Ypsomed YpsoPump User manual

More freedom. More condence. With Ypsomed.
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
Canceling the temporary basal rate function 53
3.6 Setting basal rate limit 55
4 Bolus 57
4.1 Setting bolus increment 59
4.2Activatingblindbolus 62
4.3Deactivatingblindbolus 64
Contents
1Introduction 7
1.1NoteabouttheUserGuide 8
1.2Warrantyprovisions 8
1.3Indication 11
1.4 Disposal 11
2 Operation 12
2.1Systemoverview 14
2.2Navigation 15
Touchscreen 15
Function button 17
Icons 18
Active and inactive icons 19
Conrmation and cancelation 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

4
4.4 Bolus types 66
Standard bolus 67
Extended bolus 69
Combination bolus 71
Blind bolus 74
Blind bolus programming at a glance 79
4.5 Display of last bolus 80
4.6 Setting bolus limit 82
5.Changingtheinfusionsetandcartridge 84
5.1 YpsoPump®Reservoir 87
Filling the YpsoPump® Reservoir 88
5.2 Disconnecting the infusion set 93
5.3 Changing the infusion set 94
5.4Changingthecartridge 95
Removing the cartridge 95
Inserting the cartridge 98
5.5 Priming the infusion set 99
5.6Attachingtheinfusionsettoyourbody 103
5.7 Priming the cannula 110
6 Data/History 112
6.1Therapydata 112
Example: combination bolus 114
Possible events in therapy data 116
6.2Alarmhistory 118
Possible events in alarm history 119
7Functionsandsettings 120
7.1Changingthetimeofday 121
7.2Changingthedate 122
7.3Accesslock 123
Activating access lock 124
Deactivating access lock 126
7.4 Rotating the screen by 180° 128
7.5 Bluetooth®130
Activating Bluetooth® 130
Deactivating Bluetooth® 132
Bluetooth® pairing 134
7.6 Preparing for storage 137
7.7 Internal rechargeable battery 139
7.8 Changing the battery 140

5
8 Troubleshooting 144
8.1Incidents 146
8.2Displayedwarnings 151
Cartridge level low 152
Battery charge level low 153
Threaded rod return not completed 154
Priming not completed 155
Bolus canceled 156
Temporary basal rate function completed
or canceled 157
Insulin pump stopped 158
Bluetooth® connection failed 159
8.3Alarms 160
No battery 162
Battery empty 163
Battery not suitable 164
Charge internal rechargeable battery 165
Occlusion 166
No insulin 168
Cartridge empty 169
Auto stop 170
Electronic error 171
9Everydaysituations 172
9.1 General 173
9.2 Watertightness 174
9.3Traveling 175
9.4 Sources of interference 176
9.5 Sport 177

6
10Annex 178
10.1Productspecications 178
10.2EMCsafetydistancesaccording
to Table 6 of IEC 60601-1-2 180
10.3Deliveryaccuracyaccording
to IEC 60601-2-24 182
Start-up graph 182
Trumpet curve 183
10.4 Menu map 184
10.5Iconoverview 186
Navigation aids/General icons 186
Icons in main menu and submenus 187
Alarm icons 189
Warning icons 190
10.6Explanationofsymbols 191
YpsoPump® symbols 191
YpsoPump® Orbit® symbols and
YpsoPump® Reservoir symbols 192
10.7 Glossary 193
10.8 My pump settings 199
Either swipe up/down or
tap upper/lower value
Tap on action 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 hypoglycemia or hyperglycemia, 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).
7
1Introduction
Warnings
Not following the instructions in the User Guide of your YpsoPump® or not following warnings indicated in this User Guide
can lead to hypoglycemia or hyperglycemia (read warning in the box below).
The YpsoPump® insulin pump is only available on prescription. Never use the YpsoPump® without prior training from
your doctor or diabetes advisor. Using the YpsoPump® without professional familiarization training can lead to incorrect
dosage of insulin. As is the case for any user of an insulin pump, ensuring constant access to an alternative means of
injecting 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 (NovoRapid®, Humalog®, Apidra®) may be used with the
YpsoPump® system. Using different insulin can lead to incorrect dosages of insulin, which can cause hypoglycemia or
hyperglycemia (read warning in the box 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.

8
Warranty
Ypsomed AG gives you a warranty on your YpsoPump
®
covering manufacturing and material defects for a period
of 5 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 YpsoPump® has been repaired or replaced, the term
of the warranty is not extended.
This warranty only applies if the 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
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 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 YpsoPump®article:
REF 700013408.
You nd the reference number of your YpsoPump®on your device and on the label of your Starter Kit.

