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


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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CHT-HYPERION是一款适用于直流-直流转换器和电机控制的N沟道MOSFET的高侧和低侧驱动器。它具有1Ω的典型导通电阻,两个输出均可驱动1nF负载,在200°C下具有40ns的传播延迟和15ns的过渡时间。自适应非重叠电路通过防止MOSFET交叉导电来降低开关损耗。高侧悬浮驱动器可以承受高达50V的电压。欠压锁定功能使高侧开关保持关闭状态,直到驱动器获得足够的电压以正确操作。过流保护输入独立于输入信号打开低侧驱动器,而低侧禁用引脚允许异步模式下的操作。
CISSOID - 高温半桥驱动器,HIGH-SIDE AND LOW-SIDE DRIVER,DUAL N-MOSFET DRIVER,双通道N-MOSFET驱动器,HIGH TEMPERATURE HALF-BRIDGE DRIVER,高端和低端驱动器,CHT-HYPERION-CSOIC28-T,CHT-HYPERION,CHT-HYPERION-CDIL28-T,DC-DC CONVERTERS,ELECTRIC MOTOR CONTROL,汽车,功率N沟道MOSFET,INDUSTRIAL,航空航天,POWER N CHANNEL MOSFETS,AUTOMOTIVE,OIL,AEROSPACE,GAS,油,DC-DC转换器,电动机控制,工业,燃气
高度可靠的医疗级DC/DC转换器,有助于拯救生命
博大科技 - HIGHLY RELIABLE MEDICAL GRADE DC/DC CONVERTERS,高度可靠的医疗级DC/DC转换器,MPL02,MPM20,MPM15,MPP10,MPS02,MPU01,MPP06,MPP03,MPP06W,MPD30W,MPU02,MPS04,MPP03W,MPM15W,MPP10W,MPD30,MPQ60W,MPM20W
DC-DC转换器的测试配置
本文档为DC-DC转换器测试配置应用指南,主要内容包括典型连接、输入电源、保险丝安装、反向极性保护、输出串联和并联、远程控制、远程传感、输出电压调整、测试配置(效率与调节、输出纹波与噪声、动态负载阶跃变化、启动时间、输入反射纹波电流、最大电容负载、隔离PCB布局指南等)。文档详细介绍了DC-DC转换器的测试方法和注意事项,旨在帮助用户正确进行测试和配置。
博大科技 - DC-DC CONVERTERS,DC-DC转换器,MPP XX,TEN06,DUR01,DU1P0,MPM15,RHD40W,PFKC03,MOP XX,PFKC05,SDSXX,SDSHXXW,MPH XX,PDSXX,PDL06,RHK06W,DUP75,PDL03,PDL02,PDS03W,PDSHXXW,PDSHXX,SDSHXX,MPS XX,PDSH03,PDSH03W,PDS03,RHK10W,RHM20W,TEA1P5,MPM20,DR1P5,PDSXXW,PDL03W,RHK03W,PMKC03,MPD30,SDSXXW,MPQ60W,TEM03
Si20C120D2碳化硅肖特基二极管
该资料详细介绍了SI20C120D2型碳化硅肖特基二极管的产品特性、应用领域和机械数据。该二极管适用于高频整流、高效开关级、功率因数校正和逆变器中的自由轮换二极管。产品具有低电容充电、极快切换、高反向电压和高功率耗散等特点,符合RoHS、REACH和冲突矿产标准。
DIOTEC - 碳化硅肖特基二极管,SILICON CARBIDE SCHOTTKY DIODES,SI20C120D2,BATTERY BACKED-UP REGULATED SUPPLY,COMMERCIAL,DC-DC CONVERTERS,INDUSTRIAL,高效线性调节器,HIGH EFFICIENCY LINEAR REGULATORS,ACTIVE SCSI TERMINATION REGULATOR,主动SCSI终端调节器,备用电池稳压电源,商业的,DC-DC转换器,工业
P-DUKE Offers a Broad Range of 2xMOPP Medical DC/DC Converters from 1W to 60W
P-DUKE MPQ60W series is a high-performance DC/DC converter widely used in medical and homecare applications, such as: laser treatment, electrosurgical systems, drug delivery, C-arms, defibrillation and air ambulance, etc.
DI79LxxZAB负极固定稳压器
该资料介绍了DI79LxxZAB系列负压固定电压稳压器。这些器件具有高效率线性调节器功能,适用于多种应用,包括SCSI终止调节器、开关模式DC-DC转换器的后级调节器和电池备份的稳定电源供应。它们符合商业/工业标准,并提供热过载保护和短路保护。
DIOTEC - NEGATIVE FIXED VOLTAGE REGULATORS,负固定稳压器,DA8Z,DI79L05ZAB,DI79L24ZAB,DI79L06ZAB,DI79L18ZAB,D05Z,D06Z,DI79L12ZAB,D08Z,D09Z,DI79L09ZAB,DI79L10ZAB,DI79L08ZAB,DI79L15ZAB,DI79LXXZAB,D0AZ,DA2Z,DB4Z,DA5Z,BATTERY BACKED-UP REGULATED SUPPLY,COMMERCIAL,DC-DC CONVERTERS,INDUSTRIAL,备用电池稳压电源,商业的,DC-DC转换器,工业
LDI55-ADEEN低压差正可调稳压器
LDI55-ADEEN是一款低 dropout 正向可调电压稳压器,具有低 dropout 电压、低功耗、可调输出电压等特点。适用于高效率线性稳压器、SCSI 终端稳压器、开关模式 DC-DC 转换器、电池备份稳压电源、电子电表/智能电表等应用。
DIOTEC - LOW DROPOUT POSITIVE ADJUSTABLE VOLTAGE REGULATORS,低压差正可调稳压器,LDI55-ADEEN,BATTERY BACKED-UP REGULATED SUPPLY,COMMERCIAL,DC-DC CONVERTERS,INDUSTRIAL,备用电池稳压电源,商业的,DC-DC转换器,ELECTRICITY METERS,电表,工业,智能电表,SMART-METERS
CHT-MAGMA高温PWM控制器规格书
MAGMA是一款高温脉冲宽度调制(PWM)控制器,具有高达90%的最大占空比。它以恒定频率运行,频率可调范围为50kHz至500kHz。该控制器适用于6V至30V的输入电压,并具备内部电压参考、输入前馈补偿等功能,提高了对输入电压变化的抗干扰能力。
CISSOID - HIGH TEMPERATURE PWM CONTROLLER,高温PWM控制器,HIGH TEMPERATURE PULSE WIDTH MODULATION CONTROLLER,高温脉宽调制控制器,CHT-MAGMA,MAGMA,CHT-MAGMA-CDIL28-T,CHT-MAGMA-CSOIC28-T,DC-DC CONVERTERS,OIL,汽车,INDUSTRIAL,AEROSPACE,GAS,航空航天,油,DC-DC转换器,AUTOMOTIVE,工业,燃气
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可定制电感最大电流100A,尺寸最小7 x 7 x 3.0mm到最大35 x 34 x 15.5 mm,工作频率100KHZ ~ 2MHZ,感值范围:0.15 ~ 100uh;支持大功率电感,扁平线电感,大电流电感,高频电感,汽车电感器,车规电感,一体成型电感等定制。
最小起订量: 5000 提交需求>
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