OmniPod Pod User manual

SIMPLE, NONSTOP INSULIN DELIVERY
DESIGNED SO KIDS CAN BE KIDS
CAREGIVER
GUIDE
INSULIN MANAGEMENT SYSTEM
SINCE2015
KATIE R.

+The Pod .............................................................2
+The PDM (Personal Diabetes Manager)...................................3
+How to check blood glucose and deliver a bolus ...........................4
+How to change the Pod ................................................8
Pod Placement Options ............................................10
Activate a New Pod................................................11
Step 1: Fill the Pod ................................................11
Step 2: Apply the Pod..............................................13
Step 3: Press Start ................................................15
+How to enter a temporary basal rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
+How to suspend insulin delivery ........................................18
+Supplies ...........................................................20
+PDM Personal Settings ...............................................21
GET TO KNOW THE
OMNIPOD®SYSTEM.
This guide is intended to be used in conjunction with the individual’s Diabetes Management
Plan, input from the parents and/or healthcare provider and the Omnipod®Insulin
Management System User Guide. PDM imagery is for illustrative purposes only and should
not be considered suggestions for user settings.
Refer to the Omnipod®System User Guide for complete information on how to use the
System, and for all related warnings and cautions. The User Guide is available online
at www.myomnipod.ca or by calling the Omnipod®Customer Care Program.
Caution: Consult User Guide.
This guide is for PDM model CAT45E. The PDM model number is written on
the back cover of each PDM.
Nathaniel P.
PODDER™SINCE 2014

1
GET TO KNOW THE
OMNIPOD®SYSTEM.
The Omnipod®Insulin Management System provides up to 3 days of nonstop insulin delivery*
so kids with diabetes can run, play, and move, all while staying in control of their insulin.
The system is simply 2 parts—the tubeless Pod and the handheld Personal Diabetes Manager
(PDM) that the user keeps nearby so you can both wirelessly program insulin delivery.
The Pod is waterproof†,lightweight, and discreet, and can be worn anywhere you would give an
injection. Omnipod®helps simplify insulin delivery, so kids can be kids and you can worry less.
That’s just part of what makes people so passionate about the Pod.
Preparing to start on the Omnipod®System.
Whether you’re a school nurse, daycare provider, parent, grandparent, or other secondary
caregiver for an individual using the Omnipod®Insulin Management System, this guide will lead
you through some of the key functions you may need to perform.
Have questions?
We’re here to help with our 24/7 comprehensive customer support.
*Up to 72 hours of insulin delivery
†The Pod has a waterproof IPX8 rating for up to 7.6 meters for 60 minutes.
The PDM is not waterproof.
Omnipod®Customer Care Program: 1.855.POD.INFO (1.855.763.4636)
From outside of Canada: 1.289.247.3534
www.myomnipod.ca
In an emergency you should call the individual’s healthcare provider as well as the parent
or emergency contact.
Healthcare provider name Healthcare provider number
Parent name Parent number
Emergency contact name Emergency contact number
WHAT’S DIFFERENT
ABOUT THE POD? SIMPLE.

2
Viewing window
THE POD
TOP
BOTTOM Fill port
Needle cap
A small, lightweight Pod that’s easy to apply and wear daily.
Pod shown
at actual size
Dimensions
3.9 cm wide
5.2 cm long
1.45 cm high
Weight
25 g without insulin
Adhesive Backing

3
USB port
Soft key labels
Soft keys
Home/power
Color LCD screen
User info/support
Up/down controller
Test strip port
with light
MAIN MENU ITEMS
Bolus: Deliver bolus doses to cover
carbohydrates and/or correct high blood
glucose (BG) levels.
More actions:
+ Change the Pod
+ Add BG readings
+ Assign/Edit BG tags
Temp basal: Adjust insulin delivery for exercise
or illness according to the individual’s Diabetes
Management Plan. This menu item is present
only if the Temp basal option is turned on.
My records: Review insulin delivery, blood
glucose history, alarm history, carbohydrate
history, and personal user information.
Settings:
+ Enter, edit, and name basal programs
+ Program temp basal, carbohydrate,
and bolus presets
+ Customize system settings
Suspend: Temporarily suspend, cancel, or
resume insulin delivery programs
THE PDM
A wireless Personal Diabetes Manager (PDM) that’s simple to use.
PDM shown
at actual size
3

