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Ypsomed YpsoPump, User Manual

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Ypsomed YpsoPump User Manual Download Page 84

84

5. Changing the infusion set and cartridge

Warnings

 Only rapid-acting insulin at a concentration of 100 U/ml (NovoRapid

®

, Humalog

®

, Apidra

®

) may be used with the  

YpsoPump

®

 system. Using different insulin can lead to incorrect dosages of insulin, which can cause hypoglycemia or 

hyperglycemia (read warning in the box on page 7). If you use different insulin, change the cartridge as well as the 
primed infusion set and continue therapy with the correct type of insulin. 

 With the YpsoPump

®

 you may only use the self-filled 1.6-ml reservoir YpsoPump

®

 Reservoir that is compatible with the 

YpsoPump

®

. Using a different cartridge which is not declared by the manufacturer to be compatible with YpsoPump

®

 

can lead to incorrect dosages of insulin, which can cause hypoglycemia or hyperglycemia (read warning in the box on 
page 7). In this case, change the cartridge.

 Never use tools or instruments to remove the cartridge or the infusion set. They could damage the drive or the housing 

of the YpsoPump

®

 and compromise its operability. If the insulin pump is damaged, the correct delivery of insulin cannot 

be guaranteed; this can cause hypoglycemia or hyperglycemia (read warning in the box on page 7). Ensure that 
your delivery of insulin is as recommended by your doctor or diabetes advisor and consult Customer Service. You will 
find the contact details on the back of this User Guide as well as on page 10.

 Ensure the use of the correct drug solution and check the label of the vial before filling the YpsoPump

®

 Reservoir.

Summary of Contents for YpsoPump

Page 1: ...More freedom More confidence With Ypsomed User Guide Insulin Pump ...

Page 2: ......

Page 3: ...n 53 3 6 Setting basal rate limit 55 4 Bolus 57 4 1 Setting bolus increment 59 4 2 Activating blind bolus 62 4 3 Deactivating blind bolus 64 Contents 1 Introduction 7 1 1 Note about the User Guide 8 1 2 Warranty provisions 8 1 3 Indication 11 1 4 Disposal 11 2 Operation 12 2 1 System overview 14 2 2 Navigation 15 Touchscreen 15 Function button 17 Icons 18 Active and inactive icons 19 Confirmation ...

Page 4: ...iming the infusion set 99 5 6 Attaching the infusion set to your body 103 5 7 Priming the cannula 110 6 Data History 112 6 1 Therapy data 112 Example combination bolus 114 Possible events in therapy data 116 6 2 Alarm history 118 Possible events in alarm history 119 7 Functions and settings 120 7 1 Changing the time of day 121 7 2 Changing the date 122 7 3 Access lock 123 Activating access lock 12...

Page 5: ...rate function completed or canceled 157 Insulin pump stopped 158 Bluetooth connection failed 159 8 3 Alarms 160 No battery 162 Battery empty 163 Battery not suitable 164 Charge internal rechargeable battery 165 Occlusion 166 No insulin 168 Cartridge empty 169 Auto stop 170 Electronic error 171 9 Everyday situations 172 9 1 General 173 9 2 Watertightness 174 9 3 Traveling 175 9 4 Sources of interfe...

Page 6: ...s 186 Icons in main menu and submenus 187 Alarm icons 189 Warning icons 190 10 6 Explanation of symbols 191 YpsoPump symbols 191 YpsoPump Orbit symbols and YpsoPump Reservoir symbols 192 10 7 Glossary 193 10 8 My pump settings 199 Either swipe up down or tap upper lower value Tap on action field or icon Reference to the element described in the text Note or additional information Warning and preca...

Page 7: ...perglycemia read warning in the box below The YpsoPump insulin pump is only available on prescription Never use the YpsoPump without prior training from your doctor or diabetes advisor Using the YpsoPump without professional familiarization training can lead to incorrect dosage of insulin As is the case for any user of an insulin pump ensuring constant access to an alternative means of injecting i...

Page 8: ...ns This User Guide contains all the information required for conducting insulin pump therapy with the YpsoPump safely and successfully Make sure you read the entire User Guide carefully Should any problems or questions about functions or control procedures arise during insulin pump therapy refer to the User Guide first Should you still experience problems or if your questions have not been answere...

Page 9: ...sfer of the YpsoPump Insofar as it is legally permissible this warranty and the legal remedies described are exclusive and they replace all other oral written legal and explicitly or implicitly agreed guarantees and warranties legal remedies and conditions especially including the warranty of merchantability and usability for a certain purpose Procedure in the event of a warranty claim Any defect ...

Page 10: ... service points Ypsomed Canada Inc 1 Holiday Avenue Suite 647 Pointe Claire CA QC H9R 5N3 Headquarters Ypsomed AG Brunnmattstrasse 6 CH 3401 Burgdorf info ypsomed com Toll free 1 833 695 5959 e mail info ypsomed ca ...

Page 11: ...he YpsoPump system in accor dance with the User Guide 1 3 Indication Safety instructions Read all the instructions in this User Guide attentively Only use the YpsoPump system after having received familiarization training from your healthcare professional If you are not able to use the YpsoPump in accordance with this User Guide you may jeopardize your health and safety In case of doubt consult yo...

Page 12: ...next few hours as recommended by your doctor or diabetes advisor and adapt the insulin delivery to the changed conditions If you are uncertain contact your doctor or diabetes advisor immediately Never expose the YpsoPump to radiation or heat e g radiators open fires direct sunlight This also applies to the insulin you are using For information about the correct insulin storage conditions and opera...

Page 13: ...rglycemia read warning in the box on page 7 Make sure to always carry a replacement battery with you Always monitor the self test attentively and carefully If you are uncertain whether the self test has been performed correctly repeat the self test If errors occur during the self test incomplete display no vibration signal or audible signal you must not use the YpsoPump as potential warnings and a...

Page 14: ...partment lid Function button Tubing Cannula soft or steel Tubing cap Adapter Touchscreen AAA alkaline battery LR03 Tape Cartridge compartment with viewing window Infusion set Cannula base Self filled YpsoPump Reservoir 1 6 ml reservoir ...

Page 15: ...chscreen referred to below as the screen You control the screen by using your finger to tap icons and values or swipe through menus and values The screen of the YpsoPump may only be controlled with one finger Do not use any objects to operate the screen ...

Page 16: ... or lower value directly in order to increase or reduce it by one unit The value selected is always displayed at the center of the visible values and it has a gray background Do not use the device if it shows visible signs of damage If the device no longer responds to touch stop using it In such a case contact Customer Service without delay ...

Page 17: ...ge compartment at the side The function button has two different functionalities Short press for up to 0 8 seconds Long press for at least 2 seconds until the YpsoPump vibrates With the function button you can Switch the screen on and off Program a blind bolus Return to the status screen Function button ...

Page 18: ...18 The controls on the screen are called icons Tap an icon with your finger to select it The brightness of icons is inverted when you touch them with your finger Icons ...

Page 19: ... That means the function is available and can be selected with your finger Inactive icons are displayed in a darker gray This means the function is not available and cannot be selected with your finger Active and inactive icons ...

Page 20: ...20 Confirmation and cancelation To confirm a value or select a function tap To cancel a procedure or function tap Additionally bolus cancel ation always has to be confirmed by tapping ...

Page 21: ...y mistake or made a wrong setting you can go back at any time by swiping to the right once until or appears If appears you go one step back You do not quit the function and no set values are lost If appears you move up one menu level Back function ...

