Dexcom SEVEN PLUS User Manual Supplement

Brand: Dexcom

Model: SEVEN PLUS

Type: User Manual Supplement

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

Dexcom SEVEN PLUS User Manual Supplement

Dexcom SEVEN PLUS User Manual Supplement

Dexcom SEVEN PLUS User Manual Supplement

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