Nox A1 Manual
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Instructions for Operators
The Nox A1 recorder is only intended to be set-up and maintained by professionals (healthcare
professionals and service personnel) with relevant qualifications and skills according to the
instructions given in the “Operating the Device”, “Patient Hookup” and “Maintenance” sections. The
ONLY operation that patients might have to perform by themselves at home is to start recordings that
have been configured to be manually started. In that case, the professional setting up the Nox A1
recorder and hooking up the patient shall demonstrate how to start the recording manually and train
the patient to do so according to the “Manually Starting/Stopping a Recording” section.
Operators should contact Nox Medical or its sales representatives
• for assistance, if needed, in setting up, attaching, operating or maintaining the Nox Sleep
System, its accessories, and as applicable external sensors and auxiliary devices that have
been validated with the system; or
• to report unexpected operation or events.
Support information and information about Nox Medical’s sales representative can be found on Nox
Medical’s website: www.noxmedical.com/distributors.
Warnings and Cautions for Use
Warning: The Nox Sleep System is NOT certified to be used 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 A1 recorder 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
“EMC Information” section of this manual.
Warning: The use of accessories, transducers, sensors, 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 A1 recorder(s) 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 International Special Committee on Radio Interference (CISPR)
emission requirements, causing possible patient harm.
Caution: The Nox A1 recorder is designed to be safe for use for pacemaker patients if the
pacemakers comply with the standard: EN 50061 Safety of Implantable Cardiac Pacemakers.
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