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Edwards
OPERATOR'S MANUAL CLARIFICATION
URGENT FIELD SAFETY NOTICE
Date:
03
May
2016
Attention:
lllllll/lll/111
Details on affected devices:
EV1000A
Reference #
FCA-77
EV1
OOOA
Monitor
is used to optimize
fluid management
through the use of min imally invasive
monitaring with
the FloTrac
sensor (or the
Volume
View sensor).
The EV1000A
System consists
of:
- EV1
000
Panel
- Databox
- Power Supply (external
to Panel and
Data Box)
- Cables to connect
the
components
Description of the problem:
Edwards Lifesciences has initiated
a voluntary safety alert
regarding the EV1
OOOA system to reinforce
the proper
set up of
the
external power supply according
to
the equipment's operator manual.
The
company received a recent event of an electrical
fire,
therefore
is sending this notice
to
all customers
with EV1 OOOA systems installed to confirm installation against the current requirements documented in
the Operator's Manual section
EV1
000 Power Adapter
Mounting
Bracket.
Advise
on action to be taken by the user:
All the EV1 OOOA system
installed
are within the scope of
this
action,
this is
a
reminder
that the
EV1 OOOA operators
manual
warns about immersion of
the
device or its components and warns against
letting
fluid enter the device (Reference is included
in the
Warning
and
Caution section of
the
Operator's
Manual)
and
that the
external power supply
for
the EV1 OOOA should be installed down as
illustrated in
the Operation
manual
(Figure 15-8 EV1 000 Power Adapter
Bracket
and
Figure
15-9
EV1 000 Power Adapter
Bracket included
in the Operator's
Manual)
where
the
AC Cord plugs
into the
power supply, as shown in
the illustrations.
Pieasetake
this opportunity
to
review the EV1 OOOA system configurations at your site
to ensure
they
are configured as specified within the operation
manual, to
minimize the risk of fluid ingress as
possible
in the account's environment.
Reference Warnings
and
Caution
Section
from Operators Manual
WARNING
Shock
or Iire
hazard!
Do not
immerse the
EV1000
monitor, Databox or cab!es
in
any
liquid
solution.
Do
not
allow
any
fluids
to
enter
the
instrument.
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