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The Haemocell System 350 is an autologous transfusion system designed to collect blood during or after an elective or emergency surgical procedure, filter the blood, process as required by the physician, and reinfuse the autologous blood. The Haemocell System 350 is designed to be used in accordance with the American Association of Blood Banks, Guidelines for Blood Salvage and Reinfusion in Surgery and Trauma (1993). No change to the intended use of the System 350 is proposed as compared to the predicate devices.

The Haemocell System 350 is a device designed for collecting and reinfusing a patient's own blood. It comprises an electromechanical system called a Filter Pump and a range of sterile, single use disposable products which when used in accordance with their operating instructions are safe and effective in various surgical procedures. The single use disposables comprise: Collection Sets: These are plastic, biocompatible reservoirs of 600 and 1 200ml capacity which are used to contain blood suctioned from the patient during or after surgery. In both cases a regulated vacuum is applied to the collection reservoir by means of the hospital or a portable vacuum system. During surgery, a suction catheter provided with the collection reservoir is used to collect blood, whereas collection after surgery is effected by connecting a tube provided in the set to drains located at the surgical site by the surgeon. Filter Sets: These are plastic, biocompatible, preassembled membrane filters connected to tubing and flexible containers. The sets are designed to locate on the electromechanical processing system in such a way that there is no contact between the processing system and the fluid content of the filter set, thus preserving the sterility of the fluid. Reinfusion blood bags are located within either the collection set or filter set depending on the function of the set. The reinfusion bag is connected to the output of the filter set when processing is required and is used to reinfuse the processed blood when processing has been completed. Reinfusion is carried out under gravity, no pump operated or pressurised reinfusion is provided nor recommended. The electromechanical hardware comprises: - . A mobile stand on which the Filter Pump is located for ease of movement and which provides the location for fluid reservoirs. - . A mains powered Filter Pump which when fitted with the correct disposables and set up according to the instructions for use will automatically process collected blood if required and selected by the operator. The Filter Pump is not required to be connected to the patient at any time in the procedure and can be operated by a circulating nurse or operating department assistant remote from the patient. Various reusable hardware components are used with the system, such as a . vacuum canister for use with the 1200ml sterile collection reservoir to facilitate suction.