t:slim X2 Insulin Pump Precautions
DO NOT open or attempt to repair your insulin pump. The pump is a sealed device that should be opened and repaired only by Tandem Diabetes Care. Modification could result in a safety hazard. If your pump seal is broken, the pump 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 pump 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 tubing connection between your cartridge tubing and infusion set tubing daily to ensure it is tight and secure. Leaks around the tubing 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 BG 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 insulin pump’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 insulin pump. Not having the correct time and date setting may affect safe insulin delivery. When editing time, always check that the AM/PM setting is accurate, if using the 12 hour clock. AM is to be used from midnight until 11:59 AM. PM is to be used from noon until 11:59 PM.
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/Quick Bolus 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 pump and contact Customer Technical Support.
CHECK your pump 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 pump 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/Quick Bolus button. If you are unsure about potential damage, discontinue use of the pump and contact Customer Technical Support.
AVOID exposure of your pump to temperatures below 41°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 pump.
AVOID submerging your pump in fluid beyond a depth of 3 feet (0.91 m) 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 entry. If there are signs of fluid entry, discontinue use of the pump and contact Customer Technical Support.
AVOID areas where there may be flammable anesthetics or explosive gases. The pump 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 BG using a BG meter following a gradual elevation change of up to each 1,000 feet (305 meters), 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 (305 meters). 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 BG before disconnecting from the pump and again when you reconnect and treat high 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 BG which could result in serious injury or death. Consult your healthcare provider as needed.
Interference with your 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 (16.3 cm) apart.
ALWAYS dispose of used 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 components.
Using Dexcom G6 CGM with Your t:slim X2 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 BG) or hyperglycemia (high BG) events.
AVOID injecting insulin or placing an infusion set within 3 inches (7.6 cm) of the sensor. The insulin might affect sensor accuracy and could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) 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 Dexcom G6 CGM, ALWAYS enter the exact BG value that your BG meter displays within 5 minutes of a carefully performed BG measurement. Do not enter sensor glucose readings for calibration. Entering incorrect BG values, BG 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 BG) or hyperglycemia (high BG) events.
DO NOT calibrate if your BG 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 BG is rapidly rising or falling. Calibrating during significant rise or fall of BG may affect sensor accuracy and could result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) events.
Dexcom G6 CGM accuracy may be affected when your glucose is changing at a significant rate (i.e., 2-3 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 (6 meters). The transmission range from the transmitter to the pump is up to 20 feet (6 meters) without obstruction. Wireless communication does not work well through water so the range is reduced if you are in a pool, bathtub, or on a water bed, etc. To ensure communication, it is suggested that you face your pump screen out and away from the body, and wear the pump on the same side of the body that you wear your CGM. Types of obstruction differ and have not been tested. If your transmitter and pump are farther than 20 feet (6 meters) 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 BG) or hyperglycemia (high BG) events.
DO NOT use alternative BG site testing (blood from your palm or forearm, etc.) for calibration. Alternative site BG values may be different than those taken from a fingerstick BG value and may not represent the timeliest BG value. Use a BG value taken only from a fingerstick for calibration. Alternative site BG values might affect sensor accuracy and result in you missing severe hypoglycemia (low BG) or hyperglycemia (high BG) 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 BG) or hyperglycemia (high BG) 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 G6 sensor is not compatible with older versions of transmitters or receivers. Do not mix transmitters, receivers, and sensors from different generations.
Hydroxyurea is a medication used in the treatment of diseases including cancer and sickle cell anemia. It is known to interfere with glucose readings from the Dexcom sensor. The use of hydroxyurea will result in sensor glucose readings that are higher than actual glucose levels. The level of inaccuracy in sensor glucose readings is based on the amount of hydroxyurea in the body. Relying on sensor glucose values while taking hydroxyurea could result in missed hypoglycemia alerts or errors in diabetes management, such as giving a higher dose of insulin than necessary to correct falsely high sensor glucose values. It can also result in errors when reviewing, analyzing and interpreting historical patterns for assessing glucose control. DO NOT use the Dexcom CGM readings to make diabetes treatment decisions or assess glucose control when taking hydroxyurea.
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