Important Safety Information - t:slim X2 Insulin Pump

See below for important information on how to operate your t:slim X2 Insulin Pump, as well as important warnings and cautions on proper operation and technical information to ensure your safety.

In this safety information, the t:slim X2 Pump may be referred to as “your pump” or “your t:slim X2 Pump”. The t:slim cartridge may be referred to as “your cartridge.” Together, the t:slim X2 Insulin Pump and the t:slim cartridge may be referred to as the “System”.

Review all instructions in your User Guide before using your t:slim X2 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.

 
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. 

 
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

 
Verification of Proper Functionality 

A power supply (AC adapter with micro-USB connector) is provided as part of the System. Before using your System, ensure that the following occur when you connect a power supply into the USB port of your t:slim X2 Pump:

  • 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 
CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button when you connect a power source to the USB port. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of the System and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

INDICATIONS FOR USE AND CONTRAINDICATIONS

 
Indications for Use

The t:slim X2 Insulin Delivery System is intended 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. The device is indicated for use with Humalog U-100® or NovoLog®  insulin. 

 
Contraindications

The t:slim X2 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 System alerts. 

 
Warnings and Precautions 


/!\ WARNINGS
DO NOT start to use your t:slim X2 System before reading the User Guide. Failure to follow the instructions in the User Guide can result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose which could result in serious injury or death. If you have questions or need further clarification on your System use, ask your healthcare provider or call our around-the-clock Customer Technical Support at (877) 801-6901.

DO NOT start to use your t:slim X2 System before you have been appropriately trained on its use by a certified t:slim X2 System trainer. Consult with your healthcare provider for your individual training needs for the t:slim X2 System. Failure to complete the necessary training on the System could result in serious injury or death.

DO NOT use any other insulin with your System other than U-100 Humalog® or NovoLog®. Only Humalog® and NovoLog® have been tested and found to be compatible for use in the System. Use of insulin with lesser or greater concentration can result in under delivery or over delivery of insulin. This can cause very high or a very low blood glucose.

DO NOT put any other drugs or medications inside your System cartridge. The System is designed only for Continuous Subcutaneous Insulin Infusion (CSII) using Humalog® or NovoLog® insulin. Use of other drugs or medications can damage the pump and result in injury if infused.

DO NOT start to use your System 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. Incorrect settings can result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose.

DO be prepared to inject insulin with an alternative method if delivery is interrupted for any reason. Your t:slim X2 System 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 blood glucose or Diabetic Ketoacidosis (DKA).

DO use only FDA cleared insulin infusion sets with a standard Luer-lock connection and follow their instructions for use. Failure to do so may result in over delivery or under delivery of insulin and may cause very low or very high blood glucose.

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 blood glucose.

DO NOT ignore infusion set cannula fractures. Infusion set cannulas may fracture on rare occasions. If an infusion set cannula breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken infusion set cannula, please report this to Tandem Customer Technical Support at (877) 801-6901.

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 serious injury or death from very low blood glucose.

DO NOT reuse cartridges or use cartridges other than those manufactured by Tandem Diabetes Care, Inc. Use of cartridges not manufactured by Tandem Diabetes Care, Inc. or reuse of cartridges may result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose.

ALWAYS twist the Luer-lock connection between the cartridge tubing and the infusion set tubing an extra quarter of a turn to ensure a secure connection. A loose connection can cause insulin to leak, resulting in under delivery of insulin. This can cause high blood glucose.

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 your body before tightening. Failure to disconnect before tightening can result in over delivery of insulin. This can cause low blood glucose.

DO NOT remove or add insulin from a filled cartridge after loading onto the pump. This will result in an inaccurate display of the insulin level on the Home Screen and you could run out of insulin before the pump detects an empty cartridge. This can cause very high blood glucose, or Diabetic Ketoacidosis (DKA).

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 cause very high or very low blood glucose. You can always adjust the insulin units up or down before you decide to deliver your bolus.

DO NOT allow small children (either pump users or non-users) to ingest small parts, such as the rubber USB port cover and cartridge components. Small parts could pose a choking hazard. If ingested or swallowed, these small component pieces may cause internal injury or infection.

The System 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 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.

