Do you have a question about the T:Slim X2 and is the answer not in the manual?
Questions and answers
Nancy Pereira
March 24, 2025
Can I add more insulin to cartridge without using another new one. Or do u need a new cartridge every time ?
1 comments:
Mr. Anderson
March 24, 2025
You need a new cartridge each time. Reusing or refilling cartridges not manufactured by Tandem Diabetes Care, Inc. may result in incorrect insulin delivery, which can cause very low or very high blood glucose levels. Always use a new, unopened cartridge when filling and loading insulin into your t:slim X2 pump.
Table of Contents Section 1 – Before You Begin Chapter 1 – Introduction System Description .......................22 About this User Guide ....................22 Important User Information ...................23 Important Pediatric User Information ................23 Conventions of this Guide .....................25 Chapter 2 – Important Safety Information Indications for Use ......................28 Contraindications ......................28 System Warnings ......................29...
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Table of Contents 2.10 Wireless Co-existence and Data Security ......................43 Chapter 3 – Getting to Know Your t:slim X2 System What your t:slim X2 System Package Includes .............46 System Terminology ......................46 Explanation of System Symbols..................50 Explanation of System Icons ..................52 Explanation of System Colors ..................54...
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Section 2 – Key Pump Features Chapter 4 – Getting Started Charging the t:slim X2 Pump ..................80 Using the Touch Screen ....................82 Turning on the t:slim X2 Pump Screen ................82 Unlocking the t:slim X2 Pump Screen ................82 Edit Time ........................83 Edit Date ........................83 Chapter 5 –...
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Table of Contents Filling and Loading a t:slim Cartridge ................88 Filling Tubing .........................94 Filling Cannula .......................96 Setting Site Reminder ....................97 Chapter 6 – Personal Profiles Personal Profiles Overview ..................100 Creating a New Profile ....................100 Programming a New Personal Profile .................102 Editing or Reviewing an Existing Profile ..............105 Duplicating an Existing Profile ..................106 Activating an Existing Profile ..................106...
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Table of Contents Food Bolus Using Units....................110 Food Bolus Using Grams ....................111 Correction Bolus ......................112 Extended Bolus ......................113 Canceling or Stopping a Bolus..................114 Chapter 8 – Stop/Resume Insulin Stopping Insulin Delivery .....................118 Resuming Insulin Delivery ...................118 Section 3 – Additional Pump Operations Chapter 9 –...
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Chapter 11 – t:slim X2 Pump Settings 11.1 t:slim X2 Pump Volume ....................130 11.2 Screen Options ......................130 Chapter 12 – t:slim X2 Pump Info and History 12.1 t:slim X2 Pump Info .....................134 12.2 t:slim X2 Pump History ....................134 Chapter 13 – t:slim X2 Pump Reminders 13.1...
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Table of Contents Chapter 17 – t:slim X2 Pump Malfunction 17.1 Malfunction ........................182 Section 5 – Getting Started with Your CGM System Chapter 18 – Dexcom G5 Mobile CGM Overview 18.1 CGM System Overview ....................186 18.2 Sensor Overview ......................186 18.3 Receiver (t:slim X2 Pump) Overview ................188...
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Table of Contents 20.2 Setting Your Low Glucose Alert and Repeat Feature ..........199 20.3 Rate Alerts ........................200 20.4 Setting Your Rise Alert ....................201 20.5 Setting Your Fall Alert ....................201 20.6 Setting Your Out of Range Alert ..................202 Chapter 21 – Inserting the Sensor and Placing the Transmitter 21.1 Before You Start ......................204 21.2...
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Calibration Blood Glucose Value and Correction Bolus ......................219 23.4 12 Hour Calibration Update ..................219 23.5 Other Reasons You May Need to Calibrate ..............220 Chapter 24 – Viewing CGM Data on Your t:slim X2 Pump 24.1 Overview ........................222 24.2 CGM Trend Graphs .....................223 24.3 Rate of Change Arrows ....................225...
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Table of Contents 25.1 Automatic Sensor Shut-Off ..................232 25.2 Ending a Sensor Session Before Automatic Shut-Off ..........233 25.3 Removing the Sensor and Transmitter ................233 Section 6 – CGM Alerts, Errors and Troubleshooting Chapter 26 – CGM Alerts and Errors 26.1 Startup Calibration Alert ....................238 26.2 Second Startup Calibration Alert.................239...
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Table of Contents 26.13 CGM Fall Alert ......................250 26.14 CGM Rapid Fall Alert ....................251 26.15 Unknown Sensor Reading ...................252 26.16 Out of Range Alert .......................253 26.17 Low Transmitter Battery Alert ..................254 26.18 Transmitter Error ......................255 26.19 Failed Sensor Error ......................256 26.20 CGM Error ........................257 26.21...
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Section 7 – Living With and Caring for Your System Chapter 28 – Lifestyle Issues and Travel 28.1 Overview ........................268 Chapter 29 – Taking Care of Your t:slim X2 System 29.1 Overview ........................272 Section 8 – Technical Specifications and Warranty Chapter 30 –...
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Table of Contents 30.8 Electromagnetic Emissions ..................335 30.9 Electromagnetic Immunity ...................336 30.10 Distances Between the t:slim X2 Pump and RF Equipment ........338 30.11 Quality of Wireless Service ..................341 30.12 FCC Notice Concerning Interference ................341 30.13 Warranty Information ....................342 30.14 Returned Goods Policy ....................345...
System. It also provides important cover carbohydrates eaten (food bolus) The t:slim X2 Insulin Pump can be used warnings and cautions on proper and to lower high blood glucose (cor- for basal and bolus insulin delivery operation and technical information to rection bolus).
Chapter 1 – Introduction Important User Important Pediatric Mobile CGM with your t:slim X2 Insulin Information User Information Pump. Pump screens used in this Guide to Review all instructions in this User The following recommendations are demonstrate how to use features are Guide before using the System.
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Chapter 1 – Introduction changes can potentially lead to hypo- WARNING DO NOT allow small children (either glycemic or hyperglycemic events. pump users or non-users) to ingest small parts, such as the rubber USB WARNING port cover and cartridge components. For patients whose insulin adminis- Small parts could pose a choking tration is managed by a caregiver,...
Chapter 1 – Introduction Conventions of this Guide The following are conventions used in this Guide (such as terms, icons, text format- ting, and other conventions) along with their explanations. Convention Explanation Text that is in bold and in a different font than the rest of the sentence or step Bolded Text indicates an onscreen or physical button name.
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Chapter 1 – Introduction THIS PAGE IS INTENTIONALLY LEFT BLANK Customer Technical Support: (877) 801-6901...
Maintain sufficient diabetes self- • continuous insulin delivery and as part The device is indicated for use with care skills of the t:slim X2 System to receive and NovoLog or Humalog U-100 insulin. display continuous glucose measure- See your healthcare provider(s) •...
Taking medications with acetamino- greater concentration can result in un- phen (such as Tylenol) while wearing DO NOT start to use your t:slim X2 der delivery or over delivery of insulin. the sensor may falsely raise your System before reading the User Guide.
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Use of cartridges not manufactured by blood glucose, or Diabetic Ketoacido- low blood glucose. Tandem Diabetes Care, Inc. or reuse of sis (DKA). cartridges may result in over delivery or Customer Technical Support: (877) 801-6901...
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Medical Procedures reviewed the calculated bolus amount The Feature Lock function is intended and your t:slim X2 System on the pump display. If you dose an in- to prevent inadvertent button presses sulin amount that is too high or too low,...
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Chapter 2 – Important Safety Information The t:slim X2 System is magnetic can create interference and cause WARNINGS – Using Dexcom G5 Mobile CGM with your resonance (MR) Unsafe. You must take the System to alarm. t:slim X2 Insulin Pump...
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Chapter 2 – Important Safety Information report this to Tandem Diabetes Care DO NOT insert the sensor in sites the refrigerator if it is within this tem- Customer Technical Support at (877) other than the abdomen (belly) or perature range. The sensor should not 801-6901.
PLACE your infusion set if you notice enough insulin to last through the night paired only by Tandem Diabetes Care, leaks around the site. Improperly before going to bed. If you are sleep- Inc.
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Tandem Diabetes Care attention. If these features are not Check that the System is working Customer Technical Support at (877)
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Dexcom G5 Mobile insulin delivery and cause injury. and again when you reconnect, and treat high blood glucose (BG) levels CGM with your t:slim X2 Insulin Pump CONSULT your healthcare provider as recommended by your healthcare about lifestyle changes such as weight provider.
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Chapter 2 – Important Safety Information AVOID using the same spot repeatedly To calibrate the CGM System, DO significant rate (e.g., 2 to 3 mg/dL/min for sensor insertion. Rotate your sensor enter the exact blood glucose value or more than 3 mg/dL each minute), placement sites, and do not use the that your blood glucose meter displays such as during exercise or after a meal.
(low blood BG is below the target set in your glucose) or hyperglycemia (high blood The t:slim X2 System gives you the active Personal Profile. This can • glucose) events. option of delivering a bolus all at...
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(lower A1c 795-800. • Mobile Transmitter and Sensor, values, reducing glycemic variability your t:slim X2 System can receive and time spent in low and high The Diabetes Control and Complica- CGM readings every 5 minutes, blood glucose ranges) which tions Research Group.
Chapter 2 – Important Safety Information Possible Risks From JDRF CGM Study Group. Sustained call Tandem Diabetes Care Customer Using the System Benefit of Continuous Glucose Mon- Technical Support at (877) 801-6901. itoring on A1c, Glucose Profiles, and Hypoglycemia in Adults With Type 1...
Any clinical language presented in this broken under your skin, contact your User Guide is based on the assumption healthcare provider and call Tandem that you have been educated by your Diabetes Care Customer Technical healthcare provider on certain terms Support at (877) 801-6901.
