Roche Accu-Chek Solo User manual

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USER’S MANUAL
ACCU-CHEK SOLO MICROPUMP SYSTEM
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I am a person with diabetes being treated with insulin. The insulin is delivered to my body by a micropump. If I am confused or unconscious, please do the following:
 Call the emergency services.  If I am able to swallow, give me sugar immediately, for example, juice.
Emergency card Name Address Phone In case of emergency, please contact: Name Phone
Important information
 You can call up important handling steps for the micropump system as
a video via the Help function on the diabetes manager.
 If the diabetes manager does not work, recharge the battery using the
supplied charger or connect the USB cable to a PC.
 For more information, refer to the printed User’s Manual of the
micropump system or on your local Accu-Chek homepage. From this website, you can download the User’s Manual as a PDF file.
 You can contact the Accu-Chek customer support by calling UK:
Accu-Chek Pump Careline 1): UK Freephone number: 0800 731 22 91
ROI Freephone number: 1 800 88 23 51
1)
calls may be recorded for training purposes Some mobile operators may charge for calls to these numbers.
Australia: Insulin Pump Support: 1800 633 457, Accu-Chek Enquiry
Line: 1800 251 816
My notes
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Medical certificate This is to certify that Name Date of birth has DIABETES MELLITUS. She/He relies on a regular supply of insulin from the Accu-Chek Solo micropump, which she/he wears on her/his body. Place and date Healthcare professional name Phone Fax Healthcare professional signature Stamp
Delivering a bolus with the micropump Setting the quick bolus increment The quick bolus increment is set to 0.2 U by factory default. The quick bolus increment I have set is U.
You can change the quick bolus increment here: Main menu > Settings > Bolus settings 1. Press and hold both quick bolus buttons for approximately 3 seconds. 2. Simultaneously press both quick bolus buttons repeatedly until the
desired insulin amount is reached. Check the (number of) tones.
3. Simultaneously press both quick bolus buttons to confirm the insulin
delivery.
3 s
1 2 3
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5
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 screens on the display,
the sounds and 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.
Therapy using the micropump system may
only be started after completion of the
required training from a qualified instructor.
Children and vulnerable persons should only
use the micropump system with the support
of a trained adult.
This User’s Manual is intended for people
with diabetes, their caregivers, for parents
whose children have diabetes as well as for
healthcare professionals. 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 customer
support.
Also consult the instructions for use
enclosed with the components of the
Accu-Chek Solo micropump system.
The screens shown in this User’s Manual
may differ slightly from the screens shown
on the display of the diabetes manager. The
units, numbers and settings of the screens
shown in this User’s Manual are only
examples.
The following information is highlighted in a
special way:
wWARNING
A WARNING indicates a foreseeable
serious hazard.
NOTE
A NOTE contains helpful information and
tips.
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.
Instructions for the screens shown on the
diabetes manager are structured in this
User’s Manual as in the following example.
You can see the specific situation for the
instruction on the display of your diabetes
manager.
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6
11
2Language:
3Tap the desired language. If required,
scroll the list upwards to view
additional languages.
4Tap Save.
1Number of the instruction/action step
2Title of the screen on the diabetes
manager
3Text of the instruction/action step
4Screen text/button text
Screens are shown in some of the
instructions.
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 fully
benefiting from the micropump system.
Read these chapters before using the
respective features.
Content of the kit
The kit contains the following components:
The Accu-Chek Solo pump base, the
Accu-Chek Guide Solo diabetes manager,
rechargeable battery for the Accu-Chek
Guide Solo diabetes manager, the
Accu-Chek Solo insertion device, charger,
USB cable, user’s manual, envelope
containing PIN unlock code and pump key.
Sterile Consumables
Only use consumables and accessories
from Roche.
Not included, but necessary for using the
micropump system:
ºThe Accu-Chek Solo reservoir assembly
ºThe Accu-Chek Solo cannula assembly &
pumpholder
ºThe Accu-Chek Guide test strips
ºThe Accu-Chek Guide control solution
ºA finger pricker
NOTE
ºOrder a new pump base in time before
the operating life of the first pump base
expires so that you always have one in
reserve.
ºEnsure an adequate supply of pump
holder, cannula and reservoir items are
kept in reserve so that replacements
are available when needed.
ºKeep the PIN unlock code and the
pump key in a safe place to protect
them against misuse.
