SAFE‑STONES Trial

Device information

Instructions for use and label for this medical device.

⚠ Not for emergencies

This app is not for emergencies and is not monitored around the clock. If you feel very unwell — severe pain that will not settle, a high temperature, shivering, being unable to pass urine, or blood in your urine with a fever — call 999 or go to A&E now. Do not wait for a reply in the app.

Device

MD UKCA (mark to be affixed — Class I self-certification pending)
Name
SAFE-STONES follow-up application
Version
0.1 (prototype)
UDI-DI
[UDI-DI — to be assigned]
Date of issue
2026-06-19
Manufacturer
[Legal manufacturer — Sponsor, to be confirmed]
Address
[Manufacturer address]

What this app is for

SAFE-STONES supports the follow-up of adults treated for urinary tract stone disease. It lets you record symptoms, complete health questionnaires, and tell your care team about hospital visits or procedures; it shows your own results; and it lets you contact the study team when you need to. If you report certain warning-sign symptoms, it alerts your named responsible clinician so you can be reviewed.

It is an adjunct to normal care. It does not provide a diagnosis, does not tell you what treatment to have, and does not replace your clinical team or emergency services.

Who it is for

  • Patients: adults (18+) taking part in the SAFE-STONES trial after treatment for stones.
  • Staff: research nurses, clinicians, data managers and the Data Monitoring Committee.

How to use it

  1. Sign in with the account your study team created; change your password on first sign-in.
  2. Complete questionnaires when they are due.
  3. Report a hospital visit, operation or infection using the report option.
  4. To contact the team, use "New request", describe what is happening, tick any warning-sign symptoms and rate your pain. Urgent or red-flag reports alert your responsible clinician.
  5. View your results under "My results". Ask your team if anything is unclear.

Limitations

  • Not for use in a medical emergency (use 999/A&E).
  • Not a diagnostic device; results shown are records, not clinical interpretations.
  • Not intended for children or for anything other than stone-disease follow-up in the trial.
  • Needs a working device and internet connection; if unavailable, use the alternative contact route your team gave you.

Your data & reporting a problem

Your information is handled as described in the Privacy notice.

Report any problem or safety concern with the app to the study team: [Study team — name / phone / email]. Suspected device-related incidents are reported to the MHRA where appropriate.

Symbols used

MD
Medical device
UKCA
UKCA conformity marking
Factory symbol
Manufacturer
“i” in a circle
Consult instructions for use

Symbols per EN ISO 15223-1:2021.