Inspected Dimensions:
Folded Length: 7-1/2"
Folded Width: 5-1/2"
Safety and Efficacy Considerations:
Do not use if package has been previously opened or damaged.
Warning: Read all package insert warnings, precautions and
instructions prior to use. Failure to do so may result in severe
patient injury or death.
Do not alter catheter or any other kit/set component during
insertion, use or removal.
Procedure must be performed by trained personnel well
versed in anatomical landmarks, safe technique and potential
complications.
Indications for Use:
The single-lumen catheter permits access to the arterial or
peripheral venous circulation.
Contraindications:
Inadequate collateral arterial circulation.
Arterial/Venous Warnings and Precautions:*
1. Warning: Sterile, Single use: Do not reuse, reprocess
or resterilize. Reuse of device creates a potential risk of
serious injury and/or infection which may lead to death.
2. Warning: Care should be exercised that the indwelling
catheter is not inadvertently kinked at the hub area when
securing catheter to the patient. Kinking may weaken the
wall of the catheter and cause a fraying or fatigue of the
material, leading to possible separation of the catheter.
3. Warning: Do not apply excessive force in removing guide
wire or catheter.
4. Warning: The practitioner must be aware of potential air
embolism associated with leaving open needles or catheters
in venous or arterial puncture sites or as a consequence of
inadvertent disconnects. To lessen the risk of disconnects,
only securely tightened Luer-Lock connections should be
used with this device. Follow hospital protocol to guard
against air embolism for all catheter maintenance.
5. Warning: Due to the risk of exposure to Human
Immunodeficiency Virus (HIV) or other blood borne
pathogens, health care workers should routinely use
universal blood and body-fluid precautions in the care of
all patients.
6. Warning: Do not suture directly to outside diameter
of catheter body to minimize the risk of damaging the
catheter or adversely affecting monitoring capabilities.
7. Precaution: Indwelling catheters should be routinely
inspected for desired flow rate, security of dressing, correct
catheter position and for secure Luer-Lock connection.
8. Precaution: Alcohol and acetone can weaken the structure
of polyurethane materials. Check ingredients of prep
sprays and swabs for acetone and alcohol content.
Acetone: Do not use acetone on catheter surface. Acetone
may be applied to skin but must be allowed to dry
completely prior to applying dressing.
Alcohol: Do not use alcohol to soak catheter surface
or to restore catheter patency. Care should be taken
Arterial/Venous Catheterization Product
when instilling drugs containing high concentration of
alcohol. Always allow alcohol to dry completely prior to
applying dressing.
9. Precaution: Some disinfectants used at the catheter
insertion site contain solvents which can attack the catheter
material. Assure insertion site is dry before dressing.
Arterial Catheterization
Warnings and Precautions:*
1. Warning: Practitioners must be aware of complications
associated with arterial procedures
bacteremia,
intravascular clotting and embolization, hematoma,
arterial spasm, tissue necrosis, hemorrhage, thrombosis,
peripheral ischemia and infarction, peripheral nerve
damage
12
A Suggested Procedure:
Use sterile technique.
1. Prep and drape anticipated puncture site per hospital protocol.
2. Utilize local anesthetic as required.
3. Vessel may be accessed using catheter/needle with vented plug
only, with spring-wire guide tube or with a syringe. Catheter
hub wing clip may be removed, if desired.
• Vented plug only – Remove needle guard.
• Spring-wire guide tube – Remove vented plug. Attach
spring-wire guide tube assembly (AW-04018) to hub of
needle. To ensure proper function, advance and retract
spring-wire guide using actuating lever.
to insertion actuating lever must be retracted proximally
as far as possible or blood flashback may be inhibited.
Remove needle guard.
• Syringe – Remove vented plug. Attach syringe to hub of
needle. Remove needle guard.
4. Make a 2 mm skin nick with scalpel at the desired puncture
site.
5. Puncture vessel using a continuous, controlled, slow, forward
motion. Avoid transfixing both vessel walls.
both vessel walls are punctured, subsequent advancement
of spring-wire guide could result in inadvertent sub-
arterial placement.
entry into vessel.
6. Advance entire placement device a maximum of 1 to 2 mm
further into vessel.
7. Stabilize position of introducer needle. Insert spring-wire
guide.
• Vented plug only – Remove needle and plug. Pass
0.018" guide wire through catheter.
• Spring-wire guide tube – Carefully advance spring-wire
guide as far as required into vessel using actuating lever
(refer to Fig. 1).
1
1,10,11,15
septicemia,
vessel
wall
2
and air embolism.
3
Precaution: Prior
Blood flashback indicates successful
including
perforation,
Precaution: If