Universal XactTrace
®
User Instructions
5
•
This product is for diagnostic purposes only, and is not to be used as an
apnea monitor.
•
Do not use the device in an MRI environment.
•
Do not use the device in an explosive environment
– in other words, in the
presence of flammable liquids, such as an anesthetic mixture with air, or with
oxygen or nitrous oxide.
•
Connect the cables to patient inputs of medical physiological recording
equipment that complies with IEC60601-1, type CF or BF.
•
The device contains a battery and must be disposed of properly. Local,
state, or national laws may prohibit disposal of batteries in ordinary trash.
Contact your local waste authority for information regarding available
recycling and disposal options.
•
The device has no user serviceable parts and must be serviced by Embla
and authorized parties only. Warranty void if opened. Contact Natus
Technical Support (
) for more information.
•
The device is not defibrillator proof.
•
As a result of the proliferation of radio-frequency transmitting equipment and
other sources of electrical noise in health care and other environments, high
levels of interference, due to close proximity or strength of the source, may
disrupt the performance of the device. For these reasons, special precaution
regarding electromagnetic compatibility (EMC) is needed when the device is
installed and put into service.
•
Use of cables with this equipment other than those specified or sold by the
manufacturer may result in increased emissions or decreased immunity of
the equipment and may cause the system to be non-compliant with the
requirements of IEC 60601-1-2.
•
Portable and mobile RF communications can affect the performance of the
device.
•
Electrostatic discharges (ESD) may cause artifacts in the signal from the
device. A trained operator should be able to recognize these artifacts easily.
Avoid conditions where electrostatic charge can build up because of low
humidity and friction against carpets, clothing, and sheets made from
artificial fibers.
System Components
The Universal Kit
– Complete (p/n 1421091) includes two XactTrace Universal
belts (p/n 1421040), two XactTrace Universal respiratory effort sensors (p/n
1421026 for abdomen and p/n 1421027 for thorax) that measures inductance
changes in the belt, and the XactTrace Universal cable (p/n 1451080) that
connects the sensor directly to an input on the recording device. The system
converts changes in inductance to an analog signal that provides both qualitative
and quantitative information on respiratory effort.
