Edwards EV1000

2-2
Safety and Symbols
WARNING
Use of accessories, sensors, and cables other than
those specified may result in increased electromagnetic
emissions or decreased electromagnetic immunity.
(Chapter 3, Appendix F)
WARNING
The EV1000 Clinical Platform NI meets the
requirements of IEC 60601-1:2005 for the system
configurations described in this manual. Connecting
external equipment or configuring the system in a way
not described in this manual may not meet this
standard.
(Chapter 3, 14)
WARNING
Do not use the Ethernet cable to connect anything to
the Pump-Unit other than the Monitor.
(Chapter 3)
WARNING
All non Edwards IEC/EN 60950 equipment, including
printers, must be positioned no closer than 1.5 meters
to the patient’s bed, the operating table and persons
touching the patient.
(Chapter 3)
WARNING
Do not obstruct the EV1000 Clinical Platform NI
ventilation openings.
(Chapter 3)
WARNING
Make sure the EV1000 Clinical Platform NI is securely
mounted, and that all cords and accessory cables are
appropriately arranged to minimize the risk of injury to
patients, users or the equipment. Refer to directions on
proper setup.
(Chapter 3,13)
WARNING
The Monitor must be positioned in an upright position to
ensure IPX1 fluid ingress protection.
(Chapter 3)
WARNING
The Pump-Unit must be positioned in an upright
position to ensure IP4X ingress protection.
(Chapter 3,13)
WARNING
Do not position the Pump-Unit so that it is difficult to
disconnect the mains power cord.
(Chapter 3)
WARNING
Components that are not indicated as APPLIED PARTS
should not be placed in as location where the patient
may come into contact with the component.
(Chapter 4,7)
WARNING
Do not apply ClearSight Finger Cuff(s) on a hand/finger
when external constriction (that may prevent circulation
to the hand/finger) is present.
(Chapter 4)
WARNING
Physiological visual and audible physiological alarms
are activated only if the parameter is selected and
displayed on the screens as a key parameter (1-4
parameters). If a parameter is not selected and
displayed as a key parameter, the audible physiological
alarms are silenced.
(Chapter 4,6,7,8)
WARNING
Make sure that Demo Mode is not activated in a clinical
setting to ensure that simulated data is not mistaken for
clinical data.
(Chapter 4, 11)
WARNING
Perform New Patient or clear the patient data profile
whenever a new patient is connected to the EV1000
Clinical Platform NI. Failure to do so may result in
previous patient data in the historical displays.
(Chapter 6)
WARNING
Do not turn off the audible physiological alarms in
situations in which patient safety could be
compromised.
(Chapter 6)
WARNING
Make sure that the alarm volume is set to a level that
allows alarms to be adequately monitored. Failure to do
so could result in a situation where patient safety is
compromised.
(Chapter 6)
WARNING
Do not sterilize any components of the EV1000
Noninvasive System. The EV1000 Noninvasive System
is provided non sterile.
(Chapter 7)
WARNING
Refer to cleaning instructions. Do not disinfect the
instrument by autoclave or gas sterilization.
(Chapter 7, Appendix E)
WARNING
Refer to the directions provided with each accessory for
specific instructions on placement and use, and for
relevant WARNINGS, CAUTIONS, and specifications.
(Chapter 7)
WARNING
Do not use damaged components/sensors or
components/sensors with exposed electrical contacts to
prevent patient or user shocks.
(Chapter 7, Appendix E)
WARNING
The EV1000 Noninvasive System monitoring
components are not defibrillation proof. Disconnect the
system before defibrillating.
(Chapter 7)