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t:slim User Guide - Tandem Diabetes Care

1. 2 Do Not Re Use See Instructions for Use Non Pyrogenic Temperature Limits Method of Sterilization Gamma 4 F 20 C to 140 F 60 C DO t slim 3mL cartridge 300 units REF 003380 10 pack REF 003379 Indications for Use The cartridge is indicated as a reservoir for the delivery of rapid acting insulin with the t slim Pump Humalog and NovoLog have been tested by Tandem Diabetes Care Inc and found to be safe for use in the t slim Pump Humalog was tested for up to 48 hours as labeled NovoLog was tested for up to 72 hours WARNING United States U S Federal law restricts this device to sale by or on the order of a physician Contraindications The cartridge is contraindicated for use with products other than Humalog and NovoLog WARNING The cartridge is sterile non pyrogenic and for single use only Do not use if package has been opened or damaged Dispose of filling syringe and needle safely in a sharps container Failure to remove air from filling syringe and tubing may result in inaccurate delivery of medication Always disconnect infusion set from body when filling cartridge with insulin or while priming tubing Refer to the insulin manufacturer s package insert for proper handling Customer Technical Support 1 877 801 6901 443 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge CAUTIO
2. NOTE If changing an existing number begin by tapping the numbers on the keypad to override the current value Customer Technical Support 1 877 801 6901 430 gt Section 1 Welcome Chapter 3 t slim Pump Overview 3 10 Letter Keypad Screen 1 Name of Profile 5 SAVE Saves entered information 2 BACK Returns to previous screen 6 Letters lap once for first letter displayed two quick taps for middle letter and three quick taps for third letter 3 Space Enters a space 7 lt lt Deletes last letter or number entered 4 123 Changes keypad mode from letters ABC to numbers 123 NOTE If changing an existing name begin by tapping the letters on the keypad to enter new text The maximum number of characters Is 16 Customer Technical Support 1 877 801 6901 lt 4 31 gt Section 2 Key Pump Features 4 1 4 2 4 3 4 4 4 5 Chapter 4 Getting Started EUA ma Pump eae Merron atts Ge eee 34 Tuming On t slim PUMO SCreen 25 scccs eer eee sess te ss 35 Unlocking tslim Pump Screen E a 36 CMMI An E ENE 37 EditDALE Oe gee te pea tan ie e lilt Goats 39 Section 2 Key Pump Features Chapter 4 Getting Started WARNING Before you can safely and effectively use your t slim Pump it is very important that you carefully follow the procedures in these sections The t slim Pump continues to operate normally while charging and full pump functionality is available therefore
3. 4 96 gt Section 3 Additional Pump Operations Chapter 11 t slim Pump Settings For Feature Lock 1 Tap Feature Lock to turn ON or OFF BACK Screen Options gt A screen to verify that you want to activate the Feature Lock will be displayed 2 Tap Tandem logo to return to the Home Screen NOTE If Feature Lock is turned on all screen taps will be on a high volume until the Feature Lock is turned off To Turn the Feature Lock Off 1 From the Home Screen tap OPTIONS 2 Tap My Pump 3 Tap Pump Settings 4 Tap Screen Options 5 Tap Feature Lock 6 Tap YES Customer Technical Support 1 877 801 6901 497 gt 12 1 12 2 Chapter 12 t slim Pump Info and History ES A io 99 ESTAN o UCI 100 Section 3 Additional Pump Operations 12 1 t slim Pump Info Chapter 12 t slim Pump Info and History Your t slim Pump allows access to information regarding your pump In the Pump Info screen you have access to items such as your pump Serial Number Customer Technical Support telephone number website and software hardware versions 1 From the Home Screen tap OPTIONS 2 Tap My Pump 3 Tap Pump Info 4 Scroll through the Pump Info using the Up Down arrows 5 Tap Tandem logo to return to the Home Screen Customer Technical Support 1 877 801 6901 Options My Pump Pump Info 2000111222 1 877 801 6901 www tandemdiabetes com 23251 499 gt Section 3 Ad
4. 9 View recent changes and tap SAVE 0 75 whr a Sao PALA oy y A tu 109 120 mg dL 10 Confirm Settings Confirm Settings 0 75 ulhr Tap YES if entered data is correct Tap NO to make changes 1u 10g 120 mg dL 11 Tap BACK after editing all of the time segments BACK Timed Settings NOTE Edit other time segments within the Timed Settings by tapping on them and using the same method described above 12 30 AM NOTE To Add a time segment 1 Tap ADD 2 Enter desired start time To Delete a time segment 1 Tap on the X to the left of the time segment 2 Tap YES to confirm Customer Technical Support 1 877 801 6901 lt q 64 gt Section 2 Key Pump Features Chapter 6 Personal Profile 12 Tap the Bolus Settings Panel to change DURATION anor Profile 1 MAX BOLUS or CARBS as needed Use the onscreen OS keypad to enter desired changes Tap SAVE Bolus Settings 13 Confirm Settings Confirm Settings Tap YES if entered data is correct Tap NO and make changes 14 Tap Tandem logo to return to the Home Screen 6 5 Duplicating an Existing Profile 1 From the Home Screen tap OPTIONS 2 Tap My Pump Options 3 Tap Personal Profiles My Pump Customer Technical Support 1 877 801 6901 465 gt Section 2 Key Pump Features Chapter 6 Personal Profile 4 Tap the name of the Personal Profile to duplicate aes Personal Profiles im 5 Tap Duplicate Profile 1
5. occconcccncncoconiconccconcononconnnccnnnnonnnonannononnnnnnnonancnnnnnnannnnnnnnnannnnns 118 15 4 Incomplete Temp Rate Alert ccccccscccsscccsseeceeeecsceceeeeseseesaeeesaeeeseeeeeeeeeceeessaeessneesaes 118 15 5 Incomplete Load Sequence Alerts cccccssccccseeeceseecesuseceeeecceaeeesaueeesauseesaueeesaueeesaaes 119 15 6 Incomplete Setting Alert cccccseccecsssseeceesseceeseseceeeeeseeesseaseeeeseaseeeesaeeeessasseeenaneeees 120 15 7 Basal Rate Required Alert cccccsscccssccceececsseecseeecseeceeeeceeeesaececaueeeeeeeseeesseeeeseeeseeeesaes 120 15 8 Max Bolus Ale indicando cria ad nne 121 A o o PP canas iadd in cdadesasingdaNs 122 15 10 Max Basal Ale unci n 122 15 11 Connection Error Alert aquasacamsiasaniastainisinaiania diodo eine aid ni ii 123 15 12 Power Source Alert eee eeereneereenaceeea arena aerea aerea aerea acena na eranana 123 15 13 Data Error Alert cavisinsaeioscindsdinonssncaientuderiontaniovetaaetchavensandiaiestibewandesiaerDdavouaiveusiouiactaienieinstons 124 Chapter 16 Alarms 10 1 Resume Pump Alarm ice snnstimiadanrsimntdinonamedacnendinnsuainadcnssuaidccinoiaendimssctustxanehiasssinaiiniuteandieass 126 10 2 LOW a tacos cee aes se EEE RN EREE 127 16 3 Empty Cartridge AlSrMusnesionisansionic deaseanseasneniansnnad seisuveawucdneadasdax gnesisuensexsiamcaxniedeeceiwens 128 164 CarmdosEnor Alari sanan ans 128 16 5 Cartridge Removal AQ srcocienncndscedandaniegenoneiwsesq
6. 2 Tap 0 grams or 0 units 3 Using the onscreen keypad enter grams of carb or units of insulin Tap DONE 4 f desired tap Add BG and using the onscreen keypad enter BG value Tap DONE 5 Tap NEXT to confirm the units of insulin to be delivered NOTE Tap View Calculation to display the Delivery Calculation screen 6 Confirm Request Confirm Request Tap YES if entered data is correct ae 180 mg dL Tap NO to go back to make changes or view calculations 7 Tap EXTENDED to turn ON the extended feature Extend Food Bolus then tap NEXT 12 E U EXTENDED ON 8 Tap 50 under DELIVER NOW to adjust the percentage of the food bolus that is to be units delivered immediately DELIVER NOW DELIVER LATER NOTE 50 x The percentage value for DELIVER LATER is automatically calculated by the pump The default is 50 NOW and 50 LATER The default for DURATION is 2 hours DURATION Customer Technical Support 1 877 801 6901 4 76 gt Section 2 Key Pump Features 10 11 12 13 NOTE A correction bolus will always be given in the DELIVER NOW portion Use the onscreen keypad to enter the percentage of the bolus to DELIVERED NOW and tap DONE NOTE For the DELIVER NOW portion the minimum amount is 05 units If the DELIVER NOW portion is less than 05 units you will be notified and the DELIVER NOW portion will be set to 05 units Tap 2 hrs under DURATION NOTE The DELIVER LATE
7. Draw air into syringe up to the amount of insulin desired The cartridge requires a minimum fill of 50 units after tubing has been filled The amount of insulin required to fill tubing should be added to the total amount drawn from the insulin vial For approximate tubing fill amounts see section 5 4 The maximum fill is 300 units Wipe the rubber septum of the insulin vial with an alcohol swab With insulin vial upright insert needle into vial Inject air from syringe into vial Maintain pressure on syringe plunger With needle still inserted into vial turn vial and syringe upside down Release syringe plunger Pressure will push plunger and let the insulin flow from vial into syringe Release the pressure on the plunger and slowly withdraw the desired amount of insulin equal to the amount of air you filled previously from the vial into the syringe While the filling needle is still in the vial and upside down tap the syringe and slowly push its plunger upwards forcing any air bubbles back into the vial Check the syringe for air bubbles and do one of the following If there are air bubbles present repeat step 8 If no air bubbles are present remove the filling needle from the vial Customer Technical Support 1 877 801 6901 lt q 47 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge Instructions on How to Fill a Cartridge When prompted on the pump screen fill t
8. t slim Pump Overview 3 7 Options Screen Options Options 1 BACK Returns to the Home Screen 5 Temp Rate Programs a temporary basal rate 2 STOP INSULIN Stops insulin delivery If insulin delivery is stopped RESUME INSULIN 6 Menu Arrows Indicates additional menu will be displayed options are available 3 My Pump Personal Profiles Alert Settings 7 History Displays historical log of Pump Settings and Pump Info pump events 4 Load Change Cartridge Fill Tubing Fill Cannula and Site Reminder Customer Technical Support 1 877 801 6901 428 gt Section 1 Welcome Chapter 3 t slim Pump Overview 3 8 My Pump Screen My Pump 1 Personal Profiles A group of settings that 3 Pump Settings Customize Quick defines basal and bolus delivery Bolus Pump Volume Screen Options and Time and Date 2 Alert Settings Customize Reminders and Alerts 4 Pump Info Displays t slim Pump serial number Customer Technical Support phone number and website Customer Technical Support 1 877 801 6901 429 gt Section 1 Welcome 3 9 Number Keypad Screen Chapter3 t slim Pump Overview 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 DONE Completes task and saves information entered Units Grams Value of what is entered lt Deletes last number entered
9. used in the cartridge filling process Luer Lock Tail of the Cartridge Fill Port Customer Technical Support 1 877 801 6901 444 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge 1 From the Home Screen tap OPTIONS 2 Tap Load Options NOTE During the load sequence the Tandem Logo is disabled Tapping it will not return to the Home Screen 3 Tap Change Cartridge Load 4 Screen will display that all insulin deliveries will be in order to change a cartridge stopped Tap YES all insulin deliveries including basal and any active bolus or temp rate will be stopped NOTE This screen will not be displayed if this is the first time loading a Continue new cartridge and you have not started actively pumping 5 Disconnect the infusion set from your body and tap Dlecomactihe Inician eet tenes NEXT to continue your body and press NEXT to continue gt Preparing for Cartridge screen is displayed Customer Technical Support 1 877 801 6901 4 45 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge 6 Remove the cartridge and install an unused cartridge Tap UNLOCK when completed Remove the cartridge and m install an unused CAUTION cartridge Press the lf this is the very first time you are loading the cartridge UNLOCK button e when completed remove the shipping canister which is not for human use as i
10. your pump as well Aircraft Without Cabin Pressurization Disconnect NOT stop or suspend your t slim Pump before flying in an aircraft without cabin pressurization or in planes used for aerobatics or combat simulation pressurized or not Small Parts Potentially Ingestible by Children Insulin pumps including the t slim Pump include small parts such as pieces of the infusion set rubber USB port cover and cartridge components that could be ingested by children Therefore keep your t slim Pump and accessories out of the reach of children Do Not Use in the Presence of Flammable Anesthetics or Explosive Gases The risk of ignition of flammable anesthetics and explosive gases by the pump is remote While this risk is remote it is not recommended to operate the t slim Pump in the presence of flammable anesthetics or explosive gases Submersion in Fluid The t slim Pump is watertight to a depth of 3 feet for up to 30 minutes IPX7 rating If your t slim Pump has been submerged check your pump for any signs of fluid entry If there are signs of fluid entry disconnect the set from your body and contact Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 Air Travel Follow TSA and airline guidelines whenever traveling with medical equipment For further information contact Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 Other Precautions Be sure to heed these other important precautions regardi
11. Distance Transmitter in Watts Inch Meters Bluetooth Class 3 standard 1 meter range z ce Commonly used as bluetooth headset oa eee dm a Internet to music adaptor yA dell Commonly used for FM wireless music streaming E eran LE o Bluetooth Class 1 100 meter range z D i Wireless router WiFi ao ety t CO 0 5W Typical cellular smart phone 6 4in 0 163 m m J 1W Typical microwave oven RF leakage Qin 0 23m m CE Caution Interference with pump electronics by cell phones can occur if worn in close proximity It is recommended that your pump and cell phone be worn at least 6 4 inches apart Customer Technical Support 1 877 801 6901 lt 4 145 gt Section 6 Technical Specifications Chapter 19 Technical Specifications 19 9 FCC Notice Concerning Interference The t slim Pump complies with FCC IC RF exposure limits for general population uncontrolled exposure t slim Pumps equipped with a Bluetooth RF option transmit at a maximum effective radiated power of 3 4 mW in the 2 4 GHz ISM band which covers the frequency range from 2 40 GHz to 2 50 GHz The t slim Pump complies with Part 15 of the FCC rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 This device must accept any interference received including interference that my cause undesired operation Compliance with these guidelines provides reasonable prot
12. Edit Date November Select Month Edit Date 439 gt Section 2 Key Pump Features Chapter 4 Getting Started 7 Verify the correct date is set and tap SAVE Edit Date 8 Tap Tandem Logo to return to the Home Screen Customer Technical Support 1 877 801 6901 4 40 gt Chapter 5 Infusion Site Care and Loading Cartridge 5 1 Infusion Site Selection and Care a n aaa n a e 42 5 2 Cartridge Instructions for Use ZE 43 Do Loading and Filling a t slim Cartridge 44 9 4 Las e R merPareeren ants 49 5 5 RMNO C annda e 51 5 6 Selina one Reminder a en 52 Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge 5 1 Infusion Site Selection and Care WARNING Use only FDA cleared insulin infusion sets with a standard luer lock connection and consult its instructions for use Failure to do so may result in over infusion or under infusion and may cause serious injury or death Change your infusion set every 48 72 hours Consult your healthcare provider for more information Use only single use disposable cartridges Failure to do so may result in over infusion or under infusion and may cause serious injury or death Use only Humalog or NovoLog U 100 insulin Failure to do so may result in serious health consequences General Guidelines Site Selection e Your infusion set can be worn anywhere on your body that you would normally inject insulin Absorption v
13. Introduction 2 1 Welcome Congratulations on the purchase of your new t slim System Your decision to use insulin pump therapy Is a sign of your commitment to your diabetes care The t slim Pump is designed using the latest technology The following pages provide step by step illustrative instructions on how to properly program manage and care for your pump 2 2 What your t slim Insulin Delivery System Package Includes Your t slim System should contain the following items 1 tislim Insulin Pump 2 t slim Screen Protector pre applied 3 Protective Case with Rotatable Clip 4 USB Cable 6 ft 5 Wall Power USB Adapter 6 Car Power USB Adapter 7 t slim Reference Guide 8 Emergency Wallet Card 9 USB Memory Card with User Guide If any of these items are missing contact Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 NOTE Your t slim Pump is shipped from Tandem Diabetes Care Inc with a clear screen protector Do not remove the screen protector Additional screen protectors can be ordered by contacting Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 NOTE Your t slim Pump is shipped from Tandem Diabetes Care Inc with a protective cover in the place where the cartridge is normally inserted This cover must be removed and replaced with a cartridge prior to initiating insulin therapy Customer Technical Support 1 877 801 6901 417 gt Section 1 Welcome Chapter 2
14. Technical Support 1 877 801 6901 lt 4 140 gt Section 6 Technical Specifications Chapter 19 Technical Specifications 19 4 Additional t slim Pump Specifications The following table lists additional the t slim Pump specifications and their related details Specification Type Specification Details Patient Protection from Air Infusion The pump provides subcutaneous delivery into interstitial tissue and does not deliver intravenous injections clear tubing aids in detecting air Maximum Infusion Pressure Generated 30 PSI and Occlusion Alarm Threshold Rate of delivery during Bolus Bolus gt 3 units Approximately 2 units min Bolus lt 3 units Approximately 1 6 units min Rate of delivery during Prime Approximately 7 units min Bolus Duration Bolus gt 3 units duration Approximately 30 seconds unit Bolus lt 3 units duration Approximately 37 seconds unit Frequency of Basal Delivery 5 minutes for all Basal Rates Retention Time of Electronic Memory Greater than 30 days when Internal System Battery is Fully Discharged Infusion Set used for Testing Unomedical Comfort Infusion Set 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 Rechargeable Lithium Polymer Internal System Battery Life 4 years minimum under normal use conditions Typical Operating Time when System During
15. Turn off the pump screen by pressing the Screen On Quick Bolus button before placing the pump back in its case or any pocket clothing Always position the pump screen away from the skin when worn under clothing 3 2 t slim System Terminology Basal Basal is a slow continuous delivery of insulin which keeps BG levels stable between meals and during sleep It is measured in units per hour units hr BG BG is the abbreviation for blood glucose which is the level of glucose in the blood measured in mg dL BG Target BG target is a specific blood glucose goal an exact number not a range When a BG is entered in the t slim Pump the calculated insulin bolus will be adjusted up or down as needed to attain this target Bolus A bolus is a quick dose of insulin that is usually delivered to cover food eaten or an elevated BG With t slim Pump it can be delivered as a Standard a Correction an Extended or a Quick Bolus Cannula The cannula is part of the infusion set that is inserted under the skin through which insulin is delivered Carb Carbs or Carbohydrates are sugars and starches that the body breaks down into glucose and uses as an energy source measured in grams Carb Ratio The carb ratio is the number of grams of carbohydrate that one unit of insulin will cover Also Known as insulin to carbohydrate ratio Customer Technical Support 1 877 801 6901 422 gt Section 1 Welcome Chapter 3 t slim Pump Overview Correctio
