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Getting youup to speedQuick 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

• This Quick Reference Guide provides a snapshot of the key features of your Animas® Vibe™ Insulin Pump and Dexcom G4 CGM Sensor and Transmitter (the Animas® Vibe™ System).

• Refer to the Animas® Vibe™ Owner’s Booklet for complete instructions on using your Animas® Vibe™ System.

• Make sure to review all Contraindications, Warnings, Cautions, Precautions and other Safety information regarding your Animas® Vibe™ System.

• You must take a fingerstick test (blood glucose (BG) 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 CGM Sensor and Transmitter.

• If you have questions about your Animas® Vibe™ System or need assistance, contact Animas Canada Customer Care at 1-866-406-4844.

1.CAUTION - Investigational device. Limited by Federal law to investigational use.


Up button

Down button

Display Screen

Audio bolus/ezBolus™ button

Battery CapOK button

Contrast button/CGM shortcut

Animas® Vibe™ Insulin Pump Startup Overview

Pump Startup Steps

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).



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:• Use the / buttons to scroll to the desired selection and then press the

button to select. If the cursor is flashing, it means your pump is in Edit Mode. By scrolling with the / buttons, you can edit the flashing field.

• Once you have finished editing, press to confirm your entry and to exit Edit Mode. If your pump display turns off before you press to confirm your entry, your edit/entry will not be saved.

• Carry an extra battery along with your other supplies.• If the pump is in sleep mode, pressing the Contrast button/CGM shortcut will

awaken the pump to one of the CGM Trend graphs or the CGM Data screen. 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 16.

• Due to variability in battery life, you should change the battery whenever the battery life indicator is shaded less than full. Expect actual battery life to be less than what is shown by the indicator if you access pump features on a regular basis.

2 : 27PM

Status

Basal Rate0.025U/Hr

Insulin: 105UMenu

Time of DayApproximateBattery Life Remaining Indicator

Current Basal Rate Insulin Remaining in Cartridge

Main Menu ShortcutStatus Screens Shortcut



MAIN MENU Screen: Displays all MAIn MEnU options.

• Bolus - 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.

• Suspnd/Resum - Stop all insulin delivery (Suspend), and restart basal insulin delivery (Resume).

• History - Review history of boluses, total daily dose (TDD), alarms, primes, suspend and basal information.

• Basal - Access and program your basal rate.

• Setup - Personalize the settings and features of your pump, and enable advanced features.

• Prime/Rewind - Properly load the cartridge, prime your infusion set tubing, and fill your cannula or needle.

• Status - Display your current/most recent pump settings, and basal/bolus deliveries.

• CGM - 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

BolusCGMSuspnd/ResumHistoryBasalSetupPrime/Rewind

Home

Main Menu Options 4.CAUTION - Investigational device. Limited by Federal law to investigational use.


Pump Setup

SETUP Screen: Lets you change your pump settings.

• Time/Date - Set the current time and date.

• Sound Settings - 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)

• Advanced Features - 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



Bolus Menu

BOlUS MENU Screen: Lets you calculate and deliver an insulin bolus.

• Normal Bolus - Program an insulin dose for immediate delivery.

Advanced Bolus Features

• 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:

• Pump must be primed in order to access the BOlUS MEnU (see page 9 for Prime/Rewind procedure).

• Advanced Bolus features allow access to the ezCarb, ezBG, and Combo Bolus menu options. Advanced Bolus features are activated in the Setup Advanced Menu.

• ezCarb also allows a BG Bolus to be added to an ezCarb Bolus.

• Pump will automatically calculate your bolus dose, based on the I:C ratio, ISF, BG Target range and Insulin on Board (if enabled), entered in the Setup Advanced Menu for the current time stored in the pump.

BOLUS MENU

Main Menu

NormalezCarbezBGCombo BolusReminders



BASAl MENU Screen: 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.

