96880-019

Bio-Medicus™ NextGen arterial or venous cannulae

Indications, Safety, and WarningsAdult cannula and introducerProduct descriptionAdult cannula and introducer. Sterile, nonpyrogenic, disposable, single use only.Indications for use
These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-Medicus cannula (18 cm [7.09 in] tip-length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as a venous return cannula. This product is intended for use up to 6 hours.ContraindicationsAlone, the cannula and introducer are not medical treatment devices. The cannula introducer is only to be used with the appropriately-sized Bio-Medicus cannula. These devices are intended for use only as indicated in these instructions for use. Do not use if the patient has severe peripheral atherosclerosis or severe arterial dissection.Warnings and precautions

Read all warnings, precautions, and instructions for use carefully prior to 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 patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/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 cannula prior to use to verify that the lumen and side holes (if applicable) are patent and that the cannula has not been damaged or kinked.

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

Avoid false lumen cannulation.

Never advance, position, or place the cannula without the introducer as this may kink and damage the cannula.

Carefully protect the side-hole areas from kinking as they are passed into the vessel.

Manipulate cannula in such a manner as to prevent kinks or any restrictions that may alter flow.

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

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

Use caution when attaching the cannula to other devices in the extracorporeal circuit so as not to damage the device being connected or the cannula.

Clamping too close to connector may damage connector end.

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

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

Avoid overinsertion of the cannula and possible impingement of the cannula tip against the vessel walls, ventricular walls, 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 and contribute to ventricular perforation under conditions of cannula tip pressure during manipulation of the heart.

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

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

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

As with all medical devices, this device is to be used by a trained physician only.

Initiate adequate anticoagulation therapy prior to patient cannulation.

Only physicians trained and experienced in using percutaneous cannulation techniques (such as the Seldinger technique) and cardiopulmonary bypass should use this device.

Ischemia may occur distal to the cannula placement site.

Cannula tip placement should be confirmed by using fluoroscopy.

Extreme care must be exercised to ensure that the arterial cannula and venous cannula 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 cannula is inserted in patient.

Due to the presence of phthalates in the product, the clinician must weigh the medical benefits of product use against the drawbacks of phthalate exposure for male children and pregnant or nursing women.

Pediatric cannula and introducerProduct descriptionPediatric cannula and introducers. Sterile, nonpyrogenic, disposable single use only.Indications for use
These devices are to be used by a trained physician only. Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. These products are intended for use up to 6 hours.ContraindicationsAlone, the cannula and introducer are not medical treatment devices. The introducer is to be used only with the appropriately-sized Bio-Medicus™ cannula. These devices are not intended for use except as indicated above.Warnings and precautions

Read all warnings, precautions, and Instructions for Use carefully prior to 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 Use By date.

Do not autoclave.

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

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

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

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

Avoid false lumen cannulation.

Never advance, position, or place the cannula without the introducer as this may kink and damage the cannula.

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

Manipulate cannula in such a manner as to prevent kinks or any restrictions that may alter flow.

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

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

Caution should be used when attaching the cannula to other devices in the extracorporeal circuit so as not to damage the cannula or the device being connected.

Clamping too close to connector may damage connector end.

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

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

Care must be taken to avoid overinsertion of the cannula and possible impingement of the cannula tip against the vessel/ventricular/atrial walls.

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

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

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

As with all medical devices, this device is to be used by a trained physician only.

Initiate adequate anticoagulation therapy prior to patient cannulation.

Only physicians trained and experienced in using percutaneous cannulation techniques (such as the Seldinger technique) and cardiopulmonary bypass should use this device.

Ischemia may occur distal to the cannula placement site.

Cannula tip placement should be confirmed by using fluoroscopy.

Extreme care must be exercised to ensure that the arterial cannula and venous cannula 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 cannula is inserted in patient.

Insertion kitProduct descriptionThis product contains the necessary components to achieve insertion of a Bio-Medicus™ cannula and introducer. The included items are: a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and a catheter tip syringe.Indications for use
This kit is intended for use by a trained physician only, to assist in vessel cannulation for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This kit is intended for use for up to 6 hours.ContraindicationsAlone, this kit is not a medical treatment device. Selection of patients as candidates for such procedures is the physician’s responsibility. The outcome is dependent on many variables, including patient pathology, surgical procedure, and perfusion procedures. These devices are not intended for use except as indicated above. Do not use the kit if the patient has severe peripheral atherosclerosis or severe arterial dissection.Warnings and precautions

Verify Use By date.

Do not autoclave.

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

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

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

Avoid false lumen cannulation.

Never advance, position, or place the cannula without the introducer as this may kink and damage the cannula.

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

Manipulate cannula in such a manner as to prevent kinks or any restrictions that may alter flow.

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

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

A guidewire inserted into the left ventricle through the left atrium can perforate the left ventricular apex if undue pressure is exerted by the tip.

User assumes responsibility for any variations in extracorporeal procedures that could compromise the

intended use of this device.

Thoroughly inspect the components prior to use.

As with all medical devices, this device is to be used by a trained physician only.

Initiate adequate anticoagulation therapy prior to patient cannulation.

Only physicians trained and experienced in using percutaneous cannulation techniques (such as the Seldinger technique) and cardiopulmonary bypass should use this device.

Important safety informationCare and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac procedures.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for use.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.US-CV-2500094 v1.0

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