Summary of Safety & Performance Information for 3T Heater Cooler
1. INDICATIONS FOR USE / INTENDED PURPOSE
EU: In accordance with the applicable regulations, the heater-cooler is used with a Stöckert/Sorin Heart-Lung Machine (S3/SC/S5/C5) for the controlled heating/cooling of 3 water circuits during extracorporeal perfusion. The water circuits are used for cooling/heating blood (in the oxygenator), hypothermia blankets or cardioplegic solutions.
US: The Heater-Cooler System 3T is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
There are no known contraindications for the Heater-Cooler System 3T. The attending physician is solely responsible for the use of the system.
It is important to follow the cleaning and disinfection process described in the operating instructions to help reduce the risk of contamination. Personnel and preparation:
- Only individuals trained to use the heater-cooler should perform maintenance on the heater-cooler.
- Only service technicians authorized by LivaNova may repair the heater-cooler system.
- Only refrigerant systems experts are authorized to repair the cooling circuit.
- Do not service the internal components of the heater-cooler. Only LivaNova representatives — or other service personnel deemed qualified by LivaNova — are authorized to maintain, service, and repair internal components of the heater-cooler. Materials and protective equipment:
- When performing any maintenance activities on the heater-cooler, follow your hospital’s personal protection equipment (PPE) policy to protect against exposure to hazardous materials, such as bacteria and/or disinfectant chemicals.
Do not connect the heater-cooler to a heart-lung machine’s auxiliary outlet. The heater-cooler should be connected to a separate dedicated AC line. To avoid the risk of electric shock, the heater-cooler must only be connected to a supply mains with protective earth.
Operation of the heater-cooler without an applied vacuum source will stop the collection of aerosol from the water tanks.
Do not position the heater-cooler’s and portable vacuum source’s (if applicable) exhaust flow toward the operating field. Position the exhaust flow away from the operating field and toward the exhaust vent system.
Operating the heater-cooler with the vacuum level indicated on the tank vacuum gauge in the red solid zone limits the aerosol collection set’s ability to collect aerosol from the water tanks.
Do not empty the external circuits until the patient has been discharged from the OR environment to reduce the potential of exposure to aerosol.
Do not shut off the applied vacuum source until you have drained the circuits and powered off the heater-cooler. Operate the heater-cooler with an applied vacuum source to ensure that aerosol continues to be collected from the water tanks.
Do not close all valves at once when draining water circuits. Always close one circuit valve at a time. Failure to close the external water circuit valves in the order specified below may result in increased levels of aerosol emission.
The aerosol collection canister contents are potentially hazardous due to collection of bacteria. Use appropriate Personal Protection Equipment (PPE), and handle the contents accordingly.
Do not use disinfectants in the water circuits during a surgical intervention. Only use disinfectants preoperatively and postoperatively.
Use only one disinfectant and make sure it is the same one you added when filling the tanks for disinfection.The use of both products will potentially result in a dangerous chemical reaction.
Do not use the heater cooler if the control panel is flashing. This means the heater-cooler is in service mode. Power off the heater-cooler and power it on again to exit service mode.
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. For a complete listing of precautions/cautions please refer to the Instructions for Use which accompany each product
The devices should be used by qualified and skilled personnel, able to follow the indications and instructions for use contained in the information provided by the manufacturer. Please contact us through our website to receive instructions for use containing full prescribing information including indications, contraindications, warnings, precautions and adverse events.
The information contained in this summary represents partial excerpts taken from the product labeling. The information is not intended to serve as a substitute for a complete and through understanding of the device nor does this information represent full disclosure of all pertinent information concerning the use of this product.
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