Indications For Use
Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.
Nonpyrogenic. DO NOT RESTERILIZE. DO NOT REUSE. STERILE EO.
Stainless steel guidewire with or without PTFE coating and with or without heparin bonding.
Guidewires are intended for use in the percutaneous introduction of catheters.
- Store in a cool, dark, dry place.
- The provided dispenser is the best means of storage and handling of the guidewire. Guidewires should be routinely inspected prior to use and discarded should any deformities be present in the guidewire.
- Use prior to the "Use By" date.
- Do not withdraw the guidewire through a metal cannula needle. Withdrawal may damage the guidewire or coating.
- If strong resistance is met during manipulation, discontinue the procedure and determine the cause for the resistance before proceeding. Avoid bending, kinking or modifying the shape of the wire.
Precautions for Guidewires with Heparin Bonding
- Use of heparin coated guidewires may require longer compression time at the insertion site.
- Do not wipe heparin coated guidewires, lest the heparin be wiped off.
- It has been reported that heparin induced thrombocytopenia has, in some cases, been associated with the use of heparin coated catheters. Patients exhibiting symptoms of thrombocytopenia should be monitored for a marked reduction in platelet count and for the presence of heparin associated antiplatelet antibodies. If the condition is confirmed, the physician must remove the catheter if thrombocytopenia is to be reversed and further complications avoided.
- It has been reported that certain ion-selective blood analyzers may falsely report elevated serum electrolyte levels when samples are drawn through newly inserted benzalkonium-heparin coated catheters. If ion-selective analyzers are used, we recommend that the equipment manufacturer be contacted to determine if its analyzer is affected. Flame photometry should be used to verify questionable electrolyte results.
The following complications may occur: air embolism, hematoma at the puncture site, infection, or perforation of the vessel wall.
Guidelines for Use
1. Flush the guidewire with sterile heparinized normal saline or a similar isotonic solution by connecting a syringe to the luer hub of the guidewire dispenser. 2. Insert the flexible end of the guidewire into the needle. 3. Advance the guidewire through the needle. 4. Position the guidewire. 5. Hold the guidewire in place and withdraw the needle. 6. Advance the catheter over the guidewire.
To lengthen the flexible segment of a movable-core guidewire, gently withdraw the core. To shorten the flexible segment, advance the core carefully.
Caution: While the guidewire is in a vessel, do not advance the movable core if the tip is in a curved shape. Never twist or force the core because excessive force may cause it to penetrate the coil and damage the vessel.
- Discard after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning. Guidewires are extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused. Accordingly, Navilyst Medical will not be responsible for any direct or consequential damages or expenses resulting from reuse of the guidewires.
- This is an Instructions for Use which may be used for all Navilyst Medical/SCIMED Angiographic Guidewires. Specific precautions are included for guidewires coated with heparin. Refer to package label to determine if the guidewire you are using is coated with heparin, then reference the additional heparin precautions.
Contents sterile unless package is damaged or opened. Federal (U.S.A) law restricts this device to sale by or on the order of a physician.