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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.
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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 »...
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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.
Indications for Use and Contraindications ..............21 Warnings and Precautions ....................21 Conventions of this Guide .....................26 Chapter 2 – Introduction Welcome ........................28 What your t:slim System Package Includes ..............28 Explanation of Symbols ....................29 Explanation of Icons ......................30 Explanation of System Colors ..................31 Warranty Information .....................32...
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Number Keypad Screen ....................50 3.10 Letter Keypad Screen ....................52 Section 2 – Key Pump Features Chapter 4 – Getting Started Charging the t:slim Pump ....................56 Turning on the t:slim Pump Screen ................58 Unlocking the t:slim Pump Screen ................58 Customer Technical Support: 1-877-801-6901...
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Edit Date ........................59 Chapter 5 – Infusion Site Care and Loading Cartridge Infusion Site Selection and Care ...................62 Cartridge Instructions for Use ..................64 Filling and Loading a t:slim Cartridge ................64 Filling Tubing .........................70 Filling Cannula .......................72 Setting Site Reminder ....................73 Chapter 6 –...
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Table of Contents Chapter 7 – Bolus Bolus Overview ......................86 Food Bolus Using Units....................87 Food Bolus Using Grams ....................87 Correction Bolus ......................88 Extended Bolus ......................89 Canceling or Stopping a Bolus..................91 Chapter 8 – Stop/Resume Insulin Stopping Insulin Delivery ....................94 Resuming Insulin Delivery .....................94 Section 3 –...
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Delivering Quick Bolus ....................102 Chapter 11 – t:slim Pump Settings 11.1 t:slim Pump Volume .....................106 11.2 Screen Options ......................106 Chapter 12 – t:slim Pump Info and History 12.1 t:slim Pump Info ......................110 12.2 t:slim Pump History .....................110 Chapter 13 – t:slim Pump Reminders 13.1...
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Table of Contents Section 5 – System Care and Maintenance Chapter 18 – Taking Care of Your t:slim System 18.1 Overview ........................162 Section 6 – System Technical Specifications Chapter 19 – Technical Specifications 19.1 Overview ........................166 19.2 t:slim Pump Specifications ..................166 19.3...
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(t:slim System). The t:slim System is use features are examples only. They mation on how to operate your t:slim made up of the t:slim Insulin Pump and should not be considered suggestions Pump. It provides step-by-step instruc- the t:slim 3 mL (300 units) cartridge.
Chapter 1 – About this User Guide Working with your Emergency Kit termine and help you adjust your basal Healthcare Provider rate(s), insulin-to-carbohydrate ratio(s), correction factor(s), blood glucose (BG) Make sure that you always have an in- Any clinical language presented in this target, and duration of insulin action.
Functionality (antiseptic wipes, skin adhesive) If any of these conditions fail to occur, do NOT use the t:slim System, as this may be an Diabetes identification card A power supply (AC adapter with indication that the pump’s alarms, alerts, and •...
Pump trainer. the management of diabetes mellitus in persons requiring insulin, for individuals Incorrect use of your System or failure 12 years of age and greater.
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Tandem Diabetes Care, Inc., and found nection and consult its instructions Always notify the provider/technician to be compatible for use in the t:slim for use. Failure to do so may result in about your diabetes and your insulin System. It is not intended for use with over-infusion or under-infusion and pump.
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Chapter 1 – About this User Guide electrocardiograms (EKGs) or colonos- In addition to the above, you must Small Parts Potentially Ingestible take off your t:slim System and leave copies. by Children it outside the procedure room if you The System includes small parts (such...
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Always ensure that there are no Submersion in Fluid The t:slim System is watertight to a Additional Precautions air bubbles in the tubing when filling. depth of 3 feet for up to 30 minutes Your System is a sealed device that (IPX7 rating).
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If you damage or drop your t:slim Sys- tem, ensure that it is still working prop- When you first use the Quick Bolus Always dispose of used cartridges, erly.
A list of options on your touch screen that allow you to perform specific tasks. An image on your touch screen that indicates an option or item of information, or Icon a symbol on the back of your t:slim Pump or its packaging. Customer Technical Support: 1-877-801-6901...
