Teleflex ARROW Bedienungsanleitung

Arterial Catheterization Product
For short term use (<30 days)
Rx only.
Indications for Use:
The Arrow® Arterial Catheterization Device permits access to the peripheral arterial
circulation or to other small vessels.
Contraindications:
None known.
Clinical Benefits to be Expected:
Permits access to the peripheral arterial circulation or to other small vessels. Facilitates
continuous blood pressure measurement. Facilitates blood gas sampling and analyses.
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. To minimize the risk of air embolism and blood loss
associated with disconnects use only securely tightened
Luer-Lock connections.
4. In brachial procedures, collateral flow cannot be guaranteed,
and therefore intravascular clotting can result in tissue
necrosis.
5. In radial artery procedures, practitioners must ascertain that
definite evidence of collateral ulnar flow exists.
6. Accidental infusions of drugs or therapeutics or pressure
injection into an arterial system may result in severe patient
injury or death.
7. Clinicians must be aware of complications/undesirable side-
effects associated with arterial procedures including, but not
limited to:
•
septicemia
•
vessel wall perforation
•
thrombosis
•
embolization
•
hematoma
•
arterial spasm
•
tissue necrosis
•
hemorrhage
•
peripheral ischemia
and infarction
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.
•
peripheral nerve injury
•
air embolism
•
site infection
•
cellulitis
•
catheter related blood
stream infection
(CRBSI)
3. 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 or acetone-alcohol on or near the
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.
•
Allow insertion site to dry completely prior to applying
dressing.
4. Indwelling catheter should be routinely inspected for desired
patency, security of dressing, and possible migration.
5. Use
standard precautions
institutional policies and procedures.
Kits/Sets may not contain all accessory components
detailed in these instructions for use. Become familiar with
instructions for individual component(s) before beginning
the procedure.
Insertion Instructions
A Suggested Procedure:
Prepare for Insertion:
1. Assess for adequate Collateral Arterial Circulation.
• Use of Ultrasound has been shown to increase success with catheter placement.
2. Prep and drape anticipated insertion site per institutional policies and procedures.
Where provided contoured outer trays may be used as an arm board.
3. Administer local anesthetic per institutional policies and procedures.
• A Protected Needle/Safety Needle should be used in accordance with manufacturer's
instructions for use.
4. Where applicable remove insert tube prior to use. Place on sterile field.
5. Where required, attach spring-wire tube assembly to hub of needle.
6. Remove guard. Trial advance and retract guidewire through needle using guidewire
handle to ensure proper function. Where provided, catheter hub wing clip may be
removed if desired.
Precaution: Prior to insertion, ensure guidewire is returned to the original
position before insertion or blood flashback may be inhibited.
Insert Catheter:
7. Perform arterial puncture. Blood flashback in clear hub of introducer needle indicates
successful entry into vessel (refer to Figure 1).
Precaution: If both vessel walls are punctured, subsequent advancement of
guidewire could result in inadvertent sub-arterial placement.
8. Once a blood flashback has been obtained, decrease the angle of the device to 10-20
degrees from the skin and advance entire placement device a maximum of 1 to 2 mm
further into vessel to insure that catheter is seated within the vessel.
1
and follow
Use sterile technique.
established