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Prekė: Gliukozės jutiklis SIBIONICS GS1, nuolatinio gliukozės stebėjimo sistema. Kategorija: Gliukozės matuokliai.
- Gamintojas: Sibionics
- Modelis: Sibionics GS1
The Sibionics GS1 continuous glucose monitoring system is intended for use in patients with type 1 and type 2 diabetes from 3 years of age. It is used for continuous monitoring of glucose concentration in intratissue fluid in real time, for single use. The Sibionics GS1 system can replace glucose measurement by taking a blood sample from the fingertip to make decisions about the treatment of diabetes, including insulin dosage.
The GS1 CGM system has clinically proven accuracy i enables therapeutic decisions to be made based on sensor readings, including insulin dosing*.
*Outside of situations: no value and/or no trend arrow in the application and when glucose readings in the Sibionics GS1 system are incorrect or do not correspond to well-being. Glucose glucose meter testing should be performed. Do not ignore symptoms that may be caused by low and/or high glucose levels.
Why Sibionics GS1?
- 14-day continuous glucose monitoring system
- Real-time glucose measurement
- Sensor and transmitter in one device
- Configurable alarms
- WHINING 8,83%
- Waterproof*
*IP28 protection class. Protection against penetration of large objects with a diameter of not less than 12.5 mm and the effects of continuous immersion in water over 1 hour
The package contains:
- 1 sensor applicator
- 1 sensor
- 1 safety patch
- 1 instructions for use
- 1 abbreviated instructions for use
System application locations:
- The sensor can be placed on the back of the arm.
By purchasing the CGM Sibionics GS1 sensor in this offer, you will receive an additional protective patch.
With the Sibionics GS1 system, get:
- Possibility of observing trends
- no need for puncture, scanning and calibration
- alarm with a very low glycemic level of 55 mg / dL (you will receive even when you have muted sounds on your phone)
- Improving quality of life by increasing awareness of hypoglycemia*.
- Improved glycaemic control (by reducing HbA1c) in children and adolescents*.
- The SIBIONICS GS1 CGM system replaces glucose measurement by taking a blood sample from the fingertip to make decisions about the treatment of diabetes, including insulin dosage **
*Instructions for using the Sibionics GS1 system
The Sibionics Pro View web system
- Easy and quick sharing of data with your doctor:
- The doctor has the opportunity to observe the patient's glycemia in real time
- Easy way to link accounts
- Access to rich data analytics, including m.in.:
- AGP report
- Glucose Management Index (GMI)
- TIR, TAR and TBR parameters in terms of time and percentage
- Glucose variability index (CV)
- Mean glucose
- Sensor activity time
The Sibionics mobile application works with Apple's Android and iOS operating systems.
With the Sibionics GS1 system, get:
- Possibility of observing trends
- no need for puncture, scanning and calibration
- alarm with a very low glycemic level of 55 mg / dL (you will receive even when you have muted sounds on your phone)
- Improving quality of life by increasing awareness of hypoglycemia*.
- Improved glycaemic control (by reducing HbA1c) in children and adolescents*.
- The SIBIONICS GS1 CGM system replaces glucose measurement by taking a blood sample from the fingertip to make decisions about the treatment of diabetes, including insulin dosage **
*Instructions for using the Sibionics GS1 system
The Sibionics Pro View web system
- Easy and quick sharing of data with your doctor:
- The doctor has the opportunity to observe the patient's glycemia in real time
- Easy way to link accounts
- Access to rich data analytics, including m.in.:
- AGP report
- Glucose Management Index (GMI)
- TIR, TAR and TBR parameters in terms of time and percentage
- Glucose variability index (CV)
- Mean glucose
- Sensor activity time
The Sibionics mobile application works with Apple's Android and iOS operating systems.
Purpose of medical device:
The Sibionics GS1 continuous glucose monitoring system is intended for use in patients with type 1 and type 2 diabetes from 3 years of age. It is used for continuous monitoring of glucose concentration in intratissue fluid in real time, for single use. The Sibionics GS1 system can replace glucose measurement by taking a blood sample from the fingertip to make decisions about the treatment of diabetes, including insulin dosage.
Manufacturer: Shenzhen SiSensing Co., Ltd.
Responsible person (EC-REP): Shanghai International Holding Corp. GmbH (Europe)
Importer and advertiser: Diagnosis S.A. ul. Andersa 38A, 15-113 Białystok, Poland.
This is a medical device. Use it according to the instructions for use or label.
Warnings and safety information:
Before using the SIBIONICS GS1 App for your smartphone (hereinafter referred to as the smartphone app), the SIBIONICS GSW App for your smartwatch (hereinafter referred to as the smartwatch app), and the SIBIONICS GS1 glucose monitoring system (hereinafter referred to as the GS1 CGM system), read all instructions and leaflet. Smartwach is a separate product that can be purchased in selected countries. The instructions for use shall contain all safety information and instructions for use. Consult your doctor about how to use information from the system to help manage diabetes.
Failure to follow the instructions for use of the GS1 CGM system may lead to overlooking very low or very high glucose levels and making a therapeutic decision inadequate to the patient’s health. If the results obtained with the system do not correspond to the symptoms and/or expected values, measure the glucose concentration with a glucose meter by pricking the fingertip and on this basis make a decision on treatment.
If necessary, consult a doctor.
The system can replace a blood glucose test, except in the following situations. These are situations when we perform a blood glucose test in order to make decisions related to the treatment of diabetes – then the readings from the sensor may not accurately reflect the actual blood glucose concentration:
- No value and/or no arrow
- Do a blood glucose test if you think your sensor glucose readings are abnormal or do not match your well-being. Do not ignore symptoms that may be caused by low and/or high glucose levels.
Using the GS1 CGM system in such situations can lead to wrong decisions regarding the treatment of diabetes. Read the chapter “13. Treatment decisions” in this document.
For more information on how to make treatment decisions with the GS1 CGM system, please refer to the sections “1.4 Safety Instructions”, “13. Treatment decisions” and “6. Glucose alarms.”
Specifications
| Group | Name | Value |
|---|---|---|
| Parametry | Condition | new |
| Parametry | Invoice | With VAT invoice |
| Parametry | Medical device | yes |
| Parametry | Medical device type | medical device or in-vitro diagnostic medical device |
| Parametry | Manufacturer of a medical device | Shenzhen SiSensing Co., Ltd. |
| Parametry | Authorized representative | Shanghai International Holding Corp. GmbH (Europe) |
| Parametry | Measurement | glucose |
| Parametry | Brand | Sibionics |
| Parametry | Manufacturer code | CGM000001 |
| Parametry | Model | Sibionics GS1 |
| Parametry | Average measurement | from 14 days |
| Parametry | Product width | 33.5 cm |
| Parametry | Product height | 20 cm |
| Parametry | Product depth | 5.3 cm |
| Parametry | EAN (GTIN) | 6972831642008 |
| Parametry | Packaging status | original |
| Parametry | Batteries included | no |
| Parametry | Certificates of conformity | CE |






