Nox A1 US Manual
~ 10 ~
Caution: The Nox RIP belts should fit the patient snugly without being uncomfortably tight to avoid
discomfort.
Warning: The Nox disposable RIP belts, Nox nasal cannula, Nox filter tube connector, Pro Tech
Airflow Thermocouple, Ambu Leads with attached electrode, Ambu Snap-on electrodes, Nonin
Wristband, and Westmed Mask tubing are single patient use. Using the same disposable RIP belts,
cannula, filter tube connector, thermocouple, leads, snap-on electrodes, wristband, and mask
tubing on more than one patient poses a risk of cross-infection.
Warning: The disposable RIP belts are single use. Reusing the belts may affect the quality of
recorded signals and lead to possible incorrect treatment.
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: The Nox A1 recorder and its accessories should be removed from the patient before use
of the USB connector to prevent electrical shock. The USB connector shall only be used for the
purposes of configuring the device and downloading data from the device.
Warning: There are no user serviceable parts inside the Nox A1 recorder. 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 A1 recorder is
opened (except for opening of the battery compartment).
Warning: No modification of the Nox A1 recorder and its accessories is allowed. Un-authorized
modifications could result in the device not performing as intended and cause serious harm to the
patient. To ensure patient safety and effective use of the Nox Sleep System, only use accessories
that have been validated for use by Nox Medical. Refer to section “Compatible Sensors and
Devices”.
Warning: Remove batteries from the Nox A1 recorder if it is not used within 30 days to prevent
damage from possible battery leakage and prevent possible minor burns to the operator/patient.
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 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 qualified medical technician or your local representative.
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: Make sure the conductive parts of electrodes and associated connectors, including the
neutral electrode, do not contact other conductive parts including earth to prevent potential
serious harm to the operator/patient.
Warning: Electrodes should only be used by or in consultation with a healthcare provider familiar
with their proper placement and use. Not using and placing the electrodes correctly may affect
recording of data, and therefore interpretation and diagnostics.
Warning: The electrodes should be applied only to intact, clean skin (e.g. not over open wounds,
lesions, infected or inflamed areas) to prevent infections.
Warning: The Nox EEG 5 Lead Gold Electrode Cables should be properly disposed of if they cannot
be fully cleaned between uses to prevent the risk of cross-infection between patients.
