Instructions for Use (IFU)

1. Intended Use Statement

Relaxy Riri is an AI-based digital mental health support tool intended to provide non-clinical emotional wellbeing support through structured conversation and evidence-informed self-help techniques.

For research purposes, Relaxy Riri is intended to:

• Support evaluation of user engagement, acceptability, and usability
• Assess feasibility and safety of AI-mediated emotional support
• Generate anonymized insights for service quality improvement

2. Product Description

Relaxy Riri is a conversational AI system developed by Relaxy Limited. It enables users to engage in text-based interaction designed to facilitate emotional expression, reflection, and guided self-help.

Core components:

All content is designed to support wellbeing without replacing professional judgement or care.

3. Intended Research Population

Relaxy Riri is intended for:

• Individuals aged 13 years and above (or per applicable jurisdictional approval)
• Non-clinical populations seeking emotional wellbeing support
• Participants capable of providing informed consent

Relaxy Riri is not intended for:

• Individuals in acute psychiatric crisis
• Individuals with severe or enduring mental illness requiring specialist intervention
• Users unable to consent or comprehend system limitations

4. Limitations & Contraindications

5. Warnings & Precautions

• Users interact with AI software, not a human clinician
• AI outputs may be inaccurate or incomplete
• Users should not rely on Riri for clinical decision-making
• Privacy risks may increase if used in public or shared environments
• Internet interruptions may affect system performance

Participants should be advised of these limitations during consent.

6. Adverse Events & Safety Monitoring

No serious adverse events have been identified to date.

For research deployments:

• User distress signals are monitored at a system level
• Escalation prompts encourage off-platform human support
• Adverse events or safety concerns should be documented and reviewed by Relaxy's internal safety governance team

7. Instructions for Use (Research Context)

• Access via mobile or web interface
• Text-based interaction only
• Conversations may be paused, resumed, or restarted
• No obligation for continuous use

Researchers should not modify core conversational logic without Relaxy approval.

8. Onboarding & Informed Consent

Users are informed at onboarding that:

• Riri is an AI-based wellbeing tool
• Participation is voluntary
• Data may be used in anonymized form for research and improvement
• Data can be deleted or reset at any time

Explicit consent is obtained prior to use.

9. Risk Escalation & Emergency Guidance

If high-distress language is detected, Riri:

• Encourages seeking immediate human support
• Displays emergency contact information
• Offers grounding strategies

10. User Control & Withdrawal

Participants may:

• Discontinue use at any time
• Reset or delete their data
• Withdraw consent without penalty

Data withdrawal procedures are documented and auditable.

11. Data Protection & Research Data Governance

• Conversations are encrypted
• No direct personal identifiers are required
• Research analysis uses anonymized or aggregated data only
• Access restricted to authorized Relaxy personnel and approved internal researchers
• No third-party, cross-border, or commercial data sharing
• Data used solely for research, safety, and service improvement

12. Ethical AI & Oversight

Relaxy Riri operates under:

• Human-in-the-loop governance
• Clinically informed content review
• Bias, safety, and misuse monitoring
• Continuous evaluation and refinement

AI outputs are supportive, not directive.

13. Incident Reporting & Research Contact

All incidents, safety concerns, or protocol deviations should be reported to: