GX-01S LinXCGM Continuous Glucose Monitoring System Sensor User Guide
- August 9, 2024
- LINX
Table of Contents
GX-01S LinXCGM Continuous Glucose Monitoring System Sensor
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 Model: GX-01S,GX-02S
- For use with : RC2107, RC2108, RC2109, RC2110 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 adult people (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 hyperglycemia and hypoglycemia, facilitating both acute and long-
term therapy adjustment.
Contraindications
- The Continuous Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI).
- The Continuous Glucose Monitoring System was not evaluated for the Pregnant women.
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.
- For more specific operations, please refer to the user guide in the LinX app.
For use with the LinX App
Step 1 Select Insertion Area
Abdomen: Avoid the waistband, abdominal wrinkles, scars, insulin
injection induration, belt-wearing area, and stretch marks. Also, make sure
that your insertion site is at least 5cm away from your navel.
Upper arm: the back of the upper arm (Don’t insert into the muscles on the
outer side of the upper arm.)
Step 2 Sterilize: Before the insertion, clean the insertion site with an
alcohol wipe and let it dry completely.
Step 3 Unscrew the cover from the sensor applicator and set it aside.
Step 4 Align the opening of the applicator with the skin where you want
to apply it and press it tightly on the skin. Then press the implantation
button of the applicator, wait for a few seconds after hearing the sound of
the spring retreating, to make the sensor stick on the skin, and the puncture
needle in the applicator will automatically retreat.
Step 5 Gently pull the sensor applicator away from the body, and the
sensor should now be attached to the skin.
Step 6 After installing the sensor, make sure that the sensor is firmly
in place. Put the cover back on the sensor applicator
Precautions
- Only MicroTech Medical consumables should be used with the CGMS.
- 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”
- The sensor loosens or takes off may cause the APP to have no readings.
- If a sensor tip breaks, do not handle it yourself. Please seek professional medical help.
- This product is waterproof and can be worn during showers and swimming, but do not bring sensors into the water more than 2.5 meters deep for longer than 2 hours.
- CGMS readings should only be used as a reference for the supplemental monitoring of diabetes mellitus and should not be used as a basis for clinical diagnosis.
- While extensive user testing was done on LinX CGMS in Type 1 and Type 2 diabetic patients, the study groups did not include women with gestational diabetes.
- If the product is not working properly or has been damaged, stop using the product.
- For user safety, storage, disposal and handling, plese refer to the system instruction for use.
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MORE INFORMATION
MicroTech Medical (Hangzhou) Co., Ltd. No.108 Liuze St., Cangqian, Yuhang
District, Hangzhou,311121 Zhejiang, P.R.China
1034-PMTL-432.V01 Effective date:2024-4-11