Regulatory Information
● 5
Regulatory Information
Intended Use
The Nox T3 device is intended for ambulatory recording of physiological signals during sleep. The
recorded signals are then downloaded to a PC where the signals can be viewed and analyzed by use of
the Nox T3 application.
The Nox T3 system can be used with both children and adults.
The Nox T3 system is
NOT
intended for any patient monitoring or automatic diagnosis.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test
environments, including patient’s home.
!
► Please read this manual carefully before use, especially sections marked with an
exclamation mark.
Warnings and Cautions for Use
► The device is
NOT CERTIFIED TO BE USED FOR CONTINUOUS MONITORING
where
failure to operate can cause injuries or death of the patient. The term
CONTINUOUS
MONITORING
is specified in the standard IEC60601-1.
► This system is intended only as an adjunct in patient assessment. It must be used in conjunction
with other methods of assessing clinical signs and symptoms.
► Caution: U.S. Federal law restricts this device to sale by, or on the order of, a physician.
► This system complies with international standards IEC60601-1-2 for electromagnetic compatibility
for medical electrical equipment and/or systems. This 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 device’s performance. Medical electrical equipment needs
special precautions regarding EMC, and all equipment must be installed and put into service according
to information detailed in the EMC Information section of this manual.
► The device is classified as ordinary equipment regarding ingress of liquids, that is, it is not drip-
proof, splash-proof or watertight. During use of the device avoid all unnecessary contact with
moisture.
► The device is not defibrillator proof.
► Do not use any part of the system in an MRI (Magnetic Resonance Imaging) environment.
► The device and its accessories should be removed from the patient before download of data.
► No user serviceable parts inside the device. Serviced by authorized parties only. Warranty void if
opened.
Guide to Symbols
► Consult instructions for use.
►Caution, consult accompanying documents.
► Manufacturer.
