Page 1 10:20 AM July 22, 2015 100% 235 u mg/dL Dexcom G4 PLATINUM CGM Enabled ® INSULIN ON BOARD: 1.1 u 1:09 hrs OPTIONS BOLUS...
Page 3 G4 Insulin Pump with Dexcom G4 PLATINUM CGM User Guide Software Part Number 007249 Congratulations on the purchase of Changes in equipment, software, or ©2015 Tandem Diabetes Care, Inc. your new t:slim G4 System. Your deci- procedures occur periodically; informa- All rights reserved.
Page 4 11. Except for medical emergencies, Tandem Diabetes Care must obtain the necessary informed consent prior to the start of collection or sharing of personal medical information as it relates to the purchase of Tandem products and or services.
Page 5 Sharing concerns, complaints and grievances will not compromise a patient’s care, treatment or services. 18. If a patient has a concern, complaint, or grievance, he or she may contact Tandem Diabetes Care Customer Support by: » Calling Customer Support 1-877-801-6901 »...
Page 6 7. Patients and their families are responsible to promptly meet any financial obligation agreed to with Tandem Diabetes Care. 8. Patient and their family agree to hold harmless Tandem Diabetes Care from any expenses they may incur as a result of Tandem contacting the applicable emergency medical care on their behalf.
Page 7: Table Of Contents
Table of Contents Section 1 – Before You Begin Chapter 1 – Introduction System Description .......................24 About this User Guide ....................24 Important User Information ...................25 Conventions of this Guide .....................26 Chapter 2 – Important Safety Information Indications for Use ......................28 Contraindications ......................28 System Warnings ......................29 System Precautions ......................34...
Page 8 Table of Contents Chapter 3 – Getting to Know Your t:slim G4 System What your t:slim G4 System Package Includes ............46 System Terminology ......................46 Explanation of System Symbols..................50 Explanation of System Icons ..................52 Explanation of System Colors ..................54 Screen Lock ........................56 CGM Screen Lock ......................58...
Page 9 Section 2 – Key Pump Features Chapter 4 – Getting Started Charging the t:slim G4 Pump ..................80 Using the Touch Screen ....................82 Turning on the t:slim G4 Pump Screen .................82 Unlocking the t:slim G4 Pump Screen ................82 Edit Time ........................83 Edit Date ........................83 Chapter 5 –...
Page 10 Table of Contents Chapter 6 – Personal Profile Personal Profile 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 Renaming an Existing Profile ..................107 Deleting an Existing Profile ..................107 Chapter 7 –...
Page 11 Table of Contents Chapter 8 – Stop/Resume Insulin Stopping Insulin Delivery .....................118 Resuming Insulin Delivery ...................118 Section 3 – Additional Pump Operations Chapter 9 – Temporary Basal Rate Setting a Temp Rate ....................122 Stopping a Temp Rate ....................123 Chapter 10 – Quick Bolus 10.1 Setting Up Quick Bolus ....................126 10.2...
Page 12 Chapter 11 – t:slim G4 Pump Settings 11.1 t:slim G4 Pump Volume ....................130 11.2 Screen Options ......................130 Chapter 12 – t:slim G4 Pump Info and History 12.1 t:slim G4 Pump Info .....................134 12.2 t:slim G4 Pump History ....................134 Chapter 13 – t:slim G4 Pump Reminders 13.1...
Page 13 Table of Contents Section 4 – t:slim G4 Pump Safety Alerts and Alarms Chapter 15 – t:slim G4 Pump Alerts 15.1 Low Insulin Alert ......................147 15.2 Low Power Alerts ......................148 15.3 Incomplete Bolus Alert ....................150 15.4 Incomplete Temp Rate Alert ..................151 15.5...
Page 14 Table of Contents Chapter 16 – t:slim G4 Pump Alarms 16.1 Resume Pump Alarm ....................169 16.2 Low Power Alarms ......................170 16.3 Empty Cartridge Alarm ....................172 16.4 Cartridge Error Alarm ....................173 16.5 Cartridge Removal Alarm ....................174 16.6 Temperature Alarm ......................175 16.7 Occlusion Alarms ......................176...
Page 15 18.1 CGM System Overview ....................186 18.2 Sensor Overview ......................187 18.3 Transmitter Overview ....................188 18.4 Receiver (t:slim G4 Pump) Overview ................190 Chapter 19 – CGM Settings 19.1 Entering Your Transmitter ID ..................194 19.2 Setting CGM Volume ....................195 19.3 CGM Info ........................197...
Page 16 Table of Contents Chapter 20 – Setting CGM Alerts 20.1 Setting Your High Glucose Alert and Repeat Feature ..........200 20.2 Setting Your Low Glucose Alert and Repeat Feature ..........201 20.3 Rate Alerts ........................202 20.4 Setting Your Rise Alert ....................203 20.5 Setting Your Fall Alert ....................203 20.6 Setting Your Out of Range Alert ..................204...
Page 17 Calibration Blood Glucose Value and Correction Bolus ..........223 23.4 12 Hour Calibration Update ..................223 23.5 Other Reasons You May Need to Calibrate ..............224 Chapter 24 – Viewing CGM Data on Your t:slim G4 Pump 24.1 Overview ........................226 24.2 CGM Trend Graphs .....................228 24.3...
Page 18 Table of Contents Section 6 – CGM Alerts, Errors and Troubleshooting Chapter 26 – CGM Alerts and Errors 26.1 Startup Calibration Alert ....................245 26.2 Second Startup Calibration Alert.................246 26.3 12 Hour Calibration Alert .....................247 26.4 Incomplete Calibration ....................248 26.5 Calibration Timeout .....................249 26.6 Wait 15 Minute Calibration Error Alert .................250 26.7...
Page 19 Table of Contents 26.17 Out of Range Alert .......................261 26.18 Low Transmitter Battery Alert ..................262 26.19 Transmitter Error ......................263 26.20 Failed Sensor Error ......................264 26.21 CGM Error ........................265 26.22 CGM System Error ......................266 Chapter 27 – CGM Troubleshooting 27.1 Sensor Insertion Troubleshooting ................268 27.2 Calibration Troubleshooting ..................269 27.3...
Page 20 Section 7 – Living With and Caring for Your System Chapter 28 – Lifestyle Issues and Travel 28.1 Overview ........................276 Chapter 29 – Taking Care of Your t:slim G4 System 29.1 Overview ........................280 Section 8 – Technical Specifications and Warranty Chapter 30 –...
Page 21 Table of Contents 30.8 Electromagnetic Emissions ..................331 30.9 Electromagnetic Immunity ...................332 30.10 Distances Between the t:slim G4 Pump and RF Equipment ........334 30.11 FCC Notice Concerning Interference ................337 30.12 Warranty Information ....................338 Index Customer Technical Support: 1-877-801-6901...
Page 22 Section 1 Before You Begin...
Page 23: Chapter 1 - Introduction
Chapter 1 Introduction...
Page 24: System Description
System Description About this User Guide ter is reusable and is replaced about every 6 months. The t:slim G4 System is made up of the This User Guide covers important t:slim G4 Insulin Pump, the Dexcom The sensor measures glucose in the information on how to operate your ®...
Page 25: Important User Information
User Guide, a Guide to Successful Pumping, t:connect If you are currently using the t:slim G4 Getting Started and User Guides, and Pump without Dexcom G4 PLATINUM a CGM training tutorial, are available at CGM, of if you are currently using www.tandemdiabetes.com.
Page 26: Conventions Of This Guide
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.
Page 27: Chapter 2 - Important Safety Information
Chapter 2 Important Safety Information...
Page 28: Indications For Use
Maintain sufficient diabetes self- • continuous insulin delivery and as part scription. care skills of the t:slim G4 System to receive and display continuous glucose measure- See your healthcare provider(s) • ments from the Dexcom G4 Platinum regularly Sensor and Transmitter.
Page 29: System Warnings
Taking medications with acetamino- greater concentration can result in un- phen (such as Tylenol) while wearing DO NOT start to use your t:slim G4 der delivery or over delivery of insulin. the sensor may falsely raise your System before reading the User Guide.
Page 30 Use of cartridges not manufactured by cartridge. This can cause very high insulin absorption and cause high or Tandem Diabetes Care, Inc. or reuse of blood glucose, or Diabetic Ketoacido- low blood glucose. cartridges may result in over delivery or sis (DKA).
Page 31 Medical Procedures reviewed the calculated bolus amount ter, and sensor and leave them outside and your t:slim G4 System on the pump display. If you dose an in- the procedure room if you are going to sulin amount that is too high or too low, have any of the above procedures.
Page 32 G4 PLATINUM CGM with on the equipment being used, you ferences were observed between this your t:slim G4 Insulin Pump may or may not need to remove CGM device and actual blood glucose your System. Be sure to ask your values compared to those differences healthcare provider.
Page 33 DO NOT insert the sensor in sites sor in the refrigerator if it is within this report this to Tandem Diabetes Care other than the abdomen (belly) or temperature range. The sensor should Customer Technical Support at 1-877- upper buttocks (for ages 12–17 only).
