Healthcare Professionals
Affinity CVR
Cardiotomy/Venous Reservoir
Indications, Safety, and Warnings
Minimax® Hardshell Venous Reservoir
Affinity® CVR Cardiotomy/ Venous Reservoir
Intersept® Cardiotomy Reservoir
EL Series Blood Collection and Reservoirs
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
Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. 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
Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. 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 Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. 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
Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. 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
Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. 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
Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. 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
Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions For Use which accompany each product.