LS96555-021

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Indications, Safety, and WarningsCatheter and introducer — extracorporeal membrane oxygenation and extracorporeal life supportProduct descriptionThe Bio-Medicus Life Support catheter is a single-lumen catheter used to drain or reinfuse blood. The introducer facilitates proper insertion and placement of the appropriately sized catheter over a guidewire within the vessel. These devices are intended to perfuse vessels or organs in conjunction with extracorporeal support, including Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS). Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters.These devices are sterile, nonpyrogenic, disposable, and intended for single use only. Bench studies were performed after device preconditioning including exposure (21 days) to simulated in vivo use conditions to demonstrate safety and reliability. Do not store the product above 25°C (77°F).Indications for use
The Bio-Medicus Life Support catheters and introducers are single-lumen drainage or reinfusion peripheral access catheters to be used in ECMO or ECLS with an extracorporeal circuit intended for use in adult and pediatric patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.ContraindicationsAlone, the catheter and introducer are not medical treatment devices. The introducer is to be used only with the appropriately sized Bio-Medicus Life Support catheter. These devices are intended for use only as indicated in these instructions for use. Do not insert the catheter in a vessel that has arterial dissection or severe peripheral atherosclerosis.Warnings and precautions

Read all warnings, precautions, and instructions for use carefully before use. Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient.

Verify the use-by date.

This device was designed for single use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device, which could result in patient injury, illness, or death.

Do not autoclave.

Do not use if the sterile package has been damaged or if the seal has been broken in any way.

Do not use alcohol or alcohol-based fluids for lubrication.

Thoroughly inspect the catheter before use to verify that the lumen and side holes (if applicable) are patent and that the catheter has not been damaged or kinked.

Use caution when assembling or manipulating the introducer within the catheter, or moving the suture ring.

Avoid false lumen catheterization.

Never advance, position, or place the catheter without the introducer. This action may kink and damage the catheter.

Use care to protect the side hole areas from kinking as they are passed into the vessel.

Manipulate the catheter to prevent kinks or any restrictions that may alter flow.

Manipulation of the heart with the catheter in place may cause flow restrictions.

Avoid kinking when attaching tubing and when anchoring or untethering the catheter body.

Use caution when attaching the catheter to other devices in the extracorporeal circuit to prevent damage to the device being connected or the catheter.

Clamping too close to the connector may damage the connector end.

Do not clamp wire-reinforced sections. Clamping on reinforced sections may result in permanent wall distortion or lumen collapse.

Since the catheter wall is opaque due to the presence of the spring, be sure to completely remove the air from the catheter during the priming procedure.

Avoid overinsertion of the catheter and impingement of the catheter tip against the vessel, ventricular, or atrial walls.

The use of cold solutions and cardioplegic agents, administered externally or via the coronary circulation, may increase the stiffness of urethane plastic. Increased stiffness may contribute to ventricular perforation under conditions of catheter tip pressure during manipulation of the heart.

Do not attempt to cross-clamp the catheter with the introducer in place.

Carefully monitor for signs of occlusion on both the inlet and outlet catheters.

The user assumes responsibility for any variations in extracorporeal procedures that could compromise the intended use of this device.

Initiate adequate anticoagulation therapy before patient catheterization.

Use of this product beyond the duration established by the available in vitro or in vivo data has not been demonstrated. Refer to Section 8 for a summary of bench and animal studies performed. Refer to Section 6 for possible clinical observations that may necessitate or predict the need for device replacement throughout the duration of use.

Only physicians trained and experienced in using percutaneous catheterization techniques (such as the Seldinger technique), ECMO, and ECLS should use this device.

Ischemia may occur distal to the catheter placement site.

Catheter tip placement should be confirmed by using fluoroscopy.

Use extreme caution to ensure that the return catheter and drainage catheter are not confused while being connected to the perfusion circuit.

In some cases, suture rings may not be detectable on x-ray due to the variances in anatomical densities and x-ray techniques. Modifying the x-ray angle or distance may aid in detection.

When utilizing vacuum for augmented drainage, do not exceed -100 mmHg.

Maximum pressure is 300 mmHg.

Do not expose to MRI while the catheter is inserted in the patient.

Catheter and introducer — cardiopulmonary bypassProduct descriptionThe Bio-Medicus Life Support catheter is a single-lumen catheter used to drain or reinfuse blood. These devices are sterile, nonpyrogenic, disposable, and intended for single use only. Do not store the product above 25°C (77°F).Indications for use
Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately-sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.ContraindicationsAlone, the catheter and introducer are not medical treatment devices. The introducer is to be used only with the appropriately sized Bio-Medicus Life Support catheter. These devices are intended for use only as indicated in these instructions for use. Do not insert the catheter in a vessel that has arterial dissection or severe peripheral atherosclerosis.Warnings and precautions