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Customer Technical Support:

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Technical Specifications and W

arranty

Chapter 20 – Technical Specifications

PC, USB Connector, Specifications

Output Voltage

5 Volts DC

Output Connector

USB type A

Safety Standard Compliance

60950-1 or 60601-1 or equivalent

The t:slim X2 Pump is designed to be connected to a host PC for battery charging and data transfer to t:connect. The following

minimum characteristics are required of the host PC:

•

USB 1.1 port (or later)

•

t:connect Uploader Software (available for download at www.tandemdiabetes.com)

•

PC compliant with 60950-1 or equivalent safety standard

Connecting the t:slim X2 Pump to a host PC that is attached to other equipment could result in previously unidentified risks to the

patient, operator, or a third party. The user should identify, analyze, evaluate, and control these risks.

Subsequent changes to the host PC could introduce new risks and require additional analysis. These changes can include but

are not limited to changing the configuration of the PC, connecting additional items to the PC, disconnecting items from the PC,

and updating or upgrading equipment connected to the PC.

Содержание t:slim X2

Страница 1: ...INSULIN ON BOARD IOB Units 1 1 u 1 09 hrs Time Remaining B 12 31 PM October 16 2016 235 u OPTIONS BOLUS 100...

Страница 2: ......

Страница 3: ...res occur periodically informa tion describing these changes will be included in future editions of this User Guide Please contact Tandem Diabe tes Care Customer Technical Support at 877 801 6901 to o...

Страница 4: ...ortant Pediatric User Information 17 1 5 Conventions of this Guide 18 Chapter 2 Important Safety Information 2 1 Indications for Use 20 2 2 Contraindications 20 2 3 Pump Warnings 20 2 4 System Precaut...

Страница 5: ...tem Package Includes 32 3 2 Pump Terminology 32 3 3 Explanation of Pump Symbols 34 3 4 Explanation of Pump Icons 35 3 5 Explanation of Pump Colors 36 3 6 Screen Lock 38 3 7 Home Screen 40 3 8 Status S...

Страница 6: ...n 58 4 3 Turning on the t slim X2 Pump Screen 58 4 4 Unlocking the t slim X2 Pump Screen 58 4 5 Edit Time 59 4 6 Edit Date 59 Chapter 5 Infusion Site Care and Loading Cartridge 5 1 Infusion Site Selec...

Страница 7: ...file 78 6 4 Editing or Reviewing an Existing Profile 81 6 5 Duplicating an Existing Profile 82 6 6 Activating an Existing Profile 82 6 7 Renaming an Existing Profile 83 6 8 Deleting an Existing Profil...

Страница 8: ...esuming Insulin Delivery 94 Section 3 Additional Pump Operations Chapter 9 Temporary Basal Rate 9 1 Setting a Temp Rate 98 9 2 Stopping a Temp Rate 99 Chapter 10 Quick Bolus 10 1 Setting Up Quick Bolu...

Страница 9: ...Pump Info 110 12 2 t slim X2 Pump History 110 Chapter 13 t slim X2 Pump Reminders 13 1 Low BG Reminder 112 13 2 High BG Reminder 113 13 3 After Bolus BG Reminder 114 13 4 Missed Meal Bolus Reminder 11...

Страница 10: ...erts 124 15 3 Incomplete Bolus Alert 126 15 4 Incomplete Temp Rate Alert 127 15 5 Incomplete Load Sequence Alerts 128 15 6 Incomplete Setting Alert 131 15 7 Basal Rate Required Alert 132 15 8 Max Hour...

Страница 11: ...6 2 Low Power Alarms 146 16 3 Empty Cartridge Alarm 148 16 4 Cartridge Error Alarm 149 16 5 Cartridge Removal Alarm 150 16 6 Temperature Alarm 151 16 7 Occlusion Alarms 152 16 8 Screen On Quick Bolus...

Страница 12: ...ustomer Technical Support 877 801 6901 12 Section 5 Living With and Caring for Your t slim X2 Pump Chapter 18 Lifestyle Issues and Travel 18 1 Overview 162 Chapter 19 Taking Care of Your t slim X2 Pum...

Страница 13: ...ations 171 20 3 t slim X2 Pump Options and Settings 176 20 4 t slim X2 Pump Performance Characteristics 178 20 5 Electromagnetic Compatibility 180 20 6 Electromagnetic Emissions 181 20 7 Electromagnet...

