Dexcom G4 Platinum User manual

Dexcom G4 PLATINUM
Sensor and Transmitter
Quick Start Guide
Part of the Animas®Vibe™System
1Get to Know Your Animas®Vibe™System
2Set up Transmitter ID
3Set Alert Sounds & Levels
4Insert Sensor & Place Transmitter
5Start Sensor Session
6Calibrate
7CGM Trend & Data Screens
8End Sensor Session
!Sensor Troubleshooting ?Frequently Asked QuestionsHelpful Hints
Making the Animas®Vibe™System
part of your life
The Dexcom G4 PLATINUM Sensor and Transmitter are not a
replacement for your traditional blood glucose (BG) meter. When
you use the Dexcom G4 PLATINUM Sensor and Transmitter, you
will see real-time continuous glucose readings on your Animas®
Vibe™Insulin Pump display every 5 minutes, for up to 7 days. These
readings will help you detect trends and patterns in your glucose
levels. This way, you can see where your glucose levels have been,
which direction they are headed, and how fast they may be rising
or falling.
This Quick Start Guide will help you set up the CGM part of your
Animas®Vibe™System. Before you begin or anytime you have
questions, review the Animas®Vibe™Owner’s Booklet. You may
also contact Customer Support.
NOTE: The CGM is optional with your Animas®Vibe™Insulin Pump and is sold separately.
Review all Contraindications, Warnings, Precautions, and detailed procedures
in the Animas®Vibe™Owner’s Booklet before using the Dexcom G4 PLATINUM
Sensor and Transmitter.
You must take a fingerstick test (blood glucose test using a blood sample from
your fingertip) with your BG meter and use that BG value to make any insulin
or treatment decisions. Insulin dosing decisions should not be based solely on
results from the Dexcom G4 PLATINUM Sensor and Transmitter.
What can the CGM do for me?
The CGM gives you a continuous picture of your glucose levels to help you detect trends and
patterns in your glucose levels. Trends let you see where your glucose levels have been, which
direction they are headed, and how fast they may be rising or falling.
Does the CGM replace my traditional BG meter?
No, it is meant to be used IN ADDITION TO your BG meter. When you use the CGM, you need to
take two fingerstick tests with your BG meter to start/calibrate your Sensor session. You will
also need to take at least 1 fingerstick test every 12 hours.
Should I make treatment decisions based on the results from my Animas®Vibe™System?
You must take a fingerstick test with your BG meter and use that BG value to make any insulin
or treatment decisions. Insulin dosing decisions should not be based solely on results from
the CGM readings.
Is it okay if my CGM readings and fingerstick BG readings do not match exactly?
Yes. This is normal.
Is my Transmitter reusable?
Yes. DO NOT THROW AWAY YOUR TRANSMITTER. Your Transmitter is reusable.
How close do my pump and Transmitter have to be?
They need to be within 12 feet of each other at all times, including the Startup period and
while you are sleeping.
If I confirm a CGM Alert/Alarm, does my insulin delivery continue?
Yes.
Do my CGM alerts and alarms get progressively louder if I do not confirm them the first time
they sound?
No. The sound for the CGM alerts and alarms does not get progressively louder over time.
What is the warranty for my Animas®Vibe™System?
The warranty for your pump is 4 years. The warranty for your Transmitter is 6 months.
What do I do if I see instead of a glucose value?
Unknown CGM glucose readings ( on the CGM Data and Trend screens) are periods
of time when the System does not understand the CGM glucose readings. This is usually
temporary. Your CGM will normally correct itself, after which you will see CGM glucose
readings again.
When I prime the pump, change the insulin cartridge, or when there is an occlusion alarm, do
my CGM readings continue to be received and displayed on the pump?
Yes – CGM readings will continue to be received and displayed during these pump functions.
When I put my pump in Suspend mode, do my CGM readings continue to be received and
displayed on the pump?
No – You will not receive CGM readings when your pump is in Suspend mode.
What do I do if I have questions?
Contact Customer Support.
Is the Animas®Vibe™System water resistant?
Yes. Your pump is water resistant up to 12 feet for 24 hours. Your Sensor and Transmitter are
water resistant up to 8 feet for 24 hours.
