Roche Accu-Chek Smart Pix User manual

User’s Manual
Diabetes Management System
Software version 3.0

2
User’s Manual for the Accu-Chek
®
Smart Pix diabetes management system
Date of issue: October 2016
© 2016 Roche Diabetes Care
All rights reserved
ACCU-CHEK, ACCU-CHEK AVIVA, ACCU-CHEK AVIVA COMBO, ACCU-CHEK AVIVA CONNECT,
ACCU-CHEK AVIVA EXPERT, ACCU-CHEK AVIVA NANO, ACCU-CHEK AVIVA INSIGHT, ACCU-CHEK GO,
ACCU-CHEK GUIDE, ACCU-CHEK INSIGHT, ACCU-CHEK INSTANT, ACCU-CHEK MOBILE,
ACCU-CHEK NANO, ACCU-CHEK PERFORMA, ACCU-CHEK SPIRIT, ACCU-CHEK SPIRIT COMBO,
ACCU-CHEK SMART PIX, COMBO, PERFORMA COMBO, PERFORMA CONNECT, PERFORMA INSIGHT
and PERFORMA NANO are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
System requirements:
• Microsoft Windows XP, Windows 7/Windows 8/Windows 10
• PDF reader (for PDF version 1.6/Acrobat 7 and higher)
• Screen resolution of at least 1024 x 768 pixels
Read the User’s Manual carefully before the first use. The installation, use and maintenance/data backup of the Accu-Chek
Smart Pix software are the sole responsibility of the user. Roche accepts no responsibility for any damage or loss resulting
from non-compliance with this User’s Manual.
In addition, we advise you to refrain from installing any software on your computer which is not from a trustworthy source
and to protect your computer against unauthorised third-party access. This particularly applies to the security of any
existing Internet access. Use up-to-date software for virus protection and your firewall and install the security updates and
patches recommended by the manufacturers.
If you have obtained the Accu-Chek Smart Pix software from a USB flash drive: The USB flash drive is the original medium
used to provide the software, but it is not a removable medium for storing data you have created yourself. Avoid potential
data loss (for example from damage to or loss of the USB flash drive) and always store all files locally on your computer or
on a network server.
Do not remove the USB flash drive containing the Accu-Chek Smart Pix software while data is being exchanged. Doing so
could cause irreparable damage to files.

3
Important note: Never change your therapy based on data contained in the Status report element; always talk to
your healthcare professional first.
Important note: The displayed blood glucose Status will only be meaningful if the settings have been properly
selected. We therefore strongly recommend that you talk to your healthcare professional before you change the
configuration for blood glucose data (Hypo risk, Mean blood glucose and Variability) as well as for CGM data (hypo
duration, CGM median, CGM variability).
The number of blood glucose tests per test day must be sufficient in order to draw appropriate conclusions
regarding therapy from the statistical analysis. In addition, the tests must be conducted at meaningful points in time
spread over the course of the day. Only then does the analysis in the
Status report element correctly reflect the
relevant blood glucose parameter. If, for example, blood glucose is only tested when blood glucose levels are within
the normal range (euglycaemia) or higher range (hyperglycaemia), the
Hypo risk is artificially lowered.
Important note: The Hypo limit can only be a reliable indicator of low blood glucose (hypoglycaemia) if the limit
has been properly selected. We therefore strongly recommend that you talk to your healthcare professional before
you change the limit. This function is not a substitute for hypoglycaemia training by your healthcare professional.
Important note: You do not require an Internet connection if you wish to use the Accu-Chek Smart Pix device and
the Accu-Chek Smart Pix software. All the pages and functions are stored in the device itself or in the software,
where they can be called up. An Internet connection is only required if you wish to automatically update the
Accu-Chek Smart Pix software, download it from the Internet or send data by email.
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Version note
This User’s Manual is valid for the Accu-Chek Smart Pix
software,
version 3.0 in connection with an
• Accu-Chek Smart Pix device (model 2),
version 2.2.1 or higher, or
• Accu-Chek Smart Pix device (model 1),
version 3.05 or higher.
You can check the software versions as described below:
Open the Help menu by clicking the icon (on the right-
hand edge of the button bar). You can display the software
version by clicking
About… This displays both the software
version of the Accu-Chek Smart Pix software and the version
of the connected Accu-Chek Smart Pix device.
Latest software versions
You can download the latest software versions of the
Accu-Chek Smart Pix system using the
Software update...
option in the Help menu or as an automatic download
(if configured) from the Internet.

