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Testing Summary
SpO
accuracy and low perfusion testing was conducted by Nonin Medical, Incorporated as described
2
below.
SpO
Accuracy Testing
2
SpO
accuracy testing is conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-
2
skinned subjects in an independent research laboratory. The measured arterial hemoglobin saturation value
(SpO
) of the device is compared to arterial hemoglobin oxygen (SaO
2
samples with a laboratory co-oximeter. The accuracy of the device is in comparison to the co-oximeter
samples measured over the SpO
range of 70-100%. Accuracy data is calculated using the root-mean-
2
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 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
2
9919 for pulse rate and SpO
at the lowest obtainable pulse amplitude (0.3% modulation).
2
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%
80 – 90%
90 – 100%
70 – 100%
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:
Humidity:
Operating:
Storage/Transportation:
Altitude:
Operating
Hyperbaric Pressure:
Battery Life:
Operating
Storage:
Classifications per IEC 60601-1 / CAN/CSA-C22.2 No. 601.1 / UL 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.
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 55441-5443 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
82450 Hudiksvall, Sweden
+46 650 401500 (Europe)
Fax: +46 650 401514
E-mail: serviceintl@nonin.se
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
) value, determined from blood
2
0% to 100% SpO
2
18 to 321 beats per minute (BPM)
Low Perfusion
)
rms
Oxygen Saturation (A
±2
±2
±2
±2
±2
±2
±2
±2
This graph shows plots of the error (SpO
by SaO
using the 9550 with a linear regression fit
2
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.
*):
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)
10% to 95% non-condensing
10% to 95% non-condensing
Up to 40,000 feet / 12,192 meters
Up to 4 atmospheres
Approximately 6,000 spot checks, or 36 hours of
continuous operation using new alkaline batteries.
48 months
Type BF-Applied Part
IP32
Continuous
Nonin Medical AB
Fibervägen 2
www.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
)
rms
Electrical Fast
Transient/Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
– SaO
)
2
2
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
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
0.01
0.1
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
±6 kV
±6 kV contact
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
Compliance
Electromagnetic Environment—Guidance
Test Level
Level
Recommended Separation Distance
3 Vrms
d
=
150 kHz to 80
N/A
MHz
3 V/m
80 MHz to 800 MHz
80 MHz to 2.5
[3] V/m
800 MHz to 2.5 GHz
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
[20] V/m
manufacturer and d is the recommended separation
GHz
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey
compliance level in each frequency 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
W
0.12
0.37
1
1.2
10
3.7
12
Electromagnetic Environment—
Level
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.
1.17 P
d
=
1.17 P
d
=
2.33 P
a
, should be less than the
b
800 MHz to 2.5 GHz
d
=
1.17 P
d
=
2.33 P
0.12
0.23
0.37
0.74
1.2
2.3
3.7
7.4
12
23
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