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When using the Omnipod DASH Insulin Management System, it's important to be aware of potential risks associated with the Personal Diabetes Manager (PDM) component. Users have reported issues such as battery swelling, fluid leakage, and, in rare cases, extreme overheating, which may pose a fire hazard. To minimize these risks, consider the following precautions:

• Monitor the PDM for signs of battery issues: Regularly inspect the device for any bulging of the back cover, unusual heat, or the presence of an odor during charging, use, or storage. If you notice any of these signs, discontinue use immediately and contact customer support.

• Avoid overcharging: Do not charge the PDM beyond 85% capacity. It's advisable to avoid charging the device overnight or for extended periods. Once the device reaches 85% charge, unplug it to prevent potential battery issues.

• Charge in appropriate conditions: Ensure that the PDM is charged in environments where the temperature is below 87°F (31°C) and away from direct sunlight. Charging in higher temperatures can increase the risk of battery problems.

• Do not use the PDM while charging: Using the device during charging can lead to overheating. Always allow the PDM to charge undisturbed on a hard, flat surface away from flammable materials.

• Inspect before charging: Before each charge, remove the PDM's protective gel skin and check for any deformities, such as a bulging back cover or signs of battery leakage. If any issues are detected, do not charge the device and seek assistance from customer support.

By adhering to these guidelines, you can help ensure the safe operation of your Omnipod DASH system and reduce the likelihood of encountering battery-related issues.

The Omnipod DASH Insulin Management System is designed to assist individuals with diabetes in managing their insulin delivery. While the system offers significant benefits, users should be aware of potential issues associated with the Personal Diabetes Manager (PDM), particularly concerning its battery. Some users have reported problems such as battery swelling, fluid leakage, and, in rare instances, extreme overheating that could pose a fire hazard. These issues are more likely to occur if the PDM is charged to full capacity and left connected for extended periods, like overnight. Devices in use for over 18 months may have an increased likelihood of experiencing these problems. To minimize the risk of battery-related issues, consider the following precautions:

• Monitor the PDM for signs of battery problems: Regularly inspect the device for any abnormalities.
• Avoid overcharging: Do not charge the PDM beyond 85% capacity. It's advisable to avoid charging the device overnight and to monitor it during charging sessions.
• Charge in appropriate conditions: Ensure the surrounding temperature is below 87°F (31°C) and avoid charging in direct sunlight.
• Do not use the PDM while charging: Using the device during charging can increase the risk of overheating. If you notice any of the following issues, stop using the PDM immediately and contact Insulet's Customer Care team:
• The back cover is bulging or cannot close properly.
• The device becomes extremely hot to the touch or emits an unusual odor during charging, use, or storage.
• The PDM does not turn on within 45 minutes of being connected to the charger or turns off immediately after being removed from the charger.
• The battery loses its charge more quickly than usual or takes more than 1.5 hours to reach 80% charge. Insulet has identified a solution to address these battery concerns and plans to ship updated PDMs to all current Omnipod DASH users in the coming months. Users will receive these replacements automatically when they become available. By staying vigilant and following these guidelines, users can continue to benefit from the Omnipod DASH system while minimizing potential risks associated with the PDM battery.

The Omnipod DASH® Insulin Management System is designed to deliver rapid-acting U-100 insulin, such as NovoLog®, Humalog®, Fiasp®, Admelog®, Lyumjev®, or Apidra®. It's important to note that Apidra® is compatible for use up to 48 hours, while the other insulins can be used for up to 72 hours. Using insulin that is cloudy, expired, or inactive can lead to high blood sugar levels or diabetic ketoacidosis.

The Omnipod DASH® System is not compatible with continuous glucose monitoring (CGM) systems and does not automatically adjust insulin delivery based on glucose readings. Therefore, users need to manually monitor their blood glucose levels and adjust insulin delivery as needed.

The system includes a Personal Diabetes Manager (PDM) that communicates with the Pod via Bluetooth. The PDM is not waterproof, so it should be kept dry to prevent damage. Additionally, the PDM should be kept within five feet of the Pod to ensure proper communication, especially when delivering bolus doses.

It's also important to be aware of environmental factors that can affect the system's performance. For example, exposing the Pod to extreme temperatures, such as in hot tubs, saunas, or direct sunlight for extended periods, can impact insulin delivery. Similarly, the PDM should not be exposed to extreme temperatures or moisture.

Before undergoing medical procedures like X-rays, MRIs, or CT scans, it's recommended to remove and dispose of the Pod and place the PDM outside the treatment area, as strong radiation or magnetic fields can affect the system's operation.

Always consult with your healthcare provider for personalized advice on using the Omnipod DASH® System and managing your diabetes effectively.