4
HOW TO CHECK BLOOD
GLUCOSE AND DELIVER A BOLUS.
A bolus is an extra dose of insulin that helps manage the rapid natural rise in blood glucose
(also known as blood sugar) that results when you eat carbohydrates (sugar or starch). Follow
the steps below to check the individual’s blood glucose level, determine the appropriate bolus
and deliver the bolus. These steps assume that the suggested bolus calculator has been turned
on as part of the individual’s Diabetes Management Plan.
Because food intake can be unpredictable, consult the individual’s Diabetes Management Plan
or healthcare provider to determine the appropriate timing of insulin delivery.
1. + Insert FreeStyle or FreeStyle Lite test strip into
strip port.
+ Check that the code on the vial of test strips
matches the code on the PDM screen.
+ If the codes do not match, use the Up/down
controller button to match the code on the
PDM to the code on the vial.
Caution: Consult User Guide.
FreeStyle, FreeStyle Lite, CoPilot and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions and used with permission.

5
mmol/L
3:00p 2/11
Done NextTag
Calibration code: 16
8.3
Are you going to eat
now?
Cancel YesNo
3:00p 2/11
+ When blood glucose reading appears,
press Next to continue.
+ If eating now, press Ye s .
OR
+ If not eating, press No.
+ Wash the finger with soap and water or an
alcohol wipe and dry it completely.
+ Prick finger with the lancing device.
+ Press Light to illuminate the test strip in
low-light situations.
+ Apply blood sample to test strip.
2.
3.
4.
HOW TO CHECK BLOOD GLUCOSE AND DELIVER A BOLUS
3:00p 2/11
Light
Calibration code: 16
Apply a blood sample to
the strip.
WARNING: Measurements obtained from alternate site testing should not be used to
calculate insulin doses with Omnipod®Insulin Management System.
For more information about blood glucose testing, control solution testing, manual blood
glucose test entry and the Suggested Bolus Calculator, see Chapter 7, Checking Your
Blood Glucose, in your Omnipod®Insulin Management System User Guide.

Suggested bolus: 5.00U
Carbs: 60g
BG: 150mg/dL
Back Enter
5.00 U
3:00p 2/11
Extend
Suggested bolus: 5.00U
Carbs: 60 g
BG: 8.3 mmol/L
Back EnterExtend
5.00 U
3:00p 2/11
6
Enter carbs.
Back Enter
0g
3:00p
2/11
5.
+ Press the User info/support button to view
how the suggested bolus is calculated. Then
press Close.
7.
+ If eating, press the Up/down controller
button to enter the correct number of carbs,
then press Enter.
Close
Suggested bolus:
Meal: (60/15) = 4.00 U
5.00 U
Correction:
(8.3 - 5.5)/2.8 = 1.00 U
Meal IOB:
(0.00 U) = -0.00 U
Correction IOB:
(0.00 U) = -0.00 U
Total = 5.00 U
HOW TO CHECK BLOOD GLUCOSE AND DELIVER A BOLUS
Suggested bolus: 5.00U
Carbs: 60g
BG: 150mg/dL
Back Enter
5.00 U
3:00p 2/11
Extend
Suggested bolus: 5.00U
Carbs: 60 g
BG: 8.3 mmol/L
Back EnterExtend
5.00 U
3:00p 2/11 + Review the BG and carb values to make sure
they are correct.
6.

