Animas Vibe Quick Start Manual

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Sensor Troubleshooting
Symbol on CGM Data/Trend screens
12:34 PM
Calibration needed.
BG
• Perform calibration.
IOB 5.54U
CGM Warning
Enter BG
Confirm
CGM Warning
Sensor
CGM Sensor
Sensor cannot calibrate.
Error 0,
• Press . will appear on CGM Data/Trend screens.
Insulin
Delivery
• Wait 15 minutes and then enter 1 fingerstick BG value.
Continues
• If error continues, add additional fingerstick BG value.
Confirm
• If no CGM glucose readings appear, Sensor should be replaced.
CGM Warning Sensor
CGM Sensor
Sensor is not calibrating correctly.
Error 1,
• Press . will appear on CGM Data/Trend screens.
Insulin
Delivery • Wait 1 hour, and then enter 1 fingerstick value.
Continues
• If no CGM glucose readings appear after 10 minutes, Sensor should be
Confirm
replaced.
Transmitter Low Battery
CGM Warning
Transmitter battery is low. Transmitter will continue to work but with
Replace CGM
possible data gaps.
Transmitter
Low Battery • Press . Replace Transmitter.
Confirm
CGM Data Failure
CGM Warning
CGM Failure,
Pump and CGM are having a communication problem.
Insulin
Delivery
• Press and contact AMSL Customer Technical Support.
Continues,
Call Service
XXX-XXXXXXXX
XXXXXXXXXX
Confirm
Symbol (Unknown CGM glucose readings) on CGM Data/Trend
12:34 PM
screens
???
usually resolves itself within several minutes, but may take up to
several hours.
• DO NOT calibrate.
IOB 5.54U
• Make sure Sensor Pod is sticking well to your body and nothing is
rubbing against it.
??? 3:06 A
1 hr
• Check that Transmitter is snapped in on both sides.
22.5
• When you see a glucose reading or symbol on the CGM Data or
20.5
17.5
Trend Screen, enter fingerstick BG value for calibration.
15.0
12.5
10.0
7.5
5.0
2.5
Sensor Failed
CGM Warning
CGM Sensor Sensor has shut off before end of 7-day session.
Failure,
• Press . The Status Box on the CGM Data or Trend screen will be
Insulin
Delivery shaded completely gray.
Continues
• Contact AMSL Customer Technical Support.
Confirm • Remove failed Sensor and insert new Sensor.
Out of Range Warning/ symbol on CGM Data/Trend screens
12:34 PM
Pump and CGM are not communicating or are outside of RF range.
ANT
• Make sure the pump is within 3.6 meters (12 feet) of the Transmitter/
Sensor Pod.
• Wait 20 minutes. If no glucose reading appears, contact AMSL
IOB 5.54U
Customer Technical Support.
CGM Warning
Transmitter
Out of
Range
Confirm
Helpful Hints
High/Low Glucose Alerts
• With High/Low Glucose Alerts, insulin delivery
CGM Warning
continues.
Glucose
• If Alerts are not confirmed by pressing , the Alert
Level is
Above High
will repeat every 3 minutes.
User Limit
• You can enable/disable and set Alert sounds based
Confirm
on your healthcare professional recommendations
High (Glucose) Alert
or your personal preferences.
Low Glucose Alarm
• The CGM has an automatic Low Glucose Alarm set at 3.1 mmol/L. 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 notified again in 30 minutes if your glucose reading is still
at or below 3.1 mmol/L.
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 fingerstick 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 (
CGM Data or Trend Screen.
• Calibrate a minimum of once every 12 hours.
• Calibrate whenever your glucose levels are rising or falling .
1
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 22.2 mmol/L or lower than 2.2 mmol/L.
• DO NOT use sampling sites other than your fingertips 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.
CGM History CGM Session CGM BG Cal CGM Warnings
Record
Record Record
1 1
Dec 17, 2010 Dec 17, 2010 Dec 17, 2010
Session Start
12:17PM 02:52PM
Last BG Cal.
Elapsed: 2 0 6 - 0 0 0 0 0 0 0 0
Warnings 0 0 0 0 0 0 0 0 0 0
0d, 4hr, 11m BG 5.7
Transmitter
Remaining:
mmol/L
Out of Range
6d, 19h, 49m
CGM Menu CGM History CGM History CGM History
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.
m