9
The warranty does not apply if the 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 dam aged
by dropping, impact, application of force, contact with
uids listed in chapter 9.1, page 173, water damage due to
dropping of the insulin pump, see chapter 9.2,
page 174 ,
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 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 YpsoPump
®
must be reported to
Ypsomed, or a service point authorized 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 YpsoPump
®
as well as a description of the
defect about which the claim is being led.
The YpsoPump
®
may only be returned to Ypsomed or a
service point authorized 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 YpsoPump
®
under this warranty.
1.2Warrantyprovisions

10
Authorizedservicepoints:
Ypsomed Canada Inc.
1 Holiday Avenue, Suite 647
Pointe-Claire
CA-QC H9R 5N3
Headquarters:
Ypsomed AG
Brunnmattstrasse 6
CH-3401 Burgdorf
[e-mail]
Toll free: 1-833-695-5959
e-mail: [e-mail]

11
The YpsoPump® is intended for subcutaneous insulin delivery
in diabetes mellitus therapy. Only rapid-acting insulin at a
concentration of 100 U/ml (NovoRapid®, Humalog®, Apidra®)
may be used with the YpsoPump® system. The YpsoPump®
system is designed for uninterrupted use over the entire
service lifetime. The YpsoPump
®
may be used at the dis cretion
of the supervising health care professional after appropriate
and successful training by a qualied person (physician or
other qualied personnel). The YpsoPump® may, in agree-
ment with the medical specialist, be used for insulin pump
therapy in patients from the age of 6 years.
Contraindication
The 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 YpsoPump® system in accor-
dance with the User Guide.
1.3Indication
Safety instructions
Read all the instructions in this User Guide attentively.
Only use the YpsoPump® system after having received
familiarization training from your healthcare professional.
If you are not able to use the YpsoPump® in accordance
with this User Guide, you may jeopardize your health and
safety. In case of doubt consult your doctor, diabetes advisor
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
environmental protection regulations applicable in the
particular country. Always dispose of needles and sharp
or pointed objects, such as the cannula base, the
tubing with adapter and the introducer needle of your
YpsoPump® Orbit infusion set, in a safety bin.

12
2 Operation
The YpsoPump® system is designed to be as user-friendly as possible. All operating procedures are simple and straight-
forward. 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 set-
tings 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 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 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 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 hypoglycemia or hyperglycemia (read warning in the box on page 7). Make
sure you carry the YpsoPump® in your trouser pocket or with a carrying system offered by Ypsomed to protect your
insulin pump.

13
Never use objects to operate the YpsoPump®. They could damage the screen or the function button and compromise
the operability of the YpsoPump®. If the insulin pump is damaged, correct delivery of insulin cannot be guaranteed;
this can cause hypoglycemia or hyperglycemia (read warning in the box on page 7). Ensure that your delivery of
insulin is as recommended by your doctor or diabetes advisor and consult Customer Service. You 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 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 163) cannot be maintained when a battery is discharged.
This can lead to failure of the preset insulin delivery, which can cause hyperglycemia (read warning in the box on page 7).
Make sure to always carry a replacement battery with you.
Always monitor the self-test attentively and carefully. If you are uncertain whether the self-test has been performed
correctly, repeat the self-test. If errors occur during the self-test (incomplete display, no vibration signal or audible signal),
you must not use the YpsoPump® as potential warnings and 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 hypoglycemia or hyperglycemia
(read warning in the box on page 7).
You must replace the battery compartment lid with a new one every three months. Otherwise the seal between the battery
compartment lid and the battery compartment may no longer be intact.
Choking hazard: keep the battery compartment lids out of reach of children.

14
2.1Systemoverview
Battery
compartment lid
Function buttonTubingCannula (soft or steel)
Tubing cap Adapter
Touchscreen
AAA alkaline
battery (LR03)
Tape
Cartridge compartment
with viewing windowInfusion set
Cannula
base
Self-filled
YpsoPump®
Reservoir 1.6-ml
reservoir

15
2.2Navigation
Touchscreen
The 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 YpsoPump® may only be controlled with
one nger. Do not use any objects to operate the screen.

16
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 center of the visible values and it has a gray background. Do not use the device if it shows visible signs
of damage. If the device no longer responds to touch, stop using it. In such a case, contact Customer Service without
delay.

17
Function button
The 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 YpsoPump® vibrates)
With the function button you can:
Switch the screen on and off
Program a blind bolus
Return to the status screen Function button

18
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

19
Active icons are bright. That means
the function is available and can be
selected with your nger.
Inactive icons are displayed in a darker
gray. This means the function is not
available and cannot be selected with
your nger.
Activeandinactiveicons

20
Conrmationandcancelation
To conrm a value or select a function
tap .
To cancel a procedure or function,
tap . Additionally, bolus cancel-
ation always has to be conrmed by
tapping .