Intersept

Indications, Safety, and Warnings

Indications for Use

Model 1350
The Intersept^® Cardiotomy Reservoir is indicated for use in the cardiopulmonary bypass circuit during surgery for:

• an air/fluid separation chamber;
• a temporary storage reservoir for priming solution and blood;
• the recovery and storage of blood recovered from the field by suction;
• the addition of medications or other fluids.

Model 1351/CB1351
The Intersept^® Cardiotomy Reservoir with Filter is indicated for use in the cardiopulmonary bypass circuit during surgery for:

• an air/fluid separation chamber;
• a temporary storage reservoir for priming solution and blood;
• the filtration of particulates from bank blood and the storage and filtration of blood recovered from the field by suction;
• the addition of medications or other fluids.

The Intersept^® Cardiotomy Reservoir with Filter (Model 1351 only) is also indicated for use after open heart surgery for:

• the post-operative collection of autologous blood from the chest and the aseptic return of blood to the patient for volume replacement.

Contraindications

This product used for any other purposes than for the indicated use is the responsibility of the user.

Model 1350
The cardiotomy reservoir is contraindicated for use in post-operative chest drainage/autotransfusion procedures when:

• there is an air leak in the lung or gross perforations to the chest wall exist;
• pericardial, mediastinal, pulmonary or systemic infection or malignancy is present;
• gross contamination (e.g., bone cement, lymphatic failure, perforated intestine) is present or suspected;
• aspirating blood from a site containing topical hemostatic agents, bactericidal wound irritants or antibiotics not intended for parenteral administration;
• the chest is open and vacuum is applied;
• protamine has been administered prior to the reservoir being removed from the bypass circuit;
• the patient is returned to surgery for any reason;
• vented chest tubes not incorporating vent flow regulation such as stopcock are used.

Warnings

• When used with a cell salvage system be cautious not to overfill the unit.
• Device must be properly vented to prevent over pressurization or collapse.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions and warnings, please refer to the instructions For Use which accompany each product.