EC2M11
2W medical-grade DC-DC converter with 2xMOPP isolation and ultra-low leakage for patient-connected medical equipment.
Product Overview
Description
The Cincon EC2M11 is a 2W medical-grade DC-DC converter specifically designed for patient-connected medical equipment. This converter is certified to IEC 60601-1 3rd Edition with 2xMOPP (Means of Patient Protection) isolation, providing the highest level of patient safety. The 5000VAC isolation voltage and ultra-low leakage current of less than 2µA meet stringent medical safety requirements. The converter is designed for 24V medical systems with a nominal input range of 21.6-26.4VDC. The EC2M11 outputs regulated 5V, 12V, or 15V with up to 400mA current capability (at 5V output), suitable for powering patient monitors, diagnostic sensors, and other medical equipment. The compact SIP7 package (19.5 x 7.0 x 10.0 mm) enables integration into portable medical devices where space is at a premium. Key features include 5000VAC isolation with 2xMOPP certification, ultra-low leakage current, comprehensive protection functions (short circuit, overload), and -40°C to +85°C operating temperature range. With an MTBF of 2 million hours and medical certifications, this converter offers exceptional reliability for medical devices. The EC2M11 carries IEC 60601-1, UL, and CE certifications with complete documentation package for regulatory submissions. As an authorized Cincon distributor, BeiLuo provides technical support for medical power system design and regulatory guidance.
Product Series
EC2M
Primary Application
Patient monitoring systems
Key Features
- 2W medical-grade DC-DC conversion with 84% efficiency
- IEC 60601-1 certified with 2xMOPP isolation
- 5000VAC isolation voltage for patient safety
- Ultra-low <2µA leakage current
- Compact SIP7 package for portable devices
- Extended temperature range -40°C to +85°C
- Comprehensive protection: SCP, OLP
- 2 million hour MTBF for exceptional reliability
- Complete medical certification package
Specifications
| Input Voltage Range | 21.6-26.4VDC (medical grade) |
|---|---|
| Output Voltage | 5V / 12V / 15V (model dependent) |
| Output Current | Up to 400mA (5V model) |
| Output Power | 2W maximum |
| Efficiency | 84% typical at full load |
| Isolation Voltage | 5000VAC (2xMOPP) |
| Leakage Current | <2µA at 264VAC |
| Isolation Resistance | 1000MΩ minimum |
| Switching Frequency | 100kHz typical |
| Line Regulation | ±0.5% typical |
| Load Regulation | ±5% typical |
| Ripple and Noise | 75mVp-p maximum |
| Operating Temperature | -40°C to +85°C without derating |
| Storage Temperature | -55°C to +125°C |
| MTBF | 2,000,000 hours at 25°C (MIL-HDBK-217F) |
| Package | SIP7 (19.5 x 7.0 x 10.0 mm) |
| Weight | 2.5g typical |
| Safety Standards | IEC 60601-1 3rd Ed, UL60601-1, EN60601-1 |
| EMC Standards | EN55011 Class B, EN60601-1-2 |
Applications
Patient monitoring systems
Electronic system design
Diagnostic equipment
Electronic system design
Medical sensors
Sensor signal conditioning
Infusion pumps
Electronic system design
Pulse oximeters
Electronic system design
Blood pressure monitors
Electronic system design
Home healthcare devices
Electronic system design
Portable medical instruments
Medical electronics
FAE Expert Insights
"The EC2M11 is our top recommendation for patient-connected medical devices requiring 2W or less. The 2xMOPP certification and 5000VAC isolation provide the highest level of patient safety. We've supported numerous FDA submissions using this converter with excellent results. The <2µA leakage current provides significant margin below regulatory limits. The compact SIP7 package is perfect for portable medical devices. The complete documentation package from Cincon simplifies regulatory approval. For any medical device requiring patient isolation, this converter is an excellent choice. I particularly appreciate the -40°C to +85°C operating range, which supports devices used in various environments."
Medical-grade converter with highest safety certification
— BeiLuo FAE Team, BeiLuo
Frequently Asked Questions
What is 2xMOPP and why is it important for medical devices?
