Disetronic Medical Systems 3 Bluetooth Transceiver Insulin Pump User Manual USer Manual

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Document ID	1165229
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Document Description	USer Manual
Short Term Confidential	No
Permanent Confidential	No
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Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	451.48kB (5643469 bits)
Date Submitted	2009-09-07 00:00:00
Date Available	2009-09-07 00:00:00
Creation Date	2009-08-26 14:56:06
Document Lastmod	2009-08-31 16:00:13
Document Title	USer Manual

Disetronic Medical Systems AG
Labeling Services
Prüflabel
01
Labeling Bezeichnung: Accu-Chek Spirit Combo
Manual us
Mat-Nr./R:
05504929001/B
Ersteller:
Christoph Mathys
Datum:
26.08.2009
bezieht sich auf Spezifikation:
n/a
Master: 05184843001/D
Your insulin pump
ACCU-CHEK, ACCU-CHEK SPIRIT COMBO, ACCU-CHEK AVIVA COMBO,
ACCU-CHEK ULTRAFLEX and DISETRONIC are trademarks of Roche.
USA:
Manufactured for and distributed by:
Disetronic Medical Systems Inc.
Fishers, IN 46037, USA
Toll free 1-800-280-7801
Disetronic Medical Systems AG
3401 Burgdorf, Switzerland
www.accu-chek.com
Swiss made
05504929001/B
Status: 08-2009
The Bluetooth ® word mark and logos are registered trademarks
owned by Bluetooth SIG, Inc. and any use of such marks by
ACCU-CHEK is under license. Other trademarks and trade names
are those of their respective owners.
INSULIN PUMP
Menu key
OK key
Up key
Down key
User Guide
Cartridge compartment with cartridge
Adapter
Luer lock of infusion set
Overview of ADVANCED user menu
Overview of STANDARD and CUSTOM user menus
jj Press d to move forward
jj Press d + a simultaneously
to move backward
jj Press f to select or save
jj Press a to go up
jj Press s to go down
Accessible menus in CUSTOM user
menu can be selected using
Accu-Chek PC software (sold
separately).
STOP
RUN
BRP
jj Press d to move forward
jj Press d + a simultaneously
to move backward
jj Press f to select or save
jj Press a for up
jj Press s for down
= Basal Rate Profile 2–4
= not
 accessible in STANDARD
user menu
BRP
BRP 4
BRP
BRP
BRP 2
BRP
Your contact for assistance with and /or additional information about
your Accu-Chek Spirit Combo insulin pump:
STOP
RUN
Distributed in USA by:
Disetronic Medical Systems Inc.
11800 Exit 5 Parkway, Suite 120
Fishers, IN 46037, USA
Toll Free 1-800-280-7801
info@disetronic-usa.com
www.disetronic-usa.com
For technical support please contact
Accu-Chek Pump Support at 1-800-688-4578
Pump details and accessories
Battery key
Battery cover
Battery
Infrared window
(next to Battery cover)
Adapter
Cartridge Compartment
Cartridge
Piston rod
End plate
Cartridge plunger
Dear Accu-Chek Spirit Combo insulin pump user,
This User Guide is provided for you, as a person with diabetes,
and for healthcare professionals. It contains all the necessary
information for safe and efficient use of your Accu-Chek Spirit
Combo insulin pump. Regardless of your level of experience with
pump therapy, please read this document carefully before
beginning insulin pump therapy. Always refer to this document
first, when you have questions about or have problems using
your insulin pump. If you cannot find the solution to your problem
in this document, then we recommend that you contact your
local pump support. You will find the address and phone number
on the inside back cover of this manual.
Intended Use of the Accu-Chek Spirit Combo insulin pump
The Accu-Chek Spirit Combo insulin pump is intended for the
subcutaneous continuous delivery of insulin at set and variable
rates, for the management of diabetes mellitus in persons
requiring insulin as prescribed by a physician.
The Accu-Chek Spirit Combo insulin pump is intended for the use
of U 100 rapid-acting insulin.
Do not use your insulin pump for the delivery of medication other
than U100 rapid-acting insulin.
Your Accu-Chek Spirit Combo insulin pump is a valuable medical
device. We strongly encourage you to add your insulin pump to
your home contents insurance policy to protect you in case of
accidental damage or loss. Ask your insurance agent for details.
About this User Guide
To ensure safe and convenient use of your new Accu-Chek Spirit
Combo insulin pump, some information in this User Guide requires
particular attention. This information is presented as “Warning”,
“Caution” or “Note”.
jj A “Warning” informs you about risks to your health. Neglecting
this information may even lead to life-threatening situations in
some cases.
jj A “Caution” informs you about risks to your device. Malfunction
or damage may result if you do not follow these instructions.
jj A “Note” contains important information relating the efficient
and smooth operation of your new Accu-Chek Spirit Combo
insulin pump.
1
Understanding your new system
1.1
1.2
1.3
1.4
1.5
1.6
Overview
Display and sounds
Keys and key combinations 
Accessories and disposables
Emergency kit
General safety information
Getting started
2.1 Before you begin
2.2 Inserting the battery
2.3 Start-up process
2.4 Setting the time and date
2.5 Your basal rate profile
2.6	Connecting the cartridge, adapter and infusion set
2.7 Inserting the cartridge
2.8 Priming the infusion set
2.9 Positioning the infusion set
2.10 Starting insulin delivery
2.11 Stopping insulin delivery
2.12 General safety information
Using your pump in daily life
3.1
3.2
Wearing your pump
Interruption of insulin pump therapy
15
19
22
23
25
25
25
29
32
35
42
44
49
52
55
56
57
61
61
64
3.3
3.4
3.5
3.6
Your insulin pump and water
Changing the infusion set
Changing the cartridge and infusion set
General safety information 
67
69
73
76
Boluses and Temporary Basal Rates
77
77
78
84
89
93
98
4.1 Understanding boluses
4.2 Programming a Standard Bolus
4.3 Programming an Extended Bolus
4.4 Programming a Multiwave Bolus
4.5	Programming a Temporary Basal Rate (TBR)
4.6 General safety information
Personalizing your pump
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
5.11
Introduction
Selecting a user menu
Standard user menu
Viewing your pump data
Transferring your data to a computer 
Pump settings
ADVANCED user menu
Basal rate profiles 
Setting a Reminder
Therapy settings
CUSTOM user menu 
99
99
101
103
105
111
113
120
121
124
126
130
6
Using the Accu-Chek Spirit Combo insulin
pump with the Meter
133
6.1 Meter
6.2 Switching Bluetooth ® ON and OFF
6.3 Pairing your pump with the Meter
6.4	Troubleshooting the Bluetooth ® connection
133
135
136
139
Care and Maintenance
7.1
7.2
7.3
7.4
7.5
7.6
7.7
Inspecting your pump
Damage to your pump
Your insulin pump and water
Repair of your pump
Maintaining your pump
Storing your pump
Disposing of your pump
143
143
145
146
148
149
150
150
Warnings and Errors
8.1
8.2
8.3
8.4
Confirming a Warning or Error
List of Warnings
List of Errors
List of Reminders
Troubleshooting
9.1
Therapy-related issues
151
152
153
159
170
171
172
Appendix A: Technical Data
Appendix B: Configuration parameters
Appendix C: Sterile products and accessories
Appendix D: Abbreviations
Appendix E: Beeps and melodies
Appendix F: Symbols
Appendix G: Warranty
Glossary
Index
Quick reference table for Errors, Warnings and Reminders
My notes
Bluetooth ® registration
175
189
192
194
195
201
206
209
215
219
222
223
1
Understanding your new system
1.1 Overview
Your Accu-Chek Spirit Combo insulin pump has many helpful
features that help to ensure safe and efficient pump therapy.
Note In this User Guide the term “Meter” always refers to the
Accu-Chek Aviva Combo Blood Glucose Meter.
1.1.1 Summary of features
Three user menus
Your Accu-Chek Spirit Combo insulin pump has been designed to
adapt to your level of experience in pump therapy – whether you
are a beginner or an experienced pump user. Your pump “grows”
with you!
You can use one of three menus – STANDARD, ADVANCED or
CUSTOM – to access the functions and settings you will need
from day to day.
Interaction with the Meter
The Accu-Chek Spirit Combo insulin pump is designed for use
with the Meter. This new product is an intelligent blood glucose
meter that can remote control the pump using Bluetooth ®
wireless technology.
STANDARD
This is the most basic menu – designed for
simplicity and comfort.
ADVANCED
This menu helps you to adjust your therapy
to a wider range of situations.
CUSTOM
The CUSTOM menu enables you to
fine-tune your pump according to your
personal needs and skill level.
Quick Bolus
You can program a Quick Bolus without looking at the display
screen and check that it is correctly programmed by counting the
beeps and vibrations. This is particularly useful when you want
to program the bolus discreetly in public.
Dual signalling of Warnings and Errors
For your safety, Warnings and Errors are signalled using both
audible beeps and vibration of the pump. In addition, the beep
tones are fully adjustable – from silent to loud.
See chapter 5 Personalizing your pump.
