ICU Medical LifeCare PCA, Техническое и сервисное руководство, Страница: 148 / 148

Technical Service Manual 430-97357-00
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Caution Warning
Mains supply equipment
using protective earth
Protection against vertically falling
water drops
Fragile, Handle with Care Temperature limitation
This Way Up Keep dry
Mandatory Action Follow Instructions For Use
Equipotential Terminal provided for electrical safety testing and as a means for
connection of a potential equalization conductor. Using the Equipotential Terminal for
anything but grounding purposes may contribute to damage of the device.
Device includes an RF transmitter that complies with IEEE 802.11 a/b/g
A certification mark employed on electronics products manufactured or sold in the United
States which certifies that the electromagnetic interference from the device is under limits
approved by the Federal Communications Commission.
Indicates that Federal (USA) law restricts this device to sale by or on the order of a
physician or other licensed practitioner
The patient pendant handle and button are applied parts for the LifeCare PCA infuser.
The patient pendant handle and button are Type BF applied parts complying with the
higher degree of protection against electric shock, as defined in IEC 60601-1:2012. Type
BF Applied Parts are those parts suitable for direct patient connections. Type BF parts
are not suitable for direct cardiac application.
The vial, injector and administration set, which comprises the infusion liquid pathway, are
applied parts for the LifeCare PCA infuser.
The vial, injector and administration set are Type CF applied parts complying with the
higher degree of protection against electric shock, as defined in IEC 60601-1:2012. Type
CF Applied Parts are those parts suitable for direct cardiac application.
The ‘C’ and ‘US’ indicators adjacent to the CSA Mark signify that the product has been
evaluated to the applicable CSA and ANIS/AAMI Standards, for use in Canada and the
U.S., respectively. This ‘US’ indicator includes products eligible to bear the ‘NRTL’
indicator. NRTL (National Recognized Testing Laboratory), is a designation granted by
the U.S. Occupational Safety and Health Administration (OSHA) to laboratories which
have been recognized to perform certification to U.S. Standards.
Infuser has been evaluated to IEC 60601-1:2012 Edition 3.1 - Medical Electrical
Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
C C
C
F
TYPE BF
Type CF