ARGON 20-2007-02A Arterial Catheter Products Instructions

Arterial Catheter Products
Multi-language Instructions For Use (IFU)
INSTRUCTIONS FOR USE

DESCRIPTION

Arterial Catheters are small lumen catheters that are designed to be placed into an artery in the wrist, groin or other location to measure blood pressure and/or to collect blood samples for blood gas analysis. Arterial Catheter kits contain additional components to assist in the placement and use of the Arterial Catheter.
These instructions for use cover all Arterial Catheter products.
Contents of these sets have been sterilized with ethylene oxide gas. They are only for single patient, single-use applications.

INDICATIONS FOR USE

Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or frequent blood gas measurements are required.

WARNINGS

1. Carefully read these instructions before using these products. When using sets incorporating other manufacturers’ components, also read their current Instructions For Use.
2. CARE SHOULD BE EXERCISED THROUGHOUT THE PROCEDURE TO PREVENT ASPIRATION OF AIR INTO THE VASCULATURE.
3. Inspect the packaging and product for damage prior to use. Do not use if the package is damaged as sterility may be compromised.
4. Care should be taken that acetone solutions or isopropyl alcohol do not come in contact with catheter hub. Such substances could weaken the hub and cause possible leakage.
5. Tighten all connections prior to use WITHOUT OVERTIGHTENING. Overtightening can cause damage to the components. Periodically check all connections for tightness.
6. This Device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and/or reuse. Discard after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning. This device is extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused.
7. For products containing the symbol on the label: This product contains Di(2-ethlhexyl)phthalate (DEHP) which has been shown to cause reproductive harm in male neonates, pregnant women carrying male fetuses, and peripubertal males. The following procedures have been identified as posing the greatest risk for DEHP exposure: exchange transfusion in neonates, total parenteral nutrition (TPN) in neonates (with lipids in polyvinylchloride (PVC) bag), multiple procedures in sick neonates (high cumulative exposure), heart transplantation or coronary artery bypass graft surgery (aggregate dose), and massive infusion of blood into trauma patient. It is recommended that DEHP-free medical products be considered when these procedures are to be performed on male neonates, pregnant women who are carrying male fetuses, and peripubertal males.

CAUTIONS

1. Federal Law (U.S.A.) restricts these devices to sale by or on the order of a physician.
2. Physician should be familiar with the insertion technique of arterial catheters using a guide wire (Seldinger or Modified Seldinger) technique.
3. PHYSICIAN DISCRETION should be used in determining appropriate size and length of the catheter based on individual patient needs and intended insertion site.
4. Do not withdraw the guide wire back through the thin wall needle as this may damage or shear the guide wire.
5. When suturing the catheter, place suture on hub and not on catheter tubing which may restrict flow through the catheter or damage the tubing.
6. Final position of the catheter should be verified using standard imaging techniques.
7. PERIODIC INSPECTION: Placed catheter should be routinely inspected for placement, flow rate and security of dressing. Improper placement, loose suturing, or patient movement could cause extravascular migration of catheter.

PROCEDURES FOR USE

Arterial Catheter Products
The following aseptic technique is supplied only to explain Arterial Catheter introduction. At the discretion of the physician, the procedure may be altered in accordance with a preferred technique or hospital protocol.

1. Using sterile technique, prep the skin and drape the intended puncture site.
2. Raise a skin wheal by intradermal or subcutaneous infiltration of local anesthetic, if desired.
3. Perform venipuncture using the thin wall needle. Presence of blood in the clear flash-back hub verifies placement of the needle in the artery. If blood flow is not adequate, aspirate to establish desired flow. (Repositioning of thin wall needle may be necessary.)
4. Insert the flexible end of the guide wire into the thin wall needle and gently advance 5-10 cm into the artery. It may be necessary to gently rotate the guide wire to successfully advance it into the artery. Avoid vigorous manipulation of the guide wire to prevent shearing of the guide wire or damage to the vessel. If gentle rotation fails to transverse the obstruction, remove the needle and guide wire simultaneously and select another insertion site. MAINTAIN FIRM GRIP ON GUIDE WIRE AT ALL TIMES. DO NOT WITHDRAW THE GUIDE WIRE BACK THROUGH THE THIN WALL NEEDLE AS THIS MAY RESULT IN SHEARING OF THE GUIDE WIRE.
5. Remove the needle proximally, leaving the guide wire in the artery.
6. If desired, a small skin nick may be made to widen the insertion site.
7. Thread the arterial catheter over the guide wire and advance it into the artery using a rotation motion; maintain a firm grip on the proximal end of the guide wire at all times.
8. Hold catheter in desired position and remove guide wire proximally.
9. Connect a syringe to connector of catheter and aspirate to ensure flow.
10. Remove syringe and connect the catheter hub to selected monitoring line.
11. Suture catheter in place. DO NOT PLACE SUTURE ON CATHETER TUBING AS THIS MAY RESTRICT FLOW THROUGH CATHETER OR DAMAGE TUBING.
12. Follow hospital protocol for puncture site dressing and maintenance.
13. POSITION OF THE ARTERIAL CATHETER, FOLLOWING PLACEMENT, SHOULD BE ESTABLISHED BY IMAGING TECHNIQUES.

The symbols glossary is located electronically at www.argonmedical.com/symbols

ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, TX75751, US
Tel: +1 (903) 675 9321
Tel: +1 (800) 927 4669

Brasil Detentor da Notificação:
Flex Lab Comércio de Materiais Cirúrgicos e Hospitalares Ltda
CNPJ: 02.620.178/0001-60
Endereço: Rua Barão de Mesquita 74
Tijuca ­ Rio de Janeiro/RJ, CEP: 20540-006
Notificação nº: 80081350392 and 80081359023

20-2007-02A
Date of Issue: 08/29/2023 Rev. G

References

• Product Symbols | Medical Devices Symbols | Argon Medical Devices

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