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Indications for Use

The t:slim 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 6 years of age and greater.

See below for important information on how to operate your t:slim Insulin Pump, as well as important warnings and cautions on proper operation and technical information to ensure your safety.

Review all instructions in your User Guide before using your t:slim Insulin Pump. Your User Guide contains step-by-step instructions to help you properly program, manage and care for your pump. If you are not able to use your pump according to the instructions in your User Guide, you may be putting your health and safety at risk. Pay special attention to Warnings and Precautions in your User Guide. Warnings and Precautions are identified with /!\.

If you still have questions after reading your User Guide, contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901. We are here for you 24 hours a day, 7 days a week.

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Contraindications

The t:slim Insulin Pump is not intended for anyone unable or unwilling to:

  • Test blood glucose (BG) levels as recommended by your healthcare provider
  • Demonstrate adequate carbohydrate-counting skills (preferred, not required)
  • Maintain sufficient diabetes self-care skills
  • See your healthcare provider(s) regularly

You must also have adequate vision and/or hearing in order to recognize your pump’s alerts.

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System Warnings

Before using your t:slim 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:slim Pump use, ask your healthcare provider or call our around-the-clock Customer Technical Support Department at (877) 801-6901.

Your t:slim 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:slim 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:slim 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.

 
/!\ RADIOLOGY AND MEDICAL PROCEDURES

Always notify the provider/technician about your diabetes and your insulin pump.

You must take off your t:slim 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:

  • X-ray
  • Computed Tomography (CT) scan
  • Magnetic Resonance Imaging (MRI)
  • Positron Emission Tomography (PET) scan
  • Other exposure to radiation

In addition to the above, you must take off your t:slim Pump and leave it outside the procedure room if you are going to have any of the following medical procedures:

  • Pacemaker/Automatic Implantable Cardioverter Defibrillator (AICD) placement or reprogramming
  • Cardiac Catheterization
  • Nuclear Stress Test

There are other procedures where you should proceed with caution:

  • Laser Surgery: Your t:slim Pump can usually be worn during the procedure. However, some lasers can create interference and cause the pump to alarm.
  • General Anesthes: Depending on the equipment being used, you may or may not need to remove your pump. Be sure to ask your healthcare provider.

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

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System Precautions

Avoid exposure of your t:slim 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:slim Pump at any time.

Very powerful electromagnets are sometimes used on “free-fall” or thrill rides. Remove your t:slim 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:slim 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:slim Insulin Pump is watertight to a depth of 3 feet for up to 30 minutes (IPX7 rating). If your t:slim 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 Diabetes Care Customer Technical Support at 1-877-801-6901.

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.

 
/!\ ADDITIONAL PRECAUTIONS

Your t:slim Pump is a sealed device that should be opened and repaired only by the manufacturer. If your t:slim 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.

  • Wash your hands with anti-bacterial soap before handling.
  • Use only sterile, unopened products, such as needles, cartridges, and infusion sets.
  • Thoroughly clean the insertion site on your body.

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:slim Pump and infusion set, particularly:

  • Check that your Luer-lock connection between the cartridge tubing and the infusion set tubing is tight and secure.
  • Check your infusion site for proper placement and leaks. Improperly placed sites or leaks around the infusion site can result in under-infusion.
  • Check your infusion set tubing for any damage, leaks, or kinks while using your t:slim Pump. Damaged, leaking, or kinked tubing may restrict or stop insulin delivery and result in under-infusion.
  • Check your t:slim Pump’s personal settings to ensure they are correct.
  • Check your t:slim Pump’s audible tones and vibration to ensure they are easily detectable.
  • Regularly check your t:slim Pump screen for potential failure conditions that may display.

If you damage or drop your t:slim 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 Diabetes Care 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:slim 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.

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Working with your Healthcare Provider

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.

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Emergency Kit

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:

  • Blood glucose testing supplies: meter, strips, control solution, lancets, meter batteries
  • Fast-acting carbohydrate to treat low blood glucose
  • Extra snack for longer coverage than fast-acting carbohydrate
  • Glucagon emergency kit
  • Rapid-acting insulin and syringes
  • Infusion sets (minimum of 2)
  • Insulin pump cartridges (minimum of 2)
  • Infusion site preparation products (antiseptic wipes, skin adhesive)
  • Diabetes identification card or jewelry

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Verification of Proper Functionality

A power supply (AC adapter with micro-USB connector) is provided with your t:slim Pump. Before using your pump, ensure that the following occur when you connect a power supply into its micro-USB port:

  • You hear an audible alert
  • Your see the green light illuminate from the edge around the Screen On/Quick Bolus Button
  • You feel a vibratory alert
  • You see a charge symbol (lightning bolt) on the battery level indicator

In addition, before using your t:slim Pump, ensure the following:

  • Press the Screen On/Quick Bolus Button to turn the screen on so that you can see the display
  • When the display screen is on, the touch screen responds to your finger tap

 
/!\ PRECAUTION

If any of these conditions fail to occur, do NOT use your t:slim 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.

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