Page 22: ...0 seconds and the screen lock is activated If the YpsoPump is not operated in the main menu or in a submenu the screen switches off after two minutes and the screen lock is activated Any changes that have not been saved are lost 1 6 The status screen of the YpsoPump is switched on and off by pressing the function button short button press 3 6 Swipe to the left to unlock the status screen and the m...

Page 23: ...e to the right to return to the locked status screen 6 6 Swipe to the right to access the unlocked status screen no padlock icon 5 6 When the YpsoPump has been unlocked successfully you are in the main menu Swipe to the left to access all available menu items Make sure you switch off the screen before storing the YpsoPump in your trouser pocket or in a carrying system in order to avoid unintention...

Page 24: ...th your finger The navigation bar above the icons shows you the number of menu icons available The small squares high lighted in white indicate where you currently are in the main menu When operating the YpsoPump always make sure you use the various func tions properly Bolus Cartridge change Stop Run mode Basal rates Prime infusion set Data Settings ...

Page 25: ...firm by tapping The YpsoPump vibrates briefly Run mode The YpsoPump has two different operating modes Run and Stop The Stop mode and Run mode icons show the current operating status of the insulin pump in each case Insulin delivery e g basal rate is only possible in run mode 2 4 Run and stop modes ...

Page 26: ...26 3 3 The status screen appears Basal rate delivery starts according to the programmed profile ...

Page 27: ...mp from run mode to stop mode open the main menu Insulin delivery is not possible in stop mode 2 3 Confirm by tapping The YpsoPump vibrates briefly 1 3 Open the main menu swipe to the left and tap the Run mode switch to stop mode icon ...

Page 28: ... screen The screen of the YpsoPump shows a stop warning if the insulin pump has been in stop mode for more than one hour The stop warning can be triggered prematurely directly after the insulin pump has been set into stop mode by giving the function button a long press and then confirming the warning ...

Page 29: ...button one short press If you do not use the status screen of the YpsoPump it switches off automatically after 20 seconds The YpsoPump still remains active and in run mode it delivers insulin continuously according to the pro grammed settings If the insulin pump is in run mode the status screen indicates the current basal rate profile and the current insulin delivery If you are in the main menu or...

Page 30: ...in the battery icon on the status screen of the pump The number of rectangles is proportional to the battery charge Battery charge level low Battery fully charged Current date Current time of day Access lock icon appears only if activated Battery charge level No insulin delivery Basal rate stopped Padlock icon Bluetooth icon appears only if activated ...

Page 31: ...showing how to insert the battery 2 11 Lock the battery compartment by turning the groove of the battery compartment lid clockwise until it is completely closed using the edge of a coin Inserting a battery You must replace the battery compartment lid with a new one every three months Otherwise the seal between the battery compartment lid and the battery compartment may no longer be intact ...

Page 32: ... soon as the battery has been inserted the welcome screen appears and remains until the insulin pump starts the self test The self test is used to check the operability of the YpsoPump and to give the user visual tactile and audi ble feedback A self test is performed when putting the insulin pump into operation for the first time after having started up the insulin pump from storage status and aft...

Page 33: ... 11 Three test patterns appear on the screen one after the other The 3 3 test rectangles must be dis played in full with uniform brightness 6 11 Then the YpsoPump emits two vibration signals tactile signals ...

Page 34: ...he self test by tapping If the self test is not confirmed within 5 minutes after having started up the insulin pump from storage status or after the threaded rod has been returned the insulin pump indicates this with tactile and audible warnings If the screen is now switched on using the function button the start self test screen appears again Fig 4 11 Complete the self test and confirm ...

Page 35: ...35 Setting the time of day 9 11 The screen for setting the time of day appears Set the current time of day hours minutes by selecting the desired value Confirm the values set by tapping ...

Page 36: ... Setting the date 11 11 The status screen appears The insulin pump is in stop mode To complete the putting into operation of your insulin pump please program both basal rate profiles following the steps on page 38 insert a cartridge following the steps on page 95 prime the infusion set following the steps on page 99 attach the infu sion set to your body following the steps on page 103 prime the ca...

Page 37: ...o a particular situation can lead to hypoglycemia or hyperglycemia read warning in the box on page 7 Always program both basal rate profiles A and B in accordance with the recommendations from your doctor or diabetes advisor If only one basal rate profile is needed the second one has to be programmed in the same way as the first one By doing so the basal rate will continue without any interruption...

Page 38: ... A and B If only one basal rate profile is needed profile B has to be pro grammed in the same way as basal rate profile A 1 8 Open the main menu and tap the Basal rates icon 3 1 Programming basal rate profile A 2 8 Tap the Basal rate profile A icon 38 The following values are displayed on the screen of your YpsoPump and mentioned in this User Guide using the following abbreviations U insulin units...

Page 39: ...g After each confirmation of an hourly value you automatically move to the next hour The minimum programmable basal rate greater than 0 00 U h is 0 05 U h The basal rate values between 0 05U h and 1 00U h can be set in increments of 0 01U h The basal rate values between 1 00U h and 2 00U h can be set in increments of 0 02U h The basal rate values between 2 00U h and 15 0U h can be set in increment...

Page 40: ...onfirm by tapping The YpsoPump vibrates briefly The values are saved and one event per basal rate value is written to the therapy data 6 8 Repeat step 4 8 for each individual hour segment until you have entered all 24 basal rate values 8 8 The status screen appears The YpsoPump is in stop mode To start insulin delivery switch the insulin pump into run mode The difference between run mode and stop ...

Page 41: ...enu on the corresponding basal rate icon In the settings menu you have the option to set a basal rate limit between 40 0 U h and 0 05 U h Using this function you can set an hourly basal rate up to the set basal rate limit and not higher when programming a basal rate profile see chapter 3 6 page 55 ...

Page 42: ...ramming a different basal rate profile B If only one basal rate profile is needed profile B has to be programmed in the same way as basal rate profile A You can switch between basal rate profiles A and B at any time 1 8 Open the main menu and tap the Basal rates icon 2 8 Tap the Basal rate profile B icon ...

Page 43: ...g After each confirmation of an hourly value you automatically move to the next hour The minimum programmable basal rate greater than 0 00 U h is 0 05 U h The basal rate values between 0 05U h and 1 00U h can be set in increments of 0 01U h The basal rate values between 1 00U h and 2 00U h can be set in increments of 0 02U h The basal rate values between 2 00U h and 15 0U h can be set in increment...

Page 44: ... Confirm by tapping The YpsoPump vibrates briefly The values are saved and one event per basal rate value is written to the therapy data 8 8 The status screen appears The YpsoPump is in stop mode To start insulin delivery switch the insulin pump into run mode The difference between run and stop mode is ex plained on page 25 6 8 Repeat step 4 8 for each individual hour segment until you have entere...

Page 45: ...enu on the corresponding basal rate icon In the settings menu you have the option to set a basal rate limit between 40 0 U h and 0 05 U h Using this function you can set an hourly basal rate up to the set basal rate limit and not higher when programming a basal rate profile see chapter 3 6 page 55 ...

Page 46: ...am both basal rate profiles A and B in accordance with the recommendations from your doctor or diabetes advisor If only one basal rate profile is needed the second one has to be programmed in the same way as the first one By doing so the basal rate will continue without any interruption should you unintentionally switch the basal rate profile Without programming a profile your basal rate value is ...

Page 47: ... daily dose Confirm by tapping The YpsoPump vibrates briefly Switching basal rate profiles changes basal insulin delivery Make sure such a change complies with your therapy recommendation If the temporary basal rate function is activated the switch basal rate profiles function is not available the relevant icon is inactive ...

