Roche Diagnostics Diabetes Care GW Accu-Chek Solo micropump User Manual Part 1

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Document Description	User manual Part 1
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Date Submitted	2018-03-07 00:00:00
Date Available	2018-03-07 00:00:00
Creation Date	2017-09-26 10:11:55
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Document Title	User manual Part 1
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Contents
What is the Purpose of the Micropump
System?
Putting the Micropump Into Operation
57
1.1
1.2
1.3
1.4
1.5
1.6
1.7
Intended Use
Contraindications
Risks and Benefits
General Warnings
Components of the Micropump System
Characteristics of the Micropump System
Using the Micropump System in Daily Life
4.1
4.2
Overview
Recommended Infusion Sites
57
61
Testing Your Blood Glucose
85
5.1
5.2
5.3
5.4
Checking the Unit of Measurement
Performing a Blood Glucose Test
Adding Information
Evaluating Test Results
85
86
91
96
Getting to Know the Micropump System
11
Delivering a Bolus
103
2.1
2.2
2.3
2.4
2.5
Diabetes manager overview
Status Screen
Main Menu
Information Screen
Navigation and Operation
11
14
17
20
21
Setting Up the Micropump System
31
3.1
3.2
Recharging the Battery
Setting Up the System
31
36
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
Manual Bolus Delivery
Bolus Input Display
Bolus Types
Programming a Bolus
Quick Bolus
Delivering the Bolus with a Pen or Syringe
Cancelling a Bolus
Delaying Bolus Delivery
103
104
105
107
117
121
123
126
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7
Bolus Advice
129
7.1
7.2
7.3
7.4
Overview
Setting Up Bolus Advice
Using Bolus Advice
Turning Off Bolus Advice
129
132
154
162
10.4 Standard Week
10.5 Target Range
10.6 BG Averages Table
203
206
209
11 Changing Settings
211
11.1 Making Settings
11.2 Travelling and Flight Mode
212
237
12 Reminders
241
12.1
12.2
12.3
12.4
Types of Reminders
Programming Reminders
Deleting Reminders
Issuing Reminders
242
243
251
252
Basal Rate Profiles and Temporary
Basal Rates
163
8.1
8.2
8.3
8.4
Basal Rate Profiles
Creating and Editing a Basal Rate Profile
Temporary Basal Rates
Creating and Editing a TBR
163
164
170
171
Replacing System Components
179
9.1
9.2
9.3
9.4
Starting the Replacement
Replacing the Infusion Assembly
Replacing the Reservoir
Replacing the Pump Base
180
180
184
187
13 Injection Therapy Mode
253
13.1 Removing the Micropump Temporarily
13.2 Injection Therapy Displays
13.3 Injection Therapy Settings
254
259
265
191
14 Care and Maintenance
267
191
191
198
14.1 Cleaning the Micropump System
14.2 Control Tests
14.3 Checking the System Functions
267
272
280
10 My Data
10.1 Overview
10.2 Logbook
10.3 Trend Graph
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15 Messages and Troubleshooting
283
15.1
15.2
15.3
15.4
15.5
285
286
294
301
303
Information Messages
Warning Messages
Maintenance Messages
Error Messages
Troubleshooting
16 Technical Data
309
16.1
16.2
16.3
16.4
16.5
309
310
313
317
318
Micropump System
Diabetes Manager
Micropump
Infusion Assembly
Technical Data of the Insertion Device
17 Symbols, Abbreviations, Signals
319
17.1 Symbols
17.2 Abbreviations
17.3 Signals
319
322
324
18 Appendix
325
18.1 Guarantee
18.2 Licence Information
18.3 Customer Support and Service Centre
325
325
326
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18.4 Supplies and Accessories
18.5 Disposing of the Micropump System
18.6 Bolus Calculation
327
328
329
19 Glossary
333
20 Index
341
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About this User’s Manual
Read this User’s Manual carefully before using your Accu-Chek®
Solo micropump system for the first time. This User’s Manual
provides you with the information you need to safely operate the
micropump system. In addition, this User’s Manual provides you
with the information you need for maintenance and
troubleshooting. You must be familiar with the displays on the
screen, the signals of the diabetes manager and micropump as
well as the functionality and characteristics of the system
components, in order to be able to use the micropump system
properly and reliably.
Also consult the instructions for use enclosed with the
components of the Accu-Chek Solo micropump system.
You can call up an electronic version of this User’s Manual from
the main menu of the diabetes manager under the Help menu.
This User’s Manual is intended for people with diabetes, their
caregivers, for parents whose children have diabetes as well as
for healthcare teams. This User’s Manual is your first source of
information for the micropump system or in case of any problems
using it.
If you have any questions, contact the Customer Support and
Service Centre (see Chapter 18).
IV
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The following information is highlighted in a special way:
w WARNING
A warning must be heeded because it indicates a risk of injury
or of damage to your health or the health of others. Not
heeding the warnings can lead to life-threatening situations.
Note
A note contains helpful information and tips to help you get
the most out of using the micropump system.
Example
An example shows you how a feature could be used in an
everyday situation. Note that medical- or therapy-related
details are provided for illustration purposes only, and are not
intended to match your personal medical needs.
To help you fully benefit from the micropump system, a
distinction between basic and advanced is made with regard to
the various features and properties.
Chapters highlighted in blue refer to features that are required to
be able to use the micropump system. Read these chapters
before using the Accu-Chek Solo micropump system.
Chapters highlighted in purple refer to features that are
recommended for good therapy and for fully benefitting from the
micropump system. Read these chapters before using the
respective features.
The following abbreviations are used in this User’s Manual:
jj Diabetes manager is shortened to DM.
jj Blood glucose is shortened to BG.
jj Micropump is shortened to MP.
jj Temporary basal rate is shortened to TBR.