Five basal rate profiles
You can choose from five basal rate profiles, in line with your
different daily routines.
Data transfer
The infrared port on the bottom of your Accu-Chek Spirit Combo
insulin pump enables you to transfer information between your
pump and a personal computer or handheld device.
Four bolus types
Your Accu-Chek Spirit Combo insulin pump enables you to program
four bolus types, each corresponding to different situations you
may encounter, and this provides you with a lot of flexibility.
Rotating display
Your pump’s display can be rotated 180 degrees, and you can
also adjust its contrast. Combined with the backlight, these
features make the display easier to read.
1
Reminder
As well as Warnings and Errors, your pump can signal Reminders.
This works like an electronic alarm clock.
Choice of batteries
Your Accu-Chek Spirit Combo insulin pump can be powered by
either disposable or rechargeable batteries. (If you decide to use
rechargeable batteries, you will need a battery charger recommended by the battery manufacturer.)
Keylock
The Keylock feature allows you to lock all four keys on your
pump to prevent the accidental activation of functions. For
example, you can use Keylock while you are asleep or when
playing sports.
1.2 Display and sounds
Your Accu-Chek Spirit Combo insulin pump has a Liquid Crystal
Display (LCD) screen. This display, together with the four keys,
enables you to program the pump. It also shows important
information about the status of your pump.
Warning
Changes in the status of your pump can be ­­life-threatening. If
for any reason you cannot hear the audible signals or feel the
vibrations of your pump, looking at the display is the only way
that you will be aware of changes or malfunctions in your
pump.
1.2.1 Backlight
1.2.2 Rotating display
The backlight helps you to read the information on the display in
poorly-lit areas. You can turn on the backlight while in RUN or
STOP mode, or when navigating through the menus, by pressing
a.
Your pump’s display can be rotated 180 degrees. See section
5.6.4 Display orientation.
Note that when you rotate the display, the s and a key
functions are reversed.
The backlight turns on automatically when a Reminder, Warning
or Error message is displayed, and turns off automatically after
10 seconds if no further keys are pressed.
Tip: In poorly-lit areas, begin programming with the a.
10
Caution
If incomplete characters, numbers or symbols appear on the
display, put your pump into STOP mode and remove the
battery for a few seconds. When you reinsert the battery, the
pump will perform a system check. If this does not resolve the
problem, put your pump into STOP mode and contact your
local pump support. For details see inside the back cover.
1
1.2.3 Display screens
The screens displayed by your pump relate to one of the
following modes:
jj RUN, STOP and Quick Info
jj Information
jj Function
jj Set-up
The Information, Function and Set-up screens are all accessed
from the user menus. See section 5.2 Selecting a user menu.
Note
To save battery life, the screen of your Accu-Chek Spirit
Combo insulin pump goes blank when you do not press
any key for more than 20 seconds. As long as your pump
is showing a blank screen, you have to press any key
before any other operation can be performed.
RUN screen
By default the screen is blank, to save energy, and becomes
blank again after 20 seconds without key pressing. By pressing
any key, the RUN screen is displayed when the pump is in RUN
mode. This means that insulin is being delivered to your body
according to the basal rate you have programmed.
time
current hourly
basal rate
Keylock locked
pump timer
cartridge low
battery low
active basal rate profile
The above screen shows all the possible symbols, including the
current time, the current basal rate profile, and the current hourly
basal rate in units per hour.
11
The RUN screen also displays Reminder information (such as
“cartridge low”) and special functions (such as Keylock – locked
or unlocked) in the form of symbols. (See Appendix F: Symbols)
The STOP screen also displays Reminder information (such as
“battery low”) and special functions (such as Keylock – locked or
unlocked) in the form of symbols.
Note
Your pump must be in STOP mode in the following situations:
You are
jj programming specific functions
jj changing the cartridge and / or the infusion set
jj priming the infusion set
jj transferring data to or from the pump
jj changing the battery
After you program or review information, the pump
returns to the RUN screen.
STOP screen
The STOP screen is displayed when the pump is in STOP mode.
This means that insulin is no longer being delivered to your body.
The STOP screen shows the current time and date, and the STOP
symbol.
time
Quick Info menu
You display the QUICK INFO screen by pressing the f key while
in RUN or STOP mode. The QUICK INFO screen shows the
remaining insulin content of the cartridge in units.
date
Keylock unlocked
pump timer
cartridge low
battery low
12
1
By pressing f again you enter the BOLUS DATA function. You
can view the last 30 boluses by pressing a or s.
1.2.4 Navigating through the screens
The following procedure explains how to navigate through
the screens. Think of these screens as menu choices. See
section 1.2.3 Display screens.
You can leave the Quick Info screen either by pressing f again
or pressing no key for 20 seconds.
Information, Function and Set-up screens
You access these screens when you program the pump, perform
a function, change a setting, or store or transfer information. You
can reach these screens from either the RUN or STOP screen.
1. Press the d key to select a screen of your choice.
2. Press the d key again to see the next available choice in
the menu. (After you reach the last menu choice, you will
return to the first menu choice.)
3. When you reach the screen of your choice, press the
f button.
The next set of screens are called Function screens, and all
relate to the choice you have just made. There may be one or
several Function screens.
4. Press the s or a key to increase or decrease the
displayed value, or press the d key again to move to the
next Function screen to make further changes. (After you
reach the last Function screen, you will return to the first
Function screen.)
5. Press the f button to save your changes.
13
Note
You can move backwards through the menu structure
– or return to menus you have skipped – by pressing the
d key and a key simultaneously. However, if you are
in a Function screen, pressing these buttons simultaneously moves you up one level without saving the current
changes.
1.2.5 Status messages and alarm signals
Your Accu-Chek Spirit Combo insulin pump informs you of
the status of your pump using audible beeps, vibrations and
displayed messages. It is vital that you be able to hear and / or
feel the beeps and vibrations. Be aware that some carrying
pouches may hinder the perception of the signals.
You can turn off either beeps or vibrations, but for your safety
you cannot turn off both at the same time for the initial alarm
signal.
See chapter 8 Warnings and Errors for a description of the full
range of Warnings and Errors.
STOP-Warning
The STOP-Warning is triggered when your pump switches from
RUN mode to STOP mode, or when a battery is inserted. The
pump beeps twice and vibrates once every minute. This warns
you that insulin delivery has been interrupted.
14
1
To turn off the STOP-Warning, press either a or s for three
seconds. You then hear a melody, confirming that the STOPWarning has been turned off. If you press the key too briefly, the
STOP-Warning will not be turned off.
Note
For your safety, the volume of the STOP-Warning cannot
be changed. It is independent of the programmed beep
volume.
1.3 Keys and key combinations
You use the four keys on the Accu-Chek Spirit Combo insulin
pump to program functions, access information, and set up the
pump. Each time you press a key the pump will beep, unless
the beep tone is set OFF.
f OK key
d Menu key
a Up key
s Down key
15
The following table lists the keys and their functions.
16
Key
Name
Function
Key
Name
Function
Menu
jj Move through menus, function screens
and information screens
Down
OK
jj Select a menu
jj Save changes and exit the function and
information screens
jj View the Quick Info screen
jj Move backward in the information
screens
jj Decrease a setting
jj Program a Quick Bolus
jj Cancel a Quick Bolus
jj Turn off the STOP-Warning (press and
hold 3 sec. until you hear a melody)
Up
jj Move forward in the information screens
jj Increase a setting
jj Turn on the backlight
jj Program a Quick Bolus
jj Cancel a Quick Bolus
jj Turn off the STOP-Warning (press and
hold 3 sec. until you hear a melody)
Caution
Do not press the keys with a sharp or pointed item such as the
tip of your fingernail, as this could damage the casing of your
Accu-Chek Spirit Combo insulin pump. Instead, use the pad of
your fingertip to avoid puncturing the keys.
1
1.3.1 Combining keys
You can obtain additional functions by pressing two keys
simultaneously. In the following table, a plus symbol (+) indicates
that both buttons must be pressed at the same time.
Combination
Function
d+a
jj Exits menus, function
screens and information
screens without saving your
changes.
jj Moves you to a previous
menu.
d+s
jj Unlocks the keys. Press and
hold both buttons until you
hear three short beeps (RUN
mode) or three long beeps
(STOP mode).
a+s
jj Copies an hourly basal rate
to the following hour.
Warning
If the keys on your pump are not functioning properly,
disconnect your pump and contact your local pump support
(see inside back cover).
17
1.3.2 Scrolling
1.3.3 Locking the keys
To enter larger or smaller values, the a and s keys must
sometimes be pressed several times until the desired value is
shown, with each press of the key changing the figure by a small
increment. However, you can also press and hold the key
(scrolling function) to change the value faster. When programming boluses and hourly basal rates the increment of the value
change increases if you keep the a or s key pressed.
The Keylock feature enables you to lock all four keys on your
Accu-Chek Spirit Combo insulin pump. This is a valuable safety
measure that prevents you from accidentally activating your
pump. For example, you can use Keylock while you are asleep
or when playing sports.
