Arrow SLIC, Быстрый старт

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1
Safety and Efficacy Considerations:
Do not use if package has been previously opened or
damaged.
Warning: Prior to use read all package insert
warnings, precautions, and instructions. Failure to do so
may result in severe patient injury or death.
Do not alter the SLIC
®
during insertion, use, or
removal.
Procedure must be performed by trained personnel well
versed in anatomical landmarks, safe technique, and
potential complications.
Warning: Do not place the catheter into or allow it to
remain in the right atrium or right ventricle (refer to
Fig. 1).
Fig. 1
Cardiac Tamponade: It has been documented by
many authors that placement of indwelling catheters
in the right atrium is a dangerous practice
1,2,3,4,5,7,8
that may lead to cardiac perforation and
tamponade.
1,2,3,4,7,8
Although cardiac tamponade
secondary to pericardial effusion is uncommon, there
is a high mortality rate associated with it.
9
Practitioners placing central venous catheters must be
aware of this potentially fatal complication before
advancing the catheter too far relative to patient size.
No particular route or catheter type is exempt from
this potentially fatal complication.
8
The actual
position of the tip of the indwelling catheter should be
confirmed by x-ray after insertion.
1,2,4,7,8,10
Central
venous catheters should be placed in the superior vena
cava
1,2,3,4,5,7,11
above its junction with the right atrium
and parallel to the vessel wall
6,11
and its distal tip
positioned at a level above either the azygos vein or
the carina of the trachea, whichever is better
visualized.
Central venous catheters should not be placed in the
right atrium unless specifically required for special
relatively short term procedures, such as aspiration of
air emboli during neurosurgery. Such procedures are,
nevertheless, risk prone and should be closely
monitored and controlled.
Indications:
The SLIC
®
is a two-piece assembly consisting of an
infusion catheter and an obturator. With SLIC
®
obturator
removed, the Arrow SLIC
®
permits access to the central
venous circulation through an indwelling sheath/hemostasis
valve. With the SLIC
®
obturator in place, the SLIC
®
occludes the hemostasis valve preventing air entry and
blood loss through the valve.
Contraindications:
None known.
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: The practitioner must be aware of
potential air embolism problems associated with
leaving open needles, sheaths, or catheters in venous
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 for
all sheath and side port maintenance to guard
against air embolism.
3. Warning: Practitioners must be aware of
complications associated with central vein catheters
including
cardiac tamponade
secondary to
vessel wall, atrial or ventricular perforation, pleural
and mediastinal injuries, air embolism, catheter
embolism, catheter occlusion, thoracic duct
laceration, bacteremia, septicemia, thrombosis,
inadvertent arterial puncture, nerve damage,
hematoma, hemorrhage, and dysrhythmias.
4. Warning: Hemostasis valve/side port assembly to
SLIC
®
connection and SLIC
®
to obturator
connection must be secured and routinely examined
to minimize the risk of disconnection and possible
air embolism, hemorrhage, or exsanguination.
5. Warning: Due to the risk of exposure to HIV
(Human Immunodeficiency Virus) or other
bloodborne pathogens, health care workers should
routinely use universal blood and body fluid
precautions in the care of all patients.
6. Precaution: Alcohol and acetone can weaken the
structure of polyurethane materials. Check
ingredients of prep sprays and swabs for acetone
Single Lumen Infusion Catheter (SLIC
®
)
heart
(dk. red)
warning
(dk. red)
read instr.
(dk. red)
®
Inspected Dimensions:
Folded width: 5-1/2" (14 cm)
Folded length: 7-1/2" (19 cm)