Important Safety Information

The Omnipod® Insulin Management System with blood glucose meter is comprised of two primary components:

The Insulin Pump (Pod)
The Personal Diabetes Manager (PDM)

The Pod is controlled exclusively through the use of the PDM. The Pod and PDM interact wirelessly using a secure, low power, bi-directional radio frequency (RF) communication.

The Omnipod® System is designed to use rapid acting U-100 insulin. The following U-100 rapid acting insulin analogs have been tested and found to be safe for use in the Pod: Novolog®/NovoRapid®, Humalog® or Apidra®.

NEVER use insulin that is cloudy; it may be old or inactive. Failure to use rapid acting U-100 insulin, or using insulin that is expired or inactive, may lead to hyperglycemia or diabetic ketoacidosis (DKA).

This information is not intended to replace your healthcare provider’s recommendations. Always follow the advice of your healthcare provider and the User Guide provided with the Omnipod® System.

For more detailed instructions on how to properly use the Omnipod® System and a full list of all precautions and warnings, please consult the User Guide, found here.

This User Guide is intended for use only with PDM model CAT45E for English and CAT45F for French. To learn which version of the PDM you have, turn it over. On the back of the PDM, look for “CAT45E” for English and “ CAT45F” for French. If you see it, this is the correct User Guide. If you do not see “CAT45E” or “CAT45F” on the back of the PDM, please call Customer Care.

Unless stated otherwise, references to FreeStyle Blood Glucose Test Strips or FreeStyle Test Strips includes both FreeStyle and FreeStyle Lite Test Strips.

Indications for Use

The Omnipod® Insulin Management System is intended for the subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro).

Contraindications

Insulin pump therapy is NOT recommended for people who are either:

Unable to perform at least four (4) blood glucose test per day
Unable to maintain contact with their healthcare provider
Unable to use the Omnipod® System according to instructions

Do not use the integrated FreeStyle Blood Glucose Monitoring System for:

Testing on newborns
Testing arterial blood
Diagnosing of or screening for diabetes mellitus

This device is intended for self-testing by the user.

Safety Features

The Omnipod® System’s state of the art design includes the latest safety technology. Its built-in safety features include:

Automatic priming, safety checks and insertion – every time you activate a new Pod, the Omnipod® System automatically primes and performs a safety check on the Pod, then inserts and primes the cannula. Micro-processor technology makes it possible to complete thousands of safety checks in only a few seconds. The Omnipod® System also performs safety checks on the PDM. If any problems are detected, the Omnipod® System will inform you with beeps and on-screen messages.
Occlusion detection – an occlusion is a blockage or interruption in insulin delivery. If the Omnipod® System detects an occlusion, it sounds a hazard alarm and prompts you to deactivate and change your Pod. A hazard alarm sounds when an average of 3 to 5 units of missed insulin occurs.
Alerts and alarms – the Omnipod® System provides a range of alerts and alarms to tell you that your attention is needed or to warn you of hazardous situations.

Medical Procedures

The Omnipod® System should NOT be used in a hyperbaric chamber as there is a potential for an explosion. There are active electronics inside the Pod and PDM and a hyperbaric chamber has high concentrations of oxygen.

The Pod and PDM may be affected by strong radiation or magnetic fields. Before having an X-ray, MRI or CT scan (or any similar test or procedure), remove your Pod and put it and the PDM outside the treatment area. Check with your healthcare provider for Pod removal guidelines.

Interference

The Omnipod® Insulin Management System (both the Pod and the Personal Diabetes Manager or PDM) complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

1. These devices may not cause harmful interference.

2. These devices must accept any interference received, including interference that may cause undesirable operation.

Changes or modifications not expressly approved by Insulet could void the user’s authority to operate the equipment. Both the Pod and the PDM generate, use, and can radiate radio frequency energy, and may cause harmful interference to radio communications. There are no guarantees that interference will not occur in a particular installation. If the Omnipod® System does cause harmful interference to radio and television reception, the interference may be corrected by one of the following measures:

Move or relocate the Omnipod® System.
Increase the distance between the Omnipod® System and the other device that is emitting or receiving interference.

Insulet Corporation declares that the Omnipod® System is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. This ISM device complies with Canadian ICES-003 and IC-RSS-210.

Electromagnetic Compatibility

Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this document and the instructions for use. Portable and mobile RF communications equipment can affect the function of medical electrical equipment.

Insulet Corporation declares that the Omnipod® System is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.