For more abbreviations, see Chapter 17.
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Illustrated handling instructions
Handling instructions with display images
Instructions for handling system components are shown as in the
following example:
Instructions referring to displays on the diabetes manager screen
are shown as in the following example:
Step number within a sequence of
actions
Step number within a sequence of
actions
Display
on the diabetes
manager screen
Illustration of
instruction
Touch the blood drop to the front
yellow edge of the test strip.
VI
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Handling instruction
Tap Carbohydrates.
Handling instruction
Texts in blue or purple
font are texts that are
shown on the display.
These can include
commands, menus or
list elements.
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Quick navigation in the User’s Manual
In the main menu, tap the
Settings menu.
In the Settings menu, tap the
Time Blocks item.
Some handling instructions in this User’s Manual are summarised
into a quick navigation path. At the beginning of some chapters
or sections, for example, you will find the following information:
Main menu > Settings > Time blocks
This quick navigation path represents the following steps: “In the
Main menu tap the Settings menu and then tap Time blocks”.
or purple
dot on the displays means “Tap the
The blue
display element highlighted by the dot”.
Info
jj The screen displays in this User’s Manual can differ slightly
from the displays on the diabetes manager screen.
jj Units, figures and settings on the screen displays in this
User’s Manual are only examples.
VII
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Scope of delivery
The starter kit contains the following system components:
jj Accu-Chek Solo pump base (2×)
jj Accu-Chek Aviva Solo diabetes manager (1×)
jj Rechargeable battery for the Accu-Chek Aviva Solo
diabetes manager (1×)
jj Accu-Chek Solo insertion device (1×)
jj Charger with plug (1×)
jj USB cable (1×)
jj Accu-Chek Solo carry case (1×)
jj Finger pricker (1×)
jj Lancet drums for finger pricker (2×)
jj Instructions for use
Not included, but necessary for using the micropump system:
jj Accu-Chek Solo reservoir assemblies
jj Accu-Chek Solo cannula assemblies and Accu-Chek Solo
micropump holders
Pump base
Diabetes manager
Supplies
Only use supplies from Roche.
Note
To perform blood glucose tests and control tests with the
Accu-Chek Aviva Solo diabetes manager, you need the
Accu-Chek Aviva test strips and the Accu-Chek Aviva control
solution.
VIII
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1
What is the Purpose of the Micropump System?
1.1 Intended Use
The Accu-Chek Solo micropump system is a prescription medical
device intended for the subcutaneous continuous delivery of
rapid-acting U100 insulin with variable delivery quantities and for
the quantitative determination of blood glucose in fresh, capillary
blood.
The micropump system is intended to be used by insulindependent persons with diabetes mellitus. It is intended for
personal use only and may only be used by one and the same
person. The micropump system may only be used after having
been prescribed by a healthcare professional.
The micropump system can support you in calculating the
recommended insulin or carbohydrate amounts based on your
blood glucose values and your personal data. The micropump
system can measure your blood glucose values, record and
represent the delivered insulin and carbohydrate amounts
consumed, as well as collect and display information for
evaluation purposes.
The micropump system can be used with the following U100
insulin types: Humalog®, NovoLog®, NovoRapid®, Apidra® or
Insuman® Infusat. The exact insulin type for treating your
diabetes mellitus will be prescribed by your healthcare team.
Therapy using the micropump system may only be started after
completion of the required training from a qualified instructor.
Users under the age of 12 should only use the micropump
system with the support of a trained adult.
The micropump system can be used by persons with diabetes
either on their own or with the support of a healthcare
professional or a trained individual. It is intended for persons with
diabetes who are at least 2 years of age.
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What is the Purpose of the Micropump System?
1.2 Contraindications
1.3 Risks and Benefits
Your healthcare professional must decide whether insulin pump
therapy is suitable for the treatment of your diabetes mellitus.
Talk to your healthcare team about the benefits and potential
risks that are associated with using the micropump system.
Continuous Subcutaneous Insulin Infusion (CSII) with the
micropump system is not recommended or only recommended
with limitations for the following groups of people:
jj People who are not able or willing to perform at least 4 blood
glucose tests per day.
jj People who are not able to be in regular contact with their
healthcare team.
jj People who do not understand what is required for insulin
pump therapy or who are not able to follow the instructions for
use of the micropump system.
jj People who cannot be relied upon due to drug addiction,
substance abuse or mental illness.
jj People who are exposed to high ambient temperatures
(see chapter Technical Data).
To ensure that insulin pump therapy is safe and successful, you
must actively take part in the therapy, test your blood glucose
values regularly, calculate carbohydrate intake and monitor the
micropump functions regularly.
In case of improper use of the micropump system or noncompliance with your healthcare professional’s instructions, you
risk experiencing, for example, hypoglycaemia, hyperglycaemia,
ketoacidosis or infections of the infusion site. Follow the
treatment plan you agreed on with your healthcare professional
as well as the setting for basal rate profiles and bolus advice
defined therein.
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General Warnings
1.4 General Warnings
w WARNING
w WARNING
jj The micropump system may only be used by a single
person for insulin therapy.
All objects which can come into contact with human blood
carry a potential risk of infection. There is a risk of
infections being transmitted if the same micropump
system is used by other people, even by family members,
or if healthcare professionals use the same micropump
system for insulin therapy or blood glucose tests for
different people.
jj Only use the micropump to deliver rapid-acting U100
insulin.
jj Do not change your therapy without consulting your
healthcare team first.
jj Keep all system components away from small children or
vulnerable persons. There is a risk of suffocation if small
parts (e.g. covers, caps, or similar objects) are swallowed.
jj Do not make any changes to the design of the micropump
system.
jj Check your blood glucose level at least four times a day.
jj Used devices and supplies carry a risk of infection. Dispose
of used system components according to local regulations.
jj Having the time and date set precisely is essential in order
for your micropump system to function properly. A wrong
time setting can have serious consequences.
jj Always keep alternative therapy supplies at hand (for
example, a blood glucose meter or pen) in case the
micropump system stops working properly.
jj Do not use or store the micropump system outside the
permitted ambient conditions. This may lead to
hyperglycaemia or hypoglycaemia.
jj Use sterile supplies only once and only if the use by date
has not expired.
