Page 1 User Guide Insulin Pump Freedom. Confidence. With mylife ™ YPU_IFU_V1.5_NZ-en.indd 1 16.08.19 09:55...
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Page 3: Table Of Contents
Contents 1 Introduction 2.4 Run and stop modes 1.1 Note about the User Guide Run mode 1.2 Warranty provisions Stop mode 1.3 Indications and contraindications Status screen in run mode 1.4 Potential benefits Status screen in stop mode 1.5 Potential risks 2.5 Putting into operation 1.6 Disposal Inserting a battery 1.7 System warnings...
Page 4 Possible events in alarm history 4.5 Display of last bolus 7 Functions and settings 5 Changing the infusion set and cartridge 7.1 Changing the time of day 5.1 mylife YpsoPump Reservoir 7.2 Changing the date ™ ® Filling the mylife...
Page 5 7.6 Preparing for storage Cartridge empty 7.7 Internal rechargeable battery Auto stop 7.8 Changing the battery Electronic error 8 Troubleshooting 9 Everyday situations 8.1 Incidents 9.1 General 8.2 Displayed warnings 9.2 Watertightness Cartridge level low 9.3 Traveling Battery charge level low 9.4 Sources of interference Threaded rod return not completed 9.5 Sport...
Page 6 10.8 My pump settings minor or moderate injury Indicates a hazardous situation which, if not avoided, could result in death or serious injury Read the User Guide Ypsomed AG, CH-3401 Burgdorf, Switzerland www.ypsomed.com YPU_IFU_V1.5_NZ-en.indd 6 16.08.19 09:55...
Page 7 If you suspect you may have hypoglycaemia or hyperglycaemia, check your blood glucose more frequently for the next few hours, as recommended by your doctor or diabetes advisor, and adapt the insulin delivery settings to the changed conditions. If you are uncertain, contact your doctor or diabetes advisor immediately. Check your blood glucose as often as your doctor or diabetes advisor recommends.
Page 8: Introduction
1 Introduction 1.2 Warranty provisions 1.1 Note about the User Guide Warranty Ypsomed gives you a warranty on your mylife YpsoPump ™ ® This User Guide contains all the information required for covering manufacturing and material defects for a period of conducting insulin pump therapy with the mylife 4 years from the date of purchase.
Page 9 ™ ® Warranty rights become void if the insulin pump is dam- to Ypsomed, or a service point authorised by it, in writing or aged by dropping, impact, application of force, contact on the telephone within the term of warranty.
Page 10 Headquarters: Authorised service point: Ypsomed AG Pharmaco (N.Z.) Ltd Customer Care: Brunnmattstrasse 6 4 Fisher Crescent, Mt Wellington 0800 GLUCOSE (0800 45 82 67) CH-3401 Burgdorf NZ-Auckland 1060 e-mail: support@pharmacodiabetes.co.nz info@ypsomed.com YPU_IFU_V1.5_NZ-en.indd 10 16.08.19 09:55...
Page 11: Indications And Contraindications
Procedure in case of serious incident Who are unable to maintain regular contact with their Inform Ypsomed and your local health authority in medical supervisor. case of serious health effects (such as serious injury Who do not have adequate eyesight or hearing to be able or hospitalisation) and/or malfunction of the mylife ™...
Page 12: Potential Benefits
1.4 Potential benefits 1.5 Potential risks The mylife YpsoPump insulin pump system provides As with any medical device, there are risks associated with ™ ® the common proven benefits of standard continuous using the mylife YpsoPump . Many of the risks are common ™...
Page 13: Disposal
™ Hyperglycaemia (high blood glucose) and ketosis possi- YpsoPump Orbit infusion set, in a safety bin. ® bly leading to Diabetic Ketoacidosis (DKA) due to pump failure, resulting in cessation of insulin delivery due to a hardware defect, software anomaly, insulin leakage, etc.
Page 14: System Warnings
1.7 System warnings Read the Instructions for Use in this User Guide before starting to use your mylife YpsoPump . Not following the ™ ® instructions in the User Guide of your mylife ™ YpsoPump ® or not following warnings indicated in this User Guide can cause hypoglycaemia or hyperglycaemia (read warning in the box on page 7).
Page 15 Use your own therapy settings. The shown values on the following pages are only examples. Always make the first setting or change of the basal rate according to your doctor’s or diabetes advisor’s recommendations and never on your own. Programme your basal rate profile in single steps. To do this carefully enter the hourly values and make sure that the setting before each entry corresponds to your therapy recommendations.
Page 16: System Cautions
1.8 System cautions Avoid exposure of your mylife YpsoPump to temperatures in operation above 37 °C or below 5 °C and to tempera- ™ ® tures in storage above 40 °C or below 0 °C. Insulin solutions freeze near 0 °C and degrade at high temperatures. If you are outside in cold weather, wear your pump close to your body and cover it with warm clothing.
Page 17 To prevent risk of infection, never pull the stopper of the mylife YpsoPump Reservoir beyond the 1.6-ml mark and do ™ ® not reuse the transfer adapter or the reservoir. In loud surroundings it may be difficult to hear alarms (e.g. lawn mowing, concerts, etc.). In such surroundings listen for alarms and check your insulin pump screen more frequently.
Page 18: Operation
2 Operation Use of the wrong function can lead to incorrect dosages of insulin. Refer to this User Guide for correct operation and have your doctor or diabetes advisor check the settings. If you have activated a wrong function or changed an insulin pump setting, undo it as described in this User Guide.
Page 19 Use only AAA alkaline batteries (LR03) with your mylife YpsoPump . If a different type of battery (e.g. a lithium battery or ™ ® a NiMH rechargeable battery) or a damaged battery is inserted, there is no guarantee that the insulin pump will operate properly.
Page 20: System Overview
Cannula (soft or steel) Tubing Function button Battery compartment lid Cannula Touchscreen base Self-filled Tape Tubing cap Adaptor mylife YpsoPump ™ ® Reservoir 1.6-ml Cartridge compartment AAA alkaline Infusion set reservoir with viewing window battery (LR03) YPU_IFU_V1.5_NZ-en.indd 20 16.08.19 09:55...
Page 21: Navigation
2.2 Navigation Touchscreen The mylife YpsoPump has a touchscreen (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 mylife...
Page 22 Using your finger, swipe up or down through the values displayed. In this way you can increase or reduce a value. You can also tap the upper or lower value directly in order to increase or reduce it by one unit. The value selected is always displayed at the centre of the visible values and it has a grey background.
Page 23: Function Button
Function button The mylife YpsoPump has a function button. ™ ® It is located next to the opening of the cartridge 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...
Page 24: Icons
Icons 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. YPU_IFU_V1.5_NZ-en.indd 24 16.08.19 09:55...
Page 25: Active And Inactive Icons
Active and inactive icons Active icons are bright. That means Inactive icons are displayed in a darker the function is available and can be grey. This means the function is not selected with your finger. available and cannot be selected with your finger. YPU_IFU_V1.5_NZ-en.indd 25 16.08.19 09:55...
Page 26: Confirmation And Cancelation
Confirmation and cancellation To confirm a value or select a function To cancel a procedure or function, . Additionally, bolus cancellation always has to be confirmed by tapping YPU_IFU_V1.5_NZ-en.indd 26 16.08.19 09:55...
