Nellcor N-560 User manual

Introduction

This addendum applies to the Nellcor OXIMAX® N-560 Pulse
Oximeter monitor, and provides supplemental information to
instructions found in the Nellcor O
Operator’s and Service manuals. This addendum is divided into the
following major topics:

•Safety

•Alarms

• Range of Peak Wavelengths and Maximum Output

• Data Update Period, Effect Of Data Averaging, and Other

• Test Considerations and Oximeter Accuracy

•Compliance

Safety

Sensor LED light output falls within Class 1 level, according to IEC
60825-1:2001. No special safety precautions are required.

N-560 1Addendum to Monitor Instructions

XIMAX N-560 Pulse Oximeter

Power

Signal Processing

Alarms

The default lower SpO2 alarm limit (in Neonatal mode only) is 80%,
however, institutions may reset this default limit to a greater value
by following the information in the O

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XIMAX N-560 Service Manual.

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Addendum to Monitor Instructions

Range of Peak Wavelengths and Maximum Output Power

Electrical/Optical Specifications

Nellcor pulse oximetry sensors contain light emitting diodes (LEDs)
that emit red light at a wavelength of approximately 660 nm and
infrared light at a wavelength of approximately 900 nm. The total
optical output power of the sensor LEDs is less than 15 mW. This
information may be useful to clinicians, such as those performing
photodynamic therapy.

Data Update Period, Effect Of Data Averaging, and Other Signal Processing

There are various matrices within the N-560 algorithm. Some of
these are used to assess the severity of conditions presented to the
N-560 measuring SpO
individual matrices or combinations of these matrices are used to
drive the LED indicators on the N-560 front panel.

The advanced signal processing in the algorithms automatically
extends the amount of data required for measuring SpO
rate depending on the measuring conditions. During normal
measurement conditions, the averaging time is six to seven
seconds (approximately three seconds in Fast Mode). The N-560
automatically adjusts the signal processing during degraded
conditions such as those caused by low perfusion, interference,
(e.g. external interference such as ambient light, electromagnetic
interference, and patient motion), or a combination of these, which
results in an increase in the dynamic averaging beyond the
minimum as set by the response mode. (Refer to the N-560
Operator’s Manual for more information on Setting the Response
Mode.) If the result of the dynamic averaging time exceeds 20
seconds for SpO
and the SpO

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and pulse rate will continue to be updated every

2

second. As these conditions extend, the amount of data required
continues to increase. If the dynamic averaging time for SpO
reaches 40 seconds, and/or 50 seconds for Pulse Rate, a low priority
alarm state results: The pulse search indicator begins flashing, the

and pulse rate on a patient. These

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and pulse

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, the PULSE SEARCH indicator is illuminated solid,

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Addendum to Monitor Instructions

SpO2 and pulse rate displays flash zeros indicating a loss of pulse
condition and an audible alarm state is activated.

Blip Bar Pulse Amplitude Indicator

The Blip Bar Pulse Amplitude Indicator indicates pulse beat and
shows the relative (non-normalized) pulse amplitude. As the
detected pulse becomes stronger, more bars light up with each
pulse. This indicator is only available in the blip view.

Plethysmographic Waveform Display

Similarly, when a Plethysmographic Waveform is selected, the
display provides the (non-normalized) real-time sensor signal. The
relative pulsatile strength and quality of the incoming signal can be
observed.

Test Considerations and Oximeter Accuracy

Functional Testers and Patient Simulators

Some models of commercially available bench top functional
testers and patient simulators can be used to verify the proper
functionality of Nellcor pulse oximeter sensors, cables and
monitors. See the individual testing device's operator's manual for
the procedures specific to the model of tester being used.

While such devices may be useful for verifying that the pulse
oximeter sensor, cable, and monitor are functional, they are
incapable of providing the data required to properly evaluate the
accuracy of a system's SpO

Fully evaluating the accuracy of the SpO
at a minimum, accommodating the wavelength characteristics of
the sensor and reproducing the complex optical interaction of the
sensor and the patient’s tissue. These capabilities are beyond the
scope of known bench top testers, including known devices which
claim to measure sensor LED wavelength.

SpO

measurement accuracy can only be evaluated in vivo by

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comparing pulse oximeter readings with values traceable to SaO

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measurements.

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measurements requires,

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Addendum to Monitor Instructions

measurements obtained from simultaneously sampled arterial
blood made using a laboratory CO-oximeter.

Many functional testers and patient simulators have been designed
to interface with the pulse oximeter's expected calibration curves
and may be suitable for use with Nellcor monitors and/or sensors.
Not all such devices, however, are adapted for use with the Nellcor

XIMAX digital calibration system. While this will not affect use of

O

the simulator for verifying system functionality, displayed SpO

2

measurement values may differ from the setting of the test device.

For a properly functioning monitor, this difference will be
reproducible over time and from monitor to monitor within the
performance specifications of the test device.

Accuracy with Low Perfusion

Reading accuracy in the presence of low perfusion (detected IR
pulse modulation amplitude 0.03% - 1.5%) was validated using
signals supplied by a patient simulator. SpO

and pulse rate values

2

were varied across the monitoring range over a range of weak
signal conditions and compared to the known true saturation and
pulse rate of the input signals.

Compliance

When used with Nellcor OXIMAX sensors and the appropriate
Nellcor pulse oximetry cable, the Nellcor O
Oximeter is compliant with ISO 9919:2005 with the following
exceptions:

Clause 50.101

See “Data Update Period, Effect Of Data Averaging, and Other
Signal Processing” on page 2 of this document.

Clause 201.5.4.1

See “Alarms” on page 1 of this document.

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