When you begin scrolling, the pump beeps once.
18
You turn on the Keylock function in the PUMP SETTINGS –
See section 5.6 Pump settings.
1
1.4 Accessories and disposables
High-quality sterile disposables and accessories are a vital
part of the Accu-Chek Spirit Combo insulin pump system, and
help to ensure safe pump therapy. Always follow the instructions
provided by your doctor or healthcare team – as well as the
printed instructions included with the product – relating to the
use of these items.
Note
Warning
Your pump has been designed for use with U100 insulin. Only
use sterile disposables and accessories that are designed for
use with your Accu-Chek Spirit Combo insulin pump. The
correct functioning of your pump can only be guaranteed if you
use Accu-Chek brand sterile products and genuine Accu-Chek
Spirit Combo insulin pump accessories.
Use your insulin pump, sterile disposables and accessories for the first time in the presence of your doctor or
healthcare team.
1.4.1 Sterile disposables
Each sterile disposable, such as cartridge or infusion set, should
be used only once, as re-using these products could lead to
infection or could damage your pump. Do not use a sterile
product if the package has been damaged or opened.
19
1.4.2 Adapter
Note
vents
It is essential to change the adapter at least every two
months. You must also change the adapter if the seals
become worn, are lost, or if the vents are blocked.
1.4.3 Battery
grip
seal
thread
The adapter connects the cartridge to the infusion set, and also
keeps the cartridge compartment watertight with two seals, one
inside and one outside the adapter. It holds the cartridge in place
and prevents the entry of air bubbles. The two small vents on the
adapter allow air pressure to be equalized inside and outside the
cartridge compartment. The adapter will not work properly if the
vents are blocked or dirty, or if the seals are missing.
20
Your pump requires one AA 1.5 V battery in order to function. Use
AA high-quality alkaline LR6 or lithium FR6 batteries that have a
minimum capacity of 2500 mAh. Do not use carbon zinc or nickel
cadmium (NiCd) batteries.
If you prefer, you can use rechargeable batteries – in this case,
use AA 1.2 V NiMH HR6 batteries with a minimum capacity of
2500 mAh. Always use a battery charger recommended by the
battery manufacturer. See Appendix A Technical Data p. 176.
1
Caution
Use of batteries other than those recommended may significantly reduce battery usage time. Such batteries may also
leak and corrode the battery contacts in your pump. Therefore,
the use of batteries not supplied or recommended by Roche
may void the warranty. Before inserting rechargeable batteries
make sure that they are not damaged or leaking as damaged
or leaking batteries could damage your pump.
Note
Always remember to remove the battery if your
Accu-Chek Spirit Combo insulin pump is not going to be
used for a long period, in order to conserve the battery.
Battery key
The battery key tightens and loosens the battery cover. It is also
designed to loosen the luer-lock connection between the infusion
set and adapter if it cannot be loosened by hand, by using the
notch on the side. However, never use the battery key to attach
or tighten an infusion set. Using the battery key prevents
possible damage to the battery cover.
If you lose the battery key, or if it becomes cracked or worn, order
a replacement immediately, rather than using makeshift tools.
For a list of recommended accessories and disposables, see
Appendix C.
Battery cover
The battery cover seals the battery compartment, and must be
changed at least every two months. You must remove and
replace the battery cover using the battery key – do not use
knives, screwdrivers or other sharp objects, as these may
damage your pump.
21
1.5 Emergency kit
It is highly recommended to keep accessories and disposables
with you in case of an emergency. This enables you to change
these items if necessary. Such an emergency kit should contain:
jj An Accu-Chek infusion set
jj A new AA alkaline or lithium battery
jj An Accu-Chek Spirit 3.15 ml Cartridge System
jj An insulin pen or syringe for alternative therapy
jj A vial of insulin
jj Treatment for low blood glucose levels
jj Blood glucose monitoring equipment
(such as an Accu-Chek blood glucose meter)
jj A disinfectant for skin
jj A battery key
jj A battery cover
jj An adapter
22
Warning
Make sure that you have an alternative therapy plan, provided
by your healthcare professional. Use this plan whenever you
need to interrupt pump therapy.
1
1.6 General safety information
Warning
Always make sure to accurately program your personal settings
to avoid inappropriate insulin delivery. This phrase means that
either too much or too little insulin is delivered. Too much insulin
can lead to severe hypoglycemia. Too little insulin can lead to a
life-threatening ketoacidosis.
Caution
If you should drop your pump, immediately inspect it carefully
for damage. Do not use your Accu-Chek Spirit Combo insulin
pump if cracks or chips are visible – these may allow water,
dust, insulin or other foreign substances to enter the pump
and lead to malfunction.
Warning
Your insulin pump has not been tested with cardiac pacemakers.
For information about the safe use of your Accu-Chek
Spirit Combo insulin pump with a cardiac pacemaker, contact
the pacemaker manufacturer. For reference see Appendix A
Tables 201 – 205.
23
24
2
Getting started
This chapter explains how to prepare your pump and begin
insulin pump therapy.
2.1 Before you begin
Successful insulin pump therapy requires you to check your
blood glucose levels frequently. It is therefore recommended that
you use an Accu-Chek blood glucose meter as often as directed
by your doctor or healthcare team.
Your Accu-Chek Spirit Combo insulin pump has been designed
for use with the Meter. This intelligent blood glucose meter
enables communication with your pump using Bluetooth ®
wireless technology.
2.2 Inserting the battery
Your Accu-Chek Spirit Combo insulin pump turns on as soon as
you insert the battery. When you remove the battery, your pump
keeps track of the time and date for about one hour. Your insulin
pump settings (such as the hourly basal rates, bolus increment
and active user menu) and the event memory (bolus and alarm
history, history of daily insulin totals and Temporary Basal Rates)
are always saved, regardless of battery condition or the amount
of time your pump has been without a battery. See section
1.4.3 Battery for information on batteries (both disposable and
rechargeable types).
25
Procedure for inserting and changing the battery
1.
2.
Remove or disconnect your infusion set
from the infusion site, to ensure that
there is no risk of accidental insulin
delivery.
Press d to move to the STOP YOUR
PUMP screen.
Press f to select. Your pump is now in
STOP mode and insulin delivery stops.
3.
4.
Remove the battery cover.
Use the battery key to turn the battery
cover counter-clockwise. Make sure that
the opening of the battery compartment
and the seal are clean and undamaged.
Where appropriate, remove the old
battery.
26
Insert the battery, negative (–) end first,
positive (+) end up, into the compartment.
2
5.
6.
Use the battery key to fully tighten the
battery cover. You can verify that the
battery cover is correctly tightened by
checking that it is in line with the pump
casing. Do not over-tighten.
Place the cover on the positive end and
gently push the battery in, while turning
the cover clockwise to partially tighten it.
After inserting the battery, the pump begins its start-up process
(see next section).
In case the pump does not begin the start-up process after
inserting the battery, make sure that the battery is inserted
correctly (negative end first).
27
c
Caution
To prevent water from entering the pump casing, only insert or
change the battery in a dry environment. Make sure that the
battery cover seal is not worn or missing, and that the battery
is correctly inserted.
Note
28
If your pump was in RUN mode before you removed the
battery, the Error E8: POWER INTERRUPT will occur when
the new battery is inserted. Press f twice to confirm
and snooze the Error. Check the time and date and
correct them if necessary. Then put your pump into RUN
mode. See section 2.4 Setting the time and date.
2
2.3 Start-up process
Your pump runs a start-up process when you insert a battery or
when you change the cartridge. During this process, your pump
performs a series of internal tests.
When you …
Then …
change only the
cartridge
the start-up process begins at the
SELF-TEST screen.
When you …
Then …
change the battery
the whole start-up process is
performed.
Warning
Do not interrupt the start-up process by pressing keys or
otherwise handling the insulin pump. Interruption of the
process may lead to malfunction of your pump.
Start-up process sequence
1.
2.
3.
The software version screen appears.
The Accu-Chek logo appears.
The SELF-TEST screen appears.
29
4.
The BEEP TEST screen appears and your
pump beeps.
Listen for the beeps.
Warning
If you cannot feel the vibrations, you
may not be notified of changes within
the pump in time to take action. If you
do not feel the vibrations, do stop
using the pump and contact your local
pump support. (See inside back cover)
30
Warning
If you cannot hear the beeps from your
Accu-Chek Spirit Combo insulin pump,
you may not be notified of changes
within the pump in time to take action.
If you do not hear the beeps, stop
using the pump and contact your local
pump support. (See inside back cover)
5.
The VIBRATION TEST screen appears and
your pump vibrates.
Check the vibrations.
6.
7.
The display then goes blank. Check that
the display is empty. (The backlight turns
on during this step.)
The display then shows a pattern. Check
that the pattern is even.
2
8.
9.
10.
The display turns black. Check that the
display is completely black.
If your pump detects a Warning or an
Error during the start-up process, it
signals the Error or Warning at this point.
See section 8.3 List of Errors.
After the self-test, press a or s to
select the type of battery you inserted.
11.
