Medtronic Intersept 1351 Mode D'emploi page 10

1 Description
Model Number
1351
CB1351
The Intersept filtered cardiotomy reservoir is a single-use device with a sterile, nonpyrogenic fluid path. The maximum capacity of each reservoir is
2,600 mL. The maximum recommended flow rate is 2 L/min.
Each reservoir has eight 0.6 cm (0.25 in) ID access (luer) ports:
• 4 suction access ports
• 2 predefoamer access ports
• 2 postdefoamer access ports. One of the postdefoamer access ports is intended for use as a vent.
Note: The predefoamer access port labeled VENT/VACUUM is fitted with a yellow vented cap. All other access ports are fitted with nonventing universal
caps. To convert a universal cap to a female luer fitting, twist the top portion of the cap completely off (clockwise). To provide an access port for 0.6 cm
(0.25 in) ID tubing, turn the entire universal cap counterclockwise and remove.
1.1 Model 1351/CB1351
Each Intersept filtered cardiotomy reservoir, with or without Cortiva bioactive surface, contains an open cell polyurethane defoamer with a 20-micron
microaggregate filter covered with a polyester sleeve.
Products coated with Cortiva bioactive surface include a "CB" prefix in the model number. Additional information regarding Cortiva bioactive surface is
available in Chapter 7.
2 Indications for use
2.1 Model 1351
The Intersept filtered 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 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 filtered cardiotomy reservoir is also indicated for use after open heart surgery for the postoperative collection of autologous blood from the
chest and the aseptic return of blood to the patient for volume replacement.
2.2 Model CB1351
The Intersept filtered cardiotomy reservoir with Cortiva bioactive surface 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
3 Contraindications
Use the device only as indicated.
3.1 Model 1351
The Intersept filtered cardiotomy reservoir (Model 1351 only) is contraindicated for use in postoperative 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 (eg, 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
Complications that have been associated with autotransfusion include blood trauma, blood coagulation, coagulopathies, and particulate or air
embolism.
4 Warnings
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.
English
Description
Filtered cardiotomy reservoir
Filtered cardiotomy reservoir with Cortiva
10
TM BioActive Surface