Warrenty & Safety Policy

Issued by ERGO Healthtech LimitedEffective Date: January 1, 2026

IMPORTANT SAFETY, EFFICACY, & REGULATORY COMPLIANCE STATEMENT

1. Technology Reference & Performance

Independent research, including a peer-reviewed study entitled “Far-UVC (222 nm) efficiently and safely inactivates airborne human coronaviruses” (Nature, June 2020), indicates that far-UVC light can inactivate airborne viruses. The ERGO222 (“the Product”) utilizes 222nm Far-UVC excimer lamp technology for the general reduction of bioburden in air and on surfaces.

2. Intended Use & Critical Limitations

• The Product is a portable disinfection device intended for use as a supplementary hygiene measure in personal spaces. It is designed for environmental wellness and as an extra layer of protection.
• The Product is NOT a medical device. It is not intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. It is not certified or approved by the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), or any other global medical device authority.
• The term “disinfection” herein refers only to the general reduction of microbial bioburden. Performance varies based on exposure time, distance, airflow, and environmental factors. The Product cannot disinfect areas not directly exposed to its light and does not affect pathogens already inside an infected person.
• This technology is NOT a substitute for established public health measures. Users must comply with all applicable health guidelines from authorities like the CDC and WHO.

3. Photobiological Safety & Exposure Guidelines

The Product is designed with reference to internationally recognized occupational exposure guidelines for optical radiation.

• Compliance with IEC/EN 62471 (EU/International Framework):

The Product’s safety assessment for applicable markets is based on IEC/EN 62471, harmonized under the EU Directive 2006/25/EC. This standard evaluates the “actinic UV hazard” to the skin and eye based on a spectrally weighted effective dose. For 222 nm radiation, this results in a Maximum Permissible Exposure (MPE) of approximately 22 mJ/cm² for both skin and eyes over an 8-hour period. Compliance with this limit is required for CE marking and sales in regions adopting this standard.

• Reference to ACGIH TLVs (U.S. Occupational Guidelines):

The American Conference of Governmental Industrial Hygienists (ACGIH) publishes Threshold Limit Values (TLVs) for chemical and physical agents. The 2022 TLVs for 222 nm radiation reflect newer biological data and are set at approximately 160 mJ/cm² for the eyes and 479 mJ/cm² for the skin over 8 hours. The Product’s output maintains a significant safety margin relative to these contemporary occupational health guidelines.

• Compliance Statement:

The Product is engineered to comply with the IEC/EN 62471 8-hour MPE of 22 mJ/cm² as the current, widely recognized regulatory benchmark. The reference to the higher ACGIH TLVs is for informational context regarding evolving scientific consensus. Definitive regulatory compliance in any jurisdiction is determined by the specific standard in force.

4. Mandatory Safety Precautions & Handling

1. Fragile Component: The 222nm excimer lamp is made of quartz glass. Handle the Product with care to avoid breakage.
2. Moisture Sensitivity: Keep the Product dry. Do not use in wet conditions. Cease use immediately if the Product becomes wet.
3. Power: Use only the provided charger. Use of incompatible chargers (e.g., those exceeding 2A output) voids warranty and may cause damage.
4. Physical Integrity: Do not drop, strike, or disassemble the Product. **Any attempt to open the housing will permanently void the warranty.**
5. Monitoring: Stop use and disconnect power if you observe any physical distortion, damage, or unusual operation (e.g., strange odors).
6. Responsible Use: Operate only according to the user manual. Ensure the Product is placed on a stable surface during use.