Medical Device Power Solutions

Medical Devices Application

Description

Medical-grade isolated DC-DC converters with 2xMOPP certification for safe, reliable patient-connected equipment

Core Advantages

2xMOPP Patient Protection Full 2xMOPP certification to IEC 60601-1 3rd Edition ensures highest level of patient safety with two independent protection means
5000VAC Isolation High isolation voltage provides safety margin and meets requirements for patient-connected medical equipment
Ultra-Low Leakage Current Less than 2µA leakage current meets stringent patient safety limits and allows use in direct patient contact applications
Complete Certification Package Full documentation including risk management files, test reports, and declarations simplifies regulatory approval
Compact Medical-Grade Design Small SIP packages enable portable medical devices while maintaining full medical safety certification

Recommended Bill of Materials (BOM)

Item Part Number Description Quantity Datasheet
1 EC2M11 2W medical DC-DC converter with 2xMOPP 1 📄 Download
2 Input-Cap-4.7uF 4.7µF ceramic input capacitor 1 📄 Download
3 Output-Cap-4.7uF 4.7µF ceramic output capacitor 1 📄 Download

Applications

Patient monitoring systems
Diagnostic equipment
Therapeutic devices
Infusion pumps
Pulse oximeters
Blood pressure monitors
Home healthcare devices
Portable medical instruments

Technical Specifications

Input Voltage
21.6-26.4VDC (medical grade)
Output Power
2W to 6W
Efficiency
Up to 86%
Isolation
5000VAC, 2xMOPP
Leakage Current
<2µA

Customer Success Stories

MedTech Diagnostics Inc

Medical Devices |

Challenge

Developing a new portable patient monitor requiring isolated power for ECG and blood pressure measurement circuits with FDA 510(k) approval pathway.

Solution

Implemented Cincon EC2M11 2W medical-grade converters with 2xMOPP isolation for patient circuit power. The 5000VAC isolation and <2µA leakage met all safety requirements.

Results

  • Successfully passed FDA 510(k) review on first submission
  • Patient leakage current 50% below regulatory limits
  • Compact SIP7 package enabled portable design
  • Zero safety-related issues in clinical trials
"The Cincon EC2M11 converter and complete documentation package made our FDA submission straightforward. The 2xMOPP certification gave us confidence in meeting patient safety requirements."
— Regulatory Affairs Manager, MedTech Diagnostics Inc

HomeCare Medical Systems

Home Healthcare |

Challenge

Needed reliable, safe power supplies for a new home-use blood pressure monitor with battery and AC adapter operation, requiring medical certification for home use.

Solution

Used Cincon EC2M11 for isolated patient circuit power. The converter provided required medical isolation and certifications for home healthcare use.

Results

  • Passed all IEC 60601-1 safety testing
  • Compact size enabled small product footprint
  • Low power consumption extended battery life 20%
  • Successfully launched in US and EU markets
"Cincon's medical power solutions provided the safety and reliability we needed for our home healthcare product. The certifications and documentation simplified our regulatory approval process."
— Product Manager, HomeCare Medical Systems

FAE Expert Insights

S

Senior FAE

Medical Applications Engineer

10+ years

Professional Insights

Cincon's medical power solutions are outstanding for patient-connected devices. The full 2xMOPP certification to IEC 60601-1 3rd Edition provides confidence for regulatory submissions, and the complete documentation package is invaluable for FDA and international approvals. I've supported numerous medical device designs using Cincon converters, and the results have been excellent. The 5000VAC isolation and <2µA leakage current meet the most stringent patient safety requirements. For medical designers, I strongly recommend starting with the EC2M series for low-power applications and EC6M for higher power needs. The SIP packages are perfect for space-constrained portable devices. Pay careful attention to PCB layout - maintain creepage and clearance distances, and keep patient circuits isolated. The documentation package from Cincon includes everything needed for regulatory submissions. I highly recommend these converters for any medical device requiring patient isolation.

Key Takeaways

  • Full 2xMOPP certification to latest standards
  • 5000VAC isolation provides safety margin
  • Ultra-low leakage meets strictest requirements
  • Complete documentation simplifies regulatory approval
  • Compact size enables portable designs

Decision Framework

Medical Power Solution Selection Framework
Steps:
  1. Determine power requirements with margin
  2. Select EC2M (<2W) or EC6M (>2W) series
  3. Design PCB with proper creepage/clearance
  4. Plan for regulatory documentation requirements
  5. Implement monitoring and protection as needed

Ready to Implement This Solution?

Contact our FAE team for design support and quotes

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Frequently Asked Questions

What is 2xMOPP and why is it required for medical devices?