Accu-Chek Smart Pix diabetes management system Contents
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1 Overview of the system ............................................................................................................................................................11
1.1 Overview of the device............................................................................................................................................................. 15
1.2 Overview of the status indicator signals of the system............................................................................................... 16
1.3 Software overview ..................................................................................................................................................................... 17
1.4 Buttons overview........................................................................................................................................................................ 18
1.5 Printed symbols .......................................................................................................................................................................... 20
2 Before you start using the system .................................................................................................................................21
2.1 What you require to use the system................................................................................................................................... 22
2.2 Copying software to the computer...................................................................................................................................... 24
Connecting the device ..............................................................................................................................................................25
Connecting the USB flash drive ............................................................................................................................................25
Preparing the download version ...........................................................................................................................................25
3 Launching and configuring the software ................................................................................................................29
3.1 Launching the software........................................................................................................................................................... 29
3.2 Configuring the software........................................................................................................................................................ 30
General settings ..........................................................................................................................................................................31
Selecting a language .................................................................................................................................................................32
Time and date format ................................................................................................................................................................33
Display options (graphical representation and logbook format) .............................................................................33
Personal settings ........................................................................................................................................................................34
Automatic features .....................................................................................................................................................................35
Save options .................................................................................................................................................................................42
Settings for new patients .........................................................................................................................................................44
Customised settings for the patient record currently displayed ...............................................................................54
Adjusting menu and button bar ............................................................................................................................................55

Accu-Chek Smart Pix diabetes management system Contents
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4 Using the software ........................................................................................................................................................................ 57
4.1 Reading data manually ............................................................................................................................................................ 58
4.2 Reading data automatically.................................................................................................................................................... 62
4.3 Managing records...................................................................................................................................................................... 63
Creating a new patient record .............................................................................................................................................. 63
Assigning an existing record ................................................................................................................................................. 65
Confirming the device assignment ..................................................................................................................................... 65
Importing records ...................................................................................................................................................................... 66
4.4 Further report and record management features.......................................................................................................... 67
Opening a record ....................................................................................................................................................................... 67
Closing the record and report ............................................................................................................................................... 68
Editing patient records ............................................................................................................................................................. 69
Deleting a record ....................................................................................................................................................................... 70
Archiving a record ..................................................................................................................................................................... 70
Activating the interface to Accu-Chek Connect online .............................................................................................. 71
Adjusting the patient list display .......................................................................................................................................... 73
4.5 Exporting reports as PDF files............................................................................................................................................... 75
4.6 Printing reports ........................................................................................................................................................................... 77
4.7 Emailing reports.......................................................................................................................................................................... 79
4.8 Displaying archived reports (PDF files) ............................................................................................................................. 82
4.9 Using report elements in other applications.................................................................................................................... 83
4.10 Special functions........................................................................................................................................................................ 84
Searching for software updates for the Accu-Chek Smart Pix device
and the Accu-Chek Smart Pix software ............................................................................................................................ 85
Setting the date and time in the meter .............................................................................................................................. 87
Additional special functions .................................................................................................................................................. 89

Accu-Chek Smart Pix diabetes management system Contents
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5 Reports and records ....................................................................................................................................................................91
5.1 General information about the reports.............................................................................................................................. 91
Report elements ..........................................................................................................................................................................91
Selecting and assigning preferred report elements ......................................................................................................92
Analysed data ..............................................................................................................................................................................93
Report styles .................................................................................................................................................................................94
Keys and additional information on reports .....................................................................................................................95
5.2 Overview of icons in reports.................................................................................................................................................. 96
5.3 Interactive features in the report ....................................................................................................................................... 101
Toggling panes ......................................................................................................................................................................... 101
Changing the time range ...................................................................................................................................................... 102
Changing time intervals ........................................................................................................................................................ 105
Changing chart contents ...................................................................................................................................................... 106
Toggling the display between BG and CGM results .................................................................................................. 107
Displaying additional information in charts ................................................................................................................... 108
Selecting chart contents ....................................................................................................................................................... 109
5.4 Blood glucose: contents of the report ............................................................................................................................. 110
Overview ..................................................................................................................................................................................... 110
Trend ............................................................................................................................................................................................ 115
Standard day ............................................................................................................................................................................. 119
Standard week .......................................................................................................................................................................... 123
Metabolic control .................................................................................................................................................................... 127
Statistics ...................................................................................................................................................................................... 130
Device settings ......................................................................................................................................................................... 137
Basal rate – Bolus .................................................................................................................................................................... 137
Basal rates .................................................................................................................................................................................. 139
Insulin pump lists .................................................................................................................................................................... 140