The end of the start-up process is
signalled by a melody, and the pump
displays the STOP screen.
The STOP-Warning occurs every minute
– the pump emits two short beeps and
vibrates to remind you that no insulin is
being delivered. To turn the STOP-Warning
off, press a or s until you hear a
melody and  / or feel a vibration.
Press f to save and exit.
c caution
Make sure that you choose the correct
battery type. Otherwise you may not be
informed about a low battery in time.
31
2.4 Setting the time and date
It is essential to set the time and date correctly, because basal
rates and history information are stored on the basis of the time
and date set in the pump. When you travel across time zones,
and for the change to and from daylight savings time, make sure
that the time and date are re-set correctly.
You can choose between American or European / Military time.
32
Warning
Incorrect setting of the time and date can lead to incorrect
basal insulin delivery. Make sure that the time and date of
your pump are set correctly, to ensure correct delivery and
data memory. Do not make therapy decisions based on a
single result in the pump’s memory.
American
European / Military
12-hour clock
24-hour clock
month / day / year
day / month / year
In addition, if you, your doctor, or healthcare team are
reviewing your data electronically, it is essential that you
synchronize the time and date of your pump with those of
your blood glucose meter, your personal computer or
handheld device. Otherwise, the resulting data might not be
meaningful. Check these devices regularly to ensure that the
settings remain synchronized.
Warning
2
Procedure for setting the time and date
1.
2.
3.
Press d to move to the TIME AND DATE
SETTINGS screen.
Press f to select.
Press d to move to the MINUTE screen.
The HOUR screen is displayed.
Press a or s to set the hour.
Press a or s to set the minute.
4.
5.
6.
Press d to move to the YEAR screen.
Press d to move to the MONTH screen.
Press d to move to the DAY screen.
Press a or s to set the year.
Press a or s to set the month.
Press a or s to set the day.
33
7.
8.
Press d to move to the TIME FORMAT
screen.
Press d to move to the DATE FORMAT
screen.
Press a or s to set the time format.
Press a or s to set the date format.
Press f to save and exit.
34
2
2.5 Your basal rate profile
Your Accu-Chek Spirit Combo insulin pump must be programmed
with your personal settings before you begin pump therapy. Your
doctor or healthcare team can help you to understand how to use
the pump.
Note
2.5.1 Programming your basal rate profile
An Accu-Chek Spirit Combo insulin pump basal rate profile
consists of up to 24 different hourly basal rates. Each hourly rate
may be changed independently. The total of all 24 basal rates in
one basal rate profile is called the (daily) basal rate total.
Your Accu-Chek Spirit Combo insulin pump delivers insulin every
3 minutes, in 20 equal doses every hour, 24 hours a day. This
flow of insulin, measured in international units per hour (U / h),
is called the basal rate profile and is calculated to meet your
basic insulin needs.
The pump can store up to five different basal rate profiles to
match your changing insulin needs – for example: Monday to
Friday, Exercise Day or Sleeping Late Day.
For your safety and convenience during programming,
your Accu-Chek Spirit Combo insulin pump switches to
RUN or STOP screen if no key is pressed within 20 seconds. Any changes you have made before this “time-out”
occurs will not be saved .
Example: Basal rate profile for 18 U / 24 hours
Insulin delivery
[U / h]
Hourly basal rate
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Time
35
Your basal rate profile should be reviewed:
jj After any programming changes are made to your pump
jj After a new battery is inserted
jj After confirming the Error E7: ELECTRONIC ERROR.
Note
Insulin delivery does not stop or pause during basal
rate programming.
Procedure for programming your basal rate profile
36
1.
2.
3.
Press d to move to the BASAL RATE
PROGRAMMING 1 (2, 3, 4 or 5 accordingly) screen.
Press f to select.
Press d to move to the first hour.
The daily BASAL RATE TOTAL is displayed.
This is always 12 AM – 01 AM.
2
4.
Note
Press a or s or scroll to set the
hourly basal rate given by your doctor or
healthcare team.
6.
Continue using d and a or s to set
the hourly basal rates for the remaining
hours. This allows you to program your
individual basal rate profile on an
hour-by-hour basis. Continue until all
24 hours are programmed.
The increments shown depend on
the programmed basal rate: it will
be
0.01 U from 0.05 U to 1.00 U,
0.05 U from 1.00 U to 10.0 U and
0.1 U from 10.0 U to 50.0 U
5.
Press d to move to the next hour.
7.
Press f to confirm.
The new daily BASAL RATE TOTAL is
displayed.
Press f to save the profile and exit.
37
Copying an hourly basal rate
1.
2.
Press d to move to the BASAL RATE
PROGRAMMING 1 (2, 3, 4 or 5 accordingly) screen.
Press f to select.
4.
5.
If your basal rate is the same for multiple
hours in a row, you can save time by
copying an hourly basal rate to one or
more hours.
3.
The daily BASAL RATE TOTAL is
displayed.
If you want to copy the rate to multiple
hours, press a and s repeatedly or
press and hold a and s (scroll).
Press d to move to the hourly basal
rate you want to copy.
Press a and s simultaneously.
A special beep confirms that you are
pressing the keys correctly. The same
hourly basal rate is copied to the next
hour.
38
2
6.
Note
At any point in the programming of your basal rate, you have the following options
to exit.
If you want to …
Then …
Press f to confirm.
save the changes
jj Press f and check the new daily basal rate total.
jj Press f again. Your pump returns to the RUN screen.
Review the new daily BASAL RATE
TOTAL.
undo the changes
jj Wait for your Accu-Chek Spirit Combo insulin pump to return
to the RUN screen, or
jj Press d and a simultaneously (exit feature) to exit the
Function screen.
Press f to save and exit.
39
Selecting a basal rate profile
1.
2.
Press d to move to the BASAL RATE
SELECTION screen.
Press f to select.
When you have programmed more than
one basal rate profile (ADVANCED or
CUSTOM MENU), you can select the
required profile.
The SELECT PROFILE for the current
basal rate profile is displayed.
3.
Press a or s to select a basal rate
profile.
The SELECT PROFILE screen and its daily
basal rate total appear accordingly.
40
4.
Press f to select the displayed profile.
The new basal rate profile is active
immediately.
Warning
Make sure that you select an appropriately programmed basal rate profile.
Otherwise there could be inappropriate
insulin delivery.
2
Note
When you change your user menu for example from
ADVANCED to STANDARD, your current basal rate profile
may not appear.
If the basal rate profile number(s) you want does not appear:
jj Select the ADVANCED user menu, or
jj Assign the basal rate profile to an available basal rate
profile number
A running Temporary Basal Rate increase or decrease
stays active, even if you change the basal rate profile on
your pump.
Basal rate and bolus
During normal use, your pump is in RUN mode and insulin is
continuously delivered to your body, according to the basal rate
profile you have programmed.
A bolus can be programmed as required. A bolus is the amount
of insulin delivered (in addition to the basal rate) to cover the
intake of food and to correct high blood glucose levels. The bolus
amount is determined by your doctor or healthcare team’s
guidelines and depends on your blood glucose level, your food
intake, and your activity level, as well as stress and illness. See
section 4.1 Understanding boluses.
41
2.6 C
 onnecting the cartridge, adapter
and infusion set
Before you change the cartridge, adapter or infusion set,
check that your pump is in good working order.
See section 7.1.1 Checklist.
Insulin can flow uncontrolled from the cartridge or infusion set if
the cartridge plunger and the piston rod are not properly
connected and the pump is positioned at a higher level than the
infusion site. Prevent leakage of insulin by correctly inserting the
cartridge: move the piston rod to the correct position and twist
the adapter until the cartridge plunger is aligned with the end
plate of the piston rod. (See section 3.5 Changing the cartridge
and infusion set)
42
Have the following materials ready:
jj A filled Accu-Chek Spirit 3.15 ml Cartridge System with a
luer-lock connection (for filling instructions see the instructions
for use provided with this product)
jj An Accu-Chek Spirit Combo insulin pump adapter
jj A new Accu-Chek infusion set
Warning
Ensure that the cartridge is at room temperature before use
to prevent air bubbles.
2
Procedure to connect the cartridge, adapter and infusion set
1.
2.
3.
Push the adapter all the way onto the
cartridge tip, to the stop.
Carefully prepare a new Accu-Chek
infusion set, following the instructions
supplied for use.
Remove the protective cap from the filled
cartridge. (Do not touch the cartridge tip.)
4.
Hold the adapter and twist the infusion
set luer-lock connection by hand,
clockwise into the adapter. Do not
over-tighten.
Warning
To avoid leakage, tightly attach the infusion set to the
adapter. Turn the infusion set luer-lock connector until it
stops. Do not over-tighten or use any auxiliary tools, as this
may crack the infusion set luer-lock connector and result in
leakage of insulin.
43
2.7 Inserting the cartridge
Have the following materials ready:
jj A filled Accu-Chek Spirit 3.15 ml Cartridge System with a
connected Accu-Chek Spirit Combo insulin pump adapter
jj A new Accu-Chek infusion set
Warning
Do not use your pump for the delivery of medication other than
U100 rapid-acting insulin.
Procedure for inserting the cartridge
1.
2.
Press d to move to the STOP YOUR
PUMP screen.
Press f to select.
Disconnect the infusion set.
The pump displays the STOP screen, and
insulin delivery stops.
44
3.
2
4.
Hold the pump with the adapter facing
the ground. Remove the cartridge, if
necessary. Unscrew carefully. Do not pull
the cartridge out until it is completely
unscrewed.
7.
The piston rod begins to return. Do not
touch or otherwise disturb the piston rod
while it is rewinding, as this could result
in damage to your pump.
5.
6.
Press d to move to the CARTRIDGE
CHANGE screen.
Make sure your infusion set is disconnected and the cartridge has been
removed.
Press f to select.
Press and hold f for three seconds,
until you hear a melody.
8.
When the piston rod has returned
completely, the CARTRIDGE VOLUME
screen displays the maximum volume,
315 U.
Caution
Do not change the cartridge if the
cartridge compartment is not completely
dry. When the piston rod is rewinding,
insulin solution could enter your pump
and lead to malfunction. If necessary,
use a soft cloth to dry the compartment.
45
9.
10.
see step 10
Hold your pump upright. Hold the new
filled cartridge so that the connected
adapter and infusion set points upwards,
parallel, and close to the cartridge
compartment.
see step 11
Make sure that the top edge of the
threaded part of the adapter is level with
the top of the cartridge compartment.
11.
12.
Press a or s to move the piston rod
forward until the end plate of the piston
rod is level with the bottom of the
cartridge plunger.
The CARTRIDGE VOLUME decreases
accordingly on the display.
46
2
13.
14.
It is not necessary to apply pressure.
Do not over-tighten the adapter, otherwise it will be difficult to remove the
cartridge, adapter and cartridge plunger,
and could cause damage to your pump.
Position your insulin pump upright (with
the adapter pointing upwards). Insert the
cartridge into the cartridge compartment.
Twist (do not push) the adapter clockwise
until it is correctly seated against the
cartridge compartment.
15.
16.
17.
The cartridge is correctly inserted when
the end plate of the piston rod is correctly
seated against the cartridge plunger.
If the end plate of the piston rod is not
correctly aligned with the cartridge
plunger, remove the cartridge from the
cartridge compartment and repeat steps
9. to 14.
Check that the infusion set luer-lock
connector is still correctly connected to
the adapter. Tighten the infusion set
clockwise by hand until it sits tightly in
the adapter.
47
18.
19.
See section 2.8 Priming the infusion set.
Start from step 4 in the Pocedure for
priming the infusion set.
Press f after correctly inserting the
cartridge.
Your pump performs a self-test. See
section 2.3 Start-up process.
48
When the self-test process is finished,
the Infusion set PRIMING screen is
displayed.
2
2.8 Priming the infusion set
Warning
Never prime an infusion set that is connected to your body as
you risk uncontrolled insulin delivery into your body. Always
follow the instructions for the infusion set you are using.
The Accu-Chek Spirit Combo insulin pump stops priming at
25 units of insulin. If no insulin emerges from the needle or there
are air bubbles in the tubing after priming, repeat the priming
function until the infusion set is bubble-free and completely filled
with insulin. When insulin appears at the tip of the needle, press
f to stop priming. The amount of insulin used for priming is
not added to the pump’s history of daily insulin totals.
Warning
Air bubbles in the cartridge and infusion set may result in the
infusion of air instead of insulin. If this happens, your body
will not receive the required amount of insulin. Remove
bubbles while filling the cartridge and priming the infusion
set, and without having the infusion set connected to your
body.
Your pump should be upright during priming, with the adapter
pointing upwards to help let air bubbles out of the cartridge and
infusion set.
49
Procedure for priming the infusion set
1.
2.
Press d to move to the STOP YOUR
PUMP screen.
The pump displays the STOP screen, and
insulin delivery stops.
Prepare the tubing or needle for priming
according to the infusion set’s instructions for use.
Press f to select.
50
3.
4.
5.
Press d to move to the Infusion set
PRIMING screen.
Make sure your infusion set is disconnected.
Press f to select. The priming amount
of 25 units of insulin is shown on the
display.
Press and hold f for three seconds,
until you hear a melody. The priming
process begins.
6.
To ensure that any air bubbles are
removed always hold your pump upright
and, gently tap it with the bottom in the
palm of your hand.
2
7.
The infusion set is properly primed when there are no air bubbles
visible in the tubing and a drop of insulin has come out of the
needle. When the priming process is complete, your pump
returns to STOP.
A count-up is shown on the display. Your
pump stops priming after 25 units.
You can stop the priming process at any
time by pressing f.
51
2.9 Positioning the infusion set
Always follow the instructions given to you by your doctor or
healthcare team and the instructions for the infusion set you
are using.
Change your infusion set as frequently as recommended by the
manufacturer.
2.9.1 Preparing the infusion site
Infusion site selection
Your doctor or healthcare team will help you choose your infusion
site areas according to a planned rotation pattern. Avoid your
waistline, bones, scar tissue, recent infusion sites, bruises and
sores. Choose an infusion site at least one inch (2.5 cm) away
from the navel and previous infusion sites.
Infusion site preparation
It is important to prepare the infusion site properly to reduce the
risks of infection. Your doctor or healthcare team will provide you
with infusion site preparation guidelines.
52
Have the following materials ready:
jj Your Accu-Chek Spirit Combo insulin pump
jj A disinfectant for your skin
jj A new Accu-Chek infusion set
2
2.9.2 Inserting the needle
1.
2.
Make sure that your pump is properly
connected (including cartridge, adapter
and infusion set) and correctly programmed with your personal settings.
Make sure your pump is in STOP mode.
3.
4.
5.
Wash your hands thoroughly.
Disinfect the infusion site and let it dry
completely.
Insert the needle of your Accu-Chek
infusion set according to the instructions.
53
Note
If you use a soft-cannula type infusion set, you must
proceed with a bolus to fill the air space in the needle
after removing the introducer needle, according to the
instructions for the infusion set you are using. Failure to
do so could result in missed insulin dosing. See section
4.2 Programming a Standard Bolus.
Warning
Inspect your infusion site at least twice a day for irritation or
infection. Signs of infection may include, but are not limited
to: pain, lumps, redness, heat, or discharge.
If you see redness or swelling, change your infusion set and
infusion site immediately and contact your doctor or
healthcare team.
Change your infusion headset according to the instructions for
the infusion set you are using and your doctor or healthcare
team’s recommendations.
54
If you have read and followed all instructions, cautions, Warnings
and notes found in this chapter, you should now be ready to
deliver insulin to your body using your Accu-Chek Spirit Combo
insulin pump.
2
2.10 Starting insulin delivery
Procedure for starting insulin delivery
1.
2.
3.
When your pump is in STOP mode.
Press d to move to the START YOUR
PUMP screen.
Press f to select. Your pump shows the
RUN screen.
Insulin delivery begins within 3 minutes.
55
2.11 Stopping insulin delivery
For your safety, you should only perform certain functions and
actions when the pump is in STOP mode. These functions and
actions include:
jj changing the cartridge
jj connecting and disconnecting the adapter and / or infusion set
jj priming the infusion set
jj data transfer
Caution
When your Accu-Chek Spirit Combo insulin pump is in STOP
mode, no insulin is delivered to your body. You must put your
pump into RUN mode to continue insulin delivery.
Procedure to stop insulin delivery
1.
2.
Press d to move to the STOP YOUR
PUMP screen.
Press f to select. Your pump returns to
the STOP screen.
Your pump is now in STOP mode.
No insulin is being delivered.
56
2
2.12 General safety information
STOP-Warning
The STOP-Warning is triggered when your pump switches from
RUN mode to STOP mode, or when a battery is inserted. The
pump emits two short beeps and vibrates once every minute.
This warns you that insulin delivery has been interrupted.
To turn off the STOP-Warning, press either a or s for three
seconds. You then hear a melody and /or feel a vibration,
confirming that the STOP-Warning has been turned off.
If you press the key too briefly, the STOP-Warning will not be
turned off.
Note
For your safety, the volume of the STOP-Warning cannot
be changed. It is independent of the programmed beep
volume.
Warning
The cartridge and infusion set are sterile products intended
for single use only. Sterility is guaranteed for unopened
packaging up to the indicated expiry date. Do not use sterile
products if the packaging is damaged.
Do not re-use single-use materials because this might lead to
a malfunction of your Accu-Chek Spirit Combo insulin pump,
incorrect insulin delivery and /or infection. Always handle
these items with clean hands. Avoid any contact of the
infusion set and the connecting parts of your insulin pump
with antiseptics, antibiotic creams, soaps, perfumes,
deodorants, body lotions, or any other cosmetics. They may
contaminate these parts.
57
w
Warning
A lways check your personal settings before using your new
pump, in order to avoid incorrect insulin delivery. Record your
personal settings from your current insulin pump, and ensure
that they are correctly programmed into your new Accu-Chek
Spirit Combo insulin pump. Incorrect programming of your
pump may cause incorrect insulin delivery.