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What is the Purpose of the Micropump System?
1.5 Components of the Micropump
System
Accu-Chek Solo micropump system
The Accu-Chek Solo micropump system is a system that
primarily consists of a tubeless micropump and a diabetes
manager, which also serves as a remote control. The interactive
displays on the diabetes manager screen, help you to make
individual settings and control the micropump.
Accu-Chek Solo pump base
The Accu-Chek Solo pump base is
part of the micropump. It contains
the mechanical parts as well as the
electronics to control and monitor
the operation of the pump.
Accu-Chek Aviva Solo diabetes manager
The Accu-Chek Aviva Solo diabetes
manager is used to configure and
control the micropump. It has an
LCD screen and communicates with
the micropump via Bluetooth  ®
wireless technology. The diabetes
manager can display important
system messages such as
information, warnings, maintenance
and error messages.
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Components of the Micropump System
Accu-Chek Solo reservoir
Accu-Chek Solo micropump holder
The Accu-Chek Solo reservoir is the
second part of the micropump in
addition to the pump base. The
reservoir is a sterile container for
holding the insulin that the
micropump delivers to the body. The
reservoir has a zinc-air battery,
which serves as an energy source to
the micropump.
The Accu-Chek Solo micropump
holder is a self-adhesive plate that is
adhered to the skin to fix the cannula
in place. It also holds the micropump
in place.
Accu-Chek Solo cannula assembly
Accu-Chek Solo insertion device
The Accu-Chek Solo cannula
assembly consists of the cannula
casing and the sterile cannula. It
creates a connection between the
micropump and the body. The
Accu-Chek Solo cannula assembly is
available with cannula lengths of
6 mm (orange) or 9 mm (blue).
The Accu-Chek Solo insertion device
is used to attach the infusion
assembly (micropump holder and
cannula) to the body and insert the
cannula into the subcutaneous tissue.
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What is the Purpose of the Micropump System?
1.6 Characteristics of the
Micropump System
Tubeless insulin pump
jj Small, light and removable micropump (28 g)
jj Transparent reservoir (up to 200 U), usable for approx. 4 days
jj Soft Teflon cannula with a length of 6 mm or 9 mm
jj Can be worn at different sites directly on the body
jj Filling aid for easy and controlled filling
jj Can be used with rapid-acting U100 insulin from different
manufacturers
Convenient handling with the help of the diabetes manager
jj Controls the micropump system via touchscreen and Bluetooth
wireless technology
jj Direct access to important features, such as bolus, basal rates,
and blood glucose values, via the Status screen
jj Preview of therapy and system events by means of the
information screen
jj Adjustable user menus in several languages
Customised bolus and basal features
jj Bolus delivery (up to 50 U) with diabetes manager or directly
on the micropump
jj Selectable bolus types: standard, extended, multiwave
jj Basal rates from 0.1 U per hour up to 25 U per hour
jj 5 basal rate profiles for different daily routines
jj Up to 5 Temporary Basal Rates from 0 to 250 %
man_07866364001_A_en.indb 6
jj Functional support when temporarily using a syringe or pen
Support for therapy decisions
jj Built-in bolus advice feature
jj Visual representation of therapy trends and logbook features
jj Interface to common data management software of different
providers on the PC
Assisted setup and application
jj Micropump system is set up using a setup wizard
jj Guided setup of basal rate profiles and bolus advice feature
jj Guided replacement of system components
jj Electronic User’s Manual and videos explaining handling steps
on the diabetes manager
Comfort and safety features
jj Built-in blood glucose meter in the diabetes manager
jj Illumination for test strip slot and blood application area
jj Rechargeable, long-life battery in the diabetes manager
jj Optional key lock with PIN
jj Programmable volume setting and vibration mode for different
environments
jj Built-in self-tests and automatic detection of malfunctions
jj Information on warnings and required maintenance activities
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Using the Micropump System in Daily Life
1.7 Using the Micropump System in
Daily Life
The micropump system is intended to be used continuously,
every day in any everyday situation. There are only a few
situations in which you should pay special attention to the system
or remove the micropump in order to protect it. Use the
micropump system only if it is functioning properly and does not
show any signs of damage. Always have alternative therapy
supplies at hand for your own safety.
Note
The micropump system is supplied with two pump bases.
Order a new pump base in time before the operating life of
the first pump base expires so that you always have one in
reserve.
Showering, bathing, swimming, diving
Protect the diabetes manager from moisture and water. The
micropump is splashproof, but it must not be immersed in liquids.
Therefore, remove the micropump from the pump holder before
taking a shower or bath, diving or going for a swim. Place the
protective caps on the cannula support of the infusion assembly
(yellow protective cap) and on the opening with the reservoir
man_07866364001_A_en.indb 7
needle (grey protective cap) if you are not using the micropump
temporarily.
Exercise
You can wear the micropump during a variety of physical
activities. Do not wear the pump for sports that involve frequent,
high-impact bodily contact, such as martial arts, football or
hockey. The micropump could suffer damage by being hit or
kicked or if it is hit by a ball.
Sleeping
Place the diabetes manager within reach so that you can hear
reminders and system messages. We recommend that you
recharge the diabetes manager when you go to bed.