Accu-Chek Smart Pix diabetes management system Contents
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5.5 CGM results ............................................................................................................................................................................... 141
Overview ......................................................................................................................................................................................142
Trend .............................................................................................................................................................................................144
Standard day ..............................................................................................................................................................................145
Standard week ..........................................................................................................................................................................154
Statistics ......................................................................................................................................................................................154
Metabolic control .....................................................................................................................................................................159
5.6 Logbooks..................................................................................................................................................................................... 160
Diary (record) ...........................................................................................................................................................................161
Contents of the diary ..............................................................................................................................................................162
Adjusting the diary view ........................................................................................................................................................163
Editing diary entries ................................................................................................................................................................165
Logbook .....................................................................................................................................................................................175
Daily statistics ..........................................................................................................................................................................177
5.7 Bibliography for reports......................................................................................................................................................... 179
HBGI / LBGI ..............................................................................................................................................................................179
Hypo risk ....................................................................................................................................................................................179
Blood glucose target range ................................................................................................................................................180
Variability ...................................................................................................................................................................................180
Guidance for clinical practice ............................................................................................................................................180
Ambulatory Glucose Profile ................................................................................................................................................181

Accu-Chek Smart Pix diabetes management system Contents
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6 Preparing the devices ............................................................................................................................................................. 183
6.1 Accu-Chek Active blood glucose meter......................................................................................................................... 187
6.2 Accu-Chek Aviva blood glucose meter
Accu-Chek Aviva Nano blood glucose meter .............................................................................................................. 189
6.3 Accu-Chek Aviva Combo blood glucose meter
Accu-Chek Aviva Expert blood glucose meter ............................................................................................................. 190
6.4 Accu-Chek Aviva Insight diabetes manager................................................................................................................. 191
6.5 Accu-Chek Compact blood glucose meter.................................................................................................................... 192
6.6 Accu-Chek Compact Plus blood glucose meter.......................................................................................................... 193
6.7 Accu-Chek Go blood glucose meter................................................................................................................................ 194
6.8 Accu-Chek Guide blood glucose meter.......................................................................................................................... 195
6.9 Accu-Chek Instant blood glucose meter
Accu-Chek Instant S blood glucose meter .................................................................................................................... 196
6.10 Accu-Chek Mobile blood glucose meter........................................................................................................................ 197
6.11 Accu-Chek Performa blood glucose meter
Accu-Chek Performa Nano blood glucose meter ....................................................................................................... 199
6.12 Accu-Chek Performa Combo blood glucose meter.................................................................................................... 200
6.13 Accu-Chek Performa Insight diabetes manager ......................................................................................................... 201
6.14 Accu-Chek Insight insulin pump....................................................................................................................................... 202
6.15 Accu-Chek Spirit insulin pump .......................................................................................................................................... 203
6.16 Accu-Chek Spirit Combo insulin pump........................................................................................................................... 204
6.17 Note on time settings for the Accu-Chek insulin pumps......................................................................................... 205
6.18 Accu-Chek Insight CGM system........................................................................................................................................ 207
7 Error signals and troubleshooting ............................................................................................................................... 209
7.1 Errors without error signals.................................................................................................................................................. 210
7.2 Error signals on the device................................................................................................................................................... 211

