Dexcom G5 Mobile Manuale utente

Dexcom G5 Mobile CGM System Getting Started Guide • 1

Getting Started Guide

for Dexcom G5

Mobile Continuous

Glucose Monitoring (CGM) System

2 •Dexcom G5 Mobile CGM System Getting Started Guide

Dexcom G5 Mobile CGM System Getting Started Guide • 1

Table of Contents

Section 1: Welcome ....................................................................................3

1.1 Training Options ............................................................................................................. 3

Section 2: Indications for Use and Safety Statement...............................4

Section 3: Risks and Benefits .................................................................. 12

3.1 Risks ..............................................................................................................................12

3.2 Benefits .........................................................................................................................13

Section 4: System Overview .................................................................... 15

4.1 Components...................................................................................................................15

4.2 Choose Display Device..................................................................................................16

Section 5: App Setup ............................................................................... 17

5.1 Install App......................................................................................................................17

5.2 Enter Initial BG Meter Values .......................................................................................18

5.3 View Home Screen ........................................................................................................19

5.4 Smart Device Settings ................................................................................................. 20

Section 6: Receiver Setup ........................................................................21

6.1 Set Up Receiver ............................................................................................................ 21

6.2 Insert Sensor................................................................................................................ 23

6.3 Attach Transmitter ...................................................................................................... 25

6.4 Confirm Communication and Start Sensor ................................................................ 26

6.5 Set Up Alert Sounds..................................................................................................... 27

6.6 Enter Initial BG Meter Values ..................................................................................... 29

6.7 View Receiver Trend Screen........................................................................................ 30

Section 7: App and Receiver Trend Arrows.............................................31

Section 8: App and Receiver 1, 3, 6, 12 or 24 hour Trend Graph ............31

2 •Dexcom G5 Mobile CGM System Getting Started Guide

Section 9: App and Receiver Enter BG Meter Values Every 12 Hours ....32

Section 10: End Sensor Session ..............................................................33

10.1 Remove Sensor and Transmitter............................................................................... 33

10.2 App: Ending Sensor Session Early ............................................................................ 34

10.3 Receiver: Ending Sensor Session Early .................................................................... 35

Section 11: Alarm, Alerts and Advanced Alerts ......................................36

11.1 Urgent Low Glucose Alarm......................................................................................... 36

11.2 Change Low and High Alerts ..................................................................................... 36

11.3 Advanced Alerts ......................................................................................................... 36

Section 12: Using Dexcom G5 for Treatment Decisions..........................37

12.1 Treatment Decisions: The Basics .............................................................................. 37

12.2 Treatment Decisions: Beyond The Basics ................................................................ 39

Section 13: Troubleshooting ...................................................................41

13.1 Sensor Glucose Readings .......................................................................................... 41

13.2 Calibration Errors....................................................................................................... 44

13.3 Transmitter Errors...................................................................................................... 45

13.4 Adhesive ..................................................................................................................... 46

Section 14: Warranty................................................................................47

14.1 Receiver Warranty Information ................................................................................ 47

14.2 Transmitter Warranty Information ........................................................................... 49

Section 15: Travel .....................................................................................52

Section 16: Need Help? You’re Not Alone!...............................................53

16.1 Dexcom Technical Support........................................................................................ 53

16.2 Dexcom Care Team .................................................................................................... 53

16.3 Sales Support Team ................................................................................................... 54

16.4 Web-based Education................................................................................................ 54

16.5 Dexcom Share and Follow ......................................................................................... 54

Dexcom G5 Mobile CGM System Getting Started Guide • 3

Section 1: Welcome

Congratulations on making the Dexcom G5®Mobile Continuous Glucose Monitoring

(CGM) System part of your life!

The Dexcom G5 Mobile CGM System (Dexcom G5) allows you to see real-time

continuous glucose readings every ﬁve minutes for up to seven days. These readings

can help you ﬁnd trends and patterns in your glucose levels, allowing you to see where

your glucose levels have been, which direction they are headed, and how fast they are

rising or falling.

1.1 Training Options

Knowing about the Dexcom G5 is your first step in creating a successful CGM

experience. Before using it, learn about it.

