natus Xltek EMU40EX, Руководство пользователя и обслуживания

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User and Service Manual EMU40EX™
13
Warnings and Cautions
We strongly recommend that you read the Contraindications, Warnings and Cautions section of this manual
before operating this amplifier.
General Warnings
NOTE: The amplifier base unit is classified as an IPx0 – ordinary degree of protection against ingress of water according to IEC
60529. The amplifier Breakout is classified as body worn and has an IPx1 rating while inside the pouch (-61) and meets IEC
60601-2-26 spillage requirement without the pouch.
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 Natus EMU40EX system must be reported to the manufacturer and the
competent authority of the Member State in which the user and/or patient is established.
NOTE : It is recommended that all data be stored using redundant storage capabilities. This can help to minimize data loss in the
event of a failure of the primary drive.
Proper use of this device depends on the careful reading of all instructions and labels that come with or on the
system. Inaccurate measurements may be caused by incorrect application or use.
The equipment/system is intended for use by trained users. Please read the manual before installing any of the
hardware, and refer to the appropriate section when you operate, store or re-install the system.
Only use the EMU40EX system 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-
2:2007.
The amplifier base unit is classified as an IPx0 – ordinary degree of protection against ingress of water according to
IEC 60529.
The amplifier Breakout is classified as body worn and has an IPx1 rating while inside the pouch (-61) and meets IEC
60601-2-26 spillage requirement without the pouch.
The EMU40EX system is classified as a class I device according to IEC 60601-1.
The computer used with an EMU40EX system must either be approved by Natus and supplied as part of an IEC
60601 approved system, or it must be approved to IEC 60950 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).
WARNING: Third-party software installed on the acquisition computer may interfere with the operation of the
Natus software. Please consult Natus Technical Support before installing third-party software on the computer.
Never use equipment that has parts missing or equipment that might contain loose parts inside of it (that is, inside
an enclosed portion of the equipment). If you suspect a piece of equipment has missing or loose parts, contact
Natus. Routinely inspect system cables and components for regular wear and tear.
Device accessories may include several kinds of disposable, sterile needle electrodes. These needles are labeled as
STERILE, and the method of sterilization is documented on the packaging. These electrodes should not be used if
the sterile packaging has been tampered with.