Страница 14: ...Section 1 Before You Begin...

Страница 15: ...Chapter 1 Introduction...

Страница 16: ...ssful Pumping t connect Getting Started and User Guides are available at www tandemdiabetes com 1 2 About this User Guide This User Guide covers important infor mation on how to operate your t slim X2...

Страница 17: ...wing the Quick Bolus and Feature Lock capabilities of the Tandem pump and determining how they best fit with your care plan These features are detailed in Chapters 10 and 11 of this User Guide Inadver...

Страница 18: ...hysical hardware button on your t slim X2 Pump Hold Keep pressing a button or touching an icon or menu until its function is complete Menu A list of options on your touch screen that allow you to perf...

Страница 19: ...Chapter 2 Important Safety Information...

Страница 20: ...have questions or need further clarification on your pump use ask your healthcare provider or call our around the clock Customer Technical Support at 877 801 6901 DO NOT start to use your t slim X2 P...

Страница 21: ...method of insulin delivery can lead to very high blood glucose or Diabetic Ketoacidosis DKA DO use only FDA cleared insulin infusion sets with a standard Luer lock connection and follow their instruc...

Страница 22: ...ways adjust the insulin units up or down before you decide to deliver your bolus DO NOT allow small children either pump users or non users to ingest small parts such as the rubber USB port cover and...

Страница 23: ...the following procedures X ray Computed Tomography CT scan Magnetic Resonance Imaging MRI Positron Emission Tomography PET scan Other exposure to radiation In addition to the above you must take off...

Страница 24: ...delivery of insulin CHECK your infusion set tubing daily for any leaks air bubbles or kinks Air in the tubing leaks in the tubing or kinked tubing may restrict or stop insu lin delivery and result in...

Страница 25: ...operly by plugging a power source into the USB port and confirming that the display turns on you hear audible beeps feel the pump vibrate and see the green LED light blinking around the edge of the Sc...

Страница 26: ...very and cause injury ALWAYS check with your healthcare provider for specific guidelines if you want or need to disconnect from the pump for any reason Depending on the length of time and reason you a...

Страница 27: ...ator feature allows you to enter multiple carbohydrate values and add them together The Pump s bolus calculator will recommend a bolus based on the entire amount of carbohydrates entered which can hel...

Страница 28: ...om pump failure include the following possible hypoglycemia low blood glucose from over delivery of insulin due to a hardware defect hyperglycemia high blood glucose and ketosis possibly leading to Di...

Страница 29: ...ould also always have an ap propriate emergency kit with you Talk with your healthcare provider regarding what items this kit should include Supplies to carry every day Blood glucose testing supplies...

Страница 30: ...the battery level indicator In addition before using the pump ensure the following Press the Screen On Quick Bolus Button to turn the screen on so that you can see the display When the display screen...

Страница 31: ...Chapter 3 Getting to Know Your t slim X2 Pump...

Страница 32: ...ere the cartridge is normally inserted This cover must be removed and replaced with a cartridge prior to initiating insulin delivery Supply Reordering To order cartridges infusion sets sup plies and a...

Страница 33: ...arbohydrates 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...

Страница 34: ...t Manual for Important Safety Documentation Use By Date See Instructions for Use Do Not Re Use Serial Number of Device Sterile by Radiation Part Number Non Pyrogenic Watertight Equipment protected aga...

Страница 35: ...the status area to the left or right of the time and date on your t slim X2 Pump Home Screen Icon Meaning A Pump reminder alert error or alarm is active Basal insulin is programmed and being delivered...

Страница 36: ...n of Pump Colors Red LED 1 red blink every 30 seconds indicates a malfunction or alarm condition Yellow LED 1 yellow blink every 30 seconds indicates an alert or reminder condition Green LED 1 green b...

Страница 37: ...Customer Technical Support 877 801 6901 37 Before You Begin 1 Chapter 3 Getting to Know Your t slim X2 Pump THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 38: ...el Displays the level of battery power remaining When connected for charging the charging icon lightning bolt will display 4 1 2 3 Unlocks pump screen 5 Insulin On Board IOB Amount and time remaining...

