Page 1
user’s guide
G-2-Co
Page 2
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User’s Guide
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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
Page 6
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
Page 7
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).
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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.
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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.
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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.
•
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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
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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 STARTUP 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/12HOUR 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
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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
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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
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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.
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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.
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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.
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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
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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.
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Seven™ System User’s Guide | 17
Milligrams per deciliter. e standard unit of measure for
glucose readings in the United States.
e distance between the Receiver and Transmitter. Keep the
2 devices within 5 feet (1.5 meters) from each other for best
communication.
To connect a OneTouch Ultra meter to the Receiver to make
sure the date and time match so the Receiver can accept
Auto Uploads.
Radio Frequency Transmission of the Transmitter to the
Receiver.
e portion of the Sensor that is inserted under your
skin using the Applicator. Measures glucose levels in your
surrounding tissue fluid.
Inserts the Sensor Probe. It is a disposable piece that comes
attached to the Sensor Pod. ere is a needle inside the
Applicator that you remove once you have inserted the
Sensor Probe underneath your skin.
A cell phone-like device programmed to collect and process
data from the Sensor and to display the results as a Seven
System reading (mg/dL).
A device inserted underneath the skin to continuously
monitor glucose levels.
e small base adhered to your abdomen that holds the
Transmitter in place. e Sensor Pod and Transmitter are all
that remain on your skin during each Sensor wear period.
e Sensor, Transmitter, and Receiver.
A glucose reading provided by your Receiver. is reading is
given in mg/dL units and updated every 5 minutes.
mg/dL
Range
Register
RF
Sensor Probe
Seven Applicator
Seven Receiver
Seven Sensor
Seven Sensor Pod
Seven System
Seven System
Reading
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18 | SEVEN™ CONTINUOUS GLUCOSE MONITORING SYSTEM
Device that snaps into the Sensor Pod and wirelessly sends
glucose data to your Receiver.
e small disposable piece that snaps the Transmitter into
the Sensor Pod.
Transmitter Serial Number that is programmed into your
Receiver for communication.
e 2-hour period after you notify the Receiver of a new
Sensor (Glucose information cannot be provided during this
time).
e upper right corner of the Receiver Trend Screen. When
calibrated, there will be a glucose reading or a symbol telling
you why a glucose reading is not available.
Seven Transmitter
Seven Transmitter
Latch
SN #
Start-Up Period
Status Box
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Seven™ System User’s Guide | 19
1.2 SEVEN SENSOR OVERVIEW
e Sensor is a device that continuously measures your glucose levels. You will use a
Blood Glucose (BG) meter to calibrate the readings measured by the Sensor. e glucose
levels measured by the Sensor are sent by a wireless, low-powered, radio frequency (RF)
to the Receiver every 5 minutes for up to 7 days.
e Sensor consists of an Applicator (needle, Sensor, plastic housing), Sensor Probe,
and Sensor Pod. You will insert the Sensor Probe just beneath the skin (subcutaneous
tissue) of your abdomen (belly) using a small needle (26-Gauge) inside the Applicator.
e needle is inserted about ½ inch beneath your skin and carries the Sensor Probe with
it. After you insert the needle and Sensor Probe, you will pull the needle back into the
Applicator leaving the Sensor Probe behind to continuously measure your glucose levels.
e Applicator is then removed from the Sensor Pod and should be thrown away. You
should save the Safety Lock/ Transmitter Release to remove the Transmitter at the end of
a continuous monitoring session.
e Sensor Probe lies ½ inch underneath your skin and continuously measures your
glucose levels for up to 7 days. e Sensor Pod and Transmitter (once snapped in) remain
on your abdomen for the entire wear period. e insertion site is very similar to an insulin
pump infusion site.
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20 | SEVEN™ CONTINUOUS GLUCOSE MONITORING SYSTEM
1.3 SEVEN TRANSMITTER OVERVIEW
e Transmitter wirelessly sends glucose information collected by your Sensor to your
Receiver. Once you insert your Sensor, you will snap the Transmitter into the Sensor Pod
using the Transmitter Latch. e Transmitter is used for multiple Sensor wear periods.
As your Transmitter nears the end of its useful life, it may periodically lose
communication with the Receiver even if they are within 5 feet (1.5 m) of each other.
Once your Transmitter battery has drained, you will need to replace the Transmitter.
A new Transmitter can easily be programmed to communicate with your Receiver (see
Section 7.3).
NOTE
Little warning is given when your Transmitter battery is fully drained. If you
•
frequently see the Y symbol in the Status Box (or frequently missing from the
lower right corner), this may indicate that your Transmitter Battery is low. Contact
Technical Support at 1-877-DEXCOM4 (339-2664) to order a new Transmitter so you
can continue using your Seven System.
Your Transmitter is used for multiple Seven System monitoring sessions (1-year
•
warranty).
e Receiver and Transmitter are designed and tested to withstand common
•
electromagnetic interference, including airport security systems.
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Seven™ System User’s Guide | 21
e Receiver looks similar to a cell phone and communicates the glucose information
measured by the Sensor to you. Keep your Receiver within 5 feet (1.5 m) of your Sensor
Pod (with Transmitter) at all times for best communication. e best places to keep your
Receiver are on your beltline in the carrying case provided or in your pocket. During
nighttime use you may want to place the Receiver under your pillow.
e Receiver is rechargeable. e re-chargeable battery will last for about 5 days before
needing to be charged. e Receiver will notify you when the battery charge is low. e
Receiver takes 3 hours to fully charge if the battery is completely drained. To charge the
Receiver, plug the charger cable provided into a standard wall outlet.
e Receiver has 4 buttons to guide you through its screens. e screens display glucose
readings and trend graphs (“Trend Screens”) and allow you to change your Receiver
settings (“Settings Screens”). e Receiver is programmed with a specific Transmitter
Serial Number (SN#) so your Receiver and Transmitter can “talk” (communicate) only
with each other. Each time you insert a new Sensor, you will need to notify the Receiver
(see Section 2.4).
Each Sensor must be “calibrated” before glucose readings are displayed on your Receiver.
To calibrate, you can manually enter BG readings (see Section 3.3) from any FDA cleared
meter. 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 Or you can directly connect your Receiver to the LifeScan
OneTouch Ultra meter using the connection cable (Auto Upload, see Section 3.2). By
connecting the 2 devices, you will transfer fingerstick blood glucose readings taken on
your OneTouch Ultra Meter to your Receiver. Do not use alternative site testing for BG
calibration readings.
1.4 SEVEN RECEIVER OVERVIEW
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22 | SEVEN™ CONTINUOUS GLUCOSE MONITORING SYSTEM
Seven Receiver
Display Screen
Green
OK
Button
UP p Arrow
Button
Red C Clear
Button
DOWN q Arrow
Button
Connection port to
OneTouch Meter,
battery charger
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Seven™ System User’s Guide | 23
ANTENNA: If seen in the bottom right corner of
Glucose Trend Screens, the Y indicates that the Receiver
and Transmitter are “talking” and glucose data has been
sent in the last 5 minutes
LOW BATTERY ALERT: Indicates the Receiver battery
is running low and needs to be recharged. Charge the
battery as soon as possible.
CONNECTION: Indicates the OneTouch Ultra meter
is successfully transferring readings to your Receiver via
Auto-Upload with the Connection Cable.
CONNECTION FAILURE: Indicates the OneTouch
Ultra meter and your Receiver are not connected
properly. Readings have not been successfully
transferred. is screen will only be seen when you
attempt to use the Connection Cable.
NEW METER SCREEN: Indicates that a new OneTouch
Ultra meter has been plugged into the Receiver. is
meter has a different serial number from the meter that
was last connected to the Receiver. If you receive this
screen during auto-upload calibration, you will have to
re-take any fingersticks needed for calibration and then
connect the 2 devices again for calibration update.
