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Dexcom SEVEN PLUS User Manual Supplement

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BLINDED MODE
USERS GUIDE SUPPLEMENT
2 | SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode
SEVEN PLUS Users Guide Supplement | 3
WARNING:
•
The SEVEN PLUS when set to “Blinded Mode” using the Data Manager
Software will not provide real-time continuous glucose readings, trend
graphs, low or high glucose alerts or the Low ALARM (55 mg/dL).
•
Review all contraindications, warnings, precautions and detailed
instructions in the complete SEVEN PLUS System User’s Guide prior to
using the System.
NOTE:
•
Three dashed lines (---) will appear in the upper right corner
(“Status Box”) while in blinded mode.
•
You will always need to refer to your blood glucose meter for any
treatment-related decisions.
BEFORE YOU START
1. Wash your hands thoroughly.
2. Findaatareaonyourabdomen(belly)withnoscarringorrough
patches of skin, and clean that area with an isopropyl alcohol swab.
Allow the area to dry completely.
•
Make sure your Receiver is fully charged and that your Transmitter is
talkingwithyourReceiver.Checkthisrst:
•
Look for the Antenna Symbol, , in the lower right corner of the
Receiver Screen. This symbol means they are talking.
user
’
s guide
SUPPLEMENT
SEVEN
Sensor and Applicator
SEVEN PLUS
Receiver
SEVEN PLUS
Transmitter
BLINDED MODE
4 | SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode
SEVEN PLUS Users Guide Supplement | 5
STARTING A SENSOR SESSION
Step 1: Inserting a New Sensor
These instructions describe how to insert the Sensor into your abdomen,
or belly. Please refer to the pictures and complete User’s Guide for further
help. The Sensor must only be placed on your belly.
a. After you have cleaned your skin, then
remove the adhesive backing from the
Sensor Pod. Hold the Sensor by the
plastic Applicator and try not to touch
the sticky adhesive patch.
b. Place the Sensor on the area. You can place
theSensoratfacingtotheleftorrightof
your belly button. Make sure the Sensor is
placed in the same direction shown in the
picture to the right. You should not place the
Sensor pointing in the up or down direction.
c.AfterplacingtheApplicator,pressrmlyonandaroundtheoutsideof
theadhesivepatchtomakesureitisat.
d. Hold on to the Applicator. Then pull the Safety Lock/Transmitter Key
straight out away from the Applicator, in the direction the arrows
show below.
The Safety Lock
also serves as the
“Transmitter Key.”
Keep this piece to
help you remove the
Transmitter at the end
of your Continuous
Glucose Monitoring
(CGM) session.
Hold down the Pod with one hand. With your other hand, place two
ngersabove the collar on the barrel of the Applicator. Place your thumb
on the plunger. Push the plunger down completely. This action inserts the
needle and Sensor Probe under your skin. When you are pushing down
on the plunger, do not pull back on the collar.
e. To remove the needle, keep holding the
Sensor Pod with one hand. With your other
hand,placetwongersunder the collar. Then
pull the collar back towards your thumb. Stop
when you hear 2 “clicks” or cannot pull back
any more. This step pulls the needle back into
the Applicator and keeps the Sensor Probe
under your skin.
f. Squeeze the ribbed release tabs on the sides
of the Sensor Pod to remove the Applicator.
When you squeeze the front release tabs, the
back tabs will widen, allowing you to pull off
the Applicator. After this step, only the Sensor
Pod will be left on your body. Make sure the
Transmitter Latch is down (against your body)
to remove the Applicator.
h. The used Applicator can be thrown in the trash.
To start your CGM session, you must snap your Transmitter in the Sensor
Pod and tell the Receiver of a new Sensor insertion.