Страница 39: ...nical Support 877 801 6901 39 Before You Begin 1 Chapter 3 Getting to Know Your t slim X2 Pump INSULIN ON BOARD IOB Units 1 1 u 1 09 hrs Time Remaining B 12 31 PM October 16 2016 235 u 100 2 3 1 8 6 7...

Страница 40: ...ry 5 Insulin On Board IOB Amount and time remaining of any active insulin on board 6 Time and Date Display Displays the current time and date 7 Status Displays current Pump settings and insulin delive...

Страница 41: ...ort 877 801 6901 41 Before You Begin 1 Chapter 3 Getting to Know Your t slim X2 Pump INSULIN ON BOARD IOB Units 1 1 u 1 09 hrs Time Remaining B 12 31 PM October 16 2016 235 u 100 OPTIONS BOLUS 10 11 8...

Страница 42: ...g delivered If a Temp Rate is active it is displayed in units hr 3 Last Bolus Displays the amount date and time of last bolus 4 Carbohydrates Indicates whether feature is on or off 5 Up Down Arrow Ind...

Страница 43: ...3 Getting to Know Your t slim X2 Pump BACK Current Status Weekly P Basal Rate 0 2 u hr B Carbohydrates ON Last Bolus 3 u 12 23 10 45 PM BACK Current Status Insulin Duration 5 hours Target BG 120 mg d...

Страница 44: ...iew Calculation Displays how the insulin dose was calculated using the current settings 5 Add BG Enter blood glucose level 6 Next Moves to next step 7 Back Returns to the Home Screen 8 Insulin Enter u...

Страница 45: ...45 Before You Begin 1 Chapter 3 Getting to Know Your t slim X2 Pump units NEXT BACK 0 BG View Calculation Add BG CARBS grams 0 units NEXT BACK 0 BG View Calculation Add BG INSULIN units 0 1 2 4 5 6 3...

Страница 46: ...ivery is stopped RESUME INSULIN will be displayed 3 My Pump Personal Profiles Alert Settings Pump Settings and Pump Info 4 Load Change Cartridge Fill Tubing Fill Cannula and Site Reminder 5 Temp Rate...

Страница 47: ...Customer Technical Support 877 801 6901 47 Before You Begin 1 Chapter 3 Getting to Know Your t slim X2 Pump BACK Options Load My Pump STOP INSULIN Temp Rate BACK Options History 7 6 2 3 1 4 5 8...

Страница 48: ...of settings that defines basal and bolus delivery 2 Alert Settings Customize Pump Reminders and Alerts 3 Pump Settings Customize Quick Bolus Pump Volume Screen Options and Time and Date 4 Pump Info Di...

Страница 49: ...Customer Technical Support 877 801 6901 49 Before You Begin 1 Chapter 3 Getting to Know Your t slim X2 Pump BACK My Pump Pump Settings Alert Settings Personal Profiles Pump Info 1 2 3 4...

Страница 50: ...mber Keypad Screen 1 Value Entered 2 Back Returns to previous screen 3 Keypad Numbers 4 Allows numbers to be added on gram screen If in units this displays as a decimal point 5 Done Completes task and...

Страница 51: ...Customer Technical Support 877 801 6901 51 Before You Begin 1 Chapter 3 Getting to Know Your t slim X2 Pump grams 2 1 3 0 8 7 9 5 4 6 DONE BACK 20 3 4 1 2 5 6 7...

Страница 52: ...Name of Profile 2 Back Returns to previous screen 3 Space Enters a space 4 123 Changes keypad mode from letters ABC to numbers 123 5 Save Saves entered information 6 Letters Tap once for first letter...

Страница 53: ...Customer Technical Support 877 801 6901 53 Before You Begin 1 Chapter 3 Getting to Know Your t slim X2 Pump name def abc ghi space vwx stu yz mno jkl pqr SAVE BACK Weekday 123 1 3 6 2 4 7 5...

Страница 54: ...Section 2 Key Pump Features...

Страница 55: ...Chapter 4 Getting Started...

Страница 56: ...p using a USB port on a Personal Computer PC Ensure that the PC complies with the IEC 60950 1 or equivalent safety standard 1 Plug the included USB cable into your computer 2 Plug the other end of the...

Страница 57: ...wing The screen illuminates An audible alert The LED edge around the Screen On Quick Bolus Button blinks green A vibrating alert A charge symbol lightning bolt on the battery level indicator appears P...

