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State: Released Date: 2021.03.01 22:19 GMT Effectivity: Upon Release
Warnings and Precautions
CAUTION:
Electronic Interference
CAUTION:
Aortic Reference Pressure
CAUTION:
Defibrillation
CAUTION:
System Security
WARNING:
18
OPTIS™ Integrated Next Operation and Maintenance Manual – 600173796 Rev. A
•
Never use a converter adapter to connect the AC plug to an
ungrounded wall outlet. Doing so may result in electric shock to the
patient or operator and damage to equipment.
•
Do not unplug from AC power or set system cabinet standby button to
Standby until the shutdown is complete, the screens turn black, and the
monitor LEDs turn amber. Disconnecting from AC power before the
shutdown is complete may damage the system.
•
Radio transmitting equipment, cellular phones, and strong emission
sources such as high frequency surgical equipment shall not be used in
close proximity to the OPTIS Integrated Next since this could influence
the performance of the device.
Note: The device should be used in a hospital environment
except for near active high frequency (HF) surgical equipment
and the radio frequency (RF) shielded room of a medical
equipment system for magnetic resonance imaging, where the
intensity of electromagnetic (EM) disturbances is high.
•
Check that the monitor cables and aortic pressure transducer (AO)
adapter delivered with the OPTIS Integrated Next interface are
compatible with the catheterization laboratory system to be used. The
AO should be in accordance with ANSI/AAMI BP22-1994. Once the
laboratory monitor system has been zeroed, use only the OPTIS
Integrated Next to calibrate the AO and PressureWire Guidewire.
•
The OPTIS Integrated Next is a CF Class I equipment and protected
against the effects of a discharge of a defibrillator. PressureWire
Guidewire readings may be affected by defibrillation. Recalibrate the
PressureWire Guidewire after defibrillation use.
•
To protect the privacy and security of sensitive information, including
electronic protected health information (EPHI), and to protect the integrity
of the system itself, the system should be located in a physically secure,
access-controlled environment. Do not use the OPTIS Integrated Next if
there is reason to believe the system's security has been compromised or
if the system was unaccounted for during a period of time (i.e.,
misappropriated, modified, or tampered with).
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