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.
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 5 Lead EEG Electrode Cables should be properly disposed of if they cannot
be fully cleaned between uses to prevent the risk of cross-infection between patients.
Warning: The Nox 5 Lead EEG Electrode Cables are not certified to be used for electrical
stimulation purposes. Using the product for electrical stimulation purposes might create
burns and cause injuries to the patient.
Caution: The Nox A1 recorder and its accessories should always be transported in the
accompanying carrying case to ensure adequate protection and prevent damage.
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