High/Low Glucose Alerts
• With High/Low Glucose Alerts, insulin delivery
continues.
• If Alerts are not conrmed by pressing ,
the Alert will repeat every 3 minutes.
• You can enable/disable and set Alert sounds based
on your health care professional recommendations
or your personal preferences.
Low Glucose Alarm
• The CGM has an automatic Low Glucose Alarm set at 55 mg/dL. You
cannot disable this Alarm, or change the Alarm level or its re-alert
settings. If this Alarm occurs:
• Press to confirm.
• You will be notied again in 30 minutes if your glucose reading is still
at or below 55 mg/dL.
NOTE: In a pediatric clinical study, a significant number of low glucose events were not detected
by CGM. Also in the pediatric study, larger differences were observed between CGM readings
and actual blood glucose values, compared to those differences observed in the adult clinical
study. Whenever you set your Low Glucose Limit, and whenever your current CGM reading falls
below that limit and/or 55 mg/dL, a series of pump CGM Warning screens will be displayed to
make you aware of these differences. Refer to the Owner’s Booklet for complete information.
Calibration - What to do
• Wash hands before each calibration.
• Use same BG meter for all calibrations.
• Quality-check BG meter to make sure your BG meter is giving accurate values for calibration.
• Entering the correct ngerstick BG value is critical to obtaining accurate Sensor readings.
Use proper technique when performing a fingerstick test.
• Calibrate at any time as long as you see a CGM glucose reading or BG symbol ( ) on the
CGM Data or Trend screen.
• Calibrate a minimum of once every 12 hours.
• Calibrate whenever your glucose levels are rising or falling1.
Calibration - What NOT to do
• DO NOT calibrate when you see the or symbol on the CGM Trend or Data screen.
• DO NOT calibrate if your BG is higher than 400 mg/dL or lower than 40 mg/dL.
• DO NOT use sampling sites other than your ngertips to get BG values for calibration.
CGM History
• From the CGM Menu, you can access and review a history of CGM sessions, BG calibrations
and CGM Warnings.
12:34 PM
IOB 5.54U
BG
CGM Warning
Confirm
Enter BG
Symbol on CGM Data/Trend screens
Calibration needed.
• Perform calibration.
CGM Warning
Confirm
CGM Sensor
Error 0,
Insulin
Delivery
Continues
Sensor
Sensor cannot calibrate.
• Press . will appear on CGM Data/Trend screens.
• Wait 15 minutes and then enter 1 ngerstick BG value.
• If error continues, add additional ngerstick BG value.
• If no CGM glucose readings appear, Sensor should be replaced.
CGM Warning
Confirm
CGM Sensor
Error 1,
Insulin
Delivery
Continues
Sensor
Sensor is not calibrating correctly.
• Press . will appear on CGM Data/Trend screens.
• Wait 1 hour, and then enter 1 ngerstick value.
• If no CGM glucose readings appear after 10 minutes, Sensor should be
replaced.
CGM Warning
Confirm
Replace CGM
Transmitter
Low Battery
Transmitter Low Battery
Transmitter battery is low. Transmitter will continue to work but with
possible data gaps.
• Press . Replace Transmitter.
CGM Warning
Confirm
CGM Failure,
Insulin
Delivery
Continues,
Call Service
XXX-XXXXXXXX
XXXXXXXXXX
CGM Data Failure
Pump and CGM are having a communication problem.
• Press and contact Customer Support.
12:34 PM
IOB 5.54U
???
3:06 A
1hr
400
50
200
250
300
350
150
100
???
Symbol (Unknown CGM glucose readings) on CGM Data/Trend
screens
usually resolves itself within several minutes, but may take up to
several hours.
• DO NOT calibrate.
• Make sure Sensor Pod is sticking well to your body and nothing is
rubbing against it.
• Check that Transmitter is snapped in on both sides.
• When you see a glucose reading or symbol on the CGM Data or
Trend screen, enter fingerstick BG value for calibration.
CGM Warning
Confirm
CGM Sensor
Failure,
Insulin
Delivery
Continues
Sensor Failed
Sensor has shut off before end of 7-day session.
• Press . The Status Box on the CGM Data or Trend screen will be
shaded completely gray.