Cables and accessories not specified within the instructions for use are not authorized. Using other cables and/or accessories may adversely impact safety, performance, and electromagnetic compatibility (increased emission and decreased immunity). Care should be taken if the Omnipod® System is used adjacent to other electrical equipment; if adjacent use is inevitable, such as in work environments, the System should be observed to verify normal operation in this setting. The System communicates by low level RF energy. As with all RF receivers, the potential for disturbance exists, even with equipment that complies with FCC and CISPR emissions requirements.

The Omnipod® System communicates with the following characteristics:

Frequency: 433 Mhz, FSK modulation, with an effective radiated power of 13mW

The Omnipod® System greatly exceeds the immunity requirements of the general standard for electromagnetic compatibility, IEC 60601-1-2.

Using the Omnipod® System

Precautions/Warnings

Do NOT use the Omnipod® Insulin Management System until you have been trained by your healthcare provider. He or she will initialize the Omnipod® System based on your individual needs. Inadequate training or improper setup could put your health and safety at risk.

If you are unable to use the Omnipod® System according to instructions, you may be putting your health and safety at risk. Talk with your healthcare provider if you have questions or concerns about using the Omnipod® System properly.

The Omnipod® System is NOT recommended for individuals with hearing loss. Always verify ability to hear Pod/PDM alerts and alarms.

Pod

Replace the Pod at least once every 48 – 72 hours or up to 200 units of insulin (2 – 3 days). Refer to the insulin labeling and follow your healthcare provider’s directions for how often to replace your Pod.

The Pod requires a minimum of 85 units of insulin to be operational and can deliver up to 200 units of insulin.

The Pod has an IP rating of IPX8. It is waterproof to a depth of 7.6 meters feet for 60 minutes.

Precautions/Warnings

Do NOT attempt to apply or use a Pod until you have been trained by your healthcare provider. Use of the Omnipod® System with inadequate training or improper setup could put your health and safety at risk.

Do NOT apply or use a Pod if the sterile packaging is open or damaged or if the Pod has been dropped after removal from the package, as this may increase the risk of infection. Pods are sterile unless packaging has been opened or damaged.

Do NOT apply or use a Pod if it is damaged in any way. A damaged Pod may not work properly.

To minimize the possibility of site infection, do NOT apply a Pod without first using aseptic technique. This means to:

Wash your hands
Clean the insulin vial with an alcohol prep swab
Clean the infusion site with soap and water or an alcohol prep swab
Keep sterile materials away from any possible germs

Do NOT use a Pod if you are sensitive to or have allergies to acrylic adhesives or have fragile or easily damaged skin.

Do NOT apply a new Pod until you have deactivated and removed the old Pod. A Pod that has not been deactivated properly may continue to deliver insulin as programmed, putting you at risk of over infusion and possible hypoglycemia.

Because insulin Pods use only rapid-acting insulin, users are at increased risk for developing hyperglycemia(high blood glucose) if insulin delivery is interrupted. If it is untreated, severe hyperglycemia can quickly lead to diabetic ketoacidosis (DKA). DKA can cause symptoms such as breathing difficulties, shock, coma, or death. If insulin delivery is interrupted for any reason, you may need to replace the missing insulin usually with an injection of rapid-acting insulin. Ask your healthcare provider for instructions on handling interrupted insulin delivery.

Before filling a Pod, ensure that no other Pods are being activated within 60 cm (24 inches) of your PDM.

Before filling a Pod, ensure that the Pod is above 10°C (50°F). If the Pod has been exposed to temperatures below 10°C (50°F), then allow the Pod to be brought back to room temperature before filling with insulin. Only use room temperature insulin when filling the Pod.

Make sure there is no air in the syringe before attempting to fill the Pod with insulin. Failure to expel air bubbles from the fill syringe may result in interrupted insulin delivery.

NEVER use a Pod if you feel resistance when you depress the plunger. This condition can result in interrupted insulin delivery.

Do NOT apply the Pod within 5.0 cm (2 inches) of your navel or over a mole, tattoo or scar. This may reduce insulin absorption.

Do NOT expose a Pod to direct sunlight for long periods of time. It is recommended that you remove your Pod prior to using hot tubs, whirlpools, or saunas. These conditions could expose the Pod to extreme temperatures and may also affect the insulin inside the Pod.

Do NOT expose your Pod to water at depths greater than 7.6 meters or for more than 60 minutes. Check often to make sure the Pod and soft cannula are securely attached and in place. 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.

