Warning: The Nox T3s 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: Exposure to radio frequency radiation.
Warning: External equipment and all auxiliary devices intended for connection to signal input,
signal output or other connectors shall comply with the relevant product safety standards, e.g.
IEC 60950-1 for IT equipment and the IEC 60601 series for medical electrical equipment, to
prevent electric shocks. In addition, all such combinations –systems –shall comply with the
safety requirements stated in the collateral standard IEC 60601-1-1 or the general standard IEC
60601-1, edition 3/3.1, clause 16. Any equipment not complying with the leakage current
requirements in IEC 60601-1 shall be kept outside the patient environment, i.e. at least 1.5 m
from the patient support. Any person who connects external equipment to the signal input,
signal output or other connectors has formed a system and is therefore responsible for the
system to comply with the requirements. If in doubt, contact a qualified medical technician or
your local representative.
Caution: The Nox T3s recorder is designed to be safe for use for pacemaker patients if the
pacemakers comply with the standard: EN 45502-2-1 Active implantable medical devices.
Particular requirements for active implantable medical devices intended to treat
bradyarrhythmia (cardiac pacemakers). Using non-compliant pacemakers may result in the
operation of the pacemaker being affected by the use of Nox T3s recorder and lead to possible
patient harm. Prior to using the device with pacemaker patients, the operator should consult the
accompanying documents of the pacemaker regarding its certifications and requirements of use
or, if necessary, contact the producer.
Warning: Do not use the Nox T3s recorder and accessories during radiography/X-ray studies. The
energy absorption in the device, cables or electrodes might lead to excessive heating and cause
burns.
Warning: The Nox T3s recorder and accessories are not intended to be used with high frequency
(HF) equipment. Using the device with high frequency (HF) equipment could cause potential
serious harm to the patient.
Warning: The Nox T3s recorder is not defibrillator proof. Not removing the device from a patient
before defibrillation may lead to the creation of high current density at the electrode sites,
causing burns and leading to possible patient harm. Not removing the device from a patient
before defibrillation may also alter the intended flow of the current, affecting the defibrillation
efficiency and causing injuries or death of the patient.
Warning: Do not use any part of the Nox T3s System, including patient cables and electrodes, in
a Magnetic Resonance Imaging (MRI) environment. The energy absorption in conductive
materials might lead to excessive heating and cause burns.
Caution: The Nox T3s recorder and Nox RIP belts should be worn over clothing to prevent allergic
reaction to the equipment materials.
Warning: Avoid accidental contact between connected but unused patient applied parts and
other conductive parts including those connected to protective earth to prevent potential
serious harm to the operator/patient.
Warning: Do not use damaged equipment, sensors or accessories. This may result in bad
performance of the Nox T3s System or patient/operator injury.
Warning: The Nox T3s recorder and its accessories should be removed from the patient before
use of the USB connector to prevent electric shock. The USB connector shall only be used for the
purposes of configuring the device and downloading data from the device.
