ACIST CVi - Disconnect before Flushing Air; Use of Patient Kits; Cables; Catheters

Warnings
10 | English (USA) 2019-08 901418-003,01 ACIST | CVi® System User's Guide
2 Warnings, Cautions, and Symbol Denitions
Disconnect Before Flushing Air
When ushing air, be sure the tubing is disconnected from the patient.
Use of Patient Kits
ACIST-provided patient kits are designed, manufactured, and tested for
connection to catheters used in angiographic procedures. Failure to observe the
following guidelines can result in patient injury or equipment damage:
• Do not add any components to the patient kits or in conjunction with the
catheter.
• No valves or other manifolds may be placed inline between the patient kit
and the catheter.
• Do not use the single use kits on more than one patient.
• Do not allow any patient kit loaded with ISOVUE (iopamidol injection)
contrast media to sit unused for more than 10 hours.
• Do not use a syringe kit for more than six cases.
• Dispose of all single use components, including the saline bag, Manifold Kit,
and AngioTouch Hand Controller Kit aer every case.
• Properly discard patient kits in accordance with all local, state, and federal
regulations, codes, and directives.
Cables
Be sure to plug each cable only into the connector designed for it. To avoid the
risk of electric shock, never touch the pins on the connector or cable. Do not
use the CVi system if any worn or damaged cords, cables, or connectors are
detected. For replacement information, contact an ACIST representative.
Catheters
Patient connections must be made using commercially available catheters that
have been approved for angiographic studies. e system pressure limit should
not be set higher than the rated pressure limit of the catheter. For information
on catheter pressure settings and limits, refer to the instructions provided by
the catheter manufacturer.
e CVi system was tested for use with 4Fr–7Fr catheter sizes. When using
catheters 5Fr or smaller with injection ow rates > 12ml/s, the system may
reduce the ow rate to prevent Pressure Limit while providing selected volume,
or the system may Pressure Limit and stop the injection. To obtain the desired
imaging outcome in the event of Pressure Limit, the user must either reduce
the selected ow rate or use a larger size catheter to complete the injection.
Cleaning
• To avoid the risk of electric shock, and to prevent damage to the CVi
system, always disconnect it from line power before cleaning.
• Do not use excessive water when cleaning.
• A disinfecting cap must be properly placed onto the multi-use syringe
before cleaning.
• Do not immerse any components in water. Be sure that the CVi system is
completely dry before applying power.