Ypsomed mylife YpsoPump User manual

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

3
2.5 Putting into operation 32
Inserting a battery 32
Self-test 34
Setting the time of day 37
Setting the date 38
3 Basal rate 39
3.1ProgrammingbasalrateproleA 39
3.2ProgrammingbasalrateproleB 44
3.3Switchingbasalrateprole 47
3.4Changingabasalrateprole 49
3.5 Temporary basal rate function 51
Activating the temporary basal rate function 51
Cancelling the temporary basal rate function 54
Contents
1 Introduction 7
1.1 Note about the User Guide 7
1.2 Warranty provisions 7
1.3 Indication 11
1.4 Disposal 11
2 Operation 12
2.1 System overview 13
2.2 Navigation 14
Touchscreen 14
Function button 17
Icons 19
Active and inactive icons 19
Conrmation and cancelling 20
Back function 21
2.3 User interface 22
Unlock screen 22
Overview of the main menu 24
2.4 Run and stop modes 26
Run mode 26
Stop mode 28
Status screen in run mode 30
Status screen in stop mode 31

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4 Bolus 56
4.1 Bolus increment 57
4.2Activatingblindbolus 60
4.3 Deactivating blind bolus 62
4.4 Bolus types 64
Standard bolus 65
Extended bolus 67
Combination bolus 69
Blind bolus 72
4.5 Display of last bolus 76
5. Changing the infusion set and cartridge 78
5.1 mylife™YpsoPump®Reservoir 78
Filling the mylife™ YpsoPump® Reservoir 79
5.2 Disconnecting the infusion set 86
5.3 Changing the infusion set 87
5.4 Changing the cartridge 88
Removing the cartridge 88
Inserting an insulin cartridge 90
Priming the infusion set 96
Attaching the infusion set to your body 99
6 Data 106
6.1 Therapy data 106
Example: combination bolus 108
Possible events in therapy data 110
6.2Alarmhistory 112
Possible events in alarm history 113
6.3 Data transfer 114
7 Functions and settings 115
7.1 Changing the time of day 115
7.2 Changing the date 116
7.3 Rotating the screen through 180° 117
7.4 Preparing for storage 119
7.5 Internal rechargeable battery 120
7.6 Changing the battery 121

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8 Troubleshooting 126
8.1 Incidents 126
8.2 Displayed warnings 131
Cartridge level low 132
Battery charge low 133
Threaded rod return not completed 134
Priming not completed 135
End of warranty 136
Bolus ended 137
Temporary basal rate function completed 138
Pump stopped 139
Bluetooth connection failed 140
8.3Alarms 141
Battery removed 144
Battery empty 145
Battery not suitable 146
Charge internal rechargeable battery 147
Occlusion 148
No insulin 150
Cartridge empty 151
Auto stop 152
Electronic error 153
9 Everyday situations 154
9.1 General 154
9.2 Watertightness 155
9.3 Travelling 156
9.4 Sources of interference 157
9.5 Sport 158

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10Annex 160
10.1Productspecications 160
10.2 EMC safety distances as per Table 6 of EN
60601-1-2 163
10.3 Delivery accuracy as per EN 60601-2-24 164
Start-up graph 164
Trumpet curve 165
10.4 Menu map 166
10.5 Icon overview 168
Navigation aids 168
General icons 168
Icons in main menu and submenus 169
Alarm icons 171
Warning icons 172
10.6Explanationofsymbols 173
10.7 Glossary 175
10.8 My pump settings 181
Either swipe down/up or
tap lower/upper 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

7
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.
If during insulin pump therapy any problems or questions
should arise about functions or control procedures, refer
to the User Guide rst. If after that you are still experienc-
ing problems or your questions have not been answered,
do not hesitate to call our service hotline. You will nd the
details on the back of the User Guide.
If a person is only referred to in the male or female form in order to
improve readability, it always includes both genders.
1 Introduction
1.1 Note about the User Guide
Warranty
Ypsomed AG gives you a warranty on your mylife
™
YpsoPump
®
covering manufacturing and material defects
for a period of four (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 the instruc-
1.2 Warranty provisions

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tions for use or if the mylife
™
YpsoPump
®
is operated with
accessories or supplies other than those recommended
by Ypsomed. Nor does the warranty 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 without any connection with
a manufacturing or material defect.
Warranty rights become void upon damage due to drop-
ping, impact, application of force, contact with uids,
improper cleaning or in other cases of exposure and wear
which arise from usage that is not in accordance with the
instructions for use.
This warranty only applies to the rst user and can be
transferred to another person or entity neither by sale, hire
nor any other transfer of the mylife
™
YpsoPump
®
.