Temperature
Do not expose the micropump to direct sunlight, UV radiation or
heat. The operating temperature of the micropump is between
+5 °C and +40 °C. In temperatures outside this range, the insulin
contained in the reservoir could damage the micropump system.
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What is the Purpose of the Micropump System?
Air pressure and altitude
Rapid and significant changes in air pressure or temperature can
influence insulin delivery, especially if there are air bubbles in the
reservoir.
Such changes can occur, for example, when you are
jj in an aeroplane, especially during take-off and landing
jj doing sports such as hang gliding
In such cases, do the following: Remove any air bubbles from the
reservoir and test your blood glucose at frequent intervals. If in
doubt, remove the micropump and change to an alternative
therapy method.
Do not use the micropump system in altitudes above
3,000 metres above sea level.
Travelling and flights
Before travelling, ask your healthcare team about any special
preparations you need to make. Take sufficient supplies with you
for blood glucose testing and for your micropump (consumables,
test strips, insulin and so on), and find out where you can obtain
supplies while you are travelling.
We recommend that you always have the quick reference
instructions and emergency card (SOS) with you, which can be
detached from the cover of this User’s Manual.
Some airlines and governments do not permit the use of wireless
radio devices during flight. In these situations you can activate
flight mode. Flight mode enables the micropump system to
comply with these regulations.
Communication between micropump and diabetes manager
For wireless communication between the micropump and the
diabetes manager, it is not necessary for the devices to be right
next to each other. The distance between the diabetes manager
and the micropump should not be more than 10 metres.
Obstacles, such as walls or furniture, between the pump and the
diabetes manager can reduce or interrupt the communication
range.
When communication is interrupted, a message is displayed on
the screen (see chapter 15). Communication is automatically
re-established when the cause of the interruption no longer
exists. As long as communication is interrupted, the new data is
saved on the micropump and the diabetes manager. Once
communication between the pump and the diabetes manager
has been re-established, the pump automatically transfers your
saved data to the diabetes manager.
Distance from electrical devices
There are many devices that emit electromagnetic radiation, for
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Using the Micropump System in Daily Life
example, mobile phones. It cannot be completely ruled out that a
device of this kind could affect your micropump system. It is
therefore recommended that you keep your micropump system
at least 30 cm away from these devices while they are turned on.
Remove the micropump from your body before you undergo
examinations or treatments such as magnetic resonance imaging
(MRI), computed tomography (CT), X-rays or ultrasound, or before
you enter areas with strong electromagnetic fields.
The micropump system is not protected against effects which
may occur when using a defibrillator on a person. If a defibrillator
was used on a person wearing the micropump system, this may
cause the micropump system to malfunction. Remove the
micropump system.
w WARNING
jj Do not use the micropump system close to sources of
strong electromagnetic radiation and ionizing radiation.
Strong electromagnetic fields, for example, from radar or
antenna installations, high-voltage sources, X-Ray sources,
magnetic resonance and computed tomography could
interfere with the micropump system. Stop the micropump
and remove it from your body before you enter areas with
electromagnetic or ionizing radiation.
jj Do not use or store the micropump system in environmental
conditions other than those for which it is intended.
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What is the Purpose of the Micropump System?
10
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2
Getting to Know the Micropump System
2.1 Diabetes manager overview
The Accu-Chek Aviva Solo diabetes manager is a remote control
with an integrated blood glucose meter that is used to control the
micropump. The diabetes manager supports you in your diabetes
treatment and is only suitable for self-testing.
The diabetes manager has a coloured LCD touchscreen. You can
use the diabetes manager to program the delivery of basal insulin
and boluses. The diabetes manager can calculate bolus advice
tailored to your individual needs and situations. The diabetes
manager communicates with the micropump using Bluetooth
wireless technology. It transmits commands to and receives data
from the micropump and saves the data for insulin delivery in the
electronic logbook.
Note
jj Always have the diabetes manager with you.
jj A rechargeable battery supplies power to the diabetes
manager. Charge the battery on a regular basis.
jj If the environment you are in has a high noise level, you
may not hear the system messages. Pay attention to the
displays and signals on the diabetes manager to make sure
that the micropump system is functioning properly.
11
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Getting to Know the Micropump System
12
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Diabetes manager overview
Name
Description
Power button
Turns the diabetes manager on or off.
Lanyard eyelet
Used to attach a lanyard.
Earphone socket
Socket for connecting passive earphones.
LED
LED to signalise error, maintenance and warning messages as well as reminders.
Micro USB connector
Socket for connecting the USB cable (micro-B plug) in order to recharge the battery or establish a
connection to a PC.
Screen
LCD touchscreen for calling up the diabetes manager menus and displaying information.
Function buttons
Buttons for operating context-sensitive functions.
Navigation buttons
Navigation controls for moving between menus and process steps.
Insulin button
Button for confirming a previously set insulin delivery.
10
Test strip slot
For inserting test strips for blood glucose tests and control tests.
11
Camera
Used for scanning the pairing code on the pump base to pair the micropump and the diabetes
manager.
12
Battery door
Removable cover for the battery compartment.
13
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Getting to Know the Micropump System
2.2 Status Screen
2.2.1 Overview
On the Status screen, you can see the most important, current
and most common therapy information on blood glucose result,
basal rate, ongoing boluses and reservoir level at a glance. You
can access other information and menus from the Status screen.
Depending on the application (e.g. pump therapy or injection
therapy), other contents and symbols are displayed.
14
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Status Screen
Name
Description
Blood
glucose
result
Shows the most recent blood glucose
result with the time and date of the
test. The background colour indicates
whether the test result falls within the
target range (see also Test Result
Colour Coding in chapter 5).
Basal rate
Shows the active basal rate profile
with the current basal rate. If a
Temporary Basal Rate is active, the
corresponding percentage is also
displayed.