1.4.1 SEVEN RECEIVER SCREEN SYMBOLS
e following symbols may appear on the Receiver display during use:
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24 | SEVEN™ CONTINUOUS GLUCOSE MONITORING SYSTEM
DOUBLE BLOOD DROP PROMPT: Appears 2 hours
after you insert a new Sensor and indicates that you
need to take 2 fingerstick BG readings on your BG meter
and enter them to get into calibration.
SHADEDOUT BLOOD DROP PROMPT: Notifies you
that only 1 fingerstick BG reading has been successfully
entered from the BG meter to the Receiver. You need
to take and upload at least 1 more BG reading for
calibration.
CALIBRATION UPDATE SCREEN: Indicates it is time
for you to take a calibration fingerstick on the BG meter
and enter it to the Receiver.
FAILED SENSOR SCREEN: Indicates the Sensor is not
working properly. You will need to replace your Sensor
at this time.
NO COMMUNICATION: Indicates that the Receiver
and Transmitter are not “talking” and glucose data has
not been sent in the last 5 minutes. See Section 4.6 for
more information.
AWAITING CALIBRATION FINGERSTICK: Indicates
a fingerstick BG reading is needed for calibration or the
Receiver is processing a current fingerstick BG reading.
See Section 3.4 for Calibration Troubleshooting tips.
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Seven™ System User’s Guide | 25
UNKNOWN SEVEN SENSOR GLUCOSE
READINGS: Indicates that the Sensor is sending the
Receiver glucose readings that the Receiver does not
understand. See Section 4.6 for “Glucose Data Gaps.”
ERROR CODE: Indicates the Receiver may not be
functioning properly. If you see this code, write the code
down and use your meter to check your blood glucose
readings. Notify DexCom Technical Support at
1-877-DEXCOM4 (339-2664).
6 HOUR SENSOR EXPIRATION
NOTIFICATION: Indicates that your Continuous
Glucose Monitoring Session will end in 6 hours.
2 HOUR SENSOR EXPIRATION
NOTIFICATION: Indicates that your Continuous
Glucose Monitoring Session will end in 2 hours.
30 MINUTE SENSOR EXPIRATION
NOTIFICATION: Indicates that your Continuous
Glucose Monitoring Session will end in 30 minutes.
0 HOUR SENSOR EXPIRATION
NOTIFICATION: Indicates that your Continuous
Glucose Monitoring Session has ended. Once you clear
the alert your Receiver will be notified that the Sensor
has been removed.
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26 | SEVEN™ CONTINUOUS GLUCOSE MONITORING SYSTEM
1-Hour Glucose
Trend Screen
3-Hour Glucose
Trend Screen
9-Hour Glucose
Trend Screen
Glucose Trend
Screens
(See Section 4.1)
1.4.2 VIEWING THE SEVEN RECEIVER SCREENS
By default, the Receiver’s Liquid Crystal Display (LCD) screen is turned off to save battery
power. However, you can press any Receiver button to display the 1-hour Trend Screen.
Use the Up and Down Arrow Buttons to move through screens. e OK button
confirms any change you make to a setting, and the C Button sends you back to the
previous screen or to the 1-hour trend screen if you are in the first series of a settings
screen. e chart below shows the Receiver screens you can navigate through to view
glucose readings or set your Seven System settings.
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Seven™ System User’s Guide | 27
Settings Screens
To get to these screens, once you get to the 9-hr Screen, you must hold
down the Down q arrow for at least 7 Seconds.
NOTE: The Sensor Insertion Screens only appear if a Transmitter serial number has been
entered and you are currently not in a Seven Continuous Monitoring Session.
High/Low Alert Settings Screens (See Section 7.1)
OKOK
Sensor Insertion Screens (See Section 2.4)
Manual Blood Glucose Upload Screens (See Section 3.3)
OKOK
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28 | SEVEN™ CONTINUOUS GLUCOSE MONITORING SYSTEM
Transmitter Serial Number Screens (See Section 7.3)
Sensor Removal Screens
OK
NOTE: The Sensor Removal Screens only appear if you are currently in a Seven
Continuous Monitoring Session (See Section 5.1.2)
Time/Date Screens (See Section 7.2)
OKOK
The About Screen (See Section 7.4)
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1.4.3 THE SEVEN RECEIVER DISPLAYS
SEVEN SYSTEM “OFF” MODE:
You will see this screen when the Seven System is in “off” mode (is not reading)•
is screen will show that a Sensor is not inserted and a session ended more than •
one hour ago
If you are in the Start-Up Period, the screen and Status Box will be partially shaded
•
Current Glucose Reading
Battery
Glucose Units
Antenna
Current Time
1-Hour Trend
High Glucose
Alert Level
Low Glucose
Alert Level
Glucose Readings
from Past Hour
Glucose Reading Axis
Current Glucose Reading/
Status Box
Battery Life Indicator
Glucose Units
Antenna
Current Time (A/P)
1-Hour Trend
SEVEN SYSTEM “ON” MODE:
is screen will show if the System is in “on” mode:•
e Seven System must be in calibration (a glucose reading will be showing) »
e Receiver and Transmitter are in range (the Y symbol will be showing) »
In this example, the Seven System has been on for the past hour, and the glucose •
readings for the past hour are showing.
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SECTION 2
STARTING YOUR SEVEN
CONTINUOUS GLUCOSE MONITORING SESSION
To use your Seven Continuous Glucose Monitoring System you will need a Sensor, a
Transmitter, and a Receiver. You will also need a blood glucose meter and test strips for
calibration. Once inserted and calibrated, your Sensor will continuously measure and
display your glucose readings for up to 7 days.
At the end of the 2-hour Start-Up Period the Seven System will ask for 2 calibration BG
readings. ese two fingersticks must be taken with a BG meter and uploaded to your
Receiver. Once calibrated, your Receiver will display glucose readings, trend graphs, and
provide low and high glucose alerts and a low glucose ALARM.
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The Antenna Symbol
should appear here.
2.1 SEVEN TRANSMITTER AND SEVEN RECEIVER COMMUNICATION
Keep your Receiver within 5 feet (1.5 m) of your Sensor/Transmitter for best
communication. To check that your Receiver and Transmitter are communicating
(“talking”), press any Receiver button to see the 1-hour Glucose Trend Screen:
If you can see the Antenna Symbol (Y) at the bottom right hand corner, then your
Transmitter and Receiver are communicating. If the Antenna appears in the Status Box
review the following:
Is the Receiver within 5 feet (1.5 m) of your Sensor Pod/Transmitter? If the Receiver
•
is not close enough, move it within that range and re-check the Status Box in 5-10
minutes to see if the Antenna Symbol disappears from the Status Box and re-appears
in the lower right corner of the Receiver display.
If the two devices are still not communicating check that the correct Transmitter
•
Serial Number (SN#) is programmed into your Receiver (See Section 7.3).
If the correct SN# has been entered into your Receiver and the two devices are still
•
not communicating contact DexCom™ Technical Support for further assistance
1-877-DEXCOM4 (339-2664).
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NOTE
e Transmitter and Receiver may lose communication during the following
circumstances:
When they are near metallic objects
•
While you are lying on a waterbed•
When you are using an electric blanket•
CONTRAINDICATION
e Seven System must be removed prior to Magnetic Resonance Imaging (MRI).
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Safety Lock /
Transmitter Release
Collar
Sensor Pod
Plunger
Applicator
(needle/sensor
probe inside)
Transmitter Latch
Release Tab
2.2 USING A NEW SEVEN SENSOR
e following sections will teach you how to insert your Seven Sensor and start a new
continuous glucose monitoring session. Become familiar with the Applicator diagram
below prior to insertion.
NOTE
Always check the expiration date on the Sensor packaging before opening the Sensor for use.
Do not use expired Sensors. An expiration date of “05/09” indicates that the Sensor must be
inserted before the last day in May in the year 2009.
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2.2.1 REMOVING THE SEVEN SENSOR FROM ITS PACKAGING
Carefully remove your Sensor from its packaging and examine it to make sure it is not •
damaged.
e Applicator is a single use, disposable unit. e safety lock prevents you from
•
accidentally releasing the needle before you are ready.
