Ypsomed mylife YpsoPump User manual

More freedom. More condence. With mylife™.
User Guide
Insulin Pump

3
2.5 Putting into operation 31
Inserting a battery 31
Self-test 32
Setting the time of day 35
Setting the date 36
3 Basal rate 37
3.1ProgrammingbasalrateproleA 38
3.2ProgrammingbasalrateproleB 42
3.3Switchingbasalrateprole 46
3.4Changingabasalrateprole 48
3.5 Temporary basal rate function 50
Activating the temporary basal rate function 50
Cancelling the temporary basal rate function 53
4 Bolus 55
4.1 Setting bolus increment 57
4.2Activatingblindbolus 60
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
Conrmation and cancellation 20
Back function 21
2.3 User interface 22
Unlock screen 22
Overview of the main menu 24
2.4Runandstopmodes 25
Run mode 25
Stop mode 27
Status screen in run mode 29
Status screen in stop mode 30

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4.3Deactivatingblindbolus 62
4.4 Bolus types 64
Standard bolus 65
Extended bolus 67
Combination bolus 69
Blind bolus 72
Blind bolus programming at a glance 77
4.5 Display of last bolus 78
5.Changingtheinfusionsetandcartridge 80
5.1 mylife™YpsoPump®Reservoir 83
Filling the mylife™ YpsoPump® Reservoir 84
5.2 Disconnecting the infusion set 89
5.3 Changing the infusion set 90
5.4Changingthecartridge 91
Removing the cartridge 91
Inserting the cartridge 94
5.5 Priming the infusion set 95
5.6Attachingtheinfusionsettoyourbody 99
5.7 Priming the cannula 106
6 Data/History 108
6.1Therapydata 108
Example: combination bolus 110
Possible events in therapy data 112
6.2Alarmhistory 114
Possible events in alarm history 115
7Functionsandsettings 116
7.1Changingthetimeofday 117
7.2Changingthedate 118
7.3Accesslock 119
Activating access lock 120
Deactivating access lock 122
7.4 Rotating the screen by 180° 124
7.5 Bluetooth®126
Activating Bluetooth® 126
Deactivating Bluetooth® 128
Bluetooth® pairing 130
7.6 Preparing for storage 133
7.7 Internal rechargeable battery 135
7.8 Changing the battery 136

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8 Troubleshooting 140
8.1Incidents 142
8.2Displayedwarnings 147
Cartridge level low 148
Battery charge level low 149
Threaded rod return not completed 150
Priming not completed 151
Bolus cancelled 152
Temporary basal rate function completed
or cancelled 153
Insulin pump stopped 154
Bluetooth® connection failed 155
8.3Alarms 156
No battery 158
Battery empty 159
Battery not suitable 160
Charge internal rechargeable battery 161
Occlusion 162
No insulin 164
Cartridge empty 165
Auto stop 166
Electronic error 167
9Everydaysituations 168
9.1 General 169
9.2 Watertightness 170
9.3Travelling 171
9.4 Sources of interference 172
9.5 Sport 173

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10Annex 174
10.1Productspecications 174
10.2EMCsafetydistances
accordingtoTable6ofEN60601-1-2 176
10.3Deliveryaccuracy
 accordingtoEN60601-2-24 178
Start-up graph 178
Trumpet curve 179
10.4 Menu map 180
10.5Iconoverview 182
Navigation aids/General icons 182
Icons in main menu and submenus 183
Alarm icons 185
Warning icons 186
10.6Explanationofsymbols 187
mylife™ YpsoPump® symbols 187
mylife™ YpsoPump® Orbit® and
mylife™ YpsoPump® Reservoir symbols 188
10.7 Glossary 189
10.8 My pump settings 195
Either swipe up/down or
tap upper/lower value
Tap on action eld or icon
Reference to the element
described in the text
Note or additional
information
Warning and precaution
Read the User Guide
Ypsomed AG, 3401 Burgdorf, Switzerland
w
ww.ypsomed.com

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. If you do not check your blood glucose
regularly, blood glucose uctuations will not be detected and you will not be able to adapt the insulin dosage of
the pump (e.g. bolus amount).
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1Introduction
Warnings
Not following the instructions in the User Guide of your mylife™ YpsoPump® or not following warnings indicated in this
User Guide can lead to hypoglycaemia or hyperglycaemia (read warning in the box below).
The mylife™ YpsoPump® insulin pump is only available on prescription. Never use the mylife™ YpsoPump® without prior
training from your doctor or diabetes advisor. Using the mylife™ YpsoPump® without professional familiarisation 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 insulin (e.g. in case of failure of the insulin pump system) is your own responsibility. For
further advice, please consult your doctor or diabetes advisor.
Only rapid-acting insulin at a concentration of 100 U/ml (insulin analogue) may be used with the mylife™ YpsoPump®
system. Using different insulin can lead to incorrect dosages of insulin, which can cause hypoglycaemia or hyperglycaemia
(read warning in the box below). If you use different insulin, change the cartridge as well as the primed infusion set and
continue therapy with the correct type of insulin.

