Seven
Steps to Start
T h e D e x C o m
™
S E V E N
®
P L U S Q u i c k S t a r t G u i d e
Congratulations on making the DexCom SEVEN
PLUS part of your life! The SEVEN PLUS System is
not a replacement for your traditional blood glucose
meter. When you use the SEVEN PLUS, you will
see real-time continuous glucose readings every 5
minutes for up to 7 days. These readings will help
you detect trends and patterns in your glucose
levels, allowing you to see where your glucose levels
have been, which direction your levels are headed,
and how fast they may be rising or falling.
Below are the SEVEN basic steps you’ll need to
set up and use your SEVEN PLUS. At any time, feel
free to call 1-888-SEVENGO (1-888-738-3646) for
assistance—DexCom Technical Support is available
24/SEVEN/365. Before you begin or anytime you
have questions, review the SEVEN PLUS tutorial
CD in your SEVEN PLUS Starter Kit or online at
www.DexCom.com.
WARNING
Review all Contraindications, Warnings, Precautions, and detailed
procedures in the User’s Guide before using the SEVEN PLUS
Continuous Glucose Monitoring System.
Treatment decisions should not be based solely on results from the
SEVEN PLUS. You must confirm with a blood glucose (BG) meter
before making therapeutic adjustments.
CONTRAINDICATIONS
The SEVEN PLUS System must be removed prior to Magnetic
Resonance Imaging (MRI).
Use of acetaminophen-containing medications while the SEVEN
Sensor is inserted may affect the performance of the device.
Step 1
Get to Know
Your Device
Step 2
Set Time/Date
and ID
Step 3
Set High/Low
Alerts
Step 4
Insert the Sensor
Step 5
Start Sensor
Session
Step 6
Calibrate
Step 7
End Sensor
Session
Frequently Asked Questions
What can the SEVEN
®
PLUS System do for me?
The SEVEN PLUS System can give you a continuous picture
of your glucose levels, which will help you detect trends and
patterns in your glucose levels. These glucose trends let you
see where your glucose levels have been, which direction your
levels are headed, and how fast they may be rising or falling.
Does the SEVEN PLUS replace my traditional BG meter?
No, it’s meant to be used IN ADDITION TO your BG meter.
When you use the SEVEN PLUS, you need to take 2 measure
-
ments on your BG meter to start your Sensor session and 1
measurement every 12 hours.
Should I make treatment decisions based on the results
from my SEVEN PLUS?
Treatment decisions should NOT be based solely on results
from your SEVEN PLUS. You must confirm glucose readings
with a BG meter before making therapeutic adjustments.
Is it okay if my SEVEN PLUS and fingerstick readings
don’t match exactly?
Yes. This is normal.
Does my Receiver need to be charged before set-up?
Yes. A full charge takes approximately 3 hours. Take Receiver
off charger to see if it is fully charged.
Day to day, when should I charge my Receiver?
Periodic charging every 3-5 days is ideal. Suggest not charging
overnight.
Is my Transmitter disposable?
No. DO NOT THROW AWAY YOUR TRANSMITTER.
How close do my Receiver and Transmitter have to be?
They should be within 5 feet of each other, even during the
start-up period and while you are sleeping.
My high/low glucose alerts are set to “vibrate then beep.”
Why don’t I always hear the beep?
This alert vibrates first, THEN beeps. If you confirm the alert
right away by pressing any button on the Receiver, the
re-alert (beep) will not occur.
What do I do if I see “???” instead of a glucose value?
Wait. Unknown Sensor Glucose Readings (“???” in the Status
Box) are periods of time when the system does not understand
the glucose readings. This is usually temporary. Your SEVEN
PLUS will normally correct itself, after which you will see glu
-
cose values again.
How do I reorder Sensors?
Reorder Sensors from DexCom Customer Support:
1-888-SEVENGO (1-888-738-3646)
(Monday-Friday 6
am
-5
pm
PST).
What do I do if I have questions?
Call DexCom Technical Support—1-888-SEVENGO
(1-888-738-3646)—available 24/SEVEN/365. You can also
visit www.DexCom.com to view the SEVEN PLUS tutorial for
additional product training and support.