16. been created Tap Basal 2 Using the onscreen keypad enter the desired basal rate and tap DONE CAUTION Always confirm that the decimal point placement is correct 3 Tap Correction Factor 4 Using the onscreen keypad enter the desired correction factor and tap DONE NOTE Enter the mg dL that 1 unit of insulin will lower BG 5 Tap Carb Ratio 0 75 whr 6 Using the onscreen keypad enter the desired insulin to carbohydrate ratio and tap DONE NOTE Enter the grams of carb to be covered by 1 unit of insulin Customer Technical Support 1 877 801 6901 459 gt Section 2 Key Pump Features Chapter 6 Personal Profile 7 Tap Target BG 8 Using the onscreen keypad enter the desired BG 0 75 uhr target and tap DONE 1u 50 mg dL 9 Review entered values and tap SAVE 0 75 whr 1u 50 mg dL 10 Confirm Settings Confirm Settings Tap YES if entered data is correct Tap NO to make changes 11 Tap BACK to set the Bolus Settings BACK Timed Settings Tap ADD to create additional time settings Customer Technical Support 1 877 801 6901 4 60 gt Section 2 Key Pump Features 12 13 14 15 16 Adding More Time Segments NOTE Chapter 6 Personal Profile Any settings that you defined in the previous time segment are copied and appear in the new segment This allows you to simply adjust only the specific settings you want rather than have to define them all over
17. bill A patient has the right to be advised when they are being considered for a medical care research program In this occurrence Tandem Diabetes Care will send an informed consent agreement to a patient requesting their participation in a clinical investigation A patient has the right to decide whether their personal health information could be used for any fundraising efforts A patient and when appropriate a patient s representative has the right to have any concerns complaints and grievances addressed Sharing concerns complaints and grievances will not compromise a patient s care treatment or services 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 Writing a letter to Tandem Diabetes Care ATTN Customer Support and sending it to 11045 Roselle Street San Diego CA 92121 Patients and their families are responsible for the outcomes if they do not follow the product instructions for use service and payment plans Patients and their families are responsible for being considerate of Tandem Diabetes Care s staff and property as well as other patients and their property Patients and their families are responsible to promptly meet any financial obligation agreed to with Tandem Diabetes Care Patient and their family agree to hold harmless Tandem Diabetes Care from any expenses they may incur as
18. confirmation screen bolus delivery continues No insulin delivery can take place while your pump is stopped Customer Technical Support 1 877 801 6901 lt q 81 gt Section 2 Key Pump Features Chapter 8 Stop Resume Insulin 8 2 Resuming Insulin Delivery 1 If pump screen is not on press Screen On Quick Bolus Button once to turn on your t slim Pump screen 2 Tap RESUME Resume Insulin now This will resume your basal and the active personal profile CLOSE RESUME 3 The RESUMING INSULIN splash screen is displayed RESUMING INSULIN OR 1 From the Home Screen tap OPTIONS 2 Tap RESUME INSULIN Options 3 Tap RESUME This will resume your basal and the active personal profile Resume Insulin now RESUME 4 The RESUMING INSULIN splash screen is displayed RESUMING INSULIN Customer Technical Support 1 877 801 6901 482 gt Section 3 Additional Pump Operations 9 1 9 2 Chapter 9 Temporary Basal Rate Setting a Temp Rate Stopping a Temp Rate Section 3 Additional Pump Operations Chapter 9 Temporary Basal Rate 9 1 Setting a Temp Rate A Temp Rate is used to increase or decrease by percentage the current basal rate for a period of time to accommodate special situations When you enter the Temp Rate screen the default values are 100 current basal rate and a Duration of 0 15 min The Temp Rate can be set from a minimum of 0 of current basal r
19. every setting some pump features require certain settings to be defined and activated During profile setup your pump prompts you to set up any required settings before you can continue 1 From the Home Screen tap OPTIONS 2 Tap My Pump Options Customer Technical Support 1 877 801 6901 d 57 gt Section 2 Key Pump Features Chapter 6 Personal Profile 3 Tap Personal Profiles My Pump BACK Personal Profiles 4 Tap NEW to create a new profile 5 Using the onscreen keypad enter a profile name up to 16 characters and tap SAVE NOTE Refer to section 3 10 for instructions on using the onscreen keypads 6 Tap Press to Setup to begin setting insulin BACI Weekday delivery settings Timed Settings Bolus Settings 6 3 Programming a New Personal Profile NOTE Once the Personal Profile has been created the settings must be programmed The first time segment will start at 12 00 AM midnight You must program a basal rate in order to have a valid Personal Profile that you can activate Be sure to tap SAVE after entering or changing a value Customer Technical Support 1 877 801 6901 458 gt Section 2 Key Pump Features Chapter 6 Personal Profile CAUTION If you only define a basal rate in Timed Settings your pump will only be able to deliver basal insulin and standard and extended boluses Your pump will not deliver correction boluses or trigger BG alerts 1 Once the new profile has
20. for charging the charging icon lightning bolt will display USB Port Port to charge your t slim Pump battery Close the cover when not in use BOLUS Program and deliver a bolus OPTIONS Stop Resume insulin delivery manage Pump Settings Load cartridge program a Temp Rate and view History INSULIN ON BOARD IOB Amount and time remaining of any active insulin on board Time and Date Display Displays the current time and date Customer Technical Support 1 877 801 6901 10 11 13 Chapter 3 t slim Pump Overview Status Displays current pump settings and insulin delivery status INSULIN Level Displays the current amount of insulin in the cartridge Tandem Logo Returns to the Home Screen Cartridge Tubing Tubing that is attached to the cartridge Luer Lock Connection Connects the cartridge tubing to the infusion set tubing Screen On Quick Bolus Button Turns the t slim Pump screen on off or programs a Quick Bolus if activated LED Indicator Iluminates when connected to a power supply and indicates proper functionality 425 gt Section 1 Welcome Chapter 3 t slim Pump Overview 3 5 Status Screen Current Status Current Status 1u 50 mgldL 0 2 ulhr 120 mg dL 5 hours ON 1 Profile Displays current active 6 Correction Factor Displays current Personal Profile correction factor used to calculate bolus 2 Basal Displays current basal rate being 7 BG Targ
21. infusion set tubing cap from the luer connector Be careful to keep the luer connector away from unsanitary areas c Insert the infusion set tubing to the luer connector on the cartridge tubing tail and twist clockwise to secure it Tap NEXT Customer Technical Support 1 877 801 6901 449 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge 3 Hold the pump vertically as illustrated to the right to ensure any air in the cartridge will be dispelled first Tap Start gt Starting Fill screen is displayed NOTE The following are approximate amounts of insulin to fill different tubing lengths 15 20 units for 23 inch tubing Fill Tubing 20 25 units for 32 inch tubing 25 30 units for 42 inch tubing 4 Tap STOP once 3 drops of insulin are seen at the end Fill Tubing of the tubing gt Stopping Fill screen is displayed NOTE During tubing fill your pump will stop the fill process and notify you if the tubing has been filled with 30 units You then have the option to continue filling more than this system max fill amount 5 Verify that drops are seen and tap DONE If you see drops at the end of the tubing press DONE If no insulin a a iced 53 FILL t e Ifyou do not see drops tap FILL The Fill Tubing GAN ane screen appears repeat steps 3 5 until you see 3 drops of insulin at the end of the tubing amore e 19 4 If you did not tap STOP the Max fi
22. insulin deliveries are stopped Contact Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 To Respond to the Button Alarm 1 To temporarily clear the alarm tap CLOSE ALL DELIVERIES STOPPED gt This returns to the previous screen prior to the alarm The Screen on Quick Bolus button may be stuck Contact customer support at 1 877 801 6901 2 Contact Customer Technical Support at 1 877 801 6901 CLOSE 16 9 Altitude Alarm If your t slim Pump detects a pressure change outside of the operating range the ALTITUDE ALARM occurs and all insulin deliveries are stopped To Respond to the Altitude Alarm 1 To temporarily clear the alarm tap CLOSE ALL DELIVERIES STOPPED gt This returns to the previous screen prior to the alarm Remove cartridge from pump reconnect cartridge and then resume insulin 2 Remove cartridge from the pump and reconnect the cartridge 3 Resume insulin delivery refer to section 8 2 16 10 Reset Alarm If your t slim Pump detects that one of its micro processors has experienced a reset the PUMP RESET screen appears and all insulin deliveries are stopped To Respond to the Reset Alarm 1 To temporarily clear the alarm tap CLOSE All active deliveries have been stopped and your IOB and Max Hourly Bolus have been reset 2 Contact Customer Service at 1 877 801 6901 Please contact Customer Service at 1 877 801 6901 3 Do not resume insulin before speaking with
23. insulin therapy does not need to be interrupted If you choose to disconnect the pump while charging check with your healthcare provider for specific guidelines Depending on the length of time you are disconnected you may need to compensate for missed basal and or bolus insulin Check your blood glucose before disconnecting from the pump and again when you reconnect 4 1 Charging t slim Pump Your t slim Pump is shipped in a factory set state for minimal battery usage The pump can only be switched from the original state to an operational state by charging the pump The t slim Pump is powered by an internal lithium polymer rechargeable battery Included with the pump are accessories for charging from wall or automobile outlets and a PC USB port Upon receipt of the pump you should charge it using the AC charger for at least 2 5 hours to ensure a full charge WARNING In order to maintain compliance with the IEC 60601 1 safety standard the pump must be charged with a power supply that conforms to either IEC 60601 1 or IEC 60950 1 or an equivalent safety standard when connected to an alternating current AC mains power source To Charge the Pump 1 Plug the 2 prong end of the AC charger into a grounded AC electrical outlet 2 Plug the USB cable into the AC charger and the other end into the micro USB port of your t slim Pump The screen illuminates You may also charge the t slim Pump by connecting the supplied charge adapte
24. ne Galette 136 Section 5 Care and Maintenance Chapter 18 Taking Care of your t slim Pump 18 1 Overview This section provides information on caring for and maintaining your t slim Pump Cleaning Your t slim Pump When cleaning your pump use a damp lint free cloth Do not use household or industrial cleaners solvents bleach scouring pads chemicals or sharp instruments Never submerge the pump in water or use any other liquid to clean it Do not place the pump in the dishwasher or use hot water to clean it If needed use only a very mild detergent such as a bit of liquid soap with warm water When drying your pump use a soft towel never place your pump in a microwave oven or baking oven to dry it Inspecting Your t slim Pump for Damage If you drop your t slim Pump or it has been hit against something hard ensure that it is still working properly Check that the touch screen is working and clear and that the cartridge and infusion set are properly in place Check for leaks around the cartridge and at the luer connector to the infusion set Immediately contact Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 if you notice any cracks chips or other damage Disposing of t slim Pump Accessories Regulations require controlled disposal of devices such as insulin infusion pumps and related disposables so ask your Tandem Diabetes Care Inc representative or healthcare provider about local regulations regardi
25. normal use the intermediate rate is 2 units hr battery charge can be is Operating at Intermediate Rate reasonably expected to last up to 7 days depending on the pump settings from a fully charged state to a totally discharged state Handling of Over Infusion or The method of delivery isolates the insulin chamber from the patient and the software Under Infusion performs frequent monitoring of system status Multiple software monitors provide redundant protection against unsafe conditions Over infusion is mitigated by continuous self tests layering of redundancies and confirmations and numerous other safeguard alarms Users are required to review and confirm the details of all bolus deliveries basal rates and temp rates to ensure certainty before initiating a delivery In addition once bolus deliveries are confirmed the user is given 5 seconds to cancel the delivery before it is started An optional Auto Off alarm triggers when the user has not interacted with the pump s user interface for a pre defined period of time Under infusion is mitigated by occlusion detection and blood glucose monitoring as blood glucose entries are recorded Users are prompted to treat high blood glucose conditions with a correction bolus Bolus Volume at Release of Occlusion 0 4 0 6 units at 2 units per hour with Unomedical Comfort 60cm Infusion Set Customer Technical Support 1 877 801 6901 4141 gt Section 6 19 5 19 6 Tech
26. relates to the purchase of Tandem products and or services Patient Responsibilities Patients and their families when appropriate are responsible for providing correct and complete information when requesting assistance with insurance verification and other services provided by Tandem Diabetes Care Patients and their families are responsible for reporting unexpected changes with their medical financial or insurance condition Patients and their families are responsible for asking questions when they do not understand the service being provided or the reason for the information being requested Patients and their families are responsible for following the product training instructions for use and service that have been developed by Tandem Diabetes Care and agreed to by a patient 12 13 14 15 16 17 18 Tandem Diabetes Care is committed to ensuring the safety of its customers Tandem has implemented policies covering situations when a Tandem employee believes that a customer is suffering from a medical emergency including contacting the applicable emergency medical care A patient has a right to full information and counseling on the availability of known financial resources for his or her health care received by Tandem Diabetes Care for the purpose of beneficiary coverage of Tandem Product and Services A patient has the right to examine and receive a detailed explanation of his or her financial
27. slim Insulin Pump Tandem Diabetes Care Inc Tandem warrants the t slim insulin pump against defects in materials and workmanship for the period of 4 years from the original date of shipment of the pump to the original end use purchaser the Warranty Period During the Warranty Period Tandem will replace any defective t slim Pump subject to the conditions and exclusions stated herein The warranty is valid only if the t slim Pump is used in accordance with Tandem s instructions and will not apply e If damage results from changes or modifications made to the t slim Pump by the user or third persons after the date of manufacture e f damage results from service or repairs performed to any part of the t slim Pump by any person or entity other than Tandem e f the t slim Pump seal is broken e lfanon Tandem cartridge is used with the t slim Pump e f damage results from a force majeure or other event beyond the control of Tandem or e If damage results from negligence or improper use including but not limited to improper storage or physical abuse Customer Technical Support 1 877 801 6901 419 gt Section 1 Welcome Chapter 2 Introduction This warranty shall be personal to the original end use purchaser Any sale rental or other transfer or use of the t slim Pump covered by this warranty to or by a user other than the original end use purchaser shall cause this warranty to immediately terminate This warranty only
28. stop insulin delivery and alert you or whoever is with you if there has been no interaction with the pump within a specified period of time You can adjust the Auto Off Alarm setting the default value is pre set to 12 hrs but it can be set anywhere from 5 hrs to 24 hrs or Off This alarm notifies you that there has been no interaction with the pump in the specified number of hours and the pump will shut down after 30 seconds When the number of hours since you have tapped on the screen or pressed the Screen On Quick Bolus Button passes the set value the Auto Off Alarm beeps and appears on the screen and insulin delivery stops 1 From the Home Screen tap OPTIONS 2 Tap My Pump Options Customer Technical Support 1 877 801 6901 4112 Section 3 Additional Pump Operations Chapter 14 User Settable Alerts and Alarms 3 Tap Alert Settings My Pump 4 Tap Alerts Alert Settings 5 Tap Auto Off 6 Verify Auto Off is set to ON Auto Off then tap Time 7 Using the onscreen keypad enter the number of hours from 5 24 hrs that you want the Auto Off Alarm to be triggered and tap SAVE Customer Technical Support 1 877 801 6901 4113 gt Section 3 Additional Pump Operations Chapter 14 User Settable Alerts and Alarms 8 Tap BACK on the Auto Off screen to verify your Auto Auto Off Off Alarm setting 9 When changing this feature from on to off or from off This feature wil stop all deliveries to on a confir
29. the currently active Personal Profile aMAX BOLUS ALERT occurs You are prompted to confirm whether you want to deliver the max bolus amount To Respond to the Max Bolus Alert E Your 20 u Max Bolus setting has Do one of the following been exceeded e To return to the Bolus screen and adjust the bolus Press CONTINUE to confirm a delivery amount tap BACK bolus of 20 u e To deliver the requested bolus tap CONTINUE CONTINUE If your Max Bolus amount is defined to be 25 units and you request a bolus that exceeds 25 units the MAX BOLUS ALERT occurs If you continue with this max bolus delivery of 25 units upon completion of this bolus delivery you will receive a prompt to request the remaining amount of the requested bolus if desired up to an additional 25 units To Respond to Remaining Bolus Request Do one of the following A Tap NO Your 25 u Max Bolus has been delivered There are 10 u gt This returns to the Previous screen remaining from your current request Would you like to request the remaining 10u NO e Tap YES to confirm delivery tap DELIVER Deliver 10 u Bolus CLOSE DELIVER Customer Technical Support 1 877 801 6901 lt 121 gt Section 4 Safety Alerts and Alarms Chapter 15 Alerts 15 9 Max Hourly Bolus Alert If within a 60 minute period of time you request a bolus delivery that is more than 1 5 times your Max Bolus setting the MAX HOURLY BOLUS ALERT occurs and you are prom
30. the right to have all records pertaining to his or her medical care treated as confidential except as otherwise provided by law or third party contractual arrangements A patient has the right to respectful service provided by competent personnel A patient or when appropriate a patient s representative has the right to be informed of his or her rights at the earliest possible time A patient has the right to have their personal preferences be heard A patient has the right to be free from all forms of abuse or harassment A patient has the right to receive services ina safe setting A safe setting includes environmental safety infection control security protection of emotional health and safety including respect dignity and comfort as well as physical safety A patient has the right to medical services including training without discrimination based upon race color religion gender sexual preference national origin or source of payment A patient shall not be denied the right to designate a legally allowed individual or agency who is authorized to act on his or her behalf Tandem Diabetes Care shall provide a patient or patient designee upon written request access to all information contained in their patient information record 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
