The AngioDynamics LifeGuard Safety Infusion Set is designed to access implanted vascular ports to administer fluids and/or to withdraw blood. The LifeGuard Safety Infusion Set is a 90° non-coring needle composed of wings, tubing, a universal Luer connector, optional Needleless Y-site, tubing clamp(s), needlestick guard and needle trap that facilitates the safe removal of the needle by encapsulating the needle during vascular port de-accessing (to help prevent needlestick injuries).

The LifeGuard 20 Gauge non Y-Site needles may be used with the AngioDynamics SmartPort CT implantable ports for power injection of contrast media. Maximum pressure recommended for power injection of contrast media is 300 psi and the maximum flow rate is 5 ml/sec. For information and instructions regarding the power injection procedure, please refer to the Instructions for Use Manual for the SmartPort CT Power Injectable Implantable Port Systems.

Contraindications:

Do not use with patients showing signs or symptoms of infection at the insertion site.

Do not use with patients who have exhibited prior intolerance to the materials of construction.

Warnings:

• Review all fluids to be used with this product for any incompatibility with plastics and plastic adhesives.
• A 10 ml syringe or larger is recommended.
• Maximum pressure recommended for power injection of contrast media with the SmartPort CT implantable ports is 300 psi and a maximum flow rate of 5ml/sec. Only LifeGuard 19 and 20 gauge non Y-Site needle models may be utilized for power injection with SmartPort CT.
• Do not use the device if the package has been opened or damaged.
• Clamp infusion set when not in use.
• Store in a cool dry place.
• Reuse of single-use devices creates a potential risk of patient or user infections.
• Contamination of the device may lead to injury, illness or death of the patient.
• Reprocessing may compromise the integrity of the device and / or lead to device failure.