InPen Safety Information

Indications for Use

The InPen requires a prescription. It is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.

For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.

For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.

Contraindications

The InPen system is not intended for anyone unable or unwilling to:

• Test blood glucose (BG) levels as recommended by a healthcare provider

• Maintain sufficient diabetes self-care skills

• Visit a healthcare provider regularly

InPen is not recommended for the blind or visually impaired without the assistance of a sighted individual trained to use it. Always carry a spare insulin delivery device in case your InPen is lost or damaged.

Warnings, Cautions and Other Important Notes

Pediatric Patients

Younger children may inadvertently play with the pen injector or the app, leading to unintentional logging or delivery of insulin. It is the responsibility of the healthcare provider and the caregiver to determine if the patient is appropriate for treatment with the InPen system.

Do not allow small children to chew on or ingest parts, such as the pen cap and cartridge components. Small parts could pose a choking hazard. If ingested or swallowed, these component pieces may cause internal injury or infection. For patients who do not self-manage their disease, the smart device should always be under the supervision of a caregiver. Inadvertent button presses may lead to unintentional dose logging or changes to therapy settings. These changes can potentially lead to hypoglycemic or hyperglycemic events which could result in serious injury or death.

Supported Devices, Connecting, Settings and Security

The InPen App is compatible with:

• iOS 10 or later

• Android 6 or later

Check the Companion Medical website to make sure the app is compatible before updating your smart device.

CAUTION: You must first pair your InPen with a smart device and the InPen App. This will ensure

that doses from your InPen are sent wirelessly to the App on your smart device.

IMPORTANT: Your smart device must be set up correctly to work properly and safely with the

InPen System. Your device’s internal settings override any InPen App setting. If the settings on your device are incorrect your InPen System may not function properly.

WARNING: If your InPen is out of range of the smart device the Dose Calculator may not have all of your recent insulin logged and may result in unsafe recommendations, which could lead to severe hyperglycemia, hypoglycemia, or injury.

IMPORTANT: Enable the security features of your smart device to prevent unauthorized access to

your data and settings.

WARNING: The Bluetooth® feature on your InPen sends dose information to your smart device. To prevent other people’s doses from being sent to the smart device, do not let anyone else use your InPen to dose insulin. The InPen is for single patient use only.

IMPORTANT:  Bluetooth® performance varies due to differences in phone hardware and operating systems. The InPen App is not recommended on Jailbroken or Rooted devices.

IMPORTANT: Your smart device must have enough memory storage or the InPen App will not be able to be installed or log dose. You may need to delete files or apps from your smart device.

IMPORTANT: To ensure a secure connection, pair your InPen and smart device in a secure area with limited Bluetooth® devices in range.

CAUTION: Make sure you know which InPen you are pairing with your smart device.

IMPORTANT: The use of a security code on your mobile device is recommended.

Therapy Setup, Insulin and Insulin Dose Calculation

IMPORTANT: Your Therapy Settings must be set correctly before using the Dose Calculator. Do not use the Dose Calculator if you have guessed settings or believe they may be set incorrectly.

IMPORTANT: All insulin you have recently taken must be entered to ensure that Active Insulin is correct. If you have taken any Rapid-acting or mealtime insulin from a device other than InPen, it must be logged manually.

NOTE: Long-acting insulin is not considered part of Active Insulin. Active Insulin applies to Rapid-acting or mealtime insulin only.

IMPORTANT: If you do not enter a current glucose value, Active Insulin will not be subtracted from the dose recommendation.

WARNING: Using the Dose Calculator with incorrect Therapy Settings or without all of your recent insulin logged may result in unsafe recommendations, which could lead to severe hyperglycemia, hypoglycemia, or injury.

IMPORTANT: To use the dose calculator safely, it is extremely important that Therapy Settings

are correct. Proceed only after talking to your health care provider.

IMPORTANT: Once selected and confirmed, your Meal Therapy cannot be changed. Verify with

your doctor if you are unsure of your Meal Therapy. If you choose the wrong meal therapy contact

Customer Service by tapping Settings from the Home screen and selecting Help and Support.

IMPORTANT: Before changing Meal Therapy Mode, you will need your current Meal Therapy settings from your healthcare provider. Previous Meal Therapy settings may be lost when you change to a new Meal Therapy type.

IMPORTANT: An updated prescription is required to increase the precision of your Meal Therapy

mode.

WARNING: If your InPen is out of range of the smart device the Dose Calculator may not have all of your recent insulin logged and may result in unsafe recommendations, which could lead to severe hyperglycemia, hypoglycemia, or injury.

IMPORTANT: The calculated dose is a suggestion. You decide whether to follow the suggestion or rely on your own judgment. The dose calculator cannot account for other factors like activity, illness, alcohol use, etc.

IMPORTANT: Therapy doses and Prime doses must be correctly identified, because only therapeutic doses are included in Active Insulin and used by the Dose Calculator.

WARNING: Log all insulin from all sources into the Logbook. The Dose Calculator does not account for manual injections that you do not enter and could recommend more insulin than needed. Too much insulin may cause hypoglycemia.

IMPORTANT: Your mobile device must be set to the current time to ensure that manual doses are logged correctly and your Active Insulin is correct. Incorrect time settings could result in unsafe recommendations, which could lead to severe hyperglycemia, hypoglycemia, or injury.

IMPORTANT: The Insights by InPen report is intended to supplement, not replace, medical expertise in the self-administration of insulin for the treatment of diabetes. The report provides information that can be used to identify trends to inform treatment decisions. Reports are not intended to produce medical advice and should not be relied upon for such purpose