7
Suggested bolus: 5.00U
Carbs: 60g
BG: 150mg/dL
Back Enter
5.00 U
3:00p 2/11
Extend
Suggested bolus: 5.00U
Carbs: 60 g
BG: 8.3 mmol/L
Back EnterExtend
5.00 U
3:00p 2/11 + Press Enter to accept the suggested bolus.
OR
+ Press Extend and follow on-screen
instructions to deliver a portion/percentage
of the bolus immediately and the rest over
a set period of time. Only use the Extend
option when required by the individual’s
Diabetes Management Plan.
+ If extended boluses are not part of the
individual’s Diabetes Management Plan, the
Extend option will not appear on the screen.
8.
Start bolus?
Now:
Ext:
(0.0 hr)
Total:
Back Confirm
5.00 U
0.00 U
5.00 U
3:00p 2/11
Cancel
Delivering bolus
5.00 U
3:00p 2/11 + The PDM screen will indicate when bolus delivery
has begun. If necessary, you may press Cancel to
stop a bolus while it is being delivered.
+ The individual does not need to remain near the
PDM during delivery. Delivery time varies based
on the size of the bolus dose.
+ Once bolus delivery begins, you may press and
hold the Home/power button to turn off the
PDM screen.
+ Press Confirm to start the bolus.
9.
10.
HOW TO CHECK BLOOD GLUCOSE AND DELIVER A BOLUS
Patient does not need to stay within the
communication distance of 1.5 meters during
the entire bolus delivery process. As soon as
the delivering bolus screen has shown up, the
PDM can be put away since the bolus has
begun to be delivered.

8
Status Select
3:00p 2/11
Bolus
More actions
Temp basal
My records
Settings
Suspend
HOW TO CHANGE THE POD.
You may need to change the Pod:
+ When the reservoir is low or empty, or the Pod is nearing expiration
+ In response to an alarm
+ If the Pod has become dislodged
+ If the individual has a blood glucose reading of 13.9 mmol/L or more
and has moderate to large ketones
+ If you experience unexpected elevated blood glucose levels
+ As directed by your healthcare provider
+ If a Pod is active and fails to beep
+ Turn on the PDM.
+ Press the Home/power button,
then select More actions.
+ Select Change pod.
2.
1.
Caution: Consult User Guide.

9
3:00p 2/11
Last BG 8.3 mmol/L
2:51p today
Last bolus 1.00U
2:01p today
No active pod.
Would you like to
activate a pod now?
No Yes
+ Press Ye s to activate a new Pod.
+ Follow the steps on pages 11 and 12 to fill
a new Pod with insulin. As you proceed, if
the PDM screen times out, press and hold the
Home/power button to turn it back on.
4.
3:00p 2/11
Press “Confirm” to
begin the pod change
process.
This will deactivate your
current pod.
Back Confirm
3:00p 2/11
Pod deactivated.
Remove and discard the
pod, and then press
“Next.”
Next
+ Press Confirm to deactivate Pod.
+ Gently remove the deactivated Pod by slowly
peeling back the adhesive. (Our users have
reported commercial solvent or baby oil can be
helpful to soften the adhesive if necessary.)
3.
NOTES
HOW TO CHANGE THE POD
If the PDM screen times out during the process, press
and hold the Home/power button to continue.

10
The Pod may be placed over any subcutaneous tissue in most places one would deliver an
insulin injection. Please note the recommended positioning for each body area. The individual’s
Diabetes Management Plan or healthcare provider should indicate any preferred sites.
POD PLACEMENT OPTIONS
SITE SELECTION
Change the site location each time you apply
a new Pod; improper site rotation can reduce
insulin absorption. The new site should be at
least 2.5 cm away from the previous site,
5 cm away from the navel, and not over
a mole or scar.
OPTIMAL ADHESION
Always clean the site thoroughly with an
alcohol swab to remove all body oils and
lotions, which may loosen the Pod’s
adhesive. Let the site air-dry completely;
do not blow on the site to dry it.
POD POSITIONING
Arm and Leg:
Position the Pod vertically or at a slight angle.
Front Back
Abdomen Back
Arm
Buttock
Thigh Leg Arm
Buttock
Leg
Abdomen
Leg
HOW TO CHANGE THE POD
Back, Abdomen, and Buttocks:
Position the Pod horizontally or at a slight angle.
Front Back

11
ACTIVATE A NEW POD
+ Assemble the following supplies:
• Vial of insulin at room temperature (U-100,
rapid-acting). See User Guide for insulins
approved for use with the Omnipod®System.
• One sealed Pod
• PDM
• Alcohol prep swab
+ Wash your hands.
+ Remove the Pod from its sterile packaging.
+ Use the alcohol prep swab to clean the top
of the insulin vial.
+ Assemble the fill syringe by twisting the
needle onto the syringe.
+ Remove the protective cap.
1.1
1. 2
STEP 1: FILL THE POD
CAUTION: Do not use any other type of
needle or filling device besides the syringe
provided with each Pod.
If the PDM screen times out during the process, press
and hold the Home/power button to continue.
HOW TO CHANGE THE POD

