Dexcom G6
®
System User Guide
320Appendix F: Technical Information
Adverse Events
No serious adverse events (AEs) or device-related serious adverse events occurred
during the studies. There was a total of 24 mild to moderate AEs which occurred during
the studies (among 374 sensors). 13 of these AEs occurred due to either skin irritation,
such as erythema (redness) or edema (swelling), at the sensor needle insertion area or
around the adhesive area, or mild to moderate excoriation and infection.
F.2 Product Specifications
User is the single use operator in the home environment.
Use of peripherals, accessories, transducers and cables other than those specified
or provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this equipment
and result in improper operation.
Do not touch the metal connectors on the bottom of the transmitter and other open
connectors on the receiver, charging cable and charger.
Sensor Product Specifications
Glucose Range 40 – 400 mg/dL
Sensor Useful Life Up to 10 days
Calibration Commercially available meter
Calibration Range 20 – 600 mg/dL
Storage and Transport
Conditions
Temperature: 36° F – 86° F
Store sensors in a cool, dry place
Sterilization Sterile by radiation
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