Important information

Important reminders
• 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.
• 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
• The Dexcom G4 CGM Sensor and Transmitter must be removed prior to Magnetic Resonance
Imaging (MRI), CT Scan, or diathermy treatment. The Dexcom G4 CGM Sensor and
Transmitter have not been tested during MRI or CT Scans or with diathermy treatment, and it
is unknown if there are safety or performance issues.
• Taking acetaminophen containing medications 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.
?
Frequently Asked Questions
What can the CGM do for me?
The CGM gives you a continuous picture of your glucose levels to help you detect trends and
CGM Warning
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.
Glucose
Level is
Does the CGM replace my traditional BG meter?
Below Low
User Limit
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
Confirm
also need to take at least 1 fingerstick test every 12 hours.
Low (Glucose) Alert
Should I make treatment decisions based on the results from my Animas
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.
CGM Warning
Is it okay if my CGM readings and fingerstick BG readings do not match exactly?
Glucose
Level is Yes. This is normal.
Below
3.1 mmol/L
Is my Transmitter reusable?
Confirm
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 3.6 meters (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.
) on the
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.
Is the Animas ® Vibe ™ System water resistant?
Yes. Your pump is waterproof up to 3.6 meters (12 feet) for 24 hours. Your Sensor and
Transmitter are water resistant up to 2.4 meters (8 feet) for 24 hours.
1
12:17 PM
Distributed in Australia by: Manufactured by:
200 Lawrence Drive
2 McCabe Place
West Chester, PA 19380
Chatswood NSW 2067
USA
Tel: 02 9882 3666
Fax: 02 9882 3999
Email: diabetes@amsl.com.au
Web: www.amsl.com.au
For Urgent Customer
Technical Support, call 1300
851 056
Compatible with
Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
This product is covered by one, or more, U.S. patents including 6,656,148 and other
patents pending. Dexcom and Dexcom G4 are either registered trademarks or trademarks
of Dexcom, Inc. in the United States and/or other countries. Animas
trademarks of Animas Corporation. All other trademarks and copyrights are property of
their respective owners.
© 2013 Animas Corporation. All rights reserved.
P/N: 410-286-51 Rev. A 09/2013
Dexcom G4 Continuous Glucose Monitoring
(CGM) Sensor and Transmitter
Quick Start Guide
Part of the Animas
Review all Contraindications, Warnings, Precautions, and detailed procedures in
the Animas ® Vibe ™ Owner's Booklet before using the Dexcom G4 CGM 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
® Vibe ™ System?
or treatment decisions. Insulin dosing decisions should not be based solely on
results from the CGM.
1
Get to Know Your Animas
2
Set up Transmitter ID
3
Set Alert Sounds & Levels
4
Insert Sensor & Place Transmitter
5
Start Sensor Session
6
Calibrate
7
CGM Trend & Data Screens
8
End Sensor Session
Making the Animas
part of your life
The CGM is not a replacement for your traditional blood glucose
(BG) meter. When you use the CGM, you will see real-time
continuous glucose readings on your Animas
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 ®
also contact AMSL Customer Technical Support for assistance.
NOTE: The CGM is optional with your Animas
separately. To order CGM supplies, contact AMSL on 1300 851 056
® and Vibe ™ are
® Vibe ™ System
Vibe System
® ™
Vibe System
® ™
Vibe Insulin Pump
® ™
Vibe ™ Owner's Booklet. You may
® Vibe ™ Insulin Pump and is sold