Page 48: ... h and also confirm by tapping Now repeat step 3 4 for each individual hour segment for all 24 basal rate values 1 4 Open the main menu and tap the Basal rates icon The screen dis plays the basal rate submenu If the Temporary basal rate function is activated the basal rate profiles A and B functions are not available 2 4 Tap the basal rate profile icon you want to change 3 4 Changing a basal rate ...

Page 49: ...a for each changed value and indicates the basal rate daily dose In the settings menu you have the option to set a basal rate limit between 40 0 U h and 0 05 U h Using this function you can set an hourly basal rate up to the set basal rate limit and not higher when programming a basal rate profile see chapter 3 6 page 55 ...

Page 50: ... has finished the programmed basal rate profile A or B continues To use the temporary basal rate function the YpsoPump must be in run mode 1 7 Open the main menu and tap the Basal rates icon 3 5 Temporary basal rate function 2 7 Tap the Temporary basal rate function icon The temporary basal rate function is not available in stop mode To use this function the insulin pump must be in run mode ...

Page 51: ... which you want to reduce or increase the current basal rate The period can be set from 15 minutes to 24 hours in steps of 15 minutes 5 7 The percentage of the current basal rate is displayed to you in gray as information under the period of time selected The YpsoPump starts the temporary basal rate func tion after confirmation by tapping The YpsoPump vibrates briefly If the temporary basal rate f...

Page 52: ...unction is active 7 7 In addition the period of time remaining and the selected percentage of the basal rate are displayed alternately under the basal rate value When the temporary basal rate set has completed a warning appears on the screen Confirm the warning The programmed basal rate A or B also continues if you do not confirm the warning ...

Page 53: ...l rate function 1 4 Open the main menu and tap the Basal rates icon 2 4 Tap the Temporary basal rate function activated cancel icon 3 4 Confirm cancelation of the temporary basal rate function by tapping The YpsoPump vibrates briefly ...

Page 54: ...54 4 4 The status screen appears with the basal rate originally programmed ...

Page 55: ...program a maximum hourly basal rate Using this function you can set an hourly basal rate up to the set basal rate limit and not higher when programming a basal rate profile 1 4 Open the main menu and tap the Settings icon 3 6 Setting basal rate limit 2 4 Swipe to the left and tap the Set basal rate limit icon ...

Page 56: ...56 3 4 Set the basal rate limit that was specified for you by your doctor between 40 0 U h and 0 05 U h Confirm by tapping The insulin pump vibrates briefly 4 4 The status screen appears ...

Page 57: ...ng a bolus Control every entry before confirming the bolus delivery If the bolus is not set properly this can lead to hypoglycemia or hyperglycemia read warning in the box on page 7 When using the blind bolus function make sure the bolus increment setting is correct beforehand When entering a blind bolus do not be distracted When wearing the insulin pump make sure the blind bolus function is not a...

Page 58: ... bolus the YpsoPump must be in run mode Use your own therapy settings The values displayed on the following pages are only examples A bolus is administered in the following situations Compensation for meal carbohydrates a meal bolus Reduction of blood glucose to correct a high blood glucose level ...

Page 59: ...crement indicates the increase or decrease in bolus amount per touchscreen gesture It also indicates the increase in bolus amount for each press of the function button when entering a blind bolus 1 4 Open the main menu and tap the Settings icon ...

Page 60: ...he following bolus increments 0 1U 0 5U 1 0U 2 0U Set the bolus increment value that was specified for you by your doctor Confirm your setting by tapping The insulin pump vibrates briefly 2 4 Tap the Set bolus increment icon ...

Page 61: ...he status screen appears Bear in mind that the bolus increment has a direct influence on the blind bolus function The bolus increment set equals the insulin amount increase for each press of the function button ...

Page 62: ...d tap the Blind bolus inactive activate icon 1 4 Open the main menu and tap the Settings icon When putting the YpsoPump into operation for the first time the blind bolus function is always inactive To use the blind bolus function you must activate it first ...

Page 63: ... YpsoPump vibrates briefly and the blind bolus function can be used Follow the procedure on page 74 4 4 If you open the main menu again tap the Settings icon and swipe to the left the Blind bolus active deactivate icon now appears ...

Page 64: ...vating blind bolus 2 4 Swipe to the left and tap the Blind bolus active deactivate icon 1 4 Open the main menu and tap the Settings icon With the YpsoPump you have the option of deactivating the blind bolus function ...

Page 65: ... by tapping The YpsoPump vibrates briefly and the blind bolus function is deactivated 4 4 If you open the main menu again tap the Settings icon and swipe to the left the Blind bolus inactive activate icon now appears ...

Page 66: ...lind bolus when an extended portion of a bolus is in progress A standard or blind bolus always has priority over an extended portion of a bolus If you deliver a standard or blind bolus when an extended portion of a bolus is in progress the standard or blind bolus is displayed on the status screen After its delivery the status screen switches back to the remaining amount of the extended portion of ...

Page 67: ...m bolus amount is directly dependent on the bolus increment setting If the bolus increment is set to 1 0 U for example the minimum bolus amount that can be set for a standard bolus is also 1 0 U Standard bolus 2 4 Tap the Standard bolus icon 1 4 Open the main menu and tap the Bolus icon 3 4 Select a bolus amount between 0 1U and 30 0U Bolus delivery commences immediately as soon as you confirm by ...

Page 68: ...68 4 4 The YpsoPump counts down the remaining units on the status screen You can cancel a bolus in progress at any time by tapping Cancelation must always be confirmed by tapping ...

Page 69: ... 6 Tap the Extended bolus icon 1 6 Open the main menu and tap the Bolus icon 3 6 Select a bolus amount between 0 1U und 30 0U and confirm by tapping If the default value of 0 0U is confirmed the extended bolus is canceled ...

Page 70: ...tapping Cancelation must always be con firmed by tapping 4 6 Select the extension time during which you wish to deliver the bolus amount selected The extension time can be set from 15 minutes to 12 hours in steps of 15 minutes 5 6 The set bolus amount is dis played in gray below the extension time selected The YpsoPump starts bolus delivery after confirmation by tapping The YpsoPump vibrates brief...

Page 71: ...nd 30 0U and confirm by tapping If the default value of 0 0U is confirmed the combination bolus is canceled The combination bolus function cannot be performed if the remaining insulin amount in the cartridge or the bolus limit setting is smaller than twice the bolus increment setting minimum amount for combination bolus is twice the bolus increment ...

Page 72: ...ended portion Extension time can be set from 15 minutes to 12 hours in steps of 15 minutes 4 8 Select the bolus amount that you want to deliver directly immediate portion 5 8 The percentage of the immediate portion is displayed in gray under the bolus amount selected This bolus amount must be confirmed by tapping ...

Page 73: ...ion the remaining extension time of the extended bolus is dis played You can cancel a bolus in progress at any time by tapping Cancelation must always be con firmed by tapping 7 8 The bolus amount of the extend ed portion is displayed in gray below the extension time selected The YpsoPump starts bolus delivery after confirmation by tapping The insu lin pump vibrates briefly ...

Page 74: ...the YpsoPump emits a long vibration signal Function button The blind bolus function is not available in stop mode Make sure the insulin pump is in run mode The blind bolus function is not available if the cartridge is empty if the remaining insulin amount in the cartridge is smaller than the bolus increment setting or if the bolus limit setting is lower than the bolus increment setting nor if the ...

Page 75: ...ng the function button a short press for each step of increase The insulin pump confirms each function button press with a short vibration For each function button press the bolus amount is increased depending on the bolus increment you have set The maximum bolus amount is 30 0U Function button 75 Giving the function button a long press may launch the blind bolus menu accidentally if the blind bol...

