ELMED ENDO-TEST

ELMED's Contribution To Safer Laparoscopic Surgery

 With the rapidly increasing utilization of electrosurgical instrumentation during laparoscopic procedures, the risk of injuries to patient and surgeon have multiplied. Many surgeons, having been used to open surgery, often do not appreciate that laparoscopic procedures employing high-frequency current require different waveforms and techniques. This oversight has lead to many injuries with its severe legal consequences.

 ELMED has been in the forefront, creating safer electrosurgical instrumentation for laparoscopic procedures. Based on over 40 years of experience, we developed and produced generators and many innovations in collaboration with leading laparoscopic surgeons.

 The ELMED ENDO-TEST was developed as a simple tester for use in the sterile operating room field or in the instrument cleaning and maintenance departments.

 It will aid in determining whether the laparoscopic instrument is in good state of repair regarding insulation, as well as whether the surgeon is selecting the proper waveform, which is even more important

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DESCRIPTION AND OPERATING INSTRUCTIONS

OF THE ELMED ENDO-TEST

The ELMED ENDO-TEST serves two distinctive test purposes:

            *  INSULATION INTEGRITY TEST                         *  PROPER WAVEFORM TEST

INSULATION INTEGRITY TESTINSULATION INTEGRITY TEST

The integrity of any insulated instrument being used in laparoscopic surgery, particularly when connected to a monopolar generator, is of extreme importance. A defective insulation, which in many cases cannot be detected by a visual inspection, can be the cause of a serious burn injury. We strongly recommend that any insulated instrument should be tested with the ELMED ENDO-TEST prior to use.

When the ELMED ENDO-TEST is used with sterile instruments in the sterile operating room, it should be placed near the surgical site with both test electrodes being sterile. (Sterile electrodes are not required when it is used with non-sterile instruments such as in the cleaning and maintenance departments). The appropriate size sponge insert pad (3 mm Ø, 5 mm Ø or 10 mm Ø depending on Ø size of the instrument being tested. For convenience, we suggest ordering extra spare electrode for the insulation test) is soaked with a sterile conductive solution which is commonly used for irrigation. The shaft of the laparoscopic instrument to be used in the procedure is slowly pushed back and forth through the soft sponge insert, and in case of an insulation break-down, the ELMED ENDO-TEST will signal the defect. In this case, a new instrument should be used, and the defective one returned for repair.

PROPER WAVEFORM TESTPROPER WAVEFORM TEST

Once the laparoscopic instrument, hook, spatula, grasper, scissors, etc., has been found in good state of insulation, it is inserted into the sterile metal sleeve of the ENDO-TEST. The return cable of the ENDO-TEST is connected to the ground plate already in position on the patient. The surgeon then selects the waveform and the intensity of the electrosurgical generator. When activating the generator, the shaft of the laparoscopic instrument is moved back and forth through the metal sleeve of the test electrode. In case of improper waveform utilization, the high voltage will break down the insulation and thus, the tester will give alarm. If this happens, the surgeon should select another waveform, preferably a totally non-modulated one. This test is of such importance that it may be the difference between an injury or event-free surgery. If a modulated waveform is utilized, the high voltage capacitance will conduct into the trocar sleeve or other sleeves, and may lead to burn injuries. Observing this simple rule, the laparoscopic procedure will be much more satisfactory. Of course, other considerations such as irrigation with a non-conductive solution, frequent irrigation and suction as outlined in valued publications (see bibliography), are of significant importance. The surgeon or the responsible scrub nurse must visually inspect the laparoscopic instrument prior to its use and make certain that the electrosurgical generator besides being in good operating condition has the proper wave form and output selection.

ELMED manufactures a complete line of endoscopic instruments and repairs all makes within one day. Since we have our own powder coating equipment, reinsulation can also be done without delay. ELMED also manufactures specialty electrosurgical equipment for endoscopic surgery, based on over forty years of experience.

Special electrosurgical generators, such as ELMED ESU 100 series, are optimal with regard to performance and safety. All-purpose generators should, if at all possible, not be used for endoscopic surgery, as they were designed for open procedures.

BIBLIOGRAPHYBIBLIOGRAPHY

1.  Karl Hausner, "Introduction to Electrosurgery", ELMED Publication (also available on two audio cassettes, approx. total length 90 min.).

2.  Karl Hausner, "All Generators Are Not Created Equal", ELMED Publication.

3.  Karl Hausner, "Innovative Instruments for Minimally Invasive Surgery", ELMED Publication.

4.  Karl Hausner, "Endoscopic Electrode Safety", Medical Electronics, February 1992.

5.  Karl Hausner, "The Misleading Watt Meter on Electrosurgical Generators, ELMED Publication.