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Warranty
Ypsomed AG gives you a warranty on your mylife
™
YpsoPump
®
covering manufacturing and material defects for a period of
4 years from the date of purchase.
The warranty is restricted to free repair or replacement of
possibly defective devices, at Ypsomed’s own discretion.
If the mylife™ YpsoPump® has been repaired or replaced,
the term of the warranty is not extended.
This warranty only applies if the mylife™ YpsoPump® has been
used as intended. This warranty does not apply to defects
resulting from improper or careless operation, handling or
cleaning, operation contrary to this User Guide or if the
mylife™ YpsoPump® is operated with accessories or supplies
other than those recommended by Ypsomed.
1.2Warrantyprovisions
This User Guide contains all the information required for
conducting insulin pump therapy with the mylife™ 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 rst. Should you still experience problems or if
your questions have not been answered after consulting the
User Guide, do not hesitate to call our Customer Service.
You nd the contact details on the back of this User Guide
as well as on page 10.
If the male or female form is used in order to improve
readability, both genders are referred to.
1.1NoteabouttheUserGuide
The instructions for use in this User Guide are only valid for the following mylife™YpsoPump®article:
REF 700009424.
You nd the reference number of your mylife™YpsoPump®on your device and on the label of your Starter Kit.

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The warranty does not apply if the mylife™ YpsoPump®:
has been altered or modied by anyone other than
Ypsomed,
has been serviced or repaired by anyone other than
Ypsomed or
has been damaged by natural wear, inappropriate
use or for other reasons not linked to a manufacturing
or material defect.
Warranty rights become void if the insulin pump is damaged
by dropping, impact, application of force, contact with
uids listed in chapter 9.1, page 169, water damage due
to dropping of the insulin pump, see chapter 9.2, page
170, improper cleaning or in other cases of exposure and
wear which arise from usage that is not in accordance with
this User Guide.
This warranty only applies to the rst user and cannot be
transferred to another person or entity neither by sale, hire
nor any other transfer of the mylife™ 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 in your mylife™ YpsoPump® must be reported
to Ypsomed, or a service point authorised by it, in writing or
on the telephone within the term of warranty.
The claim must contain the date of purchase and the serial
number of your mylife™ YpsoPump® as well as a description
of the defect about which the claim is being led. The mylife™
YpsoPump® may only be returned to Ypsomed or a service
point authorised by Ypsomed if prior consent has been given
by Ypsomed and if the packaging is appropriate. If the
complaint is justied, Ypsomed will pay any freight charges
for returning the mylife™ YpsoPump® under this warranty.
1.2Warrantyprovisions

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Authorisedservicepoint:
Ypsomed Ltd.
1 Park Court
Riccall Road, Escrick
GB-YO19 6ED, North Yorkshire
Consult the package leaet for the NovoRapid®PumpCart® from Novo Nordisk to use the latter with the
mylife™YpsoPump®system.
Headquarters:
Ypsomed AG
Brunnmattstrasse 6
CH-3401 Burgdorf
[e-mail]
Customer Care: 0344 856 7820
(Calls to this number are free of charge
from mobile phones and landlines,
plus your phone company’s access
charge.)
e-mail: [email protected]

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The mylife™ YpsoPump® is intended for subcutaneous insulin
delivery in diabetes mellitus therapy. Only rapid-acting insulin
at a concentration of 100 U/ml (insulin analogue) may be used
with the mylife™ YpsoPump® system. The mylife™ YpsoPump®
system is designed for uninterrupted use over the entire
service lifetime. The mylife™ YpsoPump® may be used at the
discretion of the supervising health care professional after
appropriate and successful training by a qualied person
(physician or other qualied personnel). There is no age limit
for the patient.
Contraindication
The mylife™ YpsoPump® system is not suitable for persons:
Who are unable to perform at least four blood glucose
tests a day.
Who are unable to maintain regular contact with their
medical supervisor.
Who do not have adequate eyesight or hearing to be able
to operate the mylife™ YpsoPump® system in accordance
with the User Guide.
1.3Indication
Safety instructions
Read all the instructions in this User Guide attentively. Only
use the mylife™ YpsoPump® system after having received
familiarisation training from your healthcare professional. If
you are not able to use the mylife™ YpsoPump® in accordance
with this User Guide, you may jeopardise your health and
safety. In case of doubt consult your doctor, diabetes advi-
sor or Customer Service. Should any technical problems
or questions arise, refer to the User Guide rst. Should you
still experience problems or if your questions have not been
answered after consulting the User Guide, do not hesitate
to call our Customer Service. You nd the contact details
on the back of this User Guide as well as on page 10.
1.4 Disposal
When disposing of all materials, always comply with the en-
vironmental protection regulations applicable in the particular
country. Always dispose of needles and sharp or pointed
objects, such as the cannula base, the tubing with adaptor
and the introducer needle of your mylife™ YpsoPump® Orbit
infusion set, in a safety bin.