Page 76: ... is displayed to you on the screen When you have entered the bolus amount required you have to wait 4 seconds The elapsed time is displayed to you by dots turning gray When entering a bolus that exceeds the maximum amount that can be set blind bolus programming is canceled with three short vibrations 76 ...

Page 77: ...onfirmed The long function button press must take place within 4 seconds after the long vibration signal By giving the function button a short press or not reacting to the vibration signal you have the option of quitting the blind bolus menu without any bolus delivery This is indicated by three short vibrations Function button 77 ...

Page 78: ...ched on during blind bolus programming the blind bolus delivery in progress is displayed on the screen If the screen of your YpsoPump is switched off during blind bolus programming the blind bolus delivery in progress is not displayed on the screen Give the function button a short press to switch on the screen and see the blind bolus in progress 78 ...

Page 79: ...ting confirmation from the insulin pump for each step of increase short vibration signal 4 5 Awaiting long vibration signal from the insulin pump 5 5 Long press of function button to confirm bolus delivery Start programming Blind bolus delivery 79 Time Action Act within 4 seconds Wait 4 seconds Wait 4 seconds Act within 4 seconds Blind bolus programming at a glance ...

Page 80: ... display of last bolus at any time and return to the status screen 1 4 Swipe to the right on the status screen to display the last bolus delivered The last bolus delivered can only be displayed if no bolus is active When a bolus function is active it is not possible to display the last bolus delivered 3 4 Example of an extended bolus if a bolus on the display of last bolus shows multiple items of ...

Page 81: ...81 4 4 Example of a combination bolus the display of the percentage value of the immediate portion alter nates with the display of the exten sion time of the extended portion at intervals of 2 seconds ...

Page 82: ...p the Settings icon With your YpsoPump it is possible to set a bolus amount between 0 1 U and 30 0 U Additionally you can program a maximum bolus amount Using this function you can set a bolus amount up to the set bolus limit and not higher when programming a bolus The set bolus limit applies to all bolus types ...

Page 83: ...ble bolus Confirm by tapping The insulin pump vibrates briefly 4 4 The status screen appears If the bolus limit setting is lower than the bolus increment setting the bolus icon is inactive and the function cannot be performed If the bolus limit setting is set by value of 0 0 no bolus can be performed ...

Page 84: ...ufacturer to be compatible with YpsoPump can lead to incorrect dosages of insulin which can cause hypoglycemia or hyperglycemia read warning in the box on page 7 In this case change the cartridge Never use tools or instruments to remove the cartridge or the infusion set They could damage the drive or the housing of the YpsoPump and compromise its operability If the insulin pump is damaged the corr...

Page 85: ...the reach of children Using an infusion set which is not declared by the manufacturer to be compatible with YpsoPump can lead to incorrect dosages of insulin which can cause hypoglycemia or hyperglycemia read warning in the box on page 7 If you use an infusion set which is not compatible change the infusion set Always make sure the tubing is disconnected from your body when you change the cartridg...

Page 86: ...he priming procedure Air bubbles can lead to incorrect dosages of insulin which can cause hypoglycemia or hyperglycemia read warning in the box on page 7 The Prime tubing and Prime cannula functions must never be used for bolus delivery their sole purpose is to prime the tubing and cannula without bubbles Misuse of these functions can lead to incorrect dosages of insulin which can cause hypoglycem...

Page 87: ...ed with a rapid acting insulin at a concentration of 100 U ml NovoRapid Humalog Apidra and used with the YpsoPump insulin pump Insulin vial The following components are required in order to use the YpsoPump Reservoir Alcohol swab Transfer adapter Reservoir with plunger rod ...

Page 88: ...he packaging 88 Filling the YpsoPump Reservoir The YpsoPump Reservoir is sterile provided that the packaging has neither been opened nor damaged If the packaging shows signs of damage use a different reservoir The reservoir is solely intended for single use To prevent risk of infection never pull the stopper beyond the 1 6 ml mark and do not reuse the transfer adapter or the reservoir ...

Page 89: ...your hands thoroughly with soap and water 2 12 Clean the septum of the insulin vial with an alcohol swab 3 12 Remove the reservoir and the transfer adapter from the packag ing see page 87 without touching the septum ...

Page 90: ...r adapter to the reservoir and advance the stop per all the way forward 5 12 Then pull the plunger rod backwards until the entire reservoir is filled with air 6 12 Attach the other end of the transfer adapter to the insulin vial ...

Page 91: ...8 12 Turn the reservoir including the insulin vial upside down Very gently draw the insulin into the reservoir 9 12 Check the reservoir for air bubbles If air bubbles are in the reservoir carefully tap the side of the reservoir Then press the plunger rod to push the air bubbles out of the reservoir Repeat if necessary ...

Page 92: ...er adapter from the vial Dispose of the transfer adapter in accordance with local laws 11 12 Twist off the plunger rod and dispose of it 12 12 Follow the instructions on page 98 in order to insert the reservoir into the YpsoPump ...

Page 93: ...of the cap and the tubing cap will disconnect from the infusion site The YpsoPump Orbit soft and YpsoPump Orbit micro infusion sets can be easily dis connected and reconnected offering you the option of removing the insulin pump and tubing to take a bath a shower or do sports ...

Page 94: ...follow the steps on page 95 Before attaching the tubing to your body please make sure the tubing is filled with insulin without any air bubbles Dispose of the introducer needle YpsoPump Orbit soft the used cannula base and the used tubing with adapter according to the instructions given by your doctor or diabetes advisor and in compliance with the local regulations for disposing of needles and sha...

Page 95: ... instructions on page 93 Removing the cartridge 2 7 Open the main menu and tap the Cartridge change and current cartridge level icon 3 7 Tap the Return threaded rod icon With your YpsoPump you are not required to change your infusion set every time you change your cartridge They can be changed independently ...

Page 96: ...med as described on page 32 Do not insert the new cartridge until the threaded rod has completely returned and the YpsoPump has successfully performed the self test If you insert the cartridge while the threaded rod is still returning the insulin pump may display the message Threaded rod return not completed In this case repeat the cartridge change ...

Page 97: ...pty cartridge from the YpsoPump and dispose of it in accordance with your national environmental protection regulations 6 7 Disconnect the infusion set by turning the adapter on the YpsoPump counterclockwise until it stops ...

Page 98: ...sert a self filled 1 6 ml reservoir 2 2 Place the adapter on the insert ed cartridge upright Turn the adapter clockwise to the lock position You should hear a soft click and or feel a definite mechanical stop When putting the YpsoPump into operation for the first time or when taking the insulin pump into operation after storage status the threaded rod must be returned prior to inserting the cartri...

Page 99: ...re is for guidance only It is important that the system is primed free of air and that insulin emerges from the end of the tubing It may happen that more insulin has to be delivered than the priming volume initially set 1 6 Open the main menu and tap the Prime infusion set icon 2 6 Tap the Prime tubing icon 5 5 Priming the infusion set ...

Page 100: ...tions for use of your YpsoPump Orbit infusion set until there are no more air bubbles in the cartridge in the adapter and in the tubing If the cartridge does not contain any air bubbles prime the minimum priming volume of 1 0 U Priming volume when changing the infusion set For the priming volume select a value that is suitable for your infusion set accord ing to the instructions for use of your Yp...