Chapter 2 – Important Safety Information Emergency Kit termine and help you adjust your basal Infusion site preparation products • rate(s), insulin-to-carbohydrate ratio(s), (antiseptic wipes, skin adhesive) correction factor(s), blood glucose (BG) Make sure that you always have an in- target, and duration of insulin action.
Chapter 3 – Getting to Know Your t:slim X2 System What your t:slim X2 System Terminology Your t:slim X2 Pump is shipped from System Package Includes Tandem Diabetes Care, Inc. with a Pump Terminology clear screen protector. Do not remove Your t:slim X2 System should the screen protector.
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Chapter 3 – Getting to Know Your t:slim X2 System takes longer to digest. When admin- group of settings that defines the de- Cannula The cannula is the part of the infusion istering an extended bolus with your livery of basal and bolus insulin within...
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Chapter 3 – Getting to Know Your t:slim X2 System CGM Terminology System is unable to provide a sensor glucose reading. RF is the abbreviation for radio frequen- Alternate Site BG Testing cy. RF transmission is used to send Alternate site BG testing is when you...
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Chapter 3 – Getting to Know Your t:slim X2 System System Reading A System reading is a sensor glucose reading shown on your pump. This reading is in mg/dL units and is updat- ed every 5 minutes. Transmitter The transmitter is the part that snaps...
Explanation of System Symbols The following are symbols (and their descriptions), which you may find on your t:slim X2 System and/or its packaging. These symbols tell you about the proper and safe use of the system. Some of these symbols may not have meaning in the United States, and are listed for informational purposes only.
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Chapter 3 – Getting to Know Your t:slim X2 System Symbol Meaning Symbol Meaning Alternating Current Authorized Representative in the European Community Marking Certifies That the Device Meets the European Temporary Submersion Council Directive 93/42/EEC Vertically Falling Drops Do Not Use if Package is Damaged...
Chapter 3 – Getting to Know Your t:slim X2 System Explanation of System Icon Meaning Icons CGM sensor session is active, and the transmitter is communicating with the pump. The following icons may appear in the status area (to the left or right of the time and date) on your t:slim X2 Pump CGM sensor session is active, but the transmitter is not communicating with the pump.
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Chapter 3 – Getting to Know Your t:slim X2 System If a CGM session is active, the follow- Icon Meaning ing icons may appear on the screen in the place where your sensor glucose CGM sensor session is active, but the transmitter is not communicating with the pump.
Chapter 3 – Getting to Know Your t:slim X2 System Explanation of System Colors Red LED » 1 red blink every 30 seconds indicates a malfunction or alarm condition. Yellow LED » 1 yellow blink every 30 seconds indicates an alert or reminder condition.
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Chapter 3 – Getting to Know Your t:slim X2 System THIS PAGE IS INTENTIONALLY LEFT BLANK Customer Technical Support: (877) 801-6901...
Chapter 3 – Getting to Know Your t:slim X2 System Screen Lock 1. Time and Date Display: Displays 8. Insulin Level: Displays the current the current time and date. amount of insulin in the cartridge. 2. Alert Icon: Indicates a reminder, 9.
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Chapter 3 – Getting to Know Your t:slim X2 System 10:20 AM 100% March 5, 2017 235 u INSULIN ON BOARD (IOB) Units 1.1 u Time Remaining 1:09 hrs Customer Technical Support: (877) 801-6901...
Chapter 3 – Getting to Know Your t:slim X2 System CGM Screen Lock 1. Time and Date Display: Displays 10. Status: Displays current system the current time and date. settings and insulin delivery status. 2. Antenna: Indicates communication status between 11.
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Chapter 3 – Getting to Know Your t:slim X2 System 10:20 AM March 5, 2017 100% 235 u mg/dL INSULIN ON BOARD: 1.1 u 1:09 hrs Customer Technical Support: (877) 801-6901...
Chapter 3 – Getting to Know Your t:slim X2 System Home Screen 1. Battery Level: Displays the level 8. Insulin Level: Displays the current of battery power remaining. amount of insulin in the cartridge. When connected for charging, the charging icon (lightning bolt) 9.
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Chapter 3 – Getting to Know Your t:slim X2 System 10:20 AM 100% March 5, 2017 235 u BOLUS OPTIONS INSULIN ON BOARD (IOB) Units 1.1 u Time Remaining 1:09 hrs Customer Technical Support: (877) 801-6901...
Chapter 3 – Getting to Know Your t:slim X2 System CGM Home Screen 1. Time and Date Display: Displays 10. Status: Displays current system To view CGM information on the the current time and date. settings and insulin delivery full screen: status.
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Chapter 3 – Getting to Know Your t:slim X2 System 10:20 AM March 5, 2017 100% 235 u mg/dL INSULIN ON BOARD: 1.1 u 1:09 hrs OPTIONS BOLUS Customer Technical Support: (877) 801-6901...
Chapter 3 – Getting to Know Your t:slim X2 System 3.10 Status Screen The status screen can be accessed 8. Target BG: Displays current BG from the lock screen and the Home target used to calculate a bolus. Screen. It is for display only, no chang- es can be made from this screen.
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Chapter 3 – Getting to Know Your t:slim X2 System Current Status Current Status BACK BACK Correction 1u: 50 Weekly mg/dL Factor 1u: 10 g Basal Rate 0.2 u/hr Carb Ratio Last Bolus Target BG mg/dL 12/23 - 10:45 PM...
Chapter 3 – Getting to Know Your t:slim X2 System 3.11 Bolus Screen 1. Back: Returns to the 10. View Calculation: Displays how Home Screen. the insulin dose was calculated using the current settings. 2. Carbs: Enter grams of carb.
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Chapter 3 – Getting to Know Your t:slim X2 System Using Grams Using Units BACK NEXT BACK NEXT units units CARBS INSULIN Add BG Add BG grams units View Calculation View Calculation Customer Technical Support: (877) 801-6901...
Chapter 3 – Getting to Know Your t:slim X2 System 3.12 Options Screen 1. Back: Returns to the Home 9. Pump History: Displays historical Screen. log of pump events. 2. Stop Insulin: Stops insulin 10. CGM History: Displays historical delivery. If insulin delivery is log of CGM events.
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Chapter 3 – Getting to Know Your t:slim X2 System Options Options BACK BACK STOP INSULIN Load My Pump Pump History My CGM CGM History Temp Rate Customer Technical Support: (877) 801-6901...
Chapter 3 – Getting to Know Your t:slim X2 System 3.13 My Pump Screen 1. Personal Profiles: A group of settings that define basal and bolus delivery. 2. Alert Settings: Customize Pump Reminders and Alerts. 3. Pump Settings: Customize Quick Bolus, Pump Volume, Screen Options, and Time and Date.
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Chapter 3 – Getting to Know Your t:slim X2 System My Pump BACK Personal Profiles Alert Settings Pump Settings Pump Info Customer Technical Support: (877) 801-6901...
Chapter 3 – Getting to Know Your t:slim X2 System 3.14 My CGM Screen 1. Start Sensor: Starts a CGM session. If sensor is active, STOP SENSOR will be displayed. 2. Calibrate CGM: Enter a calibration blood glucose value. Only active when sensor session is active.
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Chapter 3 – Getting to Know Your t:slim X2 System My CGM BACK START SENSOR Calibrate CGM CGM Alerts CGM Settings Customer Technical Support: (877) 801-6901...
Chapter 3 – Getting to Know Your t:slim X2 System 3.15 Number Keypad Screen 1. Value Entered. 2. Back: Returns to previous screen. 3. Keypad Numbers. 4. +/=: Allows numbers to be added on gram screen. If in units, this displays as a decimal point.
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Chapter 3 – Getting to Know Your t:slim X2 System BACK DONE grams + / = Customer Technical Support: (877) 801-6901...
Chapter 3 – Getting to Know Your t:slim X2 System 3.16 Letter Keypad Screen 1. Name of Profile. 2. Back: Returns to previous screen. 3. Space: Enters a space. 4. 123: Changes keypad mode from letters (ABC) to numbers (123).
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Chapter 3 – Getting to Know Your t:slim X2 System Weekday BACK SAVE name space Customer Technical Support: (877) 801-6901...
Power Outlet: the Home Screen reads 100% (initial The t:slim X2 Pump is powered by an charge can take up to 2.5 hours). 1. Plug the included USB cable into internal lithium polymer rechargeable the AC power adapter.
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PRECAUTION Before using a Mac or PC to charge CONFIRM that the screen display turns on, you the t:slim X2 Pump, it is recommended can hear audible beeps, feel the pump vibrate, that a driver be installed on the com-...
Turning on the t:slim X2 Unlocking the t:slim X2 Pump Screen Pump Screen To turn on your t:slim X2 Pump screen, first press the Screen On/Quick Bolus The screen lock screen appears any- 1. To turn on your t:slim X2 Pump...
Edit Time Edit Date 7. Using the onscreen keypad, enter the hour and minutes. Verify and After powering up your t:slim X2 Pump tap DONE. 1. From the Time and Date screen for the first time, set the current time tap Edit Date.
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• are the abdomen, upper buttocks, Tandem Customer Technical Support at (877) infection. Contact your healthcare provider if 801-6901. hips, upper arms, and upper legs.
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Chapter 5 – Infusion Site Care and Loading Cartridge better absorption, but are more Areas of Body for Infusion Set Insertion comfortable. Keep in mind, using the same areas may cause scarring or lumps which can affect insulin absorption. Consult your healthcare provider to •...
Vial of Humalog or NovoLog • ® ® cartridge into your t:slim X2 Pump. The insulin single-use disposable cartridge can hold up to 300 units (3.0 mL) of insulin. Alcohol prep swab • WARNING 1 new infusion set •...
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Chapter 5 – Infusion Site Care and Loading Cartridge Instructions for Drawing Insulin from Vial into Syringe PRECAUTION 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.