NOTE of your commitment to your diabetes Your t:slim Pump is shipped from Tandem care. The t:slim System delivers insulin 1. t:slim Insulin Pump Diabetes Care, Inc. with a clear screen in two ways: continuous, or basal insulin protector.
Chapter 2 – Introduction Explanation of Symbols The following are symbols (and their descriptions), which you may find on your t:slim System and/or its packaging. Symbol Meaning Symbol Meaning Caution; Consult Manual for Important Use By Date Safety Documentation See Instructions for Use...
The following icons may appear in A system reminder, alert, error, or alarm is active. the status area (to the left or right of the time and date) on your t:slim Pump Home Screen. Tap the icon to Basal insulin is programed and being delivered.
Chapter 2 – Introduction 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. Green LED »...
The warranty is valid only if the t:slim Pump is used in accordance with This warranty shall be personal to the original end use purchaser. Any sale, Tandem’s instructions and will not...
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TANDEM NOR ITS SUPPLIERS OR and exclusions stated herein. person or entity other than Tandem; DISTRIBUTORS SHALL BE LIABLE FOR ANY INCIDENTAL, CONSEQUEN- The warranty is valid only if the...
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NOTE usually delivered to cover food eaten or Factor (ISF). a high BG. With the t:slim Pump it can Turn off the pump screen by pressing the Screen On/Quick Bolus button before placing be delivered as a Standard, a Correc-...
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Personal Profile Serial Bus. The USB cable connects A personal profile is a personalized into the t:slim Pump’s micro USB port. Grams group of settings that defines the de- Grams are a unit of measurement livery of basal and bolus insulin within for carbohydrates.
Chapter 3 – t:slim Pump Overview Screen Lock 1. Time and Date Display: Displays 8. Insulin Level: Displays the current the current time and date. amount of insulin in the cartridge. 2. Alert Icon: Indicates a reminder, 9. Tandem Logo: Returns to the alert or alarm is active behind the Home Screen.
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Chapter 3 – t:slim Pump Overview 10:20 AM 100% March 15, 2015 235 u INSULIN ON BOARD (IOB) Units 1.1 u Time Remaining 1:09 hrs Customer Technical Support: 1-877-801-6901...
Chapter 3 – t:slim Pump Overview Home Screen 1. Battery Level: Displays the level 8. Insulin Level: Displays the current of battery power remaining. amount of insulin in the cartridge. When connected for charging, the charging icon (lightning bolt) 9. Tandem Logo: Returns to the will display.
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Chapter 3 – t:slim Pump Overview 10:20 AM 100% March 15, 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...
Chapter 3 – t:slim Pump Overview Status Screen 1. Profile: Displays current active NOTE Personal Profile. NA represents Not Applicable (does not apply). 2. Basal Rate: Displays current basal rate being delivered. (Temp Rate: NOTE If active, displays in units/hr.) The status screen can be accessed from the lock screen and the Home Screen.
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Chapter 3 – t:slim Pump Overview Current Status Current Status BACK BACK Correction 1u: 50 Weekly mg/dL Factor 1u: 10g Basal Rate 0.2 u/hr Carb Ratio Last Bolus Target BG mg/dL 12/23 - 10:45 PM Carbohydrates Insulin Duration hours Customer Technical Support: 1-877-801-6901...
Chapter 3 – t:slim Pump Overview Bolus Screen 1. Back: Returns to the Home 10. View Calculation: Displays how Screen. the insulin dose was calculated using the current settings. 2. Carbs: Enter grams of carb. 11. Add BG: Enter blood glucose 3.
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Chapter 3 – t:slim Pump Overview 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...
Chapter 3 – t:slim Pump Overview Options Screen 1. Back: Returns to the Home Screen. 2. Stop Insulin: Stops insulin delivery. If insulin delivery is stopped, RESUME INSULIN will be displayed. 3. My Pump: Personal Profiles, Alert Settings, Pump Settings, and Pump Info.
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Chapter 3 – t:slim Pump Overview Options Options BACK BACK STOP INSULIN History My Pump Load Temp Rate Customer Technical Support: 1-877-801-6901...
Chapter 3 – t:slim Pump Overview My Pump Screen 1. Personal Profiles: A group of settings that defines basal and bolus delivery. 2. Alert Settings: Customize Pump Reminders and Alerts. 3. Pump Settings: Customize Quick Bolus, Pump Volume, Screen Options, and Time and Date.