Page 101: ...ocedure keep the insulin pump in an upright position with the adapter facing up wards and tap the insulin pump lightly on your open palm to remove the air bubbles from the infusion set The screen counts the delivered priming volume upwards until the set value has been reached You can cancel the priming procedure at any time by tapping If the temporary basal rate function or a bolus is activated th...

Page 102: ...he priming procedure with the appropriate priming volume until there are no more air bubbles in the cartridge in the adapter or in the tubing and until insulin has emerged from the end of the tubing of the infusion set ...

Page 103: ...ch the infusion set to your body 1 12 Wash your hands thoroughly These abridged instructions are intended to be a recommendation For detailed information notes and warnings please refer to the instructions for use of the relevant YpsoPump Orbit infusion set YpsoPump Orbit soft and YpsoPump Orbit micro 5 6 Attaching the infusion set to your body ...

Page 104: ...ion site is dry 3 12 Peel the protective foil off the tape carefully Make sure you do not touch the adhesive film We recomment you to use a 70 isopropyl alcohol swab The use of 70 isopropyl supports the optimal adhesion of the tape The use of other alcohol pads has not been tested and may result in premature tape failure and interruption of insulin delivery ...

Page 105: ...t an angle of 90 or alternatively use the appropriate inserter for the infusion set The YpsoPump Orbit micro has a steel cannula that can be applied to the body without any additional introducer needle To facilitate skin penetration with the YpsoPump Orbit soft and YpsoPump Orbit micro infusion sets use the Orbit Inserter ...

Page 106: ...ess the tape onto the skin and run your fingers over the tape for a few seconds to optimize adhesion 7 12 Press the tape onto the skin with one hand and grasp the introducer cap with two fingers of your other hand ...

Page 107: ...Pump Orbit soft or the introducer cap YpsoPump Orbit micro by pressing on the two outer wings of the introducer cap and pull it from the infusion site 9 12 Cover the removed introducer needle with the blue protection cap and dispose of it in a safety bin ...

Page 108: ...108 10 12 Attach the tubing cap straight to the cannula base of the infusion set 11 12 Make sure you hear it click into place ...

Page 109: ...109 12 12 Rotate the tubing left and right at least one full turn in each direction while pulling upward on the cap to ensure the tubing cap is fully engaged and the fluid path is opened ...

Page 110: ...fter having attached the infusion set to your body the cannula has to be primed with insulin 2 4 Tap the Prime cannula icon 1 4 Open the main menu and tap the Prime infusion set icon 5 7 Priming the cannula ...

Page 111: ...cedure at any time by tapping 3 4 The screen for setting the prim ing volume appears For the priming volume select a value that is suitable for your cannula between 0 1 U and 1 0 U according to the instructions for use of your YpsoPump Orbit infu sion set Confirm by tapping The YpsoPump vibrates briefly and the cannula is primed with the set amount of insulin ...

Page 112: ...ta and Alarm history Therapy data comprise records of all therapy relevant events such as bolus delivery priming procedure or change in basal rates Alarm history lists all the alarms that have taken place If the number of events exceeds the maximum num ber the oldest events are overwritten Therapy data 500 events displayed total of 3000 stored in the insulin pump Alarm history 100 events displayed...

Page 113: ...event from a current display The icon for the event appears on the left of the screen the relevant value in the middle By swiping to the right you can quit therapy data at any time All the possible events are listed in the table on page 116 In the therapy data functions still in progress are marked by the triangular symbol under the icon ...

Page 114: ... 4 6 Display of total bolus amount 5 6 Display of immediate portion Three screens each containing different information are displayed one after the other at intervals of 2 seconds Example combination bolus ...

Page 115: ...115 6 6 Display of extended portion and extension time Remember to back up your therapy data regularly to prevent any loss of events ...

Page 116: ...erapy data Hourly value from basal rate profile A changed 1 event for each hourly value changed Hourly value from basal rate profile B changed 1 event for each hourly value changed Primed cannula Primed tubing Standard bolus or blind bolus Switched from basal rate profile A to basal rate profile B Switched from basal rate profile B to basal rate profile A ...

Page 117: ...117 Switched to run mode Switched to stop mode Temporary basal rate function Threaded rod returned Time of day changed Total insulin amount per day basal and bolus ...

Page 118: ...each event the time of day and date are displayed inverted As a result you can distinguish the event from a current display The icon for the event appears on the left of the screen By swiping to the right you can quit the alarm history at any time All the possible events are listed in the table on page 119 ...

Page 119: ...119 Possible events in alarm history Auto stop Battery empty Battery not suitable Cartridge empty Charge internal rechargeable battery Electronic error No battery No insulin Occlusion ...

Page 120: ... guarantee that the insulin pump will be put into operation or operate properly the advance warning time up to the Battery empty alarm page 163 cannot be maintained when a battery is discharged This can lead to failure of the preset insulin delivery which can cause hyperglycemia read warning in the box on page 7 Make sure to always carry a replacement battery with you For patients who do not self ...

Page 121: ...of day 1 3 Open the main menu and tap the Settings icon 2 3 Tap the Time of day icon 3 3 Set the current time of day confirm by tapping and the YpsoPump will vibrate briefly The time of day set is entered in the therapy settings ...

Page 122: ...ate year month day Confirm your setting by tapping The values displayed are only examples Always use your own settings You can adjust the time of day and the date at any time in the settings menu If you select an impossible date e g 2017 02 30 the confirmation icon will be inactive gray and you cannot confirm the date ...

Page 123: ...activated The following YpsoPump functions cannot be operated when the access lock function is activated All types of bolus delivery Temporary basal rate function Programming and switching basal rate profiles Returning threaded rod for cartridge change Priming infusion set and cannula Switch to run or stop mode Time and date settings Bolus increment settings Bolus limit settings Basal rate limit s...

Page 124: ...in menu and tap the Settings icon 2 5 Swipe to the left and tap the Access lock inactive activate icon Activating access lock 3 5 Confirm by tapping The YpsoPump vibrates briefly and the access lock function is activated ...

Page 125: ... the top of the screen 5 5 If you open the main menu again tap the Settings icon and swipe to the left the Access lock active deactivate icon now appears When the access lock function is activated all inactive icons are displayed in a darker gray This means the function is not available and cannot be selected ...

Page 126: ... menu and tap the Settings icon 2 5 Swipe to the left and tap the Access lock active deactivate icon Deactivating access lock 3 5 Confirm by tapping The YpsoPump vibrates briefly and the access lock function is deactivated ...

Page 127: ...ss lock icon at the top of the screen disappears All icons are now active and the functions can be operated again 5 5 If you open the main menu again tap the Settings icon and swipe to the left the Access lock inactive activate icon now appears ...

Page 128: ...128 7 4 Rotating the screen by 180 2 3 Swipe to the left and tap the Rotate screen icon 1 3 Open the main menu and tap the Settings icon You have the option of rotating the screen of the YpsoPump by 180 ...

Page 129: ...129 3 3 Confirm by tapping The YpsoPump vibrates briefly and the orientation of the screen is rotated by 180 ...

Page 130: ... and tap the Settings icon Use the Bluetooth function to transfer your therapy data from your YpsoPump to another supported Bluetooth enabled device If you want to use the Bluetooth connection to a Bluetooth enabled device the Bluetooth interface must firstly be activated on the YpsoPump Activating Bluetooth ...

Page 131: ...h function is activated 4 5 The status screen appears The activated Bluetooth function is visualized by a Bluetooth icon at the top of the screen 5 5 If you open the main menu again tap the Settings icon and swipe to the left the Bluetooth active deactivate icon now appears ...