For patients who do not self-manage their disease, the Feature Lock function should ALWAYS be ON when the pump is not being used by a caregiver. The Feature Lock function is intended to prevent inadvertent button presses that may lead to insulin delivery or changes in the pump settings. These changes can potentially lead to hypoglycemic or hyperglycemic events.

For patients whose insulin administration is managed by a caregiver, DO turn off the Quick Bolus feature to avoid inadvertent bolus delivery. With the Feature Lock turned on, the Quick Bolus feature is disabled. Inadvertent button presses or tampering with the insulin pump could result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose which could result in serious injury or death.

/!\ RADIOLOGY AND MEDICAL PROCEDURES AND YOUR TSLIM X2 SYSTEM 
ALWAYS notify the provider/technician about your diabetes and your t:slim X2 Insulin Pump. If you need to discontinue use of the System for medical 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.

The t:slim X2 Insulin Pump is magnetic resonance (MR) Unsafe. You must take off your t:slim X2 System and leave it outside the procedure room if you are going to have any of the following procedures:
  • 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 X2 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 Anesthesia – 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 

/!\PRECAUTIONS;
DO NOT open or attempt to repair your System. The System is a sealed device that should be opened and repaired only by Tandem Diabetes Care, Inc. Modification could result in a safety hazard. If your System seal is broken, the System is no longer watertight and the warranty is voided.

CHANGE your infusion set every 48 to 72 hours as recommended by your healthcare provider. Wash your hands with anti-bacterial soap before handling the infusion set and thoroughly clean the insertion site on your body to avoid infection. Contact your healthcare provider if you have symptoms of infection at your insulin infusion site.

ALWAYS remove all air bubbles from the System before beginning insulin delivery. Ensure there are no air bubbles when drawing insulin into the filling syringe, hold the pump with the white fill port pointed up when filling the tubing, and ensure that there are no air bubbles in the tubing when filling. Air in the system takes space where insulin should be and can affect insulin delivery.

CHECK your infusion site daily for proper placement and leaks. REPLACE your infusion set if you notice leaks around the site. Improperly placed sites or leaks around the infusion site can result in under delivery of insulin.

CHECK your infusion set tubing daily for any leaks, air bubbles, or kinks. Air in the tubing, leaks in the tubing, or kinked tubing may restrict or stop insulin delivery and result in under delivery of insulin.

CHECK the Luer-lock connection between your cartridge tubing and infusion set tubing daily to ensure it is tight and secure. Leaks around the Luer-lock connection can result in under delivery of insulin.

DO NOT change 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. 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 check that your cartridge has enough insulin to last through the night before going to bed. If you are sleeping, you could fail to hear the Empty Cartridge Alarm and miss part of your basal insulin delivery.

CHECK your System’s personal settings regularly to ensure they are correct. Incorrect settings can result in over delivery or under delivery of insulin. Consult with your healthcare provider as needed.

ALWAYS make sure that the correct time and date are set on your System. 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. Not having the correct time and date setting may affect safe insulin delivery.

CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button when you connect a power source to the USB port. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of the System and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

CHECK your System regularly for potential alarm conditions that may display. It is important to be aware of conditions that may affect insulin delivery and require your attention so you can respond as soon as possible.

DO NOT use the vibrate feature for alerts and alarms during sleep unless otherwise directed by your healthcare provider. Having the volume for alerts and alarms set to high will help ensure that you don’t miss an alert or alarm.

ALWAYS look at the screen to confirm correct programming of the bolus amount when you first use the Quick Bolus feature. Looking at the screen will ensure that you are correctly using the beep/vibration commands to pro-gram the intended bolus amount.

DO NOT use your pump if you think it might be damaged due to dropping it or hitting it against a hard surface. Check that the System is working properly by plugging a power source into the USB port and confirming that the display turns on, you hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button. If you are unsure about potential damage, discontinue use of the System and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

AVOID exposure of your System to temperatures below 40°F (5°C) or above 99°F (37°C). Insulin can freeze at low temperatures or degrade at high temperatures. Insulin that has been exposed to conditions outside of the manufacturer’s recommended ranges can affect the safety and performance of the System.

AVOID submersing your pump in fluid beyond a depth of 3 feet or for more than 30 minutes (IPX7 rating). If your pump has been exposed to fluid beyond these limits, check for any signs of fluid ingress. If there are signs of fluid entry, discontinue use of the pump and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

AVOID areas where there may be flammable anesthetics or explosive gases. The System is not suitable for use in these areas and there is a risk of explosion. Remove your pump if you need to enter these areas.

MAKE SURE to not move further than the length of the USB cable when you are connected to the pump and to a charging source. Moving further than the length of the USB cable may cause the cannula to be pulled out of the infusion site. For this reason it is recommended not to charge the pump while sleeping.

DISCONNECT your infusion set from your body while on high-speed/high gravity amusement park thrill rides. Rapid changes in altitude or gravity can affect insulin delivery and cause injury.

DISCONNECT your 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). Rapid changes in altitude or gravity can affect insulin delivery and cause injury.

CONSULT your healthcare provider about lifestyle changes such as weight gain or loss, and starting or stopping exercise. Your insulin needs may change in response to lifestyle changes. Your basal rate(s) and other settings may need adjustment.

CHECK your blood glucose using a blood glucose meter following a gradual elevation change of up to 1,000 feet, such as when snow skiing or driving on a mountain road. Delivery accuracy can vary up to 15% until 3 units of total insulin have been delivered or elevation has changed by more than 1,000 feet. Changes in delivery accuracy can affect insulin delivery and cause injury.

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.

ENSURE that your personal insulin delivery settings are programmed into the pump before you use the System if you receive a warranty replacement. Failure to enter your insulin delivery settings could result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose which could result in serious injury or death. Consult your healthcare provider as needed.

Interference with your System’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 dispose of used System components such as cartridges, syringes, needles, and infusion sets following the instructions from your healthcare provider. Wash your hands thoroughly after handling used System components.
 

Important Safety Information - t:slim Insulin Pump

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.

 
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. 

 
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

 
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.

INDICATIONS FOR USE AND CONTRAINDICATIONS

 
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.

 
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. 

 
Warnings and Precautions 


/!\ 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 Anesthesia – 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 

/!\ EXTREME TEMPERATURES 
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. 

/!\ AMUSEMENT PARK RIDES 
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. 

/!\ AIRCRAFT WITHOUT CABIN PRESSURIZATION 
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). 

/!\ SMALL PARTS POTENTIALLY INGESTIBLE BY CHILDREN 
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. 

/!\ STRANGULATION OR ASPHYXIATION 
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. 

/!\ SUBMERSION IN FLUID 
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. 

/!\ AIR TRAVEL
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..
 

Important Safety Information - t:slim G4™ Insulin Pump


Indications for Use

The t:slim G4™ Insulin Pump with Dexcom G4® Platinum CGM (“t:slim G4 System”) consists of the t:slim G4 Insulin Pump paired with the Dexcom G4 Platinum Sensor and Transmitter.

The t:slim G4 Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The t:slim G4 Insulin Pump can be used solely for continuous insulin delivery and as part of the t:slim G4 System to receive and display continuous glucose measurements from the Dexcom G4 Platinum Sensor and Transmitter.

The t:slim G4 System also includes continuous glucose monitoring (CGM) indicated for detecting trends and tracking patterns in persons with diabetes for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The t:slim G4 System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the t:slim G4 System results should be based on the trends and patterns seen with several sequential readings over time.
The t:slim G4 System is indicated for use in individuals 12 years of age and greater.
The t:slim G4 System is intended for single patient use and requires a prescription.


Contraindications

The t:slim G4 System 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 System alerts.

The t:slim G4 Pump, Dexcom G4 PLATINUM Transmitter, and Dexcom G4 PLATINUM Sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. Exposure to MRI, CT, or diathermy treatment can damage the System.

Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.


System Warnings


/!\ WARNINGS – t:slim G4 Insulin Pump

DO NOT start to use your t:slim G4 System before reading the User Guide. Failure to follow the instructions in the User Guide can result in over delivery or under delivery of insulin. This can cause very low or very high blood glu­cose which could result in serious injury or death. If you have questions or need further clarification on your System use, ask your healthcare provider or call our around-the-clock Customer Technical Support Department at (877) 801- 6901.

DO NOT start to use your t:slim G4 System before you have been appro­priately trained on its use by a certified t:slim G4 System trainer. Consult with your healthcare provider for your individual training needs for the entire G4 System. Failure to complete the necessary training on the System could result in serious injury or death.

