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What to know before using the System:
Review all product information before use.
The Sensor Pack and Sensor Applicator are packaged as a set and have the same serial
number. Check that the serial numbers match before using the Sensor Pack and Sensor
Applicator. Do not use Sensor Packs and Sensor Applicators with different serial numbers
as this will result in incorrect glucose readings.
Take standard precautions for transmission of blood borne pathogens,for example by
wiping the insertion site with an alcohol swab, to avoid contamination.
• In rare cases, insertion of the Sensor may cause insertion site pain, bleeding or Sensor probe
breakage. Seek help from your professional healthcare team if the Sensor tip breaks.
Wearing the adhesive patch may cause inflammation, skin irritation and skin allergy. Some
individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If
you notice significant skin irritation around or under your Sensor, remove the Sensor and
contact your professional healthcare team before continuing usage.
Do not modify the GS1 system without authorization of the manufacturer.
Do not use the GS1 system if you are under the age of 18, pregnant, on dialysis, or critically
ill. It is not known how health conditions or medications common to these populations
may affect performance of the system.
Performance of the system when used with other implanted medical devices, such as
pacemakers, has not been evaluated.
When not to use the system:
Do not use the Sensor if its sterile package has been damaged or opened, as it may cause
an infection. Contact our Customer Service at support@sibionics.com.
Do not use expired Sensor or Applicator.
The Sensor automatically stops working after the 14-day wear period and must be replaced.
The system must be removed prior to Magnetic Resonance Imaging (MRI), X-ray
examination, Computed Tomography (CT) scan, or high-frequency electrical heat
(diathermy) treatment. The effect of MRI, X-ray, CT scans, or diathermy on the