natus Xltek Trex HD, Руководство пользователя и обслуживания

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User & Service Manual XLTEK Trex HD Amplifier
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11. Nonin Xpod Pulse Oximeter
NOTE: Refer to the Instructions for Use for any pulse oximeter, sensor, or cable extender prior
to use.
The following topic lists the specifications for the Nonin Xpod board that is built into the Trex HD Amplifier.
The board connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other
output information via the NeuroWorks software. The Trex HD Amplifier provides power and isolates the
board from the main power and ground.
The user of this medical equipment can verify the operation of the pulse oximeter by appropriately
applying the proper sensor, and viewing the generated SpO2 signal and pulse rate display using the
NeuroWorks software. The NeuroWorks 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.
NOTE: The SpO2 and pulse rate waveforms are not normalized.
11.1. 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.
11.2. Indications for Use
The Xpod is intended to provide medical device manufacturers with a small, low-power oximeter that can
be easily attached to a host device externally. The Xpod measures functional oxygen saturation of arterial
hemoglobin (%SpO2) and pulse rate (BPM) for adult, pediatric, infant and neonatal patients. When
integrated with a medical device manufacturer’s host system, the Xpod may be used in any environment
where pulse oximetry measurements are made.
Additional safety information can be found in the labeling provided with each Nonin sensor.
11.3. Pulse Oximeter Specifications
Pulse Oximetry Specification
Displayed Oxygen Saturation Range (SpO2) 0 to 100%
Displayed Pulse Rate Range 18 to 321 beats per minute (BPM)
11.4. Pulse Oximeter 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