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Chapter 5 – Infusion Site Care and Loading Cartridge 7. With needle still inserted into vial, turn vial and syringe upside down. Release syringe plunger. Insulin will begin to flow from the vial into the syringe. 8. Slowly pull back the plunger to the desired amount of insulin (see image C). 9.
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Chapter 5 – Infusion Site Care and Loading Cartridge Instructions for Filling the Cartridge 1. Inspect the cartridge package for any signs of damage. Discard any damaged product. 2. Open the package and remove the cartridge. 3. Hold the cartridge upright and gently insert the needle into the white insulin fill port on the cartridge (see image E).
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Chapter 5 – Infusion Site Care and Loading Cartridge 6. Withdraw the needle from the fill port. 7. Turn the syringe upright and pull down on the plunger (see image H). Flick the barrel to make sure that any air bubbles rise to the top. 8.
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Chapter 5 – Infusion Site Care and Loading Cartridge Instructions on How to Install Push on the circular fill port next to 6. Disconnect the infusion set from a Cartridge your body and tap NEXT to the cartridge tubing to slide the continue.
Chapter 5 – Infusion Site Care and Loading Cartridge Filling Tubing b. Remove the infusion set tubing Ensure there are no air bubbles when drawing insulin into the filling syringe, hold the pump cap from the tubing connector. Filling the Infusion Set Tubing Be careful to keep the tubing con- with the white fill port pointed up when filling with Insulin...
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Chapter 5 – Infusion Site Care and Loading Cartridge “Detecting Insulin” screen 3. Hold the pump vertically to ensure screen. You will see one of the following on any air in the cartridge will be dis- is displayed. the screen: pelled first.
Chapter 5 – Infusion Site Care and Loading Cartridge Filling Cannula The screen will return to the Load fill amount. Filling stops at this amount. menu if the Site Reminder is turned Filling the Infusion Set Cannula off. Tap DONE to resume insulin if with Insulin finished.
1. Tap SAVE if correct. Tap Edit NOTE: First Time Use Reminder if settings need to If this is the first time using your t:slim X2 be changed. Pump and a Personal Profile has not been defined, a screen will notify you that a 2.
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Creating Personal Profiles WARNING DO NOT start to use your System before The t:slim X2 Pump uses the settings You can create up to 6 Personal Pro- in your active profile to calculate the files, however, only 1 can be active at...
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Bolus Settings are as follows: delivery calculations when applicable. When a BG is entered during bolus Correction Factor (range: 1 unit:1 Carbs (default: off if no Carb Ratio programming, your t:slim X2 Pump will • • mg/dL to 1 unit:600 mg/dL) is defined) consider any active IOB and calculate an adjusted bolus if necessary.
Chapter 6 – Personal Profile Programming a New Timed Settings Tap once for first letter displayed, Personal Profile 2 quick taps for middle letter; and 12:00 AM BACK SAVE 3 quick taps for the third letter. Once the Personal Profile has been 6.
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Chapter 6 – Personal Profile 6. Using the onscreen keypad, enter 11. Tap BACK to set the Bolus the time (hour and minutes) that your insulin-to-carbohydrate ratio Settings. you want the segment to begin, (the grams of carb to be covered and tap DONE.
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3. Using the onscreen keypad, enter the desired time for the duration Tap NO to make changes. of insulin action (2–8 hrs) and tap DONE. 9. Tap Tandem Logo to return to the Home Screen. Customer Technical Support: (877) 801-6901...
Tap YES if entered data is correct. the onscreen keypad to enter changes. Tap DONE. Tap NO and make changes. 9. View recent changes and 15. Tap Tandem Logo to return to the tap SAVE. Home Screen. Customer Technical Support: (877) 801-6901...
Chapter 6 – Personal Profile Duplicating an Existing Activating an Existing 8. Tap the Timed Settings or Bolus Profile Profile Settings Panel to make changes to the new profile. 1. From the Home Screen, 1. From the Home Screen, tap OPTIONS. tap OPTIONS.
5. Tap Delete. rename the profile name (up to 16 characters) and tap SAVE. 6. Tap YES. “Profile Deleted” screen 7. Tap Tandem Logo to return to the Home Screen. is displayed. 7. Tap Tandem Logo to return to the Home Screen.
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4. Tap NEXT to confirm the units of Your t:slim X2 Pump offers you the insulin to be delivered. ability to deliver different boluses to cover carbohydrate intake (food bolus) 5.
Chapter 7 – Bolus Food Bolus Using Grams 6. Tap DELIVER. 6. Confirm Request. 7. The bolus initiated screen is 1. From the Home Screen, Tap YES if entered data is correct. temporarily displayed. tap BOLUS. Tap NO to go back to make 2.
Chapter 7 – Bolus Correction Bolus If BG is above the Target BG, a When your blood glucose is: message screen will indicate BG is 1. From the Home Screen, above Target. » Above Target BG: the insulin for the food bolus and the correction tap BOLUS.
Chapter 7 – Bolus Extended Bolus 4. Tap NEXT to confirm the units of 4. If desired, tap Add BG and using insulin to be delivered. the onscreen keypad enter BG The Extended Bolus feature allows you value. Tap DONE. to deliver part of the bolus now and You can always tap View Cal- culation to display the Delivery...
Chapter 7 – Bolus Canceling or Stopping 9. Use the onscreen keypad to enter 12. Tap NEXT. a Bolus the percentage of the bolus to DELIVER NOW and tap DONE. You can always tap View Units to display the breakdown of units to Canceling a Bolus If delivery For the DELIVER NOW portion, be delivered NOW versus LATER.
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Chapter 7 – Bolus Stopping a Bolus if delivery of the bolus Has Started: 1. Tap 1–2–3 to access the Home Screen. 2. Tap X (stop icon) to stop delivery. 3. Tap YES. The BOLUS STOPPED screen is displayed and the units delivered are calculated.
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When you stop all insulin delivery, Screen On/Quick Bolus Button any active bolus and any active temp once to turn on your t:slim X2 rate are immediately stopped. No in- Pump screen. sulin delivery can take place while your pump is stopped.
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Chapter 9 – Temporary Basal Rate Setting a Temp Rate be set to the maximum allowable rate 8. The Screen Lock screen will be for delivery. displayed with the icon indicating A Temp Rate is used to increase or a Temp Rate is active. decrease (by percentage) the current 1.
Chapter 9 – Temporary Basal Rate Stopping a Temp Rate To stop an active temp rate: 1. From the Home Screen, tap OPTIONS. 2. On the Options screen, tap X (stop icon) on the right side of Temp Rate. 3. On the confirmation screen, tap STOP.
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7. Tap Increment Amount. pressing a button. It is a way to deliver to look at the t:slim X2 Pump’s screen. a bolus by following beep/vibration 8. Select the preferred increment Simply use the Quick Bolus Button to commands without navigating through amount.
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Chapter 10 – Quick Bolus 3. The pump will beep/vibrate once additional button presses to notify you). for each increment pressed to Look at the screen to confirm the bolus confirm desired amount. amount. » If you hear a different tone at any point 4.
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Chapter 11 – t:slim X2 Pump Settings 11.1 t:slim X2 Pump Volume 11.2 Screen Options 6. Select preferred volume. Pump Volume is pre-set to high. A 7. Continue to make changes for The Screen Options for your t:slim X2 change to the Pump Volume can be...
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Chapter 11 – t:slim X2 Pump Settings 5. Tap desired option. NOTE: Pump Volume When Feature Lock is turned on, Pump Volume will be set to high until the Feature For Screen Timeout Lock is turned off. 1. Tap Screen Timeout.
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Chapter 12 – t:slim X2 Pump Info and History 12.1 t:slim X2 Pump Info 12.2 t:slim X2 Pump History by date. The event details in each report are listed by time. Your t:slim X2 Pump allows access to Pump History displays a historical log information about your pump.
Chapter 13 – t:slim X2 Pump Reminders 13.1 Low BG Reminder Your t:slim X2 Pump lets you know every 10 minutes until acknowledged. important information about the System Reminders do not escalate. with Reminders, Alerts, and Alarms. Re- The Low BG Reminder prompts you...
Chapter 13 – t:slim X2 Pump Reminders 13.2 High BG Reminder using the onscreen keypad, enter ing the onscreen keypad, enter a a Low BG value (from 70 to 120 High BG value (from 150 to 300 mg/dL) that you want to trigger...
Chapter 13 – t:slim X2 Pump Reminders 13.3 After Bolus BG Reminder 13.4 Missed Meal Bolus 7. Tap SAVE when all changes Reminder are complete. The After Bolus BG Reminder prompts you to test your BG at a selected time The Missed Meal Bolus Reminder lets 8.
Chapter 13 – t:slim X2 Pump Reminders 13.5 Site Reminder 6. On the Missed Meal Bolus screen, 7. Tap Tandem Logo to return to tap which reminder you want to the Home Screen. set (Reminder 1 to 4) and do the The Site Reminder prompts you to change your infusion set.
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(from 10 to Your t:slim X2 Pump keeps track 40 units) that you want the Low Your t:slim X2 Pump can stop insulin of how much insulin remains in the delivery and alert you (or whoever is Insulin Alert value to be set, and cartridge and alerts you when it is low.
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(refer to Chapter 8.2). If you do not clear the warning within 9. Tap Tandem Logo to return to the 30-second countdown period, the the Home Screen. AUTO-OFF ALARM occurs, accom- panied by an audible alarm.
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Chapter 15 – t:slim X2 Pump Alerts Your t:slim X2 Pump lets you know NOTE: CGM Alerts important information about the System There is an additional list of Alerts and Errors with Reminders, Alerts, and Alarms. Re- related to CGM use in Chapter 26.
Chapter 15 – t:slim X2 Pump Alerts 15.1 Low Insulin Alert What will I see on the Screen? What does it mean? 5 units or less of insulin remain in the cartridge. LOW INSULIN ALERT How will the System notify me? Change cartridge or pump will stop all deliveries.