QUICK TIP
Before you insert a new Sensor, place your Transmitter next to your Receiver for at least five
minutes to make sure they are communicating. e Receiver will display the Antenna Symbol
in the bottom right hand corner of the Trend Screens.
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2.2.2 CHOOSING A SEVEN SENSOR INSERTION SITE
Choose a site on a fatty area of your abdomen (belly) to place your Sensor. You can
choose a site above or below your beltline. e best insertion areas are usually flat,
“pinchable”, and relatively free from where rubbing can occur (i.e. pant line, seatbelts).
Avoid areas with scarring or rough patches of skin from your insulin injections or pump.
Choose an area at least 3 inches from where you plan to inject insulin or from where your
pump infusion site is located.
Avoid using the same spot repeatedly for Sensor insertion.
You may need to shave the area where you plan to put the Sensor so that the adhesive
patch sticks well.
Make sure there are no traces of lotions, perfumes or medications by using an alcohol
swab to clean the area. Make sure the area is clean and dry prior to insertion.
PRECAUTION
Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of the Sensor.
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Pull Safety Lock Out
2.2.3 PLACING THE SEVEN SENSOR
After you have cleaned the skin site, remove the adhesive backing from the Sensor 1.
Pod. Hold the Sensor by the Applicator area, making sure not to touch the sticky
adhesive.
Place the Sensor on the site you selected, with the widest part of the pod horizontal 2.
to the ground. You can place the Sensor flat facing to the left or right of your belly
button. Press firmly on and around the adhesive to make sure it is flat.
Once you have stuck the adhesive to your abdomen (belly), pull the Safety Lock out 3.
from the Applicator. Pull near the arrow on the Safety lock, as shown below:
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NOTE
e Safety Lock also serves as the Transmitter Release. Keep the Safety Lock /
Transmitter Release with your meter or in a safe place. When your glucose monitoring
session is over, follow the steps in Section 5.2 to remove your Transmitter.
2.2.4 SEVEN SENSOR INSERTION
After placing the Applicator on your abdomen and removing the Safety Lock, place 1.
two fingers under the collar (making sure not to squeeze the applicator) and place
your thumb on the plunger. Push the plunger down completely. is action inserts
the needle and Sensor underneath your skin..
Needle/Sensor now inserted
Push down
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38 | SEVEN™ CONTINUOUS GLUCOSE MONITORING SYSTEM
Seven Applicator
Remove the Applicator by pressing the release tabs on the sides of the Sensor Pod. 3.
Once you feel the back tabs open, pull off the Applicator so that only the Sensor Pod
remains adhered to your body.
Seven Sensor Pod
Sensor now inserted
Press on the
Release Tabs
After you have pushed the plunger down, pull the collar back until you hear a click or 2.
cannot pull back any further. is step pulls the needle back into the Applicator and
leaves the Sensor underneath your skin.
Pull up
Needle now removed/
Sensor inserted
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Attach Seven Transmitter in
Seven Sensor Pod
Seven Transmitter Attached
Seven Transmitter
Latch
Remove
Seven Transmitter Latch
2.3 SEVEN TRANSMITTER ATTACHMENT
e Transmitter wirelessly sends your Sensor glucose information to your Receiver. Once
you have inserted the Sensor, you will need to snap the Transmitter into the Sensor Pod.
To do this, you must perform the following steps:
Clean and dry the bottom of the Transmitter with a damp cloth or an alcohol wipe 1.
before every use.
Place the Transmitter in the Sensor Pod with the flat side facing down.2.
Pull the Transmitter Latch over the Transmitter to snap the Transmitter into place so 3.
it lies flat in the Sensor Pod. You should hear 2 “clicks.”
If you do not hear 2 clicks, the Transmitter might not be fully snapped in and a.
might not be water resistant.
Make sure both sides of the Transmitter are secure in the Sensor Pod.4.
Do this by sliding your first and second fingers under the edge of the Sensor Pod a.
(with your fingernails against your skin under the Latch).
Place your thumb on top of the Transmitter.b.
en squeeze together to make sure it has been snapped in.c.
Remove the Transmitter Latch by holding the end of the Latch and quickly twisting 5.
off the Latch away from your body.
Ensure both sides of the Transmitter are secure in the Pod.6.
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NOTE
Make sure you hear 2 clicks when you snap the Transmitter in place (see Step 3). is
•
helps ensure your device is water resistant (see Section 4.4).
Make sure that you have the correct Transmitter Serial Number (SN#) entered into your
•
Receiver (for all new Receivers, the Manufacturer enters this number). See Section 7.3 for
instructions on how to enter the SN# into your Receiver.
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Seven™ System User’s Guide | 41
Seven Sensor Insertion Screen
2.4 STARTING A NEW SEVEN
CONTINUOUS GLUCOSE MONITORING SESSION
After you have checked that your Seven System is communicating, you need to tell your
Receiver that you have inserted a new Sensor.
To indicate that you have inserted a new Sensor and to begin the 2-hour Start-Up Period
you must do the following:
Scroll down through the Receiver Settings Screens to the Sensor Insertion Screen by 1.
pressing the Down q Arrow 3 times until you come to the 9-hour Glucose Trend
Screen.
At the 9- hour Screen, hold the Down 2. q Arrow for at least 7 seconds to get to the
Receiver Setting screens.
Scroll down until you arrive at the Sensor Insertion Screen, shown below.3.
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42 | SEVEN™ CONTINUOUS GLUCOSE MONITORING SYSTEM
Conrmation Screen
Press the 4. OK button to confirm insertion and then you will see the following series of
screens appear:
After the Receiver has successfully processed the new Sensor Insertion, the Receiver 5.
will return to the grayed out 1-hour Trend Screen and the 2-hour Start-Up period will
begin.
NOTE
e Sensor Insertion Screen will only appear again after an active continuous glucose
•
monitoring session has ended (see Section 5).
You must insert a new Sensor every time you press “
• OK” on the Sensor Insertion
screen.
Each time you insert a new Sensor and press “
• OK” on the Sensor Insertion screen,
you will restart the 2-hour Start-Up period.
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A partial gray status box
indicates your Seven Sensor is
still in the Start-Up period
2.5 SEVEN SENSOR STARTUP PERIOD
e Sensor requires a two hour Start-Up period to “equilibrate” (adjust) to its new
biological environment. e Start-Up period will last 2 hours from the time you have
confirmed the Sensor insertion.
During the Start-Up period, periodically check to see that the Antenna Symbol (Y) is
visible in the bottom right corner of the Trend Screens and that your Receiver battery is
charged.
When you press any button during the Start-Up period, your Trend graphs will be shaded
dark gray. Over time, the dark gray screen will start to disappear indicating that you are
getting closer to initial calibration time. An example of this change is shown below.
At the end of the 2-hour Start-Up period the Receiver will prompt you to notify you that it is
time to calibrate your Sensor. Section 3 describes how to calibrate your Sensor.
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Failed Sensor Screen
If you see this screen, the Sensor is not working properly or you may have dislodged the
Sensor or Transmitter. You might need to replace your Sensor. To replace your Sensor,
remove your Sensor Pod by gently peeling up the adhesive patch from your skin (this will
pull out the Sensor Probe). Remove the Transmitter from the Sensor Pod (see Section
5.2). Clean and dry the bottom of the Transmitter with a damp cloth or alcohol swab
before your next use.
To begin a new session, you must insert a new Sensor, go through a new 2-hour StartUp Period, and calibrate your Sensor before you can receive more continuous glucose
information.
2.5.1 PROBLEMS DURING THE STARTUP PERIOD
During the Start-Up period you may see the Failed Sensor Screen.
NOTE
If you have dislodged the Sensor or Transmitter you will have to replace your Sensor.
•
is screen is not the same as “???” in the Status Box (see Section 4.6.2).•
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SECTION 3
SEVEN SYSTEM CALIBRATION
Warning
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.