Page 34: System Precautions
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.
Page 35 Tandem Diabetes Care attention. If these features are not Check that the System is working Customer Technical Support at 1-877-...
Page 36 Dexcom G4 PLATINUM insulin delivery and cause injury. and again when you reconnect, and treat high blood glucose (BG) levels CGM with your t:slim G4 Insulin Pump CONSULT your healthcare provider as recommended by your healthcare about lifestyle changes such as weight provider.
Page 37 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.
Page 38: Potential Benefits From Using The System
The System’s bolus (low blood glucose) or hyperglycemia The t:slim G4 System provides an calculator will recommend a bolus • (high blood glucose) events. automated way to deliver basal based on the entire amount of and bolus insulin.
Page 39 (lower A1c 795-800. • PLATINUM Transmitter and Sensor, values, reducing glycemic variability your t:slim G4 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.
Page 40: Possible Risks From Using The System
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 1-877-801-6901. itoring on A1c, Glucose Profiles, and Hypoglycemia in Adults With Type 1...
Page 41: Working With Your Healthcare Provider
User Guide is based on the assumption healthcare provider and call Tandem from your blood glucose meter, not that you have been educated by your Diabetes Care Customer Technical replace it.
Page 42: Emergency Kit
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.
Page 43: Verification Of Proper Functionality
USB port of your t:slim G4 Pump: attention. If these features are not working, places of leisure where daily activities occur.
Page 44 Chapter 2 – Important Safety Information THIS PAGE IS INTENTIONALLY LEFT BLANK Customer Technical Support: 1-877-801-6901...
Page 45: Chapter 3 - Getting To Know Your T:slim G4 System
Chapter 3 Getting to Know Your t:slim G4 System...
Page 46: What Your T:slim G4 System Package Includes
7. Car Power USB Adapter To order cartridges, infusion sets, sup- When a BG is entered in the t:slim G4 plies, accessories, sensors and trans- Pump, the calculated insulin bolus will mitter, please contact Tandem Diabetes be adjusted up or down as needed to 8.
Page 47 An extended bolus is a bolus that is Serial Bus. The USB cable connects delivered over a period of time. It is Personal Profile into the t:slim G4 Pump’s micro USB commonly used to cover food that A personal profile is a personalized port.
Page 48 Chapter 3 – Getting to Know Your G4 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 glucose information from the transmit- Glucose Trends take a blood glucose value on your me-...
Page 49 Chapter 3 – Getting to Know Your G4 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 into the sensor pod and wirelessly sends glucose information to your pump.
Page 50: Explanation Of System Symbols
Explanation of System Symbols The following are symbols (and their descriptions), which you may find on your t:slim G4 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.
Page 51 Chapter 3 – Getting to Know Your G4 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 Two-Sided Humidity Limits Ship By Date European Union WEEE Directive 2006-66-EC...
Page 52: Explanation Of System Icons
The following icons may appear in the status area (to the left or right of the time and date) on your t:slim G4 Pump CGM sensor session is active, but the transmitter is not communicating with the pump. Home Screen: CGM calibration is required.
Page 53 Chapter 3 – Getting to Know Your G4 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. reading is normally shown: Replace CGM sensor.
Page 54: Explanation Of System Colors
Chapter 3 – Getting to Know Your G4 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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Page 56: Screen Lock
8. Insulin Level: Displays the current the current time and date. amount of insulin in the cartridge. 2. Alert Icon: Indicates a reminder, 9. Tandem Logo: Returns to the alert or alarm is active behind the Home Screen. lock screen.
Page 57 Chapter 3 – Getting to Know Your G4 System 10:20 AM 100% July 22, 2015 235 u INSULIN ON BOARD (IOB) Units 1.1 u Time Remaining 1:09 hrs Customer Technical Support: 1-877-801-6901...
Page 58: Cgm Screen Lock
Chapter 3 – Getting to Know Your G4 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. Insulin Level: Displays the current pump and transmitter.
Page 59 Chapter 3 – Getting to Know Your G4 System 10:20 AM July 22, 2015 100% 235 u mg/dL INSULIN ON BOARD: 1.1 u 1:09 hrs Customer Technical Support: 1-877-801-6901...
Page 60: Home Screen
Home Screen. 2. USB Port: Port to charge your 10. Cartridge Tubing: Tubing that is t:slim G4 Pump battery. Close the attached to the cartridge. cover when not in use. 11. Luer-lock Connection: Connects 3. Bolus: Program and deliver a the cartridge tubing to the infusion bolus.
Page 61 Chapter 3 – Getting to Know Your G4 System 10:20 AM 100% July 22, 2015 235 u BOLUS OPTIONS INSULIN ON BOARD (IOB) Units 1.1 u Time Remaining 1:09 hrs Customer Technical Support: 1-877-801-6901...
Page 62: Cgm Home Screen
Chapter 3 – Getting to Know Your G4 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.
Page 63 Chapter 3 – Getting to Know Your G4 System 10:20 AM July 22, 2015 100% 235 u mg/dL INSULIN ON BOARD: 1.1 u 1:09 hrs OPTIONS BOLUS Customer Technical Support: 1-877-801-6901...
Page 64: Status Screen
Chapter 3 – Getting to Know Your G4 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.
Page 65 Chapter 3 – Getting to Know Your G4 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 Carbohydrates Insulin Duration hours Current Status...
Page 66: Bolus Screen
Chapter 3 – Getting to Know Your G4 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. 11. Add BG: Enter blood 3.
Page 67 Chapter 3 – Getting to Know Your G4 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: 1-877-801-6901...
Page 68: Options Screen
Chapter 3 – Getting to Know Your G4 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.
Page 69 Chapter 3 – Getting to Know Your G4 System Options Options BACK BACK STOP INSULIN Load My Pump Pump History My CGM CGM History Temp Rate Customer Technical Support: 1-877-801-6901...
Page 70: My Pump Screen
2. Alert Settings: Customize Pump Reminders and Alerts. 3. Pump Settings: Customize Quick Bolus, Pump Volume, Screen Options, and Time and Date. 4. Pump Info: Displays t:slim G4 Pump serial number, Tandem Diabetes Care Customer Technical Support phone number, website, and other technical information.
Page 71 Chapter 3 – Getting to Know Your G4 System My Pump BACK Personal Profiles Alert Settings Pump Settings Pump Info Customer Technical Support: 1-877-801-6901...
Page 72: My Cgm Screen
Chapter 3 – Getting to Know Your G4 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.
Page 73 Chapter 3 – Getting to Know Your G4 System My CGM BACK START SENSOR Calibrate CGM CGM Alerts CGM Settings Customer Technical Support: 1-877-801-6901...
Page 74: Number Keypad Screen
Chapter 3 – Getting to Know Your G4 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. 5.
Page 75 Chapter 3 – Getting to Know Your G4 System BACK DONE grams + / = Customer Technical Support: 1-877-801-6901...
Page 76: Letter Keypad Screen
Chapter 3 – Getting to Know Your G4 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). 5. Save: Saves entered information. 6.
Page 77 Chapter 3 – Getting to Know Your G4 System Weekday BACK SAVE name space Customer Technical Support: 1-877-801-6901...
Page 78: Section 2 - Key Pump Features
Section 2 Key Pump Features...
Page 79: Chapter 4 - Getting Started
Chapter 4 Getting Started...
Page 80: Charging The T:slim G4 Pump
AC power adapter. the Home Screen reads 100% (initial The t:slim G4 Pump is powered by an charge can take up to 2.5 hours). 2. Plug the AC power adapter into a internal lithium polymer rechargeable grounded AC power outlet.
Page 81 PRECAUTION Before using a Mac or PC to charge CONFIRM that the screen display turns on, you the t:slim G4 Pump, it is recommended can hear audible beeps, feel the pump vibrate, that a driver be installed on the com-...
Page 82: Using The Touch Screen
Turning on the t:slim G4 Unlocking the t:slim G4 Pump Screen Pump Screen To turn on your t:slim G4 Pump screen, first press the Screen On/Quick Bolus The screen lock screen appears any- 1. To turn on your t:slim G4 Pump...
Page 83: Edit Time
Edit Time Edit Date 7. Using the onscreen keypad, enter the hour and minutes. Verify and After powering up your t:slim G4 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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Page 85: Chapter 5 - Infusion Site Care And Loading Cartridge
Chapter 5 Infusion Site Care and Loading Cartridge...
Page 86: Infusion Site Selection And Care
With experience, you will find infusion set cannula, please report this to • Tandem Customer Technical Support at 1-877- The abdomen is the most popular areas that not only provide • site because of access to fatty better absorption, but are more 801-6901.
Page 87 Chapter 5 – Infusion Site Care and Loading Cartridge Keep it clean: Areas of Body for Infusion Set Insertion When changing your infusion set, • use clean techniques to avoid an infection. Wash your hands, use antiseptic • wipes or infusion site preparation products, and keep the area clean.