DO NOT use any other insulin with your System other than U-100 Humalog® or NovoLog®. Only Humalog® and NovoLog® have been tested and found to be compatible for use in the System. Use of insulin with lesser or greater concentration can result in under delivery or over delivery of insulin. This can cause very high or a very low blood glucose.

DO NOT put any other drugs or medications inside your System cartridge. The System is designed only for Continuous Subcutaneous Insulin Infusion (CSII) using Humalog® or NovoLog® insulin. Use of other drugs or medications can damage the pump and result in injury if infused.

DO NOT start to use your System 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 very low or very high blood glucose.

DO be prepared to inject insulin with an alternative method if delivery is interrupted for any reason. Your t:slim G4 System 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 blood glucose or Diabetic Ketoacidosis (DKA).

DO use only FDA cleared insulin infusion sets with a standard Luer-lock connection and follow their instructions for use. Failure to do so may result in over delivery or under delivery of insulin and may cause very low or very high blood glucose.

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 blood glucose.

DO NOT ignore infusion set cannula fractures. Infusion set cannulas may fracture on rare occasions. If an infusion set cannula breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken infusion set cannula, please report this to Tandem Customer Technical Support at (877) 801-6901.

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 serious injury or death from very low blood glucose.

DO NOT reuse cartridges or use cartridges other than those manufactured by Tandem Diabetes Care, Inc. Use of cartridges not manufactured by Tandem Diabetes Care, Inc. or reuse of cartridges may result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose.

ALWAYS twist the Luer-lock connection between the cartridge tubing and the infusion set tubing an extra quarter of a turn to ensure a secure connection. A loose connection can cause insulin to leak, resulting in under delivery of insulin. This can cause high blood glucose.

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 your body before tightening. Failure to disconnect before tightening can result in over delivery of insulin. This can cause low blood glucose.

DO NOT remove or add insulin from a filled cartridge after loading onto the pump. This will result in an inaccurate display of the insulin level on the Home Screen and you could run out of insulin before the pump detects an empty cartridge. This can cause very high blood glucose, or Diabetic Ketoacidosis (DKA).

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 cause very high or very low blood glucose. You can always adjust the insulin units up or down before you decide to deliver your bolus.

DO ensure that your System is kept away from small children when not in use. The System includes small parts (such as the rubber USB port cover, cartridge components, and transmitter) that could pose a choking hazard for small children. The System includes parts (such as the USB cable and tubing) that could pose a strangulation or asphyxiation hazard.

ALWAYS arrange cables and tubing to minimize the risk of strangulation.

ENSURE that these parts are stored in a secure place when not in use.

/!\ WARNING – Radiology and Medical Procedures and your t:slim G4 System


ALWAYS notify the provider/technician about your diabetes and your t:slim G4 System. If you need to discontinue use of the System for medical 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.

DO NOT expose your pump, transmitter or sensor to:

  • X-ray
  • Computed Tomography (CT) scan
  • Magnetic Resonance Imaging (MRI)
  • Positron Emission Tomography (PET) scan
  • Other exposure to radiation
You must take off your pump, transmitter, and sensor and leave them outside the procedure room if you are going to have any of the above procedures.

In addition to the above, DO NOT expose your pump, transmitter, or sensor to:

  • Pacemaker/Automatic Implantable Cardioverter Defibrillator (AICD) placement or reprogramming
  • Cardiac Catheterization
  • Nuclear Stress Test
You must take off your pump, transmitter, and sensor and leave them outside the procedure room if you are going to have any of the above medical procedures.

There are other procedures where you should proceed with caution:

  • Laser Surgery – Your System can usually be worn during the procedure. However, some lasers can create interference and cause the System to alarm.
  • General Anesthesia – Depending on the equipment being used, you may or may not need to remove your System. 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

 
/!\ WARNINGS – Using Dexcom G4 PLATINUM CGM with your t:slim G4 Insulin Pump


DO NOT use CGM for treatment decisions, such as how much insulin you should take. CGM does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT ignore symptoms of high and low glucose. If your sensor glucose alerts and readings do not match your symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range. Solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decisions.

In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose.

CALIBRATE your CGM at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate and glucose alerts to become unreliable. This could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia high blood glucose) events.

DO NOT ignore sensor fractures. Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to Tandem Diabetes Care Customer Technical Support at 1-877-801-6901.

