P-DUKE’s MPQ60W Medical-grade DC-DC Converter is Rated for the Most Stringent CF-type Medical Devices

时间： 2022-02-23 来源：P-DUKE

技术问答

The use cases for DC-DC converters span across a wide range of industries, from aerospace and military applications to commercial and industrial spaces. Regardless of the circuit topology of the DC-DC converter employed, there are basic parameters, certifications, and a level of ruggedization that designers must meet in order to qualify for the most stringent medical requirements.

Certifications and testing around medical applications for power supplies, or converters, are defined primarily by their isolation and leakage current. Both these parameters relate to the level of protection a patient will experience when in electrical contact with the power supply. There are, however, also a myriad of other parameters to consider when choosing a DC-DC converter in order to ensure optimal performance over the lifetime of the device. This article P-DUKE dives into the certifications for medical-grade DC-DC converters and the basic parameters to look at when choosing these devices.

Power Considerations in Medical Devices
The range of power solutions for electronic medical devices is as varied as the applications themselves. Between the power source (e.g., battery, outlet, generator, etc.), the power delivery network (PDN), and the connected circuitry (e.g, sensors, actuators, processors, etc.), it is critical that every component function nominally in the event of a power loss, voltage fluctuations, or potential interference. For a ventilator, this means that an energy storage device such as a battery is required to rapidly switch to backup power in the event that a power loss has occurred. This avoids the catastrophic failure mode of the ventilator shutting down before the longer-term backup power such as a diesel generator is engaged.

Medical devices should be able to tolerate a degree of voltage fluctuations around their nominal values. This very same reasoning applies to all critical medical equipment such as blood pressure monitors, incubators, defibrillators, and dialysis machines. On the system level, redundant backup power and energy storage devices might be employed. However, on the device level, the power supply and/or AC-DC and DC-DC conversion must ensure both electromagnetic compliance (EMC) as well as overcurrent, overvoltage, overload, short circuit, and over-temperature protection in order to minimize unwanted emissions and protect the component and the load from undesired conditions.

The safety of the device for both the operator and the patient is also critical in medical applications. Most safety standards present parameters and testing guidelines in order to ensure this level of safety. However, the quality of the device is dependent on some basic electrical and mechanical specifications.

Basic Parameters to Look at in a DC-DC Converter
DC-DC converters are found in virtually any electronic medical device in order to take an input DC signal and provide a tightly regulated output DC signal. Regardless of the DC-DC converter’s topology, there are specific electrical, thermal, and mechanical variables that are critical to optimizing for the particular end application. The most basic parameters are the required input voltage and output voltages as well as output current/power for the use case, and they are readily defined by the system requirements. DC-DC converters begin to differentiate themselves with factors such as efficiency, power density, reliability, and certifications/standards compliance. A high power density will allow the designer to save on space by fitting a DC-DC converter with larger power ratings in a smaller form factor. For a medical application, medical certification is the major qualifying factor. Outside of this, reliability is key, so circuit protections are necessary to buffer the component from unpredictable voltage fluctuations and surge events.

Depending upon the environment in which the DC-DC converter will be deployed, additional component ruggedization can be critical. In outdoor environments, it would be necessary to ensure the converter will not meet any failure modes from cycling between hot and cold temperatures or from a high humidity environment. The MIL-STD-810 specification is the most common standard referred to in electronic component datasheets for environmental engineering considerations. This is due to the exhaustive guidelines and test conditions listed out within the standard for potential environmental stressors from high and low-temperature conditions to fungus, explosive atmosphere, and ballistic shock. While most medical components will likely not undergo mechanical strain from gunfire, parameters such as thermal shock, relative humidity, vibration, and even altitude can be tested in order to represent the mechanical robustness of the device. This illustrates the thermal stability of the DC-DC converter as well as its ability to operate in both shock and vibrations (e.g., mobile emergency/ first aid equipment) and high altitudes (e.g., mountains, aircraft, etc.).

While many of these parameters ensure the device does not meet premature failure due to undesired electrical, mechanical, and environmental conditions, the mean time between failures (MTBF) is a critical parameter that represents the long-term wear out of while the device is operating in steady-state conditions.

