Accu-Chek Solo User manual

User’s Manual
Accu-Chek Solo micropump system
DRAFT (US) 08-MAY-2020

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 911.
 If I am able to swallow, give me sugar immediately, for example, juice.
 Remove the micropump from my body.
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 visit accu-chek.com. From this website, you can
download the User’s Manual as a PDF file.
 You can contact the Accu-Chek Customer Care Service Center by
calling 1-800-688-4578.
My notes

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
321

0xxxxxxx001/A0 Last update 2020-04
Data
Matrix
Code
Approved/listed/registered under the product name:
Accu-Chek Solo micropump system
ACCU-CHEK, ACCU-CHEK GUIDE, ACCU-CHEK SMART PIX, and ACCU-CHEK SOLO
are trademarks of Roche.
The Bluetooth
®word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.
and any use of such marks by Roche is under license.
Teflon®is a registered trademark of E. I. du Pont de Nemours and Company or its affiliates.
All other product names and trademarks are the property of their respective owners.
© 2020 Roche Diabetes Care
Roche Diabetes Care GmbH Sandhofer Strasse 116
68305 Mannheim, Germany
www.accu-chek.com
Last update 2020-05

Contents
About this User’s Manual IV
Scope of delivery VI
Consumables VI
1 What is the Purpose of the Micropump
System? 1
1.1 Intended Use 1
1.2 Contraindications 2
1.3 Risks and Benefits 3
1.4 General Warnings 4
1.5 Components of the Micropump System 6
1.6 Characteristics of the Micropump System 8
1.7 Using the Micropump System in Daily Life 10
2 Getting to Know the Micropump System 13
2.1 Diabetes Manager Overview 13
2.2 Status Screen 16
2.3 Main Menu 19
2.4 Information Screen 22
2.5 Navigation and Operation 23
3 Putting the DM into Operation 33
3.1 Charging the Battery 33
3.2 Setup Wizard 39
3.3 Programming a Basal Rate Profile 52
4 Putting the Micropump into Operation 57
4.1 Overview 57
4.2 Recommended Infusion Sites 61
4.3 Putting the Components into Operation 62
4.4 Stopping and Starting the Micropump 83
5 Testing or Entering Your BG Level 85
5.1 Testing Blood Glucose 85
5.2 Entering Your Blood Glucose Value 103
6 Delivering a Bolus 105
6.1 Manual Bolus Delivery 105
6.2 Bolus Input Display 106
6.3 Bolus Types 107
6.4 Programming a Bolus 109
6.5 Quick Bolus 118
6.6 Delivering a Bolus with a Pen or Syringe 121

6.7 Canceling a Bolus 123
6.8 Setting the Delivery Lag Time 127
7 Bolus Advice 129
7.1 Overview 129
7.2 Setting Up Bolus Advice 132
7.3 Changing Bolus Advice and Time Blocks 144
7.4 Using Bolus Advice 154
7.5 Turning Off Bolus Advice 166
8 Basal Rate Profiles and Temporary Basal
Rates 167
8.1 Basal Rate Profiles 167
8.2 Creating and Editing a Basal Rate Profile 168
8.3 Temporary Basal Rates 176
8.4 Creating and Editing a TBR 177
9 Replacing System Components 185
9.1 Starting the Replacement of System Components 186
9.2 Replacing the Infusion Assembly 187
9.3 Replacing the Reservoir 190
9.4 Replacing the Pump Base 193
10 My Data 195
10.1 Overview 195
10.2 Logbook 195
10.3 Trend Graph 203
10.4 Standard Week 208
10.5 Target Range 211
10.6 BG Averages Table 214
10.7 System Events 216
10.8 Data Transfer 219
11 Changing Settings 221
11.1 Warning Limits 222
11.2 Time and Date 227
11.3 Bolus Settings 229
11.4 Tone and Vibration 234
11.5 Turning Off Signals Temporarily 237
11.6 General Settings 240
11.7 Screen Lock 242
11.8 System Information 245
11.9 Traveling and Flight Mode 247
12 Reminders 251
12.1 Overview of Reminders 252
12.2 Programming Reminders 253
12.3 Deleting Reminders 262
12.4 Issuing Reminders 263

