Animas vibe User manual

Getting you
up to speed
Quick Reference Guide
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 1 9/17/13 2:14 PM

Important Information
 
®™
®™
 ®™
®™
 
®™

 




®™
AMSL 1300 851 056
1.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 1 9/17/13 2:14 PM

Up button
Down button
Display Screen
Audio bolus/ezBolus™button
Battery Cap
OK button
Contrast button/CGM shortcut
Animas®Vibe™Insulin Pump Startup Overview

1. Insert Battery.
2. Update Time/Date and Battery Type on Verification Screen.
3. Confirm Verification Screen.
4. Proceed to Prime/Rewind Procedure (see Page 9 for Prime/Rewind Procedure).
2.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 2 9/17/13 2:14 PM

Home Screen Overview
Once the pump is set up, the Home screen is the first screen displayed when
you “wake up” your pump (press / or to wake up your pump).
Additional content may appear on the Home Screen if any of the following
features are active: •Extended bolus, •Temp basal or •Suspend.
Tips:
  /

 /
  
 

 
  



 


2 : 27PM
Status
Basal Rate
0.025U/Hr
Insulin: 105U
Menu
Time of Day
Approximate
Battery Life
Remaining Indicator
Current Basal Rate Insulin Remaining
in Cartridge
Main Menu Shortcut
Status Screens Shortcut
3.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 3 9/17/13 2:14 PM


Displays all MAIN MENU options.
• - Takes you to the Normal Bolus screen.
If you have activated Advanced Bolus features,
the Bolus Menu will be displayed. From the Bolus
Menu you can select the bolus type, then program
and deliver the bolus.
• - Stop all insulin delivery
(Suspend), and restart basal insulin delivery
(Resume).
• - Review history of boluses, total daily dose (TDD), alarms, primes,
suspend and basal information.
• - Access and program your basal rate.
• - Personalise the settings and features of your pump, and enable
advanced features.
• - Properly load the cartridge, prime your infusion set tubing,
and fill your cannula or needle.
• - Display your current/most recent pump settings, and basal/bolus
deliveries.
• - Takes you to the CGM Menu screen where you have access to all CGM
functions. CGM functions and data will not be operational on your pump
display unless you are using the Dexcom G4 CGM Sensor and Transmitter
with your pump. See page 12.
MAIN MENU
Status
Bolus
CGM
Suspnd/Resum
History
Basal
Setup
Prime/Rewind
Home
Main Menu Options 4.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 4 9/17/13 2:14 PM

Pump Setup

Lets you change your pump settings.
• - Set the current time and date.
• - Adjust sounds for pump-related
functions.
Pump sounds may be set for: Normal Bolus,
Audio Bolus, Temp Basal, Alerts, Reminders,
Warning, and Alarms
Pump sounds may be set to: Vibrate (Vib),
Low Volume (L), Medium Volume (M),
High Volume (H), or No Sound (OFF)
• - Activate additional features on your pump to help you
manage your diabetes, such as:
– Personal Settings (Insulin to Carb (I:C) Ratios, Insulin Sensitivity Factors
(ISFs), BG Target Ranges)
– Advanced Bolus options and Multiple Basal Programs
– Insulin Delivery Limits
– Insulin on Board Setting
SETUP
Home
Time/Date
Sound
Advanced
5.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 5 9/17/13 2:14 PM

Bolus Menu

Lets you calculate and deliver an insulin bolus.
• - Program an insulin dose for
immediate delivery.

•ezCarb - Calculate and then deliver a suggested
insulin dose to account for carb intake. ezCarb
Boluses can be delivered as a Normal or Combo
Bolus.
•ezBG - Calculate and deliver a suggested insulin dose to cover a high BG.
•Combo Bolus - Program an insulin dose to be delivered over an extended
period of time.
•Reminders - Set reminders to program your bolus, or check your BG at a
certain time after each bolus.
Tips:
 

 


 
 


BOLUS MENU
Main Menu
Normal
ezCarb
ezBG
Combo Bolus
Reminders
6.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 6 9/17/13 2:14 PM


Lets you set up to 4 basal programs, and program
a Temp Basal. An “A” indicates the active basal
program, and total basal insulin programmed for
the 24-hour period will appear on the top.