You can use any FDA cleared bg meter to calibrate your Seven System. You can transfer
fingerstick blood glucose (BG) readings from any FDA cleared meter manually or the
OneTouch Ultra meter transfers BG readings through the connection cable.
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NOTE
Do not use alternative site testing (blood from your palm or forearm, etc.) for
calibration. You must take your blood glucose from your fingertips only for calibration.
e Seven System requires 2 BG fingerstick readings at the first calibration prompt. e
Receiver will prompt you for these readings about 2 hours after you insert a new Sensor
(see Section 3.1).
After you complete initial calibration you must update Receiver calibration a minimum
of once every 12 hours. e Receiver will request a new BG reading for calibration update
every 12 hours if you have not uploaded any BG readings before the 12-hour period.
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Double Blood Drop Prompt
3.1 THE SEVEN SYSTEM CALIBRATION PROMPT
THE END OF THE STARTUP PERIOD
Two (2) hours after Seven Sensor insertion confirmation (see Section 2.4) your Seven
Receiver will prompt you to calibrate your Sensor by vibrating and displaying the
following screen on the Receiver:
After you see this prompt press the
• C Button to clear the display.
Take 2 fingersticks with your meter.
•
Follow the steps provided in Section 3.2 (Auto Upload) or Section3.3 (Manual Entry) •
to complete System calibration.
NOTE
If you choose to silence the Double Blood Drop Prompt •
and calibrate at a later time, the Trend Screen will display
a Blood Drop in the Status Box (upper right corner). is
indicates that BG fingerstick readings are still needed for
calibration.
If you silence the Double Blood Drop Prompt, it will reappear every 15 minutes for 3
•
hours. You will still be able to calibrate after 3 hours. e Receiver will only display a
blood drop in the Status Box as a reminder.
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HELPFUL HINTS:
Your blood glucose reading must be between 40 mg/dL and 400 mg/dL to calibrate. •
e Seven System will not use BG readings outside of this range for calibration. If you
have readings outside of this range first treat yourself and then try calibrating the
Sensor at a later time.
Always check that the Receiver and BG meter date and time are the same.
•
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MC
If you choose to use Auto Upload for calibration make sure your meter is “registered”
to your Receiver and the Receiver date/time and OneTouch Ultra date/time match.
Registration is not required for Manual Entry.
To register the devices connect the OneTouch Ultra Meter and Receiver following these
steps:
Make sure the OneTouch Ultra Meter display is off (screen is blank) before connecting. 1.
To turn the display off, press the M button once.
Using the connection cable provided: 2.
First plug the cable into the connection port of the BG meter. (e connection a.
port is at the bottom of the meter).
Second connect the wide end of the cable into the Receiver. Make sure the raised b.
Push button on the cable is facing down. (You must do these steps in order).
After a few seconds, “PC” will appear on the OneTouch Ultra Meter screen (shown 3.
below):
3.2.1 ONE TOUCH ULTRA METER SEVEN RECEIVER REGISTRATION
3.2 AUTO UPLOAD CALIBRATION
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50 | SEVEN™ CONTINUOUS GLUCOSE MONITORING SYSTEM
New Meter Screen
If you have never connected the OneTouch meter or you were using a different 4.
OneTouch meter before, then your Receiver will vibrate twice and you will see the
following screen:
Press the 5. OK button to “accept” this new meter. e symbol will then disappear
and the Receiver will return to the 1-Hour Glucose Trend Screen to indicate that
registration is complete. (Note: is process may take a few minutes to complete.)
Press the Push button on the connection cable to remove it.a.
e order that you disconnect the cable does not matter.b.
Check to see that the Receiver and meter have the same time.6.
After you have registered the devices all new BG readings taken and uploaded 7.
from this meter will be used to calibrate your Seven System. See Section 3.2.2 for
instructions on how to calibrate your Seven System.
NOTE
Blood glucose information stored in the OneTouch Ultra Meter before registering it •
to your Receiver will not be used for calibration. Always register a new meter before
uploading fingersticks to be used for calibration.
e Seven Receiver and OneTouch Ultra meter date and time must be within 2 minutes of
•
each other. If they are not, the BG fingersticks will not be accepted by the Seven System for
calibration. Anytime you change the date/time on your Receiver, connect the meter to the
Receiver using the Connection cable (without taking new BG fingerstick readings) to match
the date/time on the devices. You can upload BG readings as usual after that.
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Seven™ System User’s Guide | 51
MC
Connection Screen
e steps below will guide you through Auto Upload Calibration:
Check to see that the Receiver and OneTouch Ultra meter have the same date and 1.
time.
Take 2 fingersticks with your OneTouch Ultra meter.2.
Make sure the OneTouch Ultra Meter display is off (screen is blank) before connecting. 3.
To turn the display off, press the M button once.
Using the connection cable provided follow the steps below:4.
First plug the cable into the connection port of the BG meter. (e connection a.
port is at the bottom of the meter).
Second connect the wide end of the cable into the Receiver. Make sure the raised b.
Push button on the cable is facing down. (You must do these steps in order).
After a few seconds, “PC” will appear on the OneTouch Ultra meter screen (shown 5.
below):
3.2.2 AUTO UPLOAD USING THE CONNECTION CABLE
e Receiver will display the Connection Screen below. e following screen indicates 6.
that BG readings from the meter are successfully being uploaded to your Receiver for
calibration.
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e 1-Hour Trend Screen with a Blood Drop in the upper right hand corner (“Status Box”) 7.
shown below will appear once the upload is complete. e Blood Drop symbol will be
replaced by a glucose reading once the Sensor successfully calibrates.
Press the Push button on the connection cable to disconnect the cable from the BG 8.
meter and the Receiver (the order that you disconnect the cable does not matter).
A glucose reading will appear on the Receiver in about 15 minutes, and glucose 9.
readings will be updated every 5 minutes.
If it has been more than 20 minutes and you have not received a reading, see Section 10.
3.4 “Calibration Troubleshooting.”
NOTE
All fingerstick readings taken with your OneTouch Ultra meter are evaluated for •
calibration. Do not share your blood glucose meter with other people.
It is important that you follow these steps for Auto Upload in the exact order above
•
for successful BG reading transfer and calibration of the Seven System.
HELPFUL HINTS:
Always check that the Receiver and BG meter date and time are the same. •
If you use more than 1 OneTouch Ultra meter during Seven System use, any BG •
fingersticks you take using the “non-registered” meter will not be used for calibration
even if you attach this meter with the connection cable. You will have to register
the meter first and then take BG readings with the new meter for Auto-Upload
calibration.
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3.3 MANUAL ENTRY CALIBRATION
3.3.1 ENTERING BG READINGS TO YOUR SEVEN RECEIVER FOR
CALIBRATION USING MANUAL ENTRY
e steps below will guide you through Manual Calibration:
Take a fingerstick reading using your meter.1.
Press the Down 2.
Arrow 3 times until you see the 9-hour Glucose Trend Screen.
Hold the Down 3.
Arrow for at least 7 seconds to get to the Receiver Setting Screens.
e following Screen will appear:
Manual Entry Upload Screen
PRECAUTION
For Manual Entry 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 or fingerstick readings that ocurred
more than 5 minutes ago will affect device performance.
Press the 4. OK button to display the screen for the manual entry:
BG Entry Screen
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During initial calibration the Seven System will default to the BG reading of 120 mg/dL. 5.
To enter the BG reading taken from your BG meter, press the Up 6.
or Down Arrows
until you arrive at the correct BG reading. Press the OK button to enter the BG reading.
e Manual Entry Confirmation will appear:7.
For initial calibration, repeat steps 1-7 for the second fingerstick BG reading.8.
A glucose reading should appear on the Receiver in about 15 minutes.9.
For calibration updates (Section 4.5):10.
e BG Entry Screen will display a continuous glucose reading from the past 15
•
minutes as your starting point.
If no readings are available then 120 mg/dL will be your starting point.
•
NOTE
Only BG • readings between 40-400 mg/dL can be used for calibration. If 1 or more of
your readings entered was outside of this range, the Seven System will not calibrate.