Power Supply Requirements for Medical Applications
The default standard for medical devices is the IEC 60601-1 standard that defines the “general requirements for basic safety and essential performance.” For power supplies (i.e., AC-DC and DC-DC converters) within medical equipment, the standard is essential to make certain the medical equipment functions within safety guidelines. These guidelines are defined by the vicinity of the patient to the power supply. The classifications are as follows:

●Type B (body): no contact with the patient
●Type BF (body floating): physical contact with the patient
●Type CF (cardiac floating): physical contact with the heart

Devices without patient contact might include x-rays, MRI scanners, medical lasers, and hospital beds, while devices with limited contact include blood pressure monitors, incubators, and ultrasound equipment. The most stringent CF classification of devices is surgical equipment, dialysis machines, defibrillators, and heart-lung machines. The power supplies themselves do not qualify as medical devices and therefore are not subject to these classifications. However, it is still immensely helpful to the medical equipment designer to understand whether or not the power supply meets the isolation, creepage, insulation, and leakage current requirements for the various categories (Table 1).

Table 1 2nd edition requirements by classification

Input/Output Isolation and Leakage Current
The level of insulation protects the operators and patients from electrical shock and the insulation barrier can be air or a prespecified material for additional isolation. Clearance is the distance through air between two conductors, the goal is to keep the electrodes separated far enough away from each other to prevent arcing. Creepage distance is the distance along the surface between two conductors, and this distance ensures that there is no short-circuiting from one conductor to another in case the insulating surface becomes contaminated and begins conducting.

The level of leakage current from the power supply to the patient must be extremely low to qualify as medical grade. For instance, CF-rated supplies the leakage current limit is 10μA in normal conditions to 50μA for single fault conditions, whereas a leakage current below 500μA is satisfactory for most non-medical-grade supplies.

Fig.1

Means of Protection: MOOP and MOPP
The IEC 60601-1 specifies both the means of operator protection (MOOP) and means of patient protection (MOPP) in order to differentiate the potential hazards that each of these users might encounter with a medical device. For operator protection (1xMOOP) one layer of insulation with a creepage distance of 2.5 mm and 1500 VAC of isolation is satisfactory. Two MOOP (2xMOOP) implies a double layer of insulation with double the creepage distance and isolation. Basic patient protection (1xMOPP) requires a single layer of insulation with 1500 VAC of isolation and a 4mm creepage distance. Two MOPP (2xMOPP) is the most stringent protection with two layers of insulation, 4000 VAC of isolation, and 8 mm creepage distance. Type CF equipment requires both an IEC60601-1 qualified supply as well as an isolation barrier between the supply and the part of the equipment that is in contact with the patient. This isolation can be accomplished with a DC-DC converter that has a 2xMOPP classification.

Product Qualification and Manufacturing Quality –ISO 14971 and ISO 13485
The 3rd and 4th editions of the IEC 60601-1 require manufacturers to prepare and maintain risk management documentation according to ISO 14971 in order to[1]:

■  Estimate the associated risks of medical devices
■  Control the risks
■  Monitor the effectiveness of these controls

All of these factors must be evaluated by a certified body/test lab (e.g., UL) at each step in the process, causing compliance with the later editions of IEC 60601-1 to be much more stringent than previous iterations. This process is put in place to eliminate any unacceptable failures or degradation in device performance. An additional production quality standard for medical devices is ISO 13485. This standard specifies requirements for a quality management system of an organization.

In order to qualify, an organization must demonstrate its ability to provide medical devices that “consistently meet customer and applicable regulatory requirements”. A manufacturing process that is ISO 13485 compliant will guarantee a production process with a high level of reliability for every component fabricated.

The MPQ60W Medical-Grade 60W DC-DC Converter
P-DUKE’s MPQ60W medical-grade DC-DC converter is rated for the most stringent CF-type medical devices with less than 4.5 μA of leakage current, 5000 VAC of isolation, reinforced 2xMOPP insulation, and 8 mm of air clearance and creepage distance. The ISO 14971 risk management file supports designers to compile exhaustive technical documentation on their device while the ISO 13485 compliance ensures a quality, high-reliability DC-DC converter. Outside of meeting these standards, the MPQ60W features an industry-leading power density for a medical type CF DC-DC converter with its tiny quarter brick form factor. The DC-DC converter includes all the necessary circuit protections (i.e., OCP, OTP, OVP, SCP, UVP) and has been tested for thermal shock and vibration according to MIL-STD-810. The MPQ60W can function nominally at altitudes up to 5000 m and has a wide operating ambient temperature range between -40°C to 105°C.