Page 27: Back Function
Back function If you have selected a function or value by mistake or made a wrong setting, you can go back at any time by swiping to the right once until appears. appears, you go one step back. You do not quit the function and no set values are lost.
Page 28: User Interface
2.3 User interface Unlock screen 1/6: The status screen of the mylife 2/6: The mylife YpsoPump has a 3/6: Swipe to the left to unlock the ™ ™ ® YpsoPump is switched on and off screen lock. It is visualised by a status screen and the main menu.
Page 29 4/6: Tap the currently active number 5/6: When the mylife YpsoPump 6/6: Swipe to the right to access the ™ ® successively to unlock the status has been unlocked successfully, unlocked status screen (no padlock screen. If the three numbers on the you are in the main menu. Swipe to icon).
Page 30: Overview Of The Main Menu
The small squares highlighted in white indicate where you currently are in the main menu. When operating Basal rates Prime infusion set Stop/Run mode the mylife YpsoPump always make ™ ® sure you use the various functions properly. YPU_IFU_V1.5_NZ-en.indd 30...
Page 31: Run And Stop Modes
2.4 Run and stop modes Run mode The mylife YpsoPump has two ™ ® different operating modes, “Run” and “Stop”. The “Stop mode” and “Run mode” icons show the current operat- ing status of the insulin pump in each case. Insulin delivery (e.g. basal rate) is only possible in run mode.
Page 32 3/3: The status screen appears. Basal rate delivery starts according to the programmed profile. YPU_IFU_V1.5_NZ-en.indd 32 16.08.19 09:55...
Page 33: Stop Mode
Stop mode To switch the mylife YpsoPump from ™ ® run mode to stop mode, open the main menu. Insulin delivery is not possible in stop mode. 1/3: Open the main menu, swipe to 2/3: Confirm by tapping . The the left and tap the “Run mode/switch...
Page 34 3/3: The status screen appears. Insulin deliveries are stopped immediately. This is indicated on the screen. The screen of the mylife YpsoPump shows a stop warning if the insulin ™ ® pump has been in stop mode for more than one hour. The stop warning...
Page 35: Status Screen In Run Mode
(appears only if activated) of information and it indicates the current operating status of the mylife ™ Current time of day Current date YpsoPump . You can access the ® Battery charge status screen at any time by giving the level function button one short press.
Page 36: Status Screen In Stop Mode
Access lock icon (appears Status screen in stop mode Bluetooth icon ® only if activated) If the insulin pump is in stop mode, (appears only if activated) all insulin delivery is cancelled. Current time of day Current date Battery charge level Basal rate stopped Padlock...
Page 37: Putting Into Operation
2.5 Putting into operation Inserting a battery 1/11: Insert a new AAA alkaline battery (LR03). Make sure 2/11: Lock the battery compartment by turning the groove the negative pole of the battery is inserted first. On the of the battery compartment lid clockwise until it is completely back of the insulin pump you will see a picture showing closed using the edge of a coin.
Page 38: Self-Test
Self-test The self-test is used to check the op- erability of the mylife YpsoPump ™ ® and to give the user visual, tactile and audible feedback. A self-test is per- formed when putting the insulin pump into operation for the first time, after...
Page 39 5/11: Three test patterns appear 6/11: Then the mylife YpsoPump ™ ® on the screen one after the other. emits two vibration signals (tactile The 3 × 3 test rectangles must signals). be displayed in full with uniform brightness. YPU_IFU_V1.5_NZ-en.indd 39...
Page 40 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 7/11: The tactile signals are followed 8/11: The self-test is completed.
Page 41: Setting The Time Of Day
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 YPU_IFU_V1.5_NZ-en.indd 41 16.08.19 09:56...
Page 42: Setting The Date
Setting the date To complete the putting into operation of your insulin pump, please program both basal rate profiles following the steps on page 44, insert a cartridge following the steps on page 96, prime the infusion set following the steps 10/11: After setting the time of day, 11/11: The status screen appears.
Page 43: Basal Rate
3 Basal rate Always programme 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.
Page 44: Programming Basal Rate Profile A
“Basal rates” icon. icon. programmed in the same way as basal rate profile A. The following values are displayed on the screen of your mylife YpsoPump and mentioned in this User Guide ™ ® using the following abbreviations: U = insulin units...
Page 45 3/8: The screen to set the basal rate 4/8: Select the value specified for you 5/8: By swiping to the right you can for the first hour appears, starting at by your doctor, between 0.00 U/h and step back one hour at any time and midnight (00 –...
Page 46 6/8: Repeat step 4/8 for each individual 7/8: When all values have been entered, 8/8: The status screen appears. The hour segment until you have entered all the mylife YpsoPump shows you mylife YpsoPump is in stop mode. ™ ® ™ ® 24 basal rate values.
Page 47 The total daily dose of the programmed basal rate profile is displayed in the basal rate submenu on the corresponding basal rate icon. YPU_IFU_V1.5_NZ-en.indd 47 16.08.19 09:56...
Page 48: Programming Basal Rate Profile B
3.2 Programming basal rate profile B In addition to basal rate profile A, you have the option to programme a different basal rate profile B. If only one basal rate profile is needed, basal rate profile B has to be programmed in the same way as basal rate profile A. You can switch between basal 1/8: Open the main menu and tap the 2/8: Tap the “Basal rate profile B”...
Page 49 3/8: The screen to set the basal rate for 4/8: Select the value specified for you by 5/8: By swiping to the right you can the first hour appears, starting at your doctor, between 0.00 U/h and step back one hour at any time and midnight (00 –...
Page 50 6/8: Repeat step 4/8 for each individual 7/8: When all values have been entered, 8/8: The status screen appears. The hour segment until you have entered all the mylife YpsoPump shows you mylife YpsoPump is in stop mode. ™ ® ™ ® 24 basal rate values.
Page 51 The total daily dose of the programmed basal rate profile is displayed in the basal rate submenu on the corresponding basal rate icon. YPU_IFU_V1.5_NZ-en.indd 51 16.08.19 09:56...
Page 52: Switching Basal Rate Profile
3.3 Switching basal rate profile 1/4: Open the main menu and tap the 2/4: If basal rate profile A is active, 3/4: If basal rate profile B is active, “Basal rates” icon. tap the “Switch to basal rate profile B” tap the “Switch to basal rate profile A” icon.
Page 53 4/4: When you have made your selection, the mylife YpsoPump indicates the ™ ® relevant basal rate profile (A or B) with the basal rate daily dose. Confirm by tapping . The mylife YpsoPump vibrates briefly. ™ ® Switching basal rate profiles changes basal insulin delivery. Make sure such a change complies with your therapy recommendation.
Page 54: Changing A Basal Rate Profile
3.4 Changing a basal rate profile 1/4: Open the main menu and tap the 2/4: Tap the basal rate profile icon 3/4: The screen to set the basal rate “Basal rates” icon. The screen displays you want to change. for the first hour, starting after midnight the basal rate submenu. If the “Tempo- (00 –...
Page 55 4/4: Confirm by tapping . The mylife ™ YpsoPump vibrates briefly. The ® mylife YpsoPump saves the values, ™ ® writes an event to the therapy data for each changed value and indicates the basal rate daily dose. YPU_IFU_V1.5_NZ-en.indd 55 16.08.19 09:56...