• Contact Customer Support.
• Remove failed Sensor and insert new Sensor.
12:34 PM
IOB 5.54U
ANT
CGM Warning
Confirm
Transmitter
Out of
Range
Out of Range Warning/ symbol on CGM Data/Trend screens
Pump and CGM are not communicating or are outside of RF range.
• Make sure the pump is within 12 feet of the Transmitter/Sensor Pod.
• Wait 10 minutes. If no glucose reading appears, contact Customer
Support.
CGM Warning
Confirm
Glucose
Level is
Above High
User Limit
CGM Warning
Confirm
Glucose
Level is
Below Low
User Limit
CGM Warning
Confirm
Glucose
Level is
Below
55 mg/dL
High (Glucose) Alert Low (Glucose) Alert
CGM History
CGM Menu
Session Start
Last BG Cal.
Warnings
CGM Session
CGM History
Record 1
Dec 17, 2010
12:17PM
Elapsed:
0d, 4hr, 11m
Remaining:
6d, 19h, 49m
CGM BG Cal
CGM History
BG 103
mg/dL
Record 1
Dec 17, 2010
02:52PM
CGM Warnings
CGM History
Record 1
Dec 17, 2010
12:17 PM
206-00000000
0000000000
Tr ansmitter
Out of Range
References
1. Kamath A, Mahalingam A, Brauker J. Analysis of time lags and other sources of error of the
Dexcom SEVEN continuous glucose monitor. Diabetes Technol Ther. 2009;11(11):689-695.
mImportant information
mWarnings
• DO NOT use glucose readings from the G4 PLATINUM Sensor and Transmitter to make
treatment decisions, such as how much insulin you should take. The Sensor and Transmitter
do not replace a BG meter and BG values may differ from Sensor glucose readings. Using
glucose readings from the Sensor and Transmitter to make treatment decisions can result in
serious injury or death.
• Your Animas®Vibe™System will not automatically make insulin adjustments based on the
CGM readings.
• You should calibrate the CGM at least once every 12 hours.
CONTRAINDICATIONS
• Remove the Dexcom G4 PLATINUM Sensor and Transmitter prior to Magnetic Resonance
Imaging (MRI), Computed Tomography (CT) Scan, or diathermy treatment. The Dexcom
G4 PLATINUM Sensor and Transmitter have not been tested during MRI or CT Scans or
with diathermy treatment. The magnetic fields and heat could damage the Sensor and
Transmitter so that they might not record or transmit Sensor glucose readings or provide
alerts, and you might miss a low or high blood glucose value.
• Taking medications containing acetaminophen while wearing the Sensor may falsely raise your
Sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen
active in your body and may be different for each person.
This product is covered by one, or more, U.S. patents including 6,656,148. Other patents
pending. Animas®and Vibe™are trademarks of Animas Corporation. Dexcom, Dexcom
G4 PLATINUM, and The Glucose Sensor Company are either registered trademarks or
trademarks of Dexcom, Inc. in the United States and/or other countries. All other trademarks
and copyrights are property of their respective owners.
© 2015 Animas Corporation. All rights reserved.
P/N: 41031200 Rev. A 08/2015
Customer Support is available
24 hours a day, 7 days a week.
U.S. and Puerto Rico:
1 877 YES-PUMP (937-7867)
Visit us at www.Animas.com.
200 Lawrence Drive
West Chester, PA 19380 USA
Compatible with
Consult Owner’s Booklet
Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
41031200 RevA_QSG_Vibe_USen_Peds_R3.indd 1 8/7/15 2:34 PM

To Start the Sensor Session
a. From the CGM Menu screen, scroll down to highlight Start/Stop.
Press .
b. START will be highlighted. Press . Confirm CGM Warning by pressing .
c. 2-hour Startup period will begin. Check your pump approximately 10 minutes after starting
your Sensor session to make sure your pump and Transmitter are talking ( symbol
should NOT appear on the CGM Trend screen).
d. To show progression of the Startup period, a
shaded box will appear on CGM Trend screens
and gradually diminish over the 2 hours. No
CGM data is displayed during the Startup period.