Chapter 15 – t:slim X2 Pump Alerts 15.2 Low Power Alerts Low Power Alert 1 What does it mean? What will I see on the Screen? Less than 25% of battery power remains. How will the System notify me? LOW POWER ALERT...
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Chapter 15 – t:slim X2 Pump Alerts Low Power Alert 2 What does it mean? What will I see on the Screen? Less than 5% of battery power remains. Insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop.
Chapter 15 – t:slim X2 Pump Alerts 15.3 Incomplete Bolus Alert What will I see on the Screen? What does it mean? You started a bolus request but did not complete the request within 90 seconds. INCOMPLETE BOLUS ALERT How will the System notify me? This bolus has not been delivered.
Chapter 15 – t:slim X2 Pump Alerts 15.4 Incomplete Temp Rate Alert What will I see on the Screen? What does it mean? You started to set up a temp rate but did not complete the request within 90 seconds.
Chapter 15 – t:slim X2 Pump Alerts 15.5 Incomplete Load Sequence Alerts Incomplete Cartridge What does it mean? Change Alert You selected Change Cartridge from the Load menu but did not complete the process What will I see on the Screen? within 3 minutes.
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Chapter 15 – t:slim X2 Pump Alerts Incomplete Fill Tubing Alert What does it mean? What will I see on the Screen? You selected Fill Tubing from the Load menu but did not complete the process within 3 minutes. FILL TUBING ALERT...
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Chapter 15 – t:slim X2 Pump Alerts Incomplete Fill Cannula Alert What does it mean? What will I see on the Screen? You selected Fill Cannula from the Load menu but did not complete the process within 3 minutes. FILL CANNULA ALERT...
Chapter 15 – t:slim X2 Pump Alerts 15.6 Incomplete Setting Alert What will I see on the Screen? What does it mean? You started to set up a new Personal Profile but did not save or complete the programming within 5 minutes.
Chapter 15 – t:slim X2 Pump Alerts 15.7 Basal Rate Required Alert What will I see on the Screen? What does it mean? You did not enter a basal rate in a time segment in Personal Profiles. A basal rate must be entered in each time segment (rate can be 0 u/hr).
Chapter 15 – t:slim X2 Pump Alerts 15.8 Max Hourly Bolus Alert What will I see on the Screen? What does it mean? In the previous 60 minutes, you requested total bolus delivery that is more than 1.5 times your Max Bolus setting.
Chapter 15 – t:slim X2 Pump Alerts 15.9 Max Bolus Alerts Max Bolus Alert 1 What does it mean? What will I see on the Screen? You requested a bolus larger than the Max Bolus setting in your active Personal Profile.
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Chapter 15 – t:slim X2 Pump Alerts The following applies only if you have Carbs turned on in your active Personal Profile and your Max Bolus amount is set to 25 units. Max Bolus Alert 2 What does it mean? What will I see on the Screen? Your Max Bolus is set to 25 units and you requested a bolus larger than 25 units.
Chapter 15 – t:slim X2 Pump Alerts 15.10 Max Basal Alerts Max Basal Alert 1 What does it mean? What will I see on the Screen? When entering a basal rate or requesting a temp rate, you requested a basal rate more than 2 times the highest basal rate defined in your Personal Profile.
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Chapter 15 – t:slim X2 Pump Alerts Max Basal Alert 2 What does it mean? What will I see on the Screen? An active temp rate exceeded 2 times your highest basal setting defined in your Personal Profile. MAX BASAL ALERT...
Chapter 15 – t:slim X2 Pump Alerts 15.11 Min Basal Alerts Min Basal Alert 1 What does it mean? What will I see on the Screen? When entering a basal rate or requesting a temp rate, you requested a basal rate less than half of the lowest basal rate defined in your Personal Profile.
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Chapter 15 – t:slim X2 Pump Alerts Min Basal Alert 2 What does it mean? What will I see on the Screen? An active temp rate dropped below half of your lowest basal setting defined in your Personal Profile. MIN BASAL ALERT...
What will I see on the Screen? What does it mean? You connected your t:slim X2 Pump to a computer with the USB cable to charge it or upload data to t:connect and a connection could not be made. CONNECTION ERROR ALERT Pump cannot connect with the computer.
15.13 Power Source Alert What will I see on the Screen? What does it mean? You connected your t:slim X2 Pump to a power source that does not have enough power to charge the pump. POWER SOURCE ALERT The pump cannot charge using the current power source.
Chapter 15 – t:slim X2 Pump Alerts 15.14 Data Error Alert What will I see on the Screen? What does it mean? Your t:slim X2 Pump encountered a condition that could potentially result in a loss of data. DATA ERROR ALERT Please verify that your active...
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Chapter 16 – t:slim X2 Pump Alarms Information in this section will help you PRECAUTION CHECK your System regularly for potential learn how to respond to Alarms. alarm conditions that may display. It is Alarms notify you with 3 sequences of 3...
Chapter 16 – t:slim X2 Pump Alarms 16.1 Resume Pump Alarm What will I see on the Screen? What does it mean? You tapped STOP INSULIN in the Options menu and insulin delivery has been stopped for more than 15 minutes.
Low Power Alarm 1 What does it mean? What will I see on the Screen? Your t:slim X2 Pump detected a power level of 1% or less remaining and all deliveries have stopped. LOW POWER ALARM How will the System notify me?
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Low Power Alarm 2 What does it mean? What will I see on the Screen? Your t:slim X2 Pump detected a voltage level too low to ensure normal performance and all deliveries have stopped. LOW POWER ALARM How will the System notify me?
Chapter 16 – t:slim X2 Pump Alarms 16.3 Empty Cartridge Alarm What will I see on the Screen? What does it mean? Your t:slim X2 Pump detected that the cartridge is empty and all deliveries have stopped. EMPTY CARTRIDGE ALARM ALL DELIVERIES STOPPED!
What will I see on the Screen? What does it mean? Your t:slim X2 Pump detected that the cartridge could not be used and all deliver- ies have stopped. This can be caused by cartridge defect, not following the proper...
Chapter 16 – t:slim X2 Pump Alarms 16.5 Cartridge Removal Alarm What will I see on the Screen? What does it mean? Your t:slim X2 Pump detected that the cartridge has been removed and all deliveries have stopped. CARTRIDGE ALARM ALL DELIVERIES STOPPED! How will the System notify me? The cartridge cannot be detected.
What will I see on the Screen? What does it mean? Your t:slim X2 Pump detected an internal temperature below 35˚F (2˚C) or above 113˚F (45˚C) or a battery temperature below 35˚F (2˚C) or above 125˚F (52˚C) and all deliver- TEMPERATURE ALARM ies have stopped.
16.7 Occlusion Alarms Occlusion Alarm 1 What does it mean? What will I see on the Screen? Your t:slim X2 Pump detected that insulin delivery is blocked and all deliveries have stopped. OCCLUSION ALARM How will the System notify me?
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Occlusion Alarm 2 What does it mean? What will I see on the Screen? Your t:slim X2 Pump detected a second occlusion alarm shortly after the first occlu- sion alarm and all deliveries have stopped. OCCLUSION ALARM How will the System notify me?
16.8 Screen On/Quick Bolus Button Alarm What will I see on the Screen? What does it mean? The Screen On/Quick Bolus Button (on the top of your t:slim X2 Pump) is stuck or not functioning properly and all deliveries have stopped. BUTTON ALARM...
What will I see on the Screen? What does it mean? Your t:slim X2 Pump detected a pressure difference between inside the cartridge and the surrounding air within the validated operating range of -1,300 feet to 10,000 feet ALTITUDE ALARM and all deliveries have stopped.
16.10 Reset Alarm What will I see on the Screen? What does it mean? Your t:slim X2 Pump detected that one if its micro-processors experienced a reset and all deliveries have been stopped. PUMP HAS BEEN RESET All active deliveries have been...
17.1 Malfunction What will I see on the Screen? What does it mean? Your t:slim X2 Pump detected a If your t:slim X2 Pump detects a sys- system error and all deliveries have tem error, the MALFUNCTION screen MALFUNCTION been stopped.
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Chapter 17 – t:slim X2 Pump Malfunction THIS PAGE IS INTENTIONALLY LEFT BLANK Customer Technical Support: (877) 801-6901...
Mobile Continuous Glucose Monitoring would otherwise be unable to check open the pack, your sensor looks like (CGM) with your t:slim X2 Pump. Use your blood sugar, such as while you are one item; however, it’s actually three: of Dexcom G5 Mobile CGM is optional asleep.
Chapter 18 – Dexcom G5 Mobile CGM Overview 18.3 Receiver (t:slim X2 Pump) 9. Bolus: Program and deliver To view CGM information on the Overview a bolus. full screen: From the Home Screen tap anywhere 1. Time and Date Display: Displays 10.
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Chapter 18 – Dexcom G5 Mobile CGM Overview 10:20 AM March 5, 2017 100% 235 u mg/dL INSULIN ON BOARD: 1.1 u 1:09 hrs OPTIONS BOLUS Customer Technical Support: (877) 801-6901...
Chapter 18 – Dexcom G5 Mobile CGM Overview 18.4 Transmitter Overview » Receiver or smart devices The transmitter battery will last at prompts you when battery is least 90 days. Once you see the Low Snapping into the sensor pod, the running low.
Your 4. Tap CGM Settings. ed to start the process again. t:slim X2 Pump and Dexcom G5 Mobile Transmitter wirelessly pair together 5. Tap Transmitter ID. 10. Once matching values have been using BLE communication.
Chapter 19 – CGM Settings 19.2 Setting CGM Volume HypoRepeat 3. If the alert is not confirmed in 5 Very similar to normal profile, but it more minutes, the system vibrates You can set the sound pattern and continuously repeats the fixed low alert and beeps louder.
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Chapter 19 – CGM Settings CGM Volume Details CGM Volume Vibrate Soft Normal HypoRepeat High Alert 2 long vibrates 2 long vibrates + 2 long vibrates + 2 long vibrates + 2 low beeps 2 medium beeps 2 medium beeps Low Alert 3 short vibrates 3 short vibrates +...