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2 Operation
The mylife™ YpsoPump® system is designed to be as user-friendly as possible. All operating procedures are simple and
straightforward. Frequently used functions such as bolus, infusion set change or cartridge change can be performed
quickly and easily.
Warnings
Confusion of icons or using the wrong icon by mistake can lead to incorrect dosage of insulin. If you have confused an
icon by mistake or used the wrong icon by mistake, refer to the correct function in this User Guide and check the settings
specied by your doctor or diabetes advisor. If you have accidentally activated the wrong function or accidentally changed
an insulin pump setting, undo it as described in this User Guide. If you are uncertain, contact Customer Service.
You nd the contact details on the back of this User Guide as well as on page 10. If the accidental confusion or the
accidental mix-up has caused your insulin delivery to stop or change, check your blood glucose more frequently for
the 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 mylife™ YpsoPump® to radiation or heat (e.g. radiators, open res, direct sunlight). This also applies
to the insulin you are using. For information about the correct insulin storage conditions and operating conditions please
refer to the instructions for use of the insulin you are using.
Never drop the mylife™ YpsoPump® , never tap the insulin pump on a solid surface (table, kitchen worktop, washbasin, etc.)
and never use sharp objects (knife, screwdriver, steel wool, etc.), chemicals, solvents or strong detergents to clean the
pump. If the mylife™ YpsoPump® is dropped, tapped or cleaned with sharp objects, microcracks and/or visible damage
may inuence the functionality and watertightness of the insulin pump. If the insulin pump is damaged, the correct
delivery of insulin will not be guaranteed; this can cause hypoglycaemia or hyperglycaemia (read warning in the box on
page 7). Make sure you carry the mylife™ YpsoPump® in your trouser pocket or with a carrying system offered by
Ypsomed to protect your insulin pump.

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Never use objects to operate the mylife™ YpsoPump®. They could damage the screen or the function button and com-
promise the operability of the mylife™ YpsoPump®. If the insulin pump is damaged, correct delivery of insulin cannot be
guaranteed; this can cause hypoglycaemia or hyperglycaemia (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 nd
the contact details on the back of this User Guide as well as on page 10.
Only use AAA alkaline batteries (LR03) with your mylife™ YpsoPump®. Make sure the battery is not damaged. A damaged
battery could result in a short circuit. If a different type of battery (e.g. a lithium battery or an NiMH rechargeable battery)
or a damaged battery is inserted, there is no guarantee that the insulin pump will be put into operation or operate properly;
the advance warning time up to the “Battery empty” alarm (page 159) cannot be maintained when a battery is discharged.
This can lead to failure of the preset insulin delivery, which can cause hyperglycaemia (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 mylife™ YpsoPump® as potential warnings and alarms on the insulin pump can no longer be displayed
and indicated properly. In such a case, contact Customer Service immediately. You nd the contact details on the back
of this User Guide as well as on page 10.
Take special care when setting the time of day. If a wrong time of day is set, the timing of the basal rate prole could be
shifted. Only make changes to your settings after consulting your doctor or diabetes advisor. Incorrect programming
of the insulin pump can lead to incorrect dosages of insulin, which can cause hypoglycaemia or hyperglycaemia (read
warning in the box on page 7).
Choking hazard: keep the battery compartment lids out of reach of children.

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2.1Systemoverview
Battery compartment lidFunction buttonTubingCannula (soft or steel)
Tubing cap Adaptor
Touchscreen
AAA alkaline
battery (LR03)
Tape
Cartridge compartment
with viewing windowInfusion set
Cannula
base Self-filled
(mylife™YpsoPump®
Reservoir) 1.6-ml
reservoir or pre-filled
(NovoRapid®
PumpCart®) 1.6-ml
cartridge

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2.2Navigation
Touchscreen
The mylife™ YpsoPump® has a touchscreen (referred to below as the screen). You control the screen by using your nger
to tap icons and values or swipe through menus and values. The screen of the mylife™ YpsoPump® may only be controlled
with one nger. Do not use any objects to operate the screen.

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Using your nger, 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. 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.

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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 mylife™
YpsoPump® vibrates)
With the function button you can:
Switch the screen on and off
Programme a blind bolus
Return to the status screen Function button

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

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Active icons are bright. That means
the function is available and can be
selected with your nger.
Inactive icons are displayed in a darker
grey. This means the function is not
available and cannot be selected with
your nger.
Activeandinactiveicons

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Conrmationandcancellation
To conrm a value or select a function
tap .
To cancel a procedure or function,
tap . Additionally, bolus cancellation
always has to be conrmed by
tapping .