Personal Diabetes Manager (PDM)

The Personal Diabetes Manager (PDM) is a wireless, handheld device that:

Programs the Pod with your personalized insulin-delivery instructions
Wirelessly monitors the Pod’s operation
Includes a FreeStyle blood glucose meter

The PDM displays an identification (ID) screen, which allows you to identify that the PDM is yours. You can personalize the ID screen by adding your name and choosing its color.

Precautions/Warnings

Do NOT store or leave the PDM where it may be exposed to extreme temperatures, such as inside a car. Extreme heat or cold can cause the device to malfunction.

Do NOT use any other type of batteries than AAA alkaline batteries to power the PDM. Never use old or used batteries; the PDM may not work properly.

It is important that you always identify the PDM as yours before you use it.

If your PDM is damaged or not working as expected, call Customer Care for assistance. Be sure to check your blood glucose frequently. Remove your Pod and contact your healthcare provider for treatment guidelines to follow after you remove it.

Do NOT use IV Prep wipes, alcohol wipes, soap, detergent, or solvents. Never put any liquid into the battery compartment.

The PDM is NOT waterproof. Do NOT immerse it or place it in or near water.

FreeStyle Blood Glucose Meter

With the FreeStyle blood glucose meter, checking your blood glucose requires a very small sample size, 0.3 microliters of blood. Refer to your FreeStyle test strip instructions for use for important test strip information. You may want to test for low blood glucose:

When you feel symptoms such as weakness, sweating, nervousness, headache or confusion
When you have delayed a meal after taking insulin
When your healthcare provider advises you to do so

This device is intended for self-testing by the user.

Only use FreeStyle and FreeStyle Lite test strips and FreeStyle control solution with the System. Using other brands of test strips and control solutions with the System can produce inaccurate results.

Important test strip information

Store the blood glucose test strip package in a cool, dry place between 4.4°C and 30°C (40°F and 86°F).
Use test strips only when the PDM is within its operating temperature range, between 4.4°C and 40°C (40°F and 100°F).
Keep test strips away from direct sunlight and heat.
Store test strips in their original vial only; never transfer them to another vial or any other container.
Never store individual test strips outside the vial.
After removing a blood glucose test strip from the vial, immediately close the vial cap tightly.
With clean, dry hands, you can gently touch the test strip anywhere when removing it from the vial or inserting it into the test strip port.
Do not bend, cut, or alter blood glucose tests strips in any way.

FreeStyle Control Solution

The FreeStyle Control Solution is a red liquid that contains a fixed amount of glucose and has two important uses:

To ensure that your meter and test strips are working together properly
To practice testing without having to use your own blood

Three levels of control solution are available: Low, Normal, and High. For information on how to obtain control solution ,visit: Diabetes Express or call Customer Care (24 hours/7 days): 1.855.POD.INFO (1.855.763.4636). When calling from outside of Canada: 289-247-3534.

You should perform a control solution test:

When you suspect that your meter or test strips are not working properly
When you think your test results are not accurate or if your test results are not consistent with how you feel
When you drop or damage your PDM or expose it to liquids
When your healthcare provider advises you to do so

Check that the meter and test strips are working

A control solution test follows the same procedure as a blood glucose reading, except that you use a sample of control solution instead of a drop of blood. When you perform a control solution test, if the reading is within the control solution acceptable range, the meter is working properly.

Control solution expiration date

FreeStyle Control Solution is good for 3 months after opening the bottle, or until the expiration date printed on the label, whichever comes first. Count forward 3 months from the date you open a new bottle of control solution. This is your discard date. Write this date on the side of the control solution bottle. For example, if you open the control solution on January 15, count forward 3 months to April 15. This is the discard date to record on the bottle, as well as the date to discard it and begin using a new bottle.

Precautions/Warnings

The glucose meter and lancing device are for single-patient use. Do NOT share the device with anyone including other family members. Do NOT use on multiple patients. Parts of the device are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

Do NOT use strips beyond the expiration date printed on the package, as this may cause inaccurate results.

Please read all instructions provided in the User Guide and practice the blood glucose testing procedures before using the Omnipod® System. Monitor your blood glucose with the guidance of your healthcare provider. Undetected hyperglycemia or hypoglycemia can result without proper monitoring.

The code number on the screen of the PDM should match the code number on the side of you test strip vial. Always verify and be prepared to adjust the code on the PDM to match the code number on the test strip vial.

If you are having symptoms that are not consistent with your blood glucose test and you have followed all instructions described in the User Guide, call your healthcare provider.

Use only FreeStyle Control Solution with the Omnipod® System. Other brands of control solution may produce inaccurate results with this System.

Do NOT use control solution past the expiration date or you may get inaccurate results.