Страница 58: ...slim X2 Pump tap the Tandem Logo to return to the Home Screen or tap BACK to return to the previous screen 4 3 Turning on the t slim X2 Pump Screen 1 To turn on your t slim X2 Pump screen press the Sc...

Страница 59: ...setting may affect safe insulin delivery 1 From the Home Screen tap OPTIONS 2 Tap My Pump 3 Tap Pump Settings 4 Tap Time and Date 5 Tap Edit Time 6 Tap Time 7 Using the onscreen keypad enter the hour...

Страница 60: ...Customer Technical Support 877 801 6901 60 Chapter 4 Getting Started THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 61: ...Chapter 5 Infusion Site Care and Loading Cartridge...

Страница 62: ...ended by your healthcare provider Wash your hands with anti bacterial soap before handling the infusion set and thoroughly clean the insertion site on your body to avoid infection Contact your healthc...

Страница 63: ...Areas of Body for Infusion Set Insertion Keep it clean When changing your infusion set use clean techniques to avoid an infection Wash your hands use antiseptic wipes or infusion site preparation prod...

Страница 64: ...lt in under delivery or over delivery of insulin This can cause very high or a very low blood glucose WARNING DO NOT reuse cartridges or use cartridges other than those manufactured by Tandem Diabetes...

Страница 65: ...sulin that is not available for delivery When filling the syringe add ap proximately 45 units to the amount of insulin you want available for delivery For example the pump requires a minimum of 50 uni...

Страница 66: ...ull back the plunger to the desired amount of insulin see image C 9 While the filling needle is still in the vial and upside down tap the syringe so that any air bubbles rise to the top see image D Th...

Страница 67: ...ulin fill port on the cartridge see image E The needle is not intended to go all the way in so do not force it 4 Keeping the syringe vertically aligned with the cartridge and the needle inside the fil...

Страница 68: ...e a drop of insulin at the tip of the needle see image I 9 Re insert the needle in the fill port and slowly fill the cartridge with insulin see image J It is normal to feel some back pressure as you s...

Страница 69: ...e Z Z Preparing for Cartridge screen is displayed 6 Remove the used cartridge If needed place the cartridge removal tool or the edge of a coin in the slot at the bottom of the cartridge and twist to a...

Страница 70: ...filling the tubing and ensure that there are no air bubbles in the tubing when filling Air in the system takes space where insulin should be and can affect insulin delivery PRECAUTION CHECK your infu...

Страница 71: ...o one of the following a If you are finished filling the tub ing 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 comple...

Страница 72: ...The cannula fill amount displayed is based on your last cannula fill amount Filling stops at this amount 4 Select amount needed for cannula fill Refer to your infusion set instruc tions for use for p...

Страница 73: ...nt to respond quickly to any problems with the insertion to ensure continued insulin delivery 1 Tap SAVE if correct Tap Edit Reminder if settings need to be changed 2 Tap Remind Me In and select the n...

Страница 74: ...Customer Technical Support 877 801 6901 74 Chapter 5 Infusion Site Care and Loading Cartridge THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 75: ...Chapter 6 Personal Profiles...

Страница 76: ...tive profile is positioned at the top of the list and is marked as ON When you create a Personal Profile you can set any or all of the following Timed Settings Basal Rate your basal rate in units hr C...

Страница 77: ...ulin Duration default 5 hrs range 2 to 8 hrs Max Bolus default 10 units range 1 to 25 units Insulin Duration and Insulin on Board IOB Your t slim X2 Pump remembers how much insulin you have taken from...

Страница 78: ...onal Profile that you can activate Be sure to tap SAVE after entering or changing a value PRECAUTION ALWAYS confirm that the decimal point placement is correct when entering your Personal Profile info...

Страница 79: ...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 enter them all over again 1 On the Add S...

Страница 80: ...5 units is calculated using your Carb Ratio or Correction Factor after the bolus is delivered a reminder screen will appear The option of delivering the remaining amount of the bolus up to an addition...

Страница 81: ...d tap SAVE 10 Confirm Settings Tap YES if entered data is correct Tap NO to make changes 11 Edit other time segments within the Timed Settings by tapping on them and using the same steps described abo...

Страница 82: ...be cre ated with the same settings as the profile copied 8 Tap the Timed Settings or Bolus Settings Panel to make changes to the new profile 6 6 Activating an Existing Profile 1 From the Home Screen...

