医療グレード電源 － 簡略化

医療アプリケーションは本質的に高いリスクを持つため、対応する電子機器は安全と信頼性に関する非常に厳しい規格に従わなければなりません。RECOMのREMおよびRACMシリーズモジュラーコンバータは完全な規格準拠ソリューションで、設計時間の短縮、エンドユーザーの認証作業の簡略化、そして市場への製品投入をより迅速にします。これらのDC/DCおよびAC/DCコンバータシリーズは、2xMOPP、低漏れ電流（BF適合）、8mm以上の沿面距離と空間距離を備えた強化絶縁が特長です。すべての医療グレードコンバータは、完全に試験を実施した組み込み型の製品です。RxxPxx/RおよびRxxP2xx/Rシリーズには、高電圧アプリケーションに適した最大8kVDCの強化絶縁を備えた、医療機器向けDC/DCコンバータも用意されています。

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およびREM10は医療用グレード安定化DC/DCコンバータで、250VAC動作電圧、最大5kVAC/1分の強化絶縁、2µAの低漏れ電流が特長です。外部制御ピンによる待機時の電力消費はわずか12.5mWです。

REM15-W、REM20-W、REM30-Wシリーズは高信頼性DC/DCコンバータで、厳しい医療アプリケーションに向けたバランスの取れた仕様になっています。1.6×1インチと2×1インチという小型のケースサイズで、広範な対応が可能な非常に広い4:1の入力電圧範囲を保証しています。

RxxPxx/RおよびRxxP2xx/Rシリーズの革新的な設計により、高電圧アプリケーションに適した最大8kVDCの拡張強化絶縁を備えた医療用DC/DCコンバータも提供可能です。

REM1, REM2, REM3.5E、REM5E、REM6Eシリーズは、8mm超の沿面および空間距離を持ち、250VACの連続使用電圧での強化絶縁を特長としており2 x MOPPに対応しています。これらのコンバータは、厳しい医療アプリケーションに必要とされるすべての特徴を備えており、モジュラーソリューションのコストを低く抑えることが可能です。ピン及びSMDパッケージ有り

当社のRACMシリーズは、商用電源式医療用アプリケーション（BおよびBF）向けのIEC EN ANSI/AAMI 60601-1の安全認証を取得した、高効率6W～1200W AC/DC 2MOPP医療用電源です。これらの電源は、-40℃～+85℃の動作周囲温度、最大5000mの動作高度、4kVAC以上の絶縁、標準的なAC入力電圧範囲を備えており、/277のバージョンは最大305VACまで対応しているため、世界中で使用できます。

すべてのバージョンは待機消費電力が低く、最小負荷も必要としないため、スタンバイアプリケーションに最適です。RACMシリーズには、外部コンポーネントを必要とせず、EN 60601-1-2医療用EMC規格に準拠したクラスBのEMIフィルターも組み込まれています。