Page 88: Cartridge Instructions For Use
Vial of Humalog or NovoLog • ® ® cartridge into your t:slim G4 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 •...
Page 89 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.
Page 90 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.
Page 91 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).
Page 92 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.
Page 93 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.
Page 94: Filling Tubing
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 Luer connector. Be Filling the Infusion Set Tubing careful to keep the Luer connec- with the white fill port pointed up when filling with Insulin...
Page 95 Chapter 5 – Infusion Site Care and Loading Cartridge “Detecting Insulin” screen 3. Hold the pump vertically to screen. You will see one of the following on ensure any air in the cartridge will is displayed. the screen: be dispelled first. Tap START. The pump will beep and vibrate 5.
Page 96: Filling Cannula
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.
Page 97: Setting Site Reminder
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 G4 be changed. Pump and a Personal Profile has not been defined, a screen will notify you that a 2.
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Page 99: Chapter 6 - Personal Profile
Chapter 6 Personal Profile...
Page 100: Personal Profile Overview
Creating Personal Profiles DO NOT start to use your System before consulting with your healthcare provider to The t:slim G4 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...
Page 101 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 G4 Pump will • • mg/dL to 1 unit:600 mg/dL) is defined) consider any active IOB and calculate an adjusted bolus if necessary.
Page 102: Programming A New Personal Profile
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.
Page 103 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.
Page 104 Tap YES if entered data is correct. 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: 1-877-801-6901...
Page 105: Editing Or Reviewing An Existing Profile
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: 1-877-801-6901...
Page 106: Duplicating An Existing Profile
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.
Page 107: Renaming An Existing Profile
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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Page 109: Chapter 7 - Bolus
Chapter 7 Bolus...
Page 110: Bolus Overview
Consult your healthcare insulin to deliver the bolus. provider as needed. Your t:slim G4 Pump offers you the WARNING ability to deliver different boluses to DO NOT use CGM for treatment decisions, cover carbohydrate intake (food bolus) such as how much insulin you should take.
Page 111: Food Bolus Using Units
Chapter 7 – Bolus Food Bolus Using Units Food Bolus Using Grams 6. Tap DELIVER. If bolusing using a carb ratio skip to the 7. The bolus initiated screen is 1. From the Home Screen, next chapter, Food Bolus Using Grams. temporarily displayed.
Page 112: Correction Bolus
Chapter 7 – Bolus Correction Bolus If BG is above the Target BG, a 6. Confirm Request. message screen will indicate BG is Tap YES if entered data is correct. 1. From the Home Screen, above Target. tap BOLUS. Tap NO to go back to make Your BG is Above Target changes or view calculations.
Page 113: Extended Bolus
Chapter 7 – Bolus Extended Bolus When your blood glucose is: 4. Tap NEXT to confirm the units of insulin to be delivered. » Above Target BG: the insulin for The Extended Bolus feature allows you the food bolus and the correction to deliver part of the bolus now and You can always tap View Cal- bolus will be added together.
Page 114 Chapter 7 – Bolus 4. If desired, tap Add BG and using 9. Use the onscreen keypad to enter 12. Tap NEXT. the onscreen keypad enter BG the percentage of the bolus to value. Tap DONE. DELIVER NOW and tap DONE. You can always tap View Units to display the breakdown of units to 5.
Page 115: Canceling Or Stopping A Bolus
Chapter 7 – Bolus Canceling or Stopping Stopping a Bolus if delivery of the a Bolus bolus Has Started: Canceling a Bolus If delivery 1. Tap 1–2–3 to access the Has Not Started Home Screen. 1. Tap 1–2–3 to access the 2.
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Page 117: Chapter 8 - Stop/Resume Insulin
Chapter 8 Stop/Resume Insulin...
Page 118: Stopping Insulin Delivery
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 G4 rate are immediately stopped. No in- Pump screen. sulin delivery can take place while your pump is stopped.
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Page 120: Section 3 - Additional Pump Operations
Section 3 Additional Pump Operations...
Page 121: Chapter 9 - Temporary Basal Rate
Chapter 9 Temporary Basal Rate...
Page 122: Setting A Temp Rate
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.
Page 123: Stopping A Temp Rate
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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Page 125: Chapter 10 - Quick Bolus
Chapter 10 Quick Bolus...
Page 126: Setting Up Quick Bolus
7. Tap Increment Amount. pressing a button. It is a way to deliver to look at the t:slim G4 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.
Page 127 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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Page 129: Chapter 11 - T:slim G4 Pump Settings
Chapter 11 t:slim G4 Pump Settings...
Page 130: T:slim G4 Pump Volume
Chapter 11 – t:slim G4 Pump Settings 11.1 t:slim G4 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 G4 change to the Pump Volume can be...
Page 131 Chapter 11 – t:slim G4 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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Page 133: Chapter 12 - T:slim G4 Pump Info And History
Chapter 12 t:slim G4 Pump Info and History...
Page 134: T:slim G4 Pump Info
Chapter 12 – t:slim G4 Pump Info and History 12.1 t:slim G4 Pump Info 12.2 t:slim G4 Pump History by date. The event details in each report are listed by time. Your t:slim G4 Pump allows access to Pump History displays a historical log information about your pump.
Page 135: Chapter 13 - T:slim G4 Pump Reminders
Chapter 13 t:slim G4 Pump Reminders...
Page 136: Low Bg Reminder
Chapter 13 – t:slim G4 Pump Reminders 13.1 Low BG Reminder Your t:slim G4 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...
Page 137: High Bg Reminder
Chapter 13 – t:slim G4 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...
Page 138: After Bolus Bg Reminder
Chapter 13 – t:slim G4 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.
Page 139: Site Reminder
Chapter 13 – t:slim G4 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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Page 141: Chapter 14 - User Settable Alerts And Alarms
Chapter 14 User Settable Alerts and Alarms...
Page 142: Low Insulin Alert
(from 10 to Your t:slim G4 Pump keeps track 40 units) that you want the Low Your t:slim G4 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.
Page 143 (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.
Page 144: Section 4 - T:slim G4 Pump Safety Alerts And Alarms
Section 4 t:slim G4 Pump Safety Alerts and Alarms...
Page 145: Chapter 15 - T:slim G4 Pump Alerts
Chapter 15 t:slim G4 Pump Alerts...
Page 146 Chapter 15 – t:slim G4 Pump Alerts Your t:slim G4 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.
Page 147: Low Insulin Alert
Chapter 15 – t:slim G4 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.
Page 148: Low Power Alerts
Chapter 15 – t:slim G4 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...
Page 149 Chapter 15 – t:slim G4 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.
Page 150: Incomplete Bolus Alert
Chapter 15 – t:slim G4 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.
Page 151: Incomplete Temp Rate Alert
Chapter 15 – t:slim G4 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.
Page 152: Incomplete Load Sequence Alerts
Chapter 15 – t:slim G4 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.
Page 153 Chapter 15 – t:slim G4 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...
Page 154 Chapter 15 – t:slim G4 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...
Page 155: Incomplete Setting Alert
Chapter 15 – t:slim G4 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.
Page 156: Basal Rate Required Alert
Chapter 15 – t:slim G4 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).
Page 157: Max Hourly Bolus Alert
Chapter 15 – t:slim G4 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.
Page 158: Max Bolus Alerts
Chapter 15 – t:slim G4 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.
Page 159 Chapter 15 – t:slim G4 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.
Page 160: Max Basal Alerts
Chapter 15 – t:slim G4 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.
Page 161 Chapter 15 – t:slim G4 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...
Page 162: Min Basal Alerts
Chapter 15 – t:slim G4 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.
Page 163 Chapter 15 – t:slim G4 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...
Page 164: Connection Error Alert
What will I see on the Screen? What does it mean? You connected your t:slim G4 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.
Page 165: Power Source Alert
