The t:flex Insulin Pump is indicated for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater.
The t:flex Insulin Pump is not intended for anyone unable or unwilling to:
You must also have adequate vision and/or hearing in order to recognize your pump’s alerts.
Before using your t:flex Pump, consult with your healthcare provider for your individual training needs and ensure that you have been appropriately trained on its use by a certified Tandem pump trainer.
Incorrect use of your pump or failure to follow the appropriate instructions in your User Guide can lead to serious injury or even death. If you have questions or need further clarification on your t:flex Pump use, ask your healthcare provider or call our around-the-clock Customer Technical Support Department at (877) 801-6901.
Your t:flex 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. In order to prevent Diabetic Ketoacidosis (DKA) or a very high BG, you must be prepared to inject insulin if delivery is interrupted for any reason.
Only use Humalog or NovoLog U-100 insulin, as any lesser or greater concentration can result in serious health consequences. Only Humalog and NovoLog have been tested by Tandem, and found to be compatible for use in the t:flex Insulin Pump. It is not intended for use with any other delivery substance.
Never fill your tubing while your infusion set is connected to your body. Doing so can result in unintended delivery of insulin, which can result in serious injury or death.
Do not disconnect the Luer-lock connection between the cartridge tubing and the infusion set tubing. If the connection comes loose, disconnect the infusion set from the site (from your body) before tightening to avoid unintentional insulin delivery.
Do not deliver a bolus until you have reviewed the calculated bolus amount on the pump display. If you dose an insulin amount that is too high or too low, this could lead to a very low or very high BG level. You can always adjust the insulin units up or down before you decide to deliver your bolus.
Use only FDA cleared insulin infusion sets with a standard Luer-lock connection and consult its instructions for use. Failure to do so may result in over-infusion or under-infusion and may cause serious injury or death.
Change your infusion set every 48–72 hours. Consult your healthcare provider for more information.
Use only single-use disposable cartridges from Tandem. The efficacy of your t:flex Pump cannot be guaranteed if cartridges other than those manufactured by Tandem are used or if cartridges are filled more than once. Use of cartridges not manufactured by Tandem or reuse of cartridges may result in over-infusion or under-infusion and may cause serious injury or death.
Do not remove or add insulin from a filled cartridge. This will result in an inaccurate display of the insulin level on the Home Screen.
Do not modify Tandem products. Modification could result in a safety hazard.
Always notify the provider/technician about your diabetes and your insulin pump.
You must take off your t:flex Pump and leave it outside the procedure room if you are going to have any of the following procedures. Follow your healthcare provider’s instructions to replace missed insulin when you reconnect to the pump. Check your blood glucose before disconnecting from the pump and again when you reconnect and treat high blood glucose levels as recommended by your healthcare provider:
In addition to the above, you must take off your t:flex Pump and leave it outside the procedure room if you are going to have any of the following medical procedures:
There are other procedures where you should proceed with caution:
There is no need to disconnect for electrocardiograms (EKGs) or colonoscopies.
If you have questions, contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901
Avoid exposure of your t:flex Pump to temperatures below 40°F (5°C) or above 99°F (37°C), as insulin can freeze at low temperatures or degrade at high temperatures. Do not steam, sterilize, or autoclave your t:flex Pump at any time.
Very powerful electromagnets are sometimes used on “free-fall” or thrill rides. Remove your t:flex pump and do not take it on these types of rides. Also, you should disconnect the infusion set from your body while on high-speed/high-gravity roller coasters.
Disconnect the infusion set from your body before flying in an aircraft without cabin pressurization or in planes used for aerobatics or combat simulation (pressurized or not).
Your t:flex pump and related supplies include small parts (such as pieces of the infusion set, rubber USB port cover, and cartridge components) that could pose a choking hazard for small children. Ensure that any small parts are kept away from small children.
Your pump uses parts (such as the USB cable and the infusion set tubing) that could pose a strangulation or asphyxiation hazard. Arrange cables and tubing to minimize the risk of strangulation or asphyxiation. Ensure that these parts are stored in a secure place when not in use.
DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS OR EXPLOSIVE GASES. The risk of ignition of flammable anesthetics and explosive gases by the pump is remote. While this risk is remote, it is not recommended to operate a Tandem insulin pump in the presence of flammable anesthetics or explosive gases. If you have questions, contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.
The t:flex insulin pump is watertight to a depth of 3 feet for up to 30 minutes (IPX7 rating). If your t:flex pump has been submerged, check your pump for any signs of fluid entry. If there are signs of fluid entry, disconnect the set from your body, and contact Tandem Customer Technical Support at (877) 801-6901.