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CONTENTS
1 Purpose of the Micropump System 9
1.1 Intended Use 9
1.2 Contraindications 10
1.3 Risks and Benefits 10
1.4 General Safety Information 11
1.5 Components of the Micropump System 13
1.6 Using the Micropump System in Daily Life 17
2 Getting to Know the Micropump System 19
2.1 Diabetes Manager Overview 19
2.2 Status Screen 19
2.3 Main Menu 20
2.4 Information Screen 22
2.5 Navigation and Operation 23
3 Putting the Diabetes Manager into Operation 26
3.1 Charging the Battery 26
3.2 Setup Wizard 28
3.3 Programming a Basal Rate Profile 32
4 Putting the Micropump into Operation 34
4.1 Recommended Infusion Sites 34
4.2 Putting the Components into Operation 34
4.3 Stopping and Starting the Micropump 46
5 Testing or Entering Your Glucose Level 48
5.1 Performing a Blood Glucose Test 48
5.2 Entering Your Glucose Value 56
6 Delivering a Bolus 57
6.1 Manual Bolus Delivery 57
6.2 Bolus Input Screen 57
6.3 Bolus Types 58
6.4 Programming a Bolus 59
6.5 Quick Bolus 61
6.6 Delivering a Bolus with a Pen or Syringe 63
6.7 Cancelling a Bolus 64
6.8 Setting the Delivery Lag Time 65
7 Bolus Advice 66
7.1 Setting Up Bolus Advice 66
7.2 Changing Bolus Advice and Time Blocks 71
7.3 Using Bolus Advice 75
7.4 Turning Off Bolus Advice 79
8 Basal Rate Profiles and Temporary Basal Rates 80
8.1 Creating and Editing a Basal Rate Profile 80
8.2 Temporary Basal Rates 83
8.3 Creating and Editing a TBR 84
9 Replacing System Components 87
9.1 Starting the Replacement 87
9.2 Replacing the Infusion Assembly 88
9.3 Replacing the Reservoir 89
9.4 Replacing the Pump Base 90
10 My Data 92
10.1 Logbook 92
10.2 Trend Graph 95
10.3 Standard Week 98
10.4 Target Range 99
10.5 BG Averages Table 100
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8
CONTENTS
10.6 System Events 101
10.7 Data Transfer 103
11 Changing Settings 105
11.1 Warning Limits 105
11.2 Time and Date 107
11.3 Bolus Settings 107
11.4 Tone and Vibration 109
11.5 Mute Warnings and Reminders 110
11.6 General Settings 111
11.7 Screen Lock 111
11.8 System Information 112
11.9 Travelling and Aeroplane Mode 113
12 Reminders 115
12.1 Overview of Reminders 115
12.2 Programming Reminders 116
12.3 Deleting Reminders 118
12.4 Issuing Reminders 118
13 Injection Therapy Mode 120
13.1 Removing the Micropump Temporarily 120
13.2 Injection Therapy Screens 122
14 Care and Maintenance 125
14.1 Cleaning the System Components 125
14.2 Control Test of the Diabetes Manager 128
14.3 Checking the System Functions 131
15 Messages and Troubleshooting 133
15.1 Information 134
15.2 Warnings 134
15.3 Maintenance Messages 139
15.4 Error Messages 145
15.5 General Troubleshooting 147
16 Technical Data 152
16.1 Micropump System 152
16.2 Diabetes Manager 152
16.3 Micropump 154
16.4 Infusion Assembly 156
16.5 Insertion Device 157
16.6 Delivery Rate Accuracy 157
16.7 Electromagnetic Compatibility (EMC) 158
17 Symbols, Abbreviations, Sounds 163
17.1 Symbols 163
17.2 Abbreviations 165
17.3 Sounds 166
18 Appendix 168
18.1 Guarantee 168
18.2 Licence Information 168
18.3 Declaration of Conformity, Radio Equipment Directive 168
18.4 Connecting Non-System Devices 168
18.5 Customer Support 168
18.6 Supplies and Accessories 169
18.7 Disposing of the Micropump System 170
18.8 Bolus Calculation 170
19 Glossary 172
Index 178
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9
PURPOSE OF THE MICROPUMP SYSTEM
1 Purpose of the
Micropump System
The Accu-Chek Solo micropump system is
intended for the subcutaneous continuous
delivery of insulin via customizable hourly
rates, for the management of diabetes
mellitus in persons requiring insulin. The
Accu-Chek Solo micropump system is
intended for single patient use in home
environment, public and community
settings, including office environment.