DO NOT use Dexcom G4 PLATINUM CGM in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations. Sensor glucose readings may be inaccurate in these populations and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT use Dexcom G4 PLATINUM CGM in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the System. Sensor glucose readings may be inaccurate in critically ill patients, and solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT insert the sensor in sites other than the abdomen (belly) or upper buttocks (for ages 12–17 only). Other sites have not been studied and are not approved. Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT expect CGM alerts until after the 2-hour startup. You will NOT get any sensor glucose readings or alerts until after the 2-hour startup ends AND you complete the startup calibration. During this time you might miss severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT use your transmitter if it is damaged/cracked. This could create an electrical safety hazard or malfunction, which might cause electrical shocks.

STORE the Dexcom G4 PLATINUM CGM sensor at temperatures between 36°F to 77°F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you might miss severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT allow young children to hold the sensor, transmitter or transmitter kit box without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard. Keep the transmitter kit box away from young children; it contains a magnet that should not be swallowed.

 
System Precautions

 
/!\ PRECAUTIONS – t:slim G4 Insulin Pump


DO NOT open or attempt to repair your System. The System is a sealed device that should be opened and repaired only by Tandem Diabetes Care, Inc. Modification could result in a safety hazard. If your System seal is broken, the System is no longer watertight and the warranty is voided.

CHANGE your infusion set every 48 to 72 hours as recommended by your healthcare provider. Wash your hands with anti-bacterial soap before handling the infusion set and thoroughly clean the insertion site on your body to avoid infection. Contact your healthcare provider if you have symptoms of infection at your insulin infusion site.

ALWAYS remove all air bubbles from the System before beginning insulin delivery. Ensure there are no air bubbles when drawing insulin into the filling syringe, hold the pump with the white fill port pointed up when filling the tubing, and ensure that there are no air bubbles in the tubing when filling. Air in the system takes space where insulin should be and can affect insulin delivery.

CHECK your infusion site daily for proper placement and leaks. REPLACE your infusion set if you notice leaks around the site. Improperly placed sites or leaks around the infusion site can result in under delivery of insulin.

CHECK your infusion set tubing daily for any leaks, air bubbles, or kinks. Air in the tubing, leaks in the tubing, or kinked tubing may restrict or stop insulin delivery and result in under delivery of insulin.

CHECK the Luer-lock connection between your cartridge tubing and infusion set tubing daily to ensure it is tight and secure. Leaks around the Luer-lock connection can result in under delivery of insulin.

DO NOT change 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. 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 check that your cartridge has enough insulin to last through the night before going to bed. If you are sleeping, you could fail to hear the Empty Cartridge Alarm and miss part of your basal insulin delivery.

CHECK your System’s personal settings regularly to ensure they are correct. Incorrect settings can result in over delivery or under delivery of insulin. Consult with your healthcare provider as needed.

ALWAYS make sure that the correct time and date are set on your System. 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. Not having the correct time and date setting may affect safe insulin delivery.

CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button when you connect a power source to the USB port. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of the System and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

CHECK your System regularly for potential alarm conditions that may display. It is important to be aware of conditions that may affect insulin delivery and require your attention so you can respond as soon as possible.

DO NOT use the vibrate feature for alerts and alarms during sleep unless otherwise directed by your healthcare provider. Having the volume for alerts and alarms set to high will help ensure that you don’t miss an alert or alarm.

ALWAYS look at the screen to confirm correct programming of the bolus amount when you first use the Quick Bolus feature. Looking at the screen will ensure that you are correctly using the beep/vibration commands to program the intended bolus amount.

DO NOT use your pump if you think it might be damaged due to dropping it or hitting it against a hard surface. Check that the System is working properly by plugging a power source into the USB port and confirming that the display turns on, you hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button. If you are unsure about potential damage, discontinue use of the System and contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901.

AVOID exposure of your System to temperatures below 40°F (5°C) or above 99°F (37°C). Insulin can freeze at low temperatures or degrade at high temperatures. Insulin that has been exposed to conditions outside of the manufacturer’s recommended ranges can affect the safety and performance of the System.

AVOID submersing your pump in fluid beyond a depth of 3 feet or for more than 30 minutes (IPX7 rating). If your pump has been exposed to fluid beyond these limits, check for any signs of fluid ingress. If there are signs of fluid entry, discontinue use of the pump and contact Tandem Diabetes Care Customer Technical Support at (877) 801-6901.