Page 56: Temporary Basal Rate Function
(A or B) continues. To use the temporary basal rate function the mylife YpsoPump must be in run 1/7 Open the main menu and tap the 2/7: Tap the “Temporary basal rate ™...
Page 57 The period can be information under the period of time current basal rate, select a value set from 15 minutes to 24 hours in selected. The mylife YpsoPump ™ ® between 110 % and 200 %, e.g. if you steps of 15 minutes.
Page 58 6/7: The status screen appears with 7/7: In addition, the period of time remaining and the selected percentage of the actual basal rate. A % sign next to the basal rate are displayed alternately under the basal rate value. the basal rate profile set indicates that a temporary basal rate function is active.
Page 59: Canceling The Temporary Basal Rate Function
1/4: Open the main menu and tap the 2/4: Tap the “Temporary basal rate 3/4: Confirm cancellation of the tempo- “Basal rates” icon. function activated/cancel” icon. rary basal rate function by tapping The mylife YpsoPump vibrates briefly. ™ ® YPU_IFU_V1.5_NZ-en.indd 59 16.08.19 09:56...
Page 60 4/4: The status screen appears with the basal rate originally programmed. YPU_IFU_V1.5_NZ-en.indd 60 16.08.19 09:56...
Page 61: Bolus
4 Bolus Only change your specified bolus increment after consulting your doctor or diabetes advisor. Changing your bolus increment accidentally can lead to hypoglycaemia or hyperglycaemia (read warning in the box on page 7). If the bolus is cancelled prematurely, the warning “Bolus cancelled” appears. Premature cancellation occurs when there is an alarm or when the insulin pump is set to stop mode.
Page 62 To situations: be able to deliver a bolus the mylife Compensation for meal carbohy- ™ YpsoPump must be in run mode. drates (a meal bolus). ® Reduction of blood glucose to correct a high blood glucose level.
Page 63: Setting Bolus Increment
4.1 Setting bolus increment The bolus increment indicates the increase or decrease in bolus amount per touchscreen gesture. It also indi- cates 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”...
Page 64 2/4: Tap the “Set bolus increment” 3/4: Select one of the following bolus icon. increments: 0.1 U, 0.5 U, 1.0 U, 2.0 U. Set the bolus increment value that was specified for you by your doctor. Confirm your setting by tapping The insulin pump vibrates briefly. YPU_IFU_V1.5_NZ-en.indd 64 16.08.19 09:56...
Page 65 4/4: The 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. YPU_IFU_V1.5_NZ-en.indd 65 16.08.19 09:56...
Page 66: Activating Blind Bolus
4.2 Activating blind bolus When putting the mylife 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. 1/4: Open the main menu and tap the 2/4: Swipe to the left and tap the “Settings”...
Page 67 3/4: Confirm by tapping . The 4/4: If you open the main menu again, mylife YpsoPump vibrates briefly tap the “Settings” icon and swipe ™ ® and the blind bolus function can to the left, the “Blind bolus active/ be used. Follow the procedure on deactivate”...
Page 68: Deactivating Blind Bolus
4.3 Deactivating blind bolus With the mylife YpsoPump ™ ® have the option of deactivating the blind bolus function. 1/4: Open the main menu and tap the 2/4: Swipe to the left and tap the “Settings” icon. “Blind bolus active/deactivate” icon. YPU_IFU_V1.5_NZ-en.indd 68...
Page 69 3/4: Confirm by tapping . The mylife 4/4: If you open the main menu again, ™ YpsoPump vibrates briefly and tap the “Settings” icon and swipe ® the blind bolus function is deactivated. to the left, the “Blind bolus inactive/ activate” icon now appears.
Page 70: Bolus Types
4.4 Bolus types The mylife YpsoPump has 4 bolus types: ™ ® Standard bolus The bolus amount entered is delivered immediately. Extended bolus The bolus amount entered is delivered over an adjustable extension time, spread equally. Combination bolus The total bolus amount entered is split adjustably between a standard bolus and an extended bolus.
Page 71: Standard Bolus
. If the default value of 0.0 U is confirmed, the standard bolus is cancelled. The mylife YpsoPump vibrates briefly. ™ ® All bolus type functions are not available if the insulin pump is in stop mode, if the cartridge is empty, if the remaining insulin amount in the cartridge is smaller than the bolus increment setting or if the insulin pump displays an alarm or a warning.
Page 72 4/4: The mylife YpsoPump counts down the remaining ™ ® units on the status screen. You can cancel a bolus in progress at any time by tapping . Cancellation must always be confirmed by tapping YPU_IFU_V1.5_NZ-en.indd 72 16.08.19 09:56...
Page 73: Extended Bolus
Extended bolus 1/6: Open the main menu and tap the 2/6: Tap the “Extended bolus” icon. 3/6: Select a bolus amount between “Bolus” icon. 0.1 U und 30.0 U and confirm by tapping . If the default value of 0.0 U is confirmed, the extended bolus is cancelled.
Page 74 4/6: Select the extension time during 5/6: The set bolus amount is displayed 6/6: The mylife YpsoPump counts ™ ® which you wish to deliver the bolus in grey below the extension time down the remaining units on the amount selected. The extension time selected.
Page 75: Combination Bolus
Combination bolus 1/8: Open the main menu and tap the 2/8: Tap the “Combination bolus” 3/8: Select a total bolus amount “Bolus” icon. icon. between 0.2 U and 30.0 U and confirm by tapping . If the default value of 0.0 U is confirmed, the combination bolus is cancelled.
Page 76 4/8: Select the bolus amount that 5/8: The percentage of the immediate 6/8: Select the extension time during you want to deliver directly (immediate portion is displayed in grey under which you wish to deliver the remaining portion). the bolus amount selected. This bolus portion of the bolus amount (extended amount must be confirmed by tapping portion).
Page 77 7/8: The bolus amount of the extended 8/8: The mylife YpsoPump counts ™ ® portion is displayed in grey below down the remaining units on the the extension time selected. The mylife status screen. The immediate portion ™ YpsoPump starts bolus delivery after of the bolus is delivered first.
Page 78: Blind Bolus
You have the option of programming a bolus only by pressing the function button, without using the touchscreen. This means you can deliver a bolus discreetly, when the mylife YpsoPump ™ ® is in your trouser pocket, for example. Make sure the blind bolus function has been activated according to the 1/7: Give the function button one...
Page 79 Function button 2/7: You are now in the blind bolus menu. Here you can 3/7: Set the bolus amount required by giving the function set the bolus amount required. Begin with entering an button a short press for each step of increase. The insulin amount within 4 seconds.
Page 80 4/7: Each bolus amount set is displayed to you on the 5/7: The mylife YpsoPump confirms each step ™ ® screen. When you have entered the bolus amount required, of increase with a short vibration signal. you have to wait 4 seconds. The elapsed time is displayed to you by dots turning grey.
Page 81 Function button 6/7: After a period of 4 seconds a long vibration signal is emitted. By giving the function button a long press, bolus delivery is confirmed. 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.