At the end of the 2-hour Startup period, calibrate your CGM by taking 2 fingerstick tests with
your BG meter. BG values must be taken within 5 minutes of each other and then immediately
entered in your pump. You will also need to calibrate daily with 1 fingerstick BG value at least
once every 12 hours. Calibration values can be entered sooner or more often than every 12
hours if desired.
To Calibrate
a. After the 2-hour Startup, you will be prompted to enter 2 separate
fingerstick BG values in your pump. Press to confirm Warning.
b. Wash hands and perform fingerstick test with your BG meter.
c. From CGM Menu, BG Cal. will be highlighted.
Press .
NOTE: 120 mg/dL is the default value that appears
the first time you calibrate. Enter your actual
fingerstick BG value for calibration.
d. Use the /buttons to enter the BG value.
Press .
e. CANCEL will be highlighted. Use the /buttons to scroll to CALIBRATE and press .
f. Repeat above instructions to enter second fingerstick value.
g. A minimum of 2 calibrations are needed each day. Every 12 hours
you will be prompted to enter 1 ngerstick BG value. Follow the above
instructions for entering a BG value.
1Get to Know Your Animas®Vibe™
System
Your Animas®Vibe™System is comprised of:
• The Animas®Vibe™Insulin Pump
• The Dexcom G4 PLATINUM Transmitter
• The Dexcom G4 PLATINUM Sensor and Applicator
You can set your pump to notify you when your CGM readings become too high or low (High/
Low Alerts), or are rising or falling too quickly (Rise Rate/Fall Rate Alerts). You can also set
your pump to let you know when your Transmitter is not within RF range of your pump (Out
of Range Alert). Alerts can be enabled/disabled and set to default or customized levels.
Customized levels should be based on your health care professional’s recommendations and
your personal preferences. Some Alerts (High/Low and Out of Range Alerts) also let you set a
“snooze” period to re-alert you after a desired amount of time.
To Set Alert Sounds
a. From the CGM Setup screen, Sounds will be
highlighted. Press .
b. Highlight any Alert type. Press to activate
“Edit Mode”. Use the /buttons to set the
desired sound for the Alert (High - Medium - Low
- Vibrate options). Press .
c. Scroll down to CGM Setup. Press to return to CGM Setup screen.
To Set Alert Levels
a. From the CGM Setup screen highlight any Alert type. Press .
b. Press to activate “Edit Mode”.
CGM Trend Screens
The CGM Trend screens provide a complete picture of your glucose status. CGM Trend screens
include a graphical display of your CGM readings over a 1-3-6-12-24 hour time period, based
on your preferred screen view. CGM Trend screens also provide information to assess the
speed and direction of your glucose levels.
The CGM Data screen provides a snapshot of your current glucose status.
Access CGM Trend and Data Screens
a. From the CGM Menu screen, press to highlight Trend Graph. Press .
b. Use the /buttons to scroll through the Trend screens and then the Data screens. Press
to return to the CGM Menu screen.
c. When the pump is in sleep mode, you can access CGM Trend screens directly by pressing
the Contrast/CGM Shortcut button ( ).
CGM Data Screen
c. Where applicable, set the level and snooze time, and choose to enable/disable the Alert.
The default snooze time is 0 minutes (no snooze) and all Alerts are enabled.
d. Scroll down to CGM Setup. Press to return to CGM Setup screen.
NOTE: If you have problems with your Sensor session, keep your Sensor until you speak with
Customer Support.
From the MAIN MENU:
a. Press to highlight CGM and Press .
b. Press to highlight Setup and press .
Every time you begin using a new Transmitter you need to set the Transmitter ID. This allows
your pump and Sensor to talk to each other. Your unique Transmitter ID number makes this
possible. Be sure to remove the Transmitter from its tray when you are ready to use it. As
soon as you remove it from the tray, it begins to use battery power. Wait 10 minutes for the
Transmitter to turn on and be ready for use.
To Set Transmitter ID
a. From the CGM Setup screen, press to highlight Transmitter and press .
b. Press to highlight the S/N #. The last digit will be highlighted. Use the / buttons to
move to the first digit and press to activate “Edit Mode”. Use the / buttons to enter
the rst digit of your 5-digit ID number (found on underside of Transmitter).
c. Press after each digit is entered and repeat until the last digit is entered.
d. CGM Setup will be highlighted. Press to return to CGM Setup screen.