AVOID areas where there may be flammable anesthetics or explosive gases. The System is not suitable for use in these areas and there is a risk of explosion. Remove your pump if you need to enter these areas.

MAKE SURE to not move further than the length of the USB cable when you are connected to the pump and to a charging source. Moving further than the length of the USB cable may cause the cannula to be pulled out of the infusion site. For this reason it is recommended not to charge the pump while sleeping.

DISCONNECT your infusion set from your body while on high-speed/high gravity amusement park thrill rides. Rapid changes in altitude or gravity can affect insulin delivery and cause injury.

DISCONNECT your 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). Rapid changes in altitude or gravity can affect insulin delivery and cause injury.

CONSULT your healthcare provider about lifestyle changes such as weight gain or loss, and starting or stopping exercise. Your insulin needs may change in response to lifestyle changes. Your basal rate(s) and other settings may need adjustment.

CHECK your blood glucose using a blood glucose meter following a gradual elevation change of up to 1,000 feet, such as when snow skiing or driving on a mountain road. Delivery accuracy can vary up to 15% until 3 units of total insulin have been delivered or elevation has changed by more than 1,000 feet. Changes in delivery accuracy can affect insulin delivery and cause injury.

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.

ENSURE that your personal insulin delivery settings are programmed into the pump before you use the System if you receive a warranty replacement. Failure to enter your insulin delivery settings could result in over delivery or under delivery of insulin. This can cause very low or very high blood glucose which could result in serious injury or death.  Consult your healthcare provider as needed. 

Interference with your System’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 dispose of used System components such as cartridges, syringes, needles, infusion sets, and CGM sensors following the instructions from your healthcare provider. Wash your hands thoroughly after handling used System components.

/!\ PRECAUTIONS – Using Dexcom G4 PLATINUM CGM with your t:slim G4 Insulin Pump


DO NOT open the sensor package until you have washed your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.

DO NOT insert the sensor until you have cleaned the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allowed the skin to dry. Inserting into unclean skin might lead to infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better.

AVOID using the same spot repeatedly for sensor insertion. Rotate your sensor placement sites, and do not use the same site for two sensor sessions in a row. Using the same site might cause scarring or skin irritation.

AVOID inserting the sensor in areas that are likely to be bumped, pushed or compressed, or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might affect accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

AVOID injecting insulin or placing an infusion set within 3 inches of the sensor. The insulin might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection. To calibrate the CGM System, DO enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Do not enter sensor glucose readings for calibration. Entering incorrect blood glucose values, blood glucose values obtained more than 5 minutes before entry, or sensor glucose readings might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling. Calibrating during significant rise or fall of blood glucose may affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. The System accuracy may be affected when your glucose is changing at a significant rate (e.g., 2 to 3 mg/dL/min or more than 3 mg/dL each minute), such as during exercise or after a meal.

AVOID separating the transmitter and pump by more than 20 feet. The transmission range from the transmitter to the pump is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc. Types of obstruction differ and have not been tested. If your transmitter and pump are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor accuracy and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

ENSURE that your transmitter ID is programmed into the pump before you use the System if you receive a warranty replacement pump. The pump cannot communicate with the transmitter unless the transmitter ID is entered. If the pump and transmitter are not communicating, you will not receive sensor glucose readings and you might miss severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

DO NOT discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life.

The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible with the SEVEN/SEVEN PLUS Transmitter and Receiver. Different generations will not connect with each other and will not work.


