3
• Intended for Single Use. DO NOT REUSE. Reuse and/or repackaging may create a risk
of patient or user infection, compromise the structural integrity and/or essential material
and design characteristics of the device, which may lead to device failure, and/or lead to
injury, illness or death of the patient.
• Do not use the catheter if there is any evidence of mechanical damage or leaking.
Damage to the catheter may lead to rupture, fragmentation, possible embolism, and
surgical removal.
• If signs of extravasation exist, discontinue injections. Begin appropriate medical inter-
vention immediately.
•
The fluid level in the catheter will drop if the catheter connector is held above the level
of the patient’s heart and opened to air. To help prevent a drop in the fluid level (allowing
air entry) while changing injection caps, hold the connector below the level of the pa-
tient’s heart before removing the injection cap.
•
Exceeding the maximum flow rate or the maximum pressure of power injectors of 325
psi may result in catheter failure and/or catheter tip displacement.
• Power injector machine pressure limiting feature may not prevent over-pressurizations
of an occluded catheter, which may cause catheter failure.
• PowerMidline™ Catheter indication for power injection of contrast media implies the
catheter’s ability to withstand the procedure, but does not imply appropriateness of the
procedure for a particular patient. A suitable trained clinician is responsible for evaluat-
ing the health status of a patient as it pertains to a power injection procedure.
• Failure to warm contrast media to body temperature prior to power injection may result
in catheter failure.
• Failure to ensure patency of the catheter prior to power injection studies may result in
catheter failure.
• Use of lumens not marked “Power Injectable” for power injection may result in catheter
failure.
Placement Warnings
• If the artery is entered, withdraw the needle and apply manual pressure for several
minutes.
•
Place a finger over the orifice of the sheath to minimize the blood loss and risk of air as
-
piration. The risk of air embolism is reduced by performing this part of the procedure with
the patient performing the Valsalva maneuver until the catheter is inserted into the sheath.
• (Pediatric) This is not a right atrium catheter. Avoid positioning the catheter tip in the
right atrium. Placement or migration of the catheter tip into the right atrium may cause
cardiac arrhythmia, myocardial erosion or cardiac tamponade. The risk of these compli-
cations may be more likely in neonatal patients.
• Ensure that the stylet tip does not extend beyond the trimmed end of the catheter. Exten-
sion of the stylet tip beyond the catheter end may result in vessel damage, stylet damage,
difficult removal, stylet tip separation, potential embolism and/or risk of patient injury.
Precautions
General Precautions
• Sterilized using ethylene oxide. Do not re-sterilize.
• Carefully read and follow all instructions prior to use.