2xMOPP (Means of Patient Protection) is the highest level of isolation required for patient-connected medical equipment: Two independent protection means between patient and hazardous voltage; 5000VAC isolation voltage (higher than standard 1000-3000V); Ultra-low leakage current (<2µA) to prevent patient shock; Protection maintained even if one isolation barrier fails. This is critical for: Patient-connected equipment - devices that touch patients; Life-support equipment - where failure could harm patient; Home healthcare devices - used by non-professionals; Diagnostic equipment - ECG, EEG, ultrasound probes. Standard industrial converters typically provide 1xMOPP or MOOP, which is insufficient for patient contact. Always use 2xMOPP certified converters for patient-connected circuits. The EC2M11 meets all requirements per IEC 60601-1 3rd Edition.
Use 2xMOPP certified converters for all patient-connected circuits. EC2M11 is fully certified.
What documentation is provided for FDA submissions?
The EC2M11 comes with comprehensive medical certification documentation: Safety certificates include IEC 60601-1 3rd Edition, UL 60601-1, and EN 60601-1. CB test certificate provides international recognition. Technical documentation includes detailed datasheet with specifications, isolation diagram, leakage current test data, and dielectric withstand test reports. Regulatory files include risk management file (ISO 14971), usability file (IEC 62366), MTBF calculations, and declaration of conformity. This documentation is essential for FDA submissions (510(k), PMA), EU MDR technical files, and other international regulatory submissions. The complete package simplifies regulatory approval by providing pre-certified components with full traceability. Contact our FAE team to request documentation packages for your regulatory submissions.
Complete medical documentation package available. Contact us to request files for your submission.
How do I calculate total leakage for multi-converter medical systems?
For medical devices with multiple converters, total leakage current is the sum of all individual leakage currents: EC2M11 leakage is <2µA typical. System total = Converter 1 + Converter 2 +... + Converter N. Example: 2 converters = <4µA total; 4 converters = <8µA total. IEC 60601-1 limits: Type B (Body): <100µA normal, <500µA fault; Type BF (Body Floating): <100µA normal, <500µA fault; Type CF (Cardiac Floating): <10µA normal, <50µA fault. Design considerations: Calculate worst-case total with all converters at maximum leakage; Include other components contributing to leakage; Provide 50% safety margin below limits; Document calculations in risk management file. The EC2M11's <2µA leakage provides significant margin for multi-converter designs. For high-converter-count systems, contact our FAE team for leakage analysis.
Sum all converter leakage currents. Maintain margin below IEC limits. Contact us for analysis.
Can the EC2M11 be used in life-support equipment?
Yes, the EC2M11 can be used in life-support equipment with appropriate system design. Life-support applications include ventilators, anesthesia machines, heart-lung machines, infusion pumps for critical care, defibrillators, and dialysis machines. Considerations for life-support: 2xMOPP isolation provides required patient protection; 2M hour MTBF provides good reliability baseline; Consider redundancy for critical systems; Implement output voltage monitoring; Provide fault detection and alarms. Additional recommendations: System-level FMEA analysis; Redundant power architecture for critical functions; Comprehensive testing beyond standard requirements; Regulatory consultation for device classification; Post-market surveillance plan. The EC2M11 provides full 2xMOPP certification, high reliability, complete documentation, and compact size. For life-support applications, we recommend early engagement with our FAE team for design review.
Can be used in life-support with proper system design. Contact us for critical care design assistance.
What PCB layout considerations are important for medical converters?
PCB layout is critical for maintaining medical safety isolation: Creepage and clearance requirements include 8mm minimum creepage distance and 5mm minimum clearance distance to ensure adequate isolation at 5000VAC. Layout guidelines include keeping input and output circuits completely separate, not routing traces under the converter that bridge isolation, using slots or barriers if space is limited, and selecting appropriate CTI-rated PCB materials. Grounding requires keeping patient ground separate from protective earth, connecting converter output ground to patient circuit ground, and connecting input ground to system ground. Component placement requires placing input filter components on input side, placing output filter components on output side, and not placing components that bridge isolation barrier. Testing involves verifying isolation with hipot testing, measuring leakage current in final configuration, and documenting layout in technical file. Refer to Cincon's datasheets for detailed mechanical drawings. Contact our FAE team for layout review.
Follow datasheet layout guidelines. Maintain creepage/clearance. Contact us for layout review.