Table.2

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型号- 3201008 AA 681 G,SBIT # 7.5S,MSCI 10 000 022 X Y 10,3201009 06 470 K,TCM22 1M5 H,ESI 01 M15 1X,TCM14 XXX H,3201009 03 560 K,3201008 AA 330 G,CMC 22 XXX 2WR SERIES,CMC22 1M6 2WR,MPCI H01 2K0 1XY,3201009 02 ### Y,DLEF 42,M83446/5-16*,CMC 22,ESI 7 8K4 1S,M83446/10-51**,MPCI 10 001 000 X Y 5,MSCI 12 470 000 X Y 10,MPCI 233 002 700,MSCI 12 560 000 X Y 10,* 20 082 000 X Y 10,3201008 05 3L4 L,HTSE47-5M6-10SR,MSCI 10 003 300 X Y 10,3201009 08 111 K,SESI 9.1 6K2 2WR,3201008 AA L022 K,M83446/5-15*,3201008 AA L022 J,DBIT X 7 P10A,CMC 14 ### XWR,SESI 32 4K9 1PR,SESI 22 10K 2WR,CMC 14,CMC 15,M83446/10-86**,CMC 17,3201008 AA 681 K,CMC 18,3201008 AA 681 J,SESI 18.1 W,3201009 01 470 K,3201009 02 6L4 M,SESI 32 84K 1PR,M83446/5-14*,DBIT 2 7S,CMC17 13M,SESI 9.1 M33 1WR,CCM25 M22 1W,EFD 20 SMD,WRFT42 13R 1X,3201009 07 ### Y,CMC 15 1M0 2WR,3201009 02 8L0 M,DBIT 1 7P10,MSCI 10 002 200 X Y 2,MSCI 10 002 200 X Y 5,MPCI 233 150 000,M83446/5-13*,SESI 9.1 10K 2WR,MPCI 12 680 000 X Y 5,MPCI H01 7K1 1TS 15,MPCI 10 006 800,CT91 075 231 WR,MSCI 12 068 000 X Y 5,HTSE,MPCI 233 560 000,M83446/10-64**,CCM 6 10K 1W,SESI 32WR,TT17,TT14,TT12,3201008 AA 121 G,SESI 9.1 26K 2WR,MSCI 10 000 033 X Y 5,TT19,SESI 15 33K 1SR,MPCI 12 027 000 X Y 5,MPCI 10 000 010 X Y 10,MPCI 12 027 000 X Y 2,* 20 000 010 X Y 10,HTSE47-10K-6SR,TT20,MSCI 12 270 000 X Y 10,M83446/10-95**,HTSE18-85K-1WR,SESI 14 M18 1SR,TT07,TT05,MPCI 12 018 000 X Y 5,MPCI 12 018 000 X Y 2,CMC18 M54 2WR,3201009 03 1L8 N,MSCI,MSCI H01 12K 1TS 15,TT09,TT08,MPCI 12 150 000 X Y 5,MSCI 10 000 220 X Y 10,MPCI 12 033 000 X Y 10,3201008 AA L18 K,3201008 AA 121 J,3201008 AA 121 K,M83446/5-19*,SESI 32 12K 1#R,3201009 03 120 M,MSCI 12 330 000 X Y 5,3201009 01 3L3 M,3201008 AA 561 G,HTSE91-65K-1WR,3201009 03 680 K,ESI 01 2K7 1X,M83446/5-18*,3201009 05 330 K,SESI 32 36K 1WR,TCM19 XXX V,3201009 05 681 K,M83446/10-73**,MPCI 233 000 270,DBIT 8 7P10,3201009 06 341 K,TT29,3201008 AA 2L7 K,CCM25 33K 1W,TT26,TT25,DBIT 5 7X400,PP-C4-9-1270,CMC 22 3M3 2WR,MPCI 10 000 470 X Y 5,SESI 9.1 M10 2WR,TCM22 47M H,MPCI 20 680 000,3201008 AA 330 K,3201008 AA 330 J,3201008 AA 561 J,3201008 AA 561 K,M83446/5-17*,HCESC10 56K 1X,SESI 32 M11 1WR,PPCDR-C20-35-565,3201008 AA 2L7 G,3201009 05 4L3 M,3201008 AA 2L7 J,MSCI 12 270 000 X Y 5,CCM 5 22K 1W,3201008 AA 4L7 G,MPCI 233 004 700,MPCI 10 001 500,MSCI 10 000 470 X Y 10,3201008 05 4L6 L,3201008 AA 4L7 J,SESI 9.1 M15 1WR,3201008 AA 4L7 K,HTSE XX WR,MSCI 12 120 000 X Y 10,SESI 32 53K 1#R,MSCI 10 004 700 X Y 2,MPCI 233 003 