Bolus
Shows the active bolus type and the
remaining insulin units.
New bolus
Tap “New bolus” or
new bolus.
Main menu
Tap this button to display the main
menu.
Reservoir
level
Shows the units of insulin available in
the reservoir.
Name
Description
Remaining
bolus time
Shows the amount of time remaining
of an extended or multiwave bolus.
Bolus
progress bar
Shows the amount and duration of
the active bolus in the form of a bar.
Add data
Tap this item to add further data to
the logbook (for example, time of
test).
10
Tap this button to cancel one or all
active boluses.
to program a
15
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Getting to Know the Micropump System
2.2.2 Shortcuts on the Status screen
The touch-sensitive areas on the Status screen allow you to
quickly access important menus and features. When you tap the
areas, the corresponding menus or features are opened.
Logbook entries menu
Replace system components menu
Basal rate menu
Cancel TBR
Cancel bolus
Bolus menu
16
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Main Menu
2.3 Main Menu
The main menu is an overview of the most important features of
the diabetes manager. From here, you can open the basic menus
and features, go to the Status screen or add data.
Name
Description
Menu
Tap the menu icon to open the
desired menu or turn on the desired
feature.
Menu
selection
Provides access to menus and
submenus as well as direct access to
individual features.
Add data
Tap this button to add further data to
the logbook (for example, time of
test).
Status screen
Tap this button to display the Status
screen.
Depending on the situation (for example, pump therapy or
injection therapy), other menus can be displayed.
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Getting to Know the Micropump System
The status bar at the top edge of the screen shows the current time. In addition, the following symbols may be displayed.
Symbol
Name
Description
Status of rechargeable
battery
Shows the current level of the rechargeable battery in the diabetes manager.
No communication
Is displayed when communication between the diabetes manager and the micropump is
interrupted.
Flight mode
Is displayed when flight mode is turned on.
No acoustic signal
Is displayed when tones are turned off.
Temperature
Is displayed when the temperature of the diabetes manager is outside the temperature
range allowed for performing blood glucose tests.
Signals turned off
Is displayed when signals for warnings are turned off for a certain period of time.
Vibration
Is displayed when the vibration feature is turned on. Signals are deactivated.
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Main Menu
Menus of the Main menu
Menu icon
Description
Menu icon
Description
Deliver manual bolus, use bolus advice, cancel
bolus
Connect diabetes manager to PC in order to
transfer data
Select or set basal rate profiles, set and
cancel Temporary Basal Rates (TBR)
Turn flight mode on or off
Start micropump
Set signals
Stop micropump (cancel bolus and TBR and
interrupt basal rate)
Watch Help videos, read User’s Manual
Test blood glucose, perform control test
Replace system components (infusion
assembly, reservoir, pump base)
View or change settings, view system
information, switch therapy mode
Display or edit logbook data
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Getting to Know the Micropump System
2.4 Information Screen
The information screen is a representation of important device,
status and therapy information as well as system events. When
you tap the events, the respective menus with detailed
information open.
If you slide the upper screen edge downwards, the information
screen is shown. The bar on the sliding pane lights up blue while
it is being moved.
Event data
Bolus data
Basal rate data
Logbook entries
Total daily dose
20
Sliding pane
man_07866364001_A_en.indb 20
Slide your finger from the upper screen edge downwards. The
information screen is shown. Move the information screen to
the top again to hide it.
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Navigation and Operation
2.5 Navigation and Operation
2.5.1 Navigation buttons
Navigation and operation of the diabetes manager is done by
means of the touchscreen and navigation buttons.
You can use the navigation buttons below the screen to move
forwards and backwards or to go to the Status screen.
The insulin button is an exception. Insulin deliveries for basal
rates or a bolus that have been programmed using the diabetes
manager can only be started by pressing a separate insulin
button.
Button
Function
“Back” navigation button:
Go back to the previous display within the
process step.
“Status screen” navigation button:
Switch to the Status screen.
“Next” navigation button:
Go to the next display within the process step.
In many process steps, this button performs the
same function as the “Next” or “OK” buttons.
In some menus and when system messages are displayed, not
all navigation buttons are available. If you make settings in a
button, the settings will not
process step and then press the
be saved.
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Getting to Know the Micropump System
2.5.2 Insulin button
2.5.3 Entries
The insulin button is only used to confirm a previously set insulin
delivery. When the diabetes manager is ready to deliver basal or
bolus insulin, the button lights up green.
There are various methods of making entries in order to execute
commands, select values, set features and select display
elements.
The various entry methods are explained on the following pages.
Example
22
Check whether the settings for insulin delivery are correct.
button to start insulin delivery.
Press the
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Navigation and Operation
Executing commands
Switching a feature on or off
Whenever you tap a command on the screen, the background
colour changes.
By tapping a switch, you can turn a feature on or off. Inactive
function buttons and switches are greyed out.
Example
Example
Not selected
Selected
Next
Next
Status
screen
Add data
Status
screen
Add data
Tap the element you want to select. The background changes
from dark to light.
Tap the switch to turn the feature on. Tapping the same switch
again turns the feature off.
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Getting to Know the Micropump System
Simple lists or menus
Lists with checkboxes
No element is preselected in simple lists or menus. You can
select an element.
In these lists, you can select either one or more elements
simultaneously or no element.
Example
Example
Tap the element you want to select. The background changes
from light to dark. When you have selected an element, the
next display appears.
Tap the element you want to select. A green tick is displayed
in the checkbox. If you tap the element once more, the tick
disappears and the element is no longer selected. Tap Save to
save your selection.
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Navigation and Operation
Lists with radio buttons
Editing an element
In these lists, one element is always selected, for example, by the
factory settings. By tapping the desired element, you can change
the selection.