References
1. Kamath A, Mahalingam A, Brauker J. Analysis of time lags and other sources
of error of the DexCom SEVEN continuous glucose monitor.
Diabetes Technol
Ther
. 2009;11(11):689-695.
Helpful Hints
Charging Your Receiver
• Charge your Receiver completely before starting a Sensor
session
• A full charge can take up to 3 hours and will last 3-5 days
• To charge, insert Receiver Charging Cable into connection
port on bottom of Receiver. White arrow must face up (toward
you); cable button should face down
• Periodically charge your Receiver every 3-5 days. Suggest
not charging overnight
• Fully charged = 3 full bars on Battery Indicator. To view, take
Receiver off charger (Battery Indicator will continue to fill
when charging)
Receiver Display
Below is the screen you’ll see when you turn on
your Receiver during a Sensor session.
Calibration Tips
• Use same BG meter for all calibrations
• Wash hands before each calibration
• Quality-check BG meter (check code number and use control
solution to ensure BG meter is giving the best calibration
readings) if applicable.
Calibration “Do’s”
• Calibrate at any time as long as you see glucose value or
Blood Drop symbol in Status Box
• Calibrate a minimum of once every 12 hours
• Calibrate during any glucose rate of change
1
Calibration “Don’t’s”
• Don’t calibrate when you see
or
in Status Box
• Don’t calibrate if your BG is higher than 400 mg/dL or
lower than 40 mg/dL
• Don’t use alternative sites for calibrations (fingersticks
only)
Low Glucose Alarm
The SEVEN PLUS has an automatic
Low Glucose Alarm set at 55 mg/dL.
You cannot change or disable this
Alarm or its re-alert settings. If this
Alarm occurs:
• Press
C
to clear
• You will be notified again in
30 minutes if your glucose reading
is still at or below 55 mg/dL
Antenna symbol
(indicates Receiver
is talking with
Transmitter)
Battery life
Current time
(A =
am
; P =
pm
)
Trend arrow (how
fast glucose is
changing)
“Status box”/current
glucose reading
1-, 3-, 6-, 12-, and 24-hour glucose
trend graphs (3-hour trend graph
automatically appears when device
is
turned on; use
qp
to access
differ
ent time periods)
Blood Drop in Status Box
Calibration needed.
• Perform calibration as described in Step 6 on back
Sensor Error #0
Sensor cannot calibrate.
• Press
C. Err0
will appear in Status Box
• Enter 1 fingerstick reading within 10-15 minutes
• If error continues, add additional fingerstick reading
• If no glucose readings appear, contact Technical Support
Sensor Error #1
Sensor is not calibrating correctly.
• Press
C. Err1
will appear in Status Box
• Wait approximately 1 hour, then enter 1 fingerstick reading
• If no glucose readings appear after 10 minutes, contact Technical Sup
-
Receiver Error Code
Receiver is not working properly.
• Contact Technical Support
System Recovery Check
Receiver had a problem, but the System corrected itself.
• Press
C
and your Sensor session will continue
Unknown Sensor Glucose
Readings
in Status Box
Wait.
usually resolves itself within several minutes or up to
several hours.
• Do not calibrate
• Make sure Sensor Pod is sticking well to your body and nothing is
rubbing against it
• Check that Transmitter is snapped in on both sides
• When you see a single blood drop or glucose reading in Status Box,
enter fingerstick reading
Sensor Failed
Sensor has shut off before end of 7-day session.
• Press
C
. The Status Box will appear grayed out
• Contact Technical Support
• Remove failed Sensor and insert new Sensor
Out of Range/No Antenna
Receiver and Transmitter are not communicating.
• Make sure the Receiver is within 5 feet of the Transmitter/Sensor Pod
• Wait 5-10 minutes. If no glucose reading appears, contact Technical
Support
Troubleshooting
Refer to your User’s Guide or contact Technical Support at 1-888-SEVENGO (1-888-738-3646) for any unresolved questions/
troubleshooting issues. An online tutorial is also available at www.DexCom.com.
Beyond the Basics
You’ve learned how to use the basic features of your Dex
-
Com SEVEN PLUS. If you’re ready to learn more, these
“Beyond the Basics” features are options you can use at any
time. These features are customizable to help you best meet
your needs and your diabetes management goals.
