Nox C1 US Manual
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Warnings and Cautions for Use
Warning: The Nox Sleep System is NOT certified for continuous monitoring
where failure to operate can cause injuries or death of the patient.
Caution: U.S. federal law restricts this device to sale by, or on the order of, a
licensed medical practitioner.
Caution: The Nox C1 Access Point complies with the international standard IEC
60601-1-2 for electromagnetic compatibility for medical electrical equipment
and/or systems. That standard is designed to provide reasonable protection
against harmful interference in a typical medical installation. However, because
of the proliferation of radio-frequency transmitting equipment and other
sources of electrical noise in healthcare and other environments, it is possible
that high levels of interference due to close proximity or strength of source
might disrupt the performance of the device, affecting recorded signals and
therefore data analysis and resulting in possible incorrect treatment. Medical
electrical equipment needs special precautions regarding Electromagnetic
Compatibility (EMC), and needs to be installed and put into service according to
the EMC information provided in the “Electromagnetic Compatibility (EMC)
Information” section of this manual.
Warning: Electromagnetic Interference (EMI) can be picked up by the analog
channels of the Nox C1 Access Point, causing disturbed or altered signals to
appear in the Noxturnal US software. This may affect data analysis and result in
possible incorrect treatment.
Warning: The use of accessories and cables other than those listed in this
manual may result in increased emissions and/or decreased immunity of the
Nox Sleep System and cause injuries to the operator/patient.
Warning: The Nox C1 Access Points should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the device(s)
should be observed to verify normal operation in the configuration in which
it/they will be used and prevent abnormal operation which might cause injuries
to the operator/patient.
Warning: The Nox Sleep System may be interfered with by other equipment,
even if that equipment complies with emission requirements of the CISPR
(Special International Committee on Radio Interference) causing possible
patient harm.
Warning: The Nox C1 Access Point is not designed to give a specified degree of
protection against harmful ingress of liquids. Do not autoclave or immerse the
device in any kind of liquids. Ingress of liquids may result in electric shock.
Warning:Only use United States Environmental Protection Agency (EPA)
registered products for cleaning of the Nox C1 Access Point to prevent harm to
the operator/patient.
Warning: Do not use damaged equipment, sensors, or accessories. This may
result in bad performance of the Nox Sleep System or patient/operator injury.
Warning: There are no user serviceable parts inside the Nox C1 Access Point.
The device should be serviced by authorized parties only. Service performed by
non-authorized parties may affect data analysis and result in possible incorrect
treatment. The warranty is void if the Nox C1 Access Point is opened.