Setting a Basal Program

• 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

TempA1-WEEKDAY 2-other 3-weekend 4-exercise

Temp Basal Feature

• 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:

• If you have activated multiple basal programs in the Setup Advanced menu, all 4 basal program options will be displayed as shown above.

• The minimum basal rate that can be set is 0.025 U/Hr. Any temporary basal rate set below 0.025 U/Hr will automatically be re-set to 0.025 U/Hr. If you want to set a basal rate less than 0.025 U/Hr, you must use the Temp Basal Feature (see below) and set the “Change:” % to OFF for the desired duration.



SUSPEND/RESUME Screens: Lets you temporarily stop or restart insulin delivery

• Suspend - Stop all insulin delivery.

• Resume - Restart basal insulin delivery.

History

Suspend/Resume

HISTORY

Main Menu

BolusTotal Daily Dose (TDD)AlarmPrimeSuspendBasal

PumpDelivery

Suspend

Main Menu

PumpSuspendedat 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.

• Selecting “Resume” will begin displaying CGM data again.• Selecting “Suspend” cancels delivery of any Temp Basal or Bolus, including any

Combo Bolus that may be currently active.

Tips:• In order to navigate through records, scroll up to and

highlight the record field and press to activate Review Mode. Use the / buttons to scroll through records.

• Record 1 indicates the most recent record.

HISTORY Screen: Lets you view important historical data records in your pump.



ezPrime Screen: 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:• A full Prime/Rewind sequence is required each time you change the battery.

• Your pump must be primed in order to access the BOlUS MEnU.

• The Fill Cannula step is not required for your pump to operate. For example, when you prime your pump after a battery change and you are not inserting a new infusion set, this step is not necessary.

ezPrime

Main Menu

RewindLoad CartPrimeFill Cannula

��

• Rewind - Retract the piston to allow a new cartridge to be installed.

• load Cart - Prepare the cartridge and piston to deliver insulin.

• Prime - Remove air from the infusion set by filling it with insulin.

• Fill Cannula - Remove air from the cannula by filling it with insulin.

m WARNING: Never prime the tubing or tighten the cartridge cap while infusion set is connected to your body. Failure to disconnect your infusion set from your body before performing this step can result in over delivery of insulin, and possible injury or death. If your pump sustains internal damage, the amount of unintended insulin delivery could be significant. This could result in serious injury or death from hypoglycemia.



Status

STATUS Screens: Lets you access basal and bolus delivery data, and other information about your pump.

STATUS 1

Home

ACTIVE BASAL

24-Hr Total 13.60U0.675U/Hr

Insulin: 105U

A1-WEEKDAY

Tip:• Highlight the arrows on the bottom right of the display and press to move

through Status screens.

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



• STATUS 5 - Temp Basal

• STATUS 6 - Pump Info

• STATUS 7 - Codes

Dexcom G4 Sensor and Applicator

Dexcom G4 CGM Sensor and Transmitter Overview

CGM Startup Steps

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 (contains small Introducer needle and Sensor)

Safety Lock

Sensor Pod

Plunger

Transmitter Latch

Release Tab

Collar



CGM Menu Screen: Displays all CGM Menu options. To get to the CGM Menu screen, highlight “CGM” on the MAIn MEnU screen and press .

• BG Cal. - Calibrate your CGM readings with a fingerstick BG test result.

• Trend Graph - View the CGM Data and Trend screens.

• Start/Stop - Start a new CGM session or stop the current CGM session.

• History - 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

• Setup - 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 GraphStart/StopHistorySetup

Tip: For the pump to begin receiving CGM data, the pump must first be set up to communicate with the Transmitter. Refer to the Animas® Vibe™ Owner’s Booklet for further instructions.



CGM Setup

CGM Setup Screen: Displays all CGM Setup options.

Sounds - Adjust sounds (beeps/vib) for CGM-related alerts.

High and low Alert - 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.

Rise and Fall Rate - 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.

Out of Range - 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.