Do not use the pump without knowing your personal settings.
If you are not sure about your settings or you are inexperienced, get your doctor or healthcare team to set or check
them. Only change your settings after consulting your doctor
or healthcare team.
58
Warning
T he support of a doctor or healthcare team is vital when
training on and using your Accu-Chek Spirit Combo insulin
pump. Regular visits to your doctor or healthcare team are also
essential during insulin pump therapy. Always carefully follow
instructions from the medical professionals responsible for your
care.
Note
When an Extended Bolus, a Multiwave Bolus and  / or a
Temporary Basal Rate (TBR) is  / are active and you put
your pump into STOP mode, a Warning W6: TBR CANCELLED and  / or a Warning W8: BOLUS CANCELLED
occur(s). Press f twice for each Warning to confirm and
turn them off. See section 8.2 List of Warnings.
2
Note
Your pump cannot detect infusion set leakage. If you
detect any loss of insulin and all parts are correctly
tightened, immediately replace the leaking component.
Because insulin delivery has been interrupted, check your
blood glucose level and take appropriate action according
to your doctor’s or healthcare team’s instructions.
Note
If the battery is too low, the start-up process may not be
able to complete. In this case, the pump beeps five tones
and keeps restarting the process until you remove the
battery or until it is empty.
Note
Check the amount of insulin remaining in the cartridge at
least once a day. If you press f from the RUN or STOP
screen, your pump displays the remaining cartridge
content in units.
Before going to sleep, make sure that:
jj the Pump is in RUN mode
jj the cartridge contains enough insulin to last through
the night
jj the time and date are set correctly
59
60
3
Using your pump in daily life
This chapter provides important guidelines on how to use your
pump safely from day to day.
3.1.1 When not to wear your pump
Electromagnetic fields and hazardous areas
3.1 Wearing your pump
Attach your pump safely to your body or clothes to prevent
damage. You can use one of our special carrying systems that
enable you to carry your pump on or under your clothes.
Remember to wear your pump under your clothes or directly on
your body in cold or wet weather.
Caution
When wearing your pump, prevent any contact with objects that
could damage it or accidentally press its keys (e.g. key chains,
keys, pocket knives or coins).
Warning
Do not use your pump near electromagnetic fields such as
radar or antenna installations, high-voltage sources, X-Ray
sources, computer tomography, MRI, CAT scan, and all other
sources of electrical current, as they may cause your pump to
fail. Insulin delivery may stop and an Error E7: ELECTRONIC
ERROR may occur.
Always stop your pump, remove and leave it outside these
areas. See Appendix A: Technical Data for more information
about electromagnetic fields.
61
Your pump has been tested against, and complies with, the
regulations on electromagnetic interference. Security systems in
airports and anti-theft monitoring devices, such as those in
department stores, should not normally affect the functioning of
your pump.
Because there are so many devices, such as cellular phones,
that emit electromagnetic radiation, the effect of such devices on
your pump cannot be ruled out. It is therefore recommended to
keep your pump at least 4 inches (10 cm) away from these
devices while they are active.
Do not use your pump in hyperbaric chambers or in hazardous
areas, such as areas where flammable gases or vapours could
be present. This could cause an explosion.
Always stop and remove your pump before you enter these
areas. If you have questions, contact your local pump support
(see inside back cover).
Your pump is designed to work in normal barometric conditions
(from 700 to 1060 mbar).
62
3.1.2 Sport and exercise
Exercise is an important part of diabetes management. Your
Accu-Chek Spirit Combo insulin pump is designed to enable you
to safely perform a range of sporting activities while wearing
your pump. It is important that you protect your pump before you
begin exercise or sporting activities. Do not wear your pump
for sports that involve body contact such as boxing, football or
hockey, since rough contact could damage your pump.
Consult our sterile product brochures and accessories catalogue
for more information about carrying systems or contact your
local pump support (see the inside back cover) for more
information.
3
Note
Rapid and extreme changes in air pressure, for example
in an air plane that is taking off or when practicing sports
like hang-gliding, can influence insulin delivery, especially
if there are air bubbles in the cartridge or tubing. This also
applies to rapid and extreme changes in temperature; for
example, when leaving a heated room and going outside
in cold weather.
We therefore recommend that you wear your pump close
to your body, remove any air bubbles from the cartridge
and tubing and also measure your blood sugar more
frequently in such situations.
3.1.3 Travelling with your pump
Ask your doctor or healthcare team about any special steps you
need to take before you travel. Take extra blood glucose testing
and pump supplies with you, and find out where to obtain
supplies while you are travelling.
When you travel across time zones, make sure that the time and
date on your pump are set correctly to the local time.
If you have questions, contact your local pump support
(see the inside back cover).
Warning
You must ensure that the Bluetooth ® function is switched off
before boarding an aircraft, as emissions from your pump or
the Meter could interfere with the electronics systems of the
aircraft. See section 6.2 Switching Bluetooth ® ON and OFF
63
3.2 Interruption of insulin pump
therapy
Consult with your doctor or healthcare team about when and for
how long your insulin pump therapy can be interrupted.
Measure your blood glucose level regularly during any insulin
interruption. Use a syringe or insulin pen to inject insulin
according to the instructions of your doctor or healthcare team.
Warning
Because only rapid-acting insulin is used for insulin pump
therapy, only a small amount of insulin is stored in the body.
If insulin delivery is interrupted for any reason – such as:
jj If you stop the pump
jj There is a technical problem with the pump
jj The cartridge is leaking and /or the infusion set is leaking
jj There is occlusion in the infusion set or in the headset
jj The cannula has slipped out of the infusion site –
you must check your blood glucose level and replace the
missing insulin immediately.
64
3
3.2.1 Short interruptions
1.
2.
Press d to move to the STOP YOUR
PUMP screen.
Press f to put your pump in STOP
mode.
Resuming insulin delivery
1.
Reconnect or reinsert your infusion set
and put your pump into RUN mode.
3.
Remove the infusion set or, when using a
disconnectable infusion set, disconnect
the transfer set from the headset and use
the protective covers that came with it.
Where appropriate, attach a new
Accu-Chek infusion set. (See section
3.4 Changing the infusion set)
Measure your blood glucose level within
two hours of restarting pump therapy to
check the function of the system and to
ensure insulin delivery.
65
3.2.2 Long interruptions
When you need to interrupt your pump
therapy for more than one day, use the
following procedure.
1.
2.
3.
Remove the cartridge, adapter, and
infusion set.
Remove the battery and reinsert the
battery cover.
Put your pump into STOP mode.
Store your pump properly.
See section 7.6 Storing your pump.
66
3
3.3 Your insulin pump and water
Caution
Before any contact with water, disconnect and take off your
Accu-Chek Spirit Combo insulin pump. Check your pump daily
to ensure that it is not chipped, cracked or damaged in any
way, and that the battery cover and the adapter are correctly
closed. Otherwise water, dust, insulin, or other substances
may enter your pump and lead to malfunction.
3.3.1 Accidental contact with water
Your Accu-Chek Spirit Combo insulin pump is protected against
brief accidental contact with water. Examples of accidental water
contact include:
j Rain
j Water splashes while you are cycling, jogging or hiking
j Accidental immersion in the sink, washbasin or bath
Disconnect and remove your pump before taking a bath, or going
into a whirlpool, shower or swimming pool. Avoid exposing your
pump to high humidity, such as in a sauna, as this could result in
damage. To make it easy to remove your pump, use disconnectable Accu-Chek infusion sets.
67
What to do after any water contact
Put your pump into STOP mode, disconnect the pump from your
body, and inspect it. Use a soft cloth to dry the outside of the
pump, and check the battery compartment and the cartridge
compartment for water. If the battery compartment or cartridge
compartment are wet, turn your pump upside down to let the
water run out and leave it to dry. Do not use warm air such as
a hair dryer to dry the pump, as this could damage the pump’s
housing. Do not reinsert the battery or the cartridge until the
compartments are completely dry. See section 7.5.1 Cleaning
your pump.
Other liquids
You do not need to worry about contact between your pump and
perspiration or saliva. You must however check your pump
immediately after contact with other liquids or chemicals such as:
jj Cleaning solutions
jj Alcohol
jj Beverages
jj Oil or fat
See section 7.5.1 Cleaning your pump.
68
Caution
Avoid any contact between your Accu-Chek Spirit Combo
insulin pump, the infusion set, and the connecting parts of
your insulin pump with health and beauty products (for example:
antiseptics, antibiotic creams, soaps, perfumes, deodorants,
body lotions, or other cosmetics). These substances could
discolor your pump or fog the display.
3
3.4 Changing the infusion set
When you change the infusion set, keep the following information
in mind:
jj Infusion sets are sterile products intended for single use only.
Sterility is guaranteed for unopened packaging up to the
indicated expiry date. Do not use sterile products if the
package is damaged.
jj Correctly tighten the infusion set onto the adapter to avoid
leakage. Turn the infusion set luer-lock connector until it stops.