31. to ensure precise settings and thus facilitate safe insulin delivery When editing time always ensure that the AM PM setting is accurate AM is to be used from midnight until 11 59 AM PM is to be used from noon until 11 59 PM TAAL La 1 From the Home Screen tap OPTIONS 10 20 AM June 11 2012 1 09 hrs 2 Tap My Pump Options 3 Tap Pump Settings My Pump 4 Tap Time and Date Pump Settings Customer Technical Support 1 877 801 6901 437 gt Section 2 Key Pump Features Chapter 4 Getting Started 5 Tap Edit Time Time and Date 10 10 AM 11 16 2011 6 Tap Time Edit Time 7 Using the onscreen keypad enter the hour and minutes Verify and tap DONE hour minute 8 Tap Time of Day to set AM or PM Edit Time 9 Verify the correct time is set and tap SAVE Edit Time NOTE Any edits to Time or Date will not be saved until you tap SAVE Customer Technical Support 1 877 801 6901 438 gt Section 2 Key Pump Features 4 5 Edit Date 1 From the Time and Date screen tap Edit Date 2 Tap Month 3 Find and tap current month displayed on the right Use Up Down Arrow to view months not displayed 4 Tap Day Using the onscreen keypad enter the current day Verify and tap DONE 5 Tap Year 6 Using the onscreen keypad enter the current year Verify and tap DONE Customer Technical Support 1 877 801 6901 Chapter 4 Getting Started Time and Date 3 30 PM 11 16 2011
32. your body disconnect the infusion set from your body and contact Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 1 7 Warnings and Precautions When using your t slim Pump always take precautions regarding the following e Radiology and Medical Procedures e Extreme Temperatures e Amusement Park Rides e Aircraft Without Cabin Pressurization e Small Parts Potentially Ingestible by Children e Do Not Use in the Presence of Flammable Anesthetics or Explosive Gases e Air Travel e Submersion in Fluid e Other Precautions Radiology and Medical Procedures If you are going to have an X ray computerized tomography CAT scan magnetic resonance imaging MRI or other exposure to radiation take off your t slim Pump and remove it from the procedure room If you have questions contact Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 Your t slim Pump however has been designed to withstand common electromagnetic interference including airport and department store security systems Refer to Electromagnetic Compatibility in section 19 5 for more detailed information In addition to radiological procedures there are a number of other medical procedures which will require you to remove your t slim Pump most notably e Pacemaker Implantable Cardioverter Defibrillator AICD Disconnect your t slim Pump and leave it outside the procedure room during the insertion of the pacemaker device and reprogramming th
33. 000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 KV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage Dips Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000 4 11 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Mains power quality should be that of a typical commercial or hospital environment lf the user of the pump requires continued operation during power mains interruptions it is recommended that the pump be powered from an uninterruptible power supply or a battery NOTE Ur is the a c mains voltage prior to application of the test level Power Frequency 50 60 3 A m 400 A m IEC 60601 2 24 Power frequency magnetic fields should be at Hz Magnetic Field IEC levels characteristic of a typical location in a 61000 4 8 typical commercial or hospital environment Conducted RF 3 Vrms 10V Portable and mobile RF communications IEC 61000 4 6 150 kHz to 80 MHz equipment should be used no closer to any part of the pump including cables than the recommended separation distance calculated Radiated RF 3 V m 30 V m from the equation
34. 10 20 AM June 11 2012 options INSULIN ON ELMO PLIE touch simplicity TANDEM DIABETES CARE t slim Insulin Delivery System User Guide t slim and Tandem Diabetes Care are registered trademarks of Tandem Diabetes Care Inc touch simplicity is a trademark of Tandem Diabetes Care Inc Humalog is a registered trademark of Eli Lilly and Company NovoLog is a registered trademark of Novo Nordisk A S Comfort is a trademark of Unomedical A S Bluetooth is a registered trademark of Bluetooth SIG Inc Tandem Diabetes Care Inc san Diego CA 858 366 6900 www tandemdiabetes com 2012 Tandem Diabetes Care Inc All rights reserved t slim Pump User Guide At Tandem Diabetes Care Inc we listen closely to the diabetes community in order to understand your needs We recognize and respect the importance of your decision to begin insulin pump therapy as a member of our family We also recognize that your pump purchase is only the beginning of your relationship with Tandem Our commitment goes much deeper than simply supplying products to help you in your diabetes management We pledge to be here to support you with training and education through our network of Clinical Diabetes Specialists We also pledge to be here to support you with our dedicated Customer Technical Support This t slim User Guide is designed to assist you with the features and functions of the t slim Pump and cartridge It provides
35. 14 User Settable Alerts and Alarms Eowinsuln Alere A A O O Ge AUTO Ti Pa a A A ee A A erent ane Section 3 Additional Pump Operations Chapter 14 User Settable Alerts and Alarms 14 1 Low Insulin Alert Your t slim Pump continually tracks how much insulin is remaining in the cartridge and alerts you when it is low You can adjust the Low Insulin Alert setting the default value is pre set to 20 units but it can be set anywhere from 10 to 40 units When the insulin amount reaches the set value the Low Insulin Alert beeps vibrates and appears on the screen 1 From the Home Screen tap OPTIONS 2 Tap My Pump Options 3 Tap Alert Settings My Pump 4 Tap Alerts Alert Settings 5 Tap Low Insulin Customer Technical Support 1 877 801 6901 4111 Section 3 Additional Pump Operations Chapter 14 User Settable Alerts and Alarms 6 Using the onscreen keypad enter the number of units from 10 40 units that you want the Low Insulin Alert value to be set and tap SAVE 7 Tap Tandem logo to return to the Home Screen To Respond to the Low Insulin Alert Cartridge level To clear the reminder and return to whatever activity was in gas tian 20 G rememing progress when the reminder occurred tap CLOSE NOTE Once the LOW INSULIN ALERT occurs the low insulin indicator a single red bar on the insulin level appears in the upper right corner of the Home Screen 14 2 Auto Off Alarm Your t slim Pump can
36. 42 Preparation Products 11 43 Customer Technical Support 1 877 801 6901 Insulin Insulin Delivery 12 24 25 28 81 112 Insulin Duration 23 26 56 57 Insulin Level 24 25 48 112 118 128 Insulin on Board 23 24 25 26 57 Insulin to Carbohydrate Ratio 22 Rapid Acting Insulin 11 12 43 Resume Insulin 25 28 82 Stopping Insulin Delivery 112 U 100 Insulin 11 12 42 K Keypad 30 31 Key Pump Features 32 L LED 19 25 35 Lithium Polymer Battery 34 141 Load Cartridge 23 25 28 44 100 Low BG Reminder 102 140 Low Insulin Alert 111 118 140 Low Power Alarm 127 Low Power Alert 117 Luer Lock 15 25 42 44 49 Malfunction 19 133 Max Basal Alert 122 Max Bolus 56 57 71 121 Max Bolus Alert 121 Max Hourly Bolus Alert 122 Missed Meal Bolus Reminder 108 140 My Pump 28 My Pump Screen 29 Needle 44 47 48 New Personal Profile 56 58 NovoLog 42 43 44 O Occlusion Alarm 130 139 141 Options 25 140 Options Screen 28 Screen Options 29 95 Overview 22 136 139 Bolus Overview 71 Personal Profile Overview 56 t slim Pump Overview 22 4 148 gt AR P Personal Profile 23 26 28 29 54 55 Activating an Existing Profile 67 Adding More Personal Profiles 62 Creating a New Profile 56 Deleting an Existing Profile 69 Duplicating an Existing Profile 65 Editing an Existing Profile 63 Personal Profile Overview 56 Programming a New Personal Profile 58 Renaming an Existing Profile 68 Power So
37. 44 119 Load Cartridge 23 25 28 44 100 Charging 19 24 25 34 35 Cleaning 136 Connection Error Alert 35 123 Correction Bolus 23 74 75 77 Correction Factor 23 26 56 57 Customer Technical Support 10 29 D Data Error Alert 124 Date 24 25 29 Edit Date 39 Default 53 57 76 85 88 95 102 104 109 111 112 140 Delivery Summary 100 Disconnect 12 13 14 15 43 49 Duration of Insulin Action 140 4147 gt AR E Edit Edit Date 39 Editing an Existing Profile 63 Edit Reminder 52 Edit Time 37 Electromagnetic 142 143 Emergency Kit 11 Empty Cartridge Alarm 128 Extended Bolus 23 71 76 140 E Feature Lock 95 97 140 Fill Cartridge Fill 44 Fill Cannula 28 51 119 139 Fill Port 44 46 47 48 Fill Tubing 28 49 119 Food Bolus 71 73 75 Extended Bolus 23 71 76 140 Food Bolus Using Grams 27 73 Food Bolus Using Units 27 71 G Grams 23 27 30 71 88 Healthcare Provider 10 11 12 13 15 42 44 57 High BG Reminder 104 140 History 25 28 100 140 Home Screen 24 25 27 28 Humalog 42 43 44 Incomplete Incomplete Bolus Alert 118 Incomplete Cartridge Change Alert 119 Incomplete Fill Cannula Alert 119 Incomplete Fill Tubing Alert 119 Incomplete Load Sequence Alert 119 Incomplete Setting Alert 120 Incomplete Temp Rate Alert 118 Increment 57 85 88 91 95 140 Infusion Set 11 14 20 25 42 Fill Cannula 28 51 139 Fill Tubing 28 49 Infusion Site 15 34 42 Infusion Site Care
38. 6 Confirm profile to duplicate by tapping YES This copies all settings and saves them as a new profile 7 Using the onscreen keypad enter the name up to 16 characters for the new profile and tap SAVE Dalila tn gt Profile Duplicated screen is displayed gt Anew Personal Profile will be created with the same settings as the profile copied 8 Tap the Timed Settings or Bolus Settings Panel to ar Weekday make changes to the new profile Timed Settings 12 00a 3 00p Bolus Settings Customer Technical Support 1 877 801 6901 4 66 gt Section 2 Key Pump Features Chapter 6 Personal Profile 6 6 Activating an Existing Profile 1 From the Home Screen tap OPTIONS 2 Tap My Pump Options 3 Tap Personal Profiles My Pump 4 Tap the name of the Personal Profile to be activated Personal Profiles NEW NOTE The Activate and Delete options are disabled for the currently active profile because the profile is already activated You cannot delete a profile until you have activated another profile If you have only one profile defined you do not need to activate it that profile is automatically activated 5 Tap Activate Profile 2 gt A screen to confirm the activation of the profile is displayed 6 Tap YES gt Profile Activated screen is displayed Customer Technical Support 1 877 801 6901 lt 67 gt Section 2 Key Pump Features Chapter 6 Personal Profile 6 7 Renaming an Exis
39. B Cable 17 23 34 123 USB Port 12 25 34 V Vibrate 11 94 View Calculation 27 72 73 74 76 Volume 29 94 W Wallet Card 11 17 Warranty 14 19 20 4149 gt t slim and Tandem Diabetes Care are registered trademarks of Tandem Diabetes Care Inc touch simplicity is a trademark of Tandem Diabetes Care Inc 2012 Tandem Diabetes Care Inc All rights reserved 004898 Rev C 09 12
40. Bolus 6 Tap Increment Type Quick Bolus 7 Tap units of insulin or grams of carbohydrate BACK Increment Type 8 Tap Increment Amount Quick Bolus Quick Bolus using units Quick Bolus Quick Bolus using grams Customer Technical Support 1 877 801 6901 489 gt Section 3 Additional Pump Operations Chapter 10 Quick Bolus 9 Select the preferred increment amount pee Increment in Units NOTE The increment amount is added with each press of the Quick Bolus Button when delivering a quick bolus 10 Review entered values and tap SAVE Quick Bolus using units Quick Bolus ON units Quick Bolus using units BACK Incrementin Grams Quick Bolus using grams Quick Bolus Quick Bolus using grams 11 Confirm Settings Confirm Settings Tap YES if entered data is correct Tap NO to go back to make changes 12 Tap Tandem Logo to return to the Home Screen Customer Technical Support 1 877 801 6901 lt 90 gt Section 3 Additional Pump Operations Chapter 10 Quick Bolus 10 2 Delivering Quick Bolus If the Quick Bolus function is turned On you can deliver a bolus without having to look at the t slim Pump s screen Simply use the Quick Bolus Button to deliver your bolus Quick boluses are delivered as standard boluses there is no BG entry nor extended delivery capabilities CAUTION When you first use the Quick Bolus feature you should always look at the screen to c
41. C HON OS PORC areal saias br arde e o 74 7 5 ops code AA 76 7 6 Canceling or Stopping a BOIUS nssscraslica cicatrices dae 78 Chapter 8 Stop Resume Insulin 8 1 Stopping Insulin Delivery cccceseesseccesesececeseseeeeseaseeeeseseeeesaaseceeseaseeeeseueeeessaseesensaeees 81 8 2 Resuming Insulin Delivery oiccciadetcocetentcnetsiecnderenncapensataciusenenasxgesct encdnanagepeciaciinadteetunaanienntane 82 Section 3 Additional Pump Operations Chapter 9 Temporary Basal Rate 9 1 DE TONGA TOM alo A o A PE ON O EA 85 9 2 HOPPING a lemp RAE so iai dior iii acid 86 Chapter10 Quick Bolus 10 7 UG QUICK BOUS araceli tia 88 102 Delivering QUICK BOIUS svacitntaaoaantiacalrinr iris ccirie rele tnscalorirasia esmeril otra 91 Chapter 11 t slim Pump Settings TEL EST PUMP VOIUME aii Ea EE E A EREN 94 112 ooreen ODIOS srt 95 Chapter 12 t slim Pump Info and History 121 CSN PAM IO aaron 99 122 Com PUMP PISTON nieta 100 Table of Contents of Contents Chapter 13 Reminders 13 1 OW EG ROMINOO cs 102 132 ANBO Rendir 104 13 3 After Bolus BG RETINA ca 106 13 4 Missed Meal Bolus Reminder errar rara 108 TD MA coa 109 Chapter 14 User Settable Alerts and Alarms 14 1 LOW Insulin Alert een aan 111 14 2 Au to OF Adra 112 Section 4 Safety Alerts and Alarms Chapter 15 Alerts 15 1 LOW Power Ali casiecianninaxc iii 117 15 2 LOW Insulin ACM cisiatin cirio iio 118 15 3 Incomplete Bolus Alert
42. C ONNI Guide o e e a a 10 Working with your Healthcare Provider s 10 Important Safety Intormation ss tees eee ree 10 EMOJEN VR a a e A ce meres rea gues 11 Indications for Use and Contraindications occconcccocncnocnonannnnns 12 Verification of Proper Functionality an naaa a a 12 Warnings and Rrecautions To r a a rues 13 Conventions of this Guides eee 19 Section 1 Welcome Chapter 1 About this User Guide 1 1 Purpose of this Guide The User Guide is for users of the t slim Insulin Delivery System t slim System The intended use of the t slim System is for the Continuous Subcutaneous Insulin Infusion CSIl at set and variable rates for the management of diabetes mellitus in persons requiring insulin for individuals 12 years of age and greater WARNING United States U S Federal law restricts this device to sale by or on the order of a physician If you are unable to use the t slim System according to the instructions in this User Guide you may be putting your health and safety at risk Be sure to speak with your healthcare provider if you have questions or concerns about using your pump properly CAUTION Before using your t slim Pump ensure that you have been appropriately trained on its use by a certified t slim Pump trainer Read all of the instructions provided in this User Guide before using your t slim Pump and monitor your blood glucose BG with the guidance of your healthcare provider Acc
43. Guide CAUTION Your t slim Pump is designed to deliver insulin reliably but because it uses only rapid acting insulin you will not have long acting insulin in your body In order to prevent Diabetic Ketoacidosis DKA or a very high BG you must be prepared to inject insulin if delivery is interrupted for any reason Only use U 100 insulin as any lesser or greater concentration can result in serious health consequences Never fill your tubing while your infusion set is connected to your body Doing so can result in unintended delivery of insulin which can result in serious injury or death If you have any questions regarding these cautions call your healthcare provider or Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 Always check with your healthcare provider for specific guidelines if you want or need to disconnect from the pump for any reason Depending on the length of time and reason you are disconnecting you may need to compensate for missed basal and or bolus insulin Check your blood glucose before disconnecting from the pump and again when you reconnect 1 5 Indications for Use and Contraindications Indications for Use The t slim Insulin Delivery System is intended for the subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin for individuals 12 years of age and greater Contraindications The t slim Pump is not intende
44. Incomplete Fill Tubing Alert 119 Incomplete Load Sequence Alert 119 Incomplete Setting Alert 120 Incomplete lemp Rate Alert 118 Low Insulin Alert 111 140 Low Power Alert 117 Max Basal Alert 122 Max Bolus Alert 121 Max Hourly Bolus Alert 122 Power Source Alert 123 Altitude Alarm 131 Arrows Menu Arrows 28 Up Down Arrow 26 Auto Off Alarm 112 140 Basal 22 26 29 56 57 100 140 Basal Delivery 22 26 56 139 141 Basal Rate 22 26 56 140 Basal Rate Required Alert 120 Current Basal Rate 26 Temporary Basal Rate 23 28 84 Customer Technical Support 1 877 801 6901 Battery 24 25 34 141 Battery Level 24 25 117 127 Charging 19 24 25 34 35 Lithium Polymer Battery 34 141 BG 22 27 100 High BG 12 104 140 Low BG 102 140 Target BG 22 26 56 57 74 75 140 Bluetooth 145 146 Bolus 18 22 25 70 100 140 141 Active Bolus 81 Active Bolus Icon 24 Bolus Delivery 18 29 71 139 140 141 Bolus Overview 71 Bolus Screen 27 Bolus Settings 56 57 Correction Bolus 23 74 75 77 Extended Bolus 23 71 76 140 Food Bolus 71 73 75 Max Bolus 56 57 71 121 Quick Bolus 23 25 29 87 94 140 Rate of Delivery 141 C Cancel 78 Cannula 22 Fill Cannula 28 51 139 Carbohydrates 22 23 26 56 57 71 Carb Ratio 22 26 56 57 Carbs 27 56 65 71 88 Cartridge 11 20 23 24 25 28 41 43 48 Cartridge Error Alarm 48 128 Cartridge Fill 44 Cartridge Removal Alarm 129 Cartridge Tubing 25 Change Cartridge 28
45. Introduction 2 3 Explanation of Symbols The following are symbols and their descriptions which you may find on your t slim Pump and or its packaging A Caution Consult Manual for Important a Type BF Applied Part Safety Documentation R patient isolation not defibrillator protected 13 Consult Instructions for Use el Manufacturer i For sale by or on the order of a physician Only Serial Number of Device Re only US Part Number Direct Current DC voltage IPX Water tight Equipment protected against the effects of temporary immersion in water 2 4 Explanation of t slim Colors Touch Screen Colors Blue e The use of blue text may relate to bolus delivery activity e The orange text relates to t slim s setup or delivery settings Orange Highlight e The orange highlighted area indicates a recent change made to a setting Customer Technical Support 1 877 801 6901 418 gt Section 1 Welcome Chapter 2 Introduction LED Colors Red LED e 1 red blink every 30 seconds indicates a malfunction or alarm condition e 1 yellow blink every 30 seconds indicates an alert or reminder condition e 1 green blink every 90 seconds indicates the pump is functioning normally e 3 green blinks every 90 seconds indicate the pump is charging 2 5 Warranty Information Warranty t