Page 132: ... tap the Bluetooth active deactivate icon 1 5 Open the main menu and tap the Settings icon If you do not want to use any Bluetooth enabled devices with the YpsoPump the Bluetooth interface can be deactivated Deactivating Bluetooth ...

Page 133: ... and the Bluetooth function is switched off 4 5 The status screen appears The Bluetooth icon at the top of the screen disappears 5 5 If you open the main menu again tap the Settings icon and swipe to the left the Bluetooth inactive activate icon now appears ...

Page 134: ...ion code to allow Bluetooth connection between the two devices To use the Bluetooth pairing func tion the Bluetooth function must be activated It is possible to pair a maximum of 5 Bluetooth enabled devices with the YpsoPump 2 6 Swipe to the left and tap the Bluetooth pairing icon 1 6 Open the main menu and tap the Settings icon Bluetooth pairing ...

Page 135: ...ntered the warning Bluetooth connection failed appears Confirm the warning and repeat the procedure on page 134 3 6 The YpsoPump is ready for Bluetooth pairing and waits for the pairing request of the Bluetooth enabled device If the release does not take place within 2 minutes the screen lock is activated and the Bluetooth pairing function must be restarted 5 6 If Bluetooth pairing was successful ...

Page 136: ... and tap the Bluetooth pairing icon the active connection is shown by the rotation of the arrows An active Bluetooth connection to a Bluetooth enabled device is indicated by rotating arrows Only one Bluetooth enabled device at a time can have an active connection with the YpsoPump ...

Page 137: ...atus the settings remain intact basal rate bolus increment etc When preparing your YpsoPump for storage remove the cartridge and the infusion set and dispose of the tubing and cannula base in a safety bin After a restart all you have to do is perform the self test and reset the time of day and date After that the insulin pump is in stop mode A threaded rod return followed by priming has to be perf...

Page 138: ...p to stop mode see page 27 Remove the cartridge and the infusion set as described on page 95 2 2 Open the battery compartment lid and remove the battery Close the battery compartment lid and store the YpsoPump in a safe place ...

Page 139: ...e alkaline battery If the alkaline battery is removed the battery orientation screen appears To change the alkaline battery please follow the instructions on page 140 If the internal rechargeable battery is subjected to a heavy load it may run down In this situation the Charge internal rechargeable battery alarm appears The internal rechargeable battery is now charged by the inserted alkaline batt...

Page 140: ...nt and dispose of it in accordance with your national environmental protection regulations If the battery compartment has remained open for more than 5 minutes and the YpsoPump is in run mode an alarm is triggered After inserting a new battery all insulin pump settings are saved and do not have to be entered again If the battery compartment remains open for more than 5 minutes and the YpsoPump is ...

Page 141: ...battery sales outlets 3 5 The battery orientation screen shows the orientation of the AAA battery for insertion It appears on the status screen If the insulin pump is in run mode and the battery is not inserted for more than 5 minutes an alarm is triggered When changing the alkaline battery check the battery compartment the battery itself and the battery compartment lid for any damage If you disco...

Page 142: ...ops When the battery has been inserted the mylife icon appears first followed by the status screen or welcome screen The latter appears if the battery has been removed during a threaded rod return or during a self test after starting up from the storage status Change the battery compartment lid every three months to minimize signs of wear ...

Page 143: ...aded rod Priming in progress Standard bolus in progress Immediate portion of the combination bolus in progress Blind bolus in progress If you remove the battery while any of the following functions are in progress the battery orientation screen appears and the function continues in the background for 5 minutes until the alarm is triggered alarms lead to a discontinuation of insulin delivery Basal ...

Page 144: ...riggered simultaneously are displayed in order of priority If you have dealt with an alarm it is possible that other alarms are still pending Alarms that have not been dealt with can lead to failure of the preset insulin delivery which can cause hyperglycemia read warning in the box on page 7 In loud surroundings it may be difficult to hear alarms e g lawn mowing concerts etc In such surroundings ...

Page 145: ... can lead to failure of the preset insulin delivery which can cause hyperglycemia read warning in the box on page 7 Always make sure the infusion set is immediately disconnected from your body after an occlusion alarm in order to prevent insulin from being delivered to the body when the occlusion is suddenly eliminated Not disconnecting the infusion set can lead to incorrect dosages of insulin whi...

Page 146: ...f the temporary basal rate function is activated the Basal rate profile B function is not available and it is not possible to change the basal rate profile Blind bolus function is not available Make sure the blind bolus function is activated and the insulin pump is in run mode The blind bolus function is not available in stop mode The blind bolus function cannot be performed if the cartridge is em...

Page 147: ...olus function cannot be performed either if a threaded rod return has been performed without any subsequent priming or if the priming function has not been completed properly Cartridge change icon is not available shown in gray If the temporary basal rate function is activated and or if an extended bolus or combination bolus is active the cartridge change function is not available Combination bolu...

Page 148: ...otherwise contact Customer Service You find the contact details on the back of this User Guide as well as on page 10 Dirt on the surface Clean the insulin pump with a damp cotton cloth Then dry the surface with a dry cotton cloth If it is not possible to remove the dirt you can clean the surface with a small amount of normal cleaning liquid and a damp cotton cloth Never use sharp objects knife scr...

Page 149: ... the insulin pump to stop mode Disconnect the infusion set from your body Remove the cartridge and the infusion set and replace them The insulin pump as well as the cartridge may contain undiscovered microcracks that are not visible to the human eye and might influence delivery accuracy Check the exterior of the insulin pump for cracks and damage Pay close attention to the self test after the thre...

Page 150: ...partment Check your blood glucose level Disconnect the infusion set from your body Remove the battery from the battery compartment Then dry the battery compartment with a dry cotton cloth If the insulin pump has not suffered any apparent damage you can continue insulin pump therapy otherwise contact Customer Service You find the contact details on the back of this User Guide as well as on page 10 ...

Page 151: ...e The Battery charge level low warning always has priority over all the warnings below it except if the Cartridge level low warning occurs at the same time Unconfirmed alarms always appear with priority over warnings Displayed warnings are primarily tactile and audible and there are 4 escalation levels The levels escalate at intervals of 30 minutes The warnings appear on the status screen and have...

Page 152: ...the remaining amount of any bolus in progress is greater than or equal to the remaining contents of the cartridge Confirm by tapping and change the cartridge as soon as possible in accordance with the procedure on page 95 The Cartridge level low warning escalates to the Cartridge empty alarm if the cartridge is not changed in the meantime Cartridge level low ...

Page 153: ...d insert a new AAA alkaline battery LR03 as soon as possible Follow the procedure on page 140 Having confirmed the warning you will still see the low battery charge on your status screen The Battery charge level low warning escalates to the Battery empty alarm if the battery is not changed in the meantime Battery charge level low ...

Page 154: ...al fault This fault can also be triggered by touching the threaded rod with an object when the threaded rod is returning Confirm by tapping and perform the threaded rod return function again Make sure the cartridge is removed from the cartridge compartment first and that there is no dirt in the cartridge compartment do not touch the threaded rod with objects You will find further information about...

Page 155: ...tection the priming procedure is canceled by an alarm the force on the plunger holder decreases during the priming procedure for example because the cartridge has been removed or a wrong cartridge has been inserted Confirm by tapping and perform the priming function again Make sure the cartridge has been inserted properly and that the adapter is connected to the insulin pump properly Follow the pr...

Page 156: ... insulin pump is put into stop mode Confirm by tapping If your bolus in progress is canceled prematurely you can obtain the actual duration and the insulin amount delivered by referring to the therapy data or to the last bolus screen If you wish to continue the bolus you must reprogram it Follow the procedure on page 57 Bolus canceled ...

