Safety Information; Dexcom One+ Cgm System Safety Statements - Dexcom ONE+ User Manual

2 • Safety information

Dexcom ONE+ CGM System safety statements

Important user information
Read all indications, warnings, and precautions for your Dexcom ONE+. Read all product instructions in this User Guide. You
can request a printed version of the Dexcom ONE+ User Guide online at dexcom.com/downloadsandguides.
If you don't read and follow all Dexcom ONE+ instructions, you may get inaccurate sensor readings, miss alerts, or miss a
severe low or high glucose event. Getting familiar with Dexcom ONE+ could take days, weeks, or even months.
Dexcom doesn't recommend continuous glucose monitoring for people who can't or won't:
Use their blood glucose (BG) meter to test their blood glucose if their symptoms don't match their sensor readings
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Keep in touch with their healthcare provider about diabetes management
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Indications for use
The Dexcom ONE+ Continuous Glucose Monitoring System (Dexcom ONE+) is a glucose monitoring system indicated for
continuously measuring glucose in the interstitial fluid in persons ages 2 years and older, including pregnant women.
Dexcom ONE+ is designed to replace fingerstick blood glucose (BG) testing for treatment decisions.
Interpretation of Dexcom ONE+ results should be based on glucose trends and several sequential sensor readings over time.
Dexcom ONE+ also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term
therapy adjustments.
Dexcom ONE+ is intended for use by patients at home and in healthcare facilities.
Contraindications
No MRI/CT/diathermy — MR unsafe: Don't wear any Dexcom ONE+ component during magnetic resonance
imaging (MRI) or high-frequency electrical heat (diathermy) treatment. However, it's safe to have a CT scan if you
keep the sensor out of the scanned area and cover the sensor with a lead apron during the scan.
Dexcom ONE+ hasn't been tested in those situations. When used during an MRI scan, diathermy, or in the scanned area of a
CT scan, the magnetic fields and heat could damage components of Dexcom ONE+, which may cause inaccurate sensor
readings or prevent alerts. Without sensor readings or alerts, you might miss a severe low or high glucose event.
Warnings
Before you begin, read the Safety Statements and the instructions in this guide.
Don't ignore low or high symptoms: Use your BG meter to make treatment decisions when your sensor readings don't
match your low or high symptoms. If needed, seek immediate medical attention.
No number, no arrow, no CGM treatment decision: Use your BG meter to make treatment decisions when your
Dexcom ONE+ doesn't show both a number and trend arrow. Also use your BG meter during the 30-minute sensor warmup
period.
Don't use if you are on dialysis or critically ill: Dexcom ONE+ performance hasn't been evaluated in these populations and
sensor readings may be inaccurate.
Sensor wire breaks off: Don't ignore broken or detached sensor wires. If this happens, please contact Dexcom Technical
Support at dexcom.com or contact your local Dexcom distributor.
If a sensor wire breaks off or detaches under your skin and you can't see it, don't try to remove it. Contact your healthcare
provider if you have symptoms of infection or inflammation — redness, swelling, or pain — at the insertion site.
Where to insert — arm, abdomen, or buttocks: All patients can use their abdomen and back of upper arm. Patients 2 to 6
years old can also choose their upper buttocks. The sensor isn't tested or approved for other sites. Discuss the best site for you
with your healthcare provider.
2 • Safety information | Dexcom ONE+ User Guide
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