46. M 10 20AM dune 11 2012 e Remaining 4 19 hra 10 20 AM June 11 2012 amainina 4 19 hrs d 78 gt Section 2 Key Pump Features Chapter 7 Bolus Stopping a Bolus If delivery of the bolus Has Started IMISLELEM 1 Tap red X to stop delivery 10 20AM June 11 2012 x Standard 10 u uning 4 19 hrs 2 Tap YES Stopping the bolus will cancel the gt The BOLUS STOPPED screen is displayed and the units Unde Rvered paro of me Dola delivered are calculated Stop bolus 3 Units requested and delivered are shown Tap CLOSE XX BOLUS STOPPED Customer Technical Support 1 877 801 6901 479 gt 8 1 8 2 Chapter 8 stop Resume Insulin Stopping Insulin Delivery Resuming Insulin Delivery Section 2 Key Pump Features Chapter 8 Stop Resume Insulin 8 1 Stopping Insulin Delivery At any time even after delivery has started you can stop all insulin deliveries at once including basal and any active bolus or temp rate deliveries 1 From the Home Screen tap OPTIONS 2 Tap STOP INSULIN Options 3 Tap STOP This will stop all insulin deliveries including basal and any active bolus or temp rate gt The All Deliveries Stopped screen appears before returning to the Home Screen showing the status ALL DELIVERIES STOPPED s NOTE When you tap STOP on the confirmation screen any active bolus and any active temp rate are immediately suspended If you tap BACK on the
47. Minutes Customer Technical Support 1 877 801 6901 4139 gt Section 6 Technical Specifications 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 6 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 Temp Basal Rate 15 minutes to 72 hours with 1 minute resolution Range 0 250 Bolus Setup Can deliver based on carb input grams or insulin input units Default is units The range for carbs is 1 999 grams the range for insulin is 0 05 25 units Insulin to Carb IC Ratio 16 time segments per 24 hour period Ratio 1 unit of insulin per x grams of carbs 1 1 to 1 300 resolution is 1 above 10 and 0 1 below 10 BG Correction Target Value 16 time segments 70 to 250 mg dL in 1 mg dL increments Insulin Sensitivity Factor ISF 16 time segments Ratio 1 unit of insulin reduces glucose x mg dL 1 1 to 1 600 1 mg dL increments Duration of Insulin Action 1 time segment 2 8 hours in 1 minute increments default is 5 hrs Bolus Increment 0 01 at volumes greater than 0 05 units Quick Bolus Increments When set
48. My PMDP SOON escatimar cd 29 3 9 Number Keypad KcreeN oooccccccnnccccconoccoconnnnnononanconononnnnronnnnnnnnnnnnnrnonannnnrnnnnnnronnnnnrenannaninnns 30 3 10 Letter Keypad Screen ccoooocccocononccccononccconnnnoconnnnnononannnnnnonnnnronnnnnnrnonannnnrrnnnnnronannnarenannnnnnnns 31 section 2 Key Pump Features Chapter 4 Getting Started 4 1 AIG Si OTS ba 34 4 2 Timing On tslim PUMP SCS sirios i n 35 4 3 U locking tslim PUMP Cle 1 assa cases sateen oo A an 36 4 4 PP E E E E EE TET 37 4 5 EOI DE i dia 39 Chapter 5 Infusion Site Care and Loading Cartridge 5 1 infusi n Site Selection and Causa rd tol 42 5 2 Cartidge Instructions for USE srta dd dos 43 5 3 Loading and Filling a SIM Cartridge sist ninas 44 5 4 la e EE ea 6 EET EE A PE E O E S T E EE O E TT 49 5 5 e E E E E A 51 5 6 SOLO ote EINE camita a 52 Table of Contents of Contents Chapter 6 Personal Profile 6 1 Personal Prol VIVO coreo rei 56 6 2 Creating a New Protile corrida pea oia id 56 6 3 Programming a New Personal Profile unimarc 58 6 4 Editing an EXISUNG P TONIE A RR RR RR E 63 6 5 Duplicating am CIS UI PrO rociado 65 6 6 Achvatng an EXISUNO PROMO seirian uniaan anaa E ia 67 6 7 Renaming an EXISIINO PRONTO usina otitis 68 6 8 Deleting an ESA PORIG e ctesrisorinienicsinis aenea ea imaan oaa a Eaa ii ii 69 Chapter 7 Bolus 7 1 BOIUS OVS VICW norris T1 7 2 Food Bolus Using Units AM Pr 71 7 3 Food BONUS Using Gia Sussie sidad oligarcas res 7 4 OS
49. N Insulin should be at room temperature before filling cartridge Do not store filled cartridges Check for leaks regularly after changing cartridge and infusion set The first set up should be done in the presence of your healthcare provider Attach only FDA cleared insulin infusion sets compatible with luer connectors to the cartridge Minimize contact with insulin Wash hands thoroughly after handling any device that contains insulin 5 3 Loading and Filling a t slim Cartridge This section describes how to load the cartridge into your t slim Pump and fill the cartridge with insulin The single use disposable cartridge can hold up to 300 units 3 0 mL of insulin CAUTION Inspect the cartridge to ensure that there is no damage Never use a cartridge that is damaged cracks dislodged tip connectors etc If there is damage call Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 to request a replacement cartridge CAUTION Before you begin verify that the infusion set is NOT connected to your body Before you begin make sure you have the following items e 1 unopened disposable sterile single use cartridge e Vial of Humalog or NovoLog insulin e 3 0 mL syringe and fill needle e Alcohol prep swab e 1 new infusion set NOTE Do NOT remove the cartridge during the Load process until prompted on the t slim Pump screen The illustration below identifies the luer lock and insulin fill port
50. R portion of the Extended Bolus also has minimum and maximum rates If you program a DELIVER LATER rate outside of these limits you will be notified and the duration of the DELIVER LATER portion will be adjusted Use the onscreen keypad to adjust the length of time the bolus is to be delivered then tap DONE Tap NEXT NOTE Tap View Units to display the breakdown of units to be delivered NOW versus LATER Confirm Request Tap YES if entered data is correct Tap NO to go back to make changes or view calculations Customer Technical Support 1 877 801 6901 Chapter 7 units DELIVER NOW DELIVER LATER 40 DURATION hour minute units DELIVER NOW DELIVER LATER 40 DURATION Confirm Request 60 40 o 3 30 hrs YES Bolus 77 gt Section 2 Key Pump Features 14 Verify settings and tap DELIVER 15 The bolus splash screen is displayed 7 6 Canceling or Stopping a Bolus Canceling a Bolus If delivery Has Not Started but has been initiated 1 Tap red X to cancel the bolus The bolus button will remain inactive while the bolus is being cancelled Once cancelled the bolus button will become active again on the Home Screen Customer Technical Support 1 877 801 6901 Chapter 7 Bolus Deliver 5u Bolus 1 52 u 3 30 hrs DELIVER BOLUS INITIATED IMISLELEM 10 20AM F dune 11 2012 oe x Requesting 10 u Bolus e Remaining 4 19 hra IMISLELE
51. SAVE 7 Tap BACK on the Low BG Reminder screen to verify BACK Low BG Reminder your Low BG Reminder setting ON 8 Tap Tandem logo to return to the Home Screen 80 mg dL To Respond to the Low BG Reminder Please test BG To clear the reminder and return to whatever activity was in A low BG was entered 10 mi progress when the reminder occurred tap CLOSE min ago Customer Technical Support 1 877 801 6901 lt 4 103 gt Section 3 Additional Pump Operations Chapter 13 Reminders 13 2 High BG Reminder The High BG Reminder prompts you to re test your BG after a high BG value is entered When you turn this reminder setting on you need to specify a high BG value that triggers the reminder as well as how much time should pass before the reminder occurs The default values are pre set to Off or if On Remind Me Above 200 mg dL and Remind Me After 120 min but you can set these values from 150 300 mg dL and 1 3 hrs 1 From the Home Screen tap OPTIONS 2 Tap My Pump Options 3 Tap Alert Settings My Pump 4 Tap Reminders Alert Settings 5 Tap High BG Reminders NOTE If not first time setup previous values appear instead of Press to Turn On Customer Technical Support 1 877 801 6901 4104 gt Section 3 Additional Pump Operations 6 Tap High BG to turn ON or OFF a lap Remind Me Above and using the onscreen keypad enter a High BG value from 150 300 mg dL that you want to trigg
52. Section 2 Key Pump Features 4 3 Unlocking t slim Pump Screen 1 Press Screen On Quick Bolus Button 2 Tap 3 Tap 2 4 Tap 3 gt The pump screen is now unlocked The last screen that was viewed will be displayed NOTE You must tap 1 2 3 in sequential order to unlock the pump If you do not press 1 2 3 in sequential order the pump will force you to restart the unlock sequence from the beginning NOTE The pump will return to the Screen Lock position after all bolus and temp basal are requested NOTE Turn off the pump screen by pressing the Screen On Quick Bolus button before placing the pump back in its case or any pocket clothing to prevent unintentional interactions with the touchscreen Always position the pump screen away from the skin when worn under clothing Customer Technical Support 1 877 801 6901 Chapter 4 Getting Started 10 20 AM June 11 2012 10 20 AM June 11 2012 IMISLELEM dining 0 00 min INSULIN ne Remaining 0 00 min 10 20 AM dune 11 2012 IMISLELEM e Remaining 0 00 min 4 36 gt Section 2 Key Pump Features Chapter 4 Getting Started 4 4 Edit Time After powering up your t slim Pump for the first time set the current time and date Refer back to this section if you need to edit the time for either traveling in a different time zone or adjusting for Daylight Savings Time CAUTION It is very important to set the current time and date accurately
53. Tap Tandem Logo to return to the Home Screen NOTE Editing duplicating and renaming an inactive profile will not automatically activate that profile Refer to section 6 6 for instructions on activating profiles Adding More Personal Profiles NOTE If starting from the Home Screen tap OPTIONS tap My Pump tap Personal Profiles tap NEW Name the new profile and repeat steps 1 10 in section 6 8 NOTE If the first profile is programmed using a carb ratio any new profile will also have the Carbohydrates option turned ON but a ratio will still need to be defined Customer Technical Support 1 877 801 6901 462 gt Section 2 Key Pump Features 6 4 Editing an Existing Profile 1 From the Home Screen tap OPTIONS 2 Tap My Pump 3 Tap Personal Profiles 4 Tap the name of the Personal Profile to edit or review 5 Tap Edit 6 Tap Timed Settings Panel Customer Technical Support 1 877 801 6901 Chapter 6 Personal Profile Options My Pump BACK Personal Profiles Profile 1 BACK Profile 1 Timed Settings 12 00a 3 00p Bolus Settings Section 2 Key Pump Features Chapter 6 Personal Profile 7 Tap the desired time segment to be edited BACK Timed Settings ADD 12 00 AM 12 30 AM 8 Tap Basal Correction Factor Carb Ratio or Target BG to make changes as needed and use the onscreen keypad to enter desired changes Tap DONE 0 75 whr 1u 50 mg dL tu 109 120 mg dL
54. WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Customer Technical Support 1 877 801 6901 420 gt 3 1 3 2 3 3 3 4 3 9 3 6 3 7 3 8 3 9 3 10 Chapter 3 t slim Pump Overview CSIC UR OVENVIEW ate cree een Gan ee ate a cnt atten ote ee 22 CSME Soy temne e tee eee en en ee ree 22 Scree LOCK o o ee eer eee 24 OME Cree sh al Ea 25 Status SCIeentm ca nn a e 26 BOUS Screens A E AS 21 OpronStSCIee In se ae tet eee scan as RO Ran ream tine cee 28 NIVA Um po SCREAM la o 29 Number Keypad Screen e eC ee eee nie 30 Letter Keypad Screen Taas m e gn A eee 31 Section 1 Welcome Chapter 3 t slim Pump Overview 3 1 t slim Pump Overview Your t slim Pump uses touch screen technology lo activate and interact with your t slim Pump use the pad of your finger to quickly and lightly tap on the screen Do not use your finger nail or another object to interact with the screen It will not activate the screen or its functions Your t slim Pump is designed to give you quick and easy access to the functions that you will use in your day to day diabetes management whether basic or advanced NOTE t slim has several safety features to prevent unintentional interaction with the touch screen The screen must be unlocked by tapping 1 2 3 in sequence On all screens if three non active areas of the touch screen are tapped before an active area is tapped the screen will turn off to prevent accidental button presses NOTE
55. a Customer Service representative CLOSE Customer Technical Support 1 877 801 6901 4131 17 1 Malfunction Chapter 17 Malfunction Section 4 Safety Alerts and Alarms Chapter 17 Malfunction 17 1 Malfunction If your t slim Pump detects a system error the MALFUNCTION ALARM occurs and all insulin deliveries are stopped Malfunctions sound with three notes at the highest volume and vibe They repeat at regular intervals until acknowledged Malfunctions cannot be resolved CAUTION Monitor your blood glucose BG levels frequently with the guidance of your healthcare provider anytime there is an interruption of insulin delivery If pump therapy can not be resumed start backup plan per your healthcare provider To Respond to the Malfunction Alarm This pump cannot operate Call customer support immediately 1 Write down the Malfunction Code number that appears on the screen 1 877 801 6901 2 Tap SILENCE ALARM The alarm is silenced and the screen times out Press the Screen On Quick Bolus Button to see the screen again The MALFUNCTION SILENCE ALARM screen appears but the alarm is silenced AAA 3 Contact Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 and provide the Malfunction Code number you wrote down Customer Technical Support 1 877 801 6901 4133 Section 5 Care and Maintenance Chapter 18 Taking Care of your t slim Pump 18 1 COVERS IEW tr A S ota pale er ete
56. a red T 8 The Screen Lock screen will be displayed with the icon indicating a Temp Rate is active 9 2 Stopping a Temp Rate You can stop a temp rate that is currently being delivered 1 Onthe Home Screen tap OPTIONS 2 On the Options screen tap X stop icon Options on the right side of Temp Rate 3 On the confirmation screen tap STOP The TEMP RATE STOPPED screen appears before returning to the Options screen Stop Temp Rate B0 6 30 hrs Customer Technical Support 1 877 801 6901 4 86 gt 10 1 10 2 Chapter 10 Quick Bolus Seringas Quick BOIUS 2 Delivering Quick Bolus Section 3 Additional Pump Operations Chapter 10 Quick Bolus 10 1 Setting Up Quick Bolus Setting up the Quick Bolus function enables you to deliver a bolus by simply pressing a button lt is a way to deliver a bolus by following beep vibration commands without navigating through or viewing the pump screen The default of the Quick Bolus function is OFF Quick Bolus can be set to either units of insulin or grams of carbohydrate The increment options are 0 5 1 0 2 0 and 5 0 units or 2 5 10 and 15 carbs 1 From the Home Screen tap OPTIONS 2 Tao My Pump Options 3 lap Pump Settings My Pump 4 Tap Quick Bolus Pump Settings 5 Tap Quick Bolus to turn On Quick Bolus OFF Customer Technical Support 1 877 801 6901 lt q 88 gt Section 3 Additional Pump Operations Chapter 10 Quick
57. a result of Tandem contacting the applicable emergency medical care on their behalf Table of Contents of Contents Section 1 Welcome Chapter 1 About this User Guide 1 1 Purpose of this Guide uuuair daeseapicinas era idicaninia cri cuie fran amics na da ie Ed e 10 1 2 Working with Your Healthcare PYOVIGGN sa cucesqussiescaiciiesatrobis ii 10 1 3 Important Safety Information ccccceeseceeceeseeeeeesececsauseeeseeseeeeseuseeessaeeeessaeeeessanseesssaes 10 1 4 TSE OC Nace eats RR o eo iaa o 11 1 5 Indications for Use and Contraindications erre ererreneererenananeranaas 12 1 6 Verification of Proper Functionality ancas traccion cds 12 1 7 Warnings and Precautions AD SDRAM DOADAS RR nnne nnn nnne nnne 13 1 8 Conventions of this GUIAS vusncnissric ra 15 Chapter 2 Introduction 2 1 AEE E A AE EINE A EEE E E AAEE OE T oporto T T 17 2 2 What your t slim Insulin Delivery System Package Includes serenas 17 2 3 Explanation of Symbols aivcca tenance NR ADE O PROCR O RR RD RR A 18 2 4 Explanation OF t slim GOIOIS macia 18 2 5 Warranty alo dane og AAA nn SID RE DERRADEIRA aa ai 19 Chapter 3 t slim Pump Overview 3 1 t slim Pump Overview inconiinnindcor rigida isidro did end 22 3 2 t slim System Terminology minivan ici 22 3 3 ep LOOK PPP cared e I a 24 3 4 Home Screen necia didi id ig ii 25 3 5 e eo QS e O Po nnne nenen nenna 26 3 6 sie o AA A E o CP CUE EP E PO E 27 3 7 Options Screen A A a a 28 3 8
58. again 1 On the Add Segment screen tap Start Time 2 Using the onscreen keypad enter the time hour and minutes that you want the segment to begin and tap DONE 3 On the Add Segment screen tap Time of Day to select AM or PM 4 Tap NEXT 5 Repeat steps 1 10 from the above Programming a New Personal Profile for each segment you want to set up up to 16 NOTE Once a time segment is set beyond 12 00 PM the default will change to PM NOTE To find time segments in the list that are not displayed on the first screen tap the scroll arrows Tap the Bolus Settings Panel Tap Insulin Duration Using the onscreen keypad enter the desired time for the duration of insulin action and tap DONE Tap Max Bolus Using the onscreen keypad enter the desired amount for maximum bolus 1 25 units and tap DONE Customer Technical Support 1 877 801 6901 BACK Weekday Timed Settings 12 00a 12 00a Bolus Settings Bolus Settings 5 hrs Bolus Settings SAVE lt 4 61 gt Section 2 Key Pump Features Chapter 6 Personal Profile 17 Tap Carbohydrates to activate and use the carb ratio Bolus Settings SANE when calculating boluses NOTE If not using a carb ratio do not turn the Carbohydrates setting to ON 18 Review entered values and tap SAVE Bolus Settings SAVE 19 Confirm Settings Confirm Settings Tap YES if entered data is correct Tap NO to make changes 20
59. amount needed for cannula fill is Fill Amount NOTE If the amount needed is not listed tap Other Amount and use the onscreen keypad to enter a value between 0 1 to 1 0 unit WARNING Refer to your infusion set instructions for proper insertion and cannula fill amount Customer Technical Support 1 877 801 6901 51 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge 5 Tap START BACK Fill Cannula gt Starting Fill screen is displayed gt After fill is complete Stopping Fill screen is displayed NOTE You can tap STOP at any time during the fill process if you want to stop filling the cannula NOTE The screen will return to the Load menu if the Site Reminder is turned OFF Tap DONE to resume insulin if finished Or tap Site Reminder to set reminder If Site Reminder is ON the pump will automatically display the Site Reminder Screen refer to next section 5 6 Setting Site Reminder NOTE If starting from the Home Screen tap OPTIONS tap Load tap Site Reminder then follow the instructions below CAUTION Avoid changing an infusion set before going to bed or if you will not be able to test your BG 1 2 hours after a new set is placed 1 Tap SAVE if correct Tap Edit Reminder if settings Site Reminder need to be changed ON Thursday 5 30 pm Customer Technical Support 1 877 801 6901 lt 4 52 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care
60. and Loading Cartridge 2 Tap Remind Me In and select the number of days NOTE Default reminder is set for 3 days 3 Tap Remind Me At Use the onscreen keypad to enter time and tap DONE 4 Tap Time of Day to change AM or PM Tap BACK 5 Verify Site Reminder is set correctly and tap SAVE gt Site Reminder Set screen is displayed 6 Load screen is displayed Tap DONE gt A reminder to test BG in 1 2 hours will display Customer Technical Support 1 877 801 6901 Edit Reminder 2 days 5 30 PM Remind Me In Edit Reminder Edit Reminder 3 days Site Reminder ON Thursday 7 30 pm Load 453 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge 7 Tap RESUME Resume Insulin now NOTE This will resume your basal and If this is the first time using your t slim Pump and a Personal O ere a Eee Profile has not been defined a screen will notify you that a profile must be activated to resume insulin Tap CLOSE CLOSE RESUME 8 RESUMING INSULIN splash screen is displayed RESUMING INSULIN Customer Technical Support 1 877 801 6901 454 gt 6 1 6 2 6 3 6 4 6 5 6 6 6 7 6 8 Chapter 6 Personal Profile Personal Profile Ovenviem a Peo ec ee eee ee 56 Creating a Now Prole a eer aR eee 56 Programming a New Personal Profile 58 EGITMG ANSE XIS UNGUEO e e em RR 63 Duplicating ait ExiSiing FONG m a caido o 65 ACTIV AlING amExisingi
61. andem Diabetes Care Customer Technical Support at 1 877 801 6901 NOTE Before using a Mac or PC to charge the t slim Pump it is recommended that a driver be installed on the computer This can be done by downloading the application from the USB Memory Card that is included in the t slim System Depending on your computer charging time will vary The pump will display a CONNECTION ERROR ALERT message if it is not charging properly refer to section 15 10 Charging Tips Tandem Diabetes Care Inc recommends periodically checking the battery level indicator charging the pump for a short period of time every day 10 15 minutes and also avoiding frequent full discharges NOTE If the battery is fully discharged the Home Screen will not power on immediately when connected to a charging source The LED around the Screen On Quick Bolus Button will blink green every 2 seconds until there is enough charge to power on the touch screen 4 2 Turning On t slim Pump Screen 1 To turn on your t slim Pump screen press the Screen On Quick Bolus Button located on the top of the pump once gt The Screen Lock screen will be displayed NOTE The pump continues to function normally when the screen is INSULIN not illuminated 10 20 AM NOTE Upon completion of programming a feature tao the Tandem Logo to return to the Home Screen or tap BACK to return to the previous screen Customer Technical Support 1 877 801 6901 lt q 35 gt