Page 157: ...here is an alarm or if the insulin pump is put into stop mode Confirm by tapping If your temporary basal rate function is canceled prematurely you can obtain the actual duration and the percentage setting by referring to the therapy data If you wish to continue the temporary basal rate function you must reprogram it Follow the procedure on page 50 Temporary basal rate function completed or cancele...

Page 158: ...t to run mode again and then back to stop mode To restart the insulin pump follow the steps on page 25 Insulin pump stopped The screen of the YpsoPump shows a stop warning if the insulin pump has been in stop mode for more than one hour The stop warning can be triggered prematurely after the insulin pump has been set in stop mode by giving the function button a long press and then confirming ...

Page 159: ...ode is exceeded during the pairing process a wrong identification code is entered during pairing process an active Bluetooth connection is accidentally disconnected Confirm by tapping Do pair the insulin pump again to the required device in accordance with the procedure on page 134 Bluetooth connection failed ...

Page 160: ...tory where they can be called up All the alarms are described on the following pages The alarms are arranged in order of priority This means The No battery alarm always appears with priority over all the alarms below if multiple events occur at the same time The Battery empty alarm always appears with priority over all the alarms below but not if the No battery alarm occurs at the same time Unconf...

Page 161: ...e an electronic error appear on the status screen and have to be confirmed To do so the screen has to be switched on first using the function button Alarms always lead to cancelation of insulin delivery The alarm remains on the status screen until the actions to deal with the alarm have been performed on the pump An electronic error is the exception It is dealt with in accordance with the procedur...

Page 162: ...tes when the insulin pump is in run mode Confirm by tapping and insert a new AAA alkaline battery LR03 Follow the procedure on page 140 The No battery alarm only appears if the battery was removed while the insulin pump was in run mode If the battery is removed in stop mode the insulin pump adopts storage status after 5 minutes ...

Page 163: ...attery empty The Battery empty alarm appears if the battery no longer has sufficient power and has to be changed Confirm by tapping and insert a new AAA alkaline battery LR03 Follow the procedure on page 140 ...

Page 164: ...m appears if you insert a battery whose voltage is too high Confirm by tapping Remove the unsuitable battery from the battery compartment and insert a new AAA alkaline battery LR03 Follow the procedure on page 140 Battery not suitable ...

Page 165: ...hich is indicated by arrows rotating round the hourglass The charging process can take up to 20 minutes When you have confirmed the alarm any canceled boluses and the canceled temporary basal rate function are indicated with appropriate warnings Then the status screen is displayed but not if the Charge internal rechargeable battery alarm has appeared after the threaded rod has returned or during a...

Page 166: ... The Occlusion alarm appears if the infusion path is blocked e g adapter infusion set cannula Confirm by tapping and disconnect the infusion set from your body Then perform the following actions Occlusion ...

Page 167: ...rapy can be continued If an occlusion alarm occurs again while the new infusion set is being primed the cartridge must be changed in accordance with the procedure on page 95 If subsequent priming can be completed without an occlusion alarm therapy can be continued If an occlusion alarm occurs again while priming after having changed the cartridge the insulin pump is faulty and Customer Service mus...

Page 168: ...o priming procedure is performed within 5 minutes or if the priming procedure failed The No insulin alarm only appears if the insulin pump is in run mode Confirm by tapping Insert a cartridge and perform a priming procedure Follow the procedure on page 95 No insulin ...

Page 169: ...169 Cartridge empty The Cartridge empty alarm appears if the cartridge contains 0 0U insulin Confirm by tapping Change the cartridge in accordance with the procedure on page 95 ...

Page 170: ... stop alarm appears if the YpsoPump is in run mode and has not been operated within 24 hours Insulin delivery in progress is stopped Confirm the alarm by tapping After confirmation of the alarm the insulin delivery restarts ...

Page 171: ...ery compartment Then press the function button for 2 seconds The insulin pump is now devoid of a battery and in storage status To put the insulin pump back into operation perform the steps on page 31 and check your therapy settings Change the cartridge and the infusion set in accordance with the steps on page 94 If the electronic error remains after the insulin pump has been put into operation aga...

Page 172: ...age 7 In case of doubt consult your doctor diabetes advisor or Customer Service Make sure the infusion set does not become detached from your body during sport or physical activity A detached infusion set can lead to incorrect dosage of insulin which can cause hypoglycemia or hyperglycemia read warning in the box on page 7 If the infusion set becomes detached replace it with a new one ...

Page 173: ...chscreen to turn dull Sweat and saliva cannot damage the YpsoPump However there is a risk of damage to the insulin pump housing if the YpsoPump comes into contact with other liquids or chemicals such as detergents alcohol beverages oil or grease Never expose the YpsoPump and the infusion set to direct sources of light radiation or heat e g radiators open fires This also applies to the insulin you ...

Page 174: ...of due to undetected microcracks Since the YpsoPump Orbit infusion set can be disconnected from your body the YpsoPump is easy to remove before taking a bath or shower or going swimming Do not use the YpsoPump in areas with very high humidity or temperature e g sauna or else it may be damaged The system may be operated within a humidity range of 20 to 95 RH 9 2 Watertightness ...

Page 175: ...traveling through different time zones consult your doctor or diabetes advisor about how best to adapt your therapy to the changes in time of day The YpsoPump has only been tested for use at altitudes of up to 5500 meters above sea level If you are traveling to a region that is higher than 5500 meters above sea level you should stop the YpsoPump and take it off You do not have to switch off the Yp...

Page 176: ... any other sources of heavy electric current Such hazardous areas can cause the YpsoPump to stop delivering insulin or damage the insulin pump Examples of other hazardous areas are hyperbaric chambers and areas exposed to flammable gases or vapors Before you enter such areas you must stop the YpsoPump and take it off Industry Canada Compliance Statement This device complies with FCC Rules Part 15 ...

Page 177: ...ump safely and securely Sports which involve physical contact and hard knocks e g hockey football basketball volleyball etc can cause damage to the YpsoPump Extreme sports e g parachuting diving amateur flying etc must not be performed with the YpsoPump Heavy work e g construction work removal work etc can also cause damage to your pump YpsoPump has a water protection classification IPX8 according...

Page 178: ... 23 C 2 C with activated Bluetooth function Duration of data storage 360 three hundred and sixty months Non pyrogenic Liquid path only Protection against electric shock Type BF applied part IEC 60601 1 internally powered ME device Alarm generation Audible tactile and visual Cartridge capacity 1 6ml 160U Insulin concentration 100 U ml Water protection classification IPX8 according to IEC 60529 imme...

Page 179: ...5 at 23 C 2 C Bolus delivery accuracy for 30 0U 5 at 23 C 2 C Communication interface Bluetooth 4 0 Low Energy 2400 to 2483 5 MHz Occlusion alarm threshold 3 0 bar Maximum infusion pressure 3 0 bar Occlusion bolus volume at 1 00 U h max 5 0 U Typical time until occlusion alarm at 1 00 U h 4 hours Typical time until occlusion alarm at 0 05 U h 95 hours Delivery rate during bolus delivery 0 555 U se...

Page 180: ... distances according to Table 6 of IEC 60601 1 2 Safety distance in m To provide the YpsoPump with optimal protection against electromagnetic fields the following precautions concerning electromagnetic compatibility must be taken The YpsoPump must be put into operation in accordance with the instructions in this User Guide Wireless communication devices such as wireless computer network devices Wi...