13 Injection Therapy Mode 265
13.1 Removing the Micropump Temporarily 266
13.2 Injection Therapy Displays 272
14 Care and Maintenance 277
14.1 Cleaning and Disinfecting the Micropump System 277
14.2 Control Test of the Diabetes Manager 288
14.3 Checking the System Functions 295
15 Messages and Troubleshooting 298
15.1 Information 300
15.2 Warnings 301
15.3 Maintenance Messages 308
15.4 Error Messages 315
15.5 General Troubleshooting 318
16 Technical Data 324
16.1 Micropump System 324
16.2 Diabetes Manager 326
16.3 Micropump 329
16.4 Infusion Assembly 333
16.5 Insertion Device 334
16.6 Delivery Rate Accuracy 335
17 Symbols, Abbreviations, Signals 340
17.1 Symbols 340
17.2 Abbreviations 343
17.3 Signals 345
18 Appendix 348
18.1 Guarantee 348
18.2 License Information 352
18.3 Declaration of Conformity, Radio Equipment Directive 353
18.4 Connecting Non-System Devices 353
18.5 Accu-Chek Customer Care Service Center 353
18.6 Supplies and Accessories 354
18.7 Disposing of the Micropump System 355
18.8 Bolus Calculation 359
19 Glossary 368
20 Index 376

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.
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 the Accu-Chek Customer Care
Service Center. For more information, see chapter 18.5
Accu-Chek Customer Care Service Center.
Also consult the instructions for use enclosed with the
components of the Accu-Chek Solo micropump system.
IV

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 successful therapy and for fully benefiting from
the micropump system. Read these chapters before using the
respective features.
The following abbreviations are used in this User’s Manual:
jBlood glucose is shortened to BG.
jTemporary basal rate is shortened to TBR.
jFor more abbreviations, see chapter 17 Symbols,
Abbreviations, Signals.
V

Scope of delivery
The scope of delivery includes the following components:
jAccu-Chek Solo pump base (1×)
jAccu-Chek Guide Solo diabetes manager (1×)
jRechargeable battery for Accu-Chek Guide Solo diabetes
manager (1×)
jAccu-Chek Solo insertion device (1×)
jCharger with plug (1×)
jUSB cable (1×)
jAccu-Chek Solo carry case (1×)
jInstructions for use
jEnvelope containing PIN unlock code and pump key
Consumables
Only use consumables and accessories from Roche.
Not included, but necessary for using the micropump system:
jAccu-Chek Solo reservoir assembly
jAccu-Chek Solo cannula assembly & pump holder
jFor using the blood glucose meter in the Diabetes Manager:
Accu-Chek Guide test strips and Accu-Chek Guide control
solution
Pump base (1×)
Diabetes manager
Note
jOrder a new pump base in time before the operating life of
the first pump base expires so that you always have one in
reserve.
jMake sure you have a second pump holder and a second
reservoir available so that you have replacements if
needed.
jKeep the PIN unlock code and the pump key in a safe place
to protect them against misuse.
VI

1What is the Purpose of the Micropump System?
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.
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 amounts and the consumed
carbohydrate amounts, as well as collect and display information
for evaluation purposes.
The micropump system can be used with the following U100
insulin types: Humalog®, NovoLog®, Apidra®or Fiasp®. The exact
insulin type for treating your diabetes mellitus will be prescribed
by your healthcare professional. Consult the package insert.
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 people with
insulin-dependent 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 be used by people with diabetes
either on their own or with the support of a healthcare
professional or a trained individual. It is intended for people with
diabetes who are at least 2 years of age.
1
1

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:
jPeople 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.
jPeople who are not able to be in regular contact with their
healthcare professional.
jPeople 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.
jPeople who cannot be relied upon due to drug addiction,
substance abuse or mental illness.
jPeople who are exposed to high ambient temperatures on a
regular basis. For more information, see chapter 16 Technical
Data.
jPeople with skin that does not tolerate adhesive pads.
jPeople who often experience a cannula occlusion.
jPeople who are not able to notice alarms because of physical
limitations.
2
What is the Purpose of the Micropump System?

1.3 Risks and Benefits
Talk to your healthcare professional about the benefits and
potential risks that are associated with using the micropump
system.
To ensure that insulin pump therapy is safe and successful, you
must actively take part in your therapy, test your blood glucose
values regularly and monitor the functions of the micropump
regularly.
In case of improper use of the micropump system or non-
compliance with your healthcare professional’s instructions, you
risk experiencing, for example, hypoglycemia, hyperglycemia,
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.
1
3
Risks and Benefits