To edit the desired element, it must be selected.
Example
Example
Tap the element you want to select. The green dot is displayed
in the circle in front of the newly selected element.
Tap the element you want to edit. You can edit the element on
the display that follows.
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Getting to Know the Micropump System
Scrolling lists
Slider
In long menus and lists, you can scroll the list to display the
elements that are not visible.
You can make the desired setting by moving the slider.
Example
Scroll the list upwards to view additional list elements or
menus. Scroll the list downwards to view the top list elements
or menus.
Example
Move the slider to the desired position.
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Navigation and Operation
2.5.4 Entering Numbers
Numeric keypad
You can either use a numeric keypad to enter numbers or use the
minus/plus buttons to set them.
You can enter numeric values such as the carbohydrate amount
using the numeric keypad.
Some numbers and values, for example, for carbohydrates, can
be set using the minus/plus buttons or be entered by means of
the numeric keypad.
Display field for
entry
Decimal point
Symbol for
entry using
the numeric
keypad
Back arrow:
Deletes the
entered data
one character
at a time
Enter the desired numeric value using the numeric keypad.
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Getting to Know the Micropump System
Minus/plus buttons
2.5.5 Entering Text
and allow you to switch between entering data using the
minus/plus buttons and the numeric keypad.
Text is entered using a keyboard. Depending on the language,
key assignments may differ.
Explanation/Example
Symbol for
entering text using
the minus/plus
buttons
Button to
decrease the
value entered
28
Explanation/Example
Display field for
entry
Button to
increase the
value entered
Tap to increase the numeric value on the display. Tap to
decrease the numeric value on the display.
Keep your finger on one of the minus/plus buttons for a bit
longer to decrease or increase the numeric values in a fast
scroll mode.
man_07866364001_A_en.indb 28
Switches between
lowercase and
uppercase
Switches between a keyboard with letters
and a keyboard with numbers, punctuation
and special characters
Deletes the
entered data
one character
at a time
Confirms the
entry
Enter the desired text using the letter keyboard.
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Navigation and Operation
2.5.6 Screen Lock
Unlocking the screen
If the diabetes manager has been inactive for approx.
60 seconds, the screen is automatically locked. You can also lock
the screen by pressing the power button. A locked screen is
symbol.
indicated by the
The lock prevents others from viewing the screen and prevents
functions from being activated unintentionally on the touchscreen
while you are not using the device. The last blood glucose result,
the time and date, the reservoir level and the basal rate are
displayed even when the screen is locked.
You unlock the screen by swiping your finger from the middle of
the screen in any direction. If you have activated PIN entry, you
will have to enter the four- to eight-digit PIN on the display that
follows to unlock the screen of the diabetes manager. You have
the option of changing the settings in the menu Settings >
Screen lock.
Swipe across the screen with your finger, starting from the
symbol, until the lock symbol is outside the circle shown, then
remove your finger.
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3
Setting Up the Micropump System
3.1 Recharging the Battery
Before you start using the diabetes manager, you must charge
the battery.
Connect the diabetes manager to a PC or charger using the USB
cable. The preferred method is to use a charger and wall socket
since charging takes less time this way. It takes approx. 4 hours
to charge a fully drained battery using a charger that is
connected to a wall socket. Charging the battery using the USB
connector on a PC may take longer.
Symbols for different battery levels:
low
20 %
40 %
60 %
80 %
100 %
w WARNING
jj Use only the supplied charger with the appropriate USB
cable.
jj Use only the rechargeable battery from Roche.
Note
jj While the diabetes manager is being charged, you cannot
perform any blood glucose tests.
jj Recharge the battery regularly so that it does not become
fully drained. Keeping the diabetes manager plugged in for
a longer period to charge does not harm the battery.
jj Check regularly whether the time and date of the diabetes
manager are set correctly.
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Setting Up the Micropump System
3.1.1 Inserting the Battery into the Diabetes Manager
–
Have the diabetes manager,
rechargeable battery, charger
and USB cable ready.
Open the battery compartment
by pushing the battery door up
in the direction of the arrow.
Place the rechargeable battery
into the battery compartment
of the diabetes manager.
Close the battery compartment
by pushing the battery door in
the direction of the arrow until
it clicks into place.
The plus sign (+) and the
minus sign (-) on the
rechargeable battery must
match the respective symbols
in the battery compartment.
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Recharging the Battery
3.1.2 Charging the Battery Using a Wall Socket
Plug the larger end (USB type
A plug) of the USB cable into
the USB socket of the charger.
Plug the smaller end (USB
Micro-B plug) of the USB cable
into the USB socket of the
diabetes manager.
Plug the charger into a wall
socket.
Note
The blue LED lights up to
indicate that the battery is
being charged. If the
rechargeable battery of the
diabetes manager has been
run right down, it may take
up to 15 minutes until the
blue LED of the diabetes
manager lights up.
If the LED does not light up
after 15 minutes, proceed as
follows: Disconnect the
charger from the diabetes
manager. Wait for a short
time. Reconnect the charger
to the diabetes manager.
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Setting Up the Micropump System
3.1.3 Charging the Battery Using a Computer
The Status screen or Main menu displays the
symbol in the
status bar. It indicates that the battery is being charged.
Plug the smaller end (Micro-B
plug) of the USB cable into the
USB socket of the diabetes
manager.
Plug the larger end (USB-A
plug) of the USB cable into a
free USB port on your
computer.
symbol is displayed in
When the battery is fully charged, the
the status bar. You can remove the charger from the wall socket
and the USB cable from the diabetes manager.
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Recharging the Battery
If the connection is successful,
the diabetes manager displays
the charging screen for
3 seconds.
On the information screen, the
current status of the
rechargeable battery is shown
using the charging symbol and
a percentage.