15.13 Power Source Alert What will I see on the Screen? What does it mean? You connected your t:slim G4 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.
Page 166: Data Error Alert
Chapter 15 – t:slim G4 Pump Alerts 15.14 Data Error Alert What will I see on the Screen? What does it mean? Your t:slim G4 Pump encountered a condition that could potentially result in a loss of data. DATA ERROR ALERT Please verify that your active...
Page 167: Chapter 16 - T:slim G4 Pump Alarms
Chapter 16 t:slim G4 Pump Alarms...
Page 168 Chapter 16 – t:slim G4 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...
Page 169: Resume Pump Alarm
Chapter 16 – t:slim G4 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.
Page 170: Low Power Alarms
Low Power Alarm 1 What does it mean? What will I see on the Screen? Your t:slim G4 Pump detected a power level of 1% or less remaining and all deliveries have stopped. LOW POWER ALARM How will the System notify me?
Page 171 Low Power Alarm 2 What does it mean? What will I see on the Screen? Your t:slim G4 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?
Page 172: Empty Cartridge Alarm
Chapter 16 – t:slim G4 Pump Alarms 16.3 Empty Cartridge Alarm What will I see on the Screen? What does it mean? Your t:slim G4 Pump detected that the cartridge is empty and all deliveries have stopped. EMPTY CARTRIDGE ALARM ALL DELIVERIES STOPPED!
Page 173: Cartridge Error Alarm
What will I see on the Screen? What does it mean? Your t:slim G4 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...
Page 174: Cartridge Removal Alarm
Chapter 16 – t:slim G4 Pump Alarms 16.5 Cartridge Removal Alarm What will I see on the Screen? What does it mean? Your t:slim G4 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.
Page 175: Temperature Alarm
What will I see on the Screen? What does it mean? Your t:slim G4 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 TEMPERATURE ALARM deliveries have stopped.
Page 176: Occlusion Alarms
16.7 Occlusion Alarms Occlusion Alarm 1 What does it mean? What will I see on the Screen? Your t:slim G4 Pump detected that insulin delivery is blocked and all deliveries have stopped. OCCLUSION ALARM How will the System notify me?
Page 177 Occlusion Alarm 2 What does it mean? What will I see on the Screen? Your t:slim G4 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?
Page 178: Screen On/Quick Bolus Button Alarm
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 G4 Pump) is stuck or not functioning properly and all deliveries have stopped. BUTTON ALARM...
Page 179: Altitude Alarm
What will I see on the Screen? What does it mean? Your t:slim G4 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.
Page 180: Reset Alarm
16.10 Reset Alarm What will I see on the Screen? What does it mean? Your t:slim G4 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...
Page 181: Chapter 17 - T:slim G4 Pump Malfunction
Chapter 17 t:slim G4 Pump Malfunction...
Page 182: Malfunction
17.1 Malfunction What will I see on the Screen? What does it mean? Your t:slim G4 Pump detected a If your t:slim G4 Pump detects a sys- system error and all deliveries have tem error, the MALFUNCTION screen MALFUNCTION been stopped.
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Page 184: Section 5 - Getting Started With Your Cgm System
Section 5 Getting Started with Your CGM System...
Page 185: Chapter 18 - Dexcom G4 Platinum Cgm Overview
Chapter 18 Dexcom G4 PLATINUM CGM Overview...
Page 186: Cgm System Overview
G4 Pump therapy. In addition, the programmable screen. Dexcom G4 PLATINUM CGM alerts can help you to spot potential...
Page 187: Sensor Overview
Chapter 18 – Dexcom G4 PLATINUM CGM Overview 18.2 Sensor Overview 1. Plunger 5. Safety Lock The sensor is a disposable device and 2. Applicator Barrel 6. Collar is inserted under the skin to continu- ously monitor glucose levels for up to 3.
Page 188: Transmitter Overview
Chapter 18 – Dexcom G4 PLATINUM CGM Overview 18.3 Transmitter Overview The transmitter is a reusable device that snaps into your sensor pod. Do not throw away your transmitter. It is re- usable. The transmitter and the sensor are water-resistant when properly connected.
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Page 190: Receiver (T:slim G4 Pump) Overview
Chapter 18 – Dexcom G4 PLATINUM CGM Overview 18.4 Receiver (t:slim G4 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.
Page 191 Chapter 18 – Dexcom G4 PLATINUM CGM Overview 10:20 AM July 22, 2015 100% 235 u mg/dL INSULIN ON BOARD: 1.1 u 1:09 hrs OPTIONS BOLUS Customer Technical Support: 1-877-801-6901...
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Page 193: Chapter 19 - Cgm Settings
Chapter 19 CGM Settings...
Page 194: Entering Your Transmitter Id
4. Tap CGM Settings. ed to start the process again. Your t:slim G4 Pump and Dexcom G4 PLATINUM Transmitter wirelessly pair 5. Tap Transmitter ID. 10. Once matching values have been together using RF communication.
Page 195: Setting Cgm Volume
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.
Page 196 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 +...
Page 197: Cgm Info
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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Page 199: Chapter 20 - Setting Cgm Alerts
Chapter 20 Setting CGM Alerts...
Page 200: Setting Your High Glucose Alert And Repeat Feature
Chapter 20 – Setting CGM Alerts 20.1 Setting Your High Glucose communicating. Keep the transmitter WARNING Alert and Repeat Feature In a pediatric clinical study, a significant number and the pump within 20 feet of each other without obstruction. When the of low glucose events were not detected by transmitter and the pump are too far CGM.
Page 201: Setting Your Low Glucose Alert And Repeat Feature
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.
Page 202: Rate Alerts
Chapter 20 – Setting CGM Alerts 20.3 Rate Alerts 7. Using the onscreen keypad, enter reading remains below the Low the value below which you want to Alert Value. be notified. It can be set between Rate alerts tell you when your glucose levels are rising (Rise Alert) or falling 60 and 100 mg/dL in 1 mg/dL Use the up and down arrows to...
Page 203: Setting Your Rise Alert
Chapter 20 – Setting CGM Alerts 20.4 Setting Your Rise Alert 20.5 Setting Your Fall Alert If you set your Rise Alert to 3 mg/dL per minute and your sensor glucose readings rise at this rate or faster, the 1. From the Home Screen, 1.
Page 204: Setting Your Out Of Range Alert
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.
Page 205: Chapter 21 - Inserting The Sensor And Placing The Transmitter
Chapter 21 Inserting the Sensor and Placing the Transmitter...
Page 206: Before You Start
To use continuous glucose monitoring Place the transmitter on a clean, (CGM) with your t:slim G4 Pump, you dry cloth to dr y before you start a need a Dexcom G4 PLATINUM Sensor new sensor session.
Page 207 Chapter 21 – Inserting the Sensor and Placing the Transmitter Review the CGM Sensor Applicator Picture Before Using a New Sensor 1. Plunger 2. Applicator Barrel 3. Transmitter Latch 4. Release Tab 5. Safety Lock 6. Collar 7. Sensor Pod 8.
Page 208: Removing The Sensor From Its Packaging
Chapter 21 – Inserting the Sensor and Placing the Transmitter 21.2 Removing the Sensor 21.3 Choosing an Insertion Site from where rubbing can occur, such as From its Packaging along the waist band or seat belt strap. PRECAUTION Choose an area at least 3 inches PRECAUTION AVOID inserting the sensor in areas that are •...
Page 209: Placing The Cgm Sensor
Chapter 21 – Inserting the Sensor and Placing the Transmitter 21.4 Placing the CGM Sensor 1. Clean your skin at the sensor 3. Place the sensor horizontally (side placement site with an alcohol to side) as shown in the picture. WARNING wipe.
Page 210: Inserting The Cgm Sensor
Chapter 21 – Inserting the Sensor and Placing the Transmitter 21.5 Inserting the CGM Sensor 5. Hold the applicator and pull the 3. Place your thumb on the white safety lock straight out away from plunger. Push the plunger down the applicator, in the direction of After you place the applicator on your completely, making sure it is flush...
Page 211 Keep your thumb sensor pod to remove the and contact Tandem Diabetes Care Customer Technical Support at 1-877- lightly on top of the white plunger, applicator barrel. Only the sensor and pull the collar back towards pod will be left on your body.
Page 212: Attaching The Cgm Transmitter
Installed your sensor glucose readings to your on the transmitter with your t:slim G4 Pump. You must snap the thumb of the same hand, like you transmitter into the sensor pod after are pinching it.
Page 213 Chapter 21 – Inserting the Sensor and Placing the Transmitter support. Do not tape over the transmit- ter or any of the plastic parts of the sensor pod. Do not tape under the sensor pod or leave any substance on the skin where you insert the sensor.
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Page 215: Chapter 22 - Starting A Cgm Sensor Session
Chapter 22 Starting a CGM Sensor Session...
Page 216: Starting Sensor
ID is In a pediatric clinical study, larger differences were observed between this CGM device and 6. Your t:slim G4 Pump will return to entered. the CGM Home Screen with the 3 actual blood glucose values compared to those hour trend graph displayed.
Page 217: Sensor Startup Period
2-hour startup period ends and you complete your first calibrations. During the startup period, the CGM Home Screen on your t:slim G4 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.