“CLICK”
“ 2 CLICKS”
6 | SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode
SEVEN PLUS Users Guide Supplement | 7
Step 2: Attach Transmitter
a. Clean and dry the bottom of the Transmitter with a damp cloth or
alcohol wipe before every use.
b. Place the Transmitter into the Sensor Pod
withtheatsidefacingdown.
c. Pull the Transmitter Latch over the
Transmitter to snap it into place. The
TransmittershouldlieatintheSensor
Pod. You should hear 2 “clicks.”
d. Remove the Transmitter Latch by holding
the end of the latch and quickly twisting off
the latch away from the body.
e. Press any button on the Receiver to check
for the Antenna Symbol
at the lower right
corner of the Receiver. If the Antenna
Symbol does not appear refer to your
complete User’s Guide.
Step 3: Starting a New Session
a. Press any button to turn on the Receiver.
b. Press the OK button to reach the
Menu Screens.
c. Use the Up p and Down q Arrows to
scroll until you highlight “Start Sensor.”
d. Press the OKbuttontoconrmthestartofa
new Sensor, and you will see this screen to
theright:
e. Your Receiver will return to the 3-Hour Trend
Graph. The 2-hour Start-Up period has begun.
The Status Box will display a partially shaded
gray box that will count down during the 2-hour
Start-Up period, and the Trend Screen will
stay blank.
f. Theblank(notgray)TrendScreenconrmsyou
are in Blinded Mode and in the Start-up Period.
Step 4: Start-Up Calibration
Two hours after you start the Sensor, your
Receiver will tell you that you need to calibrate
your Sensor. The Receiver will show you the
screen to the right. The Receiver will also vibrate
and beep to notify you, but this depends on your
“Other Alert” Settings. Press the C Button to clear the prompt. A Blood
DropSymbolwillappearintheStatusBox.Take2ngerstickreadings.
8 | SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode
SEVEN PLUS Users Guide Supplement | 9
OPENCHOICE CALIBRATION
a. Press the OK button to reach the Menu screens.
b. Use the Up p and Down q Arrows to scroll
until you highlight “Enter BG.”
c. Press the OK button to select this option. You
will see a number in mg/dL units.
NOTE: The default setting is 120 mg/dL.
d.Toenterthengerstickreadingtakenfromyour
meter, press the Up p and Down q Arrows until
you arrive at the correct reading. Enter a reading
between 40-400 mg/dL taken within the past
5 minutes. Press the OK button to enter
the reading.
i) Press the OKbuttonagaintoconrmthereadingiscorrect.
ii)Ifthengerstickreadingdisplayedisincorrect,presstheC button
and enter in the correct reading for calibration.
iii) If you do not press any button, the Receiver will “time out” and no
ngerstickreadinginformationwillbeentered.
e. The Glucose Readings
Processing screen will
appear, followed by the
Results Added screen.
f. For Start-Up Calibration, repeat these steps for the second
ngerstickreading.
g. Your continuous glucose readings will be updated every 5 minutes, but
you will not see them displayed in the Status Box.
NOTE: OpenChoice calibration BG readings must be entered into the
Receiver within 5 minutes of being taken. If greater than 5 minutes has
passed,takenewngerstickreadings.
AUTO UPLOAD CALIBRATION
a. Make sure the OneTouch Ultra Meter display is off (blank screen)
before connecting. To turn the display off, press the “M” button once.
b. UsetheConnectionCabletorstplugthecableintotheconnection
port at the bottom of the OneTouch Ultra Meter.
c. Then connect the wide end of the cable into the Receiver. Make sure
the raised “Push” button on the cable is facing down. After a few
seconds “PC” will appear on the OneTouch screen.
d. ThreeReceiverscreenswillappearinthisorder:ConnectionScreeng
Processing Screen g Results Screen
e. Once you see the Results Screen, then press the Push button on the
Connection Cable to disconnect the cable from the OneTouch Ultra
Meter and the Receiver (the order that you disconnect the cable does
not matter).
10 | SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode
SEVEN PLUS Users Guide Supplement | 11
CGM BLINDED MODE
Once calibrated, the SEVEN PLUS will record
readings but will not display glucose readings,
trend graphs, glucose Alerts or ALARM.
Glucose readings can be viewed later on the
Data Manager
®
2 Software.
CALIBR AT ION U PDATE
You must update the Seven System calibration every 12 hours. The
Receiver will remind you to do this by displaying the following screen if you
haven’t recently calibrated.