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Chapter 3 – t:slim Pump Overview My Pump BACK Personal Profiles Alert Settings Pump Settings Pump Info Customer Technical Support: 1-877-801-6901...
Chapter 3 – t:slim Pump Overview 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.
Sys- When you are connected to the pump and to ed Car Power USB Adapter: tem to charge your t:slim Pump. If you a charging source, take caution when moving lose any of the accessories, or need a 1.
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USB port on the pump. If any of these conditions fail to occur, do NOT use the t:slim Pump, as this may be an NOTE indication that the pump’s alarms, alerts, and Before using a Mac or PC to charge the t:slim...
NOTE NOTE When using the t:slim Pump, tap the Tandem Logo to return to the Home Screen or tap BACK You must tap 1–2–3 in sequential order to to return to the previous screen.
Edit Time Edit Date 7. Using the onscreen keypad, enter the hour and minutes. Verify and After powering up your t:slim Pump for tap DONE. 1. From the Time and Date screen the first time, set the current time and tap Edit Date.
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» Areas within 3 inches of your both an antiseptic and an adhesive ® ® sensor site, if using Continuous are encouraged. tested by Tandem Diabetes Care, Inc., and found to be safe for use in the t:slim Pump. Glucose Monitoring. Customer Technical Support: 1-877-801-6901...
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Chapter 5 – Infusion Site Care and Loading Cartridge Areas of Body for Infusion Set Insertion Customer Technical Support: 1-877-801-6901...
NOT connected to your body. For complete cartridge labeling, consult the Cartridge Instructions for Use Before you begin, make sure you included in the t:slim Cartridge box. have the following items: Luer-Lock Tail of the Cartridge 1 unopened cartridge •...
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Instructions for Drawing Insulin from Vial into Syringe PRECAUTION Use only the syringe and needle provided by Tandem Diabetes Care, Inc. to fill the cartridge. After filling the cartridge and before connecting and filling the tubing, reduce the possibility of trapped air in the cartridge by holding your t:slim Pump vertically with the cartridge insulin fill port on top.
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Chapter 5 – Infusion Site Care and Loading Cartridge 7. With needle still inserted into vial, turn vial and syringe upside down. Release syringe plunger. Insulin will begin to flow from the vial into the syringe. 8. Slowly pull back the plunger to the desired amount of insulin (see image C). 9.
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Chapter 5 – Infusion Site Care and Loading Cartridge Instructions for Filling the Cartridge 1. Inspect the cartridge package for any signs of damage. Discard any damaged product. 2. Open the package and remove the cartridge. 3. Hold the cartridge upright and gently insert the needle into the white insulin fill port on the cartridge (see image E).
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Chapter 5 – Infusion Site Care and Loading Cartridge 6. Withdraw the needle from the fill port. 7. Turn the syringe upright and pull down on the plunger (see image H). Flick the barrel to make sure that any air bubbles rise to the top. 8.
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NOTE tool or the edge of a coin in the slot at the 7. Tap NEXT to continue. During the load sequence, the Tandem bottom of the cartridge and twist to aid in “Detecting Cartridge” screen Logo is disabled. Tapping it will not return the removal of the cartridge.
Chapter 5 – Infusion Site Care and Loading Cartridge Filling Tubing PRECAUTION cartridge and want to continue with filling the tubing. Conduct regular checks of your t:slim Pump Filling the Infusion Set Tubing and infusion set, particularly: with Insulin 1. Verify that the infusion set is »...
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Chapter 5 – Infusion Site Care and Loading Cartridge NOTE b. If you want to fill the tubing with at a time (for example, you will see 140, The following are approximate amounts of more than 30 units, tap FILL to 135, 130, 125).
Chapter 5 – Infusion Site Care and Loading Cartridge Filling Cannula NOTE NOTE The cannula fill amount displayed is based The screen will return to the Load menu if Filling the Infusion Set Cannula on your last cannula fill amount. Filling the Site Reminder is turned off.
7. Tap RESUME. Reminder if settings need to be changed. NOTE If this is the first time using your t:slim 2. Tap Remind Me In and select the Pump and a Personal Profile has not been number of days (1-3).