62. anges for all Pump Volume Pump Volume options by repeating steps 5 and 6 8 Tap Tandem Logo to return to the Home Screen 11 2 Screen Options The Screen Options for your t slim Pump include Screen Timeout and Feature Lock The Screen Timeout can be personalized to the duration the screen stays on without any touch screen interaction The default for the Screen Timeout is 30 seconds The increment options are 15 30 60 and 120 seconds Your t slim Pump is delivered from Tandem Diabetes Care Inc with the Feature Lock turned OFF With the Feature Lock turned ON you cannot deliver a bolus change any pump settings or access any Personal Profiles NOTE Turn off the pump screen by pressing the Screen On Quick Bolus button before placing the pump back in its case or any pocket clothing to prevent unintentional interactions with the touchscreen Always position the pump screen away from the skin when worn under clothing Customer Technical Support 1 877 801 6901 495 gt Section 3 Additional Pump Operations Chapter 11 t slim Pump Settings 1 From the Home Screen tap OPTIONS Options 2 Tap My Pump 3 Tap Pump Settings My Pump 4 Tap Screen Options Pump Settings Screen Options 5 Tap desired option 30 sec OFF For Screen Timeout 1 Tap Screen Timeout BACK screen Timeout 2 Select preferred time 3 Tap Tandem logo to return to the Home Screen Customer Technical Support 1 877 801 6901
63. applicable to the frequency of IEC 61000 4 3 80 MHz to 29 GHZ the transmitter Recommended separation distance d 0 35vP 80 MHz to 800 MHz d 0 12vP 800 MHz to 2 5GHz d 0 23vP Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol a relocating the pump NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the pump is used exceeds the applicable RF compliance level above the pump should be observed to verify normal operation If abnormal performance is observed additio
64. applies to the t slim Pump and does not apply to other products or accessories THE REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE FOR ANY WARRANT CLAIMS NEITHER TANDEM NOR ITS SUPPLIERS OR DISTRIBUTORS SHALL BE LIABLE FOR ANY INCIDENTAL CONSEQUENTIAL OR SPECIAL DAMAGE OF ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE PRODUCT ALL OTHER WARRANTIES EXPRESS OR IMPLIED ARE EXCLUDED INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Warranty Infusion Sets and Cartridges Tandem Diabetes Care Inc Tandem warrants its infusion sets and cartridge against defects in materials and workmanship for the period 3 days after the individual cartridge infusion set sterile packaging has been opened not to exceed 6 months from date of shipment of the infusion set or cartridge to the end user the Warranty Period During the Warranty Period Tandem will replace any defective cartridge or infusion set subject to the conditions and exclusions stated herein The warranty is valid only if the infusion sets and cartridges are used in accordance with Tandem s instructions and will not apply e Ifthe infusion set or cartridge has been used for more than a single time use by a single end user e f damage results during the improper opening of the sterile package not in conformance with the procedures outlined in the associated Instructions for Use e lf the sterile
65. aries from site to site Discuss options with your healthcare provider e The most commonly used sites are the abdomen upper buttocks hips upper arms and upper legs e The abdomen is the most popular site because of access to fatty tissue If using the abdominal area AVOID Areas that would constrict the site such as the belt line waistline or where you would normally bend Areas 2 inches around your bellybutton Any scars moles stretch marks or tattoos Site Rotation e The infusion set must be replaced and rotated every two to three days or more often if needed With experience you will find areas that not only provide better absorption but are more comfortable Keep in mind using the same areas may cause scarring or lumps which can affect insulin absorption e Consult your healthcare provider to establish a rotation schedule that best fits your needs Customer Technical Support 1 877 801 6901 442 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge Keep it clean e When changing your infusion set use clean techniques to avoid an infection e Wash your hands use antiseptic wipes or infusion site preparation products and keep area clean to avoid contamination e Site preparation products that have both an antiseptic and an adhesive are encouraged 5 2 Cartridge Instructions for Use Symbols gt lt Use By Date MM DD YYYY Model Number No Latex
66. at you recharge your t slim Pump The alert will continue until the condition has been corrected Insulin delivery will continue until the LOW POWER ALARM is triggered and insulin delivery stops To Respond to the second Low Power Alert Recharge pump or all deliveries To temporarily clear the alert and return to whatever activity wil stop was in progress when the alert occurred tap CLOSE NOTE Once the second LOW POWER ALERT occurs the low power indicator a red 5 on the battery level indicator appears in the upper left corner of the Home Screen Customer Technical Support 1 877 801 6901 4117 gt Section 4 Safety Alerts and Alarms Chapter 15 Alerts 15 2 Low Insulin Alert If your t slim Pump detects an insulin level of 5 units or less the LOW INSULIN ALERT occurs requesting you to change the cartridge The alert will continue until the condition has been corrected Insulin delivery will continue until the EMPTY CARTRIDGE ALARM is triggered and insulin delivery stops To Respond to the Low Insulin Alert Change cartridge or pump will stop all deliveries To temporarily clear the alert and return to whatever activity was in progress when the alarm occurred tao CLOSE 15 3 Incomplete Bolus Alert If you start to program a bolus but do not complete the request within 90 seconds the INCOMPLETE BOLUS ALERT occurs You are prompted to return to the Bolus screen to complete the request To Respond to the Incompl
67. ate to a maximum of 250 of current basal rate in increments of 1 If program a Temp Rate greater than 0 but less than the minimum allowable basal rate of 0 1 units hr you will be notified that the selected rate is too low and that it will be set to the minimal allowable rate for delivery If you program a Temp Rate more than the maximum allowable basal rate of 15 units hr you will be notified that the selected rate is too high and that it will be set to the maximum allowable rate for delivery Duration can be set from a minimum of 15 minutes to a maximum of 72 hours in increments of 1 minute 1 From the Home Screen tap OPTIONS 2 Tap Temp Rate Options 3 Tap Temp Rate Temp Rate 4 Using the onscreen keypad enter desired percentage Tap DONE NOTE Current rate is 100 An increase is greater than 100 and decrease is less than 100 5 Tap Duration Using the onscreen keypad enter desired length of time for temp rate Tap DONE NOTE To see the actual units to be delivered tap View Units Customer Technical Support 1 877 801 6901 48 gt Section 3 Additional Pump Operations Chapter 9 Temporary Basal Rate 6 Verify settings and tap START Temp Rate 7 The TEMP RATE STARTED splash screen is displayed TEMP RATE STARTED NOTE If a Temp Rate is currently active the status of insulin delivery displays an orange T Ifa Temp Rate of 0 is currently active the status of insulin delivery displays
68. d for anyone unable or unwilling to e Test BG levels as recommended by your healthcare provider e Demonstrate adequate carbohydrate counting skills preferred but not required e Maintain sufficient diabetes self care skills e See your healthcare provider s regularly You must also have adequate vision and or hearing in order to recognize your t slim Pump alerts 1 6 Verification of Proper Functionality A power supply AC adapter with USB micro connector is provided as part of the t slim System Before using your t slim Pump ensure that the following occur when you connect a power supply into the USB port of your t slim Pump e You hear an audible alert e You see the green light from the edge around the Screen On Quick Bolus Button illuminate e You feel a vibratory alert e You see a charge symbol lightning bolt on the battery level indicator In addition before using your t slim Pump ensure the following e Press the Screen On Quick Bolus Button to illuminate the screen so that you can easily read the display e When the screen is illuminated the touch screen responds to your finger tap Customer Technical Support 1 877 801 6901 lt 4 12 gt Section 1 Welcome Chapter 1 About this User Guide CAUTION If any of these conditions fail to occur do NOT use the t slim Pump as this may be an indication that the pump s alarms alerts and other built in safety features may not be working properly If the pump is connected to
69. delivered to cover food eaten or an elevated BG Your t slim Pump offers you the ability to deliver different boluses to cover carbohydrate intake food bolus and bring your BG back to target correction bolus Food and correction boluses can also be programmed together CAUTION Before delivering insulin always check your pump and infusion set for damage leaks or kinks in the tubing as these problems could restrict or stop insulin delivery and possibly result in under infusion If Carbohydrates is turned On in the Bolus Settings of your active Personal Profile you can deliver boluses only in grams of carbs not in units of insulin To deliver in units of insulin you need to turn off the Carbohydrates setting Note that the quick bolus delivery setting grams of carbohydrates or units of insulin is independent of the active Personal Profile bolus settings When a standard bolus is being delivered you cannot initiate another bolus However if the DELIVER LATER portion of an extended bolus is being delivered you can initiate another standard bolus Only one extended bolus can be running at any given time When attempting to deliver a bolus that exceeds either your Personal Profile s Max Bolus setting or the pump s maximum bolus amount allowed a Max Bolus Alert will occur and you will need to make a decision on whether to continue with bolus delivery adjust the amount or accept the pump s maximum allowable amount Ref
70. ditional Pump Operations Chapter 12 t slim Pump Info and History 12 2 t slim Pump History The History displays the historical log of pump events The following history reports can be viewed Delivery Summary Bolus Basal Load BG Alerts and Alarms and Complete The Delivery Summary breaks down total insulin delivery by basal and bolus types into units and percentages It can be viewed by the selected time period of Today 7 Day 14 Day and 30 Day Average The Bolus Basal Load BG Alerts and Alarms and Complete are categorized by date The event details in each report are listed by time Bolus History shows the bolus start time and the bolus completion time 1 From the Home Screen tap OPTIONS 2 Tap the Down Arrow Options 3 Tap History Options 4 Tap desired option History 5 Tap Tandem logo to return to the Home Screen History Customer Technical Support 1 877 801 6901 4100 gt 13 1 13 2 13 3 13 4 13 5 Chapter 13 Reminders Le ye BG Reminder e eres pene eee ere ees eee 102 A Reminder sa Cm Te e tare 104 After Bolus BG Remind RR 106 Missed Meal Bolus Reminder rr 108 Site en 1 Ta a nots a PD ode E bas 109 Section 3 Additional Pump Operations Chapter 13 Reminders Your t slim Pump has customizable reminders including Low BG Reminder High BG Reminder After Bolus BG Reminder Missed Meal Bolus Reminder Site Reminder Reminders sound with a single
71. e a carb ratio of 1 8 2 can be programmed In addition you can define any or all of the following Bolus Settings e Carbs ON indicates entering grams of Carb OFF indicates entering units of insulin e Insulin Duration how long a bolus lowers your BG e Max Bolus the maximum amount for a single bolus The default settings and ranges for Bolus Settings are as follows e Carbs default OFF if no Carb Ratio is defined e Insulin Duration default 5 hrs range 2 8 hrs e Max Bolus default 10 units range 1 25 units Insulin Duration and Insulin on Board IOB Your t slim Pump remembers how much insulin you have taken from previous boluses It does this by relying on the Insulin Duration The Insulin Duration reflects the amount of time that insulin is actively lowering your BG Insulin Duration in your t slim Pump is set from the factory at 5 hours but can be changed from 2 to 8 hours Please consult your healthcare provider to accurately set your Insulin Duration While the Insulin Duration setting reflects how long insulin from previous boluses lowers your BG the IOB feature reflects how much insulin is remaining in your body from previous boluses IOB is always displayed on the Home Screen and is used in bolus delivery calculations when applicable When a BG is entered during bolus programming your t slim Pump will consider any active IOB and calculate an adjusted bolus if necessary NOTE Although you do not need to define
72. e infusion set can remain in place e Cardiac Catheterization Disconnect your t slim Pump and leave it outside the procedure room e Nuclear Stress Test Disconnect your t slim Pump and leave it outside the procedure room during the scan it can remain connected during the injection of radioisotopes There are also other procedures where you should proceed with caution most notably e Laser Surgery Your t slim Pump and infusion set can usually be worn during the procedure However some lasers can create interference and cause your t slim Pump to set off an alarm e General Anesthesia Depending on the equipment being used you may or may not need to remove your t slim Pump Be sure to ask your healthcare provider There is no need to disconnect for electrocardiograms EKGs or colonoscopies Customer Technical Support 1 877 801 6901 lt 4 13 gt Section 1 Welcome Chapter 1 About this User Guide Extreme Temperatures Avoid exposure of your t slim Pump to temperatures below 40 F 5 C or above 99 F 37 C as insulin solutions can freeze at low temperatures or degrade at high temperatures Do not steam sterilize or autoclave your t slim Pump at any time Amusement Park Rides Very powerful electromagnets are sometimes used on free fall or thrill rides Remove your t slim Pump and do not take it on these types of rides Also on high speed high gravity roller coasters you should disconnect NOT stop or Suspend
73. ected a CARTRIDGE ALARM occurs and all insulin deliveries stop e The pump determines that the loaded cartridge cannot be used eg it is defective etc e The pump detects that you tried to fill the cartridge with insulin without following the proper procedure in the Load menu e The pump detects that you have filled the cartridge with more than the maximum amount 300 units of insulin and therefore the cartridge cannot be used To Respond to the Cartridge Alarm 1 To temporarily clear the alarm tap CLOSE ALL DELIVERIES STOPPED gt This returns to the previous screen prior to the alarm This cartridge cannot be used Remove and replace with a new cartridge Customer Technical Support 1 877 801 6901 4128 gt Section 4 Safety Alerts and Alarms Chapter16 Alarms 2 Use the Load menu to follow the proper procedure for a Options cartridge change refer to section 5 3 Load 16 5 Cartridge Removal Alarm If your t slim Pump detects that the cartridge has been removed the Cartridge Removal Alarm occurs and all insulin deliveries are stopped To Respond to the Cartridge Removal Alarm 1 Tap CONNECT to reattach the current cartridge ALL DELIVERIES STOPPED The catridge cannot be detected 2 lap INSTALL to install a new cartridge Press INSTALL to install a new cartridge or press CONNECT to reconnect the current cartridge CONNECT INSTALL Customer Technical Support 1 877 801 6901 4129 gt Sec
74. ection against harmful interference in a normal residential environment The t slim Pump generates uses and can radiate radio frequency energy and may cause harmful interference to radio communications There is no guarantee that interference will not occur in a particular installation If the t slim Pump does cause harmful interference to radio or television reception the interference may be corrected by one of the following measures e Move or relocate the t slim Pump e Increase the distance between the t slim Pump and the other device that is emitting or receiving interference Changes or modifications not expressly approved by Tandem Diabetes Care Inc could void the user s authority to operate the equipment Customer Technical Support 1 877 801 6901 4 146 gt AR A Accessories 34 136 AC Charger 34 Active Bolus 81 Additional Pump Operations 83 After Bolus Reminder 106 140 Air Bubbles 11 47 Alarms 94 100 110 125 Altitude Alarm 131 Auto Off Alarm 112 140 Cartridge Error 48 128 Cartridge Removal Alarm 129 Empty Cartridge Alarm 128 Low Power Alarm 127 Occlusion Alarm 130 139 141 Reset Alarm 131 Resume Pump Alarm 126 Screen On Quick Bolus Button Alarm 131 Temperature Alarm 130 Alerts 29 94 100 110 116 Alert Icon 24 Basal Rate Required Alert 120 Connection Error Alert 35 123 Data Error Alert 124 Incomplete Bolus Alert 118 Incomplete Cartridge Change Alert 119 Incomplete Fill Cannula Alert 119
75. een Customer Technical Support 1 877 801 6901 4 48 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge 8 Fill the cartridge and tap Unlock gt Fill the cartridge then press the UNLOCK button when completed 9 Tap NEXT gt Cartridge Changed screen is displayed Press NEXT to continue NOTE After completing the cartridge change the pump will automatically prompt you to fill tubing 5 4 Filling Tubing Filling the Infusion Set Tubing with Insulin This section describes how to fill the infusion set tubing with insulin WARNING Never fill the infusion set tubing while the tubing is connected to your body Filling the tubing while it is connected to your body can result in the unintended delivery of insulin NOTE If starting from the Home Screen tap OPTIONS tap Load tap Fill Tubing and then follow the instructions Insulin delivery will be stopped and must be resumed upon completion 1 Verify that the infusion set is disconnected from your body 2 Connect the infusion set tubing to the luer lock tail of Pre seg EAA the cartridge from your body and securely l connect the tubing to your a Ensure that the new infusion set package is not cartridge damaged and remove the sterile tubing from the Press NEXT to fill your tubing package If the package is damaged or opened with insulin discard of properly and use another tubing set b Remove the
76. er the reminder then tao SAVE b Tao Remind Me After and using the onscreen keypad enter the time duration from 1 3 hours then tap SAVE 7 Tap BACK on the High BG Reminder screen to verify your High BG Reminder setting 8 Tap Tandem logo to return to the Home Screen To Respond to the High BG Reminder To clear the reminder and return to whatever activity was in progress when the reminder occurred tap CLOSE Customer Technical Support 1 877 801 6901 Chapter 13 Reminders BACK High BG Reminder ON 200 mg dL 2 hrs BACK High BG Reminder ON 150 mg dL Please test BG A high BG was entered 1 30 hrs ago lt 4 105 gt Section 3 Additional Pump Operations Chapter 13 Reminders 13 3 After Bolus BG Reminder The After Bolus BG Reminder prompts you to test your BG a selected time period after a bolus has been delivered When turning this reminder on you need to specify how much time should pass before the reminder occurs The options include 1 hour 1 30 hrs 2 hrs and 3 hrs 1 From the Home Screen tap OPTIONS 2 Tap My Pump Options 3 Tap Alert Settings My Pump 4 Tap Reminders Alert Settings 5 Tap After Bolus BG Reminders NOTE If not first time setup previous values appear instead of Press to Turn On Customer Technical Support 1 877 801 6901 4 106 gt Section 3 Additional Pump Operations Chapter 13 Reminders 6 Tap After Bolus BG to turn ON o
