의료 등급 전원 - 간략형

의료 분야는 리스크가 매우 높으므로, 이 분야에 사용되는 전자 장비는 매우 높은 수준의 안전성과 신뢰성을 유지해야합니다. RECOM의 모듈식 REM 및 RACM 시리즈 컨버터를 회로에 적용하면 설계 시간을 단축하고 인증을 간소시킬 수 있으므로 제품의 품질도 높이고 출시 기간도 단축시킬 수도 있습니다. 리콤의 DC/DC 및 AC/DC 컨버터는 환자를 이중으로 보호하며 (2 x MOPP), 낮은 누설 (BF 준수) 및 >8mm 연면 거리 및 간극 거리의 강화된 절연 성능을 가지고 있습니다. 모든 의료용 변환기는 완벽하게 테스트한 후에 출하되며 완전한 드롭 인 제품입니다. RxxPxx/R & RxxP2xx/R 시리즈와 함께 RECOM은 고전압 분야에 적합한 최대 8kVDC의 확장된 절연 기능이 있는 의료용 DC/DC 컨버터도 제공합니다.

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 및 REM10 의료 등급 DC/DC 컨버터는 250VAC 작동 전압, 최대 5kVAC/1분 강화 절연 및 2μA의 매우 낮은 누설 전류를 특징으로 가지고 있는 레귤레이션 타입 컨버터입니다. 외부 제어 핀(옵션)을 통해 대기 전력 소비량을 12.5mW까지 낮출 수 있습니다.

REM15-W, REM20-W 및 REM30-W 시리즈는 의료 핵심 분야에 적합하도록 균형 잡힌 사양을 갖춘 신뢰도가 높은 컨버터입니다. 컴팩트한 1.6”x1” 및 2”x1” 소형 케이스에 4:1의 넓은 입력 전압 범위를 가지고 있으므로 호환성이 매우 높습니다.

혁신적인 RxxPxx/R 및 RxxP2xx/R 시리즈의 설계를 통해 우리는 고전압 분야에 적합한 최대 8kVDC까지의 강화 절연을 갖춘 의료용 DC/DC 컨버터를 제공할 수 있게 되었습니다.

REM1, REM2, REM3.5E, REM5E 및 REM6E 시리즈는 8mm 이상의 표면거리/공간거리를 통해 2 x MOPP를 제공하며 250VAC에서 강화된 절연 성능을 지속적으로 나타냅니다. 이 컨버터는 의료 핵심 분야에 필요한 모든 주요 기능을 제공하는 동시에 비용도 절감된 모듈형 솔루션입니다. 그들은 핀뿐만 아니라 SMD 사용할 수 있습니다.

당사의 RACM 시리즈는 매우 효율적인 6W ~ 1200W AC/DC 전원공급장치로 의료기기의 주 전원으로 사용하기 위한 2 x MOPP 안전 승인을 받은 제품입니다. 본 전원공급장치들은 범용 AC 입력전압 범위, 4kVAC 절연, 낮은 대기전력 소비, 액티브 PFC(>0.95)를 갖춘 제품으로 최소 부하 조건을 필요로 하지 않습니다.