Important Risk Information DIGNITY® CT POWER INJECTABLE PORTS Indications For Use: The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5ml/s with a 19- or 20-gauge non-coring power injectable needle. The maximum recommended infusion rate is 2ml/s with a 22-gauge non-coring power injectable needle. Contraindications: This device is contraindicated for catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates of pinch-off.1,2 The device is also contraindicated: When the presence of device related infection, bacteremia, or septicemia is known or suspected. When the patient’s body size is insufficient for the size of the implanted device. When the patient is known or is suspected to be allergic to materials contained in the device. If severe chronic obstructive lung disease exists. If the prospective insertion site has been previously irradiated. If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures. If local tissue factors will prevent proper device stabilization and/or access. PRO-FUSE® CT POWER INJECTABLE PORTS Indications For Use: The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5ml/s with a 19- or 20-gauge non-coring power injectable needle. The maximum recommended infusion rate is 2ml/s with a 22-gauge non-coring power injectable needle. Contraindications: This device is contraindicated for catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates of pinch-off.1,2 The device is also contraindicated: When the presence of device related infection, bacteremia, or septicemia is known or suspected. When the patient’s body size is insufficient for the size of the implanted device. When the patient is known or is suspected to be allergic to materials contained in the device. If severe chronic obstructive lung disease exists. If the prospective insertion site has been previously irradiated. If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures. If local tissue factors will prevent proper device stabilization and/or access. Refer to Instructions for Use for complete instructions, warnings, and contraindications. Observe all Instructions for Use prior to using products. Failure to do so may result in patient complications. For patient information please visit www.medcomp.net/patientinformation
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