Page 218 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...
Page 219: Chapter 23 - Calibrating Your Cgm System
Chapter 23 Calibrating Your CGM System...
Page 220: Calibration Overview
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.
Page 221: Startup Calibration
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...
Page 222 Chapter 23 – Calibrating Your CGM System 8. An important message reminding sensor accuracy and could result in you your meter is properly coded (if you that you must use blood missing severe hypoglycemia (low blood required). glucose values from your meter for glucose) or hyperglycemia (high blood treatment decisions will appear.
Page 223: Calibration Blood Glucose Value And Correction Bolus
Correction Bolus calibrate. Calibrate your CGM System at least Your t:slim G4 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.
Page 224: Other Reasons You May Need To Calibrate
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.
Page 225: Chapter 24 - Viewing Cgm Data On Your T:slim G4 Pump
Chapter 24 Viewing CGM Data on Your t:slim G4 Pump...
Page 226: Overview
Chapter 24 – Viewing CGM Data on Your t:slim G4 Pump 24.1 Overview CONTRAINDICATION 10:20 AM Taking medications with acetaminophen (such July 22, 2015 100% 235 u During an active sensor session, CGM as Tylenol) while wearing the sensor may readings are sent to your t:slim G4 falsely raise your sensor glucose readings.
Page 227 Chapter 24 – Viewing CGM Data on Your t:slim G4 Pump If your sensor glucose reading is in • between your High and Low Alert settings, it is shown in white. If your sensor glucose reading is • above your High Alert setting, it is shown in orange.
Page 228: Cgm Trend Graphs
Chapter 24 – Viewing CGM Data on Your t:slim G4 Pump 24.2 CGM Trend Graphs 3 Hour Trend Graph (default view) 12 Hour Trend Graph shows you shows you your current glucose your current glucose reading along You can view your past sensor glucose...
Page 229 Chapter 24 – Viewing CGM Data on Your t:slim G4 Pump 1 Hour Trend Graph shows you LOW shows when your most recent your current glucose reading along sensor glucose reading is less than with the last 1 hour of sensor 40 mg/dL.
Page 230: Rate Of Change Arrows
Chapter 24 – Viewing CGM Data on Your t:slim G4 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,...
Page 231 Chapter 24 – Viewing CGM Data on Your t:slim G4 Pump The table below shows the different trend arrows your receiver displays: Constant: Your glucose is steady (not Slowly falling: Your glucose is falling 1–2 increasing/decreasing more than 1 mg/dL mg/dL each minute.
Page 232: Additional Cgm Status Symbols
Chapter 24 – Viewing CGM Data on Your t:slim G4 Pump 24.4 Additional CGM Status Symbols The following symbols may also ap- pear on your CGM Home Screen in the place where sensor glucose readings normally show. They let you know im- portant information about the System.
Page 233 Chapter 24 – Viewing CGM Data on Your t:slim G4 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.
Page 234 Chapter 24 – Viewing CGM Data on Your t:slim G4 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 This symbol in the place where sensor glucose readings normally show means that the sensor cannot calibrate right now.
Page 235: Cgm History
Chapter 24 – Viewing CGM Data on Your t:slim G4 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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Page 237: Chapter 25 - Ending Your Cgm Sensor Session
Chapter 25 Ending Your CGM Sensor Session...
Page 238: Automatic Sensor Shut-Off
Your sensor gives you sensor glu- the place where sensor glucose cose readings for up to 7 days. The Your t:slim G4 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.
Page 239: Ending A Sensor Session Before Automatic Shut-Off
New sensor glucose readings do PRECAUTION not show on your t:slim G4 Pump DO NOT discard your transmitter. It is reusable. after your sensor session ends. The same transmitter is used for each You must remove your sensor and session until you have reached the end of the insert a new sensor.
Page 240 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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Page 242: Section 6 - Cgm Alerts, Errors And Troubleshooting
Section 6 CGM Alerts, Errors and Troubleshooting...
Page 243: Chapter 26 - Cgm Alerts And Errors
Chapter 26 CGM Alerts and Errors...
Page 244 Chapter 26 – CGM Alerts and Errors This section describes CGM alerts and errors that appear on your t:slim G4 Home Screen. It applies only to the CGM portion of your System. CGM alerts and errors do not follow the...
Page 245: Startup Calibration Alert
Chapter 26 – CGM Alerts and Errors 26.1 Startup Calibration Alert What will I see on the Screen? What does it mean? 2-hour CGM startup period is complete. CALIBRATE CGM How will the System notify me? 1 vibration, then vibration/beep every 5 minutes until confirmed. Enter 2 BGs to calibrate CGM sensor.
Page 246: Second Startup Calibration Alert
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.
Page 247: Hour Calibration Alert
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.
Page 248: Incomplete Calibration
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.
Page 249: Calibration Timeout
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.
Page 250: Wait 15 Minute Calibration Error Alert
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.
Page 251: Wait 1 Hour Calibration Error Alert
Chapter 26 – CGM Alerts and Errors 26.7 Wait 1 Hour Calibration Error Alert What will I see on the Screen? What does it mean? The System 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 1 hr.
Page 252: Calibration Required Alert
Chapter 26 – CGM Alerts and Errors 26.8 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...
Page 253: Cgm High Alert
Chapter 26 – CGM Alerts and Errors 26.9 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.
Page 254: Cgm Low Alert
Chapter 26 – CGM Alerts and Errors 26.10 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.
Page 255: Cgm Fixed Low Alert
Chapter 26 – CGM Alerts and Errors 26.11 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.
Page 256: Cgm Rise Alert
Chapter 26 – CGM Alerts and Errors 26.12 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...
Page 257: Cgm Rapid Rise Alert
Chapter 26 – CGM Alerts and Errors 26.13 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...
Page 258: Cgm Fall Alert
Chapter 26 – CGM Alerts and Errors 26.14 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...
Page 259: Cgm Rapid Fall Alert
Chapter 26 – CGM Alerts and Errors 26.15 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...
Page 260: Unknown Sensor Reading
Chapter 26 – CGM Alerts and Errors 26.16 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. July 22, 2015 100% 235 u...
Page 261: Out Of Range Alert
Chapter 26 – CGM Alerts and Errors 26.17 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...
Page 262: Low Transmitter Battery Alert
Chapter 26 – CGM Alerts and Errors 26.18 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.
Page 263: Transmitter Error
Chapter 26 – CGM Alerts and Errors 26.19 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.
Page 264: Failed Sensor Error
Chapter 26 – CGM Alerts and Errors 26.20 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.
Page 265: Cgm Error
Chapter 26 – CGM Alerts and Errors 26.21 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.
Page 266: Cgm System Error
Will the System re-notify me? 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 1-877-801-6901. Customer Technical Support: 1-877-801-6901...
Page 267 Chapter 27 CGM Troubleshooting...
Page 268: Chapter 27 - Cgm Troubleshooting
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 1-877-801-6901 Troubleshooting tip: the way up.
Page 269: Calibration Troubleshooting
Chapter 27 – CGM Troubleshooting 27.2 Calibration Possible Issue: You may use medical tape (such as • Troubleshooting Blenderm, Tegaderm, IV 3000, 3M You are not able to remove the trans- tape) over the white adhesive patch mitter latch from the sensor pod. of the sensor pod, but do not place To ensure proper calibration of your the tape over the transmitter or the...
Page 270: Unknown Sensor Reading Troubleshooting
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. 1-877-801-6901.
Page 271: Out Of Range/No Antenna Troubleshooting
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 G4 Pump is not cal Support at 1-877-801-6901. communicating with your transmitter Make sure your transmitter is •...
Page 272: Sensor Inaccuracies
Chapter 27 – CGM Troubleshooting 27.6 Sensor Inaccuracies Make sure you have selected a of low glucose events were not detected by • good insertion site. CGM. Do not rely solely on CGM alerts to detect Inaccuracies are usually related to your low glucose.
Page 273 Chapter 27 – CGM Troubleshooting the second blood glucose value. The Use the same meter you routinely • sensor glucose reading will correct use to measure your blood glucose over the next 15 minutes. If you see to calibrate. Do not switch your differences between your sensor meter in the middle of a sensor glucose readings and blood glucose...
Page 274: Section 7 - Living With And Caring For Your System
Section 7 Living With and Caring for Your System...
Page 275 Chapter 28 Lifestyle Issues and Travel...
Page 276: Chapter 28 - Lifestyle Issues And Travel
