Abstract: The medical device industry involves many industries such as medicine, machinery, electronics, and plastics. It is a multidisciplinary, knowledge-intensive, and capital-intensive high-tech industry. With the increasing investment in medical devices in various countries, the trend in the development of intelligent medical devices has increased. There are more and more applications of power supply modules in medical devices, which greatly shortens the overall product development cycle. Since the publication of the third edition of IEC60601-1, the international medical device market has become more and more concerned about whether or not the power supply can satisfy medical certification. Therefore, power supplies that meet the needs of the medical industry are also increasingly welcomed.

This article summarizes the particularity of medical power supply from the aspects of leakage current and protection level according to the IEC60601-1 3rd edition standard, and introduces the power supply solutions of several medical power supplies in the new breast milk analyzer.
Keywords: Medical Devices, Medical Power Supply, IEC60601, Breast Milk Analyzer;
1, the special needs of medical power

Medical power supplies have special considerations for safety and have their own particularities. The following is a description of leakage current and protection rating.

1.1 Leakage current

The isolated power module acts as the main isolation component of the entire medical system and also largely affects the leakage current of the entire system. Therefore, for the leakage current required by medical equipment, the power supply module must be satisfied as much as possible. At the same time, the design of the system to ground must also be considered. Leakage current is the best margin.

(1) Different medical equipment requires different leakage currents and protection levels

The current third edition of the medical certification IEC60601-1-3rd, according to the application of different parts, will be divided into three categories of medical equipment: B, BF and CF, as follows:

Category B: The lowest level of patient protection in all types of applications. Devices that do not come in contact with the patient, such as laser therapy devices.
BF class: Higher patient protection rating than type B application parts, equipment to be in contact with the patient, such as ultrasound, various monitors (including EGC equipment), and operating table.
Category CF: The highest level of patient protection, suitable for direct cardiac applications such as cardiac puncture monitors.
(2) Leakage current classification and requirements For medical devices, the leakage current can be divided into patient leakage current, patient auxiliary leakage current, contactable leakage current, and ground leakage current according to the application of the device.
The patient leakage current refers to the current flowing through the patient and the F-type application to the ground when the external voltage is applied. In the actual test, an MD module is connected in series in the loop to simulate the impedance of the human body.
The patient's auxiliary leakage current refers to the current flowing through the device through patient A in the patient, and the requirement cannot bring about the human body's physiological response.
The specific patient auxiliary current and patient leakage current according to IEC 60601-1 are shown in the following table 1-1:

Medical Device, Medical Power Supply, Breast Milk Analyzer, IEC60601

The contactable leakage current refers to the leakage current between the human body and the accessible point, which is usually 100 uA in the normal state and 500 uA in the single failure state. The leakage current between the MD module and the ground, and the earth-protected housing, etc., is usually measured during the test.
The ground leakage current refers to the current of the device to ground, the requirement is 5mA, and 10mA in a single fault condition.
The above leakage current test in the medical certification requirements is mostly 110% of the rated network voltage, which is not the definition of leakage current that we generally understand. The medical equipment usually has a network voltage range of 100-250VAC, and the test should be 265VAC and 60Hz according to the worst conditions. Therefore, when the demand for the medical power supply is proposed, it also needs to focus on the test conditions of the customer.

1.2 Degree of protection The degree of protection refers to the regulatory requirements for the protection strength of different medical devices. The medical device operator is a doctor, and the object of the action is a patient. The protection level is divided into MOOP (Means of Operator Protection) and MOPP (Means of Patient Protection) in the third edition of IEC 60601-1. Different protection levels correspond to different voltage test requirements, usually 1*MOOP, 2*MOOP, 1*MOPP, 2*MOPP are required. The requirements of withstand voltage test levels are shown in Table 1-2 below:


Medical Device, Medical Power Supply, Breast Milk Analyzer, IEC60601

It can be seen from this that the pressure resistance requirement of MOPP protection is higher than that of MOOP. The working voltage of medical equipment is usually 250VAC. To meet the protection requirements of two MOPPs, the pressure-resistant 4000VAC is the basic requirement.
Different levels of protection methods correspond to different creepage distances and clearance requirements. If altitudes and other factors are not considered, the clearances and creepage distance requirements for MOPP and MOOP are as shown in Tables 1-3 and 1-4 below:

Medical Device, Medical Power Supply, Breast Milk Analyzer, IEC60601


Medical Device, Medical Power Supply, Breast Milk Analyzer, IEC60601

2. Breast Milk Analyzer Breast milk contains the nutrients and antibodies needed for baby growth, which can effectively prevent and protect infants from infection and chronic diseases. With the continuous exposure of milk powder incidents such as Sanlu and Meisu Lier, more and more people are beginning to pay attention to how babies are scientifically fed. Therefore, reasonable breast milk quality control has become an important part of feeding guidance.
The breast milk analyzer only needs a small amount of breast milk to accurately analyze the nutrients in breast milk, such as fat, protein, lactose, minerals, and trace elements. The breast milk analyzer is of great significance to scientifically guiding the nursing mothers to properly adjust the diet structure and ensure balanced intake of nutrients during infancy. For example: When the calcium, zinc trace element content in mother's milk is relatively low, the baby obtains the calcium, the zinc element to correspond to is low, then can take the mother to increase the trace element or the infant supplement way can adjust in time, satisfies the baby growth need.
3. The power supply solution of breast milk analyzer The power supply system of a fully automatic breast milk analyzer is recommended as shown in Figure 3-1.


Medical Device, Medical Power Supply, Breast Milk Analyzer, IEC60601

Automatic breast milk analyzer power supply instructions:
Mains power is supplied to the LH25-20B12MU power supply module through the EMC filter of the FC-LX1D. The medical power supply module provides +12V power to the entire equipment.
One part is powered by the URH2405P-6WR3 module to the control unit, sampling unit and analysis unit. The sampling unit can collect breast milk in the milk or test tube and enter the analysis unit, which will contain fat, protein, lactose, minerals, trace elements and other components in breast milk. The content is analyzed and the final analysis report can be printed out by a micro printer.
The other part supplies power to the waste-liquid recovery motor, recovers the waste milk samples left over from the entire analysis process, and also cleans the entire equipment.
The power supply solution for the above breast milk analyzer power supply solution is shown in the following table:

model
Leakage current
Isolation characteristics
Certification Information
LH25-20B12MU
100uA
4000VAC
EN60601-1, ANSI/AAMI ES60601-1, CAN/CSA-C22.2 No.60601-1 Certification (2*MOPP)
URH2405P-6WR3

6000VDC
Certified by EN60601-1 3rd Edition (2*MOPP)
H1205S-1WR2
2uA

6000VDC

4200VAC

Certified by EN60601-1, ANSI/AAMI ES60601-1 (1*MOPP, 2*MOOP)

4. Summary In the “Thirteenth Five-Year Plan”, medical devices were identified as one of the key breakthrough areas, and favorable policies have stimulated the development of domestic medical device equipment. At the same time, with the mandatory implementation of the IEC60601-1 3rd edition, domestic and foreign medical device manufacturers

The level of attention to equipment preparation thresholds is getting higher and higher. Medical power supplies are bound to be used in a wide range of medical device equipment because of their industry-specific characteristics. The market prospects are broad. Jinshengyangfei has launched various dedicated power supplies for the medical industry, including 10-60W AC/DC power supplies and 6W DC and DC power supplies, which can be widely used in injection pumps, monitors, analyzers, ventilators, nutrition boxes, etc. Medical equipment. With the continuous emergence of various new types of medical devices in the later period, Jin Shengyang will continue to develop new power modules based on the requirements of the equipment, and will be happy to accept the customization of various medical modules.


For product details, please refer to the product technical manual

References: 1.IEC60601-1 Edition3-2012


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