/ ! \ Insulin Pump Warnings
DO NOT start to use your pump before reading the user guide. Failure to follow the instructions in this user guide can result in over delivery or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events. If you
have questions or need further clarification on your pump use, ask your healthcare provider or call Customer Technical Support.
DO NOT start to use your pump before you have been appropriately trained on its use by a certified trainer or through the training materials available online. Consult with your healthcare provider for your individual training needs for the pump. Failure
to complete the necessary training on your pump could result in serious injury or death.
ONLY use U-100 Humalog or U-100 NovoLog with your pump. Only U-100 Humalog and NovoLog have been tested and found to be compatible for use in the pump. Use of insulin with greater or lesser concentration can result in an over delivery or under delivery
of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
DO NOT put any other drugs or medications inside your pump cartridge. The pump is designed only for continuous subcutaneous insulin infusion (CSII) using U-100 Humalog or U-100 NovoLog insulin. Use of other drugs or medications can damage the pump and
result in injury if infused.
DO NOT use manual injections or inhaled insulins while using the Tandem Mobi pump. Using insulin not provided by the pump can cause the system to over deliver insulin, which can lead to severe hypoglycemia (low BG) events.
The pump is not intended for anyone unable or unwilling to:
- Use the pump, CGM, and all other system components in accordance with their respective instructions for use
- Test BG levels as recommended by a healthcare provider
- Demonstrate adequate carbohydrate-counting skills
- Maintain sufficient diabetes self- care skills
- See a healthcare provider(s) regularly
The user must also have adequate vision and/or hearing in order to recognize all functions of the pump, including alerts, alarms, and reminders.
DO NOT start to use your pump before consulting with your healthcare provider to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your basal rate(s), carb ratio(s), correction factor(s),
target BG, and duration of insulin action. In addition, only your healthcare provider can determine your CGM settings and how you should use your sensor trend information to help you manage your diabetes. Incorrect settings can result in over delivery
or under delivery of insulin. This can cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
ALWAYS be prepared to inject insulin with an alternative method if delivery is interrupted for any reason. Your pump is designed to deliver insulin reliably, but because it uses only rapid-acting insulin, you will not have long-acting insulin in your
body. Failure to have an alternative method of insulin delivery can lead to very high BG or Diabetic Ketoacidosis (DKA).
ONLY use cartridges and infusion sets with matching connectors and follow their instructions for use. Failure to do so may result in over delivery or under delivery of insulin and may cause hypoglycemia (low BG) or hyperglycemia (high BG) events.
DO NOT place your infusion set on any scars, lumps, moles, stretch marks or tattoos. Placing your infusion set in these areas can cause swelling, irritation or infection. This can affect insulin absorption and cause high or low BG.
ALWAYS carefully follow the instructions for use accompanying your infusion set for proper insertion and infusion site care, as failure to do so could result in over delivery or under delivery of insulin or infection.
NEVER fill your tubing while your infusion set is connected to your body. Always ensure that the infusion set is disconnected from your body before filling the tubing. Failure to disconnect your infusion set from your body before filling the tubing can
result in over delivery of insulin. This can cause hypoglycemia (low BG) events.
DO NOT change your infusion set before bedtime or if you will not be able to test your BG 1 to 2 hours after the new infusion set is placed. It is important to confirm that the infusion set is inserted correctly and delivering insulin. It is also important
to respond quickly to any problems with the insertion to ensure continued insulin delivery.
ALWAYS insert infusion set and connect to the pump before applying the sleeve to ensure the tubing is not stretched. Failure to follow these steps could result in crimping or dislodgement at the infusion site, which could affect the performance of the
cannula. This could lead to hyperglycemia (high blood glucose).
NEVER reuse cartridges or use cartridges other than those manufactured by Tandem Diabetes Care. Use of cartridges not manufactured by Tandem Diabetes Care or reuse of cartridges may result in over delivery or under delivery of insulin. This can cause
hypoglycemia (low BG) or hyperglycemia (high BG) events.
ALWAYS follow the load sequence on your t:connect mobile app prior to loading a new cartridge on the pump.
ALWAYS ensure there is a tight connection between the cartridge tubing and the infusion set tubing. A loose connection can cause insulin to leak, resulting in under delivery of insulin. This can cause hyperglycemia (high BG) events.
DO NOT disconnect the tubing connector between the cartridge tubing and the infusion set tubing while delivering insulin. If the connection comes loose, disconnect the infusion set from your body before tightening. Failure to disconnect before tightening
can result in over delivery of insulin. This can cause hypoglycemia (low BG).
DO NOT remove or add insulin from a filled cartridge after loading it onto the pump. This may result in an inaccurate display of the insulin level on the Dashboard screen, and an over or under delivery of insulin. This can cause hypoglycemia (low BG)
or hyperglycemia (high BG) events.
DO NOT allow small children (either pump users or non-users) to ingest small parts, such as the cartridge components. Small parts could pose a choking hazard. If ingested or swallowed, these small component pieces may cause internal injury or infection.
The pump includes parts (such as the USB cable and infusion set tubing) that could pose a strangulation or asphyxiation hazard. ALWAYS use the appropriate length of infusion set tubing and arrange cables and tubing to minimize the risk of strangulation.
ENSURE that these parts are stored in a secure place when not in use.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30.5 cm) to any part of the Tandem Mobi insulin pump, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
ONLY use accessories, cables, adapters, and chargers provided by the manufacturer. Use of third-party equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
ALWAYS inspect your cartridge for signs of damage. ALWAYS replace the cartridge if it is damaged and ALWAYS suspend insulin and disconnect your infusion site before replacing the cartridge.
ALWAYS inspect your cartridge to ensure the cartridge is securely attached to the pump. ALWAYS suspend insulin and disconnect your infusion site if the cartridge rotates or is not securely attached to the pump before adjusting the cartridge.
AVOID excessive exposure of your cartridge when filled with insulin to direct sunlight as this may impact the effectiveness of insulin.
DO NOT expose your pump to a magnet, such as pump cases that have a magnetic clasp or common products which include magnets such as cellphones and wireless charging cases. Exposure to magnets or products with magnets may interfere with the pump motor.
Damage to the motor can impact the pump’s functionality.
Some skin care products such as lotions, sunscreens, and insect repellents can cause cracks in the plastic used to manufacture the pump and cartridge. DO NOT allow these products to come in contact with the pump or cartridge. ALWAYS remove your pump before
applying these products and ALWAYS wash your hands before handling your pump or cartridge after using such products. ALWAYS change your cartridge if it becomes exposed to such products and immediately clean your pump. Failure to do so may result in
damage to the pump and cartridge and in some cases over or under delivery of insulin.
Magnetic Resonance Imaging Safety
The pump is magnetic resonance (MR) unsafe. You must take off your pump, transmitter, and sensor and leave them outside the procedure room.