The Animas®Vibe™Insulin Pump
Dexcom G4 PLATINUM Transmitter
(NOT DISPOSABLE)
Dexcom G4 PLATINUM Sensor
(DISPOSABLE)
Up button
Down button
Display
screen
Audio bolus/ezBolus™button
OK button
Contrast button/CGM shortcut
Safety Lock
Collar
Sensor Pod
Release Tab
Transmitter Latch
Applicator Barrel
(contains small
Needle and Sensor)
Plunger
2Set up Transmitter ID
MAIN MENU
Status
Bolus
CGM
Suspnd/Resum
History
Basal
Setup
Prime/Rewind
Home
MAIN MENU
Status
Bolus
CGM
Suspnd/Resum
History
Basal
Setup
Prime/Rewind
Home
CGM Menu
Main Menu
BG Cal.
Trend Graph
Start/Stop
History
Setup
CGM Setup
CGM Menu
Sounds
High Alert
Low Alert
Rise Rate
Fall Rate
Out of Range
Transmitter
Transmitter
CGM Setup
S/N #00000
Transmitter
CGM Setup
S/N #60000
3Set Alert Sounds & Levels
(optional)
CGM Setup
CGM Menu
Sounds
High Alert
Low Alert
Rise Rate
Fall Rate
Out of Range
Transmitter
CGM Warning
Sounds
CGM Setup
High Alert
Low Alert
Rise Rate
Fall Rate
Range
Other
H
H
H
H
H
H
CGM Setup
CGM Menu
Sounds
High Alert
Low Alert
Rise Rate
Fall Rate
Out of Range
Transmitter
Warn above
120 mg/dL
Snooze time
0minutes
Enable
Yes
High Alert
CGM Setup
High Alert
CGM Setup
Warn above
120 mg/dL
Snooze time
0minutes
Enable
Yes
High Alert
CGM Setup
Warn above
120 mg/dL
Snooze time
0minutes
Enable
Yes
4Insert Sensor & Place Transmitter
Remove Transmitter Latch
Transmitter Latch
5Start Sensor Session
6Calibrate
CGM Menu
Main Menu
BG Cal.
Trend Graph
Start/Stop
History
Setup
BG Calibrate
CALIBRATE
CANCEL
120
mg/dL
CGM Warning
Confirm
Enter 2
Startup BGs
CGM Warning
Confirm
Enter BG
7CGM Trend & Data Screens
Current CGM reading†
Trend Arrow*Current Time
Graph Time Period
High (Glucose)Alert Level
(appears when this Alert is enabled)
Low (Glucose)Alert Level
(appears when this Alert is enabled)
3:06 A
1hr

135
mg/dL
400
50
200
250
300
350
150
100
CGM readings over
the past hour*
Most recent CGM reading
*Trend Arrows (on CGM Data/Trend screens) and CGM readings (on CGM Trend screens) are
color coded. An explanation of the Trend Arrows and the color coding appears below.
†A symbol may appear in place of your current CGM reading on CGM Data/Trend screens. Refer to
the Animas®Vibe™Owner’s Booklet for more information.
8End Sensor Session
The Sensor automatically shuts off after 7 days. Your pump will alert you 6 hours, 2 hours and
30 minutes before this happens. A nal CGM Warning screen will appear when your Sensor
session has ended.
Press to confirm your Sensor session has ended.
You can also stop your Sensor session at any time
by choosing Start/Stop from CGM Menu.
To Remove the Sensor Pod and Transmitter
Loosen adhesive and peel Sensor Pod/Transmitter from body.
Place Sensor Pod/Transmitter on hard surface. Hold the
rounded edge of the Safety Lock. Insert jagged edges of
Safety Lock (from Sensor Applicator) so they “hug” the
wide end of the Transmitter in the Sensor Pod.
Press Safety Lock down until you cannot press anymore and
then pull up. The Transmitter will pop out of the Sensor Pod.
NOTE: If you did not keep the Safety Lock, you can use your
fingers to spread out the back tabs of the Sensor Pod. The
Transmitter will then pop out.
Keep Transmitter for next Sensor session.