Chapter 19 – CGM Settings 19.3 CGM Info To Select Your CGM Volume: 1. From the Home Screen, CGM info contains important informa- tion about your device. The following tap OPTIONS. can be found in CGM info: 2. Tap My CGM. Firmware Revision •...
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Chapter 20 – Setting CGM Alerts 20.1 Setting Your High Glucose shows your target range. The default Setting Your CGM Alerts Alert and Repeat Feature You can create personal settings for for the High Alert is on, 200 mg/dL. how and when you want the System The default for the Low Alert is on, 80 to tell you what is happening.
Chapter 20 – Setting CGM Alerts 20.2 Setting Your Low Glucose Once a value is selected, the pump 8. Tap DONE. Alert and Repeat Feature will return to the previous screen. The repeat feature allows you to set a time for the High Alert to sound again 11.
Chapter 20 – Setting CGM Alerts 20.3 Rate Alerts Once a value is selected, the pump 8. Tap DONE. will return to the previous screen. The repeat feature allows you to set a Rate alerts tell you when your glucose time for the Low Alert to sound again levels are rising (Rise Alert) or falling 11.
Chapter 20 – Setting CGM Alerts 20.4 Setting Your Rise Alert 20.5 Setting Your Fall Alert CGM FALL ALERT 1. From the Home Screen, 1. From the Home Screen, tap OPTIONS. tap OPTIONS. Sensor readings are falling quickly. 2. Tap My CGM. 2.
Chapter 20 – Setting CGM Alerts 20.6 Setting Your Out of To Set Your Out of Range Alert: Range Alert 1. From the Home Screen, The range from the transmitter to the tap OPTIONS. pump is up to 20 feet without obstruc- tion.
Inserting the Sensor To use continuous glucose monitoring new sensor session. (CGM) with your t:slim X2 Pump, you Wash your hands thoroughly. • need a Dexcom G5 Mobile Sensor Make sure that the time on your •...
Chapter 21 – Inserting the Sensor and Placing the Transmitter 21.2 Removing the Sensor Review the CGM Sensor Applicator From its Packaging Picture Before Using a New Sensor 1. Plunger 5. Safety Lock PRECAUTION DO NOT use the sensor if its sterile package 2.
Chapter 21 – Inserting the Sensor and Placing the Transmitter 21.3 Choosing an Insertion Site 21.4 Placing the CGM Sensor from where rubbing can occur, such as along the waist band or seat belt strap. PRECAUTION 1. Clean your skin at the sensor Choose an area at least 3 inches AVOID inserting the sensor in areas that are placement site with an alcohol...
Chapter 21 – Inserting the Sensor and Placing the Transmitter 21.5 Inserting the CGM Sensor 3. Place the sensor horizontally (side 5. Hold the applicator and pull the to side) as shown in the picture. safety lock straight out away from Do not place the sensor vertically the applicator, in the direction of After you place the applicator on your...
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Chapter 21 – Inserting the Sensor and Placing the Transmitter 3. Place your thumb on the white 4. Keep pinching up on your skin 5. Squeeze the center of the ribbed plunger. Push the plunger down with one hand. Place two fingers release tabs on the sides of the completely, making sure it is flush under the collar.
The CGM transmitter wirelessly sends Installed 801-6901. your sensor glucose readings to your t:slim X2 Pump. You must snap the transmitter into the sensor pod after you insert your sensor. Follow the steps » You may want to pinch up on below to attach your transmitter.
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Chapter 21 – Inserting the Sensor and Placing the Transmitter » Make sure the transmitter is secure by sliding your fingers under each long side of the sensor pod and pressing down on the transmitter with your thumb of the same hand, like you are pinching it.
CGM Info screen to make 2-hour sensor startup has begun. sure the correct transmitter ID is entered. 6. Your t:slim X2 Pump will return to the CGM Home Screen with the 3 c. If the correct transmitter ID is hour trend graph displayed.
2-hour startup period ends and you complete your first calibrations. During the startup period, the CGM Home Screen on your t:slim X2 Pump shows a 2-hour countdown symbol in the upper right portion of the screen. The countdown symbol fills in over time to show that you are getting closer to the first calibration time.
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Chapter 22 – Starting a CGM Sensor Session For example, if you started your sensor If you started your sensor session 90 At the end of the 2-hour startup period, session 20 minutes ago, you would see minutes ago, you would see this you will be prompted to enter 2 this countdown symbol on the CGM countdown symbol on the CGM Home...
Chapter 23 – Calibrating Your CGM System 23.1 Calibration Overview When calibrating, you must enter your CONTRAINDICATION Taking medications with acetaminophen (such blood glucose values into the pump by Your CGM System needs calibra- hand. You can use any commercially as Tylenol) while wearing the sensor may tions using blood glucose (BG) values available blood glucose meter.
Chapter 23 – Calibrating Your CGM System 23.2 Startup Calibration Make sure the antenna symbol is to the test strip following your • visible to the right of the battery meter manufacturer’s instructions. indicator on the CGM Home Screen 2 hours after you start the sensor and is active (white, not greyed out) session, the CALIBRATE CGM screen PRECAUTION...
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Chapter 23 – Calibrating Your CGM System 8. Using the onscreen keypad, enter 11. The “CALIBRATION ACCEPTED” 17. Follow steps 9–11 to enter your the blood glucose value from your screen will appear. second blood glucose value. meter. The My CGM screen will appear. PRECAUTION 12.
Correction Bolus entered to calibrate. Calibrate your CGM System at least Your t:slim X2 Pump uses the blood every 12 hours after your first calibration 1. From the Calibrate CGM Screen, glucose value entered for calibration (2-hour startup calibration) to make sure Tap CLOSE.
Chapter 23 – Calibrating Your CGM System 23.5 Other Reasons You May 5. Using the onscreen keypad, enter 8. The “CALIBRATION ACCEPTED” Need to Calibrate the blood glucose value from screen will appear, followed by your meter. the CGM Home Screen or bolus You may need to calibrate when your prompt.
Chapter 24 – Viewing CGM Data on Your t:slim X2 Pump 24.1 Overview CONTRAINDICATION 10:20 AM Taking medications with acetaminophen (such March 5, 2017 100% 235 u During an active sensor session, CGM as Tylenol) while wearing the sensor may readings are sent to your t:slim X2 falsely raise your sensor glucose readings.
Chapter 24 – Viewing CGM Data on Your t:slim X2 Pump 24.2 CGM Trend Graphs If your sensor glucose reading is in 3 Hour Trend Graph (default view) • between your High and Low Alert shows you your current glucose settings, it is shown in white.
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Chapter 24 – Viewing CGM Data on Your t:slim X2 Pump 12 Hour Trend Graph shows you 1 Hour Trend Graph shows you LOW shows when your most recent your current glucose reading along your current glucose reading along sensor glucose reading is less than...
Chapter 24 – Viewing CGM Data on Your t:slim X2 Pump 24.3 Rate of Change Arrows display. If the trend arrow is missing, and you are concerned that your blood Your rate of change arrows add detail glucose level may be rising or falling,...
Chapter 24 – Viewing CGM Data on Your t:slim X2 Pump 24.4 Additional CGM Status The table below shows the different trend arrows your receiver displays: Symbols Constant: Your glucose is steady (not increasing/decreasing more than 1 mg/dL each The following symbols may also ap- minute).
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Chapter 24 – Viewing CGM Data on Your t:slim X2 Pump Startup Calibration Needed This symbol in the place where sensor glucose readings normally show means that you need to enter startup calibrations. It remains on the screen until you calibrate with BG values.
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Chapter 24 – Viewing CGM Data on Your t:slim X2 Pump Sensor Session Ended This symbol in the place where sensor glucose readings normally show means that your sensor session has ended. Wait 15 Minute Calibration Error Either symbol will be shown in place of where the sensor glucose readings normally show means that the sensor cannot calibrate right now.
Chapter 24 – Viewing CGM Data on Your t:slim X2 Pump 24.5 CGM History The Alerts and Errors section includes the date and time for all Alerts and CGM History displays the historical log Errors that occurred. The letter “D” (D: of CGM events.
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Your sensor gives you sensor glu- the place where sensor glucose cose readings for up to 7 days. The Your t:slim X2 Pump tells you how readings normally show. performance of the sensor has not much time you have left until your sen- been tested beyond 7 days.
New sensor glucose readings do PRECAUTION not show on your t:slim X2 Pump DO NOT discard your transmitter. It is reusable. after your sensor session ends. The same transmitter is used for each session...
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Chapter 25 – Ending Your CGM Sensor Session Method 1 Method 2 Safety Lock The safety lock that you removed from If you did not save the safety lock the applicator (see Chapter 21.4) can be when you inserted the sensor, you can used as a tool to remove the transmitter.
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Chapter 26 – CGM Alerts and Errors This section describes CGM alerts and errors that appear on your t:slim X2 Home Screen. It applies only to the CGM portion of your System. CGM alerts and errors do not follow the same pattern of vibration and beeps as insulin delivery reminders, alerts, and alarms.
Chapter 26 – CGM Alerts and Errors 26.2 Second Startup Calibration Alert What will I see on the Screen? What does it mean? The System needs an additional blood glucose value to complete startup calibration. CALIBRATE CGM How will the System notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed.
Chapter 26 – CGM Alerts and Errors 26.3 12 Hour Calibration Alert What will I see on the Screen? What does it mean? The System needs a blood glucose value to calibrate. CALIBRATE CGM How will the System notify me? On screen only with no vibration or beep.
Chapter 26 – CGM Alerts and Errors 26.4 Incomplete Calibration What will I see on the Screen? What does it mean? If you start to enter a calibration value using the keypad and do not complete the entry within 90 seconds, this screen appears. INCOMPLETE CALIBRATION This CGM calibration has not been completed.
