A-A-51867A
c. The blend mode shall provide cutting waveforms with a choice of at least three degrees of hemostasis, or allow variation of the relative amounts of hemostasis and cutting at any power setting by means of stepped or stepless controls.
3. Bipolar output control shall be independent of monopolar controls, and shall produce a coagulation waveform. Bipolar output power shall be adjustable and provide a minimum range of 0 to 30 watts, as measured into a manufacturer-specified resistive load that must be between 50-300 ohms, inclusive. Maximum output power shall not exceed 100 watts, unless a label clearly states otherwise.
4. Open circuit voltage of the unit shall be high enough to allow the surgeon to fulgurate (spray coagulate) tissue. In the coag mode, open circuit voltage, peak-to-peak, shall be at least 2200 volts into a 500 ohm load. The unit shall withstand repeated and prolonged open circuit voltage.
5. The electrosurgical apparatus shall have separate, adjustable cut, coagulate, and bipolar output power level controls. The controls may be steeped or continuously variable. At the minimum power setting, there shall be zero output power at zero control setting. If the unit has no zero setting, the minimum output power at any load resistance between 100-1000 ohms shall not exceed five percent of the rated maximum output power for that mode. Power increase shall not exceed 80 watts or 50 percent, whichever is greater, for each step of a stepped control or 10 percent advance in rotation of a continuously adjustable control.
The use of momentary activation switches for selection of power level is acceptable. If momentary activation switch is provided, the unit must be set to zero power level or “standby” mode at initial power up.
6. Output shall be activated by means of a footswitch, a hand control style electrode pencil, and forceps with a built-in switch.
a. Footswitch activation. Footswitch shall be splashproof, grounded, and have suitable mechanical protection against accidental depression. Shall be designed so that pure cut mode output is activated by the leftmost control of the footswitch as viewed by the operator.
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