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174

Chapter 19 – Technical Specifications

19.4 Electromagnetic Compatibility

The information contained in this section is specific to the t:slim System. This information provides reasonable assurance of normal

operation, but does not guarantee such under all conditions. If the t:slim System must be used in close proximity with other electri-

cal equipment, the System should be observed in this environment to verify normal operation. Special precautions for electromag-

netic compatibility must be taken when using medical electrical equipment. The System shall be placed into service with adher-

ence 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:

•

Electromagnetic Emissions

•

Electromagnetic Immunity

•

Distances Between the t:slim System and RF Equipment

Summary of Contents for T:Slim

Page 1: ...INSULIN ON BOARD IOB Units 1 1 u 1 09 hrs Time Remaining B 10 20 AM March 15 2015 235 u OPTIONS BOLUS 100...

Page 2: ......

Page 3: ...procedures 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 1 877 801...

Page 4: ...in a 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 8 A...

Page 5: ...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 thei...

Page 6: ...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 5 Patients and their families are responsibl...

Page 7: ...lthcare Provider 19 1 4 Emergency Kit 19 1 5 Verification of Proper Functionality 20 1 6 Indications for Use and Contraindications 21 1 7 Warnings and Precautions 21 1 8 Conventions of this Guide 26 C...

Page 8: ...3 3 Screen Lock 38 3 4 Home Screen 40 3 5 Status Screen 42 3 6 Bolus Screen 44 3 7 Options Screen 46 3 8 My Pump Screen 48 3 9 Number Keypad Screen 50 3 10 Letter Keypad Screen 52 Section 2 Key Pump F...

Page 9: ...and Loading a t slim Cartridge 64 5 4 Filling Tubing 70 5 5 Filling Cannula 72 5 6 Setting Site Reminder 73 Chapter 6 Personal Profile 6 1 Personal Profile Overview 76 6 2 Creating a New Profile 76 6...

Page 10: ...7 3 Food Bolus Using Grams 87 7 4 Correction Bolus 88 7 5 Extended Bolus 89 7 6 Canceling or Stopping a Bolus 91 Chapter 8 Stop Resume Insulin 8 1 Stopping Insulin Delivery 94 8 2 Resuming Insulin Del...

Page 11: ...apter 11 t slim Pump Settings 11 1 t slim Pump Volume 106 11 2 Screen Options 106 Chapter 12 t slim Pump Info and History 12 1 t slim Pump Info 110 12 2 t slim Pump History 110 Chapter 13 t slim Pump...

Page 12: ...erts and Alarms Chapter 15 t slim Pump Alerts 15 1 Low Insulin Alert 123 15 2 Low Power Alerts 124 15 3 Incomplete Bolus Alert 126 15 4 Incomplete Temp Rate Alert 127 15 5 Incomplete Load Sequence Ale...

Page 13: ...slim Pump Alarms 16 1 Resume Pump Alarm 145 16 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 Oc...

Page 14: ...ystem Technical Specifications Chapter 19 Technical Specifications 19 1 Overview 166 19 2 t slim Pump Specifications 166 19 3 t slim Pump Options and Settings 172 19 4 Electromagnetic Compatibility 17...

Page 15: ...Table of Contents Customer Technical Support 1 877 801 6901 15 THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 16: ...Section 1 Welcome...

Page 17: ...Chapter 1 About this User Guide...

Page 18: ...you properly program manage and care for the System It also provides important warnings and cautions on proper operation and tech nical information to ensure your safety Review all instructions in th...

Page 19: ...ood glucose early Undetected hy perglycemia or hypoglycemia can result without proper monitoring Consult your healthcare provider before using the System to determine which features are most appropria...

Page 20: ...the Screen On Quick Bolus Button You feel a vibratory alert You see a charge symbol lightning bolt on the battery level indicator In addition before using the System ensure the following Press the Sc...

Page 21: ...m alerts 1 7 Warnings and Precautions Warnings Before using your System consult with your healthcare provider for your individ ual training needs and ensure that you have been appropriately trained on...

Page 22: ...ous injury or death Change your infusion set every 48 72 hours Consult your healthcare provid er for more information Use only single use disposable car tridges from Tandem Diabetes Care The efficacy...

Page 23: ...werful electromagnets are sometimes used on free fall or thrill rides Remove your t slim System and do not take it on these types of rides Also you should disconnect the infusion set from your body wh...

Page 24: ...facturer If your t slim System seal is broken the warranty is voided and the System is no longer watertight Replace the cartridge every 48 hours if using Humalog every 72 hours if using NovoLog Always...