• Each basal program can be set with up to 12
different basal rates in a 24-hour period.
Basal Menu
BASAL MENU
Main Menu
Total 25.50U
Temp
A1-WEEKDAY
2-other
3-weekend
4-exercise

•Increase your active basal delivery rate for events
such as sick days, or decrease it for events such
as exercise.
–Decrease basal rate by up to 90% (in 10%
decrements) or increase basal rate up to 200% (in
10% increments). Temp Basal also can be set to OFF.
– Duration up to 24 hours in half-hour increments.
A1-WEEKDAY
Main Menu
TEMP BASAL
Go
0%
4.0 Hr
Change:
Duration:
Tips:
 

 


“”
7.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 7 9/17/13 2:14 PM


Lets you temporarily stop or restart
insulin delivery
•Suspend - Stop all insulin delivery.
•Resume - Restart basal insulin
delivery.
History
Suspend/Resume
HISTORY
Main Menu
Bolus
Total Daily
Dose (TDD)
Alarm
Prime
Suspend
Basal
Pump
Delivery
Suspend
Main Menu
Pump
Suspended
at 1:13PM
Oct 2,2010
Resume
Main Menu
Tips:
If you are using the Dexcom G4 CGM Sensor and Transmitter with your
pump, CGM data will not be displayed when the pump is in Suspend mode,
but the CGM session will remain active. If you want to temporarily suspend
insulin delivery but still be able to view CGM readings, set Temp Basal to OFF
for the time you want insulin delivery suspended.
 “”
 “”

Tips:
 
 
 /

 

Lets you view important historical data records in your
pump.
8.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 8 9/17/13 2:14 PM


Lets you properly align the cartridge and piston rod.
Also lets you prime your infusion set tubing and fill
your cannula or needle, before connecting to your
pump.
Prime/Rewind
Tips:
 
 
 


ezPrime
Main Menu
Rewind
Load Cart
Prime
Fill Cannula




• - Retract the piston to allow a new cartridge to be installed.
• - Prepare the cartridge and piston to deliver insulin.
• - Remove air from the infusion set by filling it with insulin.
• - Remove air from the cannula by filling it with insulin.
m 








9.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 9 9/17/13 2:14 PM

Status

Lets you access basal and bolus delivery data, and
other information about your pump.
STATUS 1
Home
ACTIVE BASAL
24-Hr Total
13.60U
0.675U/Hr
Insulin: 105U
A1-WEEKDAY
Tip:
  

There are seven STATUS screens:
•STATUS 1 - Active Basal
•STATUS 2 - Insulin on Board, Last Bolus
•STATUS 3 - Delivery Today
•STATUS 4 - Combo Bolus
•STATUS 5 - Temp Basal
•STATUS 6 - Pump Info
•STATUS 7 - Codes
10.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 10 9/17/13 2:14 PM

•STATUS 5 - Temp Basal
•STATUS 6 - Pump Info
•STATUS 7 - Codes
Dexcom G4 Sensor and Applicator
Dexcom G4 CGM Sensor and Transmitter
Overview

1. Remove Transmitter from tray when you are ready to use it. As soon as you
remove it from the tray, it begins to use battery power.
2. Wait 10 minutes for the Transmitter to turn on and be ready for use.
3. Insert the Sensor and attach the Transmitter.
Dexcom G4 Transmitter
Applicator Barrel


Safety Lock
Sensor Pod
Plunger
Transmitter Latch
Release Tab
Collar
11.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 11 9/17/13 2:14 PM


Displays all CGM Menu options. To get to the CGM
Menu screen, highlight “CGM” on the MAIN MENU
screen and press .
•  - Calibrate your CGM readings with a
fingerstick BG test result.
•  - View the CGM Data and Trend
screens.
•  - Start a new CGM session or stop
the current CGM session.
•  - View important information about your CGM sessions:
– Date, time and value of the last BG calibration entered in your pump
– Date, time, alert code and description of your last 300 CGM alerts
– Start date and time, elapsed time, and time remaining in your current CGM
session
•  - Enter the Transmitter ID into the pump to establish communication.
Set your pump to display and sound (beep/vib) an alert when your CGM
readings are outside your CGM target range, when your CGM readings may be
rising or falling too quickly, when your Transmitter is not within RF range of
your pump, and to alert you to any other CGM warnings.
CGM Main Menu
CGM Menu
Main Menu
BG Cal.
Trend Graph
Start/Stop
History
Setup
Tip:
®™

