Dexcom SEVEN User manual

user’s guide
G-2-Co

User’s Guide

IMPORTANT CONTACTS AND NUMBERS:
DexCom Technical Support: 1-877-DEXCOM4 (339-2664)
DexCom Website: www.DexCom.com
Your Transmitter Serial Number:
Your Transmitter Expiration Date:
Your Receiver ID:
Your Healthcare Professional:
Nearest Hospital:
Other Notes:
© 2010 DexCom, Inc. All rights reserved. STS® is a registered trademark of DexCom, Inc. DexCom™ Seven™
and Take Control — Live Uninterrupted™ are trademarks of DexCom, Inc. All other trademarks and
copyrights are the property of their respective owners.
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Seven™System User’s Guide | 1
MC
Seven™Sensor and Applicator
Seven™Receiver
Blood Glucose Meter
Seven™Transmitter
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

2 | SEVEN™CONTINUOUS GLUCOSE MONITORING SYSTEM
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
KIT CONTENTS*:
Seven Transmitter•
Seven Receiver•
DexCom™ DM2 Accessory Software•
Receiver Carry Case/Belt Clip•
Receiver Charging Cable•
User’s Guide•
Package Insert•
Quick Start Guide•
Transmitter Card•
CD-ROM with electronic versions of user manuals•
* Sensors and optional Connection Cable for OneTouch® Ultra® Meter are sold
separately

Seven™System User’s Guide | 3
SEVEN SYSTEM CHECKLIST/SUMMARY
e following checklists summarize the basic information you should remember for
your continuous glucose monitoring sessions. You may find it helpful to check off each
box during your first Seven System glucose monitoring session. Refer to the Quick Start
Guide and this User’s Guide for more detailed information.
EQUIPMENT
Required Equipment for Every Session:
Seven Sensor (single use, up to 7 days)
Seven Receiver (reusable)
Seven Transmitter (reusable until battery expires)
Blood Glucose Meter and test strips (any FDA cleared meter can be used for
manual calibration)
Receiver Charging Cable
Optional Equipment:
Connection Cable (for Auto Upload of Lifescan® OneTouch® Ultra® meter to
Receiver)
DM2 Accessory Software (and included USB cable)
Receiver Carrying Case
REMEMBER
You can get your Sensor/Transmitter wet.
Do not get your Receiver wet.
Set your Receiver to the correct time. Your Receiver and meter times must
match for calibration.
If you are using Auto Upload for calibration, do not change the time on your
Meter. “Registering” the Receiver and meter will synchronize the meter to the
Receiver’s time.
If you see an Error Code, write down the number and call Technical Support at
1-877-DEXCOM4 (339-2664).

4 | SEVEN™CONTINUOUS GLUCOSE MONITORING SYSTEM
CONTINUOUS GLUCOSE MONITORING SESSION
Place the Receiver and Transmitter next to each other for at least 5 minutes to
make sure they are communicating (Y symbol in the lower right corner).
If you decide to use Auto Upload with a Lifescan OneTouch Ultra meter,
“Register” the meter to your Receiver before starting.
Insert Sensor (using Applicator).
Attach Transmitter.
Tell the Receiver you inserted a Sensor.
Keep the Receiver within 5 feet of your Sensor/Transmitter.
Wait 2 Hours.
At the Double Blood Drop Prompt, upload 2 fingersticks (Auto Upload or
Manual Entry).
Upload another fingerstick every 12 hours or when prompted by the Receiver.
View Trend Screens by Pressing the Up and Down Arrows.
Look at the Status Box (upper right corner) for glucose readings or to
troubleshoot.
Recharge your Receiver approximately every 5 days.
Watch for the Low Battery Alert.
•
It takes 3 hours to completely charge when the battery is drained.•
When you hear an Alert, press any button to stop the notification (vibrating/
beeping).
You can change the Alert settings from these factory settings:
•
80mg/dL Low»
200mg/dL High»
When you hear a Low Glucose ALARM, press any button to stop the notification
(vibrating/beeping).
e Receiver will automatically notify you again in 30 minutes if your glucose
•
readings are still at or below 55mg/dL.
You cannot change the ALARM setting of 55mg/dL.
•
Remove your Sensor when your session ends.