900,MSCI 10 004 700 X Y 5,SBIT 1 7.5S,SESI 15 M10 1WR,CMC14 M14 XWR,MSCI 10 000 068 X Y 5,MPCI 233 470 000,SBIT 8 7.5S,FW-C25-20-989,M83446/10-33**,SBIT 1 7.8P,* 20 056 000 X Y 10,SESI 15 6K4 1WR,3201009 02 1L5 N,SESI 22 33K 2WR,SESI 32 M83 1PR,3201009 08 360 M,CMC 18 60K 2WR,CMC22 M34 2WR,TCM19 3M3 V,CCM 20,SESI 18.1 WE,M83446/10-68**,ESI 7 K42 1S,MPCI 20 056 000,MSCI H01,CCM 25,TCM23 4M2 V,MPCI 233 220 000,3201009 08 120 N,CCM25 M10 1W,M83446/10-121**,3201009 02 820 K,MSCI 12 018 000 X Y 10,MSCI 10 000 082 X Y 10,CT 91 XXX 231 WR,EFD 15 SMD,M83446/10-99**,SESI 32 M83 1WR,MPCI H01 K38 1TS 15,SESI 32 M20 1WR,SESI 14 82K 1SR,ESI SERIES,SESI 32 4M7 1WR,GDT15 M50 60 1WR,SESI 32 36K 1PR,CMC22 M14 2WR,3201009 05 151 K,* 20 003 900 X Y 10,CMC18 1M1 2WR,M83446/10-42**,HCESC10 M47 1X,CMC18 2M4,MPCI 10000 SERIES,MPCI 233 12K H01 1X,MSCI 10 000 033 X Y 10,CCM 20 23K 1W,SESI 15 M10 1SR,3201009 08 351 K,HCESC10 56K,3201009 05 1L5 N,DBIT 2 3S,3201008 AA L27 K,MSCI H01 1K5 1TS 15,SESI 22 2M2 1WR,M83446/10-77**,3201009 01 150 M,MPCI 20 270 000,SESI 32 M11 1PR,MPCI H01 K67 1XY,HTSE15-M10-1WR/SR,3201009 03 151 K,3201008 AA 3L9 J,3201008 AA 3L9 K,* 20 022 000 X Y 10,3201008 AA 3L9 G,CCM 6 ### #W,SESI 15 56K 1SR,3201009 03 480 K,TCM23 10M V,CMESC17 1M2 1H,DBIT # 7 SA,MSCI 10 001 500 X Y 10,MPCI 12 047 000 X Y 10,M83446/10-20**,HTSE22-M71-1WR,M83446/10-59**,HTSE47-15K-6SR,3201008 AA 391 K,M83446/5-60*,CT91 050 231 WR,SESI SERIES,3201008 AA 391 J,3201008 AA 391 G,DBIT 8 7P*,3201008 AA L018 K,SESI 9.1WR,HTSE91-M31-1WR,CCM 20 3K3 1W,CCM25 2M2 1W,3201009 02 121 K,3201009 04 101 K,3201009 07 472 K,CCM 6 2M2 1W,SESI 18 WR,SESI 22 19K 2WR,TCM18 1M1 V,WRFT 4X SERIES,M83446/10-02**,HTSE22-17K-1WR,MSCI 10 001 800 X Y 5,M83446/10-37**,SESI 14SR,3201009 02 2L7 M,CCM 5 M10 1W,M83446/10-103**,3201009 03 160 M,3201010 01 402,WRFT42 5R0 1X,SESI 18 15K 1WR,M83446/10-90**,MPCI 20 015 000,3201009 02 232 K,MSCI H01 SERIES,MPCI 20 820 000,MPCI 12 012 000 X Y 10,3201008 AA 151 K,3201008 AA 271 K,3201008 05 1L0 L,CCM 6 68K 1W,3201009 02 330 M,3201008 AA 271 J,CCM 6 1M0 1W,MSCI 10 000 820 X Y 5,MPCI H01 M10 1TS 15,MPCI 10 000 820 X Y 5,3201008 AA 271 G,MSCI 10 000 560 X Y 5,MSCI 12 390 000 X Y 5,DBIT 8 7PA,SESI 15 ### #WR,SESI 32 73K 1#R,* 20 068 000 X Y 10,MSCI 10 000 039 X Y 10,3201009 08 730 K,* 20 000 039 X Y 10,MSCI 10 001 800 X Y 2,3201009 04 221 K,MPCI 12 1000 000 X Y 5,CMESC17 69M 1H,CMESC17 13M 1H,GDT91 6M0 135 1WR,* 20 001 000 X Y 10,3201008 AA L10 K,M83446/5-64*,TCM28 10M H,M83446/06-17,M83446/06

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