The Accu-Chek Solo micropump system can
be used by people with diabetes either on
their own or with the support of a healthcare
professional or a trained individual. The
micropump system is intended for people
with diabetes who are at least 2 years of
age.
The Accu-Chek Solo micropump system
consists of the following components:
ºThe Accu-Chek Solo pump base
ºThe Accu-Chek Solo reservoir assembly
ºThe Accu-Chek Solo cannula assembly &
pumpholder
ºThe Accu-Chek Solo insertion device
ºThe Accu-Chek Guide Solo diabetes
manager.
To use the Accu-Chek Solo micropump
system, you also need short- or fast-acting
U100 insulin or insulin analogues and test
strips for the blood glucose measurement.
The micropump system can be used with
the following U100 insulin types: Humalog®,
NovoLog®, NovoRapid®, Apidra®, Insuman®
Infusat or Fiasp®. The exact insulin type for
treating your diabetes mellitus will be
prescribed by your healthcare professional.
Consult the manufacturer’s package insert.
1.1 Intended Use
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. The
Accu-Chek Solo pump base is intended for
continuous insulin infusion in the treatment
of diabetes mellitus requiring insulin.
The Accu-Chek Solo reservoir assembly
(including the filling aid and the handling
aid) is a part of the micropump in addition to
the Accu-Chek Solo pump base. The
reservoir is a sterile container for holding
the insulin that the micropump delivers to
the body.
The Accu-Chek Solo cannula assembly &
pump holder consists of the cannula
casing, the sterile cannula and the pump
holder. The Accu-Chek Solo cannula
assembly consists of the cannula casing
and the sterile cannula. lt creates a
connection between the micropump and the
body to channel the insulin into the body.
The Accu-Chek Solo pump holder is a plate
that is adhered to the skin to fix the cannula
in place. lt also holds the Accu-Chek Solo
micropump in place.
The Accu-Chek Solo insertion device is
used to attach the infusion assembly (pump
holder and cannula) to the body and insert
the cannula into the subcutaneous tissue.
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10
PURPOSE OF THE MICROPUMP SYSTEM
The Accu-Chek Guide Solo diabetes
manager is used to configure and control
the micropump. The Accu-Chek Guide Solo
diabetes manager is needed to fulfil the
intended purpose of the Accu-Chek Solo
micropump.
The bolus advice of the Accu-Chek Guide
Solo diabetes manager gives an advice for
correction boluses or meal boluses.
The Accu-Chek Guide Solo diabetes
manager includes a blood glucose
monitoring system that is intended for
self-testing.
1.2 Contraindications
The micropump system should not be used
by children under 2years of age or by
people who regularly require less than
0.1U/h of basal insulin. It is the
responsibility of the healthcare professional
to decide whether the accuracy of the
delivery rate is adequate for the patient in
question.
Your healthcare professional must decide
whether insulin pump therapy is suitable for
the treatment of your diabetes mellitus.
Continuous Subcutaneous Insulin Infusion
(CSII) with the micropump system is not
recommended or only recommended with
limitations for the following groups of
people:
ºPeople who are not able or willing to
either perform at least 4blood glucose
tests per day or use a continuous
glucose monitoring (CGM) system
reliably.
ºPeople who are not able to be in regular
contact with their healthcare
professional.
ºPeople 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.
ºPeople who cannot be relied upon due to
drug addiction, substance abuse or
mental illness.
ºPeople who are exposed to high ambient
temperatures on a regular basis.
ºPeople with skin that does not tolerate
adhesive pads.
ºPeople who often experience a cannula
occlusion.
ºPeople who are not able to notice alarms
because of physical limitations.
1.3 Risks and Benefits
Talk to your healthcare professional about
the benefits and potential risks that are
associated with using the micropump
system.
The intended clinical benefit of the
Accu-Chek Solo micropump system for the
patient is that it enables the intensive insulin
therapy (IIT), allowing the patient to flexibly
adjust basal-bolus insulin delivery to
changing insulin requirements in order to
achieve individual treatment goals.
To ensure that insulin pump therapy is safe
and successful, you must actively take part
in your therapy, test your glucose value
regularly and monitor the functions of the
micropump regularly.
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