Accu-Chek Smart Pix diabetes management system Contents
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8 Appendix ...............................................................................................................................................................................................213
8.1 Cleaning the device................................................................................................................................................................. 213
8.2 Disposal of the device............................................................................................................................................................ 213
8.3 Cleaning the USB flash drive............................................................................................................................................... 213
8.4 Disposal of the USB flash drive .......................................................................................................................................... 214
8.5 Using a USB flash drive......................................................................................................................................................... 214
8.6 Abbreviations............................................................................................................................................................................. 215
9 Accu-Chek Smart Pix software Terms of Use .................................................................................................217
10 Customer support ........................................................................................................................................................................221

Chapter 1, Overview of the system
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1 Overview of the system
The Accu-Chek Smart Pix system is used for the easy and
automatic analysis of blood glucose values, CGM results and
therapy data from various Accu-Chek meters and insulin
pumps. The analysis is provided on a computer in the form of
a report consisting of various configurable report elements.
The system is made up of the following components:
Accu-Chek Smart Pix software
The Accu-Chek Smart Pix software generates the reports
and also allows you to manage the records of several users
or patients. You obtain the software in one of the following
ways:
• With the Accu-Chek Smart Pix device (model 2). The
setup program is stored directly on the device.
• On a USB flash drive.
• Available as a downloadable file from the website
www.accu-chek.com.
Accu-Chek Smart Pix device
The Accu-Chek Smart Pix device
1
is connected to the
computer and communicates with the meters and insulin
pumps. If you obtained the software from a USB flash drive or
as a download, you can also use the Accu-Chek Smart Pix
device (model 1) to communicate via the infrared port, or use
a suitable USB cable (USB, type A to USB, micro B) to
communicate with USB devices.
1. The Accu-Chek Smart Pix device (model 2) and the download
version of the Accu-Chek Smart Pix software are not available
in all countries.

Chapter 1, Overview of the system
12
Using the Accu-Chek Smart Pix software with the Accu-Chek
Smart Pix device (model 2)
• Connect the Accu-Chek Smart Pix device (model 2) to
the computer when you want to read data from a
meter or an insulin pump.
• Place the meter or the insulin pump with its infrared
port facing the Accu-Chek Smart Pix device,
or :
• Connect the meter with a USB port to the Accu-Chek
Smart Pix device by means of a USB cable.
• Launch the Accu-Chek Smart Pix software.
• Prepare the device for transferring data (see
chapter 6).
• Click the
Read device button.

Chapter 1, Overview of the system
13
Using the Accu-Chek Smart Pix software (USB flash drive or
download)
• Connect the Accu-Chek Smart Pix device (model 1) to
the computer when you want to read data from a
meter or an insulin pump.
• Place the meter or the insulin pump with its infrared
port facing the Accu-Chek Smart Pix device,
or :
• Connect a USB cable for transferring data first to the
meter with a USB port (USB, micro B) and then directly
connect the other end to a free USB port on your
computer (USB, type A).
• Launch the Accu-Chek Smart Pix software.
• Prepare the device for transferring data (see
chapter 6).
•Clickthe
Read device button.

Chapter 1, Overview of the system
14
The Accu-Chek Smart Pix software is a computer program
and component of the Accu-Chek Smart Pix system. It
contains the following functions:
• Create (and edit) reports.
• Archive reports with selected elements as a PDF file.
• Email reports with selected elements.
• Display and print archived reports.
• Manage and edit user or patient records.
• Importing device data as well as printing and saving
reports can be automated.
• The graphical report elements displayed have
interactive functions for customising the display.
• Install software updates for the Accu-Chek Smart Pix
system.
All reports are displayed and all functions are used from
within the Accu-Chek Smart Pix software.

Chapter 1, Overview of the system
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1.1 Overview of the device
The device is made up of the following components, which
are briefly described below.
1 Device
1
: This device enables connection to various
Accu-Chek meters and insulin pumps with infrared
or USB ports. At the same time, it contains all the files
required for installing the Accu-Chek Smart Pix
software.
1. Note: This device is not available in all countries.
2 USB plug for connecting to the computer.
3 Infrared window for communicating with similarly
equipped Accu-Chek meters and insulin pumps.
4 USB cable with USB micro B plug to connect directly
to similarly equipped Accu-Chek meters.
2
3
1
4