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Max Bolus and Carbohydrates units/hr) setting (on/off). Correction Factor (amount 1 unit • The t:slim Pump uses the settings of insulin lowers BG) in your active profile to calculate the delivery of basal insulin, food boluses Carb Ratio (grams of carbs covered •...
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2. Tap My Pump. Insulin Duration (how long a bolus • lowers your BG) Insulin Duration in your t:slim Pump is 3. Tap Personal Profiles. set from the factory at 5 hours but can Max Bolus (the maximum amount be changed from 2 to 8 hours. Please 4.
Chapter 6 – Personal Profile Programming a New NOTE Timed Settings Personal Profile Tap once for first letter displayed, 2 quick 12:00 AM BACK SAVE taps for middle letter; and 3 quick taps for NOTE the third letter. Once the Personal Profile has been created, the Basal Press to Set Up 6.
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Chapter 6 – Personal Profile 5. Tap Carb Ratio. 11. Tap BACK to set the Bolus you want the segment to begin, Settings. and tap DONE. 6. Using the onscreen keypad, enter your insulin-to-carbohydrate ratio Tap ADD to create additional 3.
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10 u Max Bolus Tap NO to make changes. Carbohydrates 9. Tap Tandem Logo to return to the Home Screen. 3. Using the onscreen keypad, enter NOTE the desired time for the duration...
OPTIONS. Tap NO to make changes. Tap NO and make changes. 2. Tap My Pump. 11. Tap BACK after editing all of the 14. Tap Tandem Logo to return to the time segments. Home Screen. 3. Tap Personal Profiles. NOTE 4.
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.
(up to 16 5. Tap Delete. characters) and tap SAVE. 6. Tap YES. 7. Tap Tandem Logo to return to the Home Screen. “Profile Deleted” screen is displayed. 7. Tap Tandem Logo to return to the Home Screen.
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BG level. You can always adjust the bolus. You are required to enter a new amount. Your t:slim Pump offers you the ability insulin units up or down before you decide to to deliver different boluses to cover deliver your bolus.
Chapter 7 – Bolus Food Bolus Using Units Food Bolus Using Grams 7. The bolus splash screen is displayed. NOTE 1. From the Home Screen, If bolusing using a carb ratio skip to the next tap BOLUS. chapter, Food Bolus Using Grams. 2.
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.
Chapter 7 – Bolus Extended Bolus NOTE 4. Tap NEXT to confirm the units of When your blood glucose is: insulin to be delivered. » Above Target BG: the insulin for the food The Extended Bolus feature allows you to deliver part of the bolus now and bolus and the correction bolus will be 5.
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Chapter 7 – Bolus NOTE 4. If desired, tap Add BG and using 12. Tap NEXT. the onscreen keypad enter BG A correction bolus will always be given in value. Tap DONE. NOTE the DELIVER NOW portion. Tap View Units to display the breakdown of 5.
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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1. If pump screen is not on, press including basal, and any active bolus or Screen On/Quick Bolus Button temp rate at any time. once to turn on your t:slim Pump screen. 1. From the Home Screen, tap OPTIONS. 2. Tap 1-2-3 to access the Home Screen.
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Chapter 9 – Temporary Basal Rate Setting a Temp Rate be set to the maximum allowable rate NOTE for delivery. If a Temp Rate is active, the status of A Temp Rate is used to increase or insulin delivery displays an orange “T”. If decrease (by percentage) the current 1.
Chapter 9 – Temporary Basal Rate Stopping a Temp Rate To stop an active temp rate: 1. From the Home Screen, tap OPTIONS. 2. On the Options screen, tap X (stop icon) on the right side of Temp Rate. 3. On the confirmation screen, tap STOP.
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7. Tap Increment Amount. pressing a button. It is a way to deliver to look at the t:slim Pump’s screen. a bolus by following beep/vibration 8. Select the preferred increment Simply use the Quick Bolus Button to commands without navigating through amount.
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Chapter 10 – Quick Bolus 2. Press Quick Bolus Button for each » If you hear a different tone at any point increment until desired amount during programming, look at the screen is reached. The pump will beep/ to confirm the bolus amount. If the vibrate for each button press.
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Pump Volume can be personalized for You can set the Screen Timeout to the Button taps, Quick Bolus, Bolus, 8. Tap Tandem Logo to return to the the length of time you want the screen Reminders, Alerts, and Alarms. Options Home Screen.