Page 25: ...able Failure to do so may re sult in the cannula becoming dislodged at the infusion site For this reason it is recommended not to charge the pump while sleeping Your insulin needs may change in respon...

Page 26: ...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 p...

Page 27: ...Chapter 2 Introduction...

Page 28: ...re 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...

Page 29: ...mportant Safety Documentation Use By Date See Instructions for Use Do Not Re Use Serial Number of Device Method of Sterilization Gamma Part Number Non Pyrogenic Watertight Equipment protected against...

Page 30: ...date on your t slim Pump Home Screen Tap the icon to access the status screen for more information Icon Meaning A system reminder alert error or alarm is active Basal insulin is programed and being d...

Page 31: ...ry 30 seconds indicates an alert or reminder condition Green LED 1 green blink every 30 seconds indicates the pump is functioning normally 3 green blinks every 30 seconds indicate the pump is charging...

Page 32: ...entity other than Tandem If the t slim Pump seal is broken If a non Tandem cartridge is used with the t slim Pump If damage results from a force majeure or other event beyond the control of Tandem or...

Page 33: ...ge results from changes or modifications made to the infusion set or cartridge by the user or third persons after the date of manufacture If damage results from service or repairs performed to any par...

Page 34: ...Customer Technical Support 1 877 801 6901 34 Chapter 2 Introduction THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 35: ...Chapter 3 t slim Pump Overview...

Page 36: ...very 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 glu cose which is the level of glucose in the...

Page 37: ...a new cartridge and infusion set mg dL Milligrams per deciliter The standard unit of measure for blood glucose readings in the United States Personal Profile A personal profile is a personalized group...

Page 38: ...ays 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 of any a...

Page 39: ...ustomer Technical Support 1 877 801 6901 39 Welcome 1 Chapter 3 t slim Pump Overview INSULIN ON BOARD IOB Units 1 1 u 1 09 hrs Time Remaining B 10 20 AM March 15 2015 235 u 100 2 3 1 8 6 7 9 5 3 4 1 2...

Page 40: ...sulin 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 system settings and insulin delivery st...

Page 41: ...chnical Support 1 877 801 6901 41 Welcome 1 Chapter 3 t slim Pump Overview INSULIN ON BOARD IOB Units 1 1 u 1 09 hrs Time Remaining B 10 20 AM March 15 2015 235 u 100 OPTIONS BOLUS 10 11 8 7 9 6 2 1 3...

Page 42: ...ff 5 Up Down Arrow Indicates there is more information 6 Correction Factor Displays current correction factor used to calculate a bolus 7 Carb Ratio Displays current carb ratio used to calculate a bol...

Page 43: ...apter 3 t slim Pump Overview 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 dL Carb Rat...

Page 44: ...lculation 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 units o...

Page 45: ...877 801 6901 45 Welcome 1 Chapter 3 t slim Pump Overview Using Grams Using Units units NEXT BACK 0 BG View Calculation Add BG CARBS grams 0 units NEXT BACK 0 BG View Calculation Add BG INSULIN units...

Page 46: ...s 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 Program...

Page 47: ...Customer Technical Support 1 877 801 6901 47 Welcome 1 Chapter 3 t slim Pump Overview BACK Options Load My Pump STOP INSULIN Temp Rate BACK Options History 2 1 3 4 5 7 6 8...

Page 48: ...ttings 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 Display...

Page 49: ...Customer Technical Support 1 877 801 6901 49 Welcome 1 Chapter 3 t slim Pump Overview BACK My Pump Pump Settings Alert Settings Personal Profiles Pump Info 1 2 3 4...

Page 50: ...ypad 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 saves...

Page 51: ...Customer Technical Support 1 877 801 6901 51 Welcome 1 Chapter 3 t slim Pump Overview grams 2 1 3 0 8 7 9 5 4 6 DONE BACK 20 3 4 1 2 5 6 7...

Page 52: ...4 123 Changes keypad mode from letters ABC to numbers 123 5 Save Saves entered information 6 Letters Tap once for first letter displayed 2 quick taps for middle letter and 3 quick taps for third lett...

Page 53: ...Customer Technical Support 1 877 801 6901 53 Welcome 1 Chapter 3 t slim Pump Overview name def abc ghi space vwx stu yz mno jkl pqr SAVE BACK Weekday 123 1 3 6 2 4 7 5...

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

Page 55: ...Chapter 4 Getting Started...

Page 56: ...er adapter 2 Plug the AC power adapter into a grounded AC power outlet 3 Plug the other end of the cable into the micro USB port on the pump To charge the pump using the includ ed Car Power USB Adapte...

