HP3500

Left facing shot of the Urchin™ Evo heart positioner

Indications, Safety, and WarningsIndicationsThis product is intended for use during coronary artery bypass grafting operations. The intended function of this product is for positioning the heart.ContraindicationsThis product is not intended for use except as indicated above. Do not attach device to:

Newly infarcted tissue

Aneurysmal tissue

Directly over a coronary artery

Fragile tissue

Warnings

Patient and procedure selection is the responsibility of the medical professional, and the outcome is dependent on many variables, including patient anatomy, pathology, and surgical techniques.

The Urchin™ Evo heart positioner is to be used only on the apex of the heart and on the left ventricle immediately proximal to the apex. Do not use on atrial tissue or on the right ventricle. Always support the heart when repositioning the heart.

Precautions

Caution: Federal law (United States) restricts this device to sale by or on the order of a physician.

The instructions for use are furnished for information purposes only.

Avoid placing the device directly over a deep sulcus in the epicardial fat as this may disrupt the vacuum seal and lead to a loss of heart capture.

This device was designed for single patient use only. Do not reuse, reprocess, or resterilize any component of the system. 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.

Canister must be oriented in a vertical position.

Do not exceed (-)250 mm Hg of suction.

Do not use this device as a suction source to remove blood from the operative field.

Do not fill past the maximum capacity line on canister.

Adverse effects

None known

UC202409167 EN

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