Edwards EV1000

2-4
Safety and Symbols
Cautions
The following cautions are presented in the Edwards EV1000
Clinical Platform NI Operator’s Manual where relevant to the
function or procedure being described.
CAUTION
Federal (USA) law restricts this device to sale by or on
the order of a physician.
(Chapter 1)
CAUTION
Do not use any damaged system components. Use of a
damaged system component may result in inaccurate
measurements or may damage the EV1000 Clinical
Platform NI.
(Chapter 3, Appendix E)
CAUTION
Do not expose the EV1000 Clinical Platform NI to
extreme temperatures.
(Chapter 3)
CAUTION
Do not expose the EV1000 Clinical Platform NI to dirty
or dusty environments.
(Chapter 3)
CAUTION
Do not apply strong shock to or drop the instrument.
(Chapter 3)
CAUTION
Clean and store the instrument and accessories after
each use.
(Chapter 3, Appendix E)
CAUTION
When moving the instrument, be sure to turn off the
power and remove the connected power cord.
(Chapter 3)
CAUTION
The EV1000 Monitor should only be connected to a
single Pump-Unit and/or single Databox.
(Chapter 3)
CAUTION
When connecting the EV1000 Clinical Platform NI to
any external device, refer to the device's instruction
manual for complete instructions. Verify proper
operation of the system before clinical use.
(Chapter 3)
CAUTION
Do not use the EV1000 Monitor in environments where
strong lighting makes the LCD screen difficult to view.
(Chapter 3)
CAUTION
Do not use the Monitor as a handheld device.
(Chapter 3)
CAUTION
Improper ClearSight Finger Cuff placement or sizing
can lead to inaccurate monitoring.
(Chapter 4,7)
CAUTION
Make sure that the HRS is correctly applied so that it
can be leveled to the phlebostatic axis.
(Chapter 4,7)
CAUTION
Pump-Unit includes a Lithium-Ion battery backup.
(Chapter 5)
CAUTION
The system power status information, including battery
information, is only displayed on EV1000 Monitor when
the Pump-Unit is connected to the EV1000 Monitor with
the supplied Ethernet cable.
(Chapter 5,14)
CAUTION
Restore Defaults replaces all settings with factory
defaults. Any settings changes or customizations will be
permanently lost. Do not restore defaults while
monitoring a patient.
(Chapter 6)
CAUTION
The effectiveness of EV1000 Noninvasive System has
not been evaluated in patients under 18 years of age.
(Chapter 7)
CAUTION
Always grasp the connector, not the cable, when
connecting or disconnecting cables. Do not twist or
bend the connectors. Confirm that all sensors and
cables are connected correctly and completely before
use.
(Chapter 7)
CAUTION
Never bend a finger cuff to a flat shape, it will damage
the cuff and affect measurement accuracy
(Chapter 7)
CAUTION
Excessive ambient light may interfere with ClearSight
Finger Cuff measurements.
(Chapter 7)
CAUTION
The effectiveness of the ClearSight finger cuff has not
been established in pre-eclamptic patients.
(Chapter 7)
CAUTION
The EV1000 Noninvasive System is not intended for
use as an apnea monitor.
(Chapter 7)
CAUTION
In patients with extreme contraction of the smooth
muscle in the arteries and arterioles in the lower arm
and hand, such as may be present in patients with
Raynaud's disease, blood pressure measurement can
become impossible.
(Chapter 7)