While the convenience and flexibility of nect from your pump, discuss a plan swimming, scuba diving, surfing, or the t:slim G4 System allow most users with your healthcare provider to com- during any other activities that could to participate in a variety of activities,...
Page 277 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...
Page 278 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: 1-877-801-6901...
Page 279 Chapter 29 Taking Care of Your t:slim G4 System...
Page 280: Chapter 29 - Taking Care Of Your T:slim G4 System
Chapter 29 – Taking Care of Your t:slim G4 System 29.1 Overview Inspecting Your System cracked, do not use it. Immediately con- for Damage tact Tandem Diabetes Care Customer This section provides information on Technical Support at 1-877-801-6901 if caring for and maintaining your System.
Page 281 Chapter 29 – Taking Care of Your t:slim G4 System until you are ready to use it. Store at instructions for disposal of potentially temperatures between 36°F and 77°F bio-hazardous materials such as used and at relative humidity levels between cartridges, needles, syringes, infusion 15% and 85%.
Page 282: Section 8 - Technical Specifications And Warranty
Section 8 Technical Specifications and Warranty...
Page 283 Chapter 30 Technical Specifications...
Page 284: Chapter 30 - Technical Specifications
30.1 Overview This section provides tables of technical specifications, performance characteristics, options, settings, and electromagnetic compli- ance information for the t:slim G4 System. The specifications in this section meet the international standards set forth in IEC 60601-1 and IEC 60601-2-24.
Page 285 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 G4 Pump in the presence of flammable anesthetics or explosive gases. Size 3.13˝...
Page 286 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.
Page 287 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...
Page 288 Chapter 30 – Technical Specifications Dexcom G4 PLATINUM Sensor Specifications Glucose Range 40 - 400 mg/dL Sensor Life Up to 7 days Calibration Commercially available blood glucose meter Calibration Range 40 - 400 mg/dL Storage Condition Temperature: 36°F to 77°F Humidity: 15% - 85% RH Sterilization Sterile by radiation...
Page 289 Chapter 30 – Technical Specifications Dexcom G4 PLATINUM Transmitter Specifications Part Number P/N 9438-01 P/N 9438-05 Dimensions (including sensor pod) Length: 1.5 inches Length: 1.5 inches Width: 0.9 inches Width: 0.9 inches Thickness: 0.5 inches Thickness: 0.4 inches Weight (including sensor pod) 0.4 ounces 0.3 ounces Power Supply...
Page 290 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...
Page 291 Safety Standard Compliance 60950-1 or 60601-1 or equivalent The t:slim G4 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) •...
Page 292: T:slim G4 Pump Options And Settings
Chapter 30 – Technical Specifications 30.3 t:slim G4 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...
Page 293 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...
Page 294: T:slim G4 Pump Performance Characteristics
Chapter 30 – Technical Specifications 30.4 t:slim G4 Pump Performance Characteristics 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...
Page 295: Dexcom G4 Platinum Transmitter Performance Characteristics
Chapter 30 – Technical Specifications 30.5 Dexcom G4 PLATINUM Transmitter Performance Characteristics Parameter Performance Characteristics TX/RX Frequencies 2.424 999 877 GHz 2.449 993 677 GHz 2.474 737 539 GHz 2.477 236 919 GHz Bandwidth 334.7 kHz Maximum Output Power 1.25 mW EIRP Modulation Minimum Shift Key Data Rate...
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Page 297: Dexcom G4 Platinum Sensor Performance Characteristics
2 sensors. Sensors were calibrated blood glucose values. Additionally, pa- approximately once every 12 hours, The t:slim G4 System is indicated tients performed self-monitoring blood using the self-monitoring blood glucose for use in individuals 12 years of...
Page 298 Chapter 30 – Technical Specifications OneTouch Verio IQ meter. The adult for and should not be used by Agreement Relative to YSI ® ® individuals less than 12 years of age. clinical study used the LifeScan One- Agreement between the System and ®...
Page 299 Chapter 30 – Technical Specifications Table 1-A. System Agreement to YSI within CGM Glucose Ranges (Pediatric Study) Percent Number Percent Percent Percent Percent Glucose Greater within within within within Range than paired 15/15% 20/20% 30/30% 40/40% mg/dL 40/40% CGM-YSI (mmol/L) Overall 2922 40–60...
Page 300 Chapter 30 – Technical Specifications Table 1-B. System Agreement to YSI within CGM Glucose Ranges (Adult Study) Percent Number Percent Percent Percent Percent Glucose Greater within within within within Range than paired 15/15% 20/20% 30/30% 40/40% mg/dL 40/40% CGM-YSI (mmol/L) Overall 9152 40–60...
Page 301 Chapter 30 – Technical Specifications Agreement When CGM Reads “LOW” or “HIGH” The System reports glucose concentrations between 40 and 400 mg/dL (2.2–22.2 mmol/L). When the System determines the glucose level is below 40 mg/dL (2.2 mmol/L), it displays “LOW” in the Receiver Status Box. When the System determines that the glucose level is above 400 mg/dL (22.2 mmol/L), it displays “HIGH”...
Page 302 Chapter 30 – Technical Specifications Table 2-B. Number and Percentage of YSI Values When CGM Readings are ‘Low’ or ‘High’* (Adult Study) YSI mg/dL (mmol/L) Total CGM-YSI < 55 < 60 < 70 < 80 ≥ 80 Readings pairs (3.1) (3.3) (3.9) (4.4)
Page 303 Chapter 30 – Technical Specifications Concurrence of System and Laboratory Reference The percentage of concurring CGM readings and YSI reference values are included in Tables 3-A (pediatric study) and 3-B (adult study). Tables 3-A (pediatric study) and 3-B (adult study) are categorized by ranges of glucose values.
Page 304 Chapter 30 – Technical Specifications Table 3-A. Concurrence of CGM Readings and YSI Values (Pediatric Study) YSI mg/dL (mmol/L) 121- 161- 201- 251- 301- 351- Sensor < 40 > 400 mg/dL Total (2.2) (2.2- (3.4- (4.5- (6.7- (8.9- (11.1- (13.9- (16.7- (19.4- (22.2)
Page 305 Chapter 30 – Technical Specifications Table 3-B. Concurrence of CGM Readings and YSI Values (Adult Study) YSI mg/dL (mmol/L) mg/dL Percent of matched pairs in each YSI glucose range (mmol/L) for each Sensor glucose range 121- 161- 201- 251- 301- 351- Number <...
Page 306 Chapter 30 – Technical Specifications tell you whether the System is reading, Accuracy Relative to YSI on average, higher or lower than the Accuracy between matched pairs YSI laboratory standard. The mean was also estimated by calculating the absolute percent difference is the av- percent difference between the System erage “distance”...
Page 307 Chapter 30 – Technical Specifications Table 4-A. System Difference to YSI within CGM Glucose Ranges (Pediatric Study) Mean Median Mean Median Glucose Number Absolute Absolute Percent Percent Ranges of Paired Percent Percent Difference Difference mg/dL CGM-YSI Difference Difference (mmol/L) Overall 2922 13.5 11.6...
Page 308 Chapter 30 – Technical Specifications Table 4-B. System Difference to YSI within CGM Glucose Ranges (Adult Study) Mean Median Mean Median Glucose Number Absolute Absolute Percent Percent Ranges of Paired Percent Percent Difference Difference mg/dL CGM-YSI Difference Difference (mmol/L) Overall 9152 13.3 *40–60...
Page 309 Chapter 30 – Technical Specifications Low and High Glucose Alerts The Low Glucose Alert The ability of the System to detect high Estimates of how well the adjustable and low glucose levels (concentrations) Low Glucose Alert performs are pre- is assessed by comparing System sented in Tables 5-A and 5-B*.
Page 310 Chapter 30 – Technical Specifications Table 5-A. Hypoglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Pediatric Study, Ages 6–17) Hypoglycemic True False Hypoglycemia Hypoglycemia Missed Alert Level Alert Alert Detection Rate Detection Rate mg/dL (mmol/L) Rate Rate...
Page 311 Chapter 30 – Technical Specifications within the 15 minute period before or 50% of the time (pediatric study) or Hypoglycemia Alert Rate after your alarm sounds. 83% of the time (adult study) and not The Alert Rate shows how often the to sound approximately 50% of the alert is right or wrong.
Page 312 Chapter 30 – Technical Specifications Table 6-A. Hyperglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Pediatric Study, Ages 6 to 17 years) Hyperglycemic Alert True False Hyperglycemia Hyperglycemia Missed Level mg/dL (mmol/L) Alert Rate Alert Rate Detection Rate Detection Rate...
Page 313 Chapter 30 – Technical Specifications (adult study) within the 15 minute peri- mg/dL (11.1 mmol/L), you can expect Hyperglycemia Alert Rate od before or after your alarm sounds. your alarm to sound 98% of the time The Alert Rate shows how often the (pediatric study) or 97% of the time alert is right or wrong.
Page 314 Chapter 30 – Technical Specifications Calibration Stability The System must be calibrated every 12 hours. To demonstrate performance of the System over a 12-hour calibration period, sensors were evaluated to verify that performance remains consistent over the 12-hour calibration period. Systems were evaluated in 2-hour increments after calibration.
Page 315 Chapter 30 – Technical Specifications Table 7-B. Percentage of System Readings within YSI Values with Data Stratified in 2-Hour Increments after Calibration (Adult Study) Percent Percent Percent Percent Percent Time Number within within within within greater than from of paired 15/15% 20/20% 30/30%...