Page 57: ...e will vary The pump will display a CONNECTION ERROR ALERT message if it is not charging properly When you charge the t slim Pump you will notice the following The screen illuminates An audible alert...

Page 58: ...1 Press Screen On Quick Bolus Button 2 Tap 1 3 Tap 2 4 Tap 3 Z Z 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 unloc...

Page 59: ...til 11 59 PM 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 and minutes Verify and tap D...

Page 60: ...Customer Technical Support 1 877 801 6901 60 Chapter 4 Getting Started THIS PAGE IS INTENTIONALLY LEFT BLANK...

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

Page 62: ...tion The infusion set must be replaced and rotated every 48 72 hours or more often if needed With experience you will find areas that not only provide better absorption but are more comfortable Keep i...

Page 63: ...Customer Technical Support 1 877 801 6901 63 Key Pump Features 2 Chapter 5 Infusion Site Care and Loading Cartridge Areas of Body for Infusion Set Insertion...

Page 64: ...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...

Page 65: ...r delivery When filling the syringe add approximately 45 units to the amount of insulin you want available for delivery For example the pump requires a minimum of 50 units available for delivery after...

Page 66: ...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 Then slowly push the plunger upwards forcing...

Page 67: ...sulin 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 fi...

Page 68: ...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 slowly press on the plunger 10 Maintain...

Page 69: ...connect the infusion set from your body and tap NEXT to continue Z Z Preparing for Cartridge screen is displayed 6 Remove the used cartridge and install a filled cartridge Tap UNLOCK icon when complet...

Page 70: ...nfusion set is disconnected from your body 2 Connect the infusion set tubing to the luer lock on the cartridge a Ensure that the new infusion set package is not damaged and remove the sterile tubing f...

Page 71: ...t to fill the tubing with more than 30 units tap FILL to go back to the Fill Tubing screen 6 Fill Tubing is complete NOTE After tubing fill is complete when the pump returns to the Home Screen an esti...

Page 72: ...then tap NEXT 3 Tap Edit Fill Amount NOTE The cannula fill amount displayed is based on your last cannula fill amount Filling stops at this amount unless you tap STOP before this amount is reached 4...

Page 73: ...eed to be changed 2 Tap Remind Me In and select the number of days 1 3 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 t...

Page 74: ...Customer Technical Support 1 877 801 6901 74 Chapter 5 Infusion Site Care and Loading Cartridge THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 75: ...Chapter 6 Personal Profile...

Page 76: ...ends based on schedule food intake activity and exercise etc 6 2 Creating a New Profile Creating Personal Profiles You can create up to 6 Personal Pro files however only 1 can be active at a time In t...

Page 77: ...n the Insulin Duration The Insulin Du ration 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 ch...

Page 78: ...Profile that you can activate Be sure to tap SAVE after entering or changing a value PRECAUTION If you only define a basal rate in Timed Settings your pump will only be able to deliver basal insulin a...

Page 79: ...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 Segme...

Page 80: ...urn on and use the carb ratio when calculating boluses NOTE If not using a carb ratio do not turn the Carbohydrates setting to ON 7 Review entered values and tap SAVE 8 Confirm Settings Tap YES if ent...

Page 81: ...ecent changes and tap SAVE 10 Confirm Settings Tap YES if entered data is correct Tap NO to make changes 11 Tap BACK after editing all of the time segments NOTE Edit other time segments within the Tim...

Page 82: ...e 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 ta...

Page 83: ...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 P...

Page 84: ...Customer Technical Support 1 877 801 6901 84 Chapter 6 Personal Profile THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 85: ...Chapter 7 Bolus...

Page 86: ...ceeds 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 a new amount WARNING Do...

Page 87: ...is correct Tap NO to go back to make changes or view calculations 6 Tap DELIVER 7 The bolus splash screen is displayed 7 3 Food Bolus Using Grams 1 From the Home Screen tap BOLUS 2 Tap 0 grams 3 Usin...

Page 88: ...n pump History whether or not a bolus is delivered NOTE Tap the view calculation screen to display the Delivery Calculation Screen Tap the displayed units calculated to override the amount If BG is ab...

Page 89: ...test your blood glucose to ensure that the treatment was successful 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 t...

Page 90: ...e given in the DELIVER NOW portion 9 Use the onscreen keypad to enter the percentage of the bolus to DELIVER NOW and tap DONE NOTE For the DELIVER NOW portion the minimum amount is 05 units If the DEL...