12
+ Draw air into the fill syringe equal to the
amount of insulin indicated in the individual’s
Diabetes Management Plan.
+ Depress air into the vial of insulin.
+ Turn the vial and syringe upside down.
+ Withdraw insulin from the vial and fill the
syringe with the amount of insulin indicated in
the individual’s Diabetes Management Plan; fill
at least to the MIN line.
+ Remove any air bubbles from the syringe.
+ Insert the needle straight down into the fill port
on the underside of the Pod. To ensure proper
fill, do not insert fill syringe at an angle into the
fill port.
+ Completely empty the syringe into the Pod.
+ The Pod will beep twice, indicating that the
System is ready to proceed.
WARNING: NEVER inject air into the fill port.
Doing so may result in unintended or interrupted insulin delivery.
1.3
1.4
WARNING: NEVER use a Pod if you hear a crackling noise or
feel resistance when you depress the plunger. These conditions
can result in underdelivery of insulin.
HOW TO CHANGE THE POD

13
Fill a new pod with
insulin.
After filling pod, listen
for 2 beeps, then press
“Next.”
NOTE: Do not remove
needle cap at this time.
Cancel
Discard
Prepare infusion site.
Remove pod’s needle
cap and adhesive
backing.
If cannula sticks out
press “Discard.”
If pod OK, apply to site.
+ Select the infusion site, being careful to avoid
areas where the Pod will be affected by folds
of skin. The new site should be at least 2.5 cm
away from the previous site, 5 cm away from
the navel, and not over a mole or scar. Refer to
the figures on page 10 for recommended sites
and placement tips.
+ Return to the PDM. If the PDM screen times out,
press and hold the Home/power button to turn
it back on.
+ Press Next.
+ The PDM establishes a one-to-one relationship
with the Pod, which will not allow it to communicate
with any other Pod while this Pod is active. Once
the Pod successfully completes its priming and
safety checks, the PDM will beep.
+ For optimal adhesion, always clean the site
thoroughly with an alcohol swab to remove all
body oils and lotions, which may loosen the
Pod’s adhesive. Let the site air-dry completely;
do not blow on the site to dry it.
1.5
2.1
2.2
STEP 2: APPLY THE POD
If the PDM screen times out during the process, press
and hold the Home/power button to continue.
HOW TO CHANGE THE POD

14
+ Remove the needle cap.
+ Remove and discard the white paper
backing from the adhesive.
+ Apply the Pod to the selected site.
+ Run your finger around the adhesive to secure it.
+ Press Next on the PDM.
+ To facilitate insertion, place one hand over the
Pod and make a wide pinch around the skin
surrounding the viewing window; this step is
critical if the insertion site does not have much
fatty tissue.
2.5
2.4
2.3
HOW TO CHANGE THE POD

15
3:00p 2/11
Press “Start” to insert
cannula and begin basal
delivery.
Start
+ Press Start. The Pod automatically inserts the
cannula and delivers a prime bolus to fill the
cannula with insulin. It takes a few seconds to
complete this process. Release the skin after
the cannula inserts.
3:00p 2/11
Pod is active.
“basal 1” has been
programmed.
Check infusion site and
cannula.
Is cannula properly
inserted?
No Yes
+ Once complete, the PDM indicates that the Pod
is active and asks you to check the infusion site.
+ Look through the Pod’s viewing window to check
that the cannula is properly inserted. When you
see the pink slide insert in this position, it means
that the cannula is inserted (see image below).
Then press Ye s .
3.2
3.1
STEP 3: PRESS START
WARNINGS: NEVER inject insulin (or anything else) into
the fill port while the Pod is on the individual’s body. Doing
so may result in unintended or interrupted insulin delivery.
If you observe blood in the cannula, check the individual’s
blood glucose more frequently to ensure insulin delivery
has not been affected. If you observe unexpected elevated
blood glucose levels, change the Pod.
Check the infusion site after insertion to ensure that the
cannula was properly inserted. The individual should check
their blood glucose 1.5 to 2 hours after each Pod change
and check the infusion site periodically. If the cannula is not
properly inserted, hyperglycemia may result. Verify there
is no wetness or scent of insulin, which may indicate the
cannula has dislodged.
At least once a day, use the Pod’s viewing window to
check the site for signs of infection and to confirm that the
soft cannula is securely in place.
Be aware of the signs of infection, including pain, swelling,
redness, discharge, or heat at the site. If you suspect
an infection, immediately remove the Pod and apply a
new one in a different location. Then call the individual’s
healthcare provider.
If the PDM screen times out during the process, press
and hold the Home/power button to continue.
HOW TO CHANGE THE POD
Slide Insert (Pink)