Страница 83: ...be renamed 5 Tap Down Arrow and then Rename 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 6 8 Deleting an Existing...

Страница 84: ...Customer Technical Support 877 801 6901 84 Chapter 6 Personal Profiles THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 85: ...Chapter 7 Bolus...

Страница 86: ...the next chapter Food Bolus Using Grams 1 From the Home Screen tap BOLUS 2 Tap 0 units 3 Using the onscreen keypad enter units of insulin to be delivered then tap DONE PRECAUTION ALWAYS confirm that t...

Страница 87: ...rst value then tap enter second value tap Continue until done To clear the value entered and start over tap the back arrow 4 Check that the grams of carb are entered in the correct location on the scr...

Страница 88: ...rent IOB 0 u Current BG 85 mg dL 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...

Страница 89: ...well as for recommendations on the split between now and later and the duration for the later portion Only 1 extended bolus can be active at any given time However if the DELIVER LATER portion of an e...

Страница 90: ...eypad to adjust the length of time the bolus is to be delivered then tap DONE 12 Tap NEXT You can always tap View Units to display the breakdown of units to be delivered NOW versus LATER 13 Confirm Re...

Страница 91: ...olus Stopping a Bolus if delivery of the bolus Has Started 1 Tap 1 2 3 to access the Home Screen 2 Tap X stop icon to stop delivery 3 Tap YES Z Z The BOLUS STOPPED screen is displayed and the units de...

Страница 92: ...Customer Technical Support 877 801 6901 92 Chapter 7 Bolus THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 93: ...Chapter 8 Stop Resume Insulin...

Страница 94: ...STOP Z Z The All Deliveries Stopped screen appears before returning to the Home Screen showing the status ALL DELIVERIES STOPPED A red exclamation mark icon also appears to the right of the time and...

Страница 95: ...Customer Technical Support 877 801 6901 95 Key Pump Features 2 Chapter 8 Stop Resume Insulin THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 96: ...Section 3 Additional Pump Operations...

Страница 97: ...Chapter 9 Temporary Basal Rate...

Страница 98: ...he selected rate is too low and that it will be set to the minimum 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...

Страница 99: ...ary Basal Rate 9 2 Stopping a Temp Rate To stop an active temp rate 1 From the Home Screen tap OPTIONS 2 On the Options screen tap X stop icon on the right side of Temp Rate 3 On the confirmation scre...

Страница 100: ...Customer Technical Support 877 801 6901 100 Chapter 9 Temporary Basal Rate THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 101: ...Chapter 10 Quick Bolus...

Страница 102: ...n Simply use the Quick Bolus Button to deliver your bolus Quick boluses are delivered as standard boluses there is no BG entry or extended bolus PRECAUTION ALWAYS look at the screen to confirm correct...

Страница 103: ...nt tone will sound to notify you if Quick Bolus is set to vibrate the pump will stop vibrating in response to additional button presses to notify you Look at the screen to confirm the bolus amount You...

Страница 104: ...Customer Technical Support 877 801 6901 104 Chapter 10 Quick Bolus THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 105: ...Chapter 11 t slim X2 Pump Settings...

Страница 106: ...se Up Down Arrow to view additional options 11 2 Screen Options The Screen Options for your t slim X2 Pump include Screen Timeout and Feature Lock You can set the Screen Timeout to the length of time...

Страница 107: ...ture Lock to turn On or Off and tap SAVE Z Z A screen to verify that you want to activate the Feature Lock will be displayed 2 Tap YES to confirm 3 Tap SAVE 4 Tap Tandem Logo to return to the Home Scr...

Страница 108: ...Customer Technical Support 877 801 6901 108 Chapter 11 t slim X2 Pump Settings THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 109: ...Chapter 12 t slim X2 Pump Info and History...

Страница 110: ...olus completion time 1 From the Home Screen tap OPTIONS 2 Tap the Down Arrow 3 Tap History 4 Tap desired option 5 Tap Tandem Logo to return to the Home Screen 12 2 t slim X2 Pump History Pump History...

Страница 111: ...Chapter 13 t slim X2 Pump Reminders...

Страница 112: ...s will be dis played third Each must be confirmed separately until all have been confirmed Information in this section will help you learn how to respond to Reminders Reminders notify you with a singl...

