美国BC高频电刀分析仪(ESU-2400)
高频电刀检测仪操作规程
高频电刀检测仪操作规程一、设备配置：美国FLUKE公司QA-ES Ⅱ型高频电刀检测仪二、工作原理1.实际输出功率测量通过直接测量被检设备输出波的高频电压（均方根），再根据测量时设置的负载阻抗计算出被检设备的实际输出功率。
2.负载/功率曲线测试测量被检设备（设定于一定输出功率时），在不同负载电阻（10Ω～1000Ω）下的输出功率，从而得到被检设备的负载/功率曲线。
3.波峰因子（CF）测量测量手术电极上输出的峰值电压，检测装置可自动计算其与高频电压均方根的比值，即波峰因子（CF）的大小，用来评定被检设备输出波形的稳定性及电切、电凝的效果。
三、操作规程：1.检测前检查（1）查看设备接地情况，电源接地端子与机器外壳短接，辅助接地良好。
（2）打开设备开关，查看设备电源开关有无损坏或接触不良现象，设备自检是否通过，各项声光指示是否正常，关机。
（3）激发手术电极、脚踏开关各个控制钮，是否控制正常。
（4）在开机、各种控制开关操作过程中注意观察被检设备的各个颜色指示灯，绿色代表电源通过，黄色代表切割输出激励，蓝色代表凝血输出激励，红色代表设备故障。
重复（2）-（3）检查三次。
2.输出功率（1）额定负载下，不同功率时实际输出功率测量连接方法: 单极输出功率测量：按图（1）连接被检测设备与测试仪，单极有电切和电凝两种模式双极输出功率测量，按图（2）连接被检测设备与测试仪。
（2）不同负载时实际输出功率测量连接方法: 单极输出功率测量：按图（1）连接被检测设备与测试仪。
双极输出功率测量，按图（2）连接被检测设备与测试仪。
图(1) 输出功率检测图(2) 输出功率检测3.波峰因子：连接方式分别与功率测量方式相同。
4.高频漏电检测：直接测量高频加载、空载时手术电极、中性电极（或双极电极）的高频漏电流。
连接无感电阻200Ω，调至最大输出额定功率，记录每个模式中最大输出高频漏电流。
（1）加载时手术电极对地高频漏电流，按图（3）连接被检测设备与测试仪。
ESU-2000电刀测试仪
ESU-2000 Series Product OverviewA Paradigm Shift In Electrosurgery Testing Technology and Capability Is HereYour current ESU Analyzer just became obsolete – no matter how new it is!1Copyright June, 2007 by BC Group International, Inc. Author: Michael R. Erwine Revision 1 – June 13, 2007INDEXThe Next Generation in ESU Testing is Finally Here.................................................................................................................... 3 Electrosurgery 101 – A Basic Review of Electrosurgery .............................................................................................................. 3 ESU Testing 101 – Some Testing History .................................................................................................................................... 7 ESU-2050: Truly Unique in the Market......................................................................................................................................... 9 ESU-2050: A Replacement for the Discontinued Fluke 8920A Instrument................................................................................. 11 ESU-2050: Unprecedented 1% Accuracy in ESU Testing.......................................................................................................... 11 ESU-2300: A More Conventional Approach ............................................................................................................................... 11 ESU-2400: More High-End Technology to Come....................................................................................................................... 11 Common Element: Patent Pending DFA Technology................................................................................................................. 11 Up To 32,768 Data Points! ......................................................................................................................................................... 12 ESU-2050: Precision Load Resistors Are Where Accuracy Starts ............................................................................................. 13 Product Development In Cooperation with ESU Manufacturers................................................................................................. 14 Industry Standard Current Sensing Technology......................................................................................................................... 13 Working With The Best In Current Sensing: Pearson Electronics .............................................................................................. 13 Current Sensing vs. Voltage Measurement................................................................................................................................ 13 Ensuring Quality By Taking Care Of The Details ....................................................................................................................... 14 Those Crazy & Exotic Pulsed Waveforms.................................................................................................................................. 15 ESU-2300: External Load Capabilities – Built In Non-Obsolescence ......................................................................................... 16 ESU-2000 Series PC Utility Software......................................................................................................................................... 16 One Picture is Worth a Thousand Words – Or Up To 32,768 Data Points ................................................................................. 16 See The Data You Want – The Way You Want ......................................................................................................................... 17 Easy Setup and Operation ......................................................................................................................................................... 18 ESU-2050: Graphical Mode ....................................................................................................................................................... 18 Product Comparison Overview................................................................................................................................................... 18 One-Stop-Source: We Make It Easy for You.............................................................................................................................. 19 Conclusion ................................................................................................................................................................................. 20 ESU-2050 Product Specifications .............................................................................................................................................. 21 ESU-2300 Product Specifications .............................................................................................................................................. 22 Technical References................................................................................................................................................................. 23 About the Author ........................................................................................................................................................................ 24APPENDICESAPPENDIX A Fluke Biomedical 454A Instrument Specifications ............................................................................................... 26 APPENDIX B Fluke Biomedical RF-303RS Instrument Specifications ........................................................................................ 27 APPENDIX C Dale Technology DALE3000 Instrument Specifications....................................................................................... 31 APPENDIX D Metron QA-ES Instrument Specifications ............................................................................................................ 33 APPENDIX E Valleylab ForceFX Generator Output waveforms ................................................................................................ 34 APPENDIX F Valleylab Force 2 Generator Output Waveforms ................................................................................................. 36 APPENDIX G Conmed System 5000 Output Waveforms .......................................................................................................... 38 APPENDIX H (Pearson Electronics Model 411 Data Sheet)...................................................................................................... 41 APPENDIX I (Pearson Electronics Model 4100 Data Sheet) ..................................................................................................... 42 APPENDIX J (Vishay Dale NH-250 Data Sheet)........................................................................................................................ 43 ® APPENDIX K (Sample Microsoft Excel Data Export Workbook) .............................................................................................. 45 APPENDIX L (Tyco Healthcare / Valleylab Recommended Test Procedures)........................................................................... 46 APPENDIX M (ESU-2000 Series PC Utility Software Screen Shots) ......................................................................................... 49 APPENDIX N (History of BC Group International, Inc.).............................................................................................................. 522Copyright June, 2007 by BC Group International, Inc. Author: Michael R. Erwine Revision 1 – June 13, 2007The Next Generation in ESU Testing is Finally HereWith the introduction of the new BC Biomedical ESU-2000 Series of Electrosurgery (ESU) Analyzers (the ESU2050 and ESU-2300 instruments)1, BC Group International, Inc. brings to market, the most exciting and technologically significant advances in electrosurgical testing to come about in well over a decade! The new BC Biomedical ESU-2050 represents an 18-month duration major product design effort in full cooperation with some of the leading electrosurgery generator manufacturers in the worldwide medical device market. The ESU-2050 is the very first instrument of its kind to be introduced, specifically designed for electrosurgery generator testing, with 1% of reading accuracy and a testing methodology that is exactly the same as the one that many medical device manufacturers currently use2. The new ESU-2300 is a more conventional “mid-range” ESU analyzer, offering features and functionality above and beyond competitive analyzers in this “mid-range” class. Both analyzers can be easily upgraded in the field via the BC Biomedical Flash Update PC Utility Software in the event of a needed firmware update. Together, these new ESU analyzers from BC Group represent an unprecedented paradigm shift in electrosurgery testing technology, and set a new baseline for the electrosurgery test device industry. The long-awaited next generation in ESU testing has finally arrived!Electrosurgery 101 – A Basic Review of Electrosurgery3The following basic review on electrosurgery is derived from technical information obtained from various sources in the public sector, including the Tyco Healthcare/ Valleylab document, Electrosurgery Self Study Guide4, Copyright September 1999, Tyco Healthcare / Valleylab. This information is intended for basic review purposes of some of the terminology and basic principles of electrosurgery technology. Electrosurgery generally deals with electrical signal frequencies in the range of approximately 200 kHz to 3.3 MHz (see Figure 1). This is well above the human body’s inherent frequency range of susceptibility to the hazards of microshock.Figure 1Frequency Spectrum Showing Range of Frequencies for ElectrosurgeryFigure 2Current Density Differences at Surgical Site vs. Return PathElectrosurgery works based upon heat generated by the density (see Figure 2) of the high frequency current being passed through human tissue. At the surgical site, the density is typically very high, resulting in high heat and a cutting or coagulating effect. The “return path” for the high frequency current is much larger and consequently much less current density exists at this area, which allows the high frequency energy to safely leave the body without any adverse effects. There are two basic modes of electrosurgery: bipolar and monopolar. Bipolar surgery (see Figure 3) is accomplished by using two parallel poles in close proximity, where the flow of high frequency current is restricted to the two poles, one being the “source” and the other being the “return path”. A patient return electrode is typically not needed in bipolar electrosurgery applications, and because these two poles are close together, theCommercial availability scheduled for July/August 2007. See Appendix L for specific information regarding Tyco Healthcare / Valleylab recommended test setup procedures and recommended test equipment. 