Always make sure the Antenna Symbol (Y) is displayed in the bottom right hand
•
corner of the Trend Screens.
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 Sensor wear.
Press the • OK button to confirm the BG reading
entered is correct.
If the BG reading displayed is incorrect press the
•
C Button and enter in the correct BG reading for
calibration.
If you do not press any button, the Receiver will “time
•
out” and no BG reading information will be entered.
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3.4 CALIBRATION TROUBLESHOOTING
e following prompts may appear during or shortly after an attempt to calibrate the
Seven System. Review the following troubleshooting methods to ensure successful
calibration.
CONNECTION FAILURE SCREEN
AUTO UPLOAD ONLY
If you see this screen (with an “X” between the dotted
lines), the BG reading transfer failed. In this case, clear the
alert by pressing any Receiver button. No additional BG
fingersticks are required. Disconnect the devices and review
the following:
Make sure that the meter screen is always blank before
•
you connect the 2 devices.
Make sure you plug the Connection Cable into the
•
meter first and into the Receiver second.
Do not disconnect the cable while uploading or before
•
you see the 1-Hour Trend Screen appear.
Re-try upload using the proper step order.
•
NEW METER SCREEN
AUTO UPLOAD ONLY
You will see this screen if you have connected a new/
different meter to your Receiver. Your Receiver will vibrate
twice.
You will be asked to register the meter with your Seven
•
System. See Section 3.2.1.
You will have to take 2 additional BG fingersticks and
•
upload them.
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REPEAT DOUBLE BLOOD DROP PROMPT
If initial calibration is not successful, the Receiver will continue
to provide the Double Blood Drop Prompt every 15 minutes
for up to 3 hours after the Sensor Start-Up Period. Make sure
you have followed the instructions in Section 3 (Seven System
Calibration) and the instructions for how to address the
Connection Failure Screen and New Meter Screen. If you have
followed these steps and you still receive the Double Blood
Drop Prompt, then one of the following errors has occurred:
Both BG fingerstick readings you took and uploaded
•
for your first calibration attempt were outside of the
40-400 mg/dL range, or
e Receiver and Transmitter were not communicating
•
with each other at the time you took the 2 BG
fingersticks uploaded for calibration, or
e Receiver could not understand (“???” in Status
•
Box) your Sensor signal at the time you took the BG
fingerstick readings for calibration.
If you get prompted by the REPEAT DOUBLE BLOOD DROP PROMPT follow the steps below:
Clear the Screen by pressing any Receiver button.1.
Check the Status Box in the upper right hand corner of the Receiver for the current 2.
Receiver status and determine what to do based on the Receiver Status Symbol
displayed:
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Seven™ System User’s Guide | 57
Awaiting a Fingerstick Screen
No Communication Screen
Unknown Glucose Reading Symbol
If the “???” Symbol (shown below) is displayed your Receiver could not understand b.
the sensor signal. Do not take any additional fingersticks for calibration at this
time. Wait until you are prompted with the Double Blood Drop Screen again and
review Steps 1 and 2.
If the “Awaiting Fingerstick Reading” Symbol (shown below) is displayed, take 2 more BG a.
fingersticks (readings must be within 40-400 mg/dL) and upload those readings to the Receiver.
If the “No Communication” Symbol (shown below) is displayed, c. do not take
any additional fingersticks for calibration at this time. Move the Receiver and
Transmitter so that they are within 5 feet of each other and wait at least 5 minutes.
If you are still having problems with communication review Section 4.6.1 also.
When you are prompted with the Double Blood Drop Prompt again, review Steps
1 and 2 to calibrate.
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Awaiting a Fingerstick Screen
To complete calibration after receiving the SHADED-OUT BLOOD DROP PROMPT
follow the steps below:
Clear the Screen by pressing any Receiver button.1.
Check the Status Box in the upper right hand corner of the Receiver for the current 2.
Receiver status and determine what to do based on the Receiver Status Symbol
displayed:
If the “Awaiting Calibration Fingerstick” Symbol (shown below) is displayed, take a.
1 more BG fingerstick (reading must be within 40-400 mg/dL) and upload that
reading to the Receiver.
SHADEDOUT BLOOD DROP PROMPT
e Shaded-Out Blood Drop Prompt indicates that 1 more
BG fingerstick is needed for calibration. e Receiver will
continue to provide the Shaded-Out Blood Drop Prompt
every 15 minutes for up to 3 hours after the Sensor Start-Up
Period until a minimum of 2 BG fingersticks are successfully
taken and uploaded to the Receiver.
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Unknown Glucose Reading Symbol
If the “???” Symbol (shown below) is displayed your Receiver could not understand the b.
sensor signal when you took your BG readings. Do not take any additional fingersticks
for calibration at this time. Wait until you are prompted with the Shaded-Out Blood
Drop Screen again and review Steps 1 and 2.
No Communication Screen
If the “No Communication” Symbol (shown below) is displayed, c. do not take
any additional fingersticks for calibration at this time. Move the Receiver and
Transmitter so that they are within 5 feet of each other and wait at least 5 minutes.
If you are still having problems with communication review Section 4.6.1 also.
When you are prompted with the Shaded-Out Blood Drop Screen again, review
Steps 1 and 2 to calibrate.
NOTE If you are still having trouble with Seven System calibration (e.g., receiving
multiple prompts) following these steps, contact DexCom Technical Support at 1-877DEXCOM4 (339-2664) for help.
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SECTION 4
VIEWING YOUR
CONTINUOUS GLUCOSE INFORMATION
is section will educate you on how to view Seven System continuous glucose trend
information. Once you have successfully calibrated, the Seven System will provide
you with continuous glucose information every 5 minutes, the Low and High Glucose
Alerts will notify you when you fall outside of your target glucose range, and the Low
Glucose ALARM will notify you of when your glucose levels may be reaching potentially
dangerous low levels. Press any button on the Seven Receiver and the following glucose
information will be shown to you:
WARNING
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.
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High Glucose
Alert Setting = 200 mg/dL (Default)
Most recent 5-minute
glucose reading (100 mg/dL)
Low Glucose
Alert Setting = 80 mg/dL (Default)
Plot of the most recent glucose
reading (100 mg/dL) on the 1-hour
Glucose Trend Screen
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Press
p
q
Press
p
q
1-Hour
Glucose Trend Screen
3-Hour
Glucose Trend Screen
9-Hour
Glucose Trend Screen
4.1 GLUCOSE TREND SCREENS
You can see trend graphs of your glucose information from the past 1-hour, 3-hour and
9-hour periods by pressing the Up
and Down Arrows on your Receiver. ese
Glucose Trend Screens allow you to see where your glucose levels have been and where
your glucose levels are headed.
WARNING
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.
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.
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e Seven System reports glucose readings from 40 to 400 mg/dL and updates •
glucose readings every 5 minutes.
e Seven System reads “LOW” when <40 mg/dL and “HIGH” when >400
•
mg/dL
4.1.1 GLUCOSE TREND SCREEN INFORMATION
Low < 40 mg/dL High > 400 mg/dL
Each “dot” on the glucose trend screen represents a glucose reading.•
e current time is on each Glucose Trend Screen (“A” is AM and “P” is PM).•
e “dashed lines” on the Glucose Trend Screens are the High Alert and Low Alert •
Settings (see Section 7.1 to change these settings)
e 1-hour Trend Screen (1 hr) shows your current glucose reading and the last 1
•
hour of glucose readings.
e 3-hour Trend Screen (3 hr) shows your current glucose reading and the last 3
•
hours of glucose readings.
e 9-hour Trend Screen (9 hr) shows your current glucose reading and the last 9
•
hours of glucose readings.
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4.2 HIGH AND LOW GLUCOSE ALERTS
One of the benefits of the Seven System is your ability to set High and Low Glucose
Alerts that tell you when your glucose readings are out of your “target range” (see Section
7.1). is feature can be helpful during periods of time when you may not test your blood
glucose (such as sleeping, driving, exercise, or long meetings).