Alert Snoozing
You can program high/low glucose alerts to “snooze” (re-alert
you) if levels continue to be outside target range. Snooze
can be set for every 30 minutes or 1, 2, 3, 4, or 5 hours. See
User’s Guide Section 2.3.2.
Trend Arrows
Trend arrows can be used along with trend graphs to assess
glucose direction and how rapidly glucose levels are changing.
Rise and Fall Alerts
Rise and Fall Alerts may let you know when your glucose is
rising or falling rapidly. See User’s Guide Section 5.3.4.
Event Markers
With the SEVEN PLUS, you can document activities and
events that may affect your diabetes, including information
about:
• Carbohydrates (grams)
• Insulin (units)
• Exercise (intensity and duration)
• Health (illness, stress, high/low symptoms, menstrual cycle,
alcohol)
Event markers can give you and your health care team
additional information that may help you make better
decisions about your diabetes management. Event markers
do not appear on the Receiver but are visible when data is
downloaded with the Data Manager software. See User’s
Constant
: Glucose steady (not increasing/
decreasing more than 1 mg/dL/min)
Slowly Rising
: Glucose rising 1-2 mg/dL/min
Rising
: Glucose rising 2-3 mg/dL/min
Rapidly Rising
: Glucose rising more than
3 mg/dL/min
Slowly Falling
: Glucose falling 1-2 mg/dL/min
Falling
: Glucose falling 2-3 mg/dL/min
Rapidly Falling
: Glucose falling more than
3 mg/dL/min
no arrow
No Rate of Change Information
: Receiver not
currently calculating how fast glucose is rising/
falling. If you are concerned that your glucose
level may be rising or falling, take a fingerstick
to check your readings.
No Glucose Data
INDICATION FOR USE
The SEVEN PLUS Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking
patterns in adults
(age 18 and older)
with diabetes. The SEVEN PLUS System is intended for use by patients at home and in health
care facilities. The device is for prescription use only.
The SEVEN PLUS Continuous Glucose Monitoring System is indicated for use as an adjunctive device to complement, not replace,
information obtained from standard home glucose monitoring devices.
The SEVEN PLUS Continuous Glucose Monitoring System aids in the detection of episodes of hyperglycemia and hypoglycemia,
facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the SEVEN PLUS
System results should be based on the trends and patterns seen with several sequential readings over time.
CONTRAINDICATIONS
The SEVEN PLUS System must be removed prior to Magnetic Resonance Imaging (MRI).
Use of acetaminophen-containing medications while the SEVEN Sensor is inserted may affect the performance of the device.
WARNINGS
This device is not designed to replace a blood glucose meter. The SEVEN PLUS must be used with a blood glucose meter.
Treatment decisions should not be based solely on results from the SEVEN PLUS. You must confirm with a blood glucose meter before
making therapeutic adjustments.
Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use your
blood glucose meter to check the SEVEN PLUS results.
You should update the SEVEN PLUS’ calibration every 12 hours at a minimum. The performance of the SEVEN PLUS System when
calibrated less frequently than every 12 hours has not been studied.
Sensors fracture 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.
The SEVEN and SEVEN PLUS Systems
are not approved for use
in children or adolescents, pregnant women or persons on dialysis.
The safety and effectiveness of the SEVEN and SEVEN PLUS Systems have not been evaluated for sensor probe insertion sites other
than the skin of the
abdomen
.
PRECAUTIONS
Always wash hands with soap and water before opening the Sensor package. After opening the package, avoid touching the adhesive
area.
Before inserting the Sensor, always clean the skin at the Sensor insertion location with a topical antimicrobial solution such as isopropyl
alcohol. Do not apply the Sensor until the cleaned area is dry.
Establish a rotation schedule for choosing each new Sensor location. Avoid Sensor locations that are constrained by clothing,
accessories, or subjected to rigorous movement during exercise.
Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of a Sensor.
The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged
or opened.
For OpenChoice Calibration you must enter the exact fingerstick reading that your blood glucose meter displays. Enter
all fingerstick readings for calibration within 5 minutes. Entering incorrect fingerstick readings that occurred more than
5 minutes ago will affect device performance.