Trend Arrows
Trend arrows can be used along with trend graphs to assess which direction your glucose levels
are headed and how rapidly they are changing. You should not dose insulin based on trend
arrow information.
Trend Arrows and CGM glucose readings on CGM Data/Trend screens are color coded.
See explanation below:
 Rapidly rising: Your CGM glucose readings are rising more than 3 mg/dL each
minute.
Rising: Your CGM glucose readings are rising 2–3 mg/dL each minute.
Slowly rising: Your CGM glucose readings are rising 1–2 mg/dL each minute.
Constant: Your CGM glucose readings are steady (not increasing/decreasing
more than 1 mg/dL each minute).
Slowly falling: Your CGM glucose readings are falling 1–2 mg/dL each minute.
Falling: Your CGM glucose readings are falling 2–3 mg/dL each minute.
 Rapidly falling: Your CGM glucose readings are falling more than 3 mg/dL each
minute.
No
arrow(s)
No Rate of Change Information: The CGM cannot always calculate how fast your
CGM glucose readings are rising or falling.
Red arrows or data points mean your most recent CGM reading was at or above the
High (Glucose) Alert limit set in the pump.
Green arrows or data points mean your most recent CGM reading was between the
High and Low (Glucose) Alert limit set in the pump.
Blue arrows or data points mean your most recent CGM reading was at or below
the Low (Glucose) Alert limit set in the pump.
CGM Warning
Confirm
CGM Session
Expires In
06:00
CGM Warning
Confirm
Sensor
Expired,
CGM Session
Ended
CGM Trend ScreenTo Place the Transmitter
a. Clean Transmitter with alcohol wipe. Let dry.
b. Using your thumb and finger, pinch up on your skin at the base of the Sensor Pod. Place
Transmitter in Sensor Pod (at side down, thinner side away from Latch).
c. Use a nger to hold Transmitter in place. With your other hand, move Transmitter Latch
forward until you hear 2 “clicks”.
d. To remove Transmitter Latch, hold sides of Sensor Pod with one hand and Transmitter Latch
with the other. Twist off Latch.
CGM Menu
Main Menu
BG Cal.
Trend Graph
Start/Stop
History
Setup
Start CGM
START
CANCEL
Start CGM
sensor
session
CGM Warning
Confirm
Always use
Fingerstick
BG for
Treatment
Decisions
and CGM
Calibration
12:34 PM
IOB 5.54U
142
mg/dL
Current Time Trend Arrow*
Current CGM reading†
Insulin on Board (Indicated by “IOB”on
the screen)
(amount displayed only if Insulin on Board
feature is activated on the pump)
Before starting this step, you should have a Sensor, Sensor Applicator, the Transmitter, and
alcohol wipes on hand.
To Insert the Sensor
a. Clean the placement site with alcohol. Let dry. The placement site should be on your belly
(or upper buttocks in children and adolescents between the ages of 2 and 17), and out of
the way of waistband or other areas where rubbing can occur. It should be at least 3 inches
away from the insulin pump infusion site.
b. Remove adhesive backing from bottom of Sensor Pod.
c. Place Sensor horizontally, NOT vertically. Press your fingers firmly around adhesive to
secure.
d. Remove Safety Lock by pulling straight out (follow arrows in picture below). Save Safety
Lock.
e. Using your thumb and finger, it may help to pinch up on your skin at base of the Sensor Pod
(use non-dominant hand).
f. With dominant hand, place 2 fingers above collar (see picture below). Put your thumb on
plunger and push down completely. You should hear 2 “clicks”.
g. Using your thumb as a base, place your 2 fingers below the
collar and pull up completely. You should hear 2 “clicks”.
h. Make sure the Transmitter Latch is ush against the skin.
While still holding the Applicator Barrel, use your other
hand to squeeze the ribbed Release Tabs on sides of the
Sensor Pod. Rock the Applicator Barrel forward and lift up
and away from your body.
“2 CLICKS”
“2 CLICKS”
Safety Lock
Sensor Pod
tab wings
Sensor Pod tabs
Sensor Applicator (DISPOSABLE)
41031200 RevA_QSG_Vibe_USen_Peds_R3.indd 2 8/7/15 2:34 PM