Do not turn it any further and do not use auxiliary tools, as this
may crack the infusion set luer-lock connector and result in
leakage.
jj Your pump cannot detect infusion set leakage. You should
inspect all parts of your infusion set regularly during the day
and before you go to sleep. If there seems to be any loss of
insulin and all parts are correctly tightened, look for and
immediately replace a leaking component. Check your blood
glucose level immediately, as insulin delivery has been
interrupted. Take appropriate action according to your doctor’s
or healthcare team’s instructions.
jj Always disconnect your infusion set before changing a
cartridge or priming the infusion set. Otherwise, you risk
uncontrolled insulin delivery into your body. Always follow the
instructions for the infusion set and cartridge system you are
using.
69
Procedure for changing the infusion set
Have the following materials ready:
jj Your Accu-Chek Spirit Combo insulin
pump
jj A disinfectant for your skin
jj A new Accu-Chek infusion set
1.
2.
Make sure your pump is in STOP mode.
Wash your hands thoroughly.
3.
Disconnect the transfer set from the
headset.
70
4.
5.
Remove the infusion set from the adapter
and dispose of it correctly.
Tip: The battery key has a notch that fits
all Accu-Chek infusion set luer-lock
connectors. You can use this tool to
loosen the luer-lock connector from the
adapter if it cannot be loosened by hand.
3
6.
7.
8.
Remove the used infusion headset and
dispose of it correctly.
Carefully prepare a new Accu-Chek
infusion set for use.
Screw the Accu-Chek infusion set
clockwise into the adapter.
Carefully tighten the luer-lock connector
by hand.
9.
10.
11.
Prime the infusion set following the
instructions found in section 2.8 Priming
the infusion set.
Put the pump in RUN mode. See
section 2.10 Starting insulin delivery.
Prepare the infusion site and insert a new
infusion set following the instructions in
section 2.9 Positioning the infusion set.
71
Note
If you use a soft cannula-type infusion set, you must
begin with a bolus to fill the air space in the cannula after
removing the introducer needle, according to the
instructions for the infusion set you are using. Failure to
do so could result in inadequate insulin dosing. See
section 4.2 Programming a Standard Bolus.
Warning
Inspect your infusion site at least twice each day for irritation
or infection. Signs of infection may include, but are not limited
to: pain, lumps, redness, heat, or discharge. If you see
redness or swelling, change the infusion headset and the
infusion site immediately and contact your doctor or
healthcare team.
Change the headset according to the instructions for the
infusion set you are using and your doctor or healthcare
team’s recommendations.
72
3
3.5 Changing the cartridge and
infusion set
Have the following materials ready:
jj Your Accu-Chek Spirit Combo insulin pump
jj A disinfectant for your skin
jj A new Accu-Chek infusion set
jj A filled Accu-Chek Spirit 3.15 ml Cartridge System
jj A new adapter (this must be changed at least every
two months)
Procedure for changing the cartridge and infusion set
1.
2.
3.
Wash your hands thoroughly.
Remove the transfer set from the
headset.
Make sure your pump is in STOP mode.
73
4.
5.
Hold your Accu-Chek Spirit Combo insulin
pump with the adapter pointing downward.
Remove the adapter and cartridge from
your pump by unscrewing the adapter
from the pump casing.
6.
Remove the transfer set from the adapter
and dispose of it correctly.
74
Note
Pulling the adapter from the pump
casing without completely
unscrewing it may result in the
plunger staying attached to the
piston rod. If this should happen,
please call your local pump
support (see inside back cover).
7.
Tip: The battery key has a notch that
fits all Accu-Chek infusion set luer-lock
connectors. You can use the battery
key to loosen the luer-lock connector
between your infusion set and adapter.
Remove the cartridge from the adapter
and dispose of the cartridge properly.
3
8.
9.
10.
Hold the adapter up to the light to check
for signs of wear or dirt (especially on the
seals inside and outside of the adapter).
If necessary, clean the adapter using
water and dry it. If it shows signs of wear
or dirt, replace it immediately.
Insert a new cartridge and a new infusion
set. See section 2.7 Inserting the
cartridge.
75
3.6 General safety information
Warning
Always carry spare sterile products and accessories (infusion
set, insulin cartridge, batteries), an insulin pen/syringe, and
insulin. Without insulin, hyperglycemia or diabetic ketoacidosis
may develop and may require in-patient hospital treatment.
Caution
Do not place your insulin pump in direct sunlight. Overheating
of the insulin and the pump must be avoided. Protect your
insulin pump from direct exposure to cold wind and temperatures over 104 °F (40 °C) and below 41 °F (5 °C). These
conditions may damage the insulin and the housing of your
insulin pump, and could also cause a malfunction of the
battery. See the instructions for the insulin you are using to
determine the acceptable temperature range.
76
Note
Check the amount of insulin remaining in the cartridge at
least once a day. Press f from the RUN or STOP screen
to display the remaining cartridge content in units. Before
going to sleep, make sure that:
jj The pump is in RUN mode
jj The cartridge contains enough insulin to last through
the night
jj The battery level is OK
jj The time and date are set correctly
4
Boluses and Temporary Basal Rates
4.1 Understanding boluses
A bolus is the amount of insulin delivered (in addition to the basal
rate) to cover the intake of food and to correct high blood glucose
levels. The bolus type and amount is determined by your doctor
or healthcare team’s guidelines, your blood glucose level, your
food intake, your health condition, and your activity level.
Discuss the timing, the amount and type of bolus you need with
your doctor or healthcare team.
Your pump can deliver three types of bolus:
Standard Bolus
fast delivery
Extended Bolus
delivery over a programmed period
of time
Multiwave Bolus
combines fast delivery with delivery
over a programmed period of time
77
4.2 Programming a Standard Bolus
There are two ways to program a Standard Bolus:
Quick Bolus
Using a and s on your insulin
pump, with bolus increments
determined by the user
Using Standard
Bolus menu
Using d and f to enter the menu
and then a and s to program the
amount
The bolus amount per delivery is limited to 50 units.
After you program a Standard Bolus, there is a delay of 5 seconds
before bolus delivery starts. This delay allows you to cancel the
bolus by pressing the a or s key if desired. The Warning W8:
BOLUS CANCELLED is displayed. Press f twice to confirm and
turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED.
78
4
4.2.1 Programming a Quick Bolus
The following process uses only the a and s keys. You can
start with either key. The recommended steps below are those
described the Down key s in step 1 and the Up key a in Step
2. For the alternative step, you can use the Up key in step 1 and
the Down key in step 2.
Because your pump beeps and vibrates to guide you through the
programming steps, you can program the Quick Bolus without
looking at the pump screen. After the bolus is programmed, you
can count the beeps and vibrations of your pump to check the
correct programming. For safety reasons, you should also check
the display as long as you are less experienced with the pump.
The factory setting for the increment of the Quick Bolus is
0.5 units. You can set the increment to 0.1, 0.2, 0.5, 1.0 or 2.0 in
your Therapy Settings. See section 5.10.1 Adjusting the bolus
increment.
Procedure for programming a Quick Bolus
1.
2.
From the RUN screen, press and hold s
until you hear a beep sequence and feel a
vibration.
This activates the Quick Bolus function.
Press a once for each increment until
the required bolus amount is reached.
You must not use the s key.
3.
With each pressing of the key, your pump
beeps and vibrates simultaneously; once
for each programmed bolus increment.
79
4.
5.
Five seconds after the last press of a,
your pump confirms the total bolus
amount with one beep and vibration for
each bolus increment programmed.
The Standard Bolus symbol blinks for
5 seconds (the bolus delivery start delay).
Warning
The bolus increment that can be programmed into your
Accu-Chek Spirit Combo insulin pump determines the Quick
Bolus amount using the a and s keys of your insulin
pump.
Incorrect programming of the bolus increment may cause
inappropriate insulin delivery.
See section 5.10.1 Adjusting the bolus increment.
80
6.
After the bolus delivery start delay, the
pump beeps three times and vibrates
and then begins to deliver the total bolus
amount programmed. A countdown of
the remaining bolus amount appears on
the display.
4
4.2.2 Cancelling a Quick Bolus
During programming
(the bolus amount
blinks):
Press the s or a key you used to enter the Quick Bolus programming
option. This will reset the bolus amount to 0.0 units. You hear a melody.
If no new bolus is programmed, your pump returns to the RUN screen and
beeps three times and vibrates after five seconds.
No bolus is delivered.
During confirmation
(when the beeps and
vibrations occur), or
During start delay
(Standard Bolus symbol
blinks):
Press s or a. You hear a melody. Your pump returns to the RUN screen.
A Warning W8: BOLUS CANCELLED occurs.
Press f twice to confirm and turn off the alert. See chapter 8 Warning W8:
BOLUS CANCELLED.
No bolus is delivered.
During bolus delivery
(countdown of bolus
amount):
Press and hold s or a for 3 seconds until you hear a melody. A Warning
W8: BOLUS CANCELLED is displayed.
Press f twice to confirm and turn off the alert. See chapter 8 Warning W8:
BOLUS CANCELLED.
Bolus delivery is
interrupted.
