18 to 321 beats per minute (BPM)
)
rms
– SaO
) by SaO
2
2
70 to 100% ±2 digits
*):
20 to 250 BPM ±3 digits
40 to 240 ±3 digits
660 nanometers @ 0.8 mW maximum average
910 nanometers @ 1.2 mW maximum average
-5 °C to 40 °C (23 °F to 104 °F)
-40 °C to 70 °C (-40 °F to 158 °F)
3 minutes to warm from -40 °C to -5 °C
5 minutes to cool from 70 °C to 40 °C
10% to 95% non-condensing
10% to 95% non-condensing
Up to 40,000 feet / 12,192 meters
Up to 4 atmospheres
Approximately 10,000 spot checks, or 63 hours of
continuous operation using new alkaline batteries.
48 months
Type BF-Applied Part
IP33
Continuous
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
nonin.com
Manufacturer's Declaration
Refer to the following tables for specific information regarding this device's compliance to IEC 60601-1-2.
Emissions Test
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
Immunity Test
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
Electrical Fast
Transient/Burst
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) Magnetic Field
IEC 61000-4-8
using the
2
NOTE: U
is the AC mains voltage before application of the test level.
T
Table 3: Guidance and Manufacturer's Declaration—Electromagnetic Immunity
Immunity Test
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.
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
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.
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.
Rated Maximum Output
Power of Transmitter
W
0.01
0.1
1
10
100
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.
Table 1: Electromagnetic Emissions
Compliance
Electromagnetic Environment—Guidance
This device uses RF energy only for its internal function.
Group 1
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Class B
This device is suitable for use in all establishments, including
N/A
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
N/A
Table 2: Electromagnetic Immunity
Compliance
IEC 60601 Test Level
Level
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
±2 kV for power supply lines
N/A
±1 kV for input/output lines
±1 kV differential mode
N/A
±2 kV common mode
±5% U
(>95% dip in U
) for
T
T
0.5 cycle
±40% U
(60% dip in U
) for
T
T
5 cycles
N/A
±70% U
(30% dip in U
) for
T
T
25 cycles
<5% U
(>95% dip in U
) for
T
T
5 sec.
3 A/m
3 A/m
IEC 60601 Test
Compliance
Electromagnetic Environment—Guidance
Level
Level
Recommended Separation Distance
3 Vrms
d
=
1.17 P
150 kHz to 80 MHz
N/A
3 V/m
80 MHz to 800 MHz
80 MHz to 2.5 GHz
3 V/m
800 MHz to 2.5 GHz
where P is the maximum output power rating of the
20 V/m
transmitter in watts (W) according to the transmitter
80 MHz to 2.5 GHz
20 V/m
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
be less than the compliance level in each frequency
b
range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
Table 4: Recommended Separation Distances
Separation Distance According to Frequency of Transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
d
=
1.17 P
d
=
1.17 P
0.12
0.12
0.37
0.37
1.2
1.2
3.7
3.7
12
12
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%.
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
d
=
1.17 P
d
=
2.33 P
a
, should
800 MHz to 2.5 GHz
d
=
2.33 P
0.23
0.74
2.3
7.4
23
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