When your Seven System glucose readings are at or below or above your Alert setting
•
the Receiver will notify you for up to 15 minutes:
1st 5-minute Alert: “Vibrate” »
2nd 5-minute Alert: “Vibrate” “Beep” “Beep” »
3rd 5-minute Alert: “Vibrate” “Beep” “Beep” (Louder) »
DEFAULT ALERT SETTINGS:
HIGH Alert = 200 mg/dL•
LOW Alert = 80 mg/dL•
Default settings can be changed or turned off (see section 7.1)
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For High Alerts the Receiver will display the following screen with the notification:•
Low Glucose Alert Screen
High Glucose Alert Screen
Press any Receiver Button to stop the Alert notification (vibrating/beeping).•
Once you press a Receiver button to acknowledge the Alert, the Receiver will not •
notify you until your glucose readings rise above or fall below your High and Low
Alert settings again.
For Low Alerts the Receiver will display the following screen with the notification:
•
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Low Glucose ALARM
4.3 LOW GLUCOSE ALARM ≤55 MG/DL
In addition to your personal glucose alert settings, your Seven Receiver also has an
automatic Low Glucose ALARM set at 55 mg/dL. You cannot change or turn off this
ALARM.
When your Seven System glucose readings are at or below 55mg/dL the Receiver will
notify you:
1st 5-minute ALARM: “Vibrate” »
2nd 5-minute ALARM: “Vibrate” “Beep” “Beep” »
3rd 5-minute ALARM: “Vibrate” “Beep” “Beep” (Louder) »
e Receiver will vibrate and beep every 5 minutes after the 3rd ALARM if your ›
readings are still at or below 55 mg/dL until you press any Receiver Button to stop
the Low ALARM notification.
For Low ALARMs the Receiver will display the following screen with the notification:•
WARNING
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.
Press any Receiver Button to stop the Low ALARM notification (vibrating/beeping).•
e Receiver will automatically notify you again in 30 minutes if your glucose •
readings are still at or below 55 mg/dL.
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4.4 THE SEVEN SYSTEM AND WATER
e Sensor and the Transmitter snapped into the Sensor Pod are water resistant when
showering, bathing, or swimming. e Sensor has been tested to be water resistant
when submerged for up to 3 ft for a maximum of 30 minutes. For added protection you
can use a shower cover. e Sensor performance has not been tested in elevated water
temperatures, such as those in a Jacuzzi or hot tub. You should avoid Sensor exposure to
Jacuzzis and hot tubs.
e Receiver is not water resistant. Do not get your Receiver wet at any time.
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Calibration Update Screen
4.5 SEVEN SENSOR RECALIBRATION/ 12HOUR UPDATE
Upload any fingerstick BG readings you take during Sensor wear. ese BG readings will
update your System calibration.
If you have not uploaded any fingerstick BG readings in the past 12 hours, the Receiver
will request a fingerstick BG reading to update its calibration as follows:
e Calibration Update Screen will appear telling you to update Seven System
•
Calibration (Note: e Receiver will not vibrate at this time).
If you see the reminder symbol below, clear this display by pressing any Receiver button. e
•
Calibration Update Screen will not go away until you acknowledge it by pressing a button.
WARNING
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.
Take a fingerstick at this time. Enter this reading to your Receiver to update your •
Sensor calibration.
is screen will reappear every 15 minutes until you upload a new BG fingerstick
•
reading that is accepted for calibration.
If this screen re-appears shortly after you have uploaded a new BG fingerstick
•
reading, review Section 4.6.3, “Missing Glucose Readings After Calibration Update/
Recalibration”.
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4.6 MISSING SEVEN GLUCOSE INFORMATION GLUCOSE DATA GAPS
At times your Seven System will not display glucose information or provide Alerts/
ALARMs. ese Glucose Data Gaps can happen when:
e Transmitter and Receiver are out of range.1.
e Receiver does not understand the Sensor signal.2.
e Seven System needs another BG fingerstick reading for calibration because the 3.
Sensor readings do not match your blood glucose meter readings.
Reasons for “Glucose Data Gaps” and what to do to receive new Seven System readings
are described in the next Sections.
WARNING
is device is not designed to replace a blood glucose meter. During Glucose Data
•
Gaps rely on your blood glucose meter.
Symptoms related to low or high blood glucose levels should not be ignored. If
•
you have symptoms of low or high glucose confirm them using your blood glucose
meter.
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No glucose data
Anytime you see the Antenna Symbol “Y” in the Status Box instead of a glucose •
reading the Receiver has “missed” the last glucose reading sent by the Transmitter to
the Receiver.
4.6.1 MISSING GLUCOSE READINGS NO “Y”
Make sure your Receiver is within 5 feet of the Transmitter/Sensor Pod. If it is not, •
move your Receiver closer and wait at least 5 minutes. e “Y” symbol in the Status
Box should go away and you will receive a glucose reading in the next 5-10 minutes.
If you are still having trouble receiving Seven System readings because of this
•
problem, contact DexCom Technical Support at 1-877-DEXCOM4 (339-2664).
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No glucose data
4.6.2 MISSING GLUCOSE READINGS “???”
During continuous glucose monitoring your Seven System may get a reading that it does
not understand. When this occurs you will see 3 question marks (???) in the Receiver
Status Box.
Check the placement of your Sensor to make sure it is still sticking well to your skin
•
and that nothing is rubbing the Sensor Pod (i.e. clothing, seat belts, etc.).
e “???” can also happen because your glucose readings are rapidly rising or rapidly falling.
•
e Receiver can tell if there are “Major” or “Minor” issues with your Sensor signal •
where it cannot calculate a Seven System glucose reading. Minor Sensor issues can
be resolved (go away) and the Seven System will be able to give you more glucose
readings.
If you receive a series of “Major” issues over time with your Sensor the Receiver may
•
automatically turn off before the end of a full 7-day session (see Section 4.7). If you
see the “Failed Sensor” Screen you will need to replace your Sensor and start a new
continuous glucose monitoring session.
During “Minor” or “Major” problems that do not cause an early Sensor Failure, glucose
•
readings can be displayed again once the Seven System determines it is okay to do so.
NOTE
e Receiver can tell when “???” is a Major or Minor issue, but you will not be able to
•
tell.
When you see “???” in the status box of the Receiver Trend Screen, taking BG
•
fingersticks with your meter and uploading them does not help the Seven System
display more glucose readings. Any BG fingersticks that you take during “???” will be
ignored by the Seven System.
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No glucose data
Calibration Update Screen
4.6.3 MISSING GLUCOSE READINGS “ ” AFTER
CALIBRATION UPDATE/RECALIBRATION
When you take and upload a BG fingerstick for calibration (Section 4.5), the Seven •
System checks how well it is functioning compared to the BG meter. e calibration
update process takes about 10-15 minutes. During each calibration update attempt,
the Seven System may determine that another BG reading is needed. e Calibration
Update Screen will appear again (shown below) and the Receiver will vibrate.
Clear this Screen by pressing any button. e display will return to the 1-hour Trend
•
Screen. You will see a blood drop symbol in the Status Box instead of a glucose
reading.
e blood drop symbol indicates that the Seven System requires at least one more
•
BG fingerstick reading to start displaying glucose readings and providing Alerts/
ALARMs again.
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NOTE
If you have not received any glucose readings in the past hour and have attempted
re-calibration by taking and uploading at least 3 BG fingersticks then contact DexCom
Technical Support at 1-877-DEXCOM4 (339-2664) as there may be a problem with your
Sensor.
Take another BG fingerstick and enter this information to the Receiver. After you •
do this your Seven System will take about 10-15 minutes to update calibration. e
blood drop symbol will remain in the upper right corner during the 10-15 minute
period.
After successful re-calibration your Seven System will display glucose readings, trends
•
and provide Alerts and ALARMs again.
