Aspect BIS VISTA, Руководство по эксплуатации

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SECTION 9 SPECIFICATIONS AND WARRANTY
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9-4
Type of Protection against Electric Shock of the System:
Class 1: Equipment in which protection against electric shock does not rely on basic
insulation only, but which includes an additional safety precaution. Means are provided for
the connection of the equipment to the protective earth conductor in the fixed wiring of the
installation in such a way that accessible metal parts cannot become live in the event of a
failure of the basic insulation.
Degree of Protection against Electric Shock of the System:
Type BF: Equipment providing a degree of protection against electric shock regarding
allowable leakage currents and reliability of the protective earth ground connection with an
F-type applied part. An F-type applied part is isolated from all other parts of the equipment
to such a degree that the patient leakage current allowable in single fault condition is not
exceeded when a voltage equal to 1.1 times the highest rated AC supply voltage is applied
between the applied part and earth. The circuitry inside the BIS VISTA monitor is isolated
from the mains in accordance with UL60601-1. Patient isolation is accomplished within the
BISx.
Degree of Protection against effects of Cardiac Defibrillation:
The BIS VISTA system provides protection for the operator and patient during cardiac
defibrillation. This protection is achieved via the isolation barrier within the BISx.
Degree of Protection against the Ingress of Water:
Monitor degree of protection rating: IPX2 (ingress of water vertically dripping).
BISx degree of protection rating: IPX4 (splash proof).
Mode of Operation of the System:
Continuous: Operation under normal load for a normal period without exceeding the
specified limits of temperature.
Classification:
MEDICAL ELECTRONIC EQUIPMENT
CLASSIFIED BY UNDERWRITERS LABORATORIES INC.
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WITH RESPECT TO
ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN
ACCORDANCE WITH UL 60601-1, IEC 60601-1, IEC 60601-2-26,
CAN/CSA-C22.2#601.1.