2xMOPP (Means of Patient Protection) is the highest level of isolation required for medical equipment that contacts patients. It provides: Two independent protection means between patient and hazardous voltages

5000VAC isolation voltage (higher than standard 1000-3000V)

Ultra-low leakage current (<2µA) to prevent patient shock

Protection 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 (Means of Operator Protection), which is insufficient for patient contact. Always use 2xMOPP certified converters for patient-connected circuits. The 2xMOPP certification requires specific construction, testing, and documentation per IEC 60601-1.

Use 2xMOPP certified converters for all patient-connected circuits. Contact us for medical design assistance.

What documentation is provided with Cincon medical converters?

Cincon medical converters come with comprehensive documentation for regulatory approval: Safety certificates include IEC 60601-1 3rd Edition, ANSI/AAMI ES60601-1 (US), CSA C22.2 No. 60601-1 (Canada), and EN 60601-1 (Europe). Technical documentation includes detailed datasheet with specifications, isolation diagram and specifications, leakage current test data, insulation resistance 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 package 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 documentation package available for regulatory submissions. Contact us to request files.

How do I calculate total leakage current for multi-converter medical systems?

For medical devices with multiple converters, total leakage current is the sum of all individual leakage currents: Calculation: Total leakage = Converter 1 + Converter 2 +... + Converter N

Each Cincon medical converter has <2µA leakage

2 converters = <4µA total

4 converters = <8µA total. IEC 60601-1 limits: Type B (Body) equipment: <100µA normal, <500µA fault

Type BF (Body Floating) equipment: <100µA normal, <500µA fault

Type CF (Cardiac Floating) equipment: <10µA normal, <50µA fault. Design considerations: Calculate worst-case total with all converters at maximum leakage

Include other components contributing to leakage (caps, filters)

Provide safety margin below limits (typically 50%)

Document calculations in risk management file. For high-converter-count systems: Consider using fewer, higher-power converters

Implement additional isolation if needed

Contact our FAE team for leakage analysis. Cincon's <2µA leakage provides significant margin for multi-converter designs.

Sum all converter leakage currents. Maintain margin below IEC limits. Contact us for leakage analysis.

Can Cincon medical converters be used in life-support equipment?

Yes, Cincon medical converters 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

Dialysis machines. Considerations for life-support: 2xMOPP isolation: Cincon converters provide required patient protection

High reliability: 2M hour MTBF provides good baseline

Redundancy: Consider dual converters with OR-ing for critical systems

Monitoring: Implement output voltage and current monitoring

Alarms: Provide fault detection and alarm outputs. Additional recommendations: System-level FMEA analysis

Redundant power architecture for critical functions

Comprehensive testing beyond standard requirements

Regulatory consultation for specific device classification

Post-market surveillance plan. Cincon converters provide: Full 2xMOPP certification for patient safety

High reliability for continuous operation

Complete documentation for regulatory compliance

Compact size for equipment integration. For life-support applications, we recommend early engagement with our FAE team for design review and reliability analysis.

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: Maintain 8mm minimum creepage distance

Maintain 5mm minimum clearance distance

These ensure adequate isolation at 5000VAC. Layout guidelines: Keep input and output circuits completely separate

Do not route traces under the converter that bridge isolation

Use slots or barriers if space is limited

Select appropriate CTI (Comparative Tracking Index) rated PCB materials. Grounding: Keep patient ground separate from protective earth

Connect converter output ground to patient circuit ground

Input ground connects to system ground. Component placement: Place input filter components on input side

Place output filter components on output side

Do not place components that bridge isolation barrier. Testing: Verify isolation with hipot testing

Measure leakage current in final configuration

Document layout in technical file. Refer to Cincon's datasheets for detailed mechanical drawings and recommended PCB layouts. Contact our FAE team for layout review.

Follow datasheet layout guidelines. Maintain creepage/clearance. Contact us for layout review.

How do I select between EC2M and EC6M series for medical applications?

Select between EC2M and EC6M based on power requirements: EC2M Series (2W): Suitable for: Low-power sensors

Small displays

Single-parameter monitors

Cost-sensitive designs

Space-critical applications. Specifications: 2W output power

Up to 400mA at 5V

SIP7 compact package

2M hour MTBF. EC6M Series (6W): Suitable for: Multi-parameter monitors

Therapeutic equipment

Higher power diagnostic devices

Systems with multiple loads

Future expansion needs. Specifications: 6W output power

Up to 1200mA at 5V

SIP8/DIP8 packages

1.8M hour MTBF. Both series offer: Full 2xMOPP certification

5000VAC isolation

<2µA leakage current

Complete medical documentation. Decision factors: Power requirement: Choose series with 50-100% headroom

Future expansion: EC6M provides more growth capability

Cost: EC2M approximately 30% less than EC6M

Size: EC2M more compact for space-constrained designs. For new designs, if power is close to 2W or may increase, consider EC6M for margin. Contact our FAE team for power budgeting assistance.

Choose EC2M for <2W, EC6M for >2W or expansion needs. Contact us for selection assistance.