16
Status Select
3:00p 2/11
Bolus
More actions
Temp basal
My records
Settings
Suspend
Enter
Enter temp basal
change.
Back
+25%
This will temporarily
increase your basal rate.
3:00p 2/11
The basal rate refers to the steady dose of insulin the individual receives at all
times. You may need to:
+ Temporarily increase the basal rate in response to high blood sugar if, for instance, the
individual is ill or insulin delivery has been interrupted.
+ Temporarily decrease the basal rate prior to increased physical activity (physical
education or organized sports) or in response to low blood sugar that does not respond
to oral carbohydrates or other efforts.
The individual’s Diabetes Management Plan or healthcare provider should provide
the appropriate temp basal rates.
+ Turn on the PDM.
+ Press the Home/power button, then select
Temp basal.
+ If temporary basal rates are not part of the
individual’s Diabetes Management Plan,
the Temp basal option will not appear on
the screen.
+ Enter % change (or temp basal rate), then
press Enter (Shown here is an example of
a temporary basal increase. In this example,
25% MORE insulin will be delivered).
1.
2.
HOW TO ENTER A
TEMPORARY BASAL RATE.
Caution: Consult User Guide.

17
Enter
Enter duration for temp
basal.
Change: +25%
Back
0.5 hr
3:00p 2/11
Confirm
Start temp basal
increase?
Back
+25%
0.5 hr
3:00p 2/11
3:00p 2/11
Last BG 12 mmol/L
12:28p today
Last bolus 1.00U
12:28p today
Temp basal
+25%0:30 remains
Home
Pod exp 6:28a 2/14
50+U
+ Enter the length of time the temp basal should
be delivered (in half-hour increments), then
press Enter.
+ Press Confirm to start the temporary basal
rate shown on the screen (In this example,
25% more basal insulin will be delivered for
0.5 hours). The Pod beeps to indicate that
the temporary basal rate is running.
+ The Status screen indicates the temp basal
rate and the remaining delivery time.
3.
4.
5.
HOW TO ENTER A TEMPORARY BASAL RATE

18
If the individual has severe low blood sugar you may need to suspend insulin delivery.
Never ignore the signs of low blood sugar (no matter how mild). Any time the individual’s blood
glucose is low, treat immediately. If blood glucose is below 3.9 mmol/L, provide the individual with
15 grams of fast-acting carbohydrates, such as glucose tablets, juice, or hard candy. Check it
every 15 minutes while you are treating, to make sure you don’t cause blood glucose levels to rise
too high. If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness.
Symptoms of hypoglycemia. Never ignore these symptoms:
+ Shakiness
+ Fatigue
+ Unexplained sweating
+ Cold, clammy skin
+ Weakness
+ Blurred vision or a headache
+ Sudden hunger
+ Rapid heart rate
+ Confusion
+ Tingling in the lips or tongue
+ Anxiety
HOW TO SUSPEND
INSULIN DELIVERY.
Status Select
3:00p 2/11
Bolus
More actions
Temp basal
My records
Settings
Suspend
Suspend insulin delivery.
Enter duration:
Back Enter
0.5 hr
3:00p 2/11 + Enter the length of time the suspension should
last (minimum 0.5 hour, maximum 2.0 hours),
then press Enter.
+ Turn on the PDM.
+ Press the Home/power button,
then select Suspend.
1.
2.
Caution: Consult User Guide.