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CentriMag
TM
Circulatory Support System Operation Manual (US)
Page 44 of 126
© 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
Table 6: Features of the Console, Monitor, and Flow Probes
FEATURE
NAME
DESCRIPTION
LOCATION
CE Mark with
Notified Body ID
CE (Conformity European) Mark with
Notified Body designation
On the serial
number label
TUV Mark
The TUV Mark is an NRTL
(Nationally Recognized Test
Laboratory) mark, which signifies
that the 2
nd
Generation CentriMag
Console was tested and meets the
minimum requirements of prescribed
product safety standards. Moreover,
the mark indicates that the
production site conforms to a range
of compliance measures and is
subject to periodic follow-up
inspections to verify continued
conformance.
On the serial
number label
Manufacturer
Indicates the Manufacturer of the
Console
On the serial
number label
Waste Electrical
and Electronic
Equipment
Waste Electrical and Electrical
Equipment (WEEE) Mark
On the serial
number label
Console Warning Label
Backup System
Warning
Indicates that a full backup System
must be available in the immediate
vicinity of the patient during use of the
main System.
On the Console’s
Back Panel
Monitor Serial Number Label
On the Monitor’s
Back Panel