A-A-51867A
b. Handpiece actuation. The hand control style electrode pencil shall provide the capability for the user to select between the coagulation and cutting modes at the handpiece in the monopolar mode. If two switches are provided the switch nearer the active electrode shall activate the cutting mode. The “cut” switch shall be color coded yellow and the “coagulation” switch shall be color coded blue. With rocker or sliding types of switch mechanisms, a forward motion (toward the electrode) or pressure on the forward part of the switch mechanism shall activate the cutting mode.
c. Forceps actuation. Monopolar or bipolar outputs shall be switch-selectable by means of a switch built into the forceps.
7. If cutting and coagulation switches are actuated simultaneously, the unit shall operate in the coagulation mode or not at all. Unless it is designed to produce a blended output under this condition.
8. Output power, as measured at the active electrode, shall remain constant within 10 percent over the full tolerance range of line voltages specified in paragraph 19.
g. The unit shall have isolated output circuits.
10. The unit shall generate minimal radio frequency interference (RFI), both radiated and conducted, through the power line. The active cable of the ESU shall be properly insulated to limit radiated losses and prevent capacitive coupling into nearby wires and metal equipment.
11. The unit shall be provided with a positive or self-lacthing on/off switch. An indicator light shall signal that the ESU has been turned on. Separate visual indicators shall be incorporated to indicate when the ESU “RF” output has been activated. In addition, a minimum of two distinct sudible tones shall indicate cut, and coag/bipolar output activation. An adjustable volume control which cannot reduce the sound level below 45 dB shall be provided.
12. Front panel controls shall be visible and easily identifiable form a distance of at least 2.5 meters (8 feet) for vision corrected to 20/20. Footswitch and electrode connections shall be clearly labeled, color coded, or size keyed to prevent accidental attachment to improper outlets. Control indicators shall be color coded. Controls and output connectors shall be arranged in an orderly sequence.
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