Teleflex ARROW ML-00701 Bedienungsanleitung

en
Central Venous Catheterization Product
for use only with Arrow MAC™ Two-Lumen Central Venous Access Device
Rx only.
Indications for Use:
The Central Venous Catheter permits venous access to the central venous circulation
through a hemostasis valve on an indwelling two-lumen central venous access device.
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. 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.
7. Using catheters not indicated for pressure injection for such
applications can result in inter-lumen crossover or rupture
with potential for injury.
8. 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.
9. 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.
10. Clinicians should be aware that slide clamps may be
inadvertently removed.
11. 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
12. Hemostasis valve to two-lumen central venous access
device connection must be secured and routinely examined
to minimize the risk of disconnection and possible air
embolism, hemorrhage, or exsanguination.
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.
•
Do not use alcohol to soak catheter surface or allow
alcohol to dwell in a catheter lumen to restore catheter
patency or as an infection prevention measure.
•
Do not use polyethylene glycol containing ointments at
insertion site.
•
Take care when infusing drugs with a high concentration
of alcohol.
1
•
thrombosis
•
inadvertent arterial
puncture
•
nerve injury
•
hematoma
•
hemorrhage
•
fibrin sheath formation
•
exit site infection
•
vessel erosion
•
catheter tip malposition
•
dysrhythmias
•
extravasation