Страница 113: ...a high BG value that triggers the reminder as well as how much time should pass before the reminder occurs The default for this reminder is pre set to off If on Remind Me Above 200 mg dL and Remind Me...

Страница 114: ...BG a Tap Remind Me After and using the onscreen keypad enter the time from 1 to 3 hours that you want to trigger the reminder then tap DONE 7 Tap SAVE when all changes are complete 8 Tap Tandem Logo t...

Страница 115: ...ONE f Tap End Time tap Time and using the onscreen keypad enter the end time then tap DONE g Tap Time of Day to select AM or PM then tap DONE h Tap SAVE when all changes are complete 7 Tap Tandem Logo...

Страница 116: ...Customer Technical Support 877 801 6901 116 Chapter 13 t slim X2 Pump Reminders THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 117: ...Chapter 14 User Settable Alerts and Alarms...

Страница 118: ...here has been no interac tion with the pump within a specified period of time The default for this alarm is pre set to 12 hours You can set it anywhere between 5 and 24 hours or off This alarm notifie...

Страница 119: ...o Auto Off Warning 1 Tap DO NOT SHUT DOWN The warning clears and the pump returns to normal operation If you do not clear the warning within the 30 second countdown period the AUTO OFF ALARM occurs ac...

Страница 120: ...Section 4 t slim X2 Pump Safety Alerts and Alarms...

Страница 121: ...Chapter 15 t slim X2 Pump Alerts...

Страница 122: ...omatically to let you know of an actual or potential stopping of insulin delivery for example an alarm that the insulin cartridge is empty Pay special attention to Alarms If multiple Reminders Alerts...

Страница 123: ...in the cartridge How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes every 5 minutes unti...

Страница 124: ...on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes every 5 minutes until acknowledged How should I respond Tap CLOSE Charge your pump as soon as possible to avoid th...

Страница 125: ...stop How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes every 5 minutes until acknowledg...

Страница 126: ...seconds How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes every 5 minutes until acknowl...

Страница 127: ...e request within 90 seconds How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes every 5 mi...

Страница 128: ...omplete the process within 3 minutes How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes e...

Страница 129: ...ll Tubing from the Load menu but did not complete the process within 3 minutes How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pu...

Страница 130: ...ad menu but did not complete the process within 3 minutes How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pu...

Страница 131: ...Personal Profile but did not save or complete the programming within 5 minutes How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pu...

Страница 132: ...segment in Personal Profiles A basal rate must be entered in each time segment rate can be 0 u hr How will the pump notify me Prompt screen only Will the pump re notify me No A basal rate must be ent...

Страница 133: ...delivery that is more than 1 5 times your Max Bolus setting How will the pump notify me Prompt screen only Will the pump re notify me No You must tap BACK or CONTINUE to deliver the bolus How should...

Страница 134: ...How will the pump notify me Prompt screen only Will the pump re notify me No You must tap BACK or CONTINUE to deliver the bolus How should I respond Tap BACK to return to the Bolus screen and adjust...

Страница 135: ...lus request How should I respond Before responding to this Alert always consider if your bolus insulin needs have changed since you requested the original bolus Tap YES to deliver the remaining amount...

Страница 136: ...rate defined in your Personal Profile How will the pump notify me Prompt screen only Will the pump re notify me No You must tap BACK or CONTINUE to move forward How should I respond Tap BACK to retur...

Страница 137: ...ing defined in your Personal Profile How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes e...

Страница 138: ...l rate defined in your Personal Profile How will the pump notify me Prompt screen only Will the pump re notify me No You must tap BACK or CONTINUE to move forward How should I respond Tap BACK to retu...

Страница 139: ...g defined in your Personal Profile How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Settings Will the pump re notify me Yes e...

Страница 140: ...to t connect and a connection could not be made How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Settings Will the pump re no...

Страница 141: ...t does not have enough power to charge the pump How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Settings Will the pump re no...

Страница 142: ...of data How will the pump notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Settings Will the pump re notify me Yes every 5 minutes until acknow...

Страница 143: ...Chapter 16 t slim X2 Pump Alarms...

Страница 144: ...now for example an alert that your insulin level is low Alarms display automatically to let you know of an actual or potential stopping of insulin delivery for example an alarm that the insulin cartri...

