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Xcela® PICC with PASV® Valve Technology

Navilyst | Critical Care | PICC
Untitled Document

Descrição

Combining The Power of PASV® and Power Injection

Now you have the power to redefine patient care with the only power injectable PICC to incorporate PASV® Valve Technology. The Xcela® PICC with PASV® Valve Technology is designed to provide a high degree of safety, ease and confidence in patient care.

Power Injectable

Advanced features such as large lumen diameters allow the Xcela® PICC with PASV® Valve Technology to deliver the power injection flow rates required for contrast-enhanced CTs compatible with up to 325 psi CT injections.

Integrated Design

The innovative design of the PASV® Valve Technology along with the advanced material of the Xcela® Power Injectable PICC offers an advanced solution to vascular access needs.

Confidence in Results

The PASV® Valve Technology design automatically resists backflow, reducing blood reflux that could lead to catheter-related complications.

Confidence in Choice

With the addition of PASV® Valve Technology to the Xcela® Power Injectable PICC, clinicians now have the ability to choose the right PICC for the right patient.

Ease of Placement

- Variety of kit configurations
- Exact-Length™ Measurement System
- Trimmable catheter tip
- Enhanced radiopacity
- Reverse taper extrusion

Simplified Care and Maintenance

- Minimum weekly saline flush recommended*
- Use of saline may limit the complications and cost associated with heparin use
- Alcohol-resistant material
- Clampless extension legs
- Freedom to choose your preferred needleless connector

Large Lumen Diameters

- Designed to provide greater flow rates at lower pressures
- Developed to minimize risk of catheter occlusion
- Designed for easier blood withdrawal
 
*Follow institutional policies and procedures for catheter flushing.

Indications For Use

Intended Use/Indications for Use: The Xcela® PICC with PASV® Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

Contraindications:

Venous thrombosis in any portion of the vein to be catheterized. Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy. Orthopedic or neurological conditions affecting the extremity. Anticipation or presence of dialysis grafts or other intraluminal devices.

Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy. Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site. Anatomical distortion of the veins from surgery, injury or trauma. Inadequate antecubital veins. Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures. Patients with known allergies to tape or adhesive.

Warnings:

Due to the risk of exposure to bloodborne pathogens, care providers must adhere to guidelines for universal blood and bodily fluid precautions in the care of all patients. Sterile technique must be strictly adhered to during any handling of the device.

Contents are supplied sterile by EO for single patient use only. Do not use if sterile barrier is damaged. Do not use if product has been damaged. Do not reuse, reprocess or resterilize, to do so may compromise device integrity and/or lead to device failure which in turn may result in patient injury, illness or death; and may also create a risk of contamination, patient infection or cross infection which may lead to injury, illness or death of the patient.

Do not place the catheter into the right atrium or the right ventricle of the heart. Do not attempt to trim the catheter with the guidewire or stylet loaded as catheter, stylet, or guidewire may become damaged resulting in patient injury.

Failure to warm the contrast media to body temperature prior to power injection may result in catheter failure. Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure. Power injector’s pressure limiting (safety cut-off) feature may not prevent over-pressurization of occluded catheter. Exceeding the maximum allowable flow rate (per the Directions for Use) may result in catheter failure and/or catheter tip displacement.

Catheter indication for power injection of contrast media implies the catheter’s ability to withstand this procedure, but does not imply appropriateness of this procedure for a particular patient. A trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure.

The maximum pressure of power injectors used with the Xcela® PICC with PASV® Valve Technology must not exceed 325 psi. Exceeding maximum allowable flow rate may result in catheter failure and/or catheter tip displacement.

Precautions:

Do not insert the stiff end of the floppy-tipped guidewire into the vein. Acetone and polyethylene glycol-containing ointments should not be used with polyurethane catheters, as these may cause failure of the device. Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion. It is recommended that institutional protocols be considered for all aspects of catheter use consistent with the instructions provided herein including flushing of occluded catheters and power injection.

The Xcela® PICC with PASV® Valve Technology catheter testing included 10 power injection cycles. Use of a needle to access the catheter is not recommended. However, if a needle is used, do not use a needle longer than 1.9 cm as it may cause damage to the valve. Do not reinsert stylet into catheter, as damage to valve, catheter and vein may result. If a needleless connector is attached to catheter hub, first ensure that it will sustain power injection.

Refer to Directions for Use provided with the product for complete instructions, warnings and precautions.

Caution:

Federal Law (USA) restricts this device to sale by or on the order of a physician.

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