Page 91: ...is being canceled Z Z Once canceled the bolus button will become active again on the Home Screen INSULIN ON BOARD IOB Units 1 1 u 1 09 hrs Time Remaining B 10 20 AM March 15 2015 235 u OPTIONS 100 Req...

Page 92: ...Customer Technical Support 1 877 801 6901 92 Chapter 7 Bolus THIS PAGE IS INTENTIONALLY LEFT BLANK...

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

Page 94: ...o the right of the time and date NOTE When you tap STOP on the confirmation screen any active bolus and any active temp rate are immediately stopped If you tap BACK on the confirmation screen bolus de...

Page 95: ...Customer Technical Support 1 877 801 6901 95 Key Pump Features 2 Chapter 8 Stop Resume Insulin THIS PAGE IS INTENTIONALLY LEFT BLANK...

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

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

Page 98: ...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 that the selected rate is too...

Page 99: ...rary 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 scr...

Page 100: ...Customer Technical Support 1 877 801 6901 100 Chapter 9 Temporary Basal Rate THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 101: ...Chapter 10 Quick Bolus...

Page 102: ...se the Quick Bolus Button to deliver your bolus Quick boluses are delivered as standard boluses there is no BG entry or extended bolus PRECAUTION When you first use the Quick Bolus feature you should...

Page 103: ...d with no input the bolus is canceled and never delivered If you want to cancel the bolus and return to the Home Screen tap CANCEL on the QUICK BOLUS screen If the amount you indicated by your button...

Page 104: ...Customer Technical Support 1 877 801 6901 104 Chapter 10 Quick Bolus THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 105: ...Chapter 11 t slim Pump Settings...

Page 106: ...Screen Timeout and Feature Lock You can set the Screen Timeout to the length of time you want the screen to stay on The default for the Screen Timeout is 30 seconds The options are 15 30 60 and 120 se...

Page 107: ...eturn to the Home Screen For Feature Lock 1 Tap Feature 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 T...

Page 108: ...Customer Technical Support 1 877 801 6901 108 Chapter 11 t slim Pump Settings THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 109: ...Chapter 12 t slim Pump Info and History...

Page 110: ...mpletion 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 Pump History Pump History displays a...

Page 111: ...Chapter 13 t slim Pump Reminders...

Page 112: ...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 single...

Page 113: ...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...

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

Page 115: ...NE 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...

Page 116: ...Customer Technical Support 1 877 801 6901 116 Chapter 13 t slim Pump Reminders THIS PAGE IS INTENTIONALLY LEFT BLANK...

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

Page 118: ...de livery and alert you or whoever is with you if there has been no interaction with the pump within a specified period of time The default for this alarm is pre set to 12 hours You can set it any whe...

Page 119: ...o 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 accom p...

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

Page 121: ...Chapter 15 t slim Pump Alerts...

Page 122: ...matically 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 a...

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

Page 124: ...in Pump Volume Will the system re notify me Yes every 5 minutes until acknowledged How should I respond Tap CLOSE Charge your pump as soon as possible to avoid the second LOW POWER ALERT LOW POWER ALE...

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

Page 126: ...conds How will the system notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Volume Will the system re notify me Yes every 5 minutes until acknow...

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

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

Page 129: ...ubing from the Load menu but did not complete the process within 3 minutes How will the system notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump...

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

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

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

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

Page 134: ...ow will the system notify me Prompt screen only Will the system 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 adjus...

Page 135: ...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 of...

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

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

Page 138: ...ate defined in your Personal Profile How will the system notify me Prompt screen only Will the system re notify me No You must tap BACK or CONTINUE to move forward How should I respond Tap BACK to ret...

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

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

Page 141: ...not have enough power to charge the pump How will the system notify me 2 sequences of 3 notes or 2 vibrations depending on the volume vibrate setting selected in Pump Settings Will the system re noti...

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

Page 143: ...Chapter 16 t slim Pump Alarms...

Page 144: ...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 and Alarms happen at the same time Alarm...

Page 145: ...3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the system re notify me Yes if not acknowledged by tapping CLOSE the system will re notify you every 3 minutes at high...

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

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

Page 148: ...ences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the system re notify me Yes The system will re notify you every 3 minutes until you change the car...

Page 149: ...or over filling the cartridge with more than 300 units of insulin How will the system notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Volume W...

Page 150: ...vibrations depending on the volume vibrate setting selected in Pump Volume Will the system re notify me Yes The system will re notify you every 3 minutes until you reconnect the current cartridge or...

Page 151: ...How will the system notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the system re notify me Yes The system will re notify you eve...