Note
jj The computer must usually be turned on in order for the
battery to be charged. With some PC models, the computer
must not be in sleep or standby mode if you want to charge
the battery.
jj The USB port on a PC that is suitable for charging is often
marked with a lightning symbol.
jj If the battery level of the diabetes manager is very low, the
screen is black at first.
jj If you want to transfer data to the computer after connecting
Connect menu in the Main menu.
the USB cable, tap the
When the battery is fully
symbol is
charged, the
displayed. You can remove the
USB cable from the diabetes
manager and the PC.
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Setting Up the Micropump System
3.2 Setting Up the System
You can set up the diabetes manager manually, directly on the
device with the help of the setup wizard, or you can use the
configuration software to do so on your PC.
3.2.1 Setup Wizard
The first time you turn the diabetes manager on, the setup wizard
is displayed. You must complete the setup wizard before you start
using the micropump or test your blood glucose.
The setup wizard is displayed every time you turn the diabetes
manager on until you complete the setup.
If you do not want to set up bolus advice during initial setup of the
micropump system, you can do so at a later point in time.
w WARNING
jj Discuss your individual settings for insulin dose, warning
limits, time blocks and bolus advice with your healthcare
professional.
jj Wrong basal rate settings may lead to hyperglycaemia or
hypoglycaemia.
Note
Check whether the settings you made match your
requirements and the specifications of your healthcare
professional.
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Setting Up the System
Caching the setup
The data and settings you enter are cached at specific points
during setup. If you want to resume setup after an interruption,
Continue setup appears on the screen.
Turning on the diabetes manager
Press and hold the power
button on the top of the
diabetes manager until the
diabetes manager turns on.
The diabetes manager
vibrates, issues a signal and
the signal LED lights up. The
start display appears briefly.
Tap this display to continue setting up the system.
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Setting Up the Micropump System
Setting the language
Entering the PIN
Note
If you have forgotten the PIN
you chose, you can unlock
the diabetes manager with a
PIN unlock code.
You can find the label with
the 8-digit PIN unlock code
on the back cover of the
User’s Manual.
Example of a PIN unlock
code:
Tap the desired language. If
required, scroll the list
upwards to view additional
languages.
Tap Save.
Enter a PIN (secret
identification number) of your
choice with 4 to 8 digits.
Choose a PIN that is easy to
remember. Note down the PIN
and keep it in a safe place.
Enter the PIN a second time.
Diabetes Manager
Tap Save.
GW0000062
12345678
PIN
Tap Save.
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Setting Up the System
Selecting Setup mode
Note
If you tapped Manual setup,
proceed with the section
Time and date settings.
If you tapped Set up on PC,
proceed with the section
Configuration on the PC.
Tap the Setup mode you want
to use.
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Setting Up the Micropump System
Setting the time and date
Time and date information
Times and time periods are always displayed or entered in the
following format HH:MM (HH=hours, MM=minutes).
24-hour time
format
01:07
16:15
HH:MM
12-hour time
format
01:07 am
04:15 pm
HH:MM am or pm
Time period
02:35
2 hours and 35 minutes
Tap Time format.
Tap the desired time format.
The date is always displayed or entered in the format DD MMM.
YYYY (DD = day, MMM = month, YYYY = year), for example,
23 Jun. 2017.
Tap Save.
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Setting Up the System
Tap Time.
The hours field is selected
(dark background).
Tap the minutes field.
Tap Date.
Use
and
to set the hours.
Use and
minutes.
to set the
Tap Save.
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Setting Up the Micropump System
10
The day field is highlighted.
Tap the month field.
Tap the year field.
Use
Use and
month.
Use
Once you have entered all
settings for time and date, tap
Save.
and
to set the day.
to set the
and
to set the year.
Tap Save.
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Setting Up the System
Setting the carbohydrate unit
The diabetes manager offers the following carbohydrate units for
selection:
Abbreviation
Unit of measurement
Gram equivalent
Gram
1 gram
BE
Broteinheit
(bread equivalent)
12 grams
KE
Kohlenhydrateinheit
(carbohydrate unit)
10 grams
CC
Carbohydrate choice
15 grams
Note
You cannot change the
selected carbohydrate unit in
the diabetes manager later
on.
Subsequent changes to the
carbohydrate unit can only be
made with the Accu-Chek
360° configuration software.
Tap the carbohydrate unit you
want to set.
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Setting Up the Micropump System
Setting warning limits
Tap Yes if the correct unit is
displayed.
The default warning limits are
displayed.
Use and to set the upper
warning limit.
If you want to change the unit,
tap No. You then return to
Step 1.
Tap Upper warning limit.
Tap Save.
You can set warning limits for
hyperglycaemia (hyper) and
hypoglycaemia (hypo) that
best fit your needs.
Whenever your blood glucose
result is above the hyper
warning limit or below the
hypo warning limit, the
diabetes manager displays a
warning.
If you do not want to change
the warning limits, tap Done.
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Setting Up the System
Tap Lower warning limit.
Use and to set the lower
warning limit.
The warning limits currently
set are displayed.
Tap Save.
Tap Done.
If you want to set up bolus
advice now, tap Yes. In Chapter
7, Setting Up Bolus Advice, you
will find the explanations on
and steps for setting up this
feature.
If you do not want to set up
bolus advice now, tap No.
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Setting Up the Micropump System
Setting time blocks
The diabetes manager allows you to define blood glucose target
ranges for certain times of day. For this purpose, the day is
divided into time blocks. By dividing the day into time blocks, you
can adjust the blood glucose target range to your specific needs.
Tap OK.
Tap Start time and then End
time.
w WARNING
Make sure that you enter carbohydrates and health events
correctly when you set up bolus advice. Incorrect settings may
lead to wrong bolus recommendations.