Page 82 7/7: You can cancel a bolus in progress at any time by tapping . Cancellation must always be confirmed by tapping If the screen of your mylife YpsoPump is switched on during blind bolus programming: ™ ® the blind bolus delivery in progress is displayed on the screen.
Page 83: Blind Bolus Programming At A Glance
Blind bolus programming at a glance Start programming Blind bolus delivery Act within Wait Wait Act within 4 seconds 4 seconds 4 seconds 4 seconds 1/5: Long press 2/5: Short press 3/5: Awaiting 4/5: Awaiting 5/5: Long press of function button of function button confirmation long vibration of function button to start blind for each step...
Page 84: Display Of Last Bolus
4.5 Display of last bolus 1/4: Swipe to the right on the status 2/4: The icon of the bolus type appears 3/4: Example of an extended bolus: screen to display the last bolus on the left of the screen, the relevant if a bolus on the display of last bolus delivered.
Page 85 4/4: Example of a combination bolus: the display of the percentage value of the immediate portion alternates with the display of the extension time of the extended portion at intervals of 2 seconds. YPU_IFU_V1.5_NZ-en.indd 85 16.08.19 09:56...
Page 86: Changing The Infusion Set And Cartridge
5 Changing the infusion set and cartridge Use only the self-filled 1.6-ml reservoir (mylife YpsoPump Reservoir) that is compatible with the mylife YpsoPump ™ ® ™ ® Using a different cartridge which is not declared by the manufacturer to be compatible with mylife ™...
Page 87 Using an infusion set which is not declared by the manufacturer to be compatible with mylife YpsoPump ™ ® lead to incorrect dosages of insulin, which can cause hypoglycaemia or hyperglycaemia (read warning in the box on page 7). If you use an infusion set which is not declared by the manufacturer to be compatible with mylife ™...
Page 88: Mylife ™ Ypsopump ® Reservoir
5.1 mylife YpsoPump Reservoir ™ ® The mylife YpsoPump Reservoir is The following components are required in order to ™ ® intended to be filled with a rapid- use the mylife ™ YpsoPump ® Reservoir: acting insulin at a concentration of...
Page 89: Filling The Mylife ™ Ypsopump ® Reservoir
Filling the mylife YpsoPump Reservoir ™ ® The mylife 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.
Page 90 1/12: Wash your hands thoroughly 2/12: Clean the septum of the insulin 3/12: Remove the reservoir and the with soap and water. vial with an alcohol swab. transfer adaptor from the packaging (see page 88) without touching the septum. YPU_IFU_V1.5_NZ-en.indd 90 16.08.19 09:56...
Page 91 5/12: Then pull the plunger rod 6/12: Attach the other end of the 4/12: Attach the transfer adaptor to backwards until the entire reservoir transfer adaptor to the insulin vial. the reservoir and advance the stopper all the way forward. is filled with air. YPU_IFU_V1.5_NZ-en.indd 91 16.08.19 09:56...
Page 92 8/12: Turn the reservoir, including the 9/12: Check the reservoir for air bub- 7/12: Inject all of the air into the insulin insulin vial, upside down. Very gently bles. If air bubbles are in the reservoir, vial. This will make it easier to then withdraw insulin from the vial.
Page 93 12/12: Follow the instructions on 10/12: Remove the transfer adaptor dispose of it. page 99 in order to insert the reservoir from the vial. Dispose of the transfer adaptor in accordance with local into the mylife YpsoPump ™ ® laws. YPU_IFU_V1.5_NZ-en.indd 93 16.08.19 09:56...
Page 94: Disconnecting The Infusion Set
5.2 Disconnecting the infusion set The mylife YpsoPump Orbit soft and mylife YpsoPump ™ ® ® ™ ® Orbit ® micro infusion sets can be easily disconnected and reconnected, offering you the option of removing the insulin pump and tubing to take a bath, a shower or do sports.
Page 95: Changing The Infusion Set
5.3 Changing the infusion set The mylife YpsoPump Orbit soft infusion set should not be used for more than 72 hours. ™ ® ® The mylife YpsoPump Orbit micro infusion set should not be used for more than 48 hours.
Page 96: Changing The Cartridge
1/7: Always disconnect the infusion set from your body first according to the instructions on page 94. With your mylife YpsoPump , you are not required to change your infusion set every time you change your ™ ® cartridge. They can be changed independently.
Page 97 4/7: Confirm by tapping . The 5/7: The threaded rod returns and mylife YpsoPump vibrates briefly. the percentage is reduced to 0 %. ™ ® Then the self-test is performed (as described on page 38). Do not insert the new cartridge until the threaded rod has completely returned and the mylife YpsoPump ™...
Page 98 6/7: Disconnect the infusion set by 7/7: Remove the empty cartridge from turning the adaptor on the mylife ™ the mylife ™ YpsoPump ® and dispose YpsoPump counterclockwise until it of it in accordance with your national ® stops. environmental protection regulations.
Page 99: Inserting The Cartridge
Inserting the cartridge For the mylife YpsoPump you may ™ ® only use a self-filled 1.6-ml reservoir (mylife ™ YpsoPump ® Reservoir) com- patible with the mylife YpsoPump ™ ® 2/2: Place the adaptor on the inserted 1/2: Hold the mylife YpsoPump ™...
Page 100: Priming The Infusion Set
5.5 Priming the infusion set 1/6: Open the main menu and tap the 2/6: Tap the “Prime tubing” icon. “Prime infusion set” icon. Refer to the Instructions for Use of your mylife YpsoPump Orbit infusion set for the correct priming ™ ®...
Page 101 Instructions for Use of your mylife ™ Instructions for Use of your mylife YpsoPump Orbit infusion set. ™ ® ® 3/6: The screen for setting the priming...
Page 102 . The mylife YpsoPump vibrates palm to remove the air bubbles from the ™ ®...
Page 103 6/6: Repeat the priming procedure with the appropriate priming volume until there are no more air bubbles in the cartridge, in the adaptor or in the tubing and until insulin has emerged from the end of the tubing of the infusion set. YPU_IFU_V1.5_NZ-en.indd 103 16.08.19 09:56...
Page 104: Attaching 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 mylife YpsoPump Orbit infusion set ™ ®...
Page 105 2/12: Clean and disinfect the infusion site with an isopropyl 3/12: Peel the protective foil off the tape carefully. alcohol swab (70 %). Before continuing, make sure there Make sure you do not touch the adhesive film. are no hairs on the site and that the infusion site is dry. We recommend you to use a 70 %-isopropyl-alcohol pad.
Page 106 5/12: Stabilise the infusion site and insert the cannula at an carefully. angle of 90° or alternatively use the appropriate inserter for the infusion set. The mylife YpsoPump Orbit micro has a steel cannula that can be applied to the body without any additional ™ ®...
Page 107 6/12: Press the tape onto the skin and run your fingers 7/12: Press the tape onto the skin with one hand and over the tape for a few seconds to optimise adhesion. grasp the introducer cap with two fingers of your other hand.
Page 108 8/12: Carefully remove the introducer needle 9/12: Cover the removed introducer needle with the blue (mylife YpsoPump Orbit soft) or the introducer cap protection cap and dispose of it in a safety bin. ™ ® ® (mylife YpsoPump Orbit micro) by pressing on ™...
