Electrical Safety Verification

The device used by the CoughMonitor Suite (CMS) has undergone rigorous, third-party electrical safety testing, according to IEC 60601-1, the global standard for basic safety and essential performance of medical electrical equipment.

Summary

• Hyfe’s CoughMonitor PASSED all applicable IEC 60601-1 safety tests.
• The device is certified as safe for its intended use as a body-worn, internally powered, Type BF applied-part medical device.
• Testing was performed by TÜV SÜD PSB, an accredited laboratory, under the Singapore Accreditation Council framework.
• No failures or safety-critical deficiencies were identified.

Scope of testing

• Standard: IEC 60601-1:2005 + A1:2012 + A2:2020
• Device tested: Hyfe Cough Watch (same as CoughMonitor), Model H026
• Testing period: 8 April – 30 July 2025
• Tested configuration: Production-equivalent hardware, not a prototype

All required tests were performed, except for sections explicitly outside the manufacturer’s request (biocompatibility, usability, and EMC), which are covered under separate standards.

Key Findings: Safety & Essential Performance

Electrical & Mechanical Safety

• The device met all creepage, clearance, and insulation requirements under normal and single-fault conditions.

• Classified as:

  • Internally powered
  • Body-worn
  • Type BF applied part (safe for close contact with the body)
  • IP27 ingress protection, suitable for daily living environments

• No high-voltage components or hazardous accessible parts were identified.

Risk Management (ISO 14971)

• Hyfe’s complete Risk Management File was reviewed and found technically consistent.
• Residual risks were all assessed as acceptable, with no unresolved safety hazards.
• The device remained single-fault safe per IEC 60601-1 requirements.

Marking, Labeling, and User Documentation

• All required markings were:

  • Present
  • Durable
  • Legible

• Packaging and labeling met international standards for consumer-usable medical devices.

• The User Guide and Quick Start Guide provide:

  • Clear intended use
  • Warnings and cautions
  • Cleaning and handling instructions
  • Explanation of symbols

• Instructions are suitable for over-the-counter (OTC) consumer use by individuals aged 21+.

Intended Use (as tested)

The Hyfe CoughMonitor:

• Quantifies cough frequency using an onboard algorithm.
• Is intended for daily-living environments by adults considering seeking medical care for problematic cough.
• Provides data (cough counts) that should be interpreted with healthcare professional guidance.

Manufacturing & Quality System Inputs

• Device manufactured by Shenzhen DO Intelligent Technology Co., Ltd.

• TÜV SÜD inspected documentation including:

  • User Guide
  • Risk Management Plan, Report, and Assessments
  • Hazard identification
  • Firmware equivalence assessment (H026 vs. ID206 hardware)

Conclusion

Hyfe’s CoughMonitor successfully passed all applicable IEC 60601-1 tests and is considered safe for its intended consumer medical use. There were no safety failures, and the device met international standards for electrical protection, mechanical integrity, labeling, and risk management.

See below for full report.

Electrical safety testing report