77. er to Max Bolus Alert in section 15 7 NOTE If the max bolus is set at 25 units and the requested bolus is greater than 25 units after the bolus is delivered a reminder screen will appear The option of delivering the remaining amount of the bolus of up to an additional 25 units will be given Refer to Max Bolus Alert in section 15 7 NOTE When attempting to deliver a bolus that exceeds the amount of insulin remaining in the cartridge a message screen appears indicating there is not enough insulin to deliver the requested bolus You are required to enter anew amount 7 2 Food Bolus Using Units NOTE If bolusing using a carb ratio skip to the next section Food Bolus Using Grams 1 From the Home Screen tap BOLUS 2 Tap O units INSULIN Customer Technical Support 1 877 801 6901 71 gt Section 2 Key Pump Features 3 Using the onscreen keypad enter desired units of insulin tap DONE CAUTION Always confirm that the decimal point placement is correct 4 Tap NEXT to confirm the units of insulin to be delivered 5 Confirm Request Tap YES if entered data is correct Tap NO to go back to make changes or view calculations 6 Tap DELIVER 7 The bolus splash is displayed Customer Technical Support 1 877 801 6901 Chapter 7 INSULIN Confirm Request 11 8 u Deliver 11 8 u Bolus EXTENDED 11 8 u DELIVER BOLUS INITIATED Bolus 4 72 gt Section 2 Key Pump Featur
78. es Chapter 7 Bolus 7 3 Food Bolus Using Grams 1 From the Home Screen tap BOLUS 2 Tap 0 grams 3 Using the onscreen keypad enter grams of carb and tap DONE NOTE To add multiple carb values enter first value then tap enter second value tap Continue until done To clear the value entered and start over tap the back arrow 4 Tap NEXT to confirm the units of insulin to be delivered NOTE Tap View Calculation to display the Delivery Calculation screen NOTE Tap the displayed units calculated to override the amount 5 Confirm Request Confirm Request Tap YES if entered data is correct 38 g Tap NO to go back to make changes or view calculations 6 Tap DELIVER Deliver 3 8 u Bolus EXTENDED 3 8 u DELIVER Customer Technical Support 1 877 801 6901 73 gt Section 2 Key Pump Features 7 The bolus splash screen is displayed 7 4 Correction Bolus 1 From the Home Screen tap BOLUS 2 Tap Add BG 3 Using the onscreen keypad enter BG value and tap DONE NOTE Once DONE is tapped the BG value is saved in pump History whether or not a bolus is delivered NOTE If BG is above the Target BG a message screen will indicate BG is above Target To add a correction bolus tap YES If BG is below Target BG a message screen advises to eat carbs and retest Tap Close If BG is at Target BG it will return to the Bolus Screen with no recommended bol
79. et Displays current BG target used delivered Temp Rate If active this to calculate bolus displayed in units hr 8 Insulin Duration Displays current insulin 3 Last Bolus Displays the amount date and duration used to calculate insulin on board time of last bolus 9 Carbohydrates Indicates whether feature 4 Carb Ratio Displays current carb ratio used is On or Off to calculate bolus 5 Up Down Arrow Indicates there is more information NOTE NA represents Not Applicable does not apply NOTE The status screen is for display only no changes can be made from this screen Customer Technical Support 1 877 801 6901 4 26 gt Section 1 Welcome 3 6 Bolus Screen Using Grams 1 BACK Returns to the Home Screen 2 CARBS Enter grams of carb to be consumed 3 Units Displays total units calculated 4 View Calculation Displays how the insulin dose was calculated using the current settings 5 BG Enter blood glucose level 6 NEXT Moves to next step Customer Technical Support 1 877 801 6901 Chapter 3 t slim Pump Overview Using Units units NSULIN BG BACK Returns to the Home Screen INSULIN Enter units of insulin Units Displays total units calculated View Calculation Displays how the insulin dose was calculated using the current settings BG Enter blood glucose level NEXT Moves to next step 427 gt Section 1 Welcome Chapter 3
80. ete Bolus Alert Tao CLOSE to return to the Bolus screen so that you can Eine Hole tae O A eros complete the bolus request 15 4 Incomplete Temp Rate Alert If you start to set up a temp rate but do not complete the setup within 90 seconds the INCOMPLETE TEMP RATE ALERT occurs You are prompted to return to the Temp Rate screen to complete the setup To Respond to the Incomplete Temp Rate Alert Tap CLOSE to return to the Temp Rate screen so that you can Laney a da complete the temp rate setup Customer Technical Support 1 877 801 6901 4118 gt Section 4 Safety Alerts and Alarms Chapter 15 Alerts 15 5 Incomplete Load Sequence Alerts Incomplete Cartridge Change Alert If you begin to change a cartridge but do not complete the process within 3 minutes the CHANGE CARTRIDGE ALERT occurs To Respond to the Incomplete Cartridge Change Alert The cartridge loading process has not been completed Tap CLOSE to return to the screen you were on prior to the alert and complete the cartridge changing process Incomplete Fill Tubing Alert If you select Fill Tubing from the Load menu but do not complete the process within 3 minutes the FILL TUBING ALERT occurs To Respond to the Incomplete Fill Tubing Alert The fill tubing process has not Tap CLOSE to return to the screen you were on prior to the Baan comica alert and complete the tube filling process Incomplete Fill Cannula Alert If you select F
81. f OFF After Bolus BG OFF 7 Tap Remind Me After After Bolus BG ON 1 30 hrs 8 Tap the preferred time duration Remind Me In 9 Tap BACK on the After Bolus BG screen to verify your After Bolus BG After BG Reminder setting 10 Tap Tandem logo to return to the Home Screen To Respond to the After Bolus BG Reminder craneo To clear the reminder and return to whatever activity was in It has been 2 hrs since your last bolus progress when the reminder occurred tap CLOSE Customer Technical Support 1 877 801 6901 lt 4 107 gt Section 3 Additional Pump Operations Chapter 13 Reminders 13 4 Missed Meal Bolus Reminder The Missed Meal Bolus Reminder is a personalized reminder that notifies you that a bolus was not delivered during a specified time period Four separate reminders are avallable When programming this reminder you need to select the Days the Start Time and End Time for each reminder 1 From the Home Screen tap OPTIONS 2 Tap My Pump Options 3 Tap Alert Settings My Pump 4 Tap Reminders Alert Settings 5 Tap Missed Meal Bolus Reminders NOTE If not first time setup previous values appear instead of Press to Set Up Customer Technical Support 1 877 801 6901 lt 108 gt Section 3 Additional Pump Operations 6 On the Missed Meal Bolus screen tap which reminder you want to set Reminder 1 4 and do the following a Tap Reminder 1 or 2 3 4 b Tao Re
82. g to Frequency of Transmitter from structures objects and people Customer Technical Support 1 877 801 6901 NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies Rated Maximum inches or feet m Output Powerof 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz WEDS TEMS d in meters d in meters d in meters 0 35vP 0 12vP 0 23vP 0 01 1 6in 0 04 0 12in 0 012 0 9in 0 023 0 1 43in 0 11 15in 0 038 29in 0 073 1 Lift 0 35 47in 0 120 9 0in 0 23 10 3 6ft 111 14 9in 0 379 2 39ft 0 727 100 11 5 ft 3 50 3 94 ft 1 20 7 54 ft 2 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection 4144 gt Section 6 Technical Specifications 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 pump Rated Maximum Recommended Output Power of Typical Devices Separation
83. he cartridge by gently inserting the syringe needle into the white insulin fill port on the t slim Cartridge The screen will automatically lock during this sequence Hold the pump upright as shown to the right Slowly depress the syringe plunger to inject insulin into the cartridge you may feel some back pressure as you fill the cartridge While maintaining pressure on the plunger remove the syringe needle from the cartridge Check the area around the white insulin fill port for leaks If you detect insulin is leaking from the white insulin fill port discard the cartridge and repeat entire process with a new cartridge If you need a replacement cartridge call Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 Dispose of used needles in a labeled sharps container in accordance with local requirements CAUTION The maximum cartridge fill amount is 300 units Do not overfill or top off when filling the cartridge as the additional amount cannot be delivered This can lead to a cartridge error which will require a new cartridge NOTE If a cartridge is filled with between 240 and 300 units the insulin level will display 240 on the Home Screen The insulin level will decline in increments of 5 units between 240 and 40 and in one 1 unit increments below 40 WARNING Do not remove or add insulin from a filled cartridge This will result in an inaccurate display of the insulin level on the Home Scr
84. ile the Quick Bolus Button does not respond to any more button presses 5 The bolus splash screen is displayed Customer Technical Support 1 877 801 6901 Chapter 10 Quick Bolus CANCEL Quick Bolus Increment 0 5 u 1 5 units Press and hold the Quick Bolus button to deliver Quick Bolus using units CANCEL Quick Bolus Increment 5g 15 1 5 grams units Press and hold the Quick Bolus button to deliver Quick Bolus using grams of carbs BOLUS INITIATED 4 92 gt 11 1 11 2 Chapter 11 tslim t slim Pump Volume Screen Options Pump Settings Section 3 Additional Pump Operations Chapter 11 t slim Pump Settings 11 1 t slim Pump Volume Your t slim Pump is delivered from Tandem Diabetes Care Inc with the volume pre set at High A change to the Pump Volume can be made in Pump Settings Pump Volume can be personalized for the Buttons Quick Bolus Bolus Reminders Alerts and Alarms Options for Pump Volume include high medium low and vibrate 1 From the Home Screen tap OPTIONS 2 Tap My Pump 3 Tap Pump Settings 4 Tap Pump Volume 5 Tap desired option Customer Technical Support 1 877 801 6901 Options My Pump Pump Settings Pump Volume HIGH HIGH HIGH HIGH 494 gt Section 3 Additional Pump Operations Chapter 11 t slim Pump Settings 6 Select preferred volume Button Volume 7 Continue to make ch
85. ill Cannula from the Load menu but do not complete the process within 3 minutes the FILL CANNULA ALERT occurs To Respond to the Incomplete Fill Cannula Alert The fill cannula process has not Tap CLOSE to return to the screen you were on prior to the baan Goma ited alert and complete the cannula filling process Customer Technical Support 1 877 801 6901 4119 gt Section 4 Safety Alerts and Alarms Chapter 15 Alerts 15 6 Incomplete Setting Alert During the setup of a new Personal Profile if you do not save or complete the programming within 5 minutes the INCOMPLETE SETTING ALERT occurs To Respond to the Incomplete Setting Alert A setting was being modified but Tap CLOSE to clear the alert and return to the previous screen hae Hak Loan cade to finish programming a Personal Profile 15 7 Basal Rate Required Alert During the setup of a new time segment in a Personal Profile you must enter a basal rate to have an active profile If you do not enter a basal rate a BASAL RATE REQUIRED ALERT occurs To Respond to the Basal Rate Required Alert A basal rate must be added to this Tap CLOSE to clear the alert and to return to the time finns soam bette can be segment to finish programming a basal rate saved Customer Technical Support 1 877 801 6901 4120 gt Section 4 Safety Alerts and Alarms Chapter 15 Alerts 15 8 Max Bolus Alert If you request a bolus amount that exceeds the Max Bolus setting in
86. important warnings and cautions on proper operation to ensure your safety as well as technical information It also provides step by step illustrative instructions on how to properly program manage and care for your t slim Pump Need help We are here for you 24 hours a day 7 days a week at 1 877 801 6901 CAUTION We know you can t wait to use your t slim Pump If your training has not been scheduled call us at 1 877 801 6901 Do not deliver insulin with your t slim Pump until you have completed your training Changes in equipment software or procedures occur periodically information describing these changes will be included in future editions of this User Guide Please contact Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 to obtain a replacement copy of the User Guide that is the correct version for your pump No part of this publication may be reproduced stored in a retrieval system nor transmitted in any form or by any means electronic or mechanical without the prior written permission of Tandem Diabetes Care Inc San Diego California USA This document is protected by copyright law Tandem Diabetes Care Inc 11045 Roselle Street san Diego CA 92121 USA Customer Technical Support 1 877 801 6901 Tandem Diabetes Care Inc Patient Bill of Rights 10 11 Patients have the right to good quality service and high professional standards that are continually maintained and reviewed A patient has
87. l loss of data the DATA ERROR ALERT occurs You are prompted to check your active Personal Profile and pump settings To Respond to the Data Error Alert Please verify that your active 1 To clear the alert tap CLOSE profile and pump settings are accurate gt This returns to the previous screen prior to the alarm 2 Check your Personal Profiles and pump settings to verify they are accurate refer to section 6 4 Customer Technical Support 1 877 801 6901 124 16 1 16 2 16 3 16 4 16 5 16 6 16 7 16 8 16 9 16 10 Chapter 16 Alarms Resume RumprAlarms Sm RM e a A 126 Con Power Alarm cen e am e nea ne waren 127 EMP Catia Alarme cc eee eer ee 128 Carndge Er e ce ete atone 128 Cartridge emo allel cae tree ee ee reer eee eee 129 Gcclusion ALANI E E ee eee 130 Temperature Alamo a St 130 Screen On Quick Bolus Button Alarm se 131 lle Alarme o a er so RO e nn E tence nity 131 Roso Alanine tren mn na SR incr nae ater ste ne pe tr ae 131 Section 4 Safety Alerts and Alarms Chapter16 Alarms Your t slim Pump has Alarms that sound for potential interruption of insulin delivery CAUTION Monitor your blood glucose BG levels frequently with the guidance of your healthcare provider anytime there is an interruption of insulin delivery Treat elevated blood glucose BG levels as recommended by healthcare provider Alarms sound with three notes at the volume vibe selected in Pump Settings If no
88. ll amount reached screen will appear Do one of the following a If you are finished filling the tubing tap DONE b If you want to fill the tubing with more than 30 units tap FILL to go back to the Fill Tubing screen 6 Fill Tubing is complete Load Customer Technical Support 1 877 801 6901 lt 4 50 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge 5 5 Filling Cannula Filling the Infusion Set Cannula with Insulin This section describes how to fill the infusion set cannula with insulin For the correct cannula fill amount as well as procedures on needle cannula insertion and attaching the tubing to your body refer to the instructions for use included with the infusion set To Fill the Cannula NOTE l starting from the Home Screen tap OPTIONS tap Load tap Fill Cannula and then follow the instructions Insulin delivery will be stooped and must be resumed upon completion If using a steel needle infusion set there is no cannula Skip this section 1 Tap Fill Cannula Load 2 Insert a new infusion set and connect tubing to site nsert a new set and connect to then tap NEXT the filled tubing Press NEXT to fill the cannula with insulin 3 Tap Edit Fill Amount Fill Cannula NOTE The cannula fill amount displayed is based on your last cannula fill amount Delivery stops at this amount unless you tao STOP before this amount is reached 4 Select
89. mation screen will appear Tap YES to if no buttons have been pressed change the setting Fondo noure Turn Auto Off on 10 Tap Tandem logo to return to the Home Screen To Respond to Auto Off Warning Auto Off alarm will shut pump 1 Tap DO NOT SHUT DOWN down if no action is taken 12 hrs The alarm clears and the pump returns to normal operation and whatever activity was in progress when the alert occurred DO NOT SHUT DOWN 30 sec If you do not clear the alarm within the 30 second countdown period the AUTO OFF ALARM occurs accompanied by an audible alarm This alarm notifies you that your pump has stopped delivering insulin Auto Off Alarm Screen ALL DELIVERIES STOPPED 1 Tap CLOSE No activity for more than 6 hours The Home Screen then appears indicating a status of All Deliveries Stopped Resuming insulin delivery must be performed manually refer to section 8 2 Customer Technical Support 1 877 801 6901 4114 Section 4 safety Alerts and Alarms 15 1 15 2 15 3 15 4 15 5 15 6 15 7 15 8 15 9 15 10 15 11 15 12 15 13 Chapter 15 Alerts EOW omen Alori ar me e E ro taa ric Eo 117 OWENS UNAS na Cem ue 118 ncompleic Bolus Alem 118 Incomplete Temp Rate Alert eee 118 Incomplete Load Sequence 87 AN gt q e PR 119 Incomplete SetingAlem mma 120 Basal Rate Required Ale e aac ooo 120 Max BOUS Alert stem a O ene 121 Max Hourly Bolus Ale o eee 122 Max BasalAlcrt 2I o 122 Co
90. minder 1 or 2 3 4 to set the reminder ON c Tap Selected Days and tap the desired day s you want the reminder to be on tao BACK d Tap Start Time tap Time and using the onscreen keypad enter the start time tao DONE e Tao Time of Day to select AM or PM tap SAVE f Tap End Time tap Time and using the onscreen keypad enter the end time tao DONE g lap Time of Day to select AM or PM tap SAVE h Tao BACK to return to the Missed Meal Bolus menu to review 7 Tap Tandem Logo to return to the Home Screen To Respond to the Missed Meal Bolus Reminder To clear the reminder and return to whatever activity was in progress when the reminder occurred tap CLOSE 13 5 Site Reminder Chapter 13 Reminders Missed Meal Bolus Missed Meal Bolus Monday 7 00a 8 004 A Missed Meal Bolus Reminder was set for 6 00pm 7 30pm Please deliver a bolus if necessary The Site Reminder prompts you to change your infusion set If enabled default is off the reminder can be set for 1 3 days and at a time of day selected by you For detailed information on the Site Reminder feature refer to section 5 6 To Respond to the Site Reminder To clear the reminder and return to whatever activity was in progress when the reminder occurred tap CLOSE Customer Technical Support 1 877 801 6901 Please change your site It has been 2 days since your site was changed 4109 gt 14 1 14 2 Chapter
91. n Bolus A correction bolus is given to correct elevated BG Correction Factor A correction factor is the amount of BG that is lowered by one unit of insulin Also Known as the Insulin Sensitivity Factor ISP Extended Bolus An extended bolus is a bolus that is delivered over a period of time It is commonly used to cover food that takes longer to digest When administering an extended bolus with your t slim Pump enter the DELIVER NOW portion to dose a percentage of insulin immediately and the remaining percentage over a period time Grams Grams are a unit of measurement for carbohydrates Insulin Duration Insulin duration is the amount of time that insulin is active and available in the body after a bolus has been delivered This also relates to the calculation for Insulin on Board IOB Insulin On Board IOB IOB is the insulin that is still active has the ability to continue to lower the BG in the body after a bolus has been delivered Load Load refers to the process of removing replacing and filling a new cartridge and infusion set Personal Profile A Personal Profile is a personalized group of settings that defines the delivery of basal and bolus insulin within specific time segments throughout a 24 hour period Quick Bolus Quick bolus using the Quick Bolus Button is a way to deliver a bolus by following beep vibration commands without navigating through or viewing the t slim Pump screen Temp Rate Temp rate is an abb