Страница 145: ...or 3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes if not acknowledged by tapping CLOSE the pump will re notify you every 3 min utes at hig...

Страница 146: ...notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes the pump will re notify you every 3 minutes until no po...

Страница 147: ...stopped How will the pump notify me A series of rapid beeps at maximum volume for at least 20 seconds before the pump shuts down Will the pump re notify me The pump will power back on once it has been...

Страница 148: ...equences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes The Pump will re notify you every 3 minutes until you change the cart...

Страница 149: ...tridge or over filling the cartridge with more than 300 units of insulin How will the pump notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Vol...

Страница 150: ...3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes The Pump will re notify you every 3 minutes until you reconnect the current car tridge or c...

Страница 151: ...5 F 52 C and all deliver ies have stopped How will the pump notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me...

Страница 152: ...ean Your t slim X2 Pump detected that insulin delivery is blocked and all deliveries have stopped How will the pump notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate set...

Страница 153: ...a second occlusion alarm shortly after the first occlu sion alarm and all deliveries have stopped How will the pump notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate se...

Страница 154: ...have stopped How will the pump notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes The Pump will re notify...

Страница 155: ...o 10 000 feet and all deliveries have stopped How will the pump notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify...

Страница 156: ...p notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the pump re notify me Yes The Pump will re notify you every 3 minutes until you...

Страница 157: ...Chapter 17 t slim X2 Pump Malfunction...

Страница 158: ...from the pump and again when you reconnect and treat high blood glucose BG levels as recommended by your healthcare provider What will I see on the Screen What does it mean Your t slim X2 Pump detecte...

Страница 159: ...Customer Technical Support 877 801 6901 159 t slim X2 Pump Safety Alerts and Alarms 4 Chapter 17 t slim X2 Pump Malfunction THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 160: ...Section 5 Living With and Caring for Your t slim X2 Pump...

Страница 161: ...Chapter 18 Lifestyle Issues and Travel...

Страница 162: ...atures You should avoid activities which could expose your pump to temperatures be low 40 F 5 C or above 99 F 37 C as insulin can freeze at low temperatures or degrade at high temperatures Other Activ...

Страница 163: ...m your HCP explaining the medical need for your insulin pump and other supplies Traveling by Air PRECAUTION DO NOT expose your pump to X ray screening used for carry on and checked luggage Newer full...

Страница 164: ...Customer Technical Support 877 801 6901 164 Chapter 18 Lifestyle Issues and Travel THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 165: ...Chapter 19 Taking Care of Your t slim X2 Pump...

Страница 166: ...nect the pump from the power source Keep the pump protected when not in use Store at temperatures between 4 F and 140 F and at relative humidity levels between 20 and 90 To bring the pump out of stora...

Страница 167: ...Care of Your t slim X2 Pump Disposing of Pump Components Consult your healthcare provider for instructions for disposal of devices con taining electronic waste such as your pump and for instructions...

Страница 168: ...Section 6 Technical Specifications and Warranty...

Страница 169: ...Chapter 20 Technical Specifications...

Страница 170: ...erview This section provides tables of technical specifications performance characteristics options settings and electromagnetic compli ance information for the t slim X2 Pump The specifications in th...

Страница 171: ...flammable anesthetics or explosive gases Size 3 13 x 2 0 x 0 6 L x W x H 7 95 cm x 5 08 cm x 1 52 cm Weight with full disposable 3 95 ounces 112 grams Operating Conditions Temperature 41 F 5 C to 98...

Страница 172: ...15 until 3 units have been delivered or elevation changes by more than 1 000 feet Bolus Delivery Accuracy at all Volumes tested per IEC 60601 2 24 5 Patient Protection from Air Infusion The pump prov...

Страница 173: ...nfusion 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 deliverie...

Страница 174: ...oltage 5 Volts DC Max Output Power 5 Watts minimum Output Connector USB type A Power Supply Charger AC Wall Mount USB Specifications Tandem P N 03933 Input 100 to 240 Volts AC 50 60 Hz Output Voltage...

Страница 175: ...connect Uploader Software available for download at www tandemdiabetes com PC compliant with 60950 1 or equivalent safety standard Connecting the t slim X2 Pump to a host PC that is attached to other...

Страница 176: ...deliver based on carb input grams or insulin input units Default is units The range for carbs is 1 to 999 grams the range for insulin is 0 05 to 25 units Insulin to Carb IC Ratio 16 time segments per...