Chapter 26 – CGM Alerts and Errors 26.5 Calibration Timeout What will I see on the Screen? What does it mean? If you start to enter a calibration value using the keypad and do not complete the entry within 5 minutes, this screen appears. CALIBRATION TIMEOUT You have exceeded the maximum time to calibrate your CGM.
Chapter 26 – CGM Alerts and Errors 26.6 Wait 15 Minute Calibration Error Alert What will I see on the Screen? What does it mean? The sensor cannot calibrate. CALIBRATION ERROR How will the System notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed. Enter a calibration BG in 15 min.
Chapter 26 – CGM Alerts and Errors 26.7 Calibration Required Alert What will I see on the Screen? What does it mean? The System needs a blood glucose value to calibrate. Sensor glucose readings will not be displayed at this time. CALIBRATE CGM How will the System notify me? Enter a BG to...
Chapter 26 – CGM Alerts and Errors 26.8 CGM High Alert What will I see on the Screen? What does it mean? Your most recent sensor glucose reading is at or above the High Alert setting. CGM HIGH ALERT How will the System notify me? 2 vibrations, then 2 vibrations/beeps every 5 minutes until confirmed or your glucose Sensor reading value drops below the Alert level.
Chapter 26 – CGM Alerts and Errors 26.9 CGM Low Alert What will I see on the Screen? What does it mean? Your most recent sensor glucose reading is at or below the Low Alert setting. CGM LOW ALERT How will the System notify me? 3 vibrations, then 3 vibrations/beeps every 5 minutes until confirmed or your Sensor reading glucose value goes above the Alert level.
Chapter 26 – CGM Alerts and Errors 26.10 CGM Fixed Low Alert What will I see on the Screen? What does it mean? Your most recent sensor glucose reading is at or below 55 mg/dL. CGM LOW ALERT How will the System notify me? 4 Vibrations, then 4 vibrations/beeps every 5 minutes until confirmed or your glucose Check BG and eat value goes above 55 mg/dL.
Chapter 26 – CGM Alerts and Errors 26.11 CGM Rise Alert What will I see on the Screen? What does it mean? Your glucose levels are rising at 2 mg/dL per minute or faster (at least 30 mg/dL in 15 minutes). CGM RISE ALERT How will the System notify me? Sensor readings are...
Chapter 26 – CGM Alerts and Errors 26.12 CGM Rapid Rise Alert What will I see on the Screen? What does it mean? Your glucose levels are rising at 3 mg/dL per minute or faster (at least 45 mg/dL in 15 minutes). CGM RISE ALERT How will the System notify me? Sensor readings are...
Chapter 26 – CGM Alerts and Errors 26.13 CGM Fall Alert What will I see on the Screen? What does it mean? Your glucose levels are falling at 2 mg/dL per minute or faster (at least 30 mg/dL in 15 minutes). CGM FALL ALERT How will the System notify me? Sensor readings are...
Chapter 26 – CGM Alerts and Errors 26.14 CGM Rapid Fall Alert What will I see on the Screen? What does it mean? Your glucose levels are falling at 3 mg/dL per minute or faster (at least 45 mg/dL in 15 minutes). CGM FALL ALERT How will the System notify me? Sensor readings are...
Chapter 26 – CGM Alerts and Errors 26.15 Unknown Sensor Reading What will I see on the Screen? What does it mean? The sensor is sending sensor glucose readings that the System does not understand. 10:20 AM You will not receive sensor glucose readings. March 5, 2017 100% 235 u...
Chapter 26 – CGM Alerts and Errors 26.16 Out of Range Alert What will I see on the Screen? What does it mean? The transmitter and pump are not communicating and you will not receive sensor glucose readings. OUT OF RANGE ALERT How will the System notify me? Transmitter out of 1 vibrate, then vibration/beep every 5 minutes until the transmitter and pump are...
Chapter 26 – CGM Alerts and Errors 26.17 Low Transmitter Battery Alert What will I see on the Screen? What does it mean? Transmitter battery is low. LOW TRANSMITTER BATTERY How will the System notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed. Please replace your transmitter soon.
Chapter 26 – CGM Alerts and Errors 26.18 Transmitter Error What will I see on the Screen? What does it mean? The transmitter has failed and the CGM session has stopped. TRANSMITTER ERROR How will the System notify me? Please replace your 1 vibration, then vibration/beep every 5 minutes.
Chapter 26 – CGM Alerts and Errors 26.19 Failed Sensor Error What will I see on the Screen? What does it mean? The sensor is not working properly and the CGM session has stopped. FAILED SENSOR How will the System notify me? 1 vibration, then vibration/beep every 5 minutes.
Chapter 26 – CGM Alerts and Errors 26.20 CGM Error What will I see on the Screen? What does it mean? Your CGM System is not working properly and the CGM session has been stopped. CGM ERROR How will the System notify me? A CGM Alert has occurred that caused the CGM session to stop.
MORE INFO How should I respond? Tap MORE INFO. A screen notifying you that your CGM System cannot operate but insulin delivery continues will appear. Call Tandem Diabetes Care Customer Technical Support at (877) 801-6901. Customer Technical Support: (877) 801-6901...
You are having trouble taking the safety Troubleshooting tips: chapter do not fix your issue, contact lock off the sensor applicator barrel. Tandem Diabetes Care Customer Make sure the collar is pulled all • Technical Support at (877) 801-6901 Troubleshooting tip: the way up.
Chapter 27 – CGM Troubleshooting 27.2 Calibration and twist the transmitter latch with You may use medical tape (such as • Troubleshooting the other hand to remove it. Blenderm, Tegaderm, IV 3000, 3M tape) over the white adhesive patch Do not try to snap it straight off. of the sensor pod, but do not place To ensure proper calibration of your •...
If it has been at least 3 hours since your last sensor glucose Make sure your insertion site • reading, contact Tandem Diabetes is clean and dry before sensor Care Customer Technical Support at insertion. (877) 801-6901.
Make sure your sensor pod is not • sensor glucose reading normally dem Diabetes Care Customer Techni- dislodged or peeling up. shows, then your t:slim X2 Pump is not cal Support at (877) 801-6901. communicating with your transmitter Make sure your transmitter is •...
Chapter 27 – CGM Troubleshooting 27.6 Sensor Inaccuracies Make sure you have selected a missing severe hypoglycemia (low blood glucose) • good insertion site. or hyperglycemia (high blood glucose) events. Inaccuracies are usually related to your Make sure your insertion site sensor only and not to your transmitter If the difference between your sensor •...
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Chapter 27 – CGM Troubleshooting when “- - -” or the Out of Range and make sure that your meter icon are on the screen. is properly coded (if required). Carefully apply the blood sample Do not use alternative blood to the test strip following the •...
While the convenience and flexibility of nect from your pump, discuss a plan swimming, scuba diving, surfing, or the t:slim X2 System allow most users with your healthcare provider to com- during any other activities that could to participate in a variety of activities,...
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Chapter 28 – Lifestyle Issues and Travel Extreme Temperatures enough supplies with you while you’re machines and request an alternate away from home. In addition to pump means of screening. You should avoid activities which could supplies, you should also always bring expose your System to temperatures the following items: Visit TSA’s website if you have any...
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Chapter 28 – Lifestyle Issues and Travel If traveling internationally, contact Tandem Diabetes Care Customer Support prior to your trip to obtain a travel loaner pump in case your pump malfunctions outside of Tandem’s replacement area. Customer Technical Support: (877) 801-6901...
Chapter 29 – Taking Care of Your t:slim X2 System 29.1 Overview Inspecting Your System If your transmitter is damaged or for Damage cracked, do not use it. Immediately con- This section provides information on tact Tandem Diabetes Care Customer caring for and maintaining your System.
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Chapter 29 – Taking Care of Your t:slim X2 System Keep the sensor in its sterile packaging your pump and transmitter and for until you are ready to use it. Store at instructions for disposal of potentially temperatures between 36°F and 77°F...
30.1 Overview This section provides tables of technical specifications, performance characteristics, options, settings, and electromagnetic compli- ance information for the t:slim X2 System. The specifications in this section meet the international standards set forth in IEC 60601-1 and IEC 60601-2-24.
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External PSU: Class II, Infusion Pump. Internally-powered equipment, Type BF applied part. 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 the t:slim X2 Pump in the presence of flammable anesthetics or explosive gases. Size 3.13˝...
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Chapter 30 – Technical Specifications …table continued from previous page Specification Type Specification Details Basal Delivery Accuracy at all Flow ±5% Rates (tested per IEC 60601-2-24) The System is designed to vent automatically when there is a pressure difference between inside the cartridge and the surrounding air.
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Chapter 30 – Technical Specifications …table continued from previous page Specification Type Specification Details Internal System Battery Life 4 years minimum under normal use conditions Typical Operating Time when System During normal use, the intermediate rate is 2 units/hr; battery charge can be reasonably expected to last up to is Operating at Intermediate Rate 7 days (5 days if using CGM) from a fully charged state to a totally discharged state Handling of Over-Infusion or...
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Chapter 30 – Technical Specifications Dexcom G5 Mobile Product Specifications User is the single use operator in the home environment. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
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Chapter 30 – Technical Specifications USB Charging/Download Cable Specifications Tandem P/N 004113 Length 6 feet Type USB A to USB Micro B Power Supply/Charger, AC, Wall Mount, USB Specifications Tandem P/N 03933 Input 100 to 240 Volts AC, 50/60 Hz...
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Safety Standard Compliance 60950-1 or 60601-1 or equivalent The t:slim X2 System is designed to be connected to a host PC for battery charging and data transfer to t:connect. The following minimum characteristics are required of the host PC: USB 1.1 port (or later) •...