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Inasmuch 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.
This device is only available on prescription. Never use the mylife™YpsoPump®without prior training from
your doctor or diabetes advisor. If you use the mylife™YpsoPump®without professional familiarisation
training, it can lead to incorrect dosage of insulin. As it is common 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.
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 descrip-
tion 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 it 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.

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Authorisedservicepoints:
Ypsomed Ltd.
1 Park Court
Riccall Road, Escrick
YO19 6ED
Great Britain
With the mylife™YpsoPump®system only fast-acting insulin at a concentration of U100 may be used (human
insulin or insulin lispro). If you use different insulin, this can lead to incorrect dosages of insulin, which can
cause hypoglycaemia or hyperglycaemia. In such a case, change the cartridge and continue therapy with the
correct type of insulin. 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 dia-
betes advisor immediately.
Consult the user guide for the NovoRapid®PumpCart®from Novo Nordisk to use the latter with the mylife™
YpsoPump®system.
Headquarters:
Ypsomed AG
Brunnmattstrasse 6
CH-3401 Burgdorf
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: [e-mail]

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The mylife™ YpsoPump® is intended for subcutaneous in-
sulin delivery in diabetes mellitus therapy. With the mylife™
YpsoPump® system only fast-acting insulin at a concen-
tration of U100 may be used (human insulin or insulin
lispro). The mylife™ YpsoPump® system is designed for
uninterrupted use over the entire service life. The mylife™
YpsoPump® may, in agreement with the medical special-
ist, be operated by patients themselves as of the age of
12 years.
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 advisor or Customer Service.
1.4 Disposal
When disposing of all materials, always comply with the
environmental protection regulations applicable in the
particular country.

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2 Operation
The mylife™ YpsoPump® system was designed to be as user-friendly as possible. All operating procedures are short and
straightforward. Frequently used functions such as bolus, infusion set change or cartridge change can be performed
quickly and easily.
Never expose the mylife™YpsoPump® to direct sources of light, radiation or heat (e.g. radiators, open res).
This also applies to the insulin you are using. For information about the correct insulin storage conditions
and operating conditions please refer to the user instructions for the insulin you are using. Make sure you
use the mylife™YpsoPump®in your trouser pocket or with a carrying system offered by Ypsomed.
Never let the mylife™YpsoPump®drop. However, if the mylife™YpsoPump®has been dropped, microcracks
and/or visible damages may inuence the functionality and watertightness of the pump.
Never tap the mylife™YpsoPump®on a solid surface (table, kitchen worktop, washbasin, etc.)
Clean the mylife™YpsoPump® regularly with a dump cotton cloth. Afterwards dry it with a dry cotton cloth.
Never use sharp objects (knife, screwdriver, steel wool, etc.), chemicals, solvents or strong detergents to
clean the pump.
If you do not follow these warnings it can lead to hypoglycaemia or hyperglycaemia. 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 you to do so. 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 pump's insulin dosage (e.g. bolus amount).

2.1 System overview
* NovoRapid® and PumpCart® are registered trademarks belonging to Novo Nordisk.
Battery
lid cover
Function buttonTubingCannula (soft or steel)
Tubing cap Adaptor
Touchscreen
AAA alkaline
battery (LR03)
Tape
Cartridge compartment
with viewing windowInfusion set
Cannula
base
Self-lled (mylife™
YpsoPump®
Reservoir) or prelled
1.6 ml cartridge
(NovoRapid®
PumpCart®)*
13

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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 your ngers.

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Using your nger, swipe down or up through the values displayed in order to scroll up or down. In this way you can in-
crease or reduce a value. You can also tap the upper or lower value directly in order to increase or reduce it by one unit
each time. 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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Never use objects to control the mylife™YpsoPump®. They could damage the screen or the function button
and compromise the operability of the mylife™YpsoPump®. If the pump is damaged, the correct delivery of
insulin will not be guaranteed. Ensure that your delivery of insulin is as recommended by your doctor or
diabetes advisor and consult Customer Service. If you suspect you may have hypoglycaemia or hyperglycae-
mia, 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.

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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 methods of input:
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
Program and cancel a blind bolus
Return to the status screen Function button

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Giving the function button a long press may launch the blind bolus menu accidentally if the blind bolus
function was previously activated in the settings. If the blind bolus function is not activated and you give the
function button a long press, there are three short vibrations to indicate that the function button is inactive at
the moment. These three short vibrations also occur if the function button is given a long press in the main
menu or in a submenu, irrespective of whether the blind bolus function is activated or deactivated.

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Icons
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.
Activeandinactiveicons
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.