This device is intended for informational use only and is not intended to diagnose, treat, cure or prevent disease. Users should always follow instructions in the user manual and consult your healthcare provider before making any medication adjustments or take any other medical action based on your sensor readings.
1. Intended Use
The LinX Vista CGM system is designed for adults (18+) to monitor glucose trends. Not evaluated for:
- Pregnant women
- Peritoneal dialysis patients
- Patients with implanted pacemakers
- Patients with coagulation disorders or those taking anticoagulant drugs
2. Critical Warnings
Discontinue use and consult your healthcare provider if:
- Readings mismatch symptoms (e.g., hypoglycemia with normal values)
- Severe skin irritation occurs at sensor site
- Sensor fails during use
3. Medical Procedure Precautions
Remove sensor before:
- MRI scans
- CT scans
- Diathermy treatments
Reapply only after completing the procedure and verifying skin integrity.
4. Substance Interference
These may affect accuracy:
- Ascorbic acid (vitamin C) >500mg/day
- Hydroxyurea
- Acetaminophen (paracetamol)
5. Usage Guidelines
To ensure safety and accuracy:
- Do not stack or place adjacent to other devices (RF interference risk)
- Calibrate with fingerstick blood glucose when:
- The SG value is rising or falling rapidly.
- Symptoms do not match the SG value.
- Sensor readings indicates hyperglycemia or hypoglycemia.
- The medication contains Ascorbic acid, Acetaminophen and Hydroxyurea.
6. Emergency Preparedness
Always have a backup blood glucose meter for:
- Confirming abnormal readings
- Calibration requirements
- Sensor failure scenarios
Compliance Note: LinX Vista complies with IVDR (EU) 2017/746. LinX Vista CGM system holds CE certification as a regulated medical device in the EU. Not a substitute for medical advice.
For information about returns, refunds, and shipping terms, see our Shipping Policy and Return Policy pages.