3 Sincere appreciation to Tyco Healthcare / Valleylab for the use of the illustrations in this section. Images and information are based upon the Valleylab publication Electrosurgery Self-Study Guide, Copyright September, 1999, Authored by Brenda C. Ulmer, RN, MN, CNOR. 4 This Tyco Healthcare / Valleylab publication can be downloaded in PDF format at /pages/list-book.html Copyright June, 2007 by BC Group International, Inc. Author: Michael R. Erwine 3 Revision 1 – June 13, 20072 1voltage level and resulting applied power are lower than in monopolar electrosurgical applications. This results in less localized tissue heating and reduced “charring” of tissue. Bipolar electrosurgery is typically used in neurosurgical and gynecological procedures, and in other procedures where there is concern due to implanted pacemakers and automatic defibrillators. In general, bipolar electrosurgery is safer that monopolar electrosurgery, and the subsequent risks of high frequency burns at the return electrode site are avoided.Figure 3Electrosurgery – Bipolar ModeFigure 4Electrosurgery – Monopolar ModeMonopolar electrosurgery (see Figure 4) is a more generalized and more frequently used mode. Monopolar electrosurgery utilizes higher voltage levels than bipolar, resulting in higher power delivered at the surgical site. The need for a well prepared and maintained patient electrode site is of paramount concern in monopolar electrosurgical applications, in order to prevent high frequency burns at the patient return electrode site. The high frequency waveform produced by the electrosurgical generator determines the physiological effect of the application of this energy to the tissue in the body. The Cut mode of an electrosurgical generator creates a continuous waveform, as shown in Figure 5. Different degrees of hemostasis (coagulation) can be achieved by utilizing varying degrees of “Blended” waveforms as shown in Figure 6.Figure 5Pure Cut - Pure Sinusoidal WaveformFigure 6Blended WaveformsThe Coag mode (see Figure 7) of an electrosurgical generator creates a waveform with large amplitude but short duration “spikes” to achieve hemostasis (coagulation). The surrounding tissue is heated when the waveform spikes and then cools down (between spikes), producing coagulation of the cells. Fulguration is achieved in the Coag mode of the electrosurgical generator, with the tip of the surgical “active electrode” held above (but not in contact with) the tissue. Electrosurgical Desiccation is achieved in either the Cut or Coag modes of the generator. The difference between Desiccation and Fulguration is the tip of the “active electrode” must contact the tissue as in Figure 8 in order to achieve Desiccation. The more desired mode to achieve tissue Desiccation through direct tissue contact is the Cut mode. Older electrosurgical generators (those produced prior to around 1968) are generally ground-referenced devices and must be used with extreme care to avoid unwanted “current division” and possible resulting high frequency burns at this site (or at multiple sites). This is illustrated in Figure 9 below. Current division can occur at any point of contact with an earth grounded point, such as the frame of the surgical table or the outer chassis of another medical device. For the most part, these types of devices are no longer used in surgical procedures, mainly due to advances in electrosurgical generator technology and concerns over safety.Copyright June, 2007 by BC Group International, Inc. Author: Michael R. Erwine Revision 1 – June 13, 20074Advances in electrosurgery generator technology brought about the “solid state” generator around 1968. Along with this more reliable and more condensed electronics technology came the introduction of the isolated-output electrosurgical generator (see Figure 10 below), thus eliminating the concern over unwanted current division and vastly improving patient safety. The outputs of these generators were no longer earth ground-referenced, so even the best electrical ground-referenced contact made to the patient would not present the risk of high frequency burns at alternate sites.Figure 7Coagulation WaveformFigure 8Tissue Penetration: Cut vs. CoagThe shift in concern now focused on the quality of the patient return electrode and electrode site, and over the succeeding years, many manufacturers introduced new monitoring techniques designed to constantly measure the integrity of the patient electrode site in order to minimize the possibility of high frequency burns at the patient electrode. The varying technologies introduced by the various electrosurgical generator manufacturers over the years have generically become know in today’s market as the Contact Quality Monitor (CQM) function (see Figure 11) of the electrosurgical generator.Figure 9Ground-Referenced Electrosurgical GeneratorFigure 10Isolated Output Electrosurgical GeneratorIn more recent years, there has been a steady stream of advances in electrosurgery generator technology, one of the most significant of which was the introduction by Tyco Healthcare / Valleylab in their Force FX Generator of “Tissue Response Technology” in the late 90’s. This technology utilizes a constant