When the Single Blood Drop Prompt appears, clear
theprompt,takeangerstickusingyourmeter,and
enter the meter reading into the Receiver.
After you enter a BG reading for calibration the
Receiver may prompt you again by displaying the Single Blood Drop
Prompt Screen (with vibrate/beep, depending on your settings). This
means the last BG reading could not be used for calibration. You will
needtoenteronemorengersticktorecalibrate.
CALIBRATION ALERT SCREENS
Duringcalibrationyoumayseethefollowingscreens:
1. New Meter Screen (Auto Upload Only):
Indicates you have connected a new One Touch
Ultra meter to the Receiver. This meter has a
different serial number from the meter that was
last connected to the Receiver. Press the
OK button.
If you receive this screen during Auto Upload calibration, your will have
tore-takeanyngersticksneededforcalibrationandthenconnectthe2
devices again for Calibration Update.
2. Connection Failure (Auto Upload Only):
Indicates the OneTouch meter and the Receiver
are not connected properly. If you see this screen
the meter readings will not be transferred
successfully. Clear the alert by pressing any
button, and disconnect the Connection Cable
from the Receiver. Make sure the meter is off, then reconnect the Cable
totheReceiver(thecablemustbepluggedintothemeterrst,asin
Auto Upload Calibration).
3. Double Blood Drop Prompt:
Appears about 2 hours after you insert a new
Sensor and tells you that you need to take 2
ngerstickreadingsonyourmeter.Clearthe
prompt by pressing any button on the Receiver,
andenter2morengersticksasprompted.
4. Shaded-Out Blood Drop Prompt:
Thistellsyouthatonly1ngerstickreadinghas
been successfully entered. You need to take and
enteratleast1morengerstickforcalibration.
Clear the prompt by pressing any button, and
enter1morengerstickasprompted.
GLUCOSE RECORD GAPS
(see MISSING GLUCOSE READINGS in the User’s Guide)
If the System does not display “---“in the Status Box it is not recording
glucosereadings.Thismaybeforthefollowingreasons:
1. Awaiting Fingerstick Reading/Blood Drop
in Status Box:
Indicates that you need at least 1 more
ngersticktocalibrate.Thissymbolwillappear
when it is time for the Start-Up Calibration or
Re-Calibration.
12 | SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode
SEVEN PLUS Users Guide Supplement | 13
2. Unknown Sensor Glucose Readings/???
In Status Box:
Sometimes the SEVEN PLUS may tell you
it cannot provide a glucose reading. Check
the placement of your Sensor to make sure
it is sticking well to your skin, and nothing is
rubbing on the Sensor. The system will display “---“when it is recording
glucose readings again.
3. Out of Range/Antenna in Status Box:
When you see the Out of Range Symbol
in the Status Box instead of a glucose
reading, this means the Receiver has
“missed” the last glucose reading sent by
the Transmitter. Move the Receiver closer to
make sure the Receiver and Transmitter are within 5 feet of each other.
If you have moved the Receiver closer and waited 5-10 minutes, the Out
of Range Symbol in the Status box should go away. The Antenna Symbol
should reappear in the lower right corner. If you are still having trouble,
contact DexCom Technical Support at 1-888-SEVENGO (738-3646).
4. Sensor Error 0/“Err0” in Status Box:
This screen means your Sensor cannot
calibrate. Enter at least 1 more calibration
ngerstickreadinginthenext10-15
minutes. If “Err0” remains in the Status Box
afteryouenter2morengersticksintothe
Receiver, you may need to replace
the Sensor.
5. Sensor Error 1/“Err1” in Status Box:
This screen tells you that the Sensor is not
calibrating correctly. If you see this screen,
wait approximately one hour. Then you may
enteratleast1morecalibrationngerstick
reading. If “Err1” remains in the Status Box
afteryouenter2morengersticksintheReceiver,youmayneedto
replace the Sensor.
