XLTEK EEG32U Amplifier User and Service Manual
16
Warnings and Cautions
Two labels identify potentially dangerous or destructive conditions and procedures:
Warning A WARNING indicates that there is a risk of death or serious injury to the user or patient.
Caution A CAUTION indicates that there is a risk of injury to the user or patient or risk of damage to the device.
Any serious incident that has occurred in relation to the XLTEK EEG32U amplifier system be reported to the manufacturer
and the competent authority of the Member State in which the user and/or patient is established.
Contraindications
There are no known contraindications under normal clinical use.
General Warnings
NOTE: It is recommended that all data be stored using redundant storage capabilities. Using redundant storage can help to
minimize data loss in the event of a failure of the primary drive.
Proper use of this device depends on careful reading of all instructions and labels that come with or on the
system.
The EEG32U amplifier is classified as an IPX0 – ordinary degree of protection against ingress of water according
to IEC 529. The EEG32U amplifier is not waterproof.
Inaccurate measurements may be caused by incorrect application or use.
Only qualified personnel should operate this equipment.
Only use the EEG32U amplifier in conjunction with approved devices and accessories.
Use of cables other than those specified or sold by the manufacturer on the equipment, may result in increased
emissions or decreased immunity of the equipment and may cause the system to be non-compliant with the
requirements of IEC 60601-1-2:2014
The computer and the peripherals used with the EEG32U amplifier and the NeuroWorks EEG system must either
be approved by XLTEK and supplied as part of an IEC 601 approved system or it must be approved to IEC 950 or
similar and kept outside of the patient environment (that is, the area within 1.5 meters of the patient laterally
and within 2.5 meters of the floor in the area occupied by the patient).
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