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Failed Sensor Screen
A grayed out Status Box indicates that your
Seven System Session has ended
The screen begins to gray out after your
Seven System Session has ended
4.7 SEVEN SYSTEM EARLY SHUTOFF
In some cases your Seven System Continuous Glucose Session may end before the end
of a full 7-day period. You should review Section 10.1, Table 11 of this User’s Guide to
review how often you should expect this to happen. Examples of why this may occur are
described below.
4.7.1 EARLY SHUTOFF SENSOR FAILURE
During use your Receiver may detect a series of “Major” issues with your Sensor signal
where it can no longer calculate Seven System glucose readings (see Section 4.6.2). At this
time the Seven System will automatically turn off and display the following screen:
If you see this screen then your Seven continuous glucose monitoring session has ended.
Press any button on the Receiver to clear this screen.
Seven System glucose readings will not be displayed and the Receiver screen will indicate
that the Seven System Session has ended by displaying the gray rectangle in the Status
Box. You must remove your Sensor and insert a new one.
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Remove your Sensor Pod by gently peeling up the adhesive patch from you skin (this will
pull out the Sensor Probe). Remove the Transmitter from the Sensor Pod and store it for
your next glucose monitoring session (see Section 5.2).
To start a new Seven System continuous glucose monitoring session, insert a new Sensor,
notify the Receiver and then calibrate at the end of the Start-Up Period (see Section 2).
NOTE
Remember to save your Transmitter after each Sensor removal. e same Transmitter
is used for each Seven session until you have reached the end of the Transmitter
battery life.
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SECTION 5
ENDING YOUR SEVEN SYSTEM
CONTINUOUS GLUCOSE MONITORING SESSION
At the end of your Sensor wear period, you can simply remove your Sensor Pod by
gently peeling up the adhesive patch from your skin (this will pull out your Sensor
Probe). Remove the Transmitter from the Sensor Pod and keep it for your next glucose
monitoring session.
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6 hour Sensor
Expiration Notication
2 hour Sensor
Expiration Notication
30-minute Sensor
Expiration Notication
Sensor Expiration Notication
END OF SESSION
5.1 CONTINUOUS GLUCOSE MONITORING PERIOD END
5.1.1 AUTOMATIC SEVEN SENSOR EXPIRATION NOTIFICATION
Your Receiver will notify you of how much time you have remaining until your Seven
System Continuous Glucose Monitoring Session is complete. e Expiration Screen will
appear 6 hours and 2 hours before your 7-Day session ends. At the 30-minute and 0-hour
Expiration Screens, the Receiver will display the Expiration Screen and will also vibrate
and beep over a 15 minute period if not cleared. You can clear all of these screens by
pressing any button on the Receiver. After the 6-hour, 2-hour, and 30-minute reminders
you will still continue to receive Seven System readings. You can remove your Sensor after
the final Sensor Expiration Screen (00:00:00) appears.
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A grayed out Status Box indicates that your
Seven System Session has ended
The screen begins to gray out after your
Seven System Session has ended
Once the Final Expiration Screen appears, press any of the Receiver buttons to clear this
notification. Glucose readings will no longer be displayed and the Receiver screen will
indicate that the Seven System Session has ended by displaying the gray rectangle in the
Status Box.
Over time the Receiver display (Trend Screen area) will continue to “gray out” if a new
Sensor is not inserted.
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Sensor Removal Screen
Conrmation Screen
5.1.2 MANUAL SEVEN SENSOR SHUTOFF
To manually end your continuous glucose monitoring period, follow the steps below:
Press the Down 1. q Arrow 3 times until you see the 9-hour Glucose Trend Screen.
Hold the Down 2. q Arrow for at least 7 seconds to get to the Receiver Settings screens.
Scroll the Down 3. q Arrow 5 times to arrive at the Sensor Removal Screen, shown
below. Once you see this screen, press the OK button to indicate removal of your
Sensor.
After you see the series of screens below, you have successfully removed your Sensor.4.
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e Receiver will default to the 1-Hour Trend Screen. Glucose readings will no longer 5.
be displayed and the Receiver screen will indicate that the Seven System Session has
ended by displaying the gray rectangle in the Status Box.
Over time, the Receiver display (Trend Screen area) will continue to “gray out” if a new
Sensor is not inserted.
A grayed out Status Box indicates that your
Seven System Session has ended
The screen begins to gray out after your
Seven System Session has ended
NOTE
If you removed your Sensor before notifying the Receiver, the Failed Sensor Screen
•
will appear automatically (See Section 4.7.1). You must press OK before inserting a
new Sensor.
Your Transmitter is used for each Sensor session. Remove the Transmitter from the
•
Sensor Pod and store it for your next glucose monitoring session.
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After pulling out the Sensor with the Transmitter still in the Sensor Pod, you will need to
remove the Transmitter. To do this you can use either of the two methods below:
e Safety Lock/Transmitter Release (Section 2.2.3) detached from the Applicator
•
can be used as a tool to remove the Transmitter. Place the Sensor Pod on a table.
Hold the rounded edge of the Transmitter Release perpendicular to the Sensor Pod
length. Make sure the jagged edge of the Transmitter Release is facing down (the
direction away from the removal arrow) as shown below:
5.2 SEVEN TRANSMITTER REMOVAL
METHOD 1
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Transmitter Release
(from Applicator)
Sensor Pod with
Transmitter snapped in
Insert the jagged edges so that they “hug” the Transmitter wings in the Sensor Pod. •
Press the Transmitter Release down until you cannot press down anymore, and the
Transmitter wings will “pop” out of the Sensor Pod.
Remove the Transmitter and store it in a cool, dry place until your next glucose
•
monitoring session.
If you did not save the Transmitter Release, you can simply use your forefinger on
•
each hand and spread out the tabs at the back of the Sensor Pod (end closest to the
wings). e Transmitter wings will “pop” out of the Sensor Pod.
METHOD 2
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SECTION 6
SEVEN RECEIVER BATTERY
Your Receiver battery is rechargeable like a cellular phone. e battery will last for about
5 days before needing to be recharged. e Receiver will take 3 hours to charge when the
battery has completely drained.
NOTE
Typically the Receiver only needs to be charged every 5 days. However, this can
•
vary by how often you check Receiver Trend Screens or receive Alerts or ALARMs.
Periodically check your battery level to make sure it has enough charge.
If your battery drains and is not charged for over a month, the Receiver’s time might
•
need to be reset.
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Battery Indicator Low Battery Alert
6.1 LOW BATTERY ALERT
e Battery indicator is located next to the Antenna Symbol (Y) on the bottom right •
corner of the screen. is indicator tells you how much charge is left in the battery.
When the Receiver’s battery is low, the Receiver will flash a large Low Battery Alert
•
across the screen. Press the C Button to clear the alert.
Charge your Receiver as soon as possible when you see the Low Battery Alert so you
•
can continue receiving glucose readings.
QUICK TIP
You can acknowledge the Low Battery Alert when the Receiver first vibrates by
•
pressing any Receiver button. e Receiver will notify you again of the Low Battery in
30 minutes and will repeat the notification every time you acknowledge it.
If you do not want the Receiver to re-alert you because of the Low Battery, allow
•
the Receiver to alert you for 15 minutes (it will vibrate/vibrate-beep-beep/vibratebeep-beep (Louder)). e Receiver will not alert you anymore if you do not press any
Receiver buttons to clear the Low Battery Alert Screen.
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6.2 CHARGING YOUR SEVEN RECEIVER BATTERY
To charge the Receiver battery, connect the charger cable into the port on the •
bottom of your Receiver. Make sure the “Push” button side of the charger cable is
facing down.
Connect the plug into a standard power outlet.
•
e Receiver will display the animated symbol below of a battery charging across the •
Receiver screen:
After a few seconds, the 1-hour Glucose Trend Screen will reappear with the •
animated Battery indicator displayed in the lower right corner next to the Antenna
Symbol (Y).
e battery will fully charge after 3 hours and will last approximately 5 days before
•
recharging is necessary.
If your charging cable has a “Push” button, press this to disconnect the cable.