Potential Benefits From Using the System

  • The t:slim G4 System provides an automated way to deliver basal and bolus insulin. Delivery can be fine-tuned based on up to 6 customizable Personal Profiles, each with up to 16 time-based settings for Basal Rate, Carb Ratio, Correction Factor, and Target BG. In addition, the Temp Rate feature allows you to program a temporary basal rate change for up to 72 hours.
  • The t:slim G4 System gives you the option of delivering a bolus all at once, or delivering a percentage over an extended period of time without navigating to different menus. You can also program a bolus more discreetly using the Quick Bolus feature, which can be used without looking at the pump, and can be programmed in increments of either units of insulin or grams of carbohydrate. 
  • From the bolus screen, the “calculator within a calculator” feature allows you to enter multiple carbohydrate values and add them together. The System’s bolus calculator will recommend a bolus based on the entire amount of carbohydrates entered, which can help eliminate guesswork.
  • The System keeps track of the amount of active insulin from food and correction boluses (IOB). When programming additional food or correction boluses, the pump will subtract the amount of IOB from the recommended bolus if your BG is below the target set in your active Personal Profile. This can help prevent insulin stacking, which can lead to hypoglycemia.
  • You can program a number of reminders that will prompt you to retest your BG after a low or high BG is entered, as well as a “Missed Meal Bolus Reminder” which will alert you if a bolus isn’t entered during a specified period of time. If activated, these can help reduce the likelihood that you will forget to check your blood glucose or bolus for meals. You have the ability to view a variety of data right on your screen, including the time and amount of your last bolus, your total insulin delivery by day, as well as broken into basal, food bolus, and correction bolus.
  • When paired with Dexcom G4 PLATINUM Transmitter and Sensor, your t:slim G4 System can receive CGM readings every 5 minutes, which are displayed as a trend graph on the Home Screen. You can also program your pump to alert you when your CGM readings are above or below a given level, or are rising or falling quickly. Unlike the readings from a standard blood glucose meter, CGM readings allow you to view trends in real time, as well as capture information when you would otherwise be unable to check your blood sugar, such as while you are asleep. This information can be useful for you and your health care provider when considering changes to your therapy. In addition, the programmable alerts can help you to spot potential low or high blood glucose sooner than you would using a only a blood glucose meter.
  • CGM use has been shown to increase time in your target glucose range, without increasing time spent above or below your target range. Real-time CGM can help improve diabetes control  (lower A1c values, reducing glycemic variability and time spent in low and high blood glucose  ranges)1, 2, 3 which can help reduce diabetes related complications.4, 5 These benefits can be seen especially with using realtime CGM at least 6 days per week2 and can be sustained over time.6 In some cases, patients perceived an increase in their quality of life and peace of mind when using real-time CGM as well as reporting a high satisfaction with CGM.7
1 Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006; 29:44-50.  2 JDRF CGM Study Group. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes. NEJM 2008;359:1464-76.  3 Battelino. Effect of continuous glucose monitoring of hypoglycemia in type 1 diabetes. Diabetes Care 2011; 34(4):795-800.  4 The Diabetes Control and Complications Research Group. The effect of intensive treatment of diabetes on the development and progression of longterm complications of insulin-dependent diabetes mellitus. N Eng J Med. 1993; 329:997-1036.  5 Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents progression of diabetic microvascular complications in Japanese patients with non-insulin dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995; 28:103-117.  6 JDRF CGM Study Group. Sustained Benefit of Continuous Glucose Monitoring on A1c, Glucose Profiles, and Hypoglycemia in Adults With Type 1 Diabetes, Diabetes Care 2009; 32:2047-2049.  7 JDRF CGM Study Group. Quality-of-Life Measures in Children and Adults With Type 1 Diabetes. Diabetes Care 2010; 33: 2175-2177.


Possible Risks From Using the System

As with any medical device, there are risks associated with using the t:slim G4 System. Many of the risks are common to insulin therapy in general, but there are additional risks associated with continuous insulin infusion and continuous glucose monitoring. Reading your User Guide and following the Instructions for Use are critical for the safe operation of your system. Consult your health care provider about how these risks may impact you.

Risks associated with using the pump functionality of the System

Inserting and wearing an infusion set might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration).

There is a remote chance that an infusion set cannula fragment could remain under your skin if the cannula breaks while you are wearing it. If you think a cannula has broken under your skin, contact your healthcare provider and call Tandem Diabetes Care Customer Technical Support at 1-877-801-6901.

Other risks associated with infusion sets include occlusions and air bubbles in the tubing, which can affect insulin delivery.

Risks that could result from pump failure include the following:

  • possible hypoglycemia (low blood glucose) from over-delivery of insulin due to a hardware defect 
  • hyperglycemia (high blood glucose) and ketosis possibly leading to Diabetic Ketoacidosis (DKA) due to pump failure resulting in cessation of insulin delivery due to either a hardware defect or software anomaly.
Risks associated with using the CGM functionality of the System

Inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain and skin irritations (readiness, swelling, bruising, itching, scarring, or skin discoloration).