Page 181: ... the frequency range of 1880 to 1900 MHz According to the table that means a recommended safety distance of approx 13 cm A mobile phone has a peak power of 2 W and it operates in the frequency range of 900 MHz GSM900 According to the table that means a recommended safety distance of approx 35 cm A mobile phone has a peak power of 1 W and it operates in the frequency range of 1880 to 1900 MHz Accor...

Page 182: ...psoPump Orbit soft 110 cm tubing length Ambient conditions 22 C 2 C humidity uncontrolled 25 to 75 10 3 Delivery accuracy according to IEC 60601 2 24 Start up graph 0 0 2 0 4 0 6 0 8 1 1 2 0 120 240 360 480 600 720 840 960 1080 1200 1320 1440 Flow U h Time min ...

Page 183: ...or of flow 20 15 10 5 0 5 10 15 25 Maximum positive measured error Minimum negative measured error Set flow rate 1 0 U h Overall percentage error 183 Material and conditions YpsoPump Orbit soft 110 cm tubing length Ambient conditions 22 C 2 C humidity uncontrolled 25 to 75 Trumpet curve ...

Page 184: ...tridge change Basal rates Bolus Unlock screen Status screen Submenu Main menu Standard bolus Extended bolus Combination bolus Temporary basal rate function Basal rate profiles A and B Prime tubing Prime cannula Switch basal rate profile 10 4 Menu map ...

Page 185: ...it Date Basal rate limit Bolus increment Rotate screen Submenu Main menu Data Settings Stop Run mode Therapy data Alarm history Blind bolus inactive active Bluetooth inactive active Access lock inactive active Bluetooth pairing ...

Page 186: ...ward to unlock Forward One menu level up One step back Warning Alarm Audible signal Vibration signal Battery charge level Battery removed Remove battery Threaded rod returning Navigation aids General icons 10 5 Icon overview ...

Page 187: ...ate profile B Switch to basal rate profile A Icons in main menu and submenus Prime tubing in progress Prime cannula in progress Disconnect infusion set from body Ready for Bluetooth pairing Bluetooth pairing in progress Press function button for 2 seconds Total insulin amount per day basal and bolus ...

Page 188: ...p mode switch to run mode Settings Time of day Date Switch to basal rate profile B Temporary basal rate function Temporary basal rate function activated cancel Cartridge change and current cartridge level Return threaded rod Prime infusion set Prime tubing Prime cannula ...

Page 189: ...rate limit Blind bolus active deactivate Blind bolus inactive activate Access lock active deactivate Access lock inactive activate Rotate screen No battery Battery empty Battery not suitable Bluetooth active deactivate Bluetooth inactive activate Bluetooth pairing ...

Page 190: ...n not completed Priming not completed Bolus canceled Temporary basal rate function completed or canceled Insulin pump stopped Bluetooth connection failed Warning icons Charge internal rechargeable battery Occlusion No insulin Cartridge empty Auto stop Electronic error ...

Page 191: ...ustomer Service number IC ID Innovation Science and Economic Devel opment ISED Canada formerly Industry Canada IC certification of radio frequency devices Device with built in Bluetooth technology The Bluetooth word mark and logos are registered trade marks owned by Bluetooth SIG Inc and any use of such marks by Ypsomed AG is under license Other trademarks and trade names are those of their respec...

Page 192: ...be sold within the EU European Union and in EFTA countries Consult the instructions for use Restriction of sale and prescription by doctors of medicine USA Sterilized using ethylene oxide Nonpyrogenic Do not reuse Manufacturer Use by date Catalog number Batch code Global trade item number Date of manufacture Keep dry Keep away from sunlight Distributor ...

Page 193: ...te amount when programming the basal rate profiles 10 7 Glossary Basal rate profile The YpsoPump has 2 programmable basal rate profiles A and B A basal rate profile consists of 24 programmable hourly basal rates Insulin delivery can thus be optimally adapted to your metabolism Blind bolus The blind bolus is a method of bolus delivery that can only be programmed and triggered by pressing the functi...

Page 194: ...e insulin to the subcutaneous tissue of the body Cannula base The cannula base is an element of the YpsoPump Orbit infusion set It consists of the cannula the tape and the septum It can be disconnected from the infusion set tubing and is located on the patient side of the infusion set Cartridge The cartridge contains the insulin The cartridge of the YpsoPump has a capacity of 1 6 ml 160U insulin w...

Page 195: ...chscreen of the YpsoPump The entire control system of the YpsoPump is based on language independent icons Infusion set The infusion set is the connection between the YpsoPump and the patient s body Infusion site An infusion site is the part of the body in which the infusion set is applied and the cannula is inserted through the skin Insulin Insulin is a hormone that is made in the beta cells of th...

Page 196: ...vered according to the settings Normally all the functions of the YpsoPump can be per formed All operable icons are active Self test The self test is the procedure that is automatically per formed when the device is put into operation for the first time and after every return of the threaded rod The insulin pump tests the functions and the operability of the visual signal screen the vibration sign...

Page 197: ...e inactive in stop mode The relevant icons are displayed in gray and are disabled Swipe Swipe is the action taken on the screen of the YpsoPump with which values are set Set a value by swiping up or down with your finger until the required value is at the center of the screen You can also tap the upper or lower value directly in order to increase or reduce it by one unit each time Temporary basal ...

Page 198: ... is the procedure in which the threaded rod of the YpsoPump returns to the starting position so that a new cartridge can be inserted Touchscreen Touchscreen means a screen that is sensitive to touch The touchscreen of the YpsoPump responds to touch and is controlled by tapping and swiping 100 U ml 100 U ml indicates the concentration of the insulin 100 units of insulin in every milliliter of liqui...

Page 199: ...M U h 07 00 to 08 00 AM U h 08 00 to 09 00 AM U h 09 00 to 10 00 AM U h 10 00 to 11 00 AM U h 11 00 to 12 00 AM U h Daily total U day 00 00 to 01 00 PM U h 01 00 to 02 00 PM U h 02 00 to 03 00 PM U h 03 00 to 04 00 PM U h 04 00 to 05 00 PM U h 05 00 to 06 00 PM U h 06 00 to 07 00 PM U h 07 00 to 08 00 PM U h 08 00 to 09 00 PM U h 09 00 to 10 00 PM U h 10 00 to 11 00 PM U h 11 00 to 12 00 PM U h ...

Page 200: ... to 08 00 AM U h 08 00 to 09 00 AM U h 09 00 to 10 00 AM U h 10 00 to 11 00 AM U h 11 00 to 12 00 AM U h Daily total U day 00 00 to 01 00 PM U h 01 00 to 02 00 PM U h 02 00 to 03 00 PM U h 03 00 to 04 00 PM U h 04 00 to 05 00 PM U h 05 00 to 06 00 PM U h 06 00 to 07 00 PM U h 07 00 to 08 00 PM U h 08 00 to 09 00 PM U h 09 00 to 10 00 PM U h 10 00 to 11 00 PM U h 11 00 to 12 00 PM U h ...

Page 201: ...al rate function Value Duration e g soccer training percent hours percent hours percent hours percent hours percent hours percent hours percent hours percent hours percent hours percent hours percent hours percent hours ...

Page 202: ...Notes 202 ...

Page 203: ...203 ...

Page 204: ...f products and services for people with diabetes This allows users easy discreet and reliable self treatment With Ypsomed Diabetescare self treatment becomes simpler and easier 700014926 10158176 MSTR CA en V03 Edition 2019 03 Ypsomed Canada Inc 1 Holiday Avenue Suite 647 Pointe Claire QC H9R 5N3 info ypsomed ca www ypsomed diabetescare ca 514 695 5959 Toll free 1 833 695 5959 ...

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