wWARNING
jThe 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.
jOnly use the micropump to deliver rapid-acting U100
insulin.
jUse sterile consumables only once and only if the use by
date has not expired and the related sterile packaging is
not damaged.
jUsed components, such as cannulas, cannula assemblies,
and lancets, that come into contact with blood or bodily
fluids carry a risk of infection. Dispose of used system
components according to local regulations (See chapter
18.7 for further information on the correct disposal of the
components of the micropump system).
jDo not change your therapy without consulting your
healthcare professional first.
wWARNING
jCheck your blood glucose level at least four times a day.
jCheck your blood glucose level more than four times a day
if your insulin sensitivity is high.
jIf the micropump has been subjected to mechanical shocks
(e.g. during sports by a punch or a ball), check your blood
glucose level at least once within 1 to 3 hours.
jKeep all parts of the micropump system away from small
children and vulnerable persons. There is a risk of
suffocation if small parts are swallowed.
jKeep pointed or sharp-edged parts away from small
children and vulnerable persons. There is a risk of injury.
jUse or store the micropump system only within the
permitted ambient conditions. Otherwise, you risk
malfunctions of the micropump system, incorrect test
results and over-delivery or under-delivery of insulin.
1.4 General Warnings
4
What is the Purpose of the Micropump System?

wWARNING
jRisk of hypoglycemia (low blood glucose level) or
hyperglycemia (high blood glucose level)
Do not expose the micropump system to extreme
acceleration forces. High g-forces occur for example during
rides on a roller coaster.
In these cases, first remove the micropump from the body.
jDo not use the micropump system close to strong
electromagnetic fields or ionizing radiation. Strong
electromagnetic fields, for example, from radar or antenna
installations, sources of high voltage or X-Ray, 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.
jMaintain a distance of at least 12inches between the
micropump system and portable High Frequency (HF)
communication devices. Portable and mobile HF
communication devices (e.g. Bluetooth device, mobile
phone) may impair the micropump and the diabetes
manager.
Note
Before starting the insulin pump therapy, find out where and
how you can obtain alternative therapy supplies (for example,
a blood glucose meter or pen) at short notice in case the
micropump system does not function properly.
wWARNING
jNever attempt to repair or modify the micropump system
yourself. Otherwise, you risk malfunctions of the
micropump system, incorrect test results and over-delivery
or under-delivery of insulin.
jDo not use the diabetes manager if the screen is damaged
or defective.
jThe correct functioning of your Accu-Chek Solo micropump
system can only be guaranteed if you use accessories,
including software and apps available in the United States,
designated for use with the Accu-Chek Solo micropump
system by Roche.
1
5
General Warnings

Accu-Chek Guide Solo diabetes manager
The Accu-Chek Guide 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.
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.
1.5 Components of the Micropump System
The Accu-Chek Solo micropump system is a system that
primarily consists of a tubeless micropump and a diabetes
manager, which serves as a remote control. The interactive
displays on the diabetes manager screen, help you to make
individual settings and control the micropump.
6
What is the Purpose of the Micropump System?

Accu-Chek Solo reservoir
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 contains a battery that acts
as an energy source for the
micropump.
Accu-Chek Solo cannula assembly
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).
Accu-Chek Solo pump holder
The Accu-Chek Solo pump holder is
an adhesive pad that is adhered to
the skin to fix the cannula in place. It
also holds the micropump in place.
Accu-Chek Solo insertion device
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.
1
7
Components of the Micropump System

Tubeless insulin pump
jSmall, light and removable micropump (approx. 1oz)
jTransparent reservoir (up to 200U), usable for up to 4days
jSoft Teflon®cannula with a length of 6mm or 9mm
jCan be worn at different sites directly on the body
jFilling aid for easy and controlled filling
jCan be used with rapid-acting U100 insulin from different
manufacturers
Convenient handling with the help of the diabetes manager
jControl of the micropump system via touchscreen and
Bluetooth wireless technology
jDirect access to important features, such as bolus, basal rates,
and blood glucose values, via the status screen
jPreview of therapy and system events by means of the
information screen
jAdjustable language selection for user menus
Customized bolus and basal features
jBolus delivery (up to 50U) with diabetes manager or
programmable directly on the micropump
jSelectable bolus types: standard, extended, multiwave
jBasal rates from 0.1U per hour up to 25U per hour
j5 basal rate profiles for different daily routines
jTemporary basal rates from 0 to 250%
jFunctional support when temporarily using an insulin syringe
or pen
Support for therapy decisions
jBuilt-in bolus advice feature
jVisual representation of therapy trends and logbook features
jInterface to common data management software of different
providers on the PC
1.6 Characteristics of the Micropump System
8
What is the Purpose of the Micropump System?