Aspect BIS VIEW, 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. The BIS VIEW monitor
utilizes a commercial Class I medical-grade power supply which provides 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. However because all components of the BIS VIEW that are classified as
Protective Earth are contained within the power supply enclosure and are not accessible to
the user, all exposed metal is classified as Functional Earth, not Protective Earth, and a
ground continuity test is not recommended. Note that all exposed metal parts on the rear of
the BIS VIEW monitor are separated from live parts by double 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 VIEW monitor is isolated
from the mains in accordance with IEC60601-1. Patient isolation is accomplished within the
BISx.
Degree of Protection against effects of Cardiac Defibrillation:
The BIS VIEW 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.

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.