Seven™System User’s Guide | 5
Remove the Transmitter from the Sensor Pod and save the Transmitter for the
next use.
Charge the Receiver at least once a month (even when not in use) to prevent the
back-up battery from draining.
Read this entire guide before using your Seven Continuous Glucose Monitoring System.
If you do not understand something or have any questions, please ask your Diabetes
Management Team or another health care provider. Contraindications, warnings,
precautions, and other important safety information can be found in the “Important
Safety Information” section, and in boxes throughout your Seven System User’s
Guide. e Troubleshooting section (Section 8) contains important information on
troubleshooting your Seven System.

6 | SEVEN™CONTINUOUS GLUCOSE MONITORING SYSTEM
BEFORE YOU START
Wash your hands thoroughly.•
Fully charge your Seven Receiver to avoid running out of battery charge during use.•
Check that the date and time are correct on your Receiver.•
Place the Seven Transmitter next to the Receiver for at least 5 minutes to make sure•
the two devices are communicating (“talking”) with each other. ere will be an
Antenna Symbol in the bottom right hand corner of the Trend Screens.
Check the expiration date on the Sensor before you start a new continuous glucose
•
monitoring session to make sure you are not using an expired Sensor. “05/09”
indicates that the Sensor must be inserted before the last day in May in the year
2009.
Quality check (“QC”) your BG Meter per the manufacturer’s instructions to make
•
sure it is providing you the best readings for calibration.
Clean the bottom of your Transmitter with a damp cloth or alcohol wipe and dry
•
before each use.
If you are using Auto Upload from a Lifescan® OneTouch® Ultra® meter, you must
•
connect (or “register”) your meter to your Receiver before starting a new continuous
glucose monitoring session.
Make sure your meter and Receiver date and time are the same.
•

Seven™System User’s Guide | 7
TABLE OF CONTENTS
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM 1
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM KIT CONTENTS 2
SEVEN SYSTEM CHECKLIST/SUMMARY 3
BEFORE YOU START 6
INTRODUCTION 11
INDICATIONS FOR USE 12
IMPORTANT SAFETY INFORMATION 13
Section 1
OVERVIEW OF THE SEVEN SYSTEM 15
1.1 GLOSSARY 16
1.2 SEVEN SENSOR OVERVIEW 19
1.3 SEVEN TRANSMITTER OVERVIEW 20
1.4 SEVEN RECEIVER OVERVIEW 21
1.4.1 Seven Receiver Screen Symbols 23
1.4.2 Viewing e Seven Receiver Screens 26
1.4.3 e Seven Receiver Display 29
Section 2
STARTING YOUR SEVEN
CONTINUOUS GLUCOSE MONITORING SESSION 30
2.1 SEVEN TRANSMITTER AND SEVEN RECEIVER COMMUNICATION 31
2.2 USING A NEW SEVEN SENSOR 33
2.2.1 Removing e Sensor From Its Packaging 34
2.2.2 Choosing A Insertion Site 35
2.2.3 Placing e Sensor 36
2.2.4 Sensor Insertion 37

8 | SEVEN™CONTINUOUS GLUCOSE MONITORING SYSTEM
2.3 SEVEN TRANSMITTER ATTACHMENT 39
2.4 STARTING A NEW SEVEN CONTINUOUS GLUCOSE MONITORING SESSION 41
2.5 SEVEN SENSOR STARTUP PERIOD 43
2.5.1 Problems During e Start-Up Period 44
Section 3
SEVEN SYSTEM CALIBRATION 45
3.1 THE SEVEN SYSTEM CALIBRATION PROMPT
THE END OF THE START UP PERIOD 47
3.2 AUTO UPLOAD CALIBRATION 49
3.2.1 OneTouch Ultra Meter - Seven Receiver Registration 49
3.2.2 Auto Upload Using the Connection Cable 51
3.3 MANUAL ENTRY CALIBRATION 53
3.3.1 Entering BG Readings To Your Receiver
For Calibration Using Manual Entry 53
3.4 CALIBRATION TROUBLESHOOTING 55
Section 4
VIEWING YOUR CONTINUOUS GLUCOSE INFORMATION 60
4.1 GLUCOSE TREND SCREENS 62
4.1.1 Glucose Trend Screen Information 63
4.2 HIGH AND LOW GLUCOSE ALERTS 64
4.3 LOW GLUCOSE ALARM ≤55 MG/DL 66
4.4 THE SEVEN SYSTEM AND WATER 67
4.5 SENSOR RECALIBRATION/12HOUR UPDATE 68
4.6 MISSING SEVEN SYSTEM GLUCOSE INFORMATION GLUCOSE DATA GAPS 69
4.6.1 Missing Glucose Readings – No “Y” 70
4.6.2 Missing Glucose Readings – “???” 71
4.6.3 Missing Glucose Readings – “ ”
After Calibration Update/Recalibration 72
4.7 SEVEN SYSTEM EARLY SHUTOFF SCREENS 74
4.7.1 Early Shut-Off – Sensor Failure 74