There is a remote chance that a sensor fragment could remain under your skin if the sensor breaks while you are wearing it. If you think a sensor has broken under your skin, contact your healthcare provider and call Tandem Diabetes Care Customer Technical Support at 1-877-801-6901.

Other risks associated with CGM use include the following:

  • You will not get sensor glucose alerts when the alert function is turned off, your transmitter and pump are out of range, or when your pump is not showing sensor glucose readings. You might not notice alerts if you are unable to hear them or feel the vibration.
  • There are a number of risks as a result of the fact that the Dexcom G4 PLATINUM CGM takes readings from fluid below the skin (interstitial fluid) instead of blood. There are differences in how glucose is measured in the blood compared to how it is measured in interstitial fluid, and glucose is absorbed into the interstitial fluid slower than it is absorbed into the blood, which can cause CGM readings to lag behind readings from a blood glucose meter. A CGM is intended to enhance the data you obtain from your blood glucose meter, not replace it. You should never rely solely on your CGM to alert you of high or low blood glucose, and you should always use your blood glucose meter for any treatment decisions.


Working with your Healthcare Provider

Any clinical language presented in this User Guide 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 to 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 the System 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. 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.


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 syringe
  • Infusion sets (minimum of 2)
  • Insulin pump cartridges (minimum of 2)
  • Infusion site preparation products (antiseptic wipes, skin adhesive)
  • Diabetes identification card or Jewelry

 
Verification of Proper Functionality

A power supply (AC adapter with micro-USB connector) is provided as part of the System. Before using your System, ensure that the following occur when you connect a power supply into the USB port of your t:slim G4 Pump:

  • 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 the System, 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


CONFIRM that the screen display turns on, you can hear audible beeps, feel the pump vibrate, and see the green LED light blinking around the edge of the Screen On Button when you connect a power source to the USB port. These features are used to notify you about alerts, alarms, and other conditions that require your attention. If these features are not working, discontinue use of the System and contact Tandem Diabetes Care Customer Technical Support at 1-877-801-6901.

 
Wireless Co-existence, Quality of Service (QoS), and Data Security

The t:slim G4 System is designed to work safely and effectively in the presence of wireless devices typically found at home, work, retail stores, and places of leisure where daily activities occur. See full User Guide for more information.

The t:slim G4 System is designed to accept Radio Frequency (RF) communication only from a linked Dexcom G4 PLATINUM Transmitter. RF communication is not established until you enter the unique Dexcom 5 digit Transmitter ID into your pump.

The t:slim G4 System and system components ensure data security via proprietary means and ensure data integrity using error checking processes, such as cyclic redundancy checks.
 

Important Safety Information - t:flex Insulin Pump

 
See below for important in­formation on how to operate your t:flex 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:flex 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.

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. 


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


Verification of Proper Functionality 

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: 

  • 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:flex 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: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.

INDICATIONS FOR USE AND CONTRAINDICATIONS
 

Indications for Use

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.

Contraindications

The t:flex 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. 

Warnings and Precautions 

/!\ WARNINGS 
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. 

/!\ RADIOLOGY AND MEDICAL PROCEDURES 

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: 

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

  • 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:flex Pump can usually be worn during the procedure. However, some lasers can create interference and cause the pump to alarm. 
  • General Anesthesia – 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 

/!\ EXTREME TEMPERATURES 

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. 

/!\ AMUSEMENT PARK RIDES 

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. 

/!\ AIRCRAFT WITHOUT CABIN PRESSURIZATION 

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). 

/!\ SMALL PARTS POTENTIALLY INGESTIBLE BY CHILDREN 

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. 

/!\ STRANGULATION OR ASPHYXIATION 

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. 

/!\ SUBMERSION IN FLUID 

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 Diabetes Care Customer Technical Support at (877) 801-6901. 

/!\ AIR TRAVEL

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: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. 

  • 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:flex 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:flex Pump. Damaged, leaking, or kinked tubing may restrict or stop insulin delivery and result in under-infusion. 
  • Check your t:flex Pump’s personal settings to ensure they are correct. 
  • Check your t:flex Pump’s audible tones and vibration to ensure they are easily detectable. 
  • Regularly check your t:flex Pump screen for potential failure conditions that may display. 
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 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: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