Chapter 30 – Technical Specifications 30.3 t:slim X2 Pump Options and Settings Option/Setting Type Option/Setting Details Time 12-hour clock Maximum Basal Rate 15 units/hr Insulin Delivery Profiles (Basal and Bolus) Basal Rate Segments 16 per delivery profile Basal Rate Increment 0.001 at programed rates equal to or greater than 0.1 units/hr...
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Chapter 30 – Technical Specifications …table continued from previous page Option/Setting Type Option/Setting Details Quick Bolus Increments When set to units: 0.5, 1, 2, 5 units (default is 0.5 units); or when set to grams/carbs: 2, 5, 10, 15 grams (default is 2 g) Maximum Extended Bolus Time 8 hours Maximum Bolus Size...
Basal Delivery To assess basal delivery accuracy, thirty-two t:slim X2 pumps were tested by delivering at low, medium, and high basal rates (0.1, 2.0, and 15 U/hr). Sixteen of the pumps were new, and sixteen had been aged to simulate four years of regular use. For both aged and unaged pumps, eight pumps were tested with a new cartridge, and eight with a cartridge which underwent two years of real time aging.
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Bolus Delivery To assess bolus delivery accuracy, thirty-two t:slim X2 pumps were tested by delivering consecutive low, medium, and high bolus volumes (0.05, 2.5, and 25 units). Sixteen of the pumps were new, and sixteen had been aged to simulate 4 years of regular use.
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Chapter 30 – Technical Specifications Summary of Bolus Delivery Performance (n=32 pumps) Individual Bolus Accuracy Performance Target Bolus Size Mean Bolus Size Min Bolus Size Max Bolus Size [Units] [Units] [Units] [Units] Min Bolus Delivery Performance 0.050 0.050 0.000 0.114 (n=800 boluses) Intermediate Bolus Delivery Performance 2.50...
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Chapter 30 – Technical Specifications Intermediate Basal Delivery Performance (2.5U) (n=800 boluses) Units of Insulin Delivered After a 2.5 U Bolus Request <0.625 0.625– 1.875– 2.25– 2.375– 2.625– 2.75– 3.125– 4.375– >6.25 (<25%) 1.875 2.25 2.375 2.625 2.75 3.125 4.375 6.25 (>250%) (25–75%)
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Chapter 30 – Technical Specifications Rate of Delivery 25 Unit Bolus Delivery Speed 2.97 Units/min Typical 2.5 Unit Bolus Delivery Speed 1.43 Units/min Typical 20 Unit Prime 9.88 Units/min Typical Bolus Duration 25 Unit Bolus Duration 8 minutes 26 seconds Typical 2.5 Unit Bolus Duration 1 minute 45 seconds Typical Time to Occlusion Alarm...
Chapter 30 – Technical Specifications 30.5 Dexcom G5 Mobile CGM Transmitter Performance Characteristics Parameter Performance Characteristics TX/RX Frequencies 2.402-2.480 GHz Bandwidth 1.02 MHz Maximum Output Power 1.0 mW EIRP Modulation Gaussian Frequency-Shift Keying Data Rate 1 Mbps Data Communication Range 20 feet The Dexcom G5 Mobile CGM is safe for use on U.S.
Chapter 30 – Technical Specifications 30.6 Dexcom G5 Mobile CGM the following, there is no commonly Software 505 Pediatric Study: the Sensor Performance accepted statistical approach for Receiver included software version Characteristics capturing performance of continuous SW10505 glucose monitors (CGMs), such as the We recommend that you review the Dexcom G5 Mobile CGM.
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Chapter 30 – Technical Specifications subjects had Type 1 or Type 2 diabetes 7-day wear period. In the Software enrolled, the number of sensors worn mellitus, and required insulin or oral 505 Adult Study, subjects were evalu- by each participant, the SMBG meter medication to manage their diabetes.
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Chapter 30 – Technical Specifications Study, all subjects wore 1 sensor only. every 5 minutes and paired with YSI Throughout the 7-day wear period, the values collected every 15 minutes in sensors were calibrated with an aver- order to characterize how well the age of 2 fingersticks per day (approx- CGM readings agreed with laboratory imately once every 12 hours), using...
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Chapter 30 – Technical Specifications Table 1-A. Agreement to YSI within CGM Glucose Ranges (Adult) Number Percent CGM Glucose Percent within Percent within Percent within Study of paired Greater than Range (mg/dL) 15/15% YSI 20/20% YSI 30/30% YSI CGM-YSI 40/40% YSI Original 9152 Overall...
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Chapter 30 – Technical Specifications Table 1-B. Agreement to YSI within CGM Glucose Ranges (Pediatric) Number Percent CGM Glucose Percent within Percent within Percent within Study of paired Greater than Range (mg/dL) 15/15% YSI 20/20% YSI 30/30% YSI CGM-YSI 40/40% YSI Original 2922 Overall...
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Chapter 30 – Technical Specifications For example, in the SW10505 Adult Agreement Relative to YSI Study (Table 1-A), the total number of Agreement between the CGM and data pairs considered in the analysis blood glucose values is characterized was 2263. Of these, 93% of the CGM using paired CGM and YSI values.
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Chapter 30 – Technical Specifications Table 2-A. Number and Percentage of YSI Values When CGM Readings are “Low” or “High” (Adult) YSI (mg/dL) Total CGM-YSI Study < 55 < 60 < 70 < 80 > 80 Readings Pairs Original Cumulative Percent “LOW”...
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Chapter 30 – Technical Specifications Table 2-B. Number and Percentage of YSI Values When CGM Readings are “Low” or “High” (Pediatric) YSI (mg/dL) Total CGM-YSI Study < 55 < 60 < 70 < 80 > 80 Readings Pairs Original Cumulative 100% Percent “LOW”...
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Chapter 30 – Technical Specifications “HIGH” (45 occasions), 100% (45 out of Agreement When CGM Reads “LOW” or “HIGH” 45) of the YSI values were greater than 240 mg/dL, and 100% (45 out of 45) of The CGM reports glucose readings the YSI values were greater than 280 between 40 and 400 mg/dL.
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Chapter 30 – Technical Specifications Table 3-A. Concurrence of CGM Readings and YSI Values (Original Adult Study) YSI (mg/dL) Row Percentage of Matched Pairs in Each CGM Glucose Range Number of Paired mg/dL CGM-YSI 121- 161- 201- 251- 301- 351- <...
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Chapter 30 – Technical Specifications Table 3-B. Concurrence of CGM Readings and YSI Values (Software 505 Adult Study) YSI (mg/dL) Row Percentage of Matched Pairs in Each CGM Glucose Range Number of Paired mg/dL CGM-YSI 121- 161- 201- 251- 301- 351- <...
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Chapter 30 – Technical Specifications Table 3-C. Concurrence of CGM Readings and YSI Values (Original Pediatric Study) YSI (mg/dL) Row Percentage of Matched Pairs in Each CGM Glucose Range Number of Paired mg/dL CGM-YSI 121- 161- 201- 251- 301- 351- <...
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Chapter 30 – Technical Specifications Table 3-D. Concurrence of CGM Readings and YSI Values (Software 505 Pediatric Study) YSI (mg/dL) Row Percentage of Matched Pairs in Each CGM Glucose Range Number of Paired mg/dL CGM-YSI 121- 161- 201- 251- 301- 351- <...
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Chapter 30 – Technical Specifications Concurrence of CGM and Laboratory Reference Table 3-A (Original Adult Study), 3-B (Software 505 Adult Study), 3-C (Origi- nal Pediatric Study) and 3-D (Software 505 Pediatric Study) are categorized by ranges of CGM glucose readings. These tables describe, for each range of CGM glucose readings, what per- centage of paired YSI values were in...
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Chapter 30 – Technical Specifications Table 4-A. Difference to YSI within CGM Glucose Ranges (Adult) CGM Glucose Number Mean Absolute Median Absolute Mean Percent Median Percent Range Study of Paired Percent Percent Difference Difference (mg/dL) CGM-YSI Difference Difference Original 9152 2.9% 1.7% 13.3%...
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Chapter 30 – Technical Specifications Table 4-B. Difference to YSI within CGM Glucose Ranges (Pediatric) CGM Glucose Number Mean Absolute Median Absolute Mean Percent Median Percent Range Study of Paired Percent Percent Difference Difference (mg/dL) CGM-YSI Difference Difference Original 2922 13.5% 11.6% 17.4%...
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Chapter 30 – Technical Specifications average, higher or lower than the YSI Accuracy Relative to YSI laboratory standard. The mean absolute Accuracy between matched pairs percent difference is the average “dis- was also estimated by calculating the tance” (regardless if positive or negative) percent difference between the CGM between CGM readings and YSI values.
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Chapter 30 – Technical Specifications Table 5-A. Hypoglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Adult) Hypoglycemic Hypoglycemia True False Hypoglycemia Alert Level Study Missed Alert Rate Alert Rate Detection Rate (mg/dL) Detection Rate Original Software 505 Original...
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Chapter 30 – Technical Specifications Table 5-B. Hypoglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6-17 Years) Hypoglycemic Hypoglycemia True False Hypoglycemia Alert Level Study Missed Alert Rate Alert Rate Detection Rate (mg/dL) Detection Rate Original...
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Chapter 30 – Technical Specifications Table 5-C. Hypoglycemic Alert and Detection Rate Evaluation in Reference to SMBG 30 Minutes Before and After (Pediatric, Ages 2-5 Years) Hypoglycemic Hypoglycemia True False Hypoglycemia Alert Level Study Missed Alert Rate Alert Rate Detection Rate (mg/dL) Detection Rate Original...
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Chapter 30 – Technical Specifications Low and High Glucose Alerts Hypoglycemia Alert Rate Hypoglycemia Detection Rate The ability of the CGM to detect high The Alert Rate shows how often The Detection Rate shows how often and low glucose levels is assessed by the alert is right or wrong.
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Chapter 30 – Technical Specifications Table 6-A. Hyperglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Adult) Hyperglycemic Hyperglycemia True False Hyperglycemia Alert Level Study Missed Alert Rate Alert Rate Detection Rate (mg/dL) Detection Rate Original Software 505 100%...