Note
If you want to use bolus advice, you must set it up. If you do
not want to set up bolus advice now, the setup wizard skips
the steps for setting up bolus advice. You can set up bolus
advice at a later time.
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Setting Up the System
Use and
time.
Tap Save.
to set the start
Use and
time.
to set the end
Tap Done.
Tap Upper limit value.
Tap Save.
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Setting Up the Micropump System
Use and
limit value.
Tap Save.
to set the upper
Tap Lower limit value.
Use and
limit value.
10
to set the lower
Tap Done.
Tap Save.
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Setting Up the System
11
Tap OK.
Note
You can set one blood
glucose target range for all
time blocks or different ones
for the various time blocks.
The settings for the first time
block are used in all copied
time blocks. Tap the
appropriate time blocks to
change these settings.
12
13
Repeat the previous steps if
you want to change more time
blocks.
Tap OK.
Once you have changed all
desired time blocks, tap Done.
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Setting Up the Micropump System
3.2.2 Programming the Basal Rate Profile
The aim of insulin pump therapy is to reproduce the natural
biorhythm of insulin delivery of a healthy pancreas as far as
possible.
Note
The factory settings provide
24 time blocks with one hour
each.
The basal rate covers the basal, meal-independent insulin
requirement. The basal rate is specified in insulin units per hour
(U/h = Units per hour). The distribution of the basal insulin
requirement over up to 24 time blocks results in the basal rate
profile.
The first time block starts
with the start time 00:00 and
ends at 01:00. The last time
block starts at 23:00 and
ends at 00:00.
For each time block, 0 U/h is
set by factory default.
Example: Basal rate profile for 18 U/24 hours
Insulin delivery
U/h
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man_07866364001_A_en.indb 50
Tap OK to set up a basal rate
profile.
Hourly
basal rate
The
button is deactivated.
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Time
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Setting Up the System
The basal rate profile with the
name Profile 1 is displayed.
Enter a name for the basal rate
profile using the keyboard.
Define the end time for the
first time block.
Use and to set the End
time for the first time block.
Tap the element with the
symbol (here: Profile 1) if you
want to change the name of
the profile.
Tap Done.
To do so, tap the top entry field
in the End column.
Tap Save.
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Setting Up the Micropump System
Define the insulin units per
hour for the first time block.
Use and to set the
insulin units for the first time
block.
Repeat Steps 4 to 7 for each time block you want to edit.
To do so, tap the top entry field
in the U/h column.
Scroll the screen upwards or downwards to display all time
blocks.
Tap Save.
If you want to view the basal rate profile as a graph, tap the
symbol .
Once you have set all time blocks, tap Save.
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Setting Up the System
Next, you must prepare the
micropump.
Tap OK to confirm the
message, and see Chapter 4
to read how to prepare the
micropump when using it for
the first time.
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Setting Up the Micropump System
3.2.3 Configuration Software
You can use the Accu-Chek 360° configuration software to set up
the micropump system on the PC. You can make all settings on
the monitor of your PC in a clear, graphical representation.
Features and options of the configuration software:
jj Setting up basal rate profiles
jj Setting user-defined Temporary Basal Rates
jj Setting up bolus advice
jj Setting reminders
jj Reviewing and editing all settings
jj Printing and saving a configuration report to be exchanged with
your healthcare team
jj Copying device settings
jj Communication via USB connection
jj Setting micropump options
jj Easy navigation due to a clearly structured user interface
The configuration software can be downloaded from the following
web address on the Internet:
www.###.com
Refer to the configuration software for instructions for use. For
more information, contact your Customer Support and Service
Centre.
Note
jj The current settings in the diabetes manager are replaced
by the settings in the configuration software. All settings
are saved in the configuration.
jj After completing configuration, you must restart the
micropump.
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Setting Up the System
Configuration on the PC
If you selected Set up on PC,
connect the diabetes manager
and the PC using a USB cable.
Start the configuration
software for setting up the
diabetes manager on the PC.
This display shows that data
connection between the
diabetes manager and the PC
was successfully established.
You can now use the
configuration software.
The diabetes manager
establishes the data
connection to the PC.
Note
For more information on Set
up on PC, see the User’s
Manual of the Accu-Chek
360° configuration software.
Continue setting up the
diabetes manager on the PC.
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Setting Up the Micropump System
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4
Putting the Micropump Into Operation
4.1 Overview
This chapter explains all steps necessary to prepare the
micropump before using it for the first time. To put the
micropump into operation, you need the following:
jj Diabetes manager
jj Pump base
jj Reservoir assembly
jj Micropump holder and cannula assembly
jj Insertion device
jj Disinfectant or a clean cloth
The following steps are necessary to put the micropump into
operation:
jj Use the insertion device to attach the micropump holder to
the body and insert the cannula
jj Fill the new reservoir with insulin
jj Connect the reservoir to the pump base
jj Pair the micropump with the diabetes manager
jj Fill the reservoir needle
jj Attach the micropump to the micropump holder
jj Start the basal rate
Cannula assembly 6 mm
(orange)
Reservoir assembly
Cannula assembly 9 mm
(blue)
Micropump holder
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Putting the Micropump Into Operation
Infusion assembly
Reservoir assembly
Micropump holder
Hook for attaching the
micropump
Filling aid
Opening for safety release of
the insertion device
Opening for cannula with
cannula support
Flap for detaching the
micropump
Protective film for battery
Handle for piston rod
Reservoir needle
Cannula assembly
Handling aid
Cannula casing
Piston rod
Protective cap for infusion assembly
58
man_07866364001_A_en.indb 58
Soft Teflon cannula
Introducer needle
Protective cap for reservoir needle
28.07.2017 12:16:06

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