Seven™System User’s Guide | 9
Section 5
ENDING YOUR SEVEN SYSTEM
CONTINUOUS GLUCOSE MONITORING SESSION 76
5.1 CONTINUOUS GLUCOSE MONITORING PERIOD END 77
5.1.1 Automatic Sensor Expiration Notification 77
5.1.2 Manual Sensor Shut-Off 79
5.2 TRANSMITTER REMOVAL 81
Section 6
SEVEN RECEIVER BATTERY 83
6.1 LOW BATTERY ALERT 84
6.2 CHARGING THE SEVEN RECEIVER BATTERY 85
Section 7
SEVEN RECEIVER SETTINGS 86
7.1 GLUCOSE ALERT SETTINGS 87
7.1.1 High And Low Glucose Alert Levels (mg/dL Units) 87
7.2 SETTING THE TIME 89
7.2.1 Receiver Time Screen 89
7.2.2 Setting the Time (AM/PM Mode) 90
7.2.3 Time Loss Alert 91
7.3 ENTERING A NEW TRANSMITTER SERIAL NUMBER SN# 92
7.4 THE ABOUT SCREEN 94
Section 8
TROUBLESHOOTING 95
8.1 PROBLEMS UPLOADING BG READINGS
TO YOUR RECEIVER WITH THE CONNECTION CABLE 96
8.2 TIME DIFFERENCE BETWEEN BG METER AND RECEIVER 97
8.3 ERROR CODE 98
8.4 SYSTEM RECOVERY 99

10 | SEVEN™CONTINUOUS GLUCOSE MONITORING SYSTEM
Section 9
SEVEN SYSTEM MAINTENANCE AND STORAGE 100
9.1 MAINTENANCE 101
9.2 STORAGE 102
9.3 CLEANING 103
Section 10
TECHNICAL INFORMATION 104
10.1 DEVICE PERFORMANCE CHARACTERISTICS 105
10.2 PRODUCT SPECIFICATIONS 128
10.3 FCC REQUIREMENTS 136

Seven™System User’s Guide | 11
INTRODUCTION
e Seven Continuous Glucose Monitoring System provides you with real-time
continuous glucose measurements every 5 minutes for up to 7 days. ese readings will
help you detect trends and patterns in your glucose levels. e Seven System also features
adjustable High and Low Glucose Alerts and a Low Glucose ALARM to notify you
when you are outside of your target glucose levels. e Seven System consists of three
components: the Sensor, the Transmitter, and the Receiver. e Seven System is currently
compatible with all FDA cleared blood glucose meters for calibration using manual entry.
e Seven System is also directly compatible with the LifeScan® OneTouch® Ultra® Blood
Glucose meter for calibration using a connection cable (Auto Upload).
e Sensor is a disposable unit that you insert into your abdomen (belly) to continuously
monitor your glucose levels for up to 7 days. e Transmitter is a reusable device that
snaps into the Sensor Pod and wirelessly sends glucose information measured by your
Sensor to the Receiver. e Receiver is a hand-held device that receives and displays
glucose information every 5 minutes sent by the Sensor/Transmitter. e Receiver
displays your current glucose reading and also shows your glucose trend information
from the past 1-hour, 3-hours, and 9-hours. ese trends allow you to see where your
glucose levels have been and which direction your glucose levels are headed. e Receiver
also vibrates and beeps to let you know when your glucose levels are high or low.
is User’s Guide describes how to use your Seven System from start to finish of a
continuous glucose monitoring session. Important safety information, warnings,
precautions, cautions, and contraindications of the Seven System are described in the
next few pages and throughout this guide. Be sure to read this entire User’s Guide before
beginning your continuous glucose monitoring session.