Page 152: ...ume insulin delivery How should I respond Tap CLOSE Check the cartridge tubing and infusion site for any sign of damage or blockage and correct the condition To resume insulin from the Options menu ta...

Page 153: ...n alarm shortly after the first occlusion alarm and all deliveries have stopped How will the system notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in...

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

Page 155: ...ll the system notify me 3 sequences of 3 notes or 3 vibrations depending on the volume vibrate setting selected in Pump Volume Will the system re notify me Yes The system will re notify you every 3 mi...

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

Page 157: ...Chapter 17 t slim Pump Malfunction...

Page 158: ...nnot be resumed start backup plan per your healthcare provider What will I see on the Screen What does it mean Your t slim Pump detected a system er ror and all deliveries have been stopped How will t...

Page 159: ...Customer Technical Support 1 877 801 6901 159 t slim Pump Safety Alerts and Alarms 4 Chapter 17 t slim Pump Malfunction THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 160: ...Section 5 System Care and Maintenance...

Page 161: ...Chapter 18 Taking Care of Your t slim System...

Page 162: ...set are properly in place Check Disposing of System Components Consult your local waste management authorities for instructions for disposal of devices containing electronic waste such as your pump a...

Page 163: ...Customer Technical Support 1 877 801 6901 163 System Care and Maintenance 5 Chapter 18 Taking Care of Your t slim System THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 164: ...Section 6 System Technical Specifications...

Page 165: ...Chapter 19 Technical Specifications...

Page 166: ...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 L x W x H 7 95...

Page 167: ...rm Threshold 30 PSI Rate of delivery during Bolus Bolus 3 units Approximately 2 8 units min Bolus 3 units Approximately 1 6 units min Rate of delivery during Prime Approximately 9 7 units min Bolus Du...

Page 168: ...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...

Page 169: ...10 Minutes Basal 1 units hr 1 Hour 57 Minutes 2 Hours 7 Minutes Basal 0 1 units hr 19 Hours 43 Minutes 25 Hours 30 Minutes Time to Occlusion Alarm USB Charging Download Cable Specifications Tandem P...

Page 170: ...imum 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 stand...

Page 171: ...Customer Technical Support 1 877 801 6901 171 System Technical Specifications 6 Chapter 19 Technical Specifications THIS PAGE IS INTENTIONALLY LEFT BLANK...

Page 172: ...olution with a range of 0 to 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 Ins...

Page 173: ...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 Remi...

Page 174: ...e observed in this environment to verify normal operation Special precautions for electromag netic compatibility must be taken when using medical electrical equipment The System shall be placed into s...

Page 175: ...liance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause a...

Page 176: ...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...

Page 177: ...e 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 m...

Page 178: ...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 r...

Page 179: ...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 0 023 0...

Page 180: ...ance 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...

Page 181: ...erence received including interference that my cause undesired operation Compliance with these guidelines provides reasonable protection against harmful interference in a normal resi dential environme...

Page 182: ...mplete Cartridge Change Alert 128 Incomplete Fill Cannula Alert 130 Incomplete Fill Tubing Alert 129 Incomplete Load Sequence Alert 128 Incomplete Setting Alert 131 Incomplete Temp Rate Alert 127 Low...

Page 183: ...Cartridge 37 40 46 64 69 110 Cleaning Your System 162 Colors Explanation of System Colors 31 Connection Error Alert 140 Correction Bolus 36 88 90 Correction Factor 36 42 76 77 Customer Technical Supp...

Page 184: ...Setting Alert 131 Incomplete Temp Rate Alert 127 Increment 102 103 172 Indications for Use 21 Infusion Set 19 28 62 63 64 69 70 72 115 Infusion Site Infusion Site Care 61 Preparation Product 20 62 In...

Page 185: ...nal Profile Overview 76 Programming a New Personal Profile 78 Renaming an Existing Profile 83 Reviewing an Existing Profile 81 Power Source Alert 141 Pump Info 46 48 110 Q Quick Bolus 37 48 101 106 17...

Page 186: ...inge 19 67 68 T Tandem Logo 38 40 58 Target BG 42 76 88 89 Temperature Alarm 151 Temp Rate 37 40 42 46 94 98 Incomplete Temp Rate Alert 127 Setting a Temp Rate 98 Stopping a Temp Rate 99 Time Edit Tim...

Page 187: ......

Page 188: ...ect touch simplicity and Tandem Diabetes Care are registered trademarks of Tandem Diabetes Care Inc For a list of patents please see www tandemdiabetes com patents 005960_B 11045 Roselle Street San Di...

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