Edwards EV1000

Appendix F: Guidance and Manufacturer's
Declaration
Electromagnetic
Compatibility
Reference: IEC/EN 60601-1-2:2007
he EV1000 Clinical Platform NI is intended for use in
the electromagnetic environment specified below. The
customer or the user of the EV1000 Clinical Platform
NI should assure that it is used in such an environment.
Instructions for Use
Medical electrical equipment needs special precautions
regarding EMC and needs to be installed and put into service
according to the EMC information provided in the following
information and tables.
Table F-1 List of Accessories, Cables and Sensors
Necessary for Compliance
Description Length
EV1000 Pressure Controller cable 11.5 ft
3.5 m
HRS cable 4.0 ft
1.2 m
ClearSight Finger Cuff, Small 7.1 in
18 cm
ClearSight Finger Cuff, Medium 7.9 in
20 cm
ClearSight Finger Cuff, Large 8.7 in
22 cm
EV1000 NI Power cable 3.3 ft or 11.5 ft
1.0 m 3.5 m
EV1000 Ethernet cable 3.3 ft or 11.5 ft
1.0 m 3.5 m
Mains Power cable USA
EU
10 ft 8.2 ft
3.1 m 2.5 m
EV1000 Patient Monitor Adaptor
cable
6.0 in
15 cm
EV1000 NI Databox Adaptor
cable
3.9 ft
1.2 m
When connected to the Databox, the following apply:
FloTrac Cable 12.2 in or 17 ft
31.0 cm or 5.2 m
FloTrac Sensor 12.2 in
31 cm
EV1000 VolumeView
Thermodilution Cable
7.75 ft
236 cm
T
WARNING
Use of accessories, sensors, and cables other than
those specified may result in increased electromagnetic
emissions or decreased electromagnetic immunity.
WARNING
No modification of the EV1000 Clinical Platform NI is
allowed.
WARNING
The EV1000 Clinical Platform NI should not be used
adjacent to, or stacked with other equipment. If
adjacent or stacked use is necessary, the EV1000
Monitor, Databox and Pump-Unit should be observed to
verify normal operation in the configuration in which it is
used.
WARNING
Portable and mobile RF communication equipment can
potentially affect all electronic medical equipment,
including the EV1000.
Guidance on maintaining appropriate separation
between communications equipment and the EV1000
is provided in Table F-3.
CAUTION
The instrument has been tested and complies with the
limits of IEC 60601-1-2. These limits are designed to
provide reasonable protection against harmful
interference in a typical medical installation. This
equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However,
there is no guarantee that interference will not occur in
a particular installation. If this equipment does cause
harmful interference to other devices which can be
determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by
one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the equipment.
• Consult the manufacturer for help.