feedback loop to theFigure 11Contact Quality Monitor (CQM) FunctionFigure 12Tyco Healthcare / Valleylab Tissue Response Technology5Copyright June, 2007 by BC Group International, Inc. Author: Michael R. Erwine Revision 1 – June 13, 2007generator’s microprocessor and actually adjusts the power level output of the generator in order to provide relatively constant power delivery (and thus a consistent surgical effect) at the surgical site, regardless of tissue impedance. Electrosurgery generator improvements continue, with new introductions by leading manufacturers like Tyco Healthcare / Valleylab, Conmed (Electrosurgery Division), Erbe, Bovie, etc. on a regular basis The need for routine testing and performance verification of these generators has not deceased due to these introductions of new technologies. In fact, there are more features and safeguards to test for proper operation on today’s average electrosurgical generator than ever.Some Common Electrosurgery TerminologyActive Electrode: an electrosurgical instrument or accessory that concentrates the high frequency current at the surgical site, thus enabling the heating effect at the site and producing the desired electrosurgical effect Blend: an electrosurgical generator output waveform that combines the features of cut and coag waveforms, cutting with various degrees of hemostasis (coagulation) Contact Quality Monitor (CQM): a system that constantly monitors the impedance of the physical connection between the patient’s body and the patient return electrode and interrupts power form the electrosurgical generator is the quality of this connection is compromised electrically Current Density: the amount of electrical current flow per unit of surface area – as current density increases so does the heating of the tissue in the immediate location Current Division: high frequency electrical current leaving the intended electrosurgical patient circuit and following an alternate low impedance path of lesser resistance to earth ground, this introducing the possibility of high frequency burns at the alternate earth ground contact point – typically a concern in ground-reference generators and not isolated output generators. Coagulation: the clotting of blood or destruction of tissue with no cutting effect – electrosurgical fulguration and desiccation. Cut Mode: electrosurgical mode that produces a low voltage continuous waveform optimized for tissue cutting Desiccation: the effect of tissue dehydration and protein denaturation caused by direct contact between the electrosurgical “active electrode” and the tissue Fulguration: using electrical arcs (sparks) to coagulate tissue, whereby the sparks jump from the electrosurgical “active electrode” across an air gap to the tissue Ground-Referenced Output: an electrosurgical generator with an output that is electrically referenced to earth ground Isolated Output: an electrosurgical generator with an output that is not electrically referenced to earth ground Leakage Current: electrical current that flows along an undesired pathway, usually to earth ground – in an electrosurgical generator, RF leakage current is high frequency current that regains its ground reference and seeks earth ground. Patient Return Electrode: an electrically conductive plate or pad (also known as the dispersive electrode) that recovers the high frequency current introduced into the patient’s body by the “active electrode” during electrosurgery. This electrode minimizes the current density of this return current flow in order to minimize the possibility of high frequency burns at this electrode site. Radio Frequency (RF): frequencies above 100 kHz that transmit radio signals – the high frequency current utilized in electrosurgery Tissue Response Technology: the Tyco Healthcare / Valleylab electrosurgical generator technology that continuously measures the impedance/resistance of the tissue in contact with the patient return electrode and automatically adjusts the output of the generator accordingly to achieve a consistent tissue effect.6Copyright June, 2007 by BC Group International, Inc. Author: Michael R. Erwine Revision 1 – June 13, 2007ESU Testing 101 – Some Testing HistoryElectrosurgery generator technology has undergone tremendous technological advances over the past decade, but the technology base of ESU analyzers has remained relatively slow-moving over this same time period. The recently discontinued Fluke Biomedical Model 454A dates back to around 1992 or 1993, and until now, represents the culmination of research and development efforts on the behalf of competitive companies in the area of electrosurgery testing. Here is a brief history of ESU testing devices over the past 15 to 20 years. Analyzers are shown in the order of their introduction to the market.Bio-Tek Instruments RF-301: The very first offering in ESU analyzers by Bio-Tek Instruments. This 5 “passive” RF thermocouple ammeter type instrument got the job done. There are still quite a few RF301 instruments in use in the field today. The design was basic and rugged.No Picture AvailableNeurodyne Dempsey Model 403A: The Neurodyne Dempsey (which later became Dynatech Nevada Inc.) Model 403A was a very small-sized ESU tester with limited functionality. This was a passive technology device with an RF thermocouple type analog ammeter and a single fixed 500 internal load. Meter range was 0.2 A to 1.0 A / 20 watts to 500 watts. It was the company’s first dedicated ESU tester. There are very few of these units left in the market.Bio-Tek Instruments RF-302: The predecessor to the Bio-Tek RF-303, the RF-302 was a “passive” RF thermocouple ammeter type instrument. This gave an advantage to the RF-302 above other competitive “active” type ESU analyzers available at time. The RF-302 offered a better high frequency range than some competitive “active” units. Bio-Tek Instruments sold quite a few of these units in the market. This instrument is very similar to the BC Biomedical ESU2000A instrument that is still available today, for those customers who prefer a legacy type RF ammeter “passive” instrument approach to ESU generator testing.Dynatech Nevada Model 443: The Dynatech Nevada Model 443 was the company’s very first “active” type6 design in ESU analyzers. Despite it’s active internal circuitry and measurement technology, the Model 443 still utilized an analog meter. The Model 443 was discontinued shortly after the introduction of the Model 453A.Dynatech Nevada Model 453A: The predecessor to the 454A, the Dynatech Nevada Model 453A was probably the very first “Hi-Tech” ESU analyzer on the market. It utilized active technology. Introduced in the mid 1980’s, the Model 453A was in production until the introduction of the Dynatech Nevada Model 454A, starting in 1992 or 1993. The 453A had a small LED 7-segment display and was a fairly large instrument weighing well over 15 pounds. There are still many 453A ESU analyzers in use in biomedical departments across the U.S. today.56Passive technology in an ESU Analyzer refers to an instrument that does not require any external power source and simply meters the RF energy without any electronic signal processing. Active technology is an ESU Analyzer refers to an instrument that requires a power supply and has active electronic circuitry including components such as A/D converters. Operational amplifiers, thermal converters, etc. Copyright June, 2007 by BC Group International, Inc. Author: Michael R. Erwine 7 Revision 1 – June 13, 2007Dynatech Nevada Model 454A: Until it was recently discontinued by Fluke Biomedical (the Model 454A is no longer listed on the Fluke Biomedical web site and customers report having been informed that the 454A is no longer available from Fluke Biomedical) in favor of the more recent Metron QA-ES (re-branded as the Fluke Biomedical QA-ES effective March 18, 2007), the 454A was probably the most popular and successful ESU analyzer on the market. Originally designed by Dynatech Nevada Inc., the 454A utilized industry standard current sensing technology and offered accuracies of 5% of reading on RMS current and 10% of range on RMS power. For the the past decade, the 454A was considered to be an electrosurgery industry icon, but despite this status in the market, it never really attained any level of actual customer recommendation for any of the leading electrosurgery generator manufacturers. See Appendix A for full specifications on the discontinued Model 454A.Fluke Biomedical RF-303RS: Originally marketed as the Bio-Tek Instruments RF-303RS, this is the current “mid-range” ESU analyzer offering from Fluke Biomedical. The RF-303RS does not utilize industry standard current sensing technology, but uses simple voltage measurement instead. This product was designed during the period of time that Lionheart Technologies owned and operated Bio-Tek Instruments, DNI Nevada, and Dale Technology. A concurrent companion product to the RF-303RS was originally introduced in 1998 under the DNI Nevada (formerly Dynatech Nevada) brand as the Model 402A. The 402A was later re-branded as the Dale Technology DALE3000 following the acquisition of the biomedical holdings of Lionheart Technologies by Fluke Electronics (Fluke Biomedical) in 1993. Instrument specifications for the Fluke Biomedical (Bio-Tek Instruments) RF-303RS, the DNI Nevada 402A, and the Dale Technology DALE3000 are (were) essentially identical. Current Fluke Biomedical advertised specifications for the RF-303RS are + 5% of reading or + 3 watts (whichever is greater) on RMS power and + 2.5% of reading or + 15ma (whichever is greater) on RMS current. See Appendix B for full specifications on the RF-303RS. DNI Nevada Model 402A: The DNI Nevada Model 402A was the “sister product” to the Bio-Tek Model RF-303, introduced concurrently with the RF-303 (see information above under the RF303RS). Actual design, development, and manufacturing of the 402A and the RF-303 took place at the DNI Nevada Inc. facility in Carson City, NV, under the ownership and management of Lionheart Technologies, Inc. In order to make the two products look sufficiently different, and in order to somehow truly differentiate the two, the 402A was given an RS232 communications port and the RF-303 was given a battery for portable operation. Slightly different enclosures were also chosen, and the 402A was given an LED 7-segment display while the RF-303 was given an LCD 7-segment display. The instrument firmware that operated the 402A and RF-303 was common between the products, with firmware subroutines that recognized which instrument was being operated by the microprocessor. The RS232 communications port was added to the RF-303 much later in time, following the discontinuance of the 402A. When Fluke Electronics (Fluke Biomedical) acquired the biomedical holdings of Lionheart Technologies in 1993, the DNI Nevada Model 402A was soon after discontinued and re-branded under the Dale Technology brand as the DALE3000. Dale Technology DALE3000: The DALE3000 existed in the market for less than three-years before it was discontinued. The re-branding of the DNI Nevada Model 402A to the Dale Technology DALE3000 was concurrent with the relocation of the Dale Technology business from its original location in Thornwood, NY to Carson City, NV, in the then-existing Fluke Biomedical manufacturing facilities (the original Dynatech Nevada manufacturing facility and offices) in Carson City, NV. The