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Chapter 30 – Technical Specifications Table 6-B. Hyperglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6-17 Years) Hyperglycemic Hyperglycemia True False Hyperglycemia Alert Level Study Missed Alert Rate Alert Rate Detection Rate (mg/dL) Detection Rate Original...
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Chapter 30 – Technical Specifications Table 6-C. Hyperglycemic Alert and Detection Rate Evaluation in Reference to SMBG 30 Minutes Before and After (Pediatric, Ages 2-5 Years) Hyperglycemic Hyperglycemia True False Hyperglycemia Alert Level Study Missed Alert Rate Alert Rate Detection Rate (mg/dL) Detection Rate Original...
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Chapter 30 – Technical Specifications For example, if you set the High Glu- For example, if you set your High The High Glucose Alert cose alert to 200 mg/dL and your alarm Glucose alert to 200 mg/dL, how often Estimates of how well the adjustable sounds, how often can you expect will your alarm alert you if your blood High Glucose Alert performs are...
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Chapter 30 – Technical Specifications Table 7-A. Percentage of CGM Readings Within YSI Values With Data Stratified in 2-Hour Increments After Calibration (Adult) Number Percent Time From Percent within Percent within Percent within Study of paired Greater than Calibration 15/15% YSI 20/20% YSI 30/30% YSI CGM-YSI...
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Chapter 30 – Technical Specifications Table 7-B. Percentage of CGM Readings Within YSI Values With Data Stratified in 2-Hour Increments After Calibration (Pediatric) Number Percent Time From Percent within Percent within Percent within Study of paired Greater than Calibration 15/15% YSI 20/20% YSI 30/30% YSI CGM-YSI...
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Chapter 30 – Technical Specifications Calibration Stability The CGM must be calibrated every 12 hours. To demonstrate performance of the CGM over a 12-hour calibration period, sensors were evaluated to verify that performance remains consistent over the 12-hour calibration period. CGMs were evaluated in 2-hour increments after calibration.
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Chapter 30 – Technical Specifications Table 8-A. Sensor Stability Relative to YSI (Accuracy Over Time ) - (Adult) Mean Median Percent Number Percent Percent Percent Absolute Absolute Greater Study of Paired Within Within Within Percent Percent Than Wear CGM-YSI 15/15% YSI 20/20% YSI 30/30% YSI Difference...
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Chapter 30 – Technical Specifications Table 8-B. Sensor Stability Relative to YSI (Accuracy Over Time ) - (Pediatric, Ages 6-17 Years) Mean Median Percent Number Percent Percent Percent Absolute Absolute Greater Study of Paired Within Within Within Percent Percent Than Wear CGM-YSI 15/15% YSI...
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Chapter 30 – Technical Specifications Table 8-C. Sensor Stability Relative to SMBG (Accuracy Over Time ) - (Pediatric, Ages 2-17 Years) Number Mean Median Percent Percent Percent Percent of Paired Absolute Absolute Within Within Within Greater Than Study CGM- Percent Percent 15/15% 20/20%...
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Chapter 30 – Technical Specifications Sensor Stability sensor will work over 7 days, all sensors Precision of Sensor Readings worn were evaluated to determine how Relative to YSI A subset of subjects wore two sensors many days/hours of readings each at the same time.
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Chapter 30 – Technical Specifications Table 9-A. Number of Readings Provided by Each Sensor Over 7-Days (Adult) % of Total Possible Total Readings Provided % of Systems Providing Study Readings Provided (Min-Max) That Number of Readings Original 167–491 0–25% Software 505 Original 719–914 26–50%...
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Chapter 30 – Technical Specifications Table 9-B. Number of Readings Provided by Each Sensor Over 7-Days (Pediatric) % of Total Possible Total Readings Provided % of Systems Providing Study Readings Provided (Min-Max) That Number of Readings Original 103–427 0–25% Software 505 60–223 Original 569–954...
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Chapter 30 – Technical Specifications Table 10-A. CGM Readings Within Wear Days (Adult) Statistic Study Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 All Days Original Mean Software 505 Original 100% 100% 100% 100% 100% 100% 100%...
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Chapter 30 – Technical Specifications Number of Readings Provided The CGM is capable of providing a reading up to every 5 minutes, or up to 288 readings per day. For a variety of reasons, the CGM may not display a glucose reading and readings are “skipped.”...
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Chapter 30 – Technical Specifications Table 11-A. Agreement to SMBG within CGM Glucose Ranges (Adult) Number Percent CGM Glucose Percent within Percent within Percent within Study of paired Greater than Range (mg/dL) 15/15% SMBG 20/20% SMBG 30/30% SMBG CGM-SMBG 40/40% SMBG Original 7508 Overall...
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Chapter 30 – Technical Specifications Table 11-B. Agreement to SMBG within CGM Glucose Ranges (Pediatric) Number Percent CGM Glucose Percent within Percent within Percent within Study of paired Greater than Range (mg/dL) 15/15% SMBG 20/20% SMBG 30/30% SMBG CGM-SMBG 40/40% SMBG Original 16318 Overall...
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Chapter 30 – Technical Specifications Table 12-A. CGM Difference to SMBG Within CGM Glucose Ranges (Adult) CGM Glucose Number Mean Absolute Median Absolute Mean Percent Median Percent Ranges Study of Paired Percent Percent Difference Difference (mg/dL ) CGM-SMBG Difference Difference Original 7508 -0.4%...
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Chapter 30 – Technical Specifications Table 12-B. Difference to SMBG Within CGM Glucose Ranges (Pediatric) CGM Glucose Number Mean Absolute Median Absolute Mean Percent Median Percent Ranges Study of Paired Percent Percent Difference Difference (mg/dL ) CGM-SMBG Difference Difference Original 16318 2.2% 0.9%...
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Chapter 30 – Technical Specifications For example, if the CGM reads 100 mg/ occurred at the sensor needle insertion Agreement and Accuracy Relative to SMBG dL, it is between 81-180 mg/dL range area or the adhesive area. and you can expect the CGM readings Agreement between the CGM and to be within 20% of the SMBG values blood glucose values is also charac-...
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Chapter 30 – Technical Specifications THIS PAGE IS INTENTIONALLY LEFT BLANK Customer Technical Support: (877) 801-6901...
The information contained in this section is specific to the t:slim X2 System. This information provides reasonable assurance of normal operation, but does not guarantee such under all conditions. If the t:slim X2 System must be used in close proximity with other electrical equipment, the System should be observed in this environment to verify normal operation.
Chapter 30 – Technical Specifications 30.8 Electromagnetic Emissions The t:slim X2 System is intended for use in the electromagnetic environment specified below. Always make sure that the System is used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions...
Chapter 30 – Technical Specifications 30.9 Electromagnetic Immunity The t:slim X2 System is intended for use in the electromagnetic environment specified below. Always make sure that the System is used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Electromagnetic Environment –...
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Chapter 30 – Technical Specifications …table continued from previous page Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Proximity Field from Electromagnetic Environment – Immunity Test Compliance Level Wireless Transmitters Guidance Conducted RF 3 Vrms 10 V Portable and mobile RF communications equipment should IEC 61000-4-6 150 kHz to 80 MHz be used no closer to any part of the pump, including...
30.10 Distances Between the t:slim X2 Pump and RF Equipment The t:slim X2 System is intended for use in an electromagnetic environment typically found in the home, at work, retail stores, and places of leisure, where daily activities occur. The chart below can be used as a guideline for determining the recommended minimum distance to maintain between a radio frequency (RF) transmitter and the t:slim X2 System.
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RF Communications Equipment and the t:slim X2 System The t:slim X2 System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the t:slim X2 System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System as recommended below, according to the maximum output power of the communications equipment.
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Chapter 30 – Technical Specifications The table below provides a list of typical devices for various levels of transmitter power and frequency, and the recommended separation distances from the transmitter and the System. Rated Maximum Recommended Output Power of Typical Devices Separation Distance Transmitter in Watts Inch (Meters)
The manufacturer defines the quality the transmitter and display are within The transmitter covered by this user’s of service of the t:slim X2 System as 20 feet of each other, and no more guide has been certified under FCC ID:...
Repair or replacement of a t:slim X2 the instructions, may cause harmful Pump will not extend the original 4 year interference to radio communications.
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The remedies provided for in this manufacture; to your t:slim X2 Pump. Tandem re- warranty are the exclusive remedies serves the right to offer those updates, available for any warranty claims.
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United Tandem will replace any defective States. No employee of Tandem or any cartridge, subject to the conditions and damage results from service or other party is authorized to make any •...
For more information about Dexcom’s of its authorized distributors may be number must be clearly written on the warranty, please visit www.dexcom. re-turned to Tandem only for the follow- outer box. If Tandem or the authorized com. ing reasons: (1) during the applicable...
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Pediatric Max Bolus Setting 101 Precautions Feature Lock 23 Max Bolus - Setting Up 104 Using t:slim X2 Pump 34 Important Pediatric User Information Max Bolus Alerts 158 Pump Info 134 Max Hourly Bolus Alert 157 Infusion Site Care 23, 86...
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Index Delivering 126 Indications for Use 28 Automatic Shutoff 232 Quick Bolus Button 60 Precautions - t:slim X2 Pump 34 Expiration Date 204, 273 Setting Up 126 Verification of Proper Functionality Insertion 206 Insertion Site 206 Screen Lock 82 Overview 186...
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Do you have a question about the T:Slim X2 and is the answer not in the manual?
Questions and answers
Can I add more insulin to cartridge without using another new one. Or do u need a new cartridge every time ?
You need a new cartridge each time. Reusing or refilling cartridges not manufactured by Tandem Diabetes Care, Inc. may result in incorrect insulin delivery, which can cause very low or very high blood glucose levels. Always use a new, unopened cartridge when filling and loading insulin into your t:slim X2 pump.
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