92. n lead to serious injury or even death If you have questions or need further clarification on your t slim Pump use ask your healthcare provider or call our around the clock Customer Technical Support Department at 1 877 801 6901 Customer Technical Support 1 877 801 6901 4 10 gt Section 1 Welcome Chapter 1 About this User Guide Your t slim Pump is designed only for the Continuous Subcutaneous Insulin Infusion CSI of U 100 insulin it is not intended for use with any other delivery substance Consult your healthcare provider before using your t slim Pump to determine which programming features are most appropriate for you Only your healthcare provider can determine your basal rate insulin to carbohydrate ratios correction factors BG target and duration of insulin action Additionally e Ensure that any small components on your t slim Pump and its accessories are kept away from small children who could potentially ingest them e Avoid changing your infusion set before bedtime or if you will not be able to test your BG at least 1 2 hours after a new Set is placed e Always check that your cartridge has insulin to last through the night e Unless otherwise recommended by your healthcare provider do not use the vibrate feature during sleep rather set the volume to high for all alarms and alerts e Since air bubbles can compromise delivery accuracy always remove all bubbles when drawing insulin into syringe always hold the p
93. nal measures may be necessary such as reorienting or gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Customer Technical Support 1 877 801 6901 4143 gt Technical Specifications Section 6 Technical Specifications Chapter 19 Technical Specifications 19 8 Distances Between the t slim Pump and RF Equipment The t slim Pump 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 Pump For specific concerns about a particular RF transmitter interfering with your Pump s operation please contact the transmitter manufacturer for its rated power and frequency Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the t slim Pump The t slim Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the t slim Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the pump as recommended below according to the maximum output power of the communications equipment Separation Distance Accordin
94. ndicated on its label from the back of the pump Do not fill the cartridge until prompted by instructions on the pump screen NOTE If needed place the edge of a coin in the slot at the bottom of the cartridge and twist to aid in the removal of the cartridge Instructions on How to Install a Cartridge Inspect cartridge package for any indication of damage Discard any damaged product Open package and remove cartridge Place bottom of the cartridge at the 4 Push on the circular fill port next end of the pump Make sure cartridge to the cartridge tubing to slide the is lined up to both guide tracks cartridge onto the pump 7 Tap NEXT gt Detecting Cartridge and Removing Air from Cartridge Press NEXT to screens are displayed continue Customer Technical Support 1 877 801 6901 4 46 gt Section 2 Key Pump Features Chapter 5 Infusion Site Care and Loading Cartridge Instructions for Drawing Insulin from Vial into Syringe CAUTION 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 Wash your hands and remove the needle and syringe from their package Securely twist needle onto syringe Safely remove protective cap from needle by pulling outward
95. ng disposal of cartridges infusion sets and other disposable accessories Customer Technical Support 1 877 801 6901 4136 Section 6 Technical Specifications 19 1 19 2 19 3 19 4 19 5 19 6 19 7 19 8 19 9 Chapter 19 Technical Specifications DUAL cans wettest Nn cnet RS ER ra O See RE 139 ESIMARU MP Specifications cu here eee eee 139 t slim Pump Options and SettingS ccoocccconncconcconcncnancnnanonas 140 Additional t slim Pump SpecificatiOnS cooccconncconnccnanconononas 141 Electromagnetic COMP AID ce te eee 142 Eleciromagnetic EMISSIONS Tar e ane ime ities hocntere mere 142 Electromagnetic IMM o tian ac 143 Distances Between the t slim Pump and RF Equipment 144 FCC Notice Concerning Interference ooocccccnccccniconniccnnonaninnns 146 Section 6 Technical Specifications 19 1 19 2 Overview Chapter 19 This appendix provides tables of technical specifications options settings and electromagnetic compliance information for the t slim Pump The specifications in this appendix meet the international standards set forth in IEC 60601 1 and IEC 60601 2 24 t sliim Pump Specifications The following table lists the t slim Pump specifications and their related details Technical Specifications Weight with full disposable Specification Type Specification Details Classification External PSU Class Il Infusion Pump internally powered equipment Type BF a
96. ng your t slim Pump e lf your t slim Pump is damaged disconnect the set from your body and contact Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 e Always follow proper aseptic clean technique when handling your pump and cartridge Wash your hands with anti bacterial soap before handling Use only sterile unopened products such as needles cartridges and infusion sets Thoroughly clean the insertion site on your body e Your t slim Pump is a sealed device that should be opened and repaired only by the manufacturer If your t slim Pump seal is broken the warranty is voided and your t slim Pump is no longer watertight Customer Technical Support 1 877 801 6901 14 gt Section 1 Welcome Chapter 1 About this User Guide e Conduct regular checks of your t slim Pump and infusion set particularly Check that your luer lock connection between the cartridge tubing and the infusion set tubing is tight and secure Check your infusion site for proper placement and leaks Improperly placed sites or leaks around the infusion site can result in under infusion Check your infusion set tubing for any damage leaks or kinks while using your t slim Pump Damaged leaking or kinked tubing may restrict or stop insulin delivery and result in under infusion Check your t slim Pump s personal settings to ensure that they are correct Check your t slim Pump s audible tones and vibratory alerts
97. nical Specifications Chapter 19 Technical Specifications Electromagnetic Compatibility The information contained in this section is specific to the t slim Pump This information provides reasonable assurance of normal operation but does not guarantee such under all conditions If the t slim Pump must be used in close proximity with other electrical equipment the pump should be observed in this environment to verify normal operation Special precautions for electromagnetic compatibility must be taken when using medical electrical equipment The system shall be placed into service with adherence to the EMC information provided here Using cables and accessories not specified in this User Guide may adversely impact safety performance and electromagnetic compatibility including increased emissions and or decreased immunity This section contains the following tables of information e Electromagnetic Emissions e Electromagnetic Immunity e Distances Between the t slim pump and RF Equipment Electromagnetic Emissions The t slim Pump is intended for use in the electromagnetic environment specified below Always make sure that the pump is used in such an environment Guidance and Manufacturer s Declaration Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The pump uses RF energy only for its internal function Therefore its RF emissions are very low and a
98. nnec HOmMENorAleItI r E e cee wearin a 123 ROWe EEA E te cee ee ees ne ce 123 Bata Error Ale ea gel 124 Section 4 Safety Alerts and Alarms Chapter 15 Alerts Your t slim Pump has Alerts that are sounded for an incomplete activity an impending alarm or if a max bolus has been reached Alerts sound with two notes at the volume vibe selected in Pump Settings They repeat at regular intervals until acknowledged Alerts do not escalate 15 1 Low Power Alert If the t slim Pump detects a power level of 25 or less remaining the LOW POWER ALERT occurs This alert screen displays the level of remaining power When the pump reaches a 5 battery level the pump has 30 minutes of remaining battery life To Respond to the Low Power Alert Power Level Less than 25 remaining To clear the Alert and return to whatever activity was In progress when the alert occurred tao CLOSE NOTE Once the LOW POWER ALERT occurs the low power indicator a single red bar on the battery level appears on the Home Screen IMISLELEM 10 20 AM NOTE dune 11 2012 The battery level will decline in increments of 5 At 5 it will decline in 1 increments NOTE Alerts sound with two notes at the volume selected in Pump Settings They repeat at regular intervals until acknowledged Alerts do not escalate 4 19 hrs If your t slim Pump detects a battery level of 5 or less power remaining a second LOW POWER ALERT occurs requesting th
99. note at the volume vibe selected in Pump Settings They repeat at regular intervals until acknowledged Reminders do not escalate 13 1 Low BG Reminder The Low BG Reminder prompts you to re test your BG after a low BG value is entered When turning this reminder setting On you need to specify a low BG value that triggers the reminder as well as how much time should pass before the reminder occurs The default values are pre set to Off or if On Remind Me Below 70 mg dL and Remind Me After 15 min but you can set these values from 70 120 mg dL and 10 20 min NOTE Reminders sound with a single note at the volume selected in Pump Settings They repeat at regular intervals until acknowledged Reminders do not escalate 1 2 3 4 From the Home Screen tap OPTIONS Tap My Pump Options Tap Alert Settings My Pump Tap Reminders Alert Settings Customer Technical Support 1 877 801 6901 4 102 gt Section 3 Additional Pump Operations Chapter 13 Reminders 5 Tap Low BG Reminders NOTE If not first time setup previous values appear instead of Press to Turn On 6 Tap Low BG to turn ON or OFF BACK Low BG Reminder a lap Remind Me Below and using the onscreen ON keypad enter a Low BG value from 70 120 mg dL that you want to trigger the reminder then tap SAVE 70 mg dL b Tap Remind Me After and using the onscreen Me After 15 min keypad enter the time duration from 10 20 min then tap
100. onfirm correct programming until you are comfortable with this feature 1 Press and hold Quick Bolus Button The Quick Bolus screen will appear Listen for 2 beeps if Pump Volume is set to beep or feel for vibrations if Pump Volume is set to vibrate NOTE t slim will beep and vibrate during a Quick Bolus if a beep volume is set It will only vibrate if the vibrate option is selected 2 Press Quick Bolus Button for each increment until desired amount is reached The pump will beep vibrate for each button press Customer Technical Support 1 877 801 6901 INSULIN 10 20 AM CANCEL Quick Bolus Increment 0 5 u units Press the Quick Bolus button to increase the amount Quick Bolus using units Quick Bolus Increment 5g 0 0 grams units Press the Quick Bolus button to increase the amount Quick Bolus using grams 491 Section 3 Additional Pump Operations 3 Please wait a few seconds for the pump to beep vibrate back for each increment pressed to confirm desired amount 4 After the pump beeps vibrates press and hold Quick Bolus button to deliver the bolus NOTE If more than 5 seconds have passed with no input the bolus is cancelled and never delivered If you want to cancel the bolus and return to the Home Screen tao CANCEL on the QUICK BOLUS screen Ifthe amount you indicated by your button presses exceeds the Max Bolus amount defined in your active Personal Prof
101. ording to the American Association of Diabetes Educators white paper Insulin Pump Therapy Guidelines for Successful Outcomes patients should routinely check their BG levels at least 4 times daily optimally 6 8 times daily in order to detect hyperglycemia and hypoglycemia early Undetected hyperglycemia or hypoglycemia can result without proper monitoring 1 2 Working with your Healthcare Provider Any clinical language presented in this User Guide is based on the assumption that you have been educated by your healthcare provider on certain terms and how they apply to you in your insulin infusion therapy Your healthcare provider can help you establish diabetes management guidelines that best fit your lifestyle and needs Your needs will influence how your healthcare provider helps you enter your initial pump settings If you have any questions about diabetes management after you start using your t slim Pump do not hesitate to contact your healthcare provider 1 3 Important Safety Information This section covers important safety information including indications for use and contraindications what to keep in an emergency kit and warnings and precautions In case of an emergency call 911 U S only CAUTION Before using your t slim Pump ensure that you have been appropriately trained on its use by a certified t slim Pump trainer Incorrect use of your t slim Pump or failure to follow the appropriate instructions in this User Guide ca
102. package is compromised while in the control of the user by any means other than purposeful opening by the user at the time of intended product use e If damage results from changes or modifications made to the infusion set or cartridge by the user or third persons after the date of manufacture e f damage results from service or repairs performed to any part of the infusions set or cartridge by any person or entity other than Tandem e f damage is caused by use of the cartridge or infusion set with any non Tandem insulin pump e f damage results from a force majeure or other event beyond the control of Tandem or e If damage results from negligence or improper use including but not limited to improper storage or physical abuse such as dropping or otherwise This warranty shall be personal to the original end use purchaser Any sale rental or other transfer or use of the product covered by this warranty to or by a user other than the original end use purchaser shall cause this warranty to immediately terminate This warranty does not apply to insulin pumps and other accessories THE REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE FOR ANY WARRANT CLAIMS NEITHER TANDEM NOR ITS SUPPLIERS OR DISTRIBUTORS SHALL BE LIABLE FOR ANY INCIDENTAL CONSEQUENTIAL OR SPECIAL DAMAGE OF ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE PRODUCT ALL OTHER WARRANTIES EXPRESS OR IMPLIED ARE EXCLUDED INCLUDING THE
103. pione mm 67 Renaming an Existing Profile iaa caian coca tania 68 Deleting an Existing Prode Pria a conri atone 69 Section 2 Key Pump Features Chapter 6 Personal Profile 6 1 Personal Profile Overview A Personal Profile is a group of settings that define the basal and bolus delivery within specific time segments throughout a 24 hour period Each profile can be personalized with a name Within a Personal Profile the following can be set e Timed Settings Basal Rate Correction Factor Carb Ratio and Target BG e Bolus Settings Insulin Duration Max Bolus and Carbohydrates setting ON OFF The t slim Pump uses the settings in your currently active profile to calculate the delivery of basal insulin food boluses and correction boluses based on your Target BG Having several Personal Profiles provides more flexibility for your body and lifestyle For example you could have Weekday and Weekend profiles if you have different insulin delivery needs on weekdays and weekends based on variables such as schedule food intake activity and exercise etc NOTE Up to 6 different Personal Profiles can be created and up to 16 different time segments can be set in each Personal Profile For example within your Weekday profile you might have time segments set up for 12 00 AM 5 30 AM and 3 00 PM based on your healthcare provider s recommendation NOTE Once defined a Personal Profile can be viewed by selecting EDIT f
104. pplied 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 x 2 0 x 0 6 LXWXH 7 95 cm x 5 08 cm x 1 52 cm 3 95 ounces 112 grams Operating Temperature Range 41 F and 98 6 F 5 C and 37 C at maximum relative humidity of 90 non condensing Storage Temperature Range 4 F and 140 F 20 C to 60 C at maximum relative humidity of 90 non condensing Atmospheric Pressure 700 hPa to 1060 hPa equivalent from sea level up to 10 000 ft Reservoir Volume 3 0 mL or 300 units Cannula Fill Amount 0 1 to 1 0 units of insulin Insulin Concentration U 100 tested per IEC 60601 2 24 Alarm Type Visual audible and vibratory Basal Delivery Accuracy at all Flow Rates 5 tested per IEC 60601 2 24 Bolus Delivery Accuracy at all Volumes 5 In extreme pressure environments delivery accuracy may vary up to 15 Extreme pressure environments include any rapid elevation change of 1 000 ft Time to Occlusion Alarm Operating Rate Typical Maximum Bolus 3 units or Greater 21 Seconds 23 Seconds Basal 2 units hr 1 Hour 4 Minutes 1 Hour 10 Minutes 1 Hour 57 Minutes 2 Hours 7 Minutes Basal 1 units hr Basal 0 1 units hr 19 Hours 43 Minutes 25 Hours 30
105. pted to confirm whether you want to deliver this bolus amount To Respond to the Max Hourly Bolus Alert Your Max Hourly Bolus has been Do one of the following PRE e To return to the Bolus screen and adjust your bolus Press CONTINUE to confirm the amount tap BACK requested 14 u bolus o To deliver the bolus tap CONTINUE CONTINUE 15 10 Max Basal Alert In either of the following scenarios if you exceed 2 times the highest basal rate defined in your Personal Profile the MAX BASAL ALERT occurs e When defining a basal rate and tapping SAVE e When requesting a temp rate and tapping START You are cautioned that you will exceed 2 times your highest basal setting and prompted to confirm whether you want to continue with this basal amount To Respond to the Max Basal Alert Before Starting a Temp Rate or Saving a Basal Rate You are going to exceed 2x your highest basal setting Press Do one of the following CONTINUE to override the setting e To return to the previous screen and adjust the amount tap BACK CONTINUE e To continue regardless of the excess amount tap CONTINUE Customer Technical Support 1 877 801 6901 lt 4 122 gt Section 4 Safety Alerts and Alarms Chapter 15 Alerts If you have already started a temp rate and while the temp rate is running you activate a new profile that exceeds 2 times your highest basal setting the MAX BASAL ALERT occurs You are prompted to review your current
106. r to an auxiliary power outlet and the USB cable to the pump or connect the pump to a USB port on a PC that complies with IEC 60950 or equivalent safety standard WARNING When using the DC vehicle adapter charger the charger must be connected to an isolated battery powered 12 Volt system such as an automobile Connecting the DC vehicle adapter charger to 12 Volt DC that is generated by a power supply connected to alternating current AC mains is prohibited CAUTION When you are connected to the pump and to a charging source take caution when moving further than the length of the USB cable Failure to do so may result in the cannula becoming dislodged at the infusion site For this reason it is recommended not to charge the pump while sleeping Customer Technical Support 1 877 801 6901 434 gt Section 2 Key Pump Features Chapter 4 Getting Started When you charge the t slim Pump the following should occur e The screen illuminates e An audible alert e The LED edge around the Screen On Quick Bolus Button illuminates green e A vibrating alert e Acharge symbol lightning bolt on the battery level indicator appears CAUTION If any of these conditions fail to occur do NOT use the t slim Pump as this may be an indication that the pump s alarms alerts and other built in safety features may not be working properly If the t slim Pump is connected to your body disconnect the set from your body and contact T
