• Universal AC input / full range
• 2 pole EU plug (Class II power, without earth pin)
• Medical safety approved (2xMOPP between primary and secondary)
• Suitable for BF application with appropriate system consideration
• Low leakage current <50µA
• No load power consumption <0.1W
• Energy efficiency level: Level VI
• Comply with EISA 2007/DoE and NRCan
• High operating temperature up to +60°C
• Protections: Short circuit, overload, over voltage
• Fully enclosed plastic case
• 100% full load burn-in test
• 3 year warranty

Technical data:

What is a medical power supply?

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.

Medical power supply requirements

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.

MOOP (Means of Operator Protection) and MOPP (Means of Patient Protection)

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.

Low leakage currents

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.

Classification of patient environment

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 2 x MOPP of input to output isolation.

EMC standard and limits

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.

Products

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 (2 x MOPP).

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 150W. 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.