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Chapter 11 – t:slim Pump Settings 1. From the Home Screen, 2. Tap YES to confirm. tap OPTIONS. 3. Tap SAVE. 2. Tap My Pump. 4. Tap Tandem Logo to return to 3. Tap Pump Settings. the Home Screen. 4. Tap Screen Options.
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Chapter 12 – t:slim Pump Info and History 12.1 t:slim Pump Info 12.2 t:slim Pump History by date. The event details in each report are listed by time. Your t:slim Pump allows access to Pump History displays a historical log information about your pump.
Chapter 13 – t:slim Pump Reminders 13.1 Low BG Reminder Your t:slim Pump lets you know import- every 10 minutes until acknowledged. ant information about the System with Reminders do not escalate. Reminders, Alerts, and Alarms. Re- The Low BG Reminder prompts you...
1. From the Home Screen, d. Tap Tandem Logo to return to tap OPTIONS. 7. Tap Tandem Logo to return to the the Home Screen. Home Screen. 2. Tap My Pump. To Respond to the Low...
End Time for each reminder. 1. From the Home Screen, are complete. tap OPTIONS. 1. From the Home Screen, 8. Tap Tandem Logo to return to the tap OPTIONS. 2. Tap My Pump. Home Screen. 2. Tap My Pump. 3. Tap Alert Settings.
Chapter 13 – t:slim 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 1–4) and do the The Site Reminder prompts you to change your infusion set.
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Chapter 14 – User Settable Alerts and Alarms 14.1 Low Insulin Alert 14.2 Auto-Off Alarm To Respond to the Low Insulin Alert Your t:slim Pump keeps track of how Your t:slim Pump can stop insulin de- LOW INSULIN ALERT much insulin remains in the cartridge...
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The warning clears and the pump of “All Deliveries Stopped.” You returns to normal operation. must resume delivery to continue 9. Tap Tandem Logo to return to therapy, (refer to Chapter 8.2). the Home Screen. If you do not clear the warning within...
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Chapter 15 – t:slim Pump Alerts Your t:slim Pump lets you know import- ant information about the System with Reminders, Alerts, and Alarms. Re- minders are displayed to notify you of an option that you have set (for exam- ple, a reminder to check you BG after a bolus).
Chapter 15 – t:slim Pump Alerts 15.1 Low Insulin Alert What will I see on the Screen? What does it mean? 5 units or less of insulin remain in the cartridge. LOW INSULIN ALERT How will the system notify me? Change cartridge or pump will stop all deliveries.
Chapter 15 – t:slim Pump Alerts 15.2 Low Power Alerts Low Power Alert 1 What does it mean? What will I see on the Screen? Less than 25% of battery power remains. How will the system notify me? LOW POWER ALERT...
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Chapter 15 – t:slim Pump Alerts Low Power Alert 2 What does it mean? What will I see on the Screen? Less than 5% of battery power remains. Insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop.
Chapter 15 – t:slim Pump Alerts 15.3 Incomplete Bolus Alert What will I see on the Screen? What does it mean? You started a bolus request but did not complete the request within 90 seconds. INCOMPLETE BOLUS ALERT How will the system notify me? This bolus has not been delivered.
Chapter 15 – t:slim 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. INCOMPLETE TEMP RATE...
Chapter 15 – t:slim Pump Alerts 15.5 Incomplete Load Sequence Alerts Incomplete Cartridge What does it mean? Change Alert You selected Change Cartridge from the Load menu but did not complete the process What will I see on the Screen? within 3 minutes.
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Chapter 15 – t:slim Pump Alerts Incomplete Fill Tubing Alert What does it mean? What will I see on the Screen? You selected Fill Tubing from the Load menu but did not complete the process within 3 minutes. FILL TUBING ALERT...
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Chapter 15 – t:slim Pump Alerts Incomplete Fill Cannula Alert What does it mean? What will I see on the Screen? You selected Fill Cannula from the Load menu but did not complete the process within 3 minutes. FILL CANNULA ALERT...
Chapter 15 – t:slim Pump Alerts 15.6 Incomplete Setting Alert What will I see on the Screen? What does it mean? You started to set up a new Personal Profile but did not save or complete the programming within 5 minutes.