107. re not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B The pump is suitable for use in all establishments Harmonie Emissions N A including domestic establishments and those IEC 61000 3 2 directly connected to the public low voltage power supply network that supplies buildings used for Voltage Fluctuations Flicker N A domestic purposes Emissions IEC 61000 3 3 Customer Technical Support 1 877 801 6901 lt 4 142 gt Section 6 19 7 Technical Specifications Chapter 19 Electromagnetic Immunity The t slim Pump is intended for use in the electromagnetic environment specified below Always make sure that the pump is used in such an environment Guidance and Manufacturer s Declaration Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 8 kV contact 15 KV air 8 kV contact 15 KV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast Transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61
108. rent ways If at any time your t slim Pump detects a voltage level too low to ensure normal performance the LOW POWER ALARM occurs and all insulin deliveries are stopped You must recharge your t slim Pump to resume insulin delivery To Respond the Low Power Alarm 1 To silence the alarm tap SILENCE ALARM ALL DELIVERIES STOPPED Your pump is about to shut down Please charge your pump immediately SILENCE ALARM Customer Technical Support 1 877 801 6901 4127 gt Section 4 Safety Alerts and Alarms Chapter16 Alarms 16 3 Empty Cartridge Alarm If your t slim Pump detects an insulin level in the cartridge of 1 unit or less the EMPTY CARTRIDGE ALARM occurs and all insulin deliveries are stopped You must change the cartridge and fill the new cartridge with insulin before you can resume delivery The alarm will continue until the condition has been corrected To Respond to the Empty Cartridge Alarm 1 Tap CLOSE ALL DELIVERIES STOPPED gt This returns to the previous screen prior to the alarm Change cartridge and Tar Wien insulin to resume delivery 2 Under OPTIONS tap Load to follow the proper procedure for a cartridge change refer to section 5 3 NOTE Once the EMPTY CARTRIDGE ALARM occurs the empty cartridge indicator a red X on the insulin level appears in the upper right corner of the Home Screen Options 16 4 Cartridge Error Alarm If any of the following cartridge error scenarios are det
109. reviation for a temporary basal rate It is used to increase or decrease the current basal rate for a short period of time to accommodate special situations 100 is the same basal rate as programmed 120 means 20 more and 80 means 20 less than the programmed basal rate Units Units are the measurement for insulin USB Cable USB is the abbreviation for Universal Serial Bus The USB cable connects into the t slim Pump s micro USB port Customer Technical Support 1 877 801 6901 423 gt Section 1 Welcome Chapter 3 t slim Pump Overview 3 3 Screen Lock 10 20 AM dune 11 2012 temaining 0 00 min 1 Time and Date Display Displays the 5 Active Bolus Icon Indicates a bolus current time and date is active 2 Alert Icon Indicates a reminder alert or 6 Status Displays current pump settings and alarm is active behind the lock screen insulin delivery status 3 BATTERY Level Displays the level of 7 INSULIN Level Displays the current battery power remaining When connected amount of insulin in the cartridge for charging the charging icon lightning bolt will display 8 Tandem Logo Returns to the Home Screen 4 INSULIN ON BOARD IOB Amount and time remaining of any active insulin on board Customer Technical Support 1 877 801 6901 424 gt Section 1 3 4 Welcome Home Screen INSULIN June 11 2012 ig 1 09 hrs BATTERY Level Displays the level of battery power remaining When connected
110. rom the profile menu 6 2 Creating a New Profile Creating Personal Profiles You can create up to 6 Personal Profiles however only one can be active at a time In the Personal Profiles screen the currently active profile is positioned at the top of the list and Is indicated as ON When you create a Personal Profile you can define any or all of the following Timed Settings e Basal your basal rate in units of insulin per hour e Correction Factor amount BG is lowered by 1 unit of insulin e Carb Ratio number of carbs covered by 1 unit of insulin e Target BG your ideal BG level NOTE An initial maximum basal rate of 2 units hr is set for each Personal Profile If you enter a basal rate greater than 2 units hr you will be prompted to confirm whether you want to continue with this basal amount Once basal rates are set in a Personal Profile the maximum basal rate becomes two times the highest basal rate in that Personal Profile The absolute maximum basal rate is 15 units hr Customer Technical Support 1 877 801 6901 4 56 gt Section 2 Key Pump Features Chapter 6 Personal Profile The ranges for Timed Settings initially inactive are e Basal range O and 0 1 15 units hr e Correction Factor range 1 unit 1 mg dL 1 unit 600 mg dL e Carb Ratio range 1 unit 1 g 1 unit 300 9 e Target BG range 70 mg dL 250 mg dL NOTE Below a carb ratio of 1 10 increments can be entered in 0 1 g For exampl
111. t acknowledged alarms escalate to highest volume and vibe Alarms repeat at regular intervals until the condition that caused the alarm is resolved 16 1 Resume Pump Alarm If insulin delivery has stopped for more than 15 minutes the RESUME PUMP ALARM occurs To Respond to the Resume Pump Alarm 1 Tap CLOSE to clear the alarm The pump has been stopped for an extended period of time Select RESUME INSULIN in the Options menu to continue therapy CLOSE INSULIN 2 From the Home Screen tap OPTIONS 10 20 AM dune 11 2012 3 Tap Resume Insulin and tap Resume Options Customer Technical Support 1 877 801 6901 lt 4 126 gt Section 4 Safety Alerts and Alarms Chapter16 Alarms 16 2 Low Power Alarms If your t slim Pump detects a power level of 1 or less power remaining the LOW POWER ALARM occurs and all insulin deliveries are stopped You must recharge your t slim Pump to resume insulin delivery The alarm will continue until the condition has been corrected or the pump shuts down To Respond to the Low Power Alarm 1 To temporarily clear the alarm tap CLOSE ALL DELIVERIES STOPPED Your pump is about to shut down NOTE Please charge your pump Once the LOW POWER ALARM occurs the low power indicator ee a red X and 1 on the battery level indicator appears in the upper left corner of the Home Screen IMISLELEM 10 20 AM June 11 2012 Your t slim Pump monitors power level in several diffe
112. temp rate To Respond to the Max Basal Alert After the Temp Rate Has Started You have exceeded 2x your highest basal setting Please review your 1 Tap CLOSE current temp rate in the Options menu gt gt The Options screen appears showing the current Temp Rate value 15 11 Connection Error Alert If you connect your t slim Pump to a computer via a USB cable in order to sync data and a connection cannot be made the CONNECTION ERROR ALERT occurs You are prompted to disconnect and reconnect the USB cable To Respond to the Connection Error Alert Pump cannot connect with the 1 To clear the alert tap CLOSE computer Press CLOSE and reconnect the USB cable to try gt This returns to the previous screen prior to the alarm again 2 Disconnect and reconnect the USB cable to try again 15 12 Power Source Alert If you attempt to charge your t slim Pump by connecting to a power source that has insufficient power to charge the t slim Pump the POWER SOURCE ALERT occurs You are prompted to try a different power source To Respond to the Power Source Alert 1 To clear the alert tap CLOSE The pump cannot charge using the current power source Source 2 Disconnect and reconnect to a different power source Customer Technical Support 1 877 801 6901 4123 gt Section 4 Safety Alerts and Alarms Chapter 15 Alerts 15 13 Data Error Alert If your t slim Pump encounters a condition that causes a potentia
113. the requirements of standard IEC60601 1 1 1 8 Conventions of this Guide The following are conventions used in this Guide Such as terms icons text formatting and other conventions along with their explanations Convention Explanation Bolded Text Text that is in bold and in a different font than the rest of the sentence or step indicates an onscreen or physical button name Touch Screen The front glass screen of your pump which displays all programming operating and alarm alert information Tap Quickly and lightly touch the screen with your finger Press Use your finger to depress a physical button the Screen On Quick Bolus Button is the only physical hardware button on your t slim Pump Hold Keep pressing a button or touching an icon or menu until its function is complete Menu Icon 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 a symbol on the back of your t slim Pump or its packaging Customer Technical Support 1 877 801 6901 lt 4 15 gt 2 1 2 2 2 3 2 4 2 9 Chapter 2 Introduction NAc ele 4 a oca RO A UPE ea DU 17 What your t slim Insulin Delivery System Package Includes 17 ExplanationorSymbols te es eet ces ere rene 18 ExplanatiomoteslimEColors Ss e ts ce cameos renee 18 Warranty Information Section 1 Welcome Chapter 2
114. ting Profile 1 From the Home Screen tap OPTIONS 2 Tap My Pump Options 3 Tap Personal Profiles My Pump 4 Tap the name of the Personal Profile to be renamed Personal Profiles 5 Tap Down Arrow and then Rename Profile 2 6 Using the onscreen keypad rename the profile name up to 16 characters and tap SAVE 7 Tap Tandem logo to return to the Home Screen Customer Technical Support 1 877 801 6901 4 68 gt Section 2 Key Pump Features 6 8 Deleting an Existing Profile 1 From the Home Screen tap OPTIONS 2 Tap My Pump 3 Tap Personal Profiles 4 Tap the name of the Personal Profile to be deleted NOTE The active Personal Profile cannot be deleted 5 Tap Delete 6 Tap YES gt Profile Deleted screen is displayed 7 Tap Tandem logo to return to the Home Screen Customer Technical Support 1 877 801 6901 Chapter 6 Personal Profile Options My Pump Personal Profiles Profile 2 This deletes all settings and removes the profile from the list Delete Profile 27 lt 4 69 gt 7 1 7 2 7 3 7 4 7 5 7 6 Chapter 7 Bolus OS io e 71 FOCOS SO A ee ee eee eee 71 ROO BOS SING Gali Sete ren ree a eee ees eee 73 Corecom BOUS aa E E ea E le cn te cnaas 74 EXtCNOCOID OWS a RR arctan encemecnrn 76 Gancelimg Or Stopping Ol eer ee eens 78 Section 2 Key Pump Features Chapter 7 Bolus 7 1 Bolus Overview A bolus is a quick dose of insulin that is usually
115. tion 4 Safety Alerts and Alarms Chapter16 Alarms 16 6 Occlusion Alarm If your t slim Pump detects insulin delivery is blocked the OCCLUSION ALARM occurs and all insulin deliveries are stopped Check the cartridge tubing and cannula to help determine the cause To Respond to the Occlusion Alarm 1 To temporarily clear the alarm tap CLOSE ALL DELIVERIES STOPPED This returns to the previous screen prior to the alarm Insulin delivery may be blocked gt P p Check cartridge tubing and site 2 Check the cartridge tubing and cannula and correct the condition 3 Resume insulin delivery refer to section 8 2 16 7 Temperature Alarm If your t slim Pump detects a temperature outside of the normal operating range the TEMPERATURE ALARM occurs and all insulin deliveries are stopped To Respond to the Temperature Alarm 1 To temporarily clear the alarm tap CLOSE ALL DELIVERIES STOPPED gt This returns to the previous screen prior to the alarm Remove pump from extreme temperatures and then resume insulin delivery 2 Remove the pump from the extreme temperature CLOSE 3 Resume insulin delivery refer to section 8 2 Customer Technical Support 1 877 801 6901 lt 130 gt Section 4 Safety Alerts and Alarms Chapter16 Alarms 16 8 Screen On Quick Bolus Button Alarm If the Screen On Quick Bolus Button on the top of your t slim Pump is stuck or not functioning properly the BUTTON ALARM occurs and all
116. to ensure they are easily detectable e Use only single use disposable t slim cartridges The efficacy of your t slim Pump cannot be guaranteed if cartridges other than those manufactured by Tandem Diabetes Care Inc are used or if cartridges are filled more than once Use of cartridges not manufactured by Tandem Diabetes Care Inc or reuse of cartridges may result in over infusion or under infusion and may cause serious injury or death e Use only FDA cleared infusion sets with a standard luer lock connection and consult its instructions for use Failure to do so may result in over infusion or under infusion and may cause serious injury or death Change your infusion set every 48 72 hours Consult your healthcare provider for more information e Do not disconnect the luer lock connection between the cartridge tubing and the infusion set tubing If the connection comes loose disconnect the infusion set from the site from your body before tightening to avoid unintentional insulin delivery e Always dispose of used cartridges and infusion sets following your community s regulations Insulin can be absorbed through the skin so wash your hands thoroughly after handling any insulin holding device e Regularly check your t slim Pump screen for potential failure conditions that may display e Everyone who connects additional equipment to the pump configures a medical system and is therefore responsible to ensure that the system complies with
117. 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 25 units Low Reservoir Volume Indicator Status indicator visible on home screen Low Insulin Alert user adjustable 10 40 units Auto Off Alarm On or Off default is On user adjustable 5 24 hours default is 12 hours which you can change when option is set to On History Storage Up to 90 days of data 11 000 events Language English Feature Lock Blocks access to insulin delivery screens and pump setting screens default is Off Screen Lock Protects from unintentional taps Site Reminder Prompts user to change infusion set Can be set for 1 3 days at a time selected by user default is Off Missed Meal Bolus Reminder After Bolus Reminder Prompts user if a bolus has not occurred during the period of time the reminder is set for 4 reminders available Prompts user to test BG at a selected time period after a Bolus has been delivered Increment options of 1 hr 1 30 hrs 2 hrs and 3 hrs High BG Reminder Prompts user to retest BG after a High BG has been entered User selects High BG value and time for reminder Default is Off Low BG Reminder Prompts user to retest BG after a Low BG has been entered User selects Low BG value and time for reminder Default is Off Customer
118. ump with the white insulin fill port pointed up when filling cartridge and always ensure that there are no air bubbles in the tubing when filling e Ensure that the t slim Pump you use for therapy has all your personal settings programmed with your specific treatment plan e lf you damage or drop your t slim Pump ensure that it is still working properly If you are unsure as to potential damage call Tandem Diabetes Care Customer Technical Support at 1 877 801 6901 1 4 Emergency Kit Make sure that you always have an insulin syringe and a vial of insulin with you as a backup for emergency situations You should also always have an appropriate emergency kit with you Talk with your healthcare provider regarding what items this kit should include Supplies to Carry Everyday e Blood glucose testing supplies meter strips lancets meter batteries e Fast acting carbohydrate for low blood glucose e Extra snack for longer coverage than fast acting carbohydrate e Glucagon emergency kit for recurrent severe hypoglycemia e Rapid acting insulin and syringes e Infusion sets a minimum of two e Insulin pump cartridges a minimum of two e Infusion site preparation products antiseptic wipes skin adhesive e Ketone testing strips e t slim Wallet Card for troubleshooting tips and pump settings e Diabetes identification card or jewelry Customer Technical Support 1 877 801 6901 411 gt Section 1 Welcome Chapter 1 About this User
119. urce Alert 123 Pump Info 28 29 99 Pump Settings 10 24 25 28 29 93 140 Pump Volume 29 94 Q Quick Bolus 23 25 29 87 94 140 Quick Bolus Button 23 25 91 R Rapid Acting Insulin 11 12 43 Reminders 29 94 101 After Bolus Reminder 106 140 High BG Reminder 104 140 Low BG Reminder 102 140 Missed Meal Bolus Reminder 108 140 Site Reminder 28 52 109 140 Reset Alarm 131 Resume Insulin 25 28 82 Resume Pump Alarm 126 S Safety 3 10 115 Screen Lock 24 35 36 140 Screen On Quick Bolus Button 25 35 Screen On Quick Bolus Button Alarm 131 Screen Options 29 95 Screen Protector 17 Screens Bolus Screen 27 Home Screen 24 25 27 28 Keypad Screen 30 31 My Pump Screen 29 Options Screen 28 Status Screen 26 Screen Timeout 95 96 Serial Number 18 29 99 Site Reminder 28 52 109 140 Customer Technical Support 1 877 801 6901 Status 24 25 Status Screen 26 Stop Stopping a Bolus 78 Stopping a lemp Rate 86 Stopping Insulin Delivery 81 Syringe 11 44 47 48 T Tandem Logo 24 25 35 Tap 12 15 22 Target BG 22 26 56 57 74 75 140 Temperature Alarm 130 Temp Rate 23 25 26 28 123 Incomplete Temp Rate Alert 118 Setting a Temp Rate 85 Stopping a Temp Rate 86 Time Edit Time 37 Time and Date Display 24 25 Time Segment 56 58 61 64 140 Timed Settings 56 57 Tubing Cartridge Tubing 25 Fill Tubing 28 49 U U 100 Insulin 11 12 42 Units 23 27 30 Unlock 36 46 USB Adapter 12 17 US
120. us amount for correction NOTE Tap the View Calculation to display the Delivery Calculation screen If there is IOB the amount will be subtracted from the correction portion of the bolus Tap the displayed units calculated to override the amount Customer Technical Support 1 877 801 6901 Chapter 7 BOLUS INITIATED Bolus 74 gt Section 2 Key Pump Features Chapter 7 Bolus NOTE When your blood glucose is Above Target BG the insulin for the food bolus and the correction bolus will be added together If IOB is present it will only be used in the calculation of the correction portion of the bolus Between 70 mg dL and Target BG No correction bolus is calculated No adjustment will be made to the food bolus even if IOB is present Below 70 mg dL The food bolus will be reduced to correct for the low blood glucose In addition if IOB is present it will also be used in the calculation of the food bolus to return your BG to target 4 Tap NEXT to confirm the units of insulin to be delivered Tap YES if entered data is correct Tap NO to go back to make changes or view calculations 6 Tap DELIVER 7 The bolus splash screen is displayed 180 mg dL 1 2u Deliver 1 2 u Bolus BACK DELIVER BOLUS INITIATED Customer Technical Support 1 877 801 6901 475 gt Section 2 Key Pump Features Chapter 7 Bolus 7 5 Extended Bolus 1 From the Home Screen tap BOLUS
121. wnsiabacuwudedeniieexdinneatoecummasiodasaundedanctencinnts 129 166 Decision AlI atar Ea E 130 16 7 Temperature AIAN wesersetwoantancanasreuanesdatedimmedinnrnsnnsdsedstanneuaneeaneduniidwededweainmsaiamsaneniviotedbeoaieias 130 16 8 Screen On Quick Bolus Button Alarm csi da LEA 169 Aoc A acosados ni sand EARE AEA ANARE Ra RENES RA AARD 131 10 10 escala sarna 191 Chapter 17 Malfunction 17 1 Maliciosa aria ra dn anders Wiens cbr cea ise nite emanated 133 Table of Contents of Contents Section 5 Care and Maintenance Chapter18 Taking Care of your t slim Pump 18 1 OVINA 136 Section 6 Technical Specifications Chapter 19 Technical Specifications LO E PE O raia 139 19 2 tslim Pump Specificati niS romantic dorar Nas eR Ene SAN 139 19 3 t slim Pump Options and Settings usina ia 140 19 4 Additional t slim Pump Specifications coooccccconnnccnonccoccnnnnnnnnnnnnnnnonnnnonancnonannnonanenonons 141 19 5 Electromagnetic Compatibility acarrea 142 19 6 Electromagnetic EMISSIONS asasspiassadiaadanes nho dnasicuacioaniaiddicoinassa jaca iene semanas nessas adia aden dnao 142 19 7 Electromagnetic IMIUNTA ssparasranee raras casa old 143 19 8 Distances Between the t slim Pump and RF Equipment serem 144 19 9 FCC Notice Concerning Interference erre reereee e errree aa erenecacna 146 Index Section 1 Welcome 1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 Chapter 1 About this User Guide PUOS

t:slim User Guide - Tandem Diabetes Care

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