CGM Glucose Monitoring Sensor
User Guide

CGM Glucose Monitoring Sensor

QUICK GUIDE
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READ THIS INSERT AND ALL OF THE LABELLING PROVIDED WITH THE CGM APP BEFORE HANDLING THE SENSOR KIT.
Product name: Continuous Glucose Monitoring System Sensor
Product Modell: GX-01, GX-02, GX-01S, GX-02S
For use with: RC2107, RC2109 CGM app
Indication for use:
The Continuous Glucose Monitoring System 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 fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the system results should be based on the glucose trends and severall sequential readings over time. The system also detects trends and tracks patterns, and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustment.
STEP 1: Install LinX CGM App
Search LinX CGM on the google play or App store

STEP 2: Register an Account
Use an e-mail account to register a LinX account.STEP 3: Apply the Sensor
Description:
The Sensor is located inside the Sensor Applicator. Follow the instructions to prepare and apply the Sensor on the back of your upper arm. The Sensor has a small, flexible tip that is inserted just under the skin. The Sensor can be worn for up to 15 days.
Action 1
Select the back of the upper arm as the insertion site (Avoid the muscle on the outer side of the upper arm).
Action 2
Disinfect the insertion site with an alcohol wipe and let it dry completely.
Action 3
Unscrew the cover of the applicator and set it aside.
Action 4
Align the opening of the applicator with the insertion site tightly and press the white implantation button of the applicator. After hearing the sound of the spring retreating, the sensor will be inserted underneath the skin and the puncture needle will automatically retreat back into the applicator.
Action 5
Gently pull the sensor applicator away from the body, and the sensor should now be attached to the skin.
Action 6
After installing the sensor, make sure that the sensor is firmly in place. Use your fingers to flatten the edge of the sensor to avoid wrinkles and warping.

STEP 4: Pair sensor with LinX CGM App

1. Log in on the LinX CGM app.
2. Make sure the phone’s Bluetooth is turned on.
3. Click “pairing” on the home dashboard.
4. Select and click the correct SN number of the sensor listed on the Nearby Device list. (Make sure the selected SN number is in accordance with the number printed on the packaging box and the applicator cover.)
5. Wait for a successful pairing.

Refer to the User Guide for more details of pairing procedures and the subsequent use.
The electronic manual should be accessible for viewing using a smartphone or computer with a web browser and PDF viewing capability. If you choose to view the electronic manual on the LinX CGM App, make sure to download the application on the compatible device models listed in our equipment list.
Please refer to the following website to check the compatible device list and User Guide:
https://www.microtechmd.com/support/download/664/666
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 (diathermy) treatment.
Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours n adults) may affect the CGMS readings and make them look higher than they really are.
The CGM System was not evaluated for the following persons:

• Pregnant women
• Peritoneal dialysis patients
• Patients with implanted pacemakers
• Patients with coagulation disorders or those taking anticoagulant drugs.

Precautions

• No modifications to the Continuous Glucose Monitoring System are allowed. Unauthorized modification of the CGMS may cause the product to malfunction and become unusable.
• Before using this product, you need to read the Instruction Manual or be trained by a professional. No doctor’s prescription is required for use at home.
• The CGMS contains many small parts that can be dangerous if swallowed.
• During rapid changes in blood glucose (more than 0.1 mmol/L per minute), glucose levels measured in interstitial fluid by the CGMS may not be the same as blood glucose levels. When blood glucose levels drop rapidly, the sensor may produce a higher reading than the blood glucose level; Conversely, when blood glucose levels rise rapidly, the sensor may produce a lower reading than the blood glucose level. In these cases, the sensor’s reading is checked by a fingertip blood test using a glucose meter.
• When it is necessary to confirm hypoglycemia or near-hypoglycemia as measured by a glucose sensor, a fingertip blood test should be performed using a glucose meter.
• Severe dehydration or excessive loss of water may result in inaccurate results.
• When you suspect you are dehydrated, consult a healthcare professional immediately.
• If you think the CGMS sensor reading is inaccurate or inconsistent with the symptoms, use a blood glucose meter to test your blood glucose level or calibrate the glucose sensor. If the problem persists, remove and replace the sensor.
• The performance of the CGMS has not been evaluated when used with another implantable medical device, such as a pacemaker.
• Details of what interferences may affect the accuracy of the detection are given in “Potential Interference information”.
• No modifications to the Continuous Glucose Monitoring System are allowed. Unauthorized modification of the CGMS may cause the product to malfunction and become unusable.
• Before using this product, you need to read the Instruction Manual or be trained by a professional. No doctor’s prescription is required for use at home.
• The CGMS contains many small parts that can be dangerous if swallowed.
• During rapid changes in blood glucose (more than 0.1 mmol/L per minute), glucose levels measured in interstitial fluid by the CGMS may not be the same as blood glucose levels. When blood glucose levels drop rapidly, the sensor may produce a higher reading than the blood glucose level; Conversely, when blood glucose levels rise rapidly, the sensor may produce a lower reading than the blood glucose level. In these cases, the sensor’s reading is checked by a fingertip blood test using a glucose meter.
• When it is necessary to confirm hypoglycemia or near-hypoglycemia as measured by a glucose sensor, a fingertip blood test should be performed using a glucose meter.
• Severe dehydration or excessive loss of water may result in inaccurate results.
• When you suspect you are dehydrated, consult a healthcare professional immediately.
• If you think the CGMS sensor reading is inaccurate or inconsistent with the symptoms, use a blood glucose meter to test your blood glucose level or calibrate the glucose sensor. If the problem persists, remove and replace the sensor.
• The performance of the CGMS has not been evaluated when used with another implantable medical device, such as a pacemaker.
• Details of what interferences may affect the accuracy of the detection are given in “Potential Interference information”.

Symbols:

Refer to Instruction Manual
Atmospheric pressure limitation
Type BF Applied Part
Single sterile barrier system with protective packaging outside using irradiation
Manufacturer
Do not use f package is damaged and consult instructions for use
Batch code
Importer
MR unsafe
Authorised Representative n the European Community
Temperature limit
Humidity limitation
Do not re-use
Caution
Date of manufacture
Use-by date
Serial number
Unique device identifier
Waste Electrical and Electronic Equipment (WEEE) – Follow ocal requirements for proper disposal
CE Mark
Medical device
Instructions for use
The level of protection against ingress of solid foreign objects s 6 (Protected against access to hazardous parts with a wire) The level of protection against ingress of water with harmful effects s 8 (Protected against the effects of continuous immersion in water)

Micro Tech Medical (Hangzhou) Co., Ltd.
No.108 Liuze St., Cangqian, Yuhang District, Hangzhou, 311121 Zhejiang, P.R.China
Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
1034-PMTL-466.V03
Effective date: 2025-05-07

Documents / Resources

LinX CGM Glucose Monitoring Sensor [pdf] User Guide CGM Glucose Monitoring Sensor, CGM, Glucose Monitoring Sensor, Monitoring Sensor, Sensor

References

• User Manual