You can train on the Dexcom G5 in the following ways:

• Self train with the Dexcom G5 Mobile Tutorial

• Train with our Dexcom Care Team: 1-877-339-2664, Monday through Friday, 6

am to 5 pm PST

• Train with your healthcare professional using this Getting Started Guide

Before you begin and anytime you have questions, review the Dexcom G5 Mobile CGM

User Guide (user guide). Your options to get the full user guide:

• Download as an eBook or view/print in a .pdf format

dexcom.com/guides

• Online request form to receive a free printed copy

dexcom.com/guides

• Request a free copy by mail

Using the business reply card found in the back of this guide

• Request a free copy by phone

1-888-738-3646 ext. 4300

4 •Dexcom G5 Mobile CGM System Getting Started Guide

Section 2: Indications for Use and Safety

Statement

Indications for Use

The Dexcom G5 Mobile Continuous Glucose Monitoring System (Dexcom G5) is a

glucose monitoring system indicated for the management of diabetes in persons age

2 years and older. The Dexcom G5 is designed to replace ﬁngerstick blood glucose

testing for diabetes treatment decisions.

Interpretation of the Dexcom G5 results should be based on the glucose trends and

several sequential readings over time. The Dexcom G5 also aids in the detection of

episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term

therapy adjustments.

The Dexcom G5 is intended for single patient use and requires a prescription.

Important User Information

Failure to use the Dexcom G5 and its components according to the instructions for use

and all indications, contraindications, warnings, precautions, and cautions may result in

you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood

glucose) occurrence and/or making a treatment decision that may result in injury. If

your glucose alerts and readings from your Dexcom G5 do not match your symptoms

or expectations, use a ﬁngerstick blood glucose value from your blood glucose meter to

make diabetes treatment decisions. Seek medical attention when appropriate.

Please review the product instructions before using the Dexcom G5. Indications,

contraindications, warnings, precautions, cautions, and other important user

information can be found in the product instructions that are included with, or

accompany, the Dexcom G5. Discuss with your healthcare professional how you should

use the information displayed on the Dexcom G5 to help manage your diabetes. The

product instructions contain important information on troubleshooting the Dexcom G5

and on the performance characteristics of the system.

Contraindications

MRI/CT/ Diathermy

Remove the Dexcom G5 sensor, transmitter, and receiver before Magnetic

Dexcom G5 Mobile CGM System Getting Started Guide • 5

Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency

electrical heat (diathermy) treatment.

The Dexcom G5 has not been tested during MRI or CT scans or with diathermy

treatment. The magnetic ﬁelds and heat could damage the components of the Dexcom

G5, which may cause it to display inaccurate blood glucose readings or may prevent

alerts.

Medications

Taking medications with acetaminophen while wearing the Dexcom G5 may

inaccurately raise the glucose readings generated by the Dexcom G5. The level of

inaccuracy depends on the amount of acetaminophen active in your body and is

different for each person. Do not rely on continuous glucose monitoring (CGM) data

produced by the Dexcom G5 if you have recently taken acetaminophen.

Warnings

Sensor Fractures

Do not ignore sensor fractures. Sensors may fracture or detach from the sensor pod

on rare occasions. If a sensor breaks and no portion of it is visible above the skin,

do not attempt to remove it. Seek professional medical help if you have symptoms

of infection or inﬂammation—redness, swelling or pain—at the insertion site. If you

experience a broken sensor, please report this to our Technical Support department at

1.877.339.2664 (toll free) or 1.858.200.0200.

Do Not Use Damaged Goods

If the Dexcom G5 Receiver or Dexcom G5 Transmitter is damaged or cracked, do not

use it. This could create an electrical safety hazard causing possible electrical shocks

resulting in injury. In addition, a damaged or cracked Dexcom G5 Receiver or Dexcom

G5 Transmitter may cause the Dexcom G5 System not to function properly.

Choking

Do not allow young children to hold the sensor or transmitter without adult supervision.

The sensor and transmitter include small parts that may pose a choking hazard.

The following warnings may result in the consequence of missing severe hypoglycemia

(low blood glucose) or hyperglycemia (high blood glucose) or making a treatment

decision that results in injury:

6 •Dexcom G5 Mobile CGM System Getting Started Guide

Review Training Materials

Thoroughly review the training materials included with your Dexcom G5 before

use. Incorrect use of the Dexcom G5 could lead you to misunderstand information

produced by the system or might affect the system’s performance.

Diabetes Treatment Decisions

If your Dexcom G5 does not display a sensor glucose reading and an arrow, or

if you are getting inaccurate or inconsistent readings, use a ﬁngerstick blood

glucose value from your blood glucose meter to make diabetes treatment

decisions.

