Waste management system is a mobile device that is used in the operating room to suck and collect fluid waste and surgical smoke from the surgical site. Basically, it has suction tubes that fluid waste is removed from surgical site during collection. An inlet ports manifold that are installed in the device is connected to the suction tubing. The canister of the rover is the part where the fluid waste is collected. There are two canisters that have a design which separates the fluid volume measurement from the suction limit settings. Each canisters has a single vacuum pump which has a filtered exhaust. The canisters can be emptied to any waste disposal area because of the mobility of the rover. When the ports is opened, the suction level decrease in either canister which causes decreasing in the suction level in the other canister, as well. A docking station which is located in the waste disposal area is used to empty the fluid waste from the rover’s canister. After that, a cleaning facilitation with clean water of any fluid waste is applied to the canister in order to use it again. The device has a smoking tube which is connected to the smoke evacuator filter, and it is used to evacuate the surgical smoke which is going to be filtered inside the rover from the surgical site in the operating room
There are two standards that refer to the Neptune 2’s ability to operate in a harsh RF environment. Conducted RF IEC 61000-4-6 is a standard that is used for the conducted immunity requirement of electrical medical devices to electromagnetic disturbances range. The IEC 60601 test level for this standard is 3 Vrms and 150 kHz to 80 MHz. the Compliance level is 3 Vrms and 150 kHz to 80 MHz. the second standard is the Radiated RF IEC 61...
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..., 2012.then, there will be a follow up mailing that has warning labels for the device and detailed instructions showing how to apply them.
The purpose of a 510(k) premarket notification to obtain a marketing clearance saying that the medical device is safe, effective as other legally marketed equipment or a standard that is used for the same purpose. Basically, medical equipment must be in the same level of effectiveness and safety as the predicate device in order to be eligible for 510(k) clearance. The comparison depends on many factors such as the purpose of the device, performance characteristics, features, and the degree of risk while using it. For instance, Premarket Notification submissions for Infusion Pumps are based on their purpose and functionality while Premarket Notification submissions for medical gloves are based on their physical characteristic.
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