医疗级电源 – 模块化

由于医疗应用存在着高风险，相关的电子设备必须受到极高的安全性和可靠性的标准检视。RECOM的模块化REM和RACM系列转换器能提供完整的解决方案，缩短设计时间、简化最终用户的认证过程并加快产品的上市时间。这些DC/DC和AC/DC转换器系列具有双重患者保护（2 x MOPP），以低漏电流（符合BF型）和 >8mm的爬电和间隙距离来加强隔离。所有医疗级转换器为嵌入式并经过全面性的测试。由于其高达8kVDC的加强型隔离特性，RECOM 的RxxPxx/R和RxxP2xx/R系列也适用于医疗的高压应用。

It is an energy source that has to possess properties that need to meet the necessary standards for medical use in a hospital or residential home. The worldwide ES/IEC/EN 60601-1 3rd Ed. standard provides us with guidelines, which are more stringent compared to guidelines for commercial or industrial appliances. Higher safety standards and lower electromagnetic interference are required, providing EMC Compliance.

What to consider for complying with ES/IEC/EN 60601-1 3rd Ed.?

The 3rd edition of IEC 60601 focuses on the safety of operating personnel and patients. To assess medical electrical equipment, a new classification system (MOP — means of protection) has been introduced.

When electronic devices do not come into direct contact with the patient and are only handled by trained operators they are classified in category MOOP, which means they typically only need to meet 60950-1 and 62368-1 ITE standards for Laboratory Environment Compliance.

The product falls into category MOPP when there will be direct physical contact between the device and the patient and then must meet extremely stringent safety standards, especially in regards to insulation.

To protect patients against electric shock, such products must feature two separate insulation barriers. The closer the contact between the device and the patient, the lower the permissible leakage current. Application devices are therefore classified according to the type of contact to the patient.

We all know that electric currents through the body are extremely dangerous and often result in death. For a healthy person, currents as low as 40mA could be fatal. For a person who is anaesthetised or weakened by an illness, this threshold is likely to be much lower.

To protect patients, power supplies for medical devices must meet stringent requirements in regards to leakage and stray currents. The limit values vary depending on the type and nature of the applied part (AP) that is brought into direct contact with the patient's body.

Although the power supply meets both leakage-current and isolation, the ended system is still required to further evaluate and confirm the compliance with the patient environment.

• Type B (Body)
  No direct physical contact with patient. Examples: LED lighting in operating theatres, medical laser units, etc.
• Type BF (Body Float)
  Physical contact with patient, or risk to patient from device failure. Examples: Incubators, ultrasonic devices, diagnostic equipment, etc.
• Type CF (Cardiac Float)
  Direct contact to patient's heart, risk of injury or death in the event of device failure. Examples: Defibrillators, heart-lung machines, etc.
• Power supplies for BF & CF applications
  Medical power supplies for type BF & CF medical devices are designed to provide 2MOPP of input to output isolation.

When it comes to life-supporting or life-saving devices, faults and malfunctions caused by electromagnetic or radio interference could obviously be fatal. The failure criteria of the IEC60601-1-2 in regards to electromagnetic interference and electromagnetic immunity must be taken into account in the risk management.

The 4th edition of the IEC standard on EMC stipulates much more stringent requirements as regards electromagnetic immunity than its ancestor. Equipment must now be immune to HF fields up to 2.7GHz, an increase by 0.2GHz. In addition, the standard wants to prevent damage caused by electrostatic discharge, and the relevant limits have been increased accordingly. For contact discharge, the threshold went up from 6 to 8kV. For air discharge, it has been increased from 8 to 15kV.

In order to meet the above requirements, in particular in regards to insulation and leakage currents, a combination of high-quality medical-grade AC/DC power supplies and DC/DC converters is often the most efficient solution. This approach makes it easier to meet the stringent requirements of double patient protection (2MOPP).

We offer a broad range of products that are certified for use in medical electrical equipment. Apart from DC/DC converters from 1 to 30W, we also manufacture AC/DC power supplies with up to 1200W. They are certified to EN/ES 60601-1 3rd edition, EN/UL 60950-1 and EN/UL 62368-1, and do not contain any hazardous substances according to the RoHS2 and REACH Directives. Another plus is the 5-year warranty that we grant on all these products.

REM3、REM6和REM10医疗级稳压DC/DC转换器具有250VAC工作电压、高达5kVAC/1分钟的增强型隔离以及2µA低漏电流。可选的外部控制引脚能使待机功耗降至仅12.5mW。

性能可靠的REM15-W、REM20-W和REM30-W系列转换器能满足高端医疗设备的要求，具有超宽4：1输入电压范围，外壳尺寸仅1.6”x1”和2”x1”。

RxxPxx/R和RxxP2xx/R系列的创新设计使我们能够提供具有高达8kVDC增强隔离、适合高压应用的医疗级DC/DC转换器。

REM1, REM2, REM3.5E、REM5E和REM6E系列具有增强的250VAC连续工作隔离性能，大于8mm爬电距离，并提供2 x MOPP的保护。这些转换器不但能提供完整的高端医疗应用所需的重要功能，同时降低了模块化解决方案的成本。提供引脚以及SMD版本。

RACM系列为高效的18W至1200W AC/DC电源，具有2 x MOPP安全认证，适用于市电供电的医疗设备。这些电源具有通用的交流输入电压范围、4kVAC隔离、低待机功耗、有源PFC（> 0.95），且无最小负载要求。