Arrow CVC Product, Quick Manual

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Central Venous Catheter (CVC) Product
Rx only.
Indications:
The Arrow CVC is intended to provide short-term (< 30 days) central venous access for 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 fl uids, medications, or chemotherapy
•
Frequent blood sampling or receiving blood transfusions/blood products
See additional labeling for product specifi c indications.
Contraindications:
None known. See additional labeling for product specifi c contraindications.
General Warnings and Cautions
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.
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 catheter into or allow it to remain in the right atrium or right ventricle. X-ray
exam or other method in compliance with institutional policies and procedures must
show catheter tip located in lower 1/3 of the Superior Vena Cava (SVC), in accordance with
institutional guidelines.
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 high 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
fl ow. 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 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
•
thrombosis
•
inadvertent arterial
puncture
•
nerve injury
•
hematoma
•
hemorrhage
•
fi brin sheath formation
•
exit site infection
•
vessel erosion
•
catheter tip malposition
•
dysrhythmias
Cautions:
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 established institutional policies and procedures.
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.
•
Allow insertion site to dry completely prior to applying dressing.
5. Ensure catheter patency prior to use. Do not use syringes smaller than 10 mL (a fl uid fi lled
1 mL syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture.
6. Minimize catheter manipulation throughout procedure to maintain proper catheter tip position.
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.
A Suggested Procedure: Use sterile technique.
Prep Puncture Site:
1. Position patient as appropriate for insertion site.
• Subclavian or Jugular approach: Place patient in slight Trendelenburg position as tolerated to
reduce risk of air embolism and enhance venous fi lling.
• Femoral approach: Place patient in supine position.
2. Prepare clean skin with an appropriate antiseptic agent.
3. Drape puncture site.
4. Administer local anesthetic per institutional policies and procedures.
5. Dispose of needle.
SharpsAway II™ Locking Disposal Cup (where provided):
The SharpsAway II Locking Disposal Cup is used for disposal of needles (15 Ga. - 30 Ga.).
• Using one-handed technique, fi rmly push needles into disposal cup holes (refer to Figure 1).
Figure 1
• Once placed into disposal cup, needles will be automatically secured in place so that they cannot be reused.
Caution: Do not attempt to remove needles that have been placed into SharpsAway II
Locking Disposal Cup. These needles are secured in place. Damage may occur to needles if
they are forced out of disposal cup.
• Where provided, a foam SharpsAway® system may be utilized by pushing needles into foam after use.
Caution: Do not re-use needles after they have been placed into the foam SharpsAway
system. Particulate matter may adhere to needle tip.
Prepare Catheter:
6. Flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s).
7. Clamp or attach Luer-Lock connector(s) to extension line(s) to contain saline within lumen(s).
8. Leave distal extension line uncapped for guidewire passage.
Warning: Do not cut catheter to alter length.
Gain Initial Venous Access:
Echogenic Needle (where provided):
An echogenic needle is used to allow access to the vascular system for the introduction of a guidewire to
facilitate catheter placement. The needle tip is enhanced for approximately 1 cm for clinician to identify
exact needle tip location when puncturing the vessel under ultrasound.
Protected Needle/Safety Needle (where provided):
A protected needle/safety needle should be used in accordance with manufacturer’s instructions for use.
Arrow® Raulerson Syringe (where provided):
Arrow Raulerson Syringe is used in conjunction with Arrow Advancer for guidewire insertion.
9. Insert introducer needle or catheter/needle with attached syringe or Arrow Raulerson Syringe
(where provided) into vein and aspirate.
Warning: Do not leave open needles or uncapped, unclamped catheters in central venous
puncture site. Air embolus can occur with these practices.
Caution: Do not reinsert needle into introducer catheter (where provided) to reduce risk of
catheter embolus.
Verify Venous Access:
Utilize one of the following techniques to verify venous access because of the potential for inadvertent
arterial placement:
• Central Venous Waveform:
• Insert fl uid primed blunt tip pressure transduction probe into rear of plunger and through
valves of Arrow Raulerson Syringe and observe for central venous pressure waveform.
◊ Remove transduction probe if using Arrow Raulerson Syringe.
• Pulsatile Flow (if hemodynamic monitoring equipment is not available):
• Use transduction probe to open syringe valving system of Arrow Raulerson Syringe and observe
for pulsatile fl ow.
• Disconnect syringe from needle and observe for pulsatile fl ow.
Warning: Pulsatile fl ow is usually an indicator of inadvertent arterial puncture.
Caution: Do not rely on blood aspirate color to indicate venous access.