Edwards EV1000

Chapter 2: Safety and Symbols
his chapter describes the symbols that appear in the
manual or on product labels, including those used to
identify warnings, cautions, and notes. A list of all
warnings and cautions used in this manual is provided
in this chapter.
This chapter also includes a list of relevant standards to which
the EV1000 Clinical Platform NI complies.
Safety Identifying Symbols
The terms warnings, cautions, and notes are graphically
identified and have specific meanings as used in this manual.
 This is a note. It draws attention to useful information
regarding a function or procedure.
Warnings
The following warnings are presented in the EV1000 Clinical
Platform NI Operator’s Manual where relevant to the
function or procedure being described.
WARNING
Advises against certain actions or situations that could
result in personal injury or death.
CAUTION
Advises against actions or situations that could damage
equipment, produce inaccurate data, or invalidate a
procedure.
WARNING
The EV1000 Clinical Platform NI is intended for use
only as an adjunct in patient assessment. This
instrument should be used in conjunction with a bedside
physiologic monitor. If the accuracy of any reading is
questionable, first check the patient’s vital signs by
alternate means.
(Chapter 1)
WARNING
Read this Manual carefully before attempting to use the
Edwards Lifesciences EV1000 Clinical Platform NI.
Improper use of the EV1000 Clinical Platform NI could
present a hazard to the patient. Carefully read the
“Warnings” section of this manual before using the
platform.
(Chapter 1)
T
WARNING
Use of the EV1000 Clinical Platform NI is restricted to
one patient at a time.
(Chapter 1)
WARNING
No modification of the EV1000 Clinical Platform NI is
allowed.
(Chapter 3, Appendix F)
WARNING
Explosion Hazard! Do not use the EV1000 Clinical
Platform NI in the presence of flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
(Chapter 3)
WARNING
To avoid the risk of electric shock, the Pump-Unit must
only be connected to a supply mains with protective
earth.
(Chapter 3)
WARNING
Grounding reliability can only be achieved in Canada
and in the USA when the instrument is connected to a
receptacle marked “hospital only”, “hospital grade”, or
its equivalent.
(Chapter 3)
WARNING
In the USA the instrument shall be connected only to a
single phase 110-120V supply system.
(Chapter 3)
WARNING
Do not use extension cords or multiple socket devices
to connect the Pump-Unit to AC mains. Do not use
detachable power cords other than the power cord
provided.
(Chapter 3)
WARNING
For noninvasive monitoring, the EV1000 Monitor must
be powered by the Pump-unit using the EV1000 NI
Power Cable.
(Chapter 3)
WARNING
Shock hazard: Do not attempt to connect/disconnect
system cables while hands are wet. Ensure that hands
are dry prior to disconnecting system cables.
(Chapter 3)
WARNING
Only use ClearSight Finger Cuffs, EV1000 Heart NI
Reference Sensor and other EV1000 Noninvasive
System accessories, cables and or components that
have been supplied and labeled by Edwards. Using
other unlabeled accessories, cables and or components
may affect patient safety and measurement accuracy.
(Chapter 3,7,13, Appendix A)