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Disposable device intended to recirculate, filtrate and perfuse physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The device is intended for use in a single procedure.

The Hang&Go PAC, just like the Hang&Go HT Basic, is a disposable, single use kit intended to circulate and filtrate physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The Hang&Go PAC is supplied sterile and packaged in a proprietary-design container and it is intended to be used only with the PERFORMER HT. The Hang&Go PAC, just like the Hang&Go HT Basic, includes all necessary tubing and components for the treatment execution: circulation tubing, heater bag, reservoir, table pack (Patient inlet and outlet tubing) with thermal protections. The Flow Reverse is a disposable, sterile component of the Hang&Go PAC. It is supplied sterile, individually packaged and included in the Hang&Go PAC carton box. The crossed layout of the 4 tubing segments allow to exchange the Patient's inlet and outlet flows by selectively opening / closing two segments at a time with the provided manual clamps.

The intended use of the PERFORMER HT is to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extra-corporeal circulation of warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician. The device must be used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The PERFORMER HT is a prescription electromechanical device intended to provide isolated hyperthermic perfusion in the thoracic or peritoneal cavity by means of extracorporeal circulation of warmed. physiologically compatible sterile solution. The PERFORMER HT equipment is designed to: - operate the treatment execution by means of a color touch-screen display . - . control the temperature of solution perfused to the Patient through the extracorporeal circuit - control the flow rates of roller pumps . - control the volume in the extracorporeal circuit and Patient's body cavity . - monitor Patient's body cavity temperatures . - monitor the extracorporeal circuit pressures . - . detect air in the circuit - change the fluid path in the extracorporeal circuit by means of 2 two-ways pinch valves . The Central Information Display (CID) enables the User to interact with the PERFORMER HT equipment. The touch-screen display allows the User to: - inout Patient information . - operate the various treatment phases - display treatment parameters (e.g, flows, pressures, temperatures) . - set treatment parameters . - . set alarm limits - display graphical trending of temperature probes connected to the HTS module - · read alarm and alert messages The PERFORMER HT is intended to be used with the HANG&GO HT BASIC, a disposable, single use kit intended to circulate and filtrate the clear solutions in the thoracic or abdominal cavity. The HANG&GO HT BASIC includes all necessary lines and accessories for the treatment execution: - · circulation line - ·. heater bag - · reservoir - · table pack (Patient inlet and outlet lines) with thermal protections The HANG&GO HT BASIC is supplied sterile, packaged in a proprietary-design container, and is intended to be used only with the PERFORMER HT.

The Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The centrifugal pump is indicated for use in pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).

The Performer CPB, is a next generation heart lung machine that integrates the primary functions and safety features needed to perform cardiopulmonary bypass and related circulatory support procedures, along with enhanced user conveniences, into a reduced sized instrument. The product is designed and manufactured by RAND S.r.1., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems. This version of the device has been changed to add conventional bypass capability to the existing device which previously only supported the use of Medtronic Resting Heart Disposable Module. The conventional bypass refers to already marketed cardiopulmonary circuits that utilize a reservoir. Typical conventional circuits include oxygenators, reservoirs, centrifugal pump, filters, tubings, connectors etc. This updated version of the Performer only supports the Medtronic Bio-Medicus centrifugal Pump as the arterial pump. The changes included in Version 1.5 of the device include the following: - . Optional Level Detection capability for reservoirs: Level detectors have been added to monitor changes in fluid or blood volume in the reservoirs. The system can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to a level sensor being activated, preventing emptying the reservoir and transmitting air into the circuit. The user can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues. The level detection system is only utilized when operating with the reservoirs in the conventional cardiopulmonary bypass mode. - Optional Retrograde Detection and Occlusion capability: An AutoClamp System . has been added that utilizes a Remote Tube Clamp (RTC), placed on the arterial line which serves to prevent retrograde flow from the aorta into the venous reservoir if the Bio-Pump run mode changes. The AutoClamp System can be configured to automatically clamp the arterial line when the Bio-Pump speed changes, prevent retrograde flow and thereby prevent the potential to entrainment air around the aortic cannulation site. The AutoClamp System is only utilized when operating in the conventional cardiopulmonary bypass mode.

The Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The centrifugal pump is indicated for use in pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).

The Performer CPB, is a next generation heart lung machine that integrates the primary functions and safety features needed to perform cardiopulmonary bypass and related circulatory support procedures. along with enhanced user conveniences, into a reduced sized instrument. The product is designed and manufactured by RanD S.r.l., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems. It's initial configuration and features are optimized for use with the Medtronic Resting Heart System (K03170). The key differences between the competitive heart lung machines and the Performer CPB arc: - . A small foot print for the machine and pump's layout optimized (vertical orientation) for extracorporcal volume reduction. Collapsible feature for storage and easy transportation. - . Electrically adjustable height and stability system. - . Integrated Active Air Removal System. - . A built in printer. - Pre configured roller pump rotation . (unidirectional) and built in Handcrank in roller pumps for emergencies. - . Integrated "Memory Card" for treatment data recording and software updates. - . Integrated SatO2/Hct and Tcmperature monitoring system. - . Cardioplegia delivery air detector with pump stop feed back. - Selectable alcrt/alarm tones (including voice). . - . Active Air removal with arterial flow servo control. - . Predominant 'icon' based GUI. - Independent status colored LED system (traffic . light style) for alerts and alarms in addition to the audio and visual set ups on the actual user interface screen. - Roller pump cover sensors. - . . Real time integrated parameters' trending.