Transmitter - Enter the Transmitter ID into the pump to enable communication between your pump and Transmitter.

CGM Setup

CGM Menu

SoundsHigh AlertLow AlertRise RateFall RateOut of RangeTransmitter



• 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: For best communication, keep the pump within 3.6 meters (12 feet) of the Transmitter.

Transmitter ID appears on underside



BG Calibration

BG Calibration Screen: Lets you enter fingerstick BG values for CGM calibration.

When to calibrate• 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

CALIBRATECANCEL

6.7mmol/L

Tips:• 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 Dexcom G4 CGM Sensor and Transmitter.

• A BG value must meet the following criteria to be used for calibration:– The BG test must have been taken within the last 5 minutes.– The value must be within 2.2–22.2 mmol/l.– The value must be from a fingerstick. Do Not use a BG test result from an

alternative sampling site (e.g., palm or forearm) for CGM calibration.– A BG value entered when using the ezCarb and/or ezBG feature on the pump can

also be used for a CGM calibration.



• 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 A1 hr

9.7mmol/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

7.9mmol/L

Current Time

Trend Arrow*

Current CGM reading†

* Trend Arrows (on CGM Data and CGM Trend screens) and CGM data points (readings) on the CGM Trend screen are colour coded. An explanation of the Trend Arrows and the colour coding appears on the next page.

† A symbol may appear in place of your current CGM reading on CGM Data and Trend screens. Refer to the Animas® Vibe™ Owner’s Booklet for more information.

(appears when this Alert is enabled)

(appears when this Alert is enabled)

Most recent CGM reading

16.

Insulin on Board (Indicated by “IOB” on the screen)(amount displayed only if Insulin on Board feature is activated on the pump)

• Press / to scroll through the CGM Data and Trend screens. Press to return to the CGM Menu screen.



CGM Data Screen and Trend Screens

Explanation of CGM Data and Trend Screen colours

Rapidly rising: Your CGM glucose readings are rising more than 0.17 mmol/l each minute.

Rising: Your CGM glucose readings are rising 0.11–0.17 mmol/l each minute.

Slowly rising: Your CGM glucose readings are rising 0.06–0.11 mmol/l each minute.

Constant: Your CGM glucose readings are steady (not increasing/decreasing more than 0.06 mmol/l each minute).

Slowly falling: Your CGM glucose readings are falling 0.06–0.11 mmol/l each minute.

Falling: Your CGM glucose readings are falling 0.11–0.17 mmol/l each minute.

Rapidly falling: Your CGM glucose readings are falling more than 0.17 mmol/l each minute.

No arrow(s)

No Rate of Change Information: The CGM cannot always calculate how fast your glucose is rising or falling.

Explanation of Trend Indicator symbols

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 History Screen: Lets you review historical CGM records in your pump.

• Session Start - Start time and date, elapsed time, and the amount of time remaining in the current session.

• last BG Cal. - Value, date and time of your last fingerstick BG used for CGM calibration.

• Warnings - 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 confirm the prompt at any of the reminder times.

CGM History

CGM Menu

Session StartLast BG Cal.Warnings



19.Accessories

Personalize your pump with skins, pump cases and covers, and re-order pump supplies, such as cartridges, infusion sets and batteries. Contact Animas Canada Customer Care at 1-866-406-4844 to order supplies and accessories, including Sensors and Transmitters.



P/N: 410-285-51 Rev. ARev. date: 09/2013

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® and Vibe™ are trademarks of Animas Corporation. All other trademarks and copyrights are property of their respective owners.

©2013 Animas Corporation. All rights reserved. 410-285-51

Distributed in Canada by:

200 Whitehall DriveMarkham, ON L3R 0T5, Canada

Tel: 1 866 406-4844Fax: 1 866 406-4033Email: [email protected]: www.Animas.ca

Manufactured by:

200 Lawrence DriveWest Chester, PA 19380, USA

Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA

Compatible with



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