discontinuance of the DALE3000 was actually fairly close in time to the Fluke acquisition of Metron AS of Trondheim, Norway, which brought the Metron QA-ES “highend” ESU analyzer to the Fluke Biomedical family of products.BC Biomedical ESU-2000A: The BC Biomedical ESU-2000A was originally introduced in the year 2000, based upon strong customer demand for a “simple but effective” legacy tester similar to the original Bio-Tek Instruments RF-302. With accuracy of + 2% of full scale on current and power, the ESU-2000A remains popular with customers today. It is still available from BC Group International. Full instrument specifications for the ESU-2000A ESU analyzer can be found on the BC Group International web site at: /acatalog/BCBiomedicalESU2000ADatasheet.pdf.8Copyright June, 2007 by BC Group International, Inc. Author: Michael R. Erwine Revision 1 – June 13, 2007。
高频电刀产品技术参数
高频电刀产品技术参数（国产）
1.电源：220V±22V；50Hz±1Hz；最大电流≤4A。
2.I类CF型防除颤普通设备
3.工作制：间歇加载连续运行10s/30s
4.使用条件：环境温度5℃-40℃，湿度≤80%
5.输出功率：单极纯切 0～300W（500Ω非电抗性负载）
单极混切1 0～250W（500Ω非电抗性负载）
单极混切2 0～200W（500Ω非电抗性负载）
单极混切3 0～120W（500Ω非电抗性负载）
单极凝 0～120W（500Ω非电抗性负载）
双极凝 0～50W（100Ω非电抗性负载）
6.主载频率：0.512MHz
7.高频漏电流≤150mA。
8.全数字控制：功率输出为闭环调幅型电刀。
9.功能齐全：单、双极兼备，适用范围广，从小儿手术、精细手术、以至大型手术，其柔和的输出特性更适于美容、配合腹腔镜、宫腔镜、关节镜、电子胃镜等手术。
10.电磁兼容：符合相关标准。
11.电切：四种切割模式供选择，其热损伤小、炭化少，热别适用于整形美容科、耳鼻喉科以及烧伤切痂等精细手术。
12.电凝：采用4us凝血窄工作脉冲、凝血迅速有效。
13.控制方式：单极由双脚踏防水开关控制输出，采用机械互锁方式，
手控刀既可手控输出，也可脚控输出，脚控刀由脚控输出，双极凝血由单脚踏防水开关控制输出。
手术过程中不必进行单、双极模式转换。
14.安全装置：装有被全球临床应用证实安全的质量型中性极板监控系统。
电刀检测仪技术参数
电刀检测仪技术参数电刀检测仪是一种在手术中用于实时检测电刀电流参数的设备。
电刀是一种常见的医疗工具，用于手术过程中切割和凝固组织。
因此，电刀电流参数的准确测量对手术的成功和患者的安全至关重要。
以下是一些常见的电刀检测仪技术参数。
1.测量范围：电刀检测仪应具有广泛的测量范围，以覆盖不同手术过程中可能出现的不同电流强度。
通常，电刀检测仪的测量范围为10mA至5000mA。
2.分辨率：电刀检测仪应具有高分辨率，以确保对不同电流强度的准确测量。
通常，分辨率在1mA至10mA之间。
3.准确性：电刀检测仪应具有高精度，以确保对电刀电流参数的准确测量。
通常，准确度在±5%至±10%之间，具体取决于测量范围和分辨率。
4.响应时间：电刀检测仪应具有快速的响应时间，以实时监测电刀电流参数的变化。
通常，响应时间在1毫秒至100毫秒之间，取决于检测仪的设计和测量算法。
5.显示和报警：电刀检测仪应具有清晰的数字显示屏，以显示当前的电刀电流参数。
同时，它还应该具有报警功能，一旦电刀电流超出设定的安全范围，就能发出声音或光信号警报。
6.数据记录和存储：电刀检测仪应具有数据记录和存储功能，以便后续的回顾和分析。
这可以帮助医生了解手术过程中的电刀使用情况，并为质量控制和培训提供依据。
7.电源：电刀检测仪通常使用可充电电池或交流电源。
充电电池可以提供便携性，并在没有电源插座的情况下使用。
交流电源则可以持续供电，无需担心电池电量耗尽。
8.安全性：电刀检测仪应具有良好的电气隔离和绝缘，以防止电流泄漏和电击风险。
它还应具有防护功能，以防止外界干扰和损坏。
除了上述技术参数外，一些电刀检测仪还可能具有其他附加功能，如声音记录、网络连接和远程监控。
这些功能可以进一步提高电刀检测仪的功能和实用性。
总之，电刀检测仪是一种重要的医疗设备，用于实时监测手术中的电刀电流参数。
准确的测量和监测可以帮助医生确保手术过程的安全和成功。
正确选择和使用电刀检测仪对于手术医生和患者来说都是至关重要的。
电刀检测仪技术参数
电刀检测仪技术参数1.仪器类型：电刀检测仪是一种电子仪器设备，用于检测电刀的性能。
2.测量对象：电刀检测仪主要用于检测电刀的电流、电压、功率和波形等性能。
3.测量范围：电刀检测仪的测量范围通常为0-500W的功率，0-1000V的电压和0-10A的电流。
4.负载模式：电刀检测仪通常支持恒流负载、恒压负载和恒功率负载三种负载模式。
5.精度：电刀检测仪的精度通常在±3%左右，具体取决于仪器的设计和制造工艺。
6.采样率：电刀检测仪的采样率通常在1000Hz以上，用于捕捉电刀输出波形的细节。
7. 响应时间：电刀检测仪的响应时间通常在10ms以下，用于实时监测电刀的变化。
8.波形显示：电刀检测仪通常配备有液晶屏幕，可以实时显示电刀输出波形，并提供数据分析功能。
9.数据传输：电刀检测仪通常支持USB、RS232和以太网等接口，可实现与计算机的数据传输和远程控制。
10.电源要求：电刀检测仪通常需要接入稳定的交流电源，电压范围为100-240V，频率范围为50-60Hz。
11. 外形尺寸：电刀检测仪的外形尺寸通常为300mm×220mm×100mm，重量在2kg左右，方便携带和使用。
12.工作环境：电刀检测仪通常适用于温度在5-40℃、湿度在10-90%RH的环境下正常工作。
13.安全性能：电刀检测仪通常具有过压、过流、短路和过热保护等功能，确保仪器和使用者的安全。
14.软件支持：电刀检测仪通常配备有专门的软件，可用于数据分析、波形绘制和报表生成等功能。
15.认证标准：电刀检测仪通常符合CE、RoHS等国际认证标准，符合相关安全和环保要求。
以上是电刀检测仪的技术参数，这些参数可以根据具体的产品型号和需求进行调整和定制。
电刀检测仪作为一种专业的仪器设备，为医疗、科研等领域提供了可靠的电刀检测和性能评估手段，进一步提高了电刀的使用安全性和效果。
关注高频电刀(一)
关注高频电刀(一)正文：电外科装置（ESU）即国内所称高频电刀，即可列入手术器械类，也可归于手术设备类。
它象手术刀一样具有切割功能，是一种取代原始切割的现代科技化的设备性的手术器械。
设备性手术器械目前已蔚为大观，有冷刀，超声刀，激光刀，微波刀，等离子刀，分子刀，水刀，红外凝固刀，立体定向放射外科刀（X刀，质子刀，自动控制刀）以及本文所述的高频电刀等。
这些刀都是运用各种先进科学技术达到切割目的的设备，虽然还不能完全取代常规使用的传统手术刀，但是在某些外科手术方面，却可取得比运用传统手术刀更好的效果，如不用切开，失血少，省时省力等。
高频电刀主要用在手术室中对组织进行切割和凝血，从这一使用角度来说，又和麻醉机，呼吸机，无影灯，手术床，吸引器等构成手术设备类产品。
1. 用途高频电刀主要用在控制失血，其方法是对手术部位进行凝血（止血），但它也可用于外科切割。
这类装置通过作用电极端释放出高频电流，对目标组织进行加热，以产生干燥，汽化和炭化作用。
高频电刀也可用于腹腔导管结扎和经尿道切除前列腺（TURP）之类的手术，由于其止血效果好，这类装置还可以具有渗出毛细血管床的脏器进行手术，如肝，脾，甲状腺和肺；以及用于需要大量抗凝剂的开胸手术中。
采用氩气可增强电外科凝血作用。
这类装置可对血管丰富的脏器的出血表面进行快速止血，氩气增强系统也可用来控制其它组织如骨髓，肺和肌肉出血。
有的高频电刀组有氩气增强系统；氩气增强系统也有单独式的，可和某些高频电刀配合使用。
与器械手术相比，高频电刀的优点是可对某些手术部位同时进行切割和凝血。
2. 工作原理\r2．1单极高频电刀单频高频电刀采用电路对组织进行切割和凝血，这一电路由高频电刀内的高频振荡器和放大器，病人，连接导线和电极组成。
在大多数应用中，采用有功导线和电极将电流输出到手术部位。
然后，电流通过手术病人由与之相连的回路电极及其导线发散到高频功率发生器的中性一端，回路电极通常置于手术病人手术部位另一端。
高频电刀技术参数
保修
1
保修期：二年（人为损坏除外）
7
供电电源：电源连接：220V∕, 50HZ,输出电流：4. 0A/220V；
8
工作模式：单极纯切、混切1、混切2、混切3、单极凝、双极凝
8. 1
单极纯切：工作频率512KHZ定额输出350W定额负载500 C
8.2
单极混1：工作频率512KHZ定额输出250W定额负载500。
8.3
单极混2：工作频率512KHZ定额输出200W定额负载500 Q
8.4
单极混3：工作频率512KHZ定额输出120W定额负载500 Q
8.5
单极凝：工作工作频率512KHZ定额输出50W定额负载IooC
9
输出方式：单极手控输出、单极脚控输出和双极脚控凝输出。
10
保护功能：本机具有开路、短路、过功率、过电流自动保护功能。 允许连续使用，允许长时间开路和短路。
高频电刀技术参数
N
技术参数
投标响应
1
适用范围：本机适用于需要切割和/或凝血的各类外科手术。
2
本机具有手控和脚控两路控制输出(只能交叉使用)，可使用单 片中性电极和双片中性电极。配备的连续性接触质量检测器可靠 性高，能随时监测中性电极状态。若接触质量低于设定值，会有 声光报警并切断输出，确保安全。
3
输出特性：CF等级低频电流隔离、全悬浮式输出。
11
安全指标符合国家标准《GB9706. 1T995医用电气设备第一部分： 安全通用要求》及≪GB9706. 4-1999医用电气设备高频手术设备 专用安全要求》。
12
主机尺寸：456mm (D) ×382mm (W) × 186mm (H)
主机净重：11. 5kg
高频电刀参数
设备名称：高频电刀
设备要求与用途：智能化、多功能，具备稳定的安全性。
最大功率：0－300W可调。
满足普外科，骨科，消化科内窥镜、整形外科、皮肤科、口腔科、等技术要求及主要参数：
1．最大功率：0－300W可调
2．工作频率：
3．开机系统自动检测功能
4．输出功率可显示最大功率水平，以W为单位，精确到1W可调。
5．有三种操作方式可供选择：双脚踏开关、手笔控制开关、单脚踏开关
6．前面板轻触式按键防水设计，易于清洁消毒，功率调节快捷精确
7．设备在运行中出现故障能能立刻停止功率输出并显示相应错误代码，及时提醒使用者
8．设备输出时的音量大小可调
9．负极板实时检测报警功能
10．电压电流超差报警
11．双极具有2种模式：自动双极和标准双极
12．VIO自动功率补偿技术13．具有9组智能记忆存储输出功能各模式下最大输出功率：
纯切：0-300W
混切1：0-250W
混切2：0-200W
精细电切：0-150W
内窥电切：0-150W
水下电切：0-300W
点凝：0-50W
面凝：0-100W
喷凝：0-200W
妇科电灼：0-120W
腔镜电凝：0-120W
双极电凝：0-100W
精细双极：0-25W
标准双极：0-50W
腔镜双极：0-100W
如有侵权请联系告知删除，感谢你们的配合！。
高频电刀检定仪操作程序
计量标准操作程序（高频电刀检测仪）一、编制依据本计量标准操作程序依据JJF1217-2009《高频电刀校准规范》。
二、设备配备美国FLUKE公司QA-ES Ⅱ型高频电刀检测仪。
三、工作原理1、实际输出功率测量通过直接测量被检设备输出波的高频电压（均方根），再根据测量时设置的负载阻抗计算出被检设备的实际输出功率；2、负载/功率曲线测试测量被检设备（设定于一定输出功率时），在不同负载电阻（10Ω～1000Ω）下的输出功率，从而得到被检设备的负载/功率曲线；3、波峰因子（CF）测量测量手术电极上输出的峰值电压，检测装置可自动计算其与高频电压均方根的比值，即波峰因子（CF）的大小，用来评定被检设备输出波形的稳定性及电切、电凝的效果。
四、环境条件（一）环境温度：（0-40）℃；（二）相对湿度：＜85%；五、操作规程1、检测前检查（1）查看设备接地情况，电源接地端子与机器外壳短接，辅助接地良好；（2）打开设备开关，查看设备电源开关有无损坏或接触不良现象，设备自检是否通过，各项声光指示是否正常，关机；（3）激发手术电极、脚踏开关各个控制钮，是否控制正常；（4）在开机、各种控制开关操作过程中注意观察被检设备的各个颜色指示灯，绿色代表电源通过，黄色代表切割输出激励，蓝色代表凝血输出激励，红色代表设备故障。