Page 316 Chapter 30 – Technical Specifications Sensor Stability Relative to YSI Sensors can be worn for up to 7 days. Performance was estimated by calculating the percentage of System readings within 15 mg/dL (0.9 mmol/L) or 15%, 20 mg/dL (1.1 mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30% , 40 mg/dL (2.2 mmol/L) or 40% and greater than 40 mg/dL (2.2 mmol/L) or 40% of the YSI values at the beginning (Day 1), middle (Day 4) and end (Day 7) of the System lifecycle.
Page 317 Chapter 30 – Technical Specifications Table 8-B. Sensor Stability (Accuracy over Time, Adult Study) Mean Median Percent Number Percent Percent Percent Percent Absolute Absolute greater within within within within Percent Percent than paired 15/15% 20/20% 30/30% 40/40% Wear Differences Differences 40/40% CGM-YSI Day 1...
Page 318 Chapter 30 – Technical Specifications days/hours of readings each sensor Tables 10-A (pediatric study) and 10-B Precision of System Readings provided. Eighty-five percent (85%) (adult study). In the adult study 36 participants wore of the sensors lasted until at least the two Systems.
Page 319 Chapter 30 – Technical Specifications Table 9-A. Number of Readings Provided by Each Sensor Over 7-Days (Pediatric Study) % of Total Possible Total Readings Provided % of Systems Providing that Readings Provided (Min-Max) Number of Readings 0–25% 103–427 2.6% 26–50% 569–954 2.6% 51–75%...
Page 320 Chapter 30 – Technical Specifications Table 10-A. System Readings Within Wear Days (Pediatric Study) All Days Statistic Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 (N = 108) Mean Median Table 10-B. System Readings Within Wear Days (Adult Study) All Days Statistic Day 1...
Page 321 Chapter 30 – Technical Specifications Agreement and Accuracy Relative to SMBG During the study, agreement between the System and blood glucose values is also characterized using paired System and SMBG results (Tables 11–12). The System and SMBG values were compared by pairing the compar- ative SMBG value to a System glucose reading that occurred immediately after the SMBG was collected.
Page 322 Chapter 30 – Technical Specifications Table 11-A. System Agreement to SMBG Within CGM Glucose Ranges (Pediatric Study) CGM Glucose Number Percent Percent Percent Percent Percent Ranges within within within within greater than mg/dL paired 15/15% 20/20% 30/30% 40/40% 40/40% (mmol/L) CGM-SMBG SMBG SMBG...
Page 323 Chapter 30 – Technical Specifications Table 11-B. System Agreement to SMBG Within CGM Glucose Ranges (Adult Study) CGM Glucose Number Percent Percent Percent Percent Percent Ranges within within within within greater than mg/dL paired 15/15% 20/20% 30/30% 40/40% 40/40% (mmol/L) CGM-SMBG SMBG SMBG...
Page 324 Chapter 30 – Technical Specifications Tables 11-A and 11-B are categorized within CGM glucose ranges. For read- ings less than or equal to 80 mg/dL (4.4 mmol/L) the absolute difference in mg/dL (mmol/L) between the two glucose results was calculated. For values greater than 80 mg/dL (4.4 mmol/L) the absolute percent differ- ence (%) from the SMBG values was...
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Page 326 Chapter 30 – Technical Specifications Table 12-B. System Difference to SMBG within CGM Glucose Ranges (Adult Study) Mean Median Number Mean Median Absolute Absolute Percent Percent Glucose Percent Percent Paired Difference Difference Ranges mg/dL (mmol/L) Difference Difference CGM-SMBG Overall 7508 -0.4 -1.4 14.0...
Page 327 Chapter 30 – Technical Specifications In the pediatric study, overall the Sensor Stability Relative to SMBG System reads, on average, 2.2% lower (Mean Percent Difference) than SMBG Sensors can be worn for up to 7 values and 15.3% absolute different days.
Page 328 Chapter 30 – Technical Specifications Table 13. Sensor Stability Relative to SMBG (Accuracy over Time, Pediatric Study) Mean Median Percent Number Percent Percent Percent Percent Absolute Absolute greater within within within within Percent Percent than paired 15/15% 20/20% 30/30% 40/40% Wear Differences Differences...
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Page 330: Electromagnetic Compatibility
The information contained in this section is specific to the t:slim G4 System. This information provides reasonable assurance of normal operation, but does not guarantee such under all conditions. If the t:slim G4 System must be used in close proximity with other electrical equipment, the System should be observed in this environment to verify normal operation.
Page 331: Electromagnetic Emissions
Chapter 30 – Technical Specifications 30.8 Electromagnetic Emissions The t:slim G4 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...
Page 332: Electromagnetic Immunity
Chapter 30 – Technical Specifications 30.9 Electromagnetic Immunity The t:slim G4 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 –...
Page 333 Chapter 30 – Technical Specifications …table continued from previous page Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Electromagnetic Environment – Immunity Test IEC 60601 Test Level Compliance Level 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...
Page 334: Distances Between The T:slim G4 Pump And Rf Equipment
30.10 Distances Between the t:slim G4 Pump and RF Equipment The t:slim G4 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 G4 System.
Page 335 RF Communications Equipment and the t:slim G4 System The t:slim G4 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 G4 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.
Page 336 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)
Page 337: Fcc Notice Concerning Interference
Chapter 30 – Technical Specifications 30.11 FCC Notice Concerning Reorient or relocate the receiving Warning (Part 15.21) • Interference antenna. Changes or modifications not express- The transmitter covered by this user’s ly approved by the party responsible Increase the separation between •...
Page 338: Warranty Information
If: the t:slim G4 Pump seal is or special damages of any kind • The expected life of the t:slim G4 Pump broken; caused by or arising out of a is a maximum of 4 years. Tandem Di- defect in the product.
Page 339 If: damage results from an event particular purpose. • If: the cartridge has been used for beyond the control of Tandem; or • Warranty more than a single-time use by a single end-user; If: damage results from negligence •...
Page 340 Chapter 30 – Technical Specifications this replacement transmitter, and this 3. What are Dexcom’s Obligations The limited warranty of Dexcom warranty page shall be void. Under the Limited Warranty? described above is exclusive and in lieu of all other warranties, express During the Warranty Period, Dexcom 2.
Page 341 Chapter 30 – Technical Specifications ity shall not affect the enforceability of the remainder of this limited war- ranty which purchaser acknowledg- es is and will always be construed to be limited by its terms or as limited as the law permits. Customer Technical Support: 1-877-801-6901...
Page 342 Index Alerts 141, 145 Max Basal Alerts 160 Index Max Bolus Alerts 158 Alert Icon 56 Accessories 46, 80 Max Hourly Bolus Alert 157 Alert Settings 70 AC Power Adapter 80 Min Basal Alerts 162 Basal Rate Required Alert 156 Active Bolus 56, 58 Power Source Alert 165 CGM Calibration Alerts 245...
Page 343 Index Battery 80 Food Bolus Using Grams 111 Cartridge Error Alarm 173 Food Bolus Using Units 111 Cartridge Removal Alarm 174 Battery Level 56, 60 Max Bolus 101 Cartridge Tubing 60 Battery Power Alerts 148 Max Bolus - Setting Up 104 Change Cartridge 93 Charging 80 Quick Bolus 47, 125...
Page 344 Index Setting Up 204 Correction Bolus, Below Target 112 High BG Reminder 137 CGM Overview 186 Correction Factor 47 Insulin Duration 101 Low BG Reminder 136 CGM Rise Alerts 256 Correction Factor Setting 101 Low Insulin Alert 142 Correction Factor - Setting Up 102 Setting Up 203 Max Bolus 101 Customer Technical Support 3...
Page 345 Index Electromagnetic Immunity 332 Food Bolus Using 67, 111 Incomplete Setting Alert 155 Incomplete Temp Rate Alert 151 Emergency Kit 42 Indications for Use 28 Empty Cartridge Alarm 172 Infusion Set Risks 40, 86 Extended Bolus 47, 113 Healthcare Provider 41 Infusion Site Care 86 High BG Reminder 137 Insulin...
Page 346 Low Power Alerts 148 Options Screen 68 Power Source Alert 165 Luer-lock 60, 88, 94 Overview Precautions CGM Overview 186 Using t:slim G4 Pump 34 System Description 24 Pump Info 134 Malfunction 182 Max Basal Alerts 160 Max Bolus 101 Performance Characteristics...
Page 347 Emergency Kit 42 Applicator 48, 187 t:slim G4 Pump 285 Indications for Use 28 Automatic Shutoff 238 Startup Precautions - t:slim G4 Pump 34 Expiration Date 206, 281 CGM Startup Period 217 Verification of Proper Functionality Insertion 209 Status Insertion Site 208...
Page 348 Cartridge Tubing 60 Target BG - Setting Up 103 Dexcom G4 Sensor 276 Filling Tubing 94 Temperature Alarm 175 t:slim G4 Pump 276, 285 Temp Rate 47 Incomplete Temp Rate Alert 151 Setting a Temp Rate 122 Units 47 Stopping a Temp Rate 123...
Page 349 Index Customer Technical Support: 1-877-801-6901...
Page 350 © 2015 Tandem Diabetes Care, Inc. All rights reserved. t:slim, t:connect, touch simplicity and Tandem Diabetes Care are registered trademarks and t:slim G4 is a trademark of Tandem Diabetes Care, Inc. For a list of patents, please see www.tandemdiabetes.com/patents.