Page 109 10/12: Attach the tubing cap straight to the cannula base 11/12: Make sure you hear it click into place. of the infusion set. YPU_IFU_V1.5_NZ-en.indd 109 16.08.19 09:56...
Page 110 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. YPU_IFU_V1.5_NZ-en.indd 110 16.08.19 09:56...
Page 111: Priming The Cannula
5.7 Priming the cannula After having attached the infusion set to your body, the cannula has to be primed with insulin. 1/4: Open the main menu and tap the 2/4: Tap the “Prime cannula” icon. “Prime infusion set” icon. YPU_IFU_V1.5_NZ-en.indd 111 16.08.19 09:56...
Page 112 0.1 U and been reached. You can cancel 1.0 U, according to the Instructions for the priming procedure at any time by Use of your mylife tapping ™ YpsoPump ® Orbit ® infusion set. Confirm by tapping The mylife YpsoPump vibrates briefly ™...
Page 113: Data/History
Alarm history lists all the alarms that data menu. have taken place. If the number of events exceeds the maximum number, The mylife YpsoPump has a data the oldest events are overwritten. ™ ® backup that typically covers at least 6 months.
Page 114: Therapy Data
6.1 Therapy data 1/6: Open the main menu and tap the 2/6: Tap the “Therapy data” icon. 3/6: For each event, the time of day “Data” icon. 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, the relevant value in the middle.
Page 115: Example: Combination Bolus
Example: combination bolus Three screens each containing different information are displayed one after the other at intervals of 2 seconds: 4/6: Display of total bolus amount. 5/6: Display of immediate portion. YPU_IFU_V1.5_NZ-en.indd 115 16.08.19 09:56...
Page 116 6/6: Display of extended portion and extension time. Remember to back up your therapy data regularly to prevent any loss of events. YPU_IFU_V1.5_NZ-en.indd 116 16.08.19 09:56...
Page 117: Possible Events In Therapy Data
Possible events in therapy data Battery removed Primed cannula Bolus increment changed Primed tubing Combination bolus Standard bolus or blind bolus Switched from basal rate profile A to basal rate Date changed profile B Switched from basal rate profile B to basal rate Extended bolus profile A Hourly value from basal rate profile A changed...
Page 118 Temporary basal rate function Threaded rod returned Time of day changed Total insulin amount per day (basal and bolus) YPU_IFU_V1.5_NZ-en.indd 118 16.08.19 09:56...
Page 119: Alarm History
6.2 Alarm history 1/3: Open the main menu and tap the 2/3: Tap the “Alarm history” icon. 3/3: For each event, the time of day “Data” icon. 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.
Page 120: Possible Events In Alarm History
Possible events in alarm history Auto stop No insulin Battery empty Occlusion Battery not suitable Cartridge empty Charge internal rechargeable battery Electronic error No battery YPU_IFU_V1.5_NZ-en.indd 120 16.08.19 09:56...
Page 121: Functions And Settings
7 Functions and settings For patients who do not self-manage their diabetes, the access lock function should always be activated when the insulin pump is not being used by a caregiver. The access lock function is intended to prevent inadvertent operation that may lead to insulin delivery or changes in the insulin pump settings.
Page 122: Changing The Time Of Day
1/3: Open the main menu and tap the 2/3: Tap the “Time of day” icon. 3/3: Set the current time of day, “Settings” icon. confirm by tapping and the mylife YpsoPump will vibrate briefly. ™ ® The time of day set is entered in the therapy settings. YPU_IFU_V1.5_NZ-en.indd 122...
Page 123: Changing The Date
7.2 Changing the date 1/3: Open the main menu and tap the 2/3: Tap the “Date” icon. 3/3: Set the current date (day, “Settings” icon. month, year). 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.
Page 124: Access Lock
7.3 Access lock The access lock function offers access protection (e.g. for The following mylife YpsoPump functions cannot be ™ ® children). operated when the access lock function is activated: All types of bolus delivery When the access lock function is activated, only the following...
Page 125: Activating Access Lock
1/5: Open the main menu and tap the 2/5: Swipe to the left and tap the 3/5: Confirm by tapping . The “Settings” icon. “Access lock inactive/activate” icon. mylife YpsoPump vibrates ™ ® briefly and the access lock function is activated. YPU_IFU_V1.5_NZ-en.indd 125...
Page 126 4/5: The status screen appears. 5/5: If you open the main menu again, The activated access lock function is tap the “Settings” icon and swipe visualised by an access lock icon at to the left, the “Access lock active/ the top of the screen. deactivate”...
Page 127: Deactivating Access Lock
1/5: Open the main menu and tap the 2/5: Swipe to the left and tap the 3/5: Confirm by tapping . The “Settings” icon. “Access lock active/deactivate” icon. mylife YpsoPump vibrates ™ ® briefly and the access lock function is deactivated. YPU_IFU_V1.5_NZ-en.indd 127...
Page 128 4/5: The status screen appears. The ac- 5/5: If you open the main menu again, cess lock icon at the top of the screen tap the “Settings” icon and swipe disappears. All icons are now active and to the left, the “Access lock inactive/ the functions can be operated again.
Page 129: Rotating The Screen By
7.4 Rotating the screen by 180° You have the option of rotating the screen of the mylife ™ YpsoPump ® by 180°. 1/3: Open the main menu and tap the 2/3: Swipe to the left and tap the “Settings” icon. “Rotate screen” icon.
Page 130 3/3: Confirm by tapping . The mylife YpsoPump vibrates ™ ® briefly and the orientation of the screen is rotated by 180°. YPU_IFU_V1.5_NZ-en.indd 130 16.08.19 09:56...
Page 131: Bluetooth
7.5 Bluetooth ® Activating Bluetooth ® Use the Bluetooth function to transfer ® your therapy data from your mylife ™ YpsoPump ® to another supported Bluetooth enabled device. If you want ® to use the Bluetooth connection ® to a Bluetooth enabled device, the ®...
Page 132 3/5: Confirm by tapping . The 4/5: The status screen appears. The 5/5: If you open the main menu mylife YpsoPump vibrates briefly and activated Bluetooth function is again, tap the “Settings” icon and ™ ® ® the Bluetooth function is activated. visualised by a Bluetooth icon at the swipe to the left, the “Bluetooth...
Page 133: Deactivating Bluetooth
If you do not want to use any Bluetooth enabled devices with the ® mylife ™ YpsoPump ® , the Bluetooth ® interface can be deactivated. 1/5: Open the main menu and tap the 2/5: Swipe to the left and tap the “Settings”...
Page 134 3/5: Confirm by tapping . The 4/5: The status screen appears. 5/5: If you open the main menu again, mylife YpsoPump vibrates The Bluetooth icon at the top of the tap the “Settings” icon and swipe ™ ® ® briefly and the Bluetooth function screen disappears.
Page 135: Bluetooth ® Pairing
Bluetooth pairing ® The first time you establish Bluetooth ® connectivity between the mylife ™ YpsoPump ® and another Bluetooth ® enabled device, you have to enter an identification code to allow Bluetooth ® connection between the two devices. To use the Bluetooth pairing function, ®...
Page 136 3/6: The mylife YpsoPump is ready 4/6: A six-digit number code appears 5/6: If Bluetooth pairing was suc- ™ ® ® for Bluetooth pairing and waits for on the screen of the mylife YpsoPump cessful, the display automatically ® ™ ® the pairing request of the Bluetooth and the arrows rotate.
