System Description
Thank you for choosing the GlucoRx Vixxa™ 3 Continuous Glucose Monitoring (CGM) System. This CGM System consists of two devices: a Continuous Glucose Monitoring System Sensor and a Continuous Glucose Monitoring App. The GlucoRx Vixxa™ 3 CGM provides real-time glucose levels and allows you to continuously view your sensor glucose values on your selected mobile device. The system tracks your glucose every minute by measuring the amount of glucose in the interstitial fluid. A sensor, inserted in your skin, sends glucose results to the GlucoRx Vixxa™ Continuous Glucose Monitoring App.
The App then displays your glucose levels and long-term glucose trends. The App also provides alerts if your glucose is in or projected to be in an unsafe zone. The GlucoRx Vixxa™ 3 CGM also detects trends and tracks patterns and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating both acute and long-term therapy adjustments. Interpretation of the system results should be based on the glucose trends and several sequential results over time.
Note: Please read all the instructions provided in this Instructions for Use before using the system.
Important Information
This section covers crucial details regarding the safe and effective use of the GlucoRx Vixxa™ 3 CGMS sensor. It includes indications for use, intended purpose, patient eligibility, intended user profiles, contraindications, warnings, precautions, potential clinical side-effects, and additional security information.
- Indications for Use: The GlucoRx Vixxa™ 3 CGMS sensor is a real-time, continuous glucose monitoring device indicated for the management of diabetes in adults (age 18 and older) when used with compatible devices. It is designed to replace finger stick blood glucose testing for diabetes treatment decisions.
- Intended Purpose: The sensor measures glucose in interstitial fluid, and the app displays trends and alerts.
- Patients: Adult patients with diabetes (≥18 years old).
- Intended User: Individuals aged 18 and above with basic cognitive, literacy, and independent mobility skills, including medical professionals and non-professional adults.
- Contraindications: The system must be removed prior to Magnetic Resonance Imaging (MRI). Do not wear the sensor during CT scans or high-frequency electrical heat treatments. High doses of acetaminophen may affect readings. The system has not been evaluated for pregnant women or peritoneal dialysis patients.
Product List
Details on the components included in the GlucoRx Vixxa 3 system.
Apps and Software
Information on downloading and installing the required software, including minimum system requirements and IT environment considerations.
Vixxa™ App Overview
A guide to the Vixxa™ App, covering CGM service life, app setup, software registration, login, logout, updates, and various functions like the Home Dashboard, History Dashboard, Trends Dashboard, Fingerstick BG Dashboard (Record and Calibration), and Events Dashboard.
Using a New Glucose Sensor
Instructions on applying, starting, unpairing, removing, and replacing the glucose sensor.
Personal Settings
Guidance on customizing personal settings, including reminder settings, share/follow features, local log management, permission management, account security, language preferences, and theme adjustments.
Maintenance
Information on cleaning, disposal, transportation, and storage of the CGM system components.
Troubleshooting
Assistance with common issues and solutions for the GlucoRx Vixxa 3 system.
Performance Characteristics
Details on the performance metrics and capabilities of the GlucoRx Vixxa 3 system.
Specifications
Technical specifications for the GlucoRx Vixxa 3 Continuous Glucose Monitoring System.
Electromagnetic Compatibility
Information regarding the electromagnetic compatibility of the device.
Appendix
Includes symbols used, potential interference information, potential risks, and potential clinical benefits associated with the system.
Glossary
Definitions of key terms used throughout the document.