Do Not Ignore Low/High Symptoms

Do not ignore symptoms of low or high glucose. If your glucose alerts and

readings do not match your symptoms or expectations, you should obtain a

ﬁngerstick blood glucose value from your blood glucose meter to make diabetes

treatment decisions or seek immediate medical attention.

Who Should Not Use

The Dexcom G5 was not evaluated or approved for the following persons:

• Pregnant women

• Persons on dialysis

Do not use the Dexcom G5 Mobile CGM System in critically ill patients. It is

not known how different conditions or medications common to the critically ill

population may affect performance of the system. Sensor glucose readings may

be inaccurate in critically ill patients.

The Dexcom G5’s accuracy has not been tested in people within these groups

and the system’s glucose readings may be inaccurate.

Calibrate on Schedule

Calibrate the Dexcom G5 at least once every 12 hours. The Dexcom G5 needs to

be calibrated in order to provide accurate readings. Do not use the Dexcom G5

for diabetes treatment decisions unless you have followed the prompts from the

device and calibrated every 12 hours after the initial calibration.

Placement

Do not insert the sensor component of the Dexcom G5 in a site other than the

Dexcom G5 Mobile CGM System Getting Started Guide • 7

belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17

years). The placement and insertion of the sensor component of the Dexcom G5

is not approved for other sites. If placed in other areas, the Dexcom G5 may not

function properly.

Initial Calibration: Data/Alarm/Alert

Do not expect sensor glucose readings or alarms/alerts from the Dexcom G5 until

after the 2-hour startup. The Dexcom G5 will NOT provide any sensor glucose

readings or alarms/alerts until after the 2-hour startup ends AND you complete

the startup calibration. Use ﬁngerstick glucose values from your blood glucose

meter during the 2-hour startup.

Sensor Storage

Store the sensor at temperatures between 36°F-77°F for the length of the

sensor’s shelf life. You may store the sensor in the refrigerator if it is within this

temperature range. The sensor should not be stored in the freezer.

Storing the sensor improperly might cause the sensor glucose readings to be

inaccurate.

Smart Device Settings

Your smart device’s internal settings override any Dexcom G5 Mobile App setting.

In addition, accessory devices (like a smart watch or other wearable smart

devices) might override your smart device’s Alarm, Alert, and notiﬁcation settings.

To receive Alarm or Alerts you must:

1. Make sure the notiﬁcations for the Dexcom G5 Mobile App are turned on in the

setting’s menu of your smart device.

2. Check that the Dexcom G5 Mobile App hasn’t been shut down by your smart

device.

3. Turn on

Bluetooth

on your smart device.

4. Turn off the Do Not Disturb feature on your smart device (if available).

5. Restart the Dexcom G5 Mobile App after your smart device is restarted.

6. Set the volume on your smart device at a level you can hear.

7. Always run the app in the background; do not close the Dexcom G5 Mobile

App.

8. Make sure accessory devices do not override your smart device settings.

If the settings on your smart device are incorrect, your Dexcom G5 may not

function properly.

8 •Dexcom G5 Mobile CGM System Getting Started Guide

The Dexcom G5 Alarm/Alert vibrations are not any different from other vibrating

apps on your smart device. Medical device apps, like the Dexcom G5 Mobile App,

do not have any special priorities over your smart device’s features. You cannot

determine if a vibration is a notiﬁcation from your Dexcom G5 Mobile App or

another app. The only way to know is to look at the screen.

Missed an Alarm or Alert?

An Alarm or Alert from the Dexcom G5 Mobile App cannot be heard through your

smart device’s speakers if headphones are plugged in.

Make sure you unplug your headphones when you are done using them,

otherwise you might not hear an Alarm or Alert from the Dexcom G5.

Precautions

Sensor Package

Do not use the Dexcom G5 Sensor if its sterile package has been damaged or opened.

Using a non-sterile sensor might cause infection.

Clean and Dry Before Using

Do not open the sensor package until you have washed your hands with soap and

water, and let them dry. You may contaminate the insertion site and suffer an infection

if you have dirty hands while inserting the sensor.

Do not insert the sensor until you have cleaned the skin near the insertion site with a

topical antimicrobial solution, such as isopropyl alcohol, and allowed the skin to dry.

Inserting into unclean skin might lead to infection. Do not insert the sensor until the

cleaned area is dry so the sensor adhesive will stick better.

Reusable: Don’t Throw Away

Do not discard your transmitter. It is reusable. The same transmitter is used for each

session until you have reached the end of the transmitter’s battery life.

The following precautions may result in the consequence of missing severe

hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a

treatment decision that results in injury:

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