Teleflex ARROW ZVK Bedienungsanleitung

en
Pressure Injectable Central Venous
Catheter (CVC) Product
Rx only.
Indications for Use:
The Arrow catheter is indicated to permit short-term (< 30 day) central venous access for
the treatment of diseases or conditions requiring central venous access, including, but not
limited to the following:
•
Lack of usable peripheral IV sites
•
Central venous pressure monitoring
•
Total parenteral nutrition (TPN)
•
Infusions of fluids, medications, or chemotherapy
•
Frequent blood sampling or receiving blood transfusions/blood products
•
Injection of contrast media
When used for pressure injection of contrast media, do not exceed the maximum indicated
flow rate for each catheter lumen. The maximum pressure of power injector equipment
used with the pressure injectable CVC may not exceed 400 psi.
Contraindications:
None known.
Clinical Benefits to be Expected:
The ability to gain access to the central circulation system through a single puncture site for
applications that include fluid infusion, blood sampling, medication administration, central
venous monitoring, and the ability to inject contrast media.
General Warnings and Precautions
Warnings:
1. 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. Reprocessing of
medical devices intended for single use only may result in
degraded performance or a loss of functionality.
2. Read all package insert warnings, precautions and
instructions prior to use. Failure to do so may result in severe
patient injury or death.
3. Do not place/advance catheter into or allow it to remain in
the right atrium or right ventricle. The catheter tip should be
advanced into the lower 1/3 of the Superior Vena Cava.
For femoral vein approach, catheter should be advanced into
vessel so catheter tip lies parallel to vessel wall and does not
enter right atrium.
Catheter tip location should be confirmed according to
institutional policy and procedure.
4. Clinicians must be aware of potential entrapment of
the guidewire by any implanted device in circulatory
system. It is recommended that if patient has a circulatory
system implant, catheter procedure be done under direct
visualization to reduce risk of guidewire entrapment.
5. Do not use excessive force when introducing guidewire or
tissue dilator as this can lead to vessel perforation, bleeding,
or component damage.
6. Passage of guidewire into the right heart can cause
dysrhythmias, right bundle branch block, and a perforation
of vessel, atrial or ventricular wall.
7. Do not apply excessive force in placing or removing catheter
or guidewire. Excessive force can cause component damage
or breakage. If damage is suspected or withdrawal cannot be
easily accomplished, radiographic visualization should be
obtained and further consultation requested.
8. Using catheters not indicated for pressure injection for such
applications can result in inter-lumen crossover or rupture
with potential for injury.
9. Do not secure, staple and/or suture directly to outside
diameter of catheter body or extension lines to reduce risk of
cutting or damaging the catheter or impeding catheter flow.
Secure only at indicated stabilization locations.
10. Air embolism can occur if air is allowed to enter a central
venous access device or vein. Do not leave open needles or
uncapped, unclamped catheters in central venous puncture
site. Use only securely tightened Luer-Lock connections
with any central venous access device to guard against
inadvertent disconnection.
11. Clinicians should be aware that slide clamps may be
inadvertently removed.
12. Clinicians must be aware of complications/undesirable side-
effects associated with central venous catheters including,
but not limited to:
•
cardiac tamponade
secondary to vessel,
atrial, or ventricular
perforation
•
pleural (i.e.,
pneumothorax) and
mediastinal injuries
•
air embolism
•
catheter embolism
•
catheter occlusion
•
thoracic duct laceration
•
bacteremia
•
septicemia
Precautions:
1. Do not alter the catheter, guidewire or any other kit/set
component during insertion, use or removal.
2. Procedure must be performed by trained personnel well
versed in anatomical landmarks, safe technique and
potential complications.
3. Use standard precautions and follow institutional policies for
all procedures including safe disposal of devices.
4. Some disinfectants used at catheter insertion site contain
solvents which can weaken the catheter material. Alcohol,
acetone, and polyethylene glycol can weaken the structure
of polyurethane materials. These agents may also weaken the
adhesive bond between catheter stabilization device and skin.
•
Do not use acetone on catheter surface.
1 1
•
thrombosis
•
inadvertent arterial
puncture
•
nerve injury
•
hematoma
•
hemorrhage
•
fibrin sheath formation
•
exit site infection
•
vessel erosion
•
catheter tip malposition
•
dysrhythmias
•
extravasation