Chapter 15 – t:slim Pump Alerts 15.7 Basal Rate Required Alert What will I see on the Screen? What does it mean? You did not enter a basal rate in a time segment in Personal Profiles. A basal rate must be entered in each time segment (rate can be 0 u/hr).
Chapter 15 – t:slim Pump Alerts 15.8 Max Hourly Bolus Alert What will I see on the Screen? What does it mean? In the previous 60 minutes, you requested total bolus delivery that is more than 1.5 times your Max Bolus setting.
Chapter 15 – t:slim Pump Alerts 15.9 Max Bolus Alerts Max Bolus Alert 1 What does it mean? What will I see on the Screen? You requested a bolus larger than the Max Bolus setting in your active Personal Profile.
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Chapter 15 – t:slim Pump Alerts NOTE The following applies only if you have Carbs turned on in your active Personal Profile and your Max Bolus amount is set to 25 units. Max Bolus Alert 2 What does it mean? What will I see on the Screen? Your Max Bolus is set to 25 units and you requested a bolus larger than 25 units.
Chapter 15 – t:slim Pump Alerts 15.10 Max Basal Alerts Max Basal Alert 1 What does it mean? What will I see on the Screen? When entering a basal rate or requesting a temp rate, you requested a basal rate more than 2 times the highest basal rate defined in your Personal Profile.
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Chapter 15 – t:slim Pump Alerts Max Basal Alert 2 What does it mean? What will I see on the Screen? An active temp rate exceeded 2 times your highest basal setting defined in your Personal Profile. MAX BASAL ALERT...
Chapter 15 – t:slim Pump Alerts 15.11 Min Basal Alerts Min Basal Alert 1 What does it mean? What will I see on the Screen? When entering a basal rate or requesting a temp rate, you requested a basal rate less than half of the lowest basal rate defined in your Personal Profile.
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Chapter 15 – t:slim Pump Alerts Min Basal Alert 2 What does it mean? What will I see on the Screen? An active temp rate dropped below half of your lowest basal setting defined in your Personal Profile. MIN BASAL ALERT...
What will I see on the Screen? What does it mean? You connected your t:slim Pump to a computer with the USB cable to charge it or upload data to t:connect and a connection could not be made. CONNECTION ERROR ALERT Pump cannot connect with the computer.
15.13 Power Source Alert What will I see on the Screen? What does it mean? You connected your t:slim 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.
15.14 Data Error Alert What will I see on the Screen? What does it mean? Your t:slim Pump encountered a condition that could potentially result in a loss of data. DATA ERROR ALERT How will the system notify me? Please verify that your active...
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Chapter 16 – t:slim Pump Alarms Your t:slim Pump lets you know import- Alarms repeat regularly until the condi- ant information about the System with tion that caused the alarm is corrected. Reminders, Alerts, and Alarms. Re- minders are displayed to notify you of...
Chapter 16 – t:slim Pump Alarms 16.1 Resume Pump Alarm What will I see on the Screen? What does it mean? You tapped STOP INSULIN in the Options menu and insulin delivery has been stopped for more than 15 minutes.
Low Power Alarm 1 What does it mean? What will I see on the Screen? Your t:slim Pump detected a power level of 1% or less remaining and all deliveries have stopped. LOW POWER ALARM How will the system notify me?
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Low Power Alarm 2 What does it mean? What will I see on the Screen? Your t:slim 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?
16.3 Empty Cartridge Alarm What will I see on the Screen? What does it mean? Your t:slim Pump detected that the cartridge is empty and all deliveries have stopped. EMPTY CARTRIDGE ALARM How will the system notify me? ALL DELIVERIES STOPPED!
What will I see on the Screen? What does it mean? Your t:slim Pump detected that the cartridge could not be used and all deliveries have stopped. This can be caused by cartridge defect, not following the proper procedure CARTRIDGE ALARM to load the cartridge, or over filling the cartridge (with more than 300 units of insulin).
Chapter 16 – t:slim Pump Alarms 16.5 Cartridge Removal Alarm What will I see on the Screen? What does it mean? Your t:slim 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.
16.6 Temperature Alarm What will I see on the Screen? What does it mean? Your t:slim Pump detected a temperature below 35.6 °F (2 °C) or above 113 °F (45 °C) and all deliveries have stopped. TEMPERATURE ALARM ALL DELIVERIES STOPPED!
