natus Xltek EMU40EX, Руководство пользователя и обслуживания

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User and Service Manual EMU40EX™
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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
(plethysmography).
3.
The arterio-venous shunting is highly variable, and that fluctuating absorbance by venous blood is a major component
of noise during pulse.