12.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 12 9/17/13 2:14 PM

CGM Setup

Displays all CGM Setup options.
 - Adjust sounds (beeps/vib) for CGM-
related alerts.
 - Set the levels for the alert that
will display/sound if the current CGM reading falls
at or above/below the level. In addition, you can set
a snooze time for the alert and enable/disable the
alert.
 - Set the rate limits for the alert that will display/sound if your
glucose begins to rise or fall at or faster than the limits. You can also enable/
disable the alert.
 - Set the range limit for the alert that will display/sound if your
pump and Transmitter are no longer in RF range. In addition, you can set the
snooze time and enable/disable this alert.
 - Enter the Transmitter ID into the pump to enable communication
between your pump and Transmitter.
CGM Setup
CGM Menu
Sounds
High Alert
Low Alert
Rise Rate
Fall Rate
Out of Range
Transmitter
13.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 13 9/17/13 2:14 PM

•To enter the Transmitter ID, scroll to “Setup” on
the CGM Menu screen and press . Then select
“Transmitter” from the CGM Setup screen and
press to display the Transmitter screen.
•Communication between the pump and
Transmitter will be activated when you enter the
unique Transmitter ID into the pump. The number
is located on the underside of the Transmitter.
• After the ID number has been entered, scroll
to “CGM Setup” and press to establish the
communication link between the devices.
• Scroll to “Start/Stop” on the CGM Menu screen
and press to begin the 2-hour startup period.
Wait at least 8 seconds for the CGM session to
start before pressing any other buttons on the
pump.
CGM Initial Session Startup
Transmitter
S/N#687AB
CGM Setup
Tip: 

Transmitter ID appears
on underside
14.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 14 9/17/13 2:14 PM

BG Calibration

Lets you enter  for CGM
calibration.

•When the 2-hour CGM startup period ends.
– The pump will prompt you to enter BG values
from two separate fingersticks.
•At least once every 12 hours.
– You may enter a fingerstick BG value at any time,
or the pump will prompt you if you forget.
•If the fingerstick BG value you enter for startup calibration or calibration
update has not been accepted.
– The pump will prompt you to enter a fingerstick BG value, and will repeat the
prompt every 15 minutes until a value is accepted.
BG Calibrate
CALIBRATE
CANCEL
6.7
mmol/L
Tips:
 


 
 
 
 Do Not

 

15.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 15 9/17/13 2:14 PM

The CGM Trend
screen provides a
more detailed view
of your glucose
status and includes
a graphical display
of your CGM readings
over a time period
you select (1, 3, 6,
12, or 24 hours).
CGM Trend Screen
CGM Data Screen
• The CGM Data screen
provides a snapshot
of your current
glucose status.
Current
CGM
reading†
Trend Arrow*Current Time
Graph Time
Period
High (Glucose)
Alert Level
Low (Glucose)
Alert Level
3:06 A
1hr
9.7
mmol/L
22.5
5.0
2.5
12.5
15.0
17.5
20.5
10.0
7.5

CGM
readings
over the
past hour*
12:34 PM
IOB 5.54U
7.9
mmol/L
Current
Time
Trend Arrow*
Current
CGM
reading†
*

†
®™




Most recent
CGM reading
16.
Insulin on Board
(Indicated by
“IOB”on the
screen)




Press / to scroll through the CGM Data
and Trend screens. Press to return to the
CGM Menu screen.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 16 9/17/13 2:14 PM

CGM Data Screen and Trend Screens
Explanation of CGM Data and Trend Screen colours
 Rapidly rising:

Rising:
Slowly rising:
Constant:

Slowly falling:

Falling:
 Rapidly falling:

No
arrow(s)
No Rate of Change Information:

Explanation of Trend Indicator symbols
Red arrows

Green arrows

Blue arrows

17.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 17 9/17/13 2:14 PM


Lets you review historical CGM records in your
pump.
  - Start time and date, elapsed time,
and the amount of time remaining in the current
session.
  - Value, date and time of your last
fingerstick BG used for CGM calibration.
  - Date, time, alert code and description
of your last 300 CGM alerts.
CGM History
Tip: When you are within six hours of the Sensor’s expiration time, the pump will
provide a series of reminders that the CGM session will be ending shortly. Reminder
prompts sound at 6, 2, and ½ hour remaining. Press to conrm the prompt at any
of the reminder times.
CGM History
CGM Menu
Session Start
Last BG Cal.
Warnings
18.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 18 9/17/13 2:14 PM

19.
Accessories
Personalise your pump with skins, pump cases and covers, and re-order
pump supplies, such as cartridges, infusion sets and batteries.
Call the Australian Customer Care Team on 02 9882 3666 or order online
today at www.amsl.com.au.
CAUTION - Investigational device. Limited by Federal law to investigational use.
41028551 RevA_QRG_Unity_CA_EN_mmolL_r1.indd 19 9/17/13 2:14 PM