12 | SEVEN™CONTINUOUS GLUCOSE MONITORING SYSTEM
INDICATION FOR USE
e SEVEN Continuous Glucose Monitoring System is a glucose-monitoring device
indicated for detecting trends and tracking patterns in adults (age 18 and older) with
diabetes. e SEVEN System is intended for use by patients at home and in health care
facilities. e device is for prescription use only.
e SEVEN Continuous Glucose Monitoring System is indicated for use as an adjunctive
device to complement, not replace, information obtained from standard home glucose
monitoring devices.
e SEVEN 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 System
results should be based on the trends and patterns seen with several sequential readings
over time.

Seven™System User’s Guide | 13
IMPORTANT SAFETY INFORMATION
Read this entire guide before using your Seven Continuous Glucose Monitoring System.
If you do not understand something or have any questions, please ask your Diabetes
Management Team or another health care provider. Contraindications, warnings,
precautions, cautions, and other important safety information can be found in this section
and in boxes throughout your SEVEN System User’s Guide. The Troubleshooting section
(Section 8) contains important information on troubleshooting your SEVEN System.
The Technical Information Section (Section 10) provides information on the performance
characteristics of the device
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
WARNINGS
•
•
•
•
e SEVEN 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.
•
is device is not designed to replace a blood glucose meter. e SEVEN System must
be used with a blood glucose meter.
Treatment decisions should not be based solely on results from the SEVEN System.
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 System results.
You should update the SEVEN System’s calibration every 12 hours at a minimum to
ensure device performance. e performance of the SEVEN System when calibrated
less frequently than the recommendation to calibrate a minimum of every 12 hours
has not been studied.

14 | SEVEN™CONTINUOUS GLUCOSE MONITORING SYSTEM
PRECAUTIONS
•
•
•
•
•
•
CAUTION
U.S. federal law restricts the sale of the Seven System to sale by or on order of a physician.
WARNINGS
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.
e SEVEN System is not approved for use in children or adolescents, pregnant
women or persons on dialysis.
e safety and effectiveness of the SEVEN System has not been evaluated for sensor
probe insertion sites other than the skin of the abdomen.
•
•
•
Always wash hands with soap and water before opening the SEVEN 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
SEVEN Sensor until the cleaned area is dry.
Establish a rotation schedule for choosing each new SEVEN 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.
e 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.
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Seven™System User’s Guide | 15
SECTION 1
OVERVIEW OF THE SEVEN SYSTEM

16 | SEVEN™CONTINUOUS GLUCOSE MONITORING SYSTEM
e following list of terms will help you while reading though this guide.
1.1 GLOSSARY
Auto Upload
BG meter
BG reading
Calibration
Glucose Data
Gaps
Glucose Trends
Manual Entry
To transfer BG readings from the OneTouch Ultra Meter to
your Receiver directly with the connection cable.
Blood Glucose Meter. All FDA cleared meters are compatible
with the Seven System.
Blood Glucose reading. A fingerstick blood glucose reading
taken on your FDA cleared meter.
Required for the Seven System to display continuous glucose
data and trend information. Performed by uploading
blood glucose readings to the Seven Receiver. (Do not use
alternative site testing for calibration.)
When the Receiver does not display glucose readings sent
from the Sensor to the Receiver. A symbol will appear instead
of a glucose reading to notify you of the Sensor issue
Allow you to see the pattern of your glucose levels; you can
see where your glucose levels have been and where your
glucose levels are headed. e Seven System has three glucose
trend screens: the 1-Hour, 3-Hour, and 9-Hour Screens. Each
trend screen shows glucose trends over the amount of time
indicated.
To manually enter BG readings from a FDA cleared meter to
your Receiver. You should always use the same glucose meter
to calibrate your Seven System that you routinely use to
measure your blood glucose. Do not switch your BG meter in
the middle of a Sensor session.