Page 137 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 mylife YpsoPump ™ ® YPU_IFU_V1.5_NZ-en.indd 137 16.08.19 09:56...
Page 138: Preparing For Storage
If you will not be using the mylife After a restart all you have to do is ™ perform the self-test and reset YpsoPump ® for a longer period, set your insulin pump into stop mode the time of day and date. After that, and remove the battery from the insulin the insulin pump is in stop mode.
Page 139 1/2: Set the mylife YpsoPump 2/2: Open the battery compartment ™ ® stop mode (see page 33). Remove lid and remove the battery. Close the cartridge and the infusion set as the battery compartment lid and store described on page 96. the mylife YpsoPump in a safe place.
Page 140: Internal Rechargeable Battery
7.7 Internal rechargeable battery The mylife YpsoPump has an internal rechargeable battery that is charged by the inserted alkaline battery. If the alkaline ™ ® battery is removed, all functions still work. If the insulin pump is in run mode and a new battery is not inserted within 5 minutes, the “No battery”...
Page 141: Changing The Battery
Replace the battery as soon your national environmental protection regulations. as possible. If the battery compartment has remained open for more than 5 minutes and the mylife 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.
Page 142 3/5: The battery orientation screen 4/5: Insert a new, size AAA, alkaline battery (LR03). Make shows the orientation of the AAA sure the negative pole of the battery is inserted first. battery for insertion. It appears on the On the back of the insulin pump you will see a picture status screen.
Page 143 5/5: Lock the battery compartment by inserting a coin in the groove of the battery compartment lid and turning it clockwise until it stops. When the battery has been inserted, the mylife icon appears first, followed by the status screen or ™...
Page 144 If you remove the battery while you are in the main menu or in a submenu, all the current settings, which have not yet been confirmed, will be discarded and the battery orientation screen appears. After removal of the battery the following functions are completed first before the battery orientation screen appears: Return of the threaded rod Priming in progress...
Page 145: Troubleshooting
8 Troubleshooting Simultaneously triggered alarms are displayed in the order of their priority. If you have handled an alarm, it is possible that further alarms are pending. Unsolved alarms may result in failure of the preset insulin delivery, which can cause hypoglycaemia or hyperglycaemia (read warning in the box on page 7).
Page 146: Incidents
59. Blind bolus function is not Make sure the blind bolus function is activated and the mylife ™ YpsoPump ® is in available run mode. The blind bolus function is not available in stop mode. To put the insulin pump into run mode, follow the instructions on page 31.
Page 147 ® on page 131. “Bolus” icon is not available Make sure the mylife YpsoPump is in run mode. The bolus function is not available ™ ® (shown in grey) in stop mode. To put the insulin pump into run mode, follow the instructions on page 31.
Page 148 Dirt in the cartridge Set the insulin pump into stop mode. Disconnect the infusion set from your body. compartment Remove the cartridge from the cartridge compartment. To clean the insulin pump, follow the cleaning instructions on page 16. Dirt on the surface To clean the insulin pump, follow the cleaning instructions on page 16.
Page 149 Insulin pump dropped Check your blood glucose level frequently. Set 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 dose accuracy.
Page 150 “Switch basal rate profile” icon is If the temporary basal rate function is activated, the switch basal rate profile not available (shown in grey) function is not available. To cancel the temporary basal rate function, follow the instructions on page 59. Water in the battery Set the insulin pump into stop mode.
Page 151: Displayed Warnings
8.2 Displayed warnings The mylife YpsoPump has a safety system that constantly monitors all functions. If there is a deviation from the defined ™ ® operating status, the insulin pump triggers a warning or an alarm, depending on the situation. You will find a description of the alarms on page 160.
Page 152: Cartridge Level Low
Cartridge level low The “Cartridge level low” warning is triggered if the programmed basal rate (including the temporary basal rate function) for the next 12 hours, together with the remaining amount of any bolus in progress, is greater than or equal to the remaining contents of the cartridge.
Page 153: Battery Charge Level Low
Battery charge level low If the “Battery charge level low” warning appears, the mylife YpsoPump can still be operated for at least two days. ™ ® Confirm by tapping and insert a new AAA alkaline battery (LR03) as soon as possible. Follow the procedure on page 141.
Page 154: Threaded Rod Return Not Completed
Threaded rod return not completed The “Threaded rod return not completed” warning appears if it has not yet been possible to perform the threaded rod return function properly. The warning can occur on account of dirt (sand, dried insulin, etc.) in the cartridge compartment or generally if the drive has a mechanical fault.
Page 155: Priming Not Completed
Priming not completed The “Priming not completed” warning appears if: the drive is fully extended (cartridge empty) without a plunger having been detected. the priming procedure is cancelled by the user during plunger detection. the priming procedure is cancelled 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.
Page 156: Bolus Canceled
Bolus cancelled The “Bolus cancelled” warning appears if a bolus is cancelled prematurely. Premature cancellation happens if there is an alarm or if the insulin pump is put into stop mode. Confirm by tapping If your bolus in progress is cancelled prematurely, you can obtain the actual duration and the insulin amount delivered by referring to the therapy data or to the last bolus screen.
Page 157: Temporary Basal Rate Function Completed Or Canceled
Temporary basal rate function completed or cancelled The “Temporary basal rate function completed or cancelled” warning appears if the temporary basal rate function has been completed or if it is cancelled prematurely. Premature cancellation happens if there is an alarm or if the insulin pump is put into stop mode.
Page 158: Insulin Pump Stopped
. The warning now no longer appears unless the insulin pump is set to run mode again and then back to stop mode. To restart the insulin pump, follow the steps on page 31. The screen of the mylife YpsoPump shows a stop warning if the insulin ™...
Page 159: Bluetooth ® Connection Failed
Bluetooth connection failed ® The “Bluetooth connection failed” warning appears if: ® the 30-second time limit to enter the identification code is exceeded during the pairing process. a wrong identification code is entered during pairing process. an active Bluetooth connection is accidentally disconnected. ®...
Page 160: Alarms
8.3 Alarms The mylife YpsoPump has a safety system that constantly monitors all functions. If there is a deviation from the defined ™ ® operating status, the insulin pump triggers an alarm, depending on the situation. You will find a description of the warnings on page 151.
Page 161 Alarms given are primarily tactile and audible and there are 4 escalation levels. The levels escalate at intervals of 5 minutes. If an alarm is confirmed but not dealt with, it is given again by audible and tactile means after 30 minutes. An electronic error is the exception.
Page 162: No Battery
No battery The “No battery” alarm appears if you remove the alkaline battery from the battery compartment for more than 5 minutes when the insulin pump is in run mode. Confirm by tapping and insert a new AAA alkaline battery (LR03). Follow the procedure on page 141.
Page 163: Battery Empty
Battery 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 141. YPU_IFU_V1.5_NZ-en.indd 163 16.08.19 09:56...
Page 164: Battery Not Suitable
Battery not suitable The “Battery not suitable” alarm 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 141.