Tandem t:slim G4 User Manual

Chapter 1 - Introduction

Chapter 2 - Important Safety Information

Chapter 3 - Getting to Know Your T:slim G4 System

Chapter 4 - Getting Started

Chapter 5 - Infusion Site Care and Loading Cartridge

Chapter 6 - Personal Profile

Chapter 7 - Bolus

Chapter 8 - Stop/Resume Insulin

Chapter 9 - Temporary Basal Rate

Chapter 10 - Quick Bolus

Chapter 11 - T:slim G4 Pump Settings

Chapter 12 - T:slim G4 Pump Info and History

Chapter 13 - T:slim G4 Pump Reminders

Chapter 14 - User Settable Alerts and Alarms

Chapter 15 - T:slim G4 Pump Alerts

Chapter 16 - T:slim G4 Pump Alarms

Chapter 17 - T:slim G4 Pump Malfunction

Chapter 18 - Dexcom G4 PLATINUM CGM Overview

Chapter 19 - CGM Settings

Chapter 20 - Setting CGM Alerts

Chapter 21 - Inserting the Sensor and Placing the Transmitter

Chapter 22 - Starting a CGM Sensor Session

Chapter 23 - Calibrating Your CGM System

Chapter 24 - Viewing CGM Data on Your T:slim G4 Pump

Chapter 25 - Ending Your CGM Sensor Session

Chapter 26 - CGM Alerts and Errors

Chapter 27 - CGM Troubleshooting

Chapter 28 - Lifestyle Issues and Travel

Chapter 29 - Taking Care of Your T:slim G4 System

Chapter 30 - Technical Specifications

Quick Links

Troubleshooting

Related Manuals for Tandem t:slim G4

Summary of Contents for Tandem t:slim G4