Страница 177: ...torage At least 90 days of data Language English Feature Lock Blocks access to insulin delivery screens and pump setting screens default is Off Screen Lock Protects from unintentional taps Site Remind...

Страница 178: ...ion alarm is based on insulin volume not delivered During an occlusion event boluses of less than 3 units may not trigger an occlusion alarm if no basal insulin is being delivered The bolus amount wil...

Страница 179: ...Customer Technical Support 877 801 6901 179 Technical Specifications and Warranty 6 Chapter 20 Technical Specifications THIS PAGE IS INTENTIONALLY LEFT BLANK...

Страница 180: ...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 compa...

Страница 181: ...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 are not likely to cause...

Страница 182: ...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...

Страница 183: ...d be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 30 V...

Страница 184: ...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...

Страница 185: ...to Frequency of Transmitter inches or feet m 150 kHz to 80 MHz d in meters 0 35 P 80 MHz to 800 MHz d in meters 0 12 P 800 MHz to 2 5 GHz d in meters 0 23 P 0 01 1 6 in 0 04 0 12 in 0 012 0 9 in 0 02...

Страница 186: ...ce Inch Meters 0 001W Bluetooth Class 3 standard 1 meter range Commonly used as bluetooth headset 0 3 in 0 007 m 0 01W Internet to music adaptor Commonly used for FM wireless music streaming 0 5 in 0...

Страница 187: ...ference received including interference that my cause undesired operation Compliance with these guidelines provides reasonable protection against harmful interference in a normal residential environme...

Страница 188: ...y part of the t slim X2 Pump by any person or entity other than Tandem the t slim X2 Pump seal is broken a non Tandem cartridge is used with the t slim X2 Pump damage consists of scratches and wear to...

Страница 189: ...e subject to the conditions and exclusions stated herein The warranty is valid only if the cartridges are used in accordance with the accompanying instructions for use and user guide and will not appl...

Страница 190: ...ed materials authorization number must be clearly written on the outer box If Tandem or the authorized distributor provides a label the label must be attached or taped to the outer box If no label is...

Страница 191: ...Customer Technical Support 877 801 6901 191 Technical Specifications and Warranty 6 Chapter 20 Technical Specifications lect This policy is subject to applicable law...

Страница 192: ...78 Basal Delivery Accuracy 172 Basal Rate 76 Basal Rate Required Alert 132 Current Basal Rate 42 Frequency of Basal Delivery 172 Setting Basal Rate 78 Temp Basal Rate 33 Temp Basal Rate Setting Up 98...

Страница 193: ...lus 90 C Canceling a Bolus 90 Cannula 33 Fill Cannula 46 Filling Cannula 72 Car 56 Charging In 56 USB Car Adapter Specifcations 174 Carbohydrates 33 42 Carbohydrates Setting 77 Carbohydrates Setting U...

Страница 194: ...it Date 59 Editing an Existing Profile 81 Edit Site Reminder 73 Edit Time 59 Electromagnetic Electromagnetic Compatibility 180 Electromagnetic Emissions 181 Electromagnetic Immunity 182 Emergency Kit...

Страница 195: ...me Insulin Delivery 46 94 Stop Insulin Delivery 94 U 100 Insulin 16 20 21 K Keypad 50 Letter Keypad 52 Number Keypad 50 L LED 36 40 Lifestyle Issues 161 Load Cartridge 64 69 Low BG Reminder 112 Low In...

Страница 196: ...11 After Bolus BG Reminder 114 High BG Reminder 113 Low BG Reminder 112 Missed Meal Bolus Reminder 114 Site Reminder 46 73 115 Reset Alarm 156 Resume Insulin 46 Resume Pump Alarm 145 Resuming Insulin...

Страница 197: ...tting Up 79 Temperature Alarm 151 Temp Rate 33 46 Incomplete Temp Rate Alert 127 Setting a Temp Rate 98 Stopping a Temp Rate 99 Time Edit Time 59 Time and Date Display 38 Time Segment 76 78 79 Timed S...

Страница 198: ...abetes com 2016 Tandem Diabetes Care Inc All rights reserved Tandem Diabetes Care t slim touch simplicity t connect are registered trademarks and t slim X2 is a trademark of Tandem Diabetes Care Inc F...

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