Your pump should not be exposed to X-ray screening used for carry-on and checked luggage. Newer full body scanners used in airport security screening are also a form of X-ray and your pump should not be exposed to them. Notify the Transportation Security Administration (TSA) Agent that your pump cannot be exposed to X-ray screening and request alternate means of screening other than X-ray.
Your pump has been designed to withstand common electromagnetic interference including airport metal detectors. For further information, contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.
Your t:flex pump is a sealed device that should be opened and repaired only by the manufacturer. If your t:flex Pump seal is broken, the warranty is voided and the pump is no longer watertight.
Replace the cartridge every 48 hours if using Humalog; every 72 hours if using NovoLog.
Always follow proper aseptic (clean) technique when handling your pump, filling syringe/needle, cartridge, and infusion set.
Always remove all air bubbles when drawing insulin into the filling syringe. Always hold the pump with the white fill port pointed up when filling the cartridge. Always ensure that there are no air bubbles in the tubing when filling.
Avoid changing your infusion set before bedtime or if you will not be able to test your blood glucose 1-2 hours after the new infusion set is placed.
Before bedtime, always check that your cartridge has enough insulin to last through the night.
Unless otherwise directed by your healthcare provider, do not use the vibrate feature during sleep. Having the volume for alerts and alarms set to high will help ensure that you don’t miss an alert or alarm.
Conduct regular checks of your t:flex pump and infusion set, particularly:
If you damage or drop your t:flex pump, ensure that it is still working properly. If you are unsure about potential damage, disconnect the infusion set from your body and contact Tandem Customer Technical Support at (877) 801-6901.
It is very important to set the current time and date accurately to ensure safe insulin delivery. When editing time, always check that the AM/PM setting is accurate. AM is to be used from midnight until 11:59 AM. PM is to be used from noon until 11:59 PM.
When you are connected to your pump and to a charging source, take caution when moving further than the length of the USB cable. Failure to do so may result in the cannula becoming dislodged at the infusion site. For this reason it is recommended not to charge the pump while sleeping.
Your insulin needs may change in response to lifestyle changes such weight gain or loss, and starting or stopping exercise. Consult your healthcare provider for help with adjusting your basal rate(s) and other settings.
When you first use the Quick Bolus feature, you should always look at the screen to confirm correct programming until you are comfortable with this feature.
Interference with your t:flex pump’s electronics by cell phones can occur if worn in close proximity. It is recommended that your pump and cell phone be worn at least 6.4 inches apart.
Always check with your healthcare provider for specific guidelines if you want or need to disconnect from the pump for any reason. Depending on the length of time and reason you are disconnecting, you may need to replace missed basal and/or bolus insulin. Check your blood glucose before disconnecting from the pump and again when you reconnect, and treat high blood glucose (BG) levels as recommended by your healthcare provider.
If you receive a warranty replacement pump from Tandem, ensure that your personal settings are programmed before using the pump.
Always dispose of used cartridges, syringes, needles, and infusion sets following your community’s regulations. Wash your hands thoroughly after handling any insulin-holding device
Any clinical language presented below is based on the assumption that you have been educated by your healthcare provider on certain terms and how they apply to you in your diabetes management. Your healthcare provider can help you establish diabetes management guidelines that best fit your lifestyle and needs.
Monitor your blood glucose (BG) with the guidance of your healthcare provider. According to the American Association of Diabetes Educators’ white paper "Insulin Pump Therapy: Guidelines for Successful Outcomes," patients should routinely check their BG levels at least 4 times daily (optimally 6-8 times daily) in order to detect hyperglycemia (high blood glucose) and hypoglycemia (low blood glucose) early. Undetected hyperglycemia or hypoglycemia can result without proper monitoring.
Consult your healthcare provider before using your pump to determine which features are most appropriate for you. Only your healthcare provider can determine and help you adjust your basal rate(s), insulin-to-carbohydrate ratio(s), correction factor(s), blood glucose (BG) target, and duration of insulin action.
Make sure that you always have an insulin syringe and vial of insulin with you as a backup for emergency situations. You should also always have an appropriate emergency kit with you. Talk with your healthcare provider regarding what items this kit should include.
Supplies to carry every day:
A power supply (AC adapter with micro-USB connector) is provided with your t:flex Pump. Before using your pump, ensure that the following occur when you connect a power supply into its micro-USB port:
In addition, before using your t:flex Pump, ensure the following:
If any of these conditions fail to occur, do NOT use your t:flex Pump, as this may be an indication that the pump’s alarms, alerts, and other built-in safety features may not be working properly. If the pump is connected to your body, disconnect the infusion set from your body and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.