ADDITIONAL ALERTS AND FEATURES
Alerts
Even though High and Low Glucose Alerts and the Low Glucose
ALARM (55mg/dL) are disabled in blinded mode, “Other Alerts” will
remain active (e.g. battery, calibration update, out of range).
Event Markers
You will still be able to enter event information (insulin, carbs, exercise,
health, etc.) while in Blinded Mode.
Please refer to your complete SEVEN PLUS User’s Guide for
information on how to use and set these additional Alerts and use
these features.
SENSOR EXPIRATION NOTIFICATION
The Receiver displays screens that notify you how long you have until
theendofyourCGMSession.Youwillbenotiedat6hours,2hours,
30 minutes, and at the end of your session.
Once the session completely counts down, press
the C button to clear the prompt, and remove the
Sensor. Glucose readings will stop recording and
the Status Box will be completely gray.
14 | SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode
SEVEN PLUS Users Guide Supplement | 15
MANUALLY ENDING A SESSION
To intentionallyendaSevenSensorsessionearly:
1. Select the “Stop Sensor” Menu.
2. Press the OK button to indicate that you want
to stop the Sensor.
3. Press the OK button again to Stop the
Sensor, or press the C button if you do not
want to stop.
4. Your Receiver will no longer record glucose readings and you can
remove your Sensor. A gray box will appear in the Status Box.
EARLY SENSOR SHUTOFF
You may see the Failed Sensor Screen during
your continuous glucose monitoring session.
If the screen to the right appears, the
TransmitterhasnotiedtheReceiverthatthe
Sensor is no longer working. A gray box will
appear in the Status Box.
Remove the Sensor and insert a new one. The Failed Sensor Screen can
appear during the Start-Up period or at any time after calibration.
ERROR CODE
The Error Code indicates the Receiver is not
working properly.
Note the Error Code displayed, and
contact DexCom Technical Support
at 1-888-SEVENGO (738-3646).
REMOVING THE SENSOR/ TRANSMITTER
Remove the Sensor Pod by gently peeling up the adhesive patch from the
skin and pulling out the Sensor Probe. Make sure the Transmitter is still
inside the Sensor Pod.
Once the Sensor is off your body, you will need to remove the Transmitter
from the Sensor Pod. Follow either of the two methods below to remove
the Transmitter.
Method 1 requires you to use the Safety Lock/Transmitter Key once
removed from the Applicator. Method 2 allows you to remove the
Transmitterwithyourngers.AfteryouremovetheTransmitter,storeitin
a cool, dry place until your next glucose monitoring session.
Method 1:
1. PlacetheSensorPodonaatsurface.
Hold the rounded edge of the Transmitter
Key. Make sure the jagged edge of the
Transmitter Key is facing down away from
theremovalarrowasshowntotheright:
16 | SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode
SEVEN PLUS Users Guide Supplement | 17
2. Insert the jagged edges so
that they “hug” the Transmit-
ter wings in the Sensor Pod.
Press the Transmitter Key
down until you cannot press
down anymore, and the
Transmitter wings will “pop”
out of the Sensor Pod.
Method 2:
Useyourpointerngeroneachhandandspreadoutthetabs
on the back end of the Sensor Pod (the end closest to the
Transmitter wings), and the Transmitter wings will “pop”
out of the Sensor Pod.
UPLOADING RECEIVER READINGS
AFTER YOUR SESSION ENDS
Use the Data Manager
®
Software to upload Receiver readings to your
personal computer. The Data Manager Software displays the glucose
readings and calibration blood glucose readings to help analyze trends
and patterns in glucose levels.
The Data Manager Software can also be used to blind and unblind
the Receiver.
Transmitter Key
(from Applicator)
Sensor
Pad with
Transmitter
snapped in
user’s guide
SUPPLEMENT
BLINDED MODE
20 | SEVEN PLUS Continuous Glucose Monitoring System Blinded Mode
LBL 010116 Rev 02 MT 20485 Rev 01
DexCom, Inc. | 6340 Sequence Drive | San Diego, CA 92121 USA
Technical Support 1-888-SEVENGO (738-3646) | www.DexCom.com
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