High frequency surgery is the technique to employ high frequency current in surgery with exceptional precision and reduction in operation blood loss. Minimally invasive surgery is a procedure with a minimum surgical opening compare to an open surgery while achieving a surgical purpose, patient may only need a band-aid on the incision minimizing the patient recovery time. Both of these surgical techniques are commonly used in today’s clinical practices, and both of these are employing the same technology behind their benefit – high-frequency current pass through the electrode tip in contact with the tissue and generate heat to denature and shrink tissue and blood vessels, hence induce coagulation and tissue transection.
With the application of high frequency and high voltage technology, it is inevitable that the insulation and leakage current of these surgical equipment must go under stringent guidelines to protect the safety of patients and medical professionals. It is the requirement of the International Standard IEC 60601-2-2 to test the dielectric strength and leakage current for both mono-polar, bi-polar HF surgical accessories (Active accessories). The Standard also required that the manufacturer to test the thermal performance and contact impedance in regards to NE (Neutral Electrode).
Note*: No current probe is required when the HFIT600A is used as a generator. In the NE thermal performance test, IEC standard stated that the NE under test shall be applied on human skin, surrogate media or test devices with electrical and thermal equivalent properties. Since impedance varies with different contact surfaces, in some cases (especially with high impedance), the HFIT600A is not capable to provide current up to 770mArms (maximum output of HFIT600A is150W), and in such case, an ESU along with a current probe will be required to conduct the test.
However, to perform the high frequency insulation testing (according to IEC 60601-2-2:2009, 18.104.22.168.10x, HF leakage and HF dielectric strength) a transformer has traditionally been setup with the electrosurgical equipment (ESU) in order to obtain the required voltage together with a HV probe to monitor the voltage. This traditional set up creates number of problems for the test: An ESU is intended for brute output and not fine voltage adjustment. Thus, the output may be unstable and the crest factor cannot be adjusted. Moreover, the addition of a transformer can create resonant circuits and other unexpected results. The ESU and high frequency transformer can be very expensive. The HV probes, although readable in the MHz region, it inherits a typical error in the 10-20% region, creating uncertainly in monitoring. Ad hoc set ups for measuring HF leakage current can also suffer from accuracy issues. To combat these inherit troubles for ESU engineers, WhaleTeq develops a series of ESU Accessories Test Solution – Providing manufacturer a simple and accurate testing tool for regulatory compliance.
Here are cross reference tables to illustrate our testing.
Select your WhaleTeq testing equipment
You can depend on our WhaleTeq testing equipment for the complete and compliant tests to fulfill the regulatory requirements. Click on the specific model for more product description or let us help you choose the right product for you; contact our customer service representative to get more details.
|Model||Description||Standard||Links / Downloads||Inquiry|
|HFPA150||Neutral Electrodes Impedance Tester
- Specifically designed for NE contact impedance test
- Generates 10 Vrms, 200 mArms sine wave over the frequency range from 50KHz to 5MHz
- Bulit-in conversion circuit eliminates the needs of the expensive probe for current measurement
|HF Surgical Accessories Test System||Test System for ESU Active Accessories and Cord Tests
- Applicable for mono-polar & bi-polar HF surgical accessories
- For testing HF leakage current and HF dielectric strength
|NE Test System||Test System for Neutral Electrodes and Cord Tests
- NE cord attachment test
- NE cord insulation test
- NE contact impedance test