User and Service Manual Xltek
®
EMU40EX™
53
Pulse Oximeter
The following topics list the specifications cleared by the FDA under K990966 for Masimo SET
®
board
that is built into the EMU40EX. The board connects to sensors and provides oxygen saturation, pulse
rate, pulse waveform, and other output information via the NeuroWorks software. The EMU40EX provides
power and isolates the board from the main power and ground. The NeuroWorks/SleepWorks software
currently provides two types of SpO2 data: a 4 beat averaged pulse rate based on the previous four
continuous acceptable pulse rates, and a beat to beat pulse rate value which is calculated based on the
previous beat.
Masimo Patents
This device is covered under one or more of the following U.S.A. Patents: 5,758,644; 5,823,950;
6,011,986; 6,157,850; 6,263,222; 6,501,975, international equivalents, or one or more of the patents
referenced at www.masimo.com/patents. Other U.S.A and international patents pending.
No Implied License
Possession or purchase of this device does not convey any express or implied license to use the device
with replacement parts which would, alone, or in any combination with this device, fall within the scope of
one or more of the patents relating to this device.
Indications for Use
The pulse oximeter and accessories are indicated for the continuous noninvasive monitoring of functional
oxygen saturation of arterial hemoglobin (SpO
2
) and pulse rate (measured by an SpO
2
sensor). The
Masimo SET
®
pulse oximeter and accessories are indicated for use with adult, pediatric, and neonatal
patients during both no motion and motion conditions, and for patients who are well or poorly perfused in
hospitals, hospital-type facilities, mobile, and home environments.
Instruction for Use
The indication of a signal inadequacy and/or probe faults for the SP02 sensor is alarmed through the
Neuroworks 9.0 software and is displayed on the computer monitor. Software will indicate the following if
an anomaly, signal degradation or probe fault is noted during monitoring:
1. Oximeter Event, notes the time of the event and is recorded
2. Pulse rate Event, notes the time of the event and is recorded
3. "Channel Off" indication
4. Low Quality
5. "-----" indication if the probe is misaligned or is not receiving a signal
How the Pulse Oximeter Works
The Masimo SET
®
pulse oximeter is based on three principles:
1. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light
(spectrophotometry).
2. The volume of arterial blood in tissue (and hence, light absorption by that blood) changes during
the pulse (plethsymography).
3. The arterio-venous shunting is highly variable, and that fluctuating absorbance by venous blood is
a major component of noise during pulse.
The Masimo SET
®
pulse oximeter as well as traditional pulse oximetry determines SpO
2
by passing red
and infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle.
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