Page 165: Charge Internal Rechargeable Battery
Charge internal rechargeable battery The “Charge internal rechargeable battery” alarm appears if the internal rechargeable battery of the mylife YpsoPump ™ ® depleted on account of a high load. All the insulin deliveries in progress are cancelled: boluses, temporary basal rate and basal rate.
Page 166: Occlusion
Occlusion The “Occlusion” alarm appears if the infusion path is blocked (e.g. adaptor, infusion set, cannula). Confirm by tapping and disconnect the infusion set from your body. Then perform the following actions: YPU_IFU_V1.5_NZ-en.indd 166 16.08.19 09:56...
Page 167 Change the infusion set in accordance with the procedure on page 95. Prime the tubing with the priming volume specified for the tubing according to the Instructions for Use of your mylife ™ YpsoPump ® Orbit ® infusion set. If priming of the new infusion set can be completed without an occlusion alarm, therapy can be continued.
Page 168: No Insulin
No insulin The “No insulin” alarm appears if after a threaded rod return no 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 .
Page 169: Cartridge Empty
Cartridge empty The “Cartridge empty” alarm appears if the cartridge contains 0.0 U insulin. Confirm by tapping Change the cartridge in accordance with the procedure on page 96. YPU_IFU_V1.5_NZ-en.indd 169 16.08.19 09:56...
Page 170: Auto Stop
Auto stop The “Auto stop” alarm appears if the mylife 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, insulin delivery restarts.
Page 171: Electronic Error
Electronic error If the mylife YpsoPump detects an ™ ® internal malfunction, an electronic error is displayed. All the functions of the insulin pump are cancelled. In the event of an electronic error the insulin pump displays two different screens alternately which show you how to restart the insulin pump in a few steps.
Page 172: Everyday Situations
Sport and physical activity which involve physical contact and hard knocks (e.g. hockey, football, etc.) can cause damage to the mylife ™ YpsoPump ® . Extreme sports (e.g. parachuting, diving, amateur flying, etc.) must not be performed with the mylife YpsoPump .
Page 173: General
9.1 General Always wear the mylife YpsoPump in your trouser pocket or use a carrying system offered by Ypsomed. Position the ™ ® tubing in a way that strangulation is impossible, especially at night. Make sure the insulin pump is not subjected to any jolts, hard knocks or other mechanical interference.
Page 174: Watertightness
9.2 Watertightness The mylife YpsoPump has the water protection classification IPX8 according to EN 60529 (immersion to a depth ™ ® of 1 m for up to 60 minutes). For water sports that cannot comply with these specifications (e.g. diving), disconnect the insulin pump from your body following the instructions on page 94 and measure your blood glucose regularly.
Page 175: Traveling
9.3 Travelling Consult your doctor or diabetes advisor to find out what preparations have to be made in order to travel with the mylife ™ YpsoPump . Make sure you take sufficient supplies for your mylife YpsoPump and blood glucose meter with ®...
Page 176: Sources Of Interference
9.4 Sources of interference The mylife YpsoPump meets the required standards for electromagnetic interference immunity. The functions of the ™ ® mylife YpsoPump should not be affected by security systems at airports or anti-theft systems in department stores. ™ ®...
Page 177: Sport
9.5 Sport Consult your doctor or diabetes advisor to find out what preparations have to be made in order to do sports with the mylife YpsoPump . Make sure you take sufficient supplies for your mylife YpsoPump and blood glucose ™...
Page 178: 10 Annex
10 Annex 10.1 Product specifications Insulin pump dimensions: 7.8 × 4.6 × 1.6 cm Touchscreen dimensions: 4.1 × 1.6 cm Weight: 83 g (including battery and filled cartridge) Temperature range: Operation: from + 5 °C to + 37 °C Storage: from 0 °C to + 40 °C Humidity range: Operation: 20 % to 95 % RH, non-condensing Storage: 20 % to 95 % RH, non-condensing...
Page 179 Minimum basal rate greater than 0.00 U/h: 0.02 U/h Basal rate increments: Range 0.02 U/h to 1.00 U/h: increment 0.01 U/h Range 1.00 U/h to 2.00 U/h: increment 0.02 U/h Range 2.00 U/h to 15.0 U/h: increment 0.1 U/h Range 15.0 U/h to 40.0 U/h: increment 0.5 U/h Bolus types: Standard bolus, extended bolus, combination bolus and blind bolus Minimum bolus:...
Page 180: Electromagnetic Compatibility (Emc)
Moving away from, or turning off, these other devices may enable communication. Radiofrequency communications specifications Radiofrequency communication interface Bluetooth 4.0 Low Energy with an Ypsomed proprietary data format ® Operating frequencies 2400 MHz – 2483.5 MHz Channel spacing...
Page 181 – Reorient or relocate the receiving antenna. – Increase the separation between the equipment and receiver. Important: Do not change or modify the internal RF transmitter or antenna unless expressly approved by Ypsomed. Doing so could interfere with your ability to operate the equipment.
Page 182: Precautions Regarding Electromagnetic Compatibility
Data security The mylife YpsoPump insulin pump is designed to only accept radio frequency (RF) communications from paired and ™ ® authenticated devices. “Pairing and authentication” means to set up a connection between the two devices using Bluetooth ® Low Energy (BLE) wireless technology. This is a secure connection, and there is no risk of your pump receiving signals from any other device.
Page 183: Emc Separation Distances
EMC separation distances To provide the mylife YpsoPump with optimal protection against electromagnetic fields the following precautions ™ ® concerning electromagnetic compatibility must be taken: The mylife YpsoPump must be put into operation in accordance with the instructions in this User Guide.
Page 184 Examples: A Wi-Fi router has a transmitting power of 0.1 W limited by law and it operates in the frequency range of 2400 MHz. According to the table that means a recommended safety distance of 22 cm. A DECT cordless telephone has a peak power of 0.25 W and it operates in the frequency range of 1880 to 1900 MHz. According to the table that means a recommended safety distance of approx.
Page 185: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions The mylife YpsoPump is intended for use in the electromagnetic environment specified below. Always make sure that ™ ® the mylife YpsoPump is used in such an environment. ™ ® Emission test Compliance Electromagnetic environment –...
Page 186: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity The mylife YpsoPump is intended for use in the electromagnetic environment specified below. Always make sure that ™ ® the mylife YpsoPump is used in such an environment. ™ ® Electromagnetic Immunity test...
Page 187 Radio frequency Category R Category R On airfields your mylife ™ susceptibility (radiated) (airport radar) (airport radar) YpsoPump may be exposed ® RTCA DO-160G, to strong radar radiation. To Section 20 avoid possible interferences of radar with your insulin pump...
Page 188 Guidance and manufacturer’s declaration – electromagnetic immunity The mylife YpsoPump is intended for use in the electromagnetic environment specified below. Always make sure that ™ ® the mylife YpsoPump is used in such an environment. ™ ® Proximity field from Immunity test...
Page 189 Proximity field from Immunity test wireless transmitters Compliance level Radiated RF electromagnetic field 65 A/m @ 134.3 kHz 65 A/m @ 134.3 kHz AIM Standard 7351731, table 3 7.5 A/m @ 13.56 MHz 7.5 A/m @ 13.56 MHz 7.5 A/m @ 13.56 MHz 7.5 A/m @ 13.56 MHz 5 A/m, 12 A/m @ 13.56 MHz 5 A/m, 12 A/m @ 13.56 MHz...