Chapter 1, Overview of the system
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1.2 Overview of the status indicator signals of the system
The Accu-Chek Smart Pix system indicates various operating
states with the status indicators on top of the device. If all
status indicators are off, the Accu-Chek Smart Pix device is
not connected to a computer or the computer is not switched
on. The following status indicators may be lit up:
5 Device name:
• Glows continuously when the device is connected to
a computer and the computer is switched on. The
device is ready for operation.
• Flashes when a setting or update file is being
received.
6 Luminous surface:
• Off: the device is ready for operation but not active.
• Pulsates slowly: the device is actively searching for a
meter.
• Glows continuously: the device is reading data,
analysing it or is transferring information (for
example, the time) to the meter.
• Flashes quickly: the device is displaying an error.
Software updates for the Accu-Chek Smart Pix system can
be installed via the computer. The device name flashes while
this type of update is being installed.
5
6

Chapter 1, Overview of the system
17
1.3 Software overview
The Accu-Chek Smart Pix software consists of the following
elements:
The user interface needs a screen resolution of at least
1024 x 768 pixels. On larger screens, the window size can be
maximised in any way within the screen area.
Note about the illustrations in this User’s Manual
Bear in mind that all illustrations of screen content (screen-
shots) used in this User’s Manual only serve as examples in
terms of both their visual appearance and content. The
actual appearance depends on your individual system and
software settings. The content displayed depends on the
meter data or insulin pump data that was read.
7 Title bar of the program window, showing the
program name and the buttons for minimising,
maximising and closing the window.
8 Navigation panel for selecting the displayed report
element
9 Button bar containing the buttons for calling up
program functions.
10 Display pane for showing the reports and records.
11 Interactive time axis for displaying and selecting the
time range.
12 Statistics, display options and key (distributed over
three tabs)
7 8 10911
12

Chapter 1, Overview of the system
18
1.4 Buttons overview
In the program window you will find the following buttons:
13 Back button
Returns to the report element that was displayed last.
This button is only activated once you leave the
displayed start screen to display another report
element.
14 Read device button
Activates the data transfer from an available device.
15 Open patient list button
You can open an existing record from the patient list
or create a new record.
16 Save button
You can save a record that was just displayed but has
not yet been assigned to a patient.
17 Print button
Selected report elements are output to a printer of
your choice.
18 Email button
The default email program on the computer is
launched and selected report elements (in PDF
format) as well as the associated record (if selected)
are automatically attached to an empty email.
13 17 18161514

Chapter 1, Overview of the system
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*If you do not yet have a program for displaying PDF files on
your computer, you can, for example, download Adobe Reader
from the Adobe website (http://get.adobe.com/reader/) free of
charge.
You can configure the arrangement of functions and buttons
on the button bar according to your needs (see page 55).
19 Save as PDF report button
Selected report elements are saved in a PDF file.
20 Open PDF report button
Open reports previously saved as PDF files in order to
display or print them using the PDF reader installed
on the computer (for example, Adobe Reader).*
21 Software settings button
Use this button to adjust the settings for the
Accu-Chek Smart Pix software.
22 Device settings button
Access to special functions such as the configuration
of suitable devices
23 Help button
This is where you can find menu options for direct
access to the User’s Manual and to the software
update, and for displaying the program version.
2322212019

Chapter 1, Overview of the system
20
1.5 Printed symbols
Some passages in this User’s Manual are highlighted by
symbols. Read these passages very carefully. There are more
symbols on the type plate of the device and/or on the
packaging.
Symbol Description
This symbol identifies safety information that indicates a possible risk of damage to your health.
This symbol draws your attention to important information.
Manufacturer
Catalogue number
Batch code - year of manufacture
• The Accu-Chek Smart Pix software fulfils the requirements of the European Directive
93/42/EEC on medical devices.
• The USB flash drive fulfils the requirements of the European Directive 2014/30/EU on
electromagnetic compatibility.
This product fulfils the legal requirements of the People’s Republic of China on the use of certain
substances in electronic products.
The USB flash drive falls inside the scope of the European Directive 2012/19/EU (Directive on
waste electrical and electronic equipment, WEEE).
Consult instructions for use. The User’s Manual for the Accu-Chek Smart Pix diabetes
management system can be opened by clicking on the
Help button.
A printed version of the User’s Manual for the Accu-Chek Smart Pix diabetes management
system can be requested by email from
[email protected]om .
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Email:
[email protected]