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Xcela® Power Injectable PICCs

Navilyst | Critical Care | PICC
Untitled Document

Descrição

The Xcela Power Injectable PICC from Navilyst Medical is powered for confidence. With fundamental PICC requirements as its foundation, it is also designed to deliver the flow rates required for successful contrast-enhanced CTs.

Confidence in Power

With fundamental PICC requirements as its foundation, the Xcela PICC is also designed to deliver the power injection flow rates required for contrast-enhanced CTs.

Confidence in Performance

Advanced features such as large lumen diameters, reverse tapered catheter body and radiopacity are designed to augment catheter performance, from catheter placement to care and maintenance.

Confidence in Preference

With its broad range of sizes and kit configurations, the Xcela PICC provides options in a variety of placement settings, insertion techniques and patient clinical requirements.

Features

Power Injectable

- Designed to achieve flow rates for power injection necessary for contrast-enhanced CTs

Clear Extension Tubes

- Early visualization of blood return

Low Profile Hub

- Assists in easier hub manipulation
- Designed with increased patient comfort in mind

2.5 cm Reverse Taper

- Designed for kink resistance
- Firm pushability for easier placement
- Designed to minimize bleeding at the insertion site, but not occlude vessel
- “0 cm” marker location reduces chance of suture wing insertion

Alcohol-Resistant Material

- Durable
- Designed to prolong catheter life
- Compatible with most commonly used catheter care products

Large Lumen Diameters

- Designed to provide greater flow rates at lower pressures
- Developed to reduce risk of catheter occlusion
- Designed for easier blood withdrawal

Radiopacity

- Designed for visualization under fluoroscopic guidance and chest x-ray

Indications For Use

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

Indications:

The Xcela® Power Injectable PICC 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
- Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures

Warnings:

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Navilyst Medical representative.

For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.

Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

This Product Contains No Detectable Latex.
If using bacteriostatic saline, do not exceed 30 mL in a 24-hour period.
Do not fully insert catheter up to suture wing.
Do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.
Do not place the catheter into the right atrium of the heart.
Failure to warm 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 (Table 1) 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 power injectable PICC must not exceed 300 psi.

Precautions:

- If catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.
- If using an introducer sheath other than the one provided (as in Modified Seldinger and IR kits), verify that the catheter fits easily through the sheath.
- Do not insert the blunt end of the guidewire into the vein.
- Exercise care when advancing the catheter or guidewire to avoid trauma to the vessel intima. Do not use clamps, ribbed forceps, or other instruments to advance or position catheter. Use non-serrated forceps only.
- Avoid sharp or acute angles during insertion which may compromise catheter functionality.
- Acetone and polyethylene glycol-containing ointments should not be used with polyurethane catheters, as these may cause failure of the device.
- Catheter replacement may be required if catheter is cut too short.
- Do not use sharp instruments near the extension tubes or catheter shaft.
- Do not suture through any part of the catheter. If using sutures to secure catheter, make sure they do not occlude, puncture, or cut the catheter.
- Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion.
- Ensure that gloves are free of residue.
- It is recommended that only Luer lock accessories be used with the Xcela® Power Injectable PICC. Repeated over-tightening may reduce hub connector life. Do not use hemostats to secure Luer lock hub connections.
- If resistance is met while attempting to flush catheter, follow institutional protocol for occluded catheters
- When discarding used accessories, follow institutional protocol.
- Incompatible drug delivery within the same lumen may cause precipitation. Flush catheter lumen following each infusion.
- It is recommended that institutional protocols be considered for all aspects of catheter use consistent with the instructions provided herein. Bench testing has demonstrated that the Xcela® Power Injectable PICC is capable of withstanding five power injections, which could reasonably occur during a 90-day catheter indwelling period.
- Do not attempt to repair the catheter. If breaks or leaks are apparent in the catheter, remove the catheter immediately.
- Catheter removal is to be undertaken only by trained personnel.
- Use of force to remove the catheter may lead to catheter separation. Hold the catheter distal to the suture wing during removal.
- Patients must be educated regarding the care and maintenance of their PICC. The healthcare provider is responsible for this patient instruction.
- Avoid blood pressure measurement or the application of a tourniquet to an arm with an implanted device, since occlusion or other damage to the device may occur.
- Avoid pressure on the inner surface area or axilla of the cannulated arm while using crutches. 

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