ACIST RXI - Cautions

Warnings, Cautions, and Symbol Denitions
ACIST RXi System User’s Guide | 7901700-001,01 2019-09 English
Cautions
e following cautions refer to hazards that could result in minor injury or
damage to the system or other equipment. Read this section carefully.
• is system is not intended for use as a blood pressure monitoring
system.
• Use only the supplied medical grade power converter (Model
MENB1030A1249F02) to ensure safe operation of the ACIST RXi
System.
• To prevent equipment damage, accessory equipment connected to the
analog or digital interfaces on the RXi System must be certied to the
respective IEC standard UL/IEC 60601-1 for medical equipment. Any
person who connects equipment to the input or output signal port is
conguring a medical system. erefore, this person is responsible for
ensuring that the system complies with the requirements of the system
standard UL/IEC 60601-1. If in doubt, consult ACIST Medical Systems
Technical Services or your local ACIST representative for assistance.
• Mains power quality should be that of a typical commercial or hospital
environment. To ensure that the RXi System remains operational
during power mains interruptions, ACIST recommends that an
uninterruptible power supply or battery backup be used to power the
system.
• Connect only to certied hemodynamic systems that have no more
than 36 VDC output voltage.
• Ensure aortic pressure is correctly set to zero on the ACIST RXi
System. Always verify that the Pa value is zero.
• Only qualied medical professionals may use the ACIST RXi System.
User vigilance is required at all times when using the system.
• To avoid inaccurate arterial pressure measurements, the use of guide
catheters larger than 8F or guide catheters with side holes are not
recommended. Avoid blocking blood ow to the selected artery. Do not
wedge the guide catheter in the selected artery.
• Carefully place the Navvus MicroCatheter on the guidewire to avoid
damage to the tip. Avoid contact between the guidewire and the small
pressure sensor that is just proximal to the microcatheter tip.
• Tighten the Tuohy Borst adapter on the guide catheter aer placing the
Navvus MicroCatheter distal sha inside the guide catheter, or false
low aortic pressure readings may result.
• Open the hemostasis valve fully to avoid damage to the Navvus
MicroCatheter tip.
• Do not perform high pressure (greater than 600 psi) uid injections
while the Navvus MicroCatheter tip is inside a guide catheter.
• Observe all Navvus MicroCatheter movement in the vessel. When
the microcatheter is in the body, it should be manipulated only under
uoroscopy. Do not attempt to move the microcatheter without
observing the resultant tip response.
Cautions