Affinity CVR

Indications, Safety, and Warnings

Minimax^® Hardshell Venous Reservoir

Affinity^® CVR Cardiotomy/ Venous Reservoir

Intersept^® Cardiotomy Reservoir

EL Series Blood Collection and Reservoirs

Assist Reservoir for ECMO

MVR^® Bag

Affinity Venous Reservoir Bag

Minimax Hardshell Venous Reservoir

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

Indication
The Minimax^® Filtered Hardshell Reservoir is indicated for use in procedures requiring the storage and filtration of blood during extracorporeal circulation at venous blood flow rates of up to 4 liters per minute and cardiotomy filtration rates of up to 2 liters per minute.

Warning
When using vacuum assisted venous drainage with a hardshell reservoir, adjustment of a centrifugal pump flow rate may be necessary.

Do not allow the reservoir to empty as this could deliver air to the patient. Gas emboli are hazardous to the patient.

If leaks are observed during priming and/or operation, this may result in air embolism to the patient and /or fluid loss. The extracorporeal circuit must be continually monitored. Do not use the device if these conditions are observed.

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

Affinity CVR Cardiotomy/ Venous Reservoir

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

Indication
The Affinity^® NT Cardiotomy/Venous Reservoir (CVR) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.

Warning
When using vacuum assisted venous drainage with a hardshell reservoir, adjustment of a centrifugal pump flow rate may be necessary.

Do not allow the reservoir to empty as this could deliver air to the patient. Gas emboli are hazardous to the patient.

If leaks are observed during priming and/or operation, this may result in air embolism to the patient and /or fluid loss. The extracorporeal circuit must be continually monitored. Do not use the device if these conditions are observed. This may result in air embolism to the patient and /or fluid loss. The extracorporeal circuit must be continually monitored. Do not use the device if these conditions are observed.

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

Intersept Cardiotomy Reservoir

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

Indication
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 filtration of particulates from bank blood and the storage and filtration of blood recovered from the field by suction and the addition of medications or other fluids.

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 complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions For Use which accompany each product.

EL Series Blood Collection and Reservoirs

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

Indication
Cardiotomy Reservoirs are indicated for use with patients undergoing cardiopulmonary bypass or autotransfusion procedures. The reservoir has been designed to collect, filter and store blood aspirated during surgery or trauma.

Warning
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 complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions For Use which accompany each product.

Assist Reservoir for ECMO

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

Indication
The R-14 and R-38 Assist Reservoirs are intended for use as venous reservoirs in conjunction with oxygenators that are indicated for use for extracorporeal membrane oxygenation (ECMO) procedures.

Warning
Gas emboli must be cleared from the extracorporeal circuit before initiating bypass. Gas emboli are hazardous to the patient. If leaks are observed during priming and/or operation, this may result in air embolism to the patient and /or fluid loss. The extracorporeal circuit must be continually monitored. Do not use the device if these conditions are observed. Caution Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions For Use which accompany each product.

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

MVR Bag

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

Indication
This product is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator.

Warning
Gas emboli must be cleared from the extracorporeal circuit before initiating bypass. Gas emboli are hazardous to the patient.

If leaks are observed during priming and/or operation, this may result in air embolism to the patient and /or fluid loss. The extracorporeal circuit must be continually monitored. Do not use the device if these conditions are observed.

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

Affinity Venous Reservoir Bag

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

Indication
The Affinity Venous Reservoir Bag is intended for use in conjunction with extracorporeal circulation devices to accommodate systemic venous and cardiotomy return blood, during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Warning
Gas emboli must be cleared from the extracorporeal circuit before initiating bypass. Gas emboli are hazardous to the patient.

If leaks are observed during priming and/or operation, this may result in air embolism to the patient and /or fluid loss. The extracorporeal circuit must be continually monitored. Do not use the device if these conditions are observed.

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