•
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SECTION 7
SEVEN RECEIVER SETTINGS
You can reach all of the Receiver Settings Screens by scrolling down to the 9-Hour
Glucose Trend Screen and holding the Down
Arrow for at least 7 seconds. Please refer
to Section 1.4.2 for an overview of all Receiver screens.
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7.1 GLUCOSE ALERT SETTINGS
e default setting for the High Glucose Alert is 200 mg/dL. e default setting for the
Low Glucose Alert is 80 mg/dL. Set these alerts at settings that will help monitor when
your glucose levels are too high or too low. Work with your Diabetes Management Team
to help you choose your appropriate Glucose Alert settings.
7.1.1 HIGH AND LOW GLUCOSE ALERT LEVELS mg/dL UNITS
Press the Down • Arrow 3 times until you come to the 9-hour Glucose Trend Screen.
Hold the Down
• Arrow for at least 7 seconds until you come to Settings Screens.
Scroll down until you arrive at the Glucose Alert Screens:
•
Once you are at the Glucose Alert Screen, press • OK to begin setting your alert levels.
You will see the following High Glucose Alert Screen:
Use the Up
• or Down Arrows to increase or decrease the High Glucose Alert
level by 20 mg/dL (i.e. 220, 240, 260 mg/dL ).
You may select High Glucose Alert levels from 140 mg/dL to 400 mg/dL. Select the
•
level recommended by your Diabetes Management Team by pressing the OK Button.
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NOTE
If you scroll above 400 mg/dL the display will read NO. If you press the OK Button to
select this option, you will turn off the high glucose alert. You will not receive any high
glucose alerts at this Alert setting. e High Glucose Alert line will no longer appear on
the Receiver Trend Screens.
Once you press • OK to select your High Glucose Alert level, you will see the Low
Glucose Alert Screen:
Use the Up
• p or Down q Arrows to increase or decrease the Low Glucose Alert
level by 10 mg/dL.
You may select Low Glucose Alert levels from 60 mg/dL to 90 mg/dL.
•
Select the level recommended by your Diabetes Management Team by pressing the •
OK Button.
Press the
• OK Button after you set the Low Glucose Alert to confirm both high and
low alert settings and then you will return to the Glucose Alert Screen.
NOTE
If you scroll below 60 mg/dL the display will read NO. If you press the OK Button to
select this option, you will turn off the Low Glucose Alert. You will not receive any Low
Glucose Alerts at this Alert setting. e Low Glucose Alert line will no longer appear on
the Receiver Trend Screens. (For safety, there is a Low Glucose ALARM set at 55 mg/dL
that you cannot turn off. See section 4.3).
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Time / Date Screen
7.2 HOW TO SET THE SEVEN RECEIVER TIME
7.2.1 SEVEN RECEIVER TIME SCREEN
Press the Down • q Arrow 3 times to get to the 9-hour glucose trend screen.
Hold the Down
• q Arrow again for at least 7 seconds to get to the Settings Screens.
Press the Down
• q Arrow until you arrive at the Time/Date Screen:
Press the
• OK Button on the Receiver to set the time.
NOTE:
Make sure to set the correct time on your Seven Receiver.
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p or q
OK
p or q
OK
NOTE
e Receiver date is preset to Pacific Standard Time (PST) at the factory.•
If you are unable to adjust the date/time to the current time zone’s date/time, there •
may be a problem with the Receiver. Please contact DexCom Technical Support at
1-877-DEXCOM4 (339-2664).
Press • OK Button to move to the date.
Use Up
• or Down Arrows to choose the date.
Press
• OK Button to move to the hour.
Use Up
• or Down Arrows to choose the hour
Press
• OK Button to move to minutes.
Use Up
• or Down Arrows to choose the minutes.
When you choose the hours and minutes, the AM/PM will adjust automatically (e.g.
•
if you go from 11:59 AM to 12:00 PM, AM will automatically switch to PM).
Note: If you pass 11:59 PM the date will automatically update to the next day or the
•
previous day based on the arrow direction you are pressing.
If you press
• C at any time, this will not set the time and return you to the Time/Date
Screen.
7.2.2 SETTING THE TIME
Once you select the Time/Date Screen and press • OK, the Time Settings Screen will
appear.
Press the Up
• or Down Arrows to choose the year.
Press the
• OK Button to move to the month.
Press the Up
• or Down Arrows to choose the month.
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7.2.3 TIME LOSS ALERT
If the Receiver’s back-up battery has drained, you will need to re-set the time and date.
e Time Setting Screen will be shown on the display.
Follow the steps in section 7.2.2 to set the time and date.
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Transmitter Serial Number Screen
7.3 ENTERING A NEW SEVEN TRANSMITTER SERIAL NUMBER SN#
Any time you use a new Transmitter or new Receiver as part of your Seven System, you
must enter the Transmitter Serial Number (SN#) into your Receiver. e Transmitter
Serial Number (SN#) is located as a series of 5 numbers and letters on the back of the
Transmitter.
Entering the SN# will begin the unique wireless radio-frequency (RF) communication
between the Transmitter and Receiver. To do this perform the following steps:
Press the Down 1.
Arrow 3 times until you come to the 9-hour Glucose Trend Screen.
Hold the Down 2.
Arrow for at least 7 seconds until you come to the Settings
Screens.
From this screen, press the Down 3.
Arrow until you arrive at the Transmitter Serial
Number Screen below:
Press the 4. OK Button to display the entry screen for the Transmitter SN#:
e SN# is a series of 5 letters and numbers printed on the back of your Transmitter 5.
(SN# XXXXX).
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To enter your SN# press the Up 6. or Down Arrows until you arrive at the first
number or letter.
Press the 7. OK Button to accept that number/letter and to move to the next number
or letter.
Continue steps 6 and 7 until you have entered all 5 numbers/letters.8.
Press the 9. OK Button once more to confirm the entire Transmitter Serial Number.
Pressing 10. C at any time while entering in the new Transmitter Serial Number will
return you to the first Transmitter Serial Number Screen and the SN# will not be
changed.
When you have programmed the new Transmitter Serial Number check the Receiver 11.
display in 5 minutes to make sure the Antenna Symbol appears in the lower right
corner and the two devices are communicating.
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e About Screen shows information about the Receiver, including the software number
and version, hardware number and version, Transmitter type, and Receiver serial number.
SW8201 STS
v5.0.7.24
HW8205 19 GTX
S#12456
About Screen
e About Screen appears after you enter a new Transmitter Serial Number. Follow the
steps in Section 7.3 to enter your Transmitter Serial Number and see the About Screen.
You will also see the About Screen when your Receiver “boots up” for the first time or the
first use after recharging a completely drained battery.
7.4 THE ABOUT SCREEN
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SECTION 8
TROUBLESHOOTING
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Connection Failure Screen
8.1 PROBLEMS UPLOADING BG READINGS TO YOUR SEVEN
RECEIVER WITH THE CONNECTION CABLE
If the OneTouch Ultra meter and Receiver have trouble connecting to each other, the •
following symbol will be displayed:
Make sure you have done the following during upload:
•
e meter must be “OFF” prior to performing the upload (no display). If necessary, »
press the M button once to turn the meter off, and then reconnect the two devices.
Do not push any meter buttons while performing the upload.
»
e Connection Cable is plugged into the connection port properly. Remember to »
plug the cable into the meter first and then into the Receiver.
e Antenna Symbol (Y) is present in the bottom right corner of the Receiver.
»
If you are still unable to successfully transfer readings to the Receiver:•
Press the M button on the BG meter to view its display and to ensure the meter is »
functioning.
If the meter has no display, replace the meter’s battery. (Note: e meter’s battery
»
should last at least a year.)
If the meter still fails to function after replacing the meter’s battery, replace the •
meter.
Press one of the Receiver buttons and check to see that it is functioning.
•
If the Receiver’s display does not appear, plug the Receiver into the charger to make •
sure that the battery is charged.
If you still do not see a display, contact DexCom Technical Support at
•
1-877-DEXCOM4 (339-2664) for additional help.
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