Page 190 Continuation of the table Electromagnetic environment – guidance Portable and mobile RF communications equipment should be used no closer to any part of the mylife YpsoPump ™ ® including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Page 191 AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the mylife YpsoPump is used exceeds ™...
Page 192: Delivery Accuracy According To
Measured values 1080 1200 1320 1440 Time (min) Material and conditions mylife ™ YpsoPump ® Orbit ® soft, 110 cm tubing length Ambient conditions 22 °C (± 2 °C), humidity uncontrolled (25 % to 75 %) YPU_IFU_V1.5_NZ-en.indd 192 16.08.19 09:56...
Page 193: Trumpet Curve
Minimum negative measured error Overall percentage error Observation window (min) Material and conditions mylife ™ YpsoPump ® Orbit ® soft, 110 cm tubing length Ambient conditions 22 °C (± 2 °C), humidity uncontrolled (25 % to 75 %) YPU_IFU_V1.5_NZ-en.indd 193...
Page 194: Menu Map
10.4 Menu map Status screen Display of last bolus Unlock screen Bolus Basal rates Cartridge change Prime infusion set Standard Extended Combination Temporary basal Switch basal Basal rate Prime Prime bolus bolus bolus rate function rate profile profiles A and B tubing cannula YPU_IFU_V1.5_NZ-en.indd 194...
Page 195 Data Stop/Run mode Settings Therapy Alarm Time Bolus Blind bolus Access lock Rotate Bluetooth Bluetooth ® ® data history of day Date increment inactive/active inactive/active screen inactive/active pairing YPU_IFU_V1.5_NZ-en.indd 195 16.08.19 09:56...
Page 196: Icon Overview
10.5 Icon overview Navigation aids General icons Cancel Warning Confirm Alarm Forward to unlock Audible signal Forward Vibration signal One menu level up Battery charge level One step back Battery removed Remove battery Threaded rod returning YPU_IFU_V1.5_NZ-en.indd 196 16.08.19 09:56...
Page 197: Icons In Main Menu And Submenus
Icons in main menu and submenus Prime tubing in progress Bolus Prime cannula in progress Standard bolus Disconnect infusion set from body Extended bolus Ready for Bluetooth pairing Combination bolus ® Bluetooth pairing in progress Basal rates ® Press function button for 2 seconds Basal rate profile A Total insulin amount per day (basal and bolus) Basal rate profile B...
Page 198 Switch to basal rate profile B Data Temporary basal rate function Therapy data Temporary basal rate function activated/cancel Alarm history Cartridge change and current cartridge level Run mode/switch to stop mode Return threaded rod Stop mode/switch to run mode Prime infusion set Settings Prime tubing Time of day...
Page 199: Alarm Icons
Set bolus increment Bluetooth pairing ® Blind bolus active/deactivate Alarm icons Blind bolus inactive/activate Access lock active/deactivate No battery Access lock inactive/activate Battery empty Rotate screen Battery not suitable Bluetooth active/deactivate Charge internal rechargeable battery ® Bluetooth inactive/activate Occlusion ® YPU_IFU_V1.5_NZ-en.indd 199 16.08.19 09:56...
Page 200: Warning Icons
Warning icons No insulin Cartridge level low Cartridge empty Battery charge level low Auto stop Threaded rod return not completed Electronic error Priming not completed Bolus cancelled Temporary basal rate function completed or cancelled Insulin pump stopped Bluetooth connection failed ®...
Page 201: Explanation Of Symbols
Bluetooth ® SIG, Inc., and any use of such marks by Ypsomed is under license. Other trademarks EU (European Union) and in EFTA countries. and trade names are those of their respective owners. Warning/Caution! Refer to accompanying document.
Page 202: Mylife ™ Ypsopump ® Orbit ® And Mylife ™ Ypsopump ® Reservoir Symbols
YpsoPump Orbit and mylife YpsoPump Reservoir symbols ™ ® ® ™ ® The product was designed and manufac- Manufacturer tured in accordance with the relevant stan- dards/directives and may be sold within the Catalogue number EU (European Union) and in EFTA countries.
Page 203: Glossary
10.7 Glossary Adaptor Basal rate profile The adaptor fixes the cartridge in place in the mylife The mylife YpsoPump has 2 programmable basal rate ™ ™ ® YpsoPump and at the same time pierces the septum of profiles, A and B. A basal rate profile consists of 24 pro- ®...
Page 204 The bolus increment relates to all four bolus types. It indicates The cartridge contains the insulin. The cartridge of the by how many units the bolus amount is increased/reduced mylife YpsoPump has a capacity of 1.6 ml (160 U) insulin ™ ®...
Page 205 Extended bolus Infusion site An extended bolus is delivered by the mylife YpsoPump An infusion site is the part of the body in which the infusion ™ ® over the period of time you select. set is applied and the cannula is inserted through the skin.
Page 206 In run mode, insulin is delivered according to the settings. (screen), the vibration signal and the audible signal. Normally, all the functions of the mylife YpsoPump can be ™ ®...
Page 207 The status screen indicates the current operating status of Swipe is the action taken on the screen of the mylife ™ the mylife YpsoPump (current time of day, current date, YpsoPump with which values are set. Set a value by swiping ™...
Page 208 Threaded rod Touchscreen The threaded rod is a mechanical drive component of Touchscreen means a screen that is sensitive to touch. The the mylife YpsoPump which pushes the plunger of the touchscreen of the mylife YpsoPump responds to touch ™...
Page 209: My Pump Settings
10.8 My pump settings Basal rate profile A Daily total U/day 00:00 to 01:00 12:00 to 13:00 01:00 to 02:00 13:00 to 14:00 02:00 to 03:00 14:00 to 15:00 03:00 to 04:00 15:00 to 16:00 04:00 to 05:00 16:00 to 17:00 05:00 to 06:00 17:00 to 18:00 06:00 to 07:00 18:00 to 19:00...
Page 210 Basal rate profile B Daily total U/day 00:00 to 01:00 12:00 to 13:00 01:00 to 02:00 13:00 to 14:00 02:00 to 03:00 14:00 to 15:00 03:00 to 04:00 15:00 to 16:00 04:00 to 05:00 16:00 to 17:00 05:00 to 06:00 17:00 to 18:00 06:00 to 07:00 18:00 to 19:00 07:00 to 08:00...
Page 211 Temporary basal rate function Value Duration e.g. soccer training per cent hours per cent hours per cent hours per cent hours per cent hours per cent hours per cent hours per cent hours per cent hours per cent hours per cent hours per cent hours...
Page 212 Notes YPU_IFU_V1.5_NZ-en.indd 212 16.08.19 09:56...
Page 213 YPU_IFU_V1.5_NZ-en.indd 213 16.08.19 09:56...
Page 214 Freedom. Conﬁ dence. With mylife ™ Pharmaco (N.Z.) Ltd 4 Fisher Crescent, Mt Wellington Auckland 1060 support@pharmacodiabetes.co.nz www.PharmacoDiabetes.co.nz Customer Care: 0800 GLUCOSE (0800 45 82 67) YPU_IFU_V1.5_NZ-en.indd 214 16.08.19 09:56...

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