GlucoRX Vixxa3 Continuous Glucose Monitoring System
Important Information
1.1 Indications for Use
The GlucoRx Vixxa™ 3 CGMS sensor
is a real-time, continuous glucose monitoring device. When the system is used together with compatible devices, it is indicated for the management of diabetes in adults (age 18 and older). It is designed to replace finger stick blood glucose testing for diabetes treatment decisions. Interpretation of the system results should be based on the glucose trends and several sequential readings over time. The system also detects trends and tracks patterns, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating both acute and long-term therapy adjustment.
1.1.1 Intended Purpose
Continuous Glucose Monitoring System Sensor: When the Continuous Glucose Monitoring System Sensor is used together with compatible software application, it is intended to continuously measure the glucose in the interstitial fluid and is designed to replace fingerstick blood glucose (BG) testing for treatment decisions.
Continuous Glucose Monitoring App (iOS/Android): When the Continuous Glucose Monitoring App is used together with compatible sensors, it is intended to continuously measure the glucose in the interstitial fluid and is designed to replace fingerstick blood glucose (BG) testing for treatment decisions.
1.1.2 Indications
1) Type 1 & 2 Diabetes Mellitus
2) Special types of diabetes (excluding monogenic diabetes syndromes , diseases of the exocrine pan- creas and drug or chemical induced diabetes)
3) Abnormal blood glucose levels
4) Patients requiring improved glycaemic control
5) People requiring frequent or continuous monitoring of blood glucose.
1.2 Patients
Adult patients with diabetes (2:18 years old).
1.3 Intended User
The target users of this medical device are individuals aged 18 and above, who possess basic cognitive, literacy and independent mobility skills. It is intended for both medical professionals and non-professional adults who need to continuously or periodically monitor their own or others’ glucose levels.
1.4 Contraindications
The Continuous Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI).
Don’t wear your CGM sensor for computed tomography (CT) scan or high-frequency electrical heat (dia – thermy) treatment.
Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may affect the CGM readings and make them look higher than they really are.
The CGM System was not evaluated for the following persons:
Product List
Product list: The continuous glucose monitoring sys- tem sensor is intended to be used together with CGM App as a system. The compatibility list is as follows:
Each model of sensor can be used in conjunction with any model of the App.
Apps and Software
3.1 Software Download
You can download the Vixxa™ App from Apple App Store or Google Play. Please check the Operating Sys- tem (OS) on your mobile device to make sure you get the correct App version.
3.2 Minimum Requirements for
Software Installation iOS
Model No: RC2111
Operating System (OS): iOS 14 and above
Memory: 2GB RAM
Storage: Minimum 200 MB
Network: WLAN (Wireless Local Area Network) or cel-
lular network, as well as Bluetooth function
Screen Resolution: 1334*750 pixels
Android
Model No: RC2112
Operating System (OS): Android 10.0 and above.
Memory: 8GB RAM
Storage: Minimum 200 MB
Network: WLAN (Wireless Local Area Network) or cel-
lular network, as well as Bluetooth function
Screen Resolution: 1080*2400 pixels and above
Note
• To receive alerts, make sure:
– Turning on the Alert function.
– Keeping your mobile phone and CGM equipment within 2 meters (6,56ft) maximum. If you want to receive alerts from the App, make sure your device is connected.
– Do not force-quit the Vixxa™ App that must be running in the background to receive alerts. Otherwise, alerts can not be received.
If alerts are unavailable, restarting the App may help you.
– Check to make sure that you have the correct phone settings and per- missions enabled. If your phone is not configured properly, you will not receive alerts.
• When you are not using headphones or speakers, you should take them off your smartphone, otherwise, you may not hear the alert. When you use headphones, put them in your ears.
• If you use a peripheral connected to your smartphone, such as a wireless headset or smart watch, you may receive alerts on only one device or peripheral rather than all devices.
• Your smartphone should always be charged and turned on.
• Open the App after the operating system is updated.
3.3 IT Environment
Do not use the App when the Bluetooth function is turned off, in a complex Bluetooth environment or a high electrostatic discharge environment, otherwise it will cause the data reading failure of the continuous glucose detection system. Because Bluetooth will have communication barriers in complex Bluetooth environments or high electrostatic discharge environ- ments. Users need to ensure that they stay away from complex Bluetooth environments or high electrostatic discharge environments and ensure that the Bluetooth function is turned on. No other external software or applications have been found to cause critical defects.
Using in an environment with poor communication may cause signal loss, connection interruption, incomplete data and other issues.
Vixxa™ App Overview
4.1 CGM Service Life
The App will cease maintenance five years after the final batch of CGM devices is discontinued from the market. During the maintenance period, it is necessary to ensure the normal operation of the servers and the interactive functions related to CGM devices should not be affected.
4.2 App Setup
4.2.1 Software Registration
If you do not have an account, click the “Register” but- ton to enter the registration screen. Please input your email address and password. Read the Terms of Use and Privacy Policy before ticking the box. By ticking the box, you agree to comply with the Terms of Use and the Privacy Policy. Click “Send verification code to my email” to receive a six-digit code. After keying in the verification code, click “Continue” to complete your registration. The rules for setting a username and password are:
Username:
Use your email address as
your username.
Password:
Password must contain at
least 8 characters.
く
Password must contain 1
capital letter, 1 small letter
and 1 numerical number.
4.2.2 Software Login
Use your registered account email address and Pass-
word to log in to the App.
Note
• You may only log in to your account on one mobile device
at a time.
• You are responsible for properly securing and managing
your phone. If you suspect an adverse cybersecurity event
related to the Vixxa ™ App, contact GlucoRx.
Make sure that your phone is kept in a safe place, under
your control. Do not disclose your password to others. This
is important to help prevent anyone from accessing or tam-
pering with the System.
• It is recommended to use the protection system of your
mobile phone, such as lock screen password, biometrics, to
strengthen the data protection of the App.
Documents / Resources
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GlucoRX Vixxa3 Continuous Glucose Monitoring System [pdf] Instruction Manual IFU1034-PMTL-578.V01, 1034-PMTL-578.V01, Vixxa3 Continuous Glucose Monitoring System, Vixxa3, Continuous Glucose Monitoring System, Glucose Monitoring System, Monitoring System |