重复（2）-（3）检查三次。
2、输出功率（1）额定负载下，不同功率时实际输出功率测量连接方法:单极输出功率测量：按图（1）连接被检测设备与测试仪，单极有电切和电凝两种模式双极输出功率测量，按图（2）连接被检测设备与测试仪。
（2）不同负载时实际输出功率测量连接方法: 单极输出功率测量：按图（1）连接被检测设备与测试仪。
双极输出功率测量，按图（2）连接被检测设备与测试仪。
图（1）输出功率检测图（2）输出功率检测3.波峰因子：连接方式分别与功率测量方式相同；4.高频漏电检测：直接测量高频加载、空载时手术电极、中性电极（或双极电极）的高频漏电流。
康美SABRE 2400高频电刀电路维修2例
康美SABRE 2400高频电刀电路维修2例
陈华;冯靖祎
【期刊名称】《现代医学仪器与应用》
【年(卷),期】2004(016)002
【摘要】SABRE 2400高频电刀是一款较早进入我国的电外科手术设备。
它由微机控制，提供多路安全的、完全独立的输出。
能根据作用组织的阻抗不同，自动调整输出能量，保证切割效果一致。
又能在手术中持续监测并显示同路极板同病人的接触阻抗，当阻抗变化超过安全值，电刀产生声光报警并终止能量输出。
系统可以预设10种不同的工作模式，同时还能记忆住最后次使用时能量所设定值，方便使用人员的操作和切换。
SABRE 2400高频电刀还能满足各种常规手术和各种内镜手术的需要。
在我院长期使用过程中，有着稳定和良好的表现。
下面就近年来所遇到的情况进行探讨。
【总页数】2页(P36-37)
【作者】陈华;冯靖祎
【作者单位】310003,浙江大学医学院附属第一医院设备科;310003,浙江大学医学院附属第一医院设备科
【正文语种】中文
【中图分类】TH77
【相关文献】
1.ERBE T71D高频电刀功放电路故障维修 [J], 刘松峰
2.ERBE ICC80高频电刀典型电路分析与维修 [J], 李向东;云庆辉;晋虎
3.Sabre 2400型电刀的校准 [J], 李广
4.SABRE2400高频电刀极板故障维修 [J], 尤伟
5.康美SABRE2400高频电刀电路维修2例 [J], 陈华;冯靖祎
因版权原因，仅展示原文概要，查看原文内容请购买。
高频电刀检测仪操作规程
高频电刀检测仪操作规程
1. 确保高频电刀检测仪的电源线插座没有松动，接好并插入电源。
2. 打开仪器的电源开关，待指示灯亮起。
3. 将需要检测的高频电刀连接到仪器的测试接口上，确保连接牢固且接触良好。
4. 检查仪器的显示屏，确保其显示正常并处于待机状态。
5. 如果需要调整仪器的参数，如音量、灵敏度等，根据需要进行调整。
6. 检查被测高频电刀是否处于关机状态，确保仪器连接正确且稳定。
7. 确保周围环境安全无隐患，准备进行检测。
8. 按下仪器的开始测试按钮，仪器会开始对被测试的高频电刀进行测量。
9. 在测量过程中，注意观察仪器的显示屏，确保测量结果准确。
10. 完成测试后，根据需要保存测试结果或导出数据。
11. 关闭电源开关，拔出电源线，并保持仪器的清洁和良好的
存放状态。
备注：以上操作规程仅供参考，具体操作步骤和注意事项可参考高频电刀检测仪的用户手册或相关操作指南。
高频电刀质量控制检测参数的设定及测量方法
高频电刀质量控制检测参数的设定及测量方法邓文艳;徐楚天;周嫱【摘要】The electrosurgical unit (ESU) is a kind of generally-used buthigh-risk equipment. Our hospital implemented quality control of ESU in 2015 in line with the requirements of Beijing Municipal Administration of Hospital. FLUKE QA-ES II high frequency electrosurgical detector and ESA 615 electrical safety analyzer were used to perform the quality inspectionof the Model ERBE high frequency electric knife and Force frequency electric knife from multiple aspects, including high frequency leakage current detection, output power detection, wave crest factor detection, etc.. According to the test, 90%of ESU in our hospital met the standards. Eventually, the precautions and problems during the test were analyzed in this paper.%高频电刀是临床手术中常用的高风险医疗设备，根据北京市医院管理局的要求，我院在2015年针对在用高频电刀开展质量控制工作。
高频电刀技术参数要求
高频电刀技术参数要求1. 美国原装进口，主机具有精确的微型电脑功率输出控制，单双极通用电刀。
2．*可以同时接两个单极电刀笔，更便于开展手术。
3. *电刀有效输出功率98﹪。
4. 电刀必须具备三种单极切割模式；四种单极凝血模式；三种双极输出模式。
5.三种切割模式1低电压切割：功率≤300W，最大峰值电压1350V，专为腹腔镜手术设计2纯切：功率≤300W，最大峰值电压2300V3混切：功率≤200W，最大峰值电压3300V6．四种单极凝血模式1干燥凝血：功率≤120W，最大峰值电压3500V2电灼凝血：功率≤120W，最大峰值电压8500V*3 LCF电灼凝血：功率≤120W，最大峰值电压6900V，专为腹腔镜手术设计*4 喷射式凝血：功率≤120W，最大峰值电压9000V7 三种双极输出模式1精确双极：功率≤70W，最大峰值电压450V2标准双极：功率≤70W，最大峰值电压320V3宏双极：功率≤70W，最大峰值电压750V，用于现代腔镜外科，可以实现双极切割和凝血8. *电刀主机带有回路负极板接触质量监测系统,可随时监测负极板和病人体表的接触面积质量,接触质量不好时主机立刻停止输出,彻底消除负极板烫伤的危险.9. *设备具有组织密度即时反馈系统，该系统可依组织密度变化而由电脑控制进行输出的自动调节，而不必人为调节。
10.带射频启动口,可以连接吸烟装置。
11．带有RS232串口，通过通讯装置或者多媒体可采集电刀的有关信息，为医疗事故提供依据。
12. 可与所有内窥镜相连，将来可联接氩气车而升级为氩气刀，并且有CEM 接口，可以连接超声外科吸引器。
1;具备单、双极电凝功能主机 1台2；手控刀笔（含刀笔保护套） 5套/台3；软式病人回路电击板（带回路电极监测功能） 20套/台4；双极脚踏开关 1个/台5; 腔镜转换接头 1个/台。
高频电刀两套参数一
13.2、标准：功率1-70W，峰值电压415V。
13.3、宏：功率1-70W，峰值电压530V。
14、FT双极模式≥三种：低，中，高。
14.1、低：功率1，峰值电压214V。
14.3、高：功率45-95W，峰值电压462V。
11.2、智能模式器械：具备三按钮刀笔。
11.2.1、黄色（切割）按钮可启动切割功能。
11.2.2、透明按钮可启动止血功能并同时提供切割。
11.2.3、蓝色（凝血）按钮可启动凝血功能。
11.2.4、器械上双滑块控件：通过滑动控件，在无菌区调整模式和功率输出。
12、单极凝血模式≥三种：软凝，电灼，喷凝。
15、精确模式、标准模式和宏模式与低模式、中模式、高模式是不一致的；每一个双极模式和效果都有它的独特输出。
16、演示模式：具备演示模式功能，方便教学或检修。
17、排烟系统：具备排烟系统连接功能。
18、心电图（EKG）消隐功能：提供互连线插口，用于向心电图设备发送信号。
19、以太网：对设备执行维修操作。
3
只
4
双极脚踏开关
3
只
5
按钮式手控电刀笔
15
支
6
使用说明书
3
份
10.具有4种或以上混切模式：医生可根据需要,任意调节止血程度，可通过前部面板简单快速选择4个设置值是手术更精确、效果更好。
11.操作模式：独立操作，单极输出和双极输出，均采用独立的输出线路
12．电凝功能：接触式电凝和喷射式电凝,双极电凝；
13.开机自检功能：开机时如有问题声光报警
14.▲可预设定并储存10种操作模式：满足各外科医生的使用模式的储存并记忆，可以在工作中方便的切换。
电外科设备进展介绍
复，2019，26（9）：1148-1151.
［14 ］ 司永芳 . 骨科大手术后下肢深静脉血栓的预防及护理［J］. 中
用［J］. 河南医学高等专科学校学报，2019，31（1）：97-99.
［15 ］ 管巧玲，马雯 . 空气波压力泵预防神经外科术后昏迷患者下
［8 ］ 周红 . 预见性护理在颅内动脉瘤介入术后并发症预防中的应
electrosurgery unit，ESU）迅速商品化并成为了外科
者皮肤的病损，受此启发，他尝试使用这种电弧电
900HC 诞 生 开 始 ，电 外 科 设 备（一 般 简 称 为 电 刀 ，
［1］
机电流治疗失眠症患者的时候，火花电弧凝固了患
手术中应用最广、使用价值最高的设备 ，目前最常
流治疗皮肤溃疡，这是有记录以来首例高频电流手
血 栓 护 理 的 临 床 效 果［J］. 中 外 医 学 研 究 ，2019，17（13）：
94-96.
［17 ］ 李素慧 . 高龄患者髋关节置换术后下肢静脉血栓的预防和护
理分析［J］. 中国现代药物应用，2018，12（17）：172-174.
（收稿日期：2020-09-18）
作，这就是等离子凝固，目前临床上最常用的是氩
术将各种电切、电凝、氩等离子凝固等集成于一体，
气等离子凝固器，在进行相关操作时，由于外周氩
可作为基本的电外科设备，也可根据需求配置不同
气隔离了周围的氧气，大幅降低氧化反应，组织碳
的电外科模块，以满足不同专业外科的需要，如德
化轻并且愈合快，而由于电能集中，转换成无效热
对于不同的组织血
对于出血点的止血效果亦有提升。
研 究 已 经 证 明 ，氩 等 离 子 凝 固 在 开 放 性 手 术
Saber 2400 高频电刀操作说明
Sabre 2400 高频电刀操作说明一．电刀面板上的英文说明Monopolar Cut ——单极电切Coat ——电凝Return Monitor ——电极板监测系统Pure ——纯切Standard——点凝Dual ——双片电极板Blend ——混切Spray ——面凝Single ——单片电极板Bipolar ——双极Monitor Set ——极板阻抗锁定Presets ——程序记忆模式设定Store ——储存Hand Control ——单极手控刀Power ——电源开关Foot Control ——单极脚控刀Hi ——接触面大Lo ——接触面小二．操作说明：1．插上电刀上各有关插头，如电源线、手控刀、电极板、脚控开关等，并检查这些接头是否插紧。
2．将电极板粘贴到病人身上，要注意尽可能贴紧粘牢。
3．打开电源开关，电刀进行自检，如有故障，面板上会显示HLP字样和错误编码，并会切断电流功率输出。
4．按极板监测部分的Dual或Single键，来选择所使用的电极板种类（单片电极或双片电极），选择双片电极板时，病人接触指示灯在4—7格为正常，按下Monitor Set 键将监测到的阻抗值锁定。
5．调节所需的电切功率和方式（Pure或Blend）,按下手控刀上的Cut键或踩下脚控开关（Cut）即可进行切割。
6．调节所需的电凝功率和方式（Standard或Spray）,按下手控刀上的Coag键或踩下脚控开关（Coag）即可进行电凝。
7．根据使用的环境噪声，凋节电刀工作时的指示音量。
8．关机时，关掉电源开关,折掉所有连线即可。
杭州恒睿科学仪器有限公司注意事项：1．Sabre 2400 电刀提供了9组程序记忆模式。
首先，按Sel键设定模式1，分别调节纯切（Pure）、混切（Blend）、电凝（Coag）、双极电凝（Bipolar）的功率值为30、20、10W；然后按Store键储存；再按Sel键设定模式2，分别调节纯切、混切、电凝、双极的功率值为35、25、15W，按Store键储存。
高频电刀
内窥镜电刀手术时, 6,内窥镜电刀手术时,操作医生应使用 非金属框架眼镜, 非金属框架眼镜,防止高频辐射在全属 框架中产生涡流加热而烫伤医生脸部. 框架中产生涡流加热而烫伤医生脸部. 病员体内植有金属物体(钢环, 7,病员体内植有金属物体(钢环,钢钉 等)时,要使高频电流通道避开全属植入 物,这也是为了防止高频涡流加热而烫 伤病员组织(内部) 伤病员组织(内部). 电刀试验或手术中, 8,电刀试验或手术中,不要用裸露指头 点接触处于启动状态的电刀极板或刀头, 点接触处于启动状态的电刀极板或刀头, 因为刀头和极板上存在高频辐射, 因为刀头和极板上存在高频辐射, 即使 高频漏电流低于安全标准(150mA) (150mA)无大的 高频漏电流低于安全标准(150mA)无大的 危险,但仍可能产生刺激或灼痛. 危险,但仍可能产生刺激或灼痛.
同时, 同时,随着医疗技术的发展和临床提出 的要求, 的要求,以高频手术器为主的复合型电 外科设备也有了相应的发展: 外科设备也有了相应的发展:高频氩气 高频超声手术系统, 刀,高频超声手术系统,高频电切内窥 镜治疗系统,高频旋切去脂机等设备, 镜治疗系统,高频旋切去脂机等设备, 在临床中都取得了显著的效果. 在临床中都取得了显著的效果.而随之 派生出来的各种高频手术器专用附件 双极电切剪,双极电切镜, (如:双极电切剪,双极电切镜,电切 镜汽化滚轮电极等) 镜汽化滚轮电极等)也为临床手术开拓 了更广泛的使用范围. 了更广泛的使用范围.
极板,刀头, 5,极板,刀头,连接电缆和病员构成的 电刀外系统不得与接地金属或对地有较 大电容的金属接触, 大电容的金属接触,否则电刀从悬浮状 态变成了接地状态.手术时病员身上也 态变成了接地状态. 不得携带或接触未接地的导体(金属) 不得携带或接触未接地的导体(金属), 这些导体虽未接地但会集中高频电磁场 发生严重高频辐射. 发生严重高频辐射.手术中医扩人员必 须配戴绝缘良好的橡胶手套, 须配戴绝缘良好的橡胶手套,防止通过 医护人员接触病员形成接地点而使病员 和医护人员同时灼伤. 和医护人员同时灼伤.
医疗器械知识总结
医疗器械知识总结医疗器械——指单独或组合使用于人体的仪器、设备、器具、材料或其他物品。
准确度——测量值与理论值的偏离程度。
精密度——是指多次重复测定同一量时各测定值之间彼此相符合的程度。
输入阻抗——（广义：外加输入变量与相应变量之比，用于有能量或信号转换的系统。
狭义：电信号放大器的输入阻抗。
）灵敏度——输出变化量与输入变化量之比。
频率响应——仪器保持线性输出时允许其输入频率变化的范围。
信噪比——信号功率与噪声功率之比。
零点漂移——在信号输入量恒定或无信号输入时，输出量偏离原起始值而上下漂动变化的现象。
共模抑制比——差模增益与共模增益之比。
第Ⅰ类风险安全级别——指通过常规管理足以保证其安全性、有效性的医疗器械。
第Ⅱ类风险安全级别——指对其安全性、有效性应当加以控制的医疗器械。
第Ⅲ类风险安全级别——指植入人体、用于支持、维持生命、对人体具有潜在危险，对其安全性、有效性必须严格控制的医疗器械。
电极——为了测量和记录生物机体的生物电位或电流而安置在机体和测量仪器之间的导电界面。
共模干扰——进行生物电测量时，被测体因受到各种交变电磁场的作用，而在人体表各部位上产生的幅度、频率和相位均相同的交流感应电位。
心电图——用体表电极，以时间为单位记录下来的心脏电活动（主要是心房肌、心室肌的激动）经过躯体在体表形成的电位差变化的图形。
心电图导联——体表电信号通过电极接入生物电放大器的方式。
标准导联——亦称双极肢体导联，它反映两个肢体之间的电位差，有Ⅰ导联、Ⅱ导联、Ⅲ导联。
单极肢体导联——也称加压单极肢体导联。
把RA、LA、LL之间的均值作为零电位点，测量各肢体电极与零电位之间的电位差。
胸导联——也称单极胸导联，测量胸部电极与零电位之间的电位差。
有V1、V2、V3、V4、V5、V6运动心电图——又称运动负荷试验心电图，指在运动负荷下检测受试者的心电信号，以评估心脏功能和诊断心血管疾病。
动态心电图——又称Holter心电图，是一种长时间连续记录并编集分析人体心脏活动在活动和安静状态下心电图变化的方法。
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ESU-2400高频电刀分析仪是一款完全新标准的全功能的电外科分析仪，拥有前所未有的新功能。
采用行业标准的射频电流测量技术，基于和领先的电外科行业制造商多年的合作经验，业内最全面最准确的高频电刀全功能质量检测仪。
图一：高频电刀分析仪（ESU-2400）
我们是一家专注于医疗器械测试产品和技术的研发、销售与服务为一体的“国家高新技术企业”，我们拥有自主研发的国家发明专利技术并且代理了众多国外先进专业测试产品，如无创血压（NIBP）寿命测试系统、液压式有创压测试系统、模拟肺等。
产品特性
1、采用DFA专利技术和严格遵守电外科业界的射频电流测量标准；
2、使用0 欧到6400欧范围的内部高精度非感性测试负载，同时支持外接负载测试；
3、大屏幕显示测试连接图；
4、嵌入式实时的VGA彩色触摸屏显示操作系统；
5、可选负载曲线，自动功率分布测量；
6、RS232或USB打印机的打印检测报告；
7、通过专用端口兼容外接键盘和鼠标；
8、根据负载设置的多种功率自动设置。
图二：页面图
图三：功能介绍
技术参数
1、功率范围：0—500W，分辨率0.1W, 精度为（±4%+1W）%；
2、电流范围（RMS）：2.0—700.0mA（低量程）、20—7000mA（高量程），分辨率0.1mA（低量程）、1mA（高量程）；
3、电压范围（RMS）：0.20—70.00mV（低量程）、2.0—700.0mV（高量程），分辨率0.01mV（低量程）、0.1mV（高量程）；
4、精度：最高可达±1%；
5、内置负载范围：0—6400Ω，步进1Ω，精度为±（1%+0.5Ω）；
6、带宽：10kHz—10MHz ；
7、波峰因子：1.4—500。
图四：负载选择
图五：功率测量
图六：REM/ARM/CQM测试
图七：漏电流测试
以上就是美国BC高频电刀分析仪的相关信息，如果您还想了解更多的相关事项可以拨打我们的热线电话，可以点击我们的官网在线实时咨询我们，或者关注我们的官方微信公众号，我们会有专业的工作人员为您解答。
我们通过与国际优秀的医疗器械测试仪器制造商和专业实验室的广泛深入合作以及国内行业专家的紧密交流与协作，并严格按照ISO9001:2015质量管理体系要求为医疗器械产业在研发、生产，监督、检验，在用售后、培训，教学与研究等各领域客户提供完善的医疗器械测试整体解决方案和专业的技术服务。