16.7 Occlusion Alarms * Occlusion Alarm 1 What does it mean? What will I see on the Screen? Your t:slim Pump detected that insulin delivery is blocked and all deliveries have stopped. OCCLUSION ALARM How will the system notify me?
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Occlusion Alarm 2 What does it mean? What will I see on the Screen? Your t:slim Pump detected a second occlusion alarm shortly after the first occlusion alarm and all deliveries have stopped. OCCLUSION ALARM How will the system notify me?
16.8 Screen On/Quick Bolus Button Alarm What will I see on the Screen? What does it mean? The Screen On/Quick Bolus Button (on the top of your t:slim Pump) is stuck or not functioning properly and all deliveries have stopped. BUTTON ALARM...
Chapter 16 – t:slim Pump Alarms 16.9 Altitude Alarm What will I see on the Screen? What does it mean? Your t:slim Pump detected a pressure change outside of the operating range and all deliveries have stopped. ALTITUDE ALARM ALL DELIVERIES STOPPED!
16.10 Reset Alarm What will I see on the Screen? What does it mean? Your t:slim 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...
Chapter 17 – t:slim Pump Malfunction 17.1 Malfunction What will I see on the Screen? What does it mean? Your t:slim Pump detected a system er- If your t:slim Pump detects a system ror and all deliveries have been stopped. error, the MALFUNCTION screen MALFUNCTION appears and all deliveries are stopped.
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Chapter 18 – Taking Care of Your t:slim System 18.1 Overview for leaks around the cartridge and at Disposing of System Components the luer connector to the infusion set. This section provides information on Immediately contact Tandem Diabe- Consult your local waste management caring for and maintaining your System.
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External PSU: Class II, Infusion Pump. Internally-powered equipment, Type BF applied part. The risk of ignition of flammable anesthetics and explosive gases by the pump is remote. While this risk is remote, it is not recommended to operate the t:slim Pump in the presence of flammable anesthetics or explosive gases. Size 3.13˝...
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Chapter 19 – 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) Bolus Delivery Accuracy at all Volumes ±5% * (tested per IEC 60601-2-24) Patient Protection from Air Infusion The pump provides subcutaneous delivery into interstitial tissue and does not deliver intravenous injections.
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Chapter 19 – Technical Specifications …table continued from previous page Specification Type Specification Details Statement of Meaning of the Claimed IPX7: watertight to a depth of 3 feet for up to 30 minutes Ingress Protection (IP) Classification 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;...
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1 Hour 57 Minutes 2 Hours 7 Minutes Basal (0.1 units/hr) 19 Hours 43 Minutes 25 Hours 30 Minutes 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...
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Safety Standard Compliance 60950-1 or 60601-1 or equivalent The t:slim 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) •...
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Chapter 19 – Technical Specifications 19.3 t:slim Pump Options and Settings The following table lists the t:slim Pump options and settings, and their related details. Option/Setting Type Option/Setting Details Time 12-hour clock Maximum Basal Rate 15 units/hr Insulin Delivery Profiles...
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Chapter 19 – 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...
The information contained in this section is specific to the t:slim System. This information provides reasonable assurance of normal operation, but does not guarantee such under all conditions. If the t:slim System must be used in close proximity with other electri- cal equipment, the System should be observed in this environment to verify normal operation.
Chapter 19 – Technical Specifications 19.5 Electromagnetic Emissions The t:slim System is intended for use in the electromagnetic environment specified below. Always make sure that the System is used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions...
Chapter 19 – Technical Specifications 19.6 Electromagnetic Immunity The t:slim System is intended for use in the electromagnetic environment specified below. Always make sure that the System is used in such an environment. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Electromagnetic Environment –...
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Chapter 19 – 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...
19.7 Distances Between the t:slim Pump and RF Equipment The t:slim 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 System.
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RF Communications Equipment and the t:slim System The t:slim 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 System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System as recommended below, according to the maximum output power of the communications equipment.
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Chapter 19 – 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)
There is no guarantee that RF exposure limits for general popula- interference will not occur in a particu- tion/uncontrolled exposure. lar installation. If the t:slim Pump does cause harmful interference to radio or t:slim Pumps equipped with a Blue- television reception, the interference...
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