Edwards EV1000

Safety and Symbols
2-3
WARNING
Do not touch system connectors of the EV1000 Clinical
Platform NI and the patient at the same time.
(Chapter 7)
WARNING
Always remove EV1000 Noninvasive System sensors
and components from the patient and completely
disconnect the patient from the instrument before
bathing the patient.
(Chapter 7)
WARNING
Do not overtighten the Pressure Controller Band or
ClearSight Finger Cuff(s).
(Chapter 7)
WARNING
Do not apply the ClearSight Finger Cuff or Pressure
Controller on injured skin as this can cause further
injury.
(Chapter 7)
WARNING
Measurement on one finger in contradiction with the
instructions for use may affect patient comfort and/or
lead to minor injuries.
(Chapter 7)
WARNING
To reduce the risk of skin irritation and tissue damage,
do not monitor longer than 8 hours continuously on a
single finger. To continue to monitor, apply the
ClearSight Finger Cuff to another finger or use two cuffs
to measure more than 8 hours.
(Chapter 7)
WARNING
Do not use two ClearSight Finger Cuffs simultaneously
on the same finger.
(Chapter 7)
WARNING
If using the instrument during full body irradiation, keep
all EV1000 Noninvasive System monitoring
components out of the irradiation field. If a monitoring
component is exposed to the irradiation, the readings
may be affected.
(Chapter 7)
WARNING
Strong magnetic fields may cause malfunction of the
instrument and burn wounds to the patient. Do not use
the instrument during magnetic resonance imaging
(MRI) scanning. Induced current could potentially cause
burns.The device may affect the MR image, and the
MRI unit may affect the accuracy of the measurements.
(Chapter 7)
WARNING
Do not use the EV1000 Clinical Platform NI as a heart
rate monitor.
(Chapter 7)
WARNING
The analog output signal from the EV1000 Clinical
Platform NI will experience brief interruptions due to
Physiocal which will be displayed on the bedside patient
monitor.
(Chapter 7)
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 11)
WARNING
EV1000 Databox and EV1000 Monitor power must be
supplied through the same Pump-Unit when using
integrated noninvasive and minimally invasive
technologies for patient monitoring.
(Chapter 14)
WARNING
The EV1000 Clinical Platform NI, cables and sensors
contain no user-serviceable parts. Removing the cover
or any other disassembly will expose you to hazardous
voltages.
(Appendix E)
WARNING
Shock or fire hazard! Do not immerse the EV1000
Monitor, Pump-Unit, Pressure Controller or Cables in
any liquid solution. Do not allow any fluids to enter the
instrument.
(Appendix E)
WARNING
DO NOT:
• Allow any liquid to come in contact with the power
connector
• Allow any liquid to penetrate connectors or
openings in the case
If any liquid does come in contact with any of the above
mentioned items, DO NOT attempt to operate the
platform. Disconnect power immediately and call your
Biomedical Department or local Edwards
Representative.
(Appendix E)
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.
(Appendix F)
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.
(Appendix F)