Evaluation: Encision AEM EndoShield 2 Active Laparoscopic Electrode Shielding System
October 7, 2020 | Evaluations & Guidance
Preview
- The primary purpose of the system is to conduct potentially dangerous leakage current away from the patient in cases of insulation failure or unintentional capacitive coupling during laparoscopic monopolar electrosurgery. In cases of excessive leakage current, the system also automatically shuts down the electrosurgical unit's (ESU) output.
- Major system components:
- AEM EndoShield 2: a cell-phone-size, plastic-encased device (approximately 5 × 10 cm 2 × 4 in, 140 g 5 oz) that plugs into an ESU's standard return-electrode contact-quality monitor (RECQM) receptacle. The device ensures proper connections before enabling energy delivery; monitors the active monopolar electrode shaft, directing stray leakage current back to the ESU; and disables the generator's output in the event of excessive stray energy.
- The AEM EndoShield 2 communicates its status via a green check mark (indicating that the device is ready) or a red X (indicating a fault); either will flash when the battery is approaching depletion.
- The AEM EndoShield 2 is reposable (i.e., allowing a limited number of reuses). It has a reported 10- to 14-hour battery life and lasts an estimated 18 procedures. The battery will only drain when a return electrode is plugged into the EndoShield 2 outlet.
- The AEM EndoShield 2 is currently compatible with the following ESUs, though Encision claims the ability to add new generators as the market requires:
- ConMed System 5000
- Covidien (Medtronic) i) Force FX/FX-C ii) ForceTriad iii) FT10
- Erbe VIO 300D
- Megadyne Mega Power
- Olympus ESG-400
- A reusable ESU adapter is required for systems having a recessed RECQM outlet that does not allow for direct insertion of the AEM EndoShield 2 (required for the ConMed System 5000 and Olympus ESG-400).
- Connector cable: a 2.7 m (9 ft) disposable cord that connects the shielding device to the active electrode instrument and the ESU's laparoscopic monopolar accessory port. The connector cable also features a quick-reference indicator/alarm guide for the shield.
- Instrumentation: The AEM EndoShield 2 can be used only with the vendor's proprietary instruments. Encision offers a large variety of active laparoscopic instruments (e.g., scissors, graspers, dissectors, forceps, hooks, spatulas) with internally insulated and shielded shafts beneath another layer of insulating material. The insulated, shielded shafts direct stray leakage current to the shield, while the external insulating material mitigates glare from the shielded shaft, as well as providing general peace of mind for the operator.
- AEM EndoShield 2: a cell-phone-size, plastic-encased device (approximately 5 × 10 cm 2 × 4 in, 140 g 5 oz) that plugs into an ESU's standard return-electrode contact-quality monitor (RECQM) receptacle. The device ensures proper connections before enabling energy delivery; monitors the active monopolar electrode shaft, directing stray leakage current back to the ESU; and disables the generator's output in the event of excessive stray energy.