You can view the actual bolus amount delivered before the cancellation by
looking at the bolus history. See section 5.4.1 Viewing your bolus history.
Note
Make sure that the cancellation was deliberate, and then program a new bolus, if required.
81
82
4.2.3 Programming a Standard Bolus using Standard
bolus menu
1.
Independent of the bolus increment setting, the bolus increments
for the menu-guided Standard Bolus are fixed at 0.1 unit. You
can program this bolus in the Standard Bolus screen by
holding the a or s key (scrolling) until the bolus amount is
displayed.
Press d to move to the Standard
Bolus screen.
2.
3.
4.
Press f to select. The BOLUS AMOUNT
screen appears.
Press or scroll a to increase or s to
decrease the bolus amount.
Press f to confirm the bolus amount.
The Standard Bolus symbol blinks for five
seconds (the bolus delivery start delay).
4
After this bolus delivery start delay, your pump beeps three times
and vibrates and begins to deliver the total bolus amount
programmed. The countdown of the remaining bolus amount
appears on the display.
4.2.4 Cancelling a Standard Bolus
During programming
(the bolus amount
blinks):
You have three options for cancelling during programming:
j If you do not press any key for 20 seconds after programming the bolus
amount, your pump returns to the RUN screen.
j Exit to the Standard Bolus menu by pressing d + a simultaneously.
j Set the bolus amount to 0.0 units. Press f to exit.
No bolus is delivered.
During the start delay
(Standard Bolus symbol
blinks):
Press s or a. You hear a melody. Your pump returns to the RUN screen.
A Warning W8: BOLUS CANCELLED occurs.
Press f twice to confirm and turn off the alert. See chapter 8 Warning W8:
BOLUS CANCELLED.
No bolus is delivered.
During bolus delivery
(countdown of bolus
amount):
Press and hold s or a for 3 seconds until you hear a melody.
You can view the actual bolus amount delivered before the cancellation by
looking at the bolus history. See section 5.4.1 Viewing your bolus history.
Bolus delivery is
interrupted.
83
Cancellation during the start delay and during the bolus delivery
will cause a WARNING W8: BOLUS CANCELED. Press f twice
to confirm and snooze the Warning. See chapter 8.
Note
Make sure that the cancellation was deliberate and
program a new bolus, if needed.
4.3 Programming an Extended Bolus
The Extended Bolus option enables you to program a bolus to be
delivered over a period of time. This function is helpful during
long meals, dinners, or receptions, or when you have meals that
are digested slowly. The Extended Bolus may also be appropriate
for people who have gastroparesis (delayed digestion).
The duration of bolus delivery can be programmed in 15-minute
intervals up to 12 hours and begins immediately after confirmation. Throughout the bolus delivery, the remaining time and
amount of the Extended Bolus and the current hourly basal rate
are displayed in the RUN screen.
84
4
Tip: You can program a Standard or Quick Bolus while an
Extended Bolus is ongoing. If you cancel the Standard Bolus, the
Extended Bolus continues to run.
During the delivery of an Extended Bolus, the programming of
another Extended Bolus or a Multiwave Bolus is blocked. If you
try to do this, you will receive the Error message: “Bolus
currently running”.
If you want to program a different Extended Bolus, put the pump
in STOP mode to cancel the current bolus. Then put the pump in
RUN mode again to program a new Extended Bolus.
Procedure for programming an Extended Bolus
1.
2.
3.
Press d to move to the Extended Bolus
screen.
Press f to select. The BOLUS AMOUNT
screen appears.
Press a to increase or s to decrease
the bolus amount.
The duration of the last Extended Bolus
delivered appears.
85
4.
5.
Tip: Press d to switch between
programming the bolus amount and bolus
duration.
Press d to move to the BOLUS
DURATION screen.
Press f to confirm the bolus amount
and duration. The pump returns to the
RUN screen. The bolus delivery begins
within the next 3 minutes.
Press a to increase or s to decrease
the bolus duration.
Note
If a Temporary Basal Rate is active at the same time as
the Extended Bolus, the remaining time and amount of
the bolus and the amount of the increased or decreased
hourly basal rate are displayed in the RUN screen.
Time Clock
Current Basal Rate
(including TBR where
appropriate)
86
Bolus Duration
Remaining Bolus
4
4.3.1 Cancelling an Extended Bolus
During programming
(the bolus amount or
bolus duration blinks):
You can either:
j wait for your pump to return to the RUN screen.
j press d and a simultaneously to exit the Function screen.
j set the bolus amount to 0.0 units and press f.
No bolus is delivered.
During bolus delivery
j If the Extended Bolus delivery has begun, it can be cancelled by putting your
pump into STOP mode. This cancels the bolus delivery and a Warning W8:
BOLUS CANCELLED is displayed. Press f twice to confirm and turn off the
alert. See chapter 8 Warning W8: BOLUS CANCELLED. Put your pump back in
RUN mode afterwards.
Bolus delivery is
interrupted.
The bolus amount delivered up to the cancellation can be reviewed in the
BOLUS HISTORY screen. See section 5.4.1 Viewing your bolus history.
87
Note	If a Temporary Basal Rate is active at the same time,
it is also cancelled when your pump is put into
STOP mode. A Warning W8: BOLUS CANCELLED and
a Warning W6: TBR CANCELLED are displayed.
Press f twice to confirm and turn off the first Warning.
The second alert appears on the display. Press f twice
to confirm and turn off the second Warning. Both alerts
are recorded in the Warnings history.
88
	See chapter 8 Warning W6: TBR CANCELLED and
Warning W8: BOLUS CANCELLED. Make sure that the
cancellation was deliberate and then program a new
Extended Bolus (and /or Temporary Basal Rate) if needed.
4
4.4 Programming a Multiwave Bolus
The Multiwave Bolus option is available in the ADVANCED user
menu. It is designed to better simulate the body’s insulin
delivery, and combines an immediate bolus delivery followed by
an Extended Bolus delivery. This option can be helpful when you
have meals that include both rapidly and slowly absorbed
carbohydrates.
The duration of bolus delivery can be programmed in 15-minute
intervals for up to 12 hours.
Note
When programming a Multiwave Bolus, make sure that you are
using the ADVANCED user menu and your pump is in RUN mode.
j T he Multiwave Bolus is available only in the ADVANCED
user menu.
jj You can add a Standard Bolus to an ongoing Multiwave
Bolus. If you cancel the Standard Bolus, the Multiwave
Bolus remains running.
jj During the delivery of a Multiwave Bolus, the programming of a second Multiwave Bolus or an Extended
Bolus is blocked. If you need a different Multiwave
Bolus, put your pump in STOP mode to cancel the
current bolus and program a new one.
89
Procedure for programming a Multiwave Bolus
90
1.
2.
3.
Press d to move to the Multiwave Bolus
screen.
Press f to select. The BOLUS AMOUNT
screen appears.
Press a or s to increase or decrease
the total bolus amount.
Note The first time you press a,
the bolus duration of the last
Multiwave Bolus and a default
immediate bolus amount appear.
The latter increases or decreases
proportionally as you increase or
decrease the total bolus amount.
4.
5.
Press d to move to the IMMEDIATE
BOLUS screen.
Press d to move to the BOLUS
DURATION screen.
Press a or s to correct and set the
immediate bolus amount.
Press a or s to correct and set the
Extended Bolus duration in increments of
15 minutes for up to 12 hours.
4
6.
7.
Check the total and immediate bolus
amounts and the Extended Bolus duration
programmed on the screens.
Press f to confirm both bolus amounts
and the bolus duration. The Multiwave
Bolus symbol blinks for 5 seconds (bolus
delivery start delay).
Tip: Press d to loop between programming the total BOLUS AMOUNT, IMMEDIATE BOLUS and BOLUS DURATION.
8.
The pump beeps three times and
vibrates. The immediate bolus delivery
begins. The countdown of the remaining
bolus continues to appear on the display.
Note
If a Temporary Basal Rate is active
at the same time, the remaining
time and amount of the bolus and
the amount of the increased or
decreased hourly basal rate are
displayed on the RUN screen.
91
4.4.1 Cancelling a Multiwave Bolus
During programming
(the bolus amount
blinks):
There are three ways to cancel a Multiwave Bolus during programming:
j Do not press any key for 20 seconds. The pump returns to the RUN screen.
j E xit to the Multiwave Bolus screen by pressing d + a simultaneously.
j Set the total bolus amount to 0.0 units and press f.
No bolus is delivered.
During the start delay
(Multiwave symbol
blinks):
j Press s or a. The pump beeps and vibrates. The pump returns to the
RUN screen.
No bolus is delivered.
During immediate
bolus delivery
j You can cancel immediate delivery by pressing and holding s or a for
3 seconds until you hear a melody. This cancels the whole bolus (immediate
and Extended Bolus delivery).
Bolus delivery is
interrupted.
During extended
delivery
j You can cancel the extended delivery by putting the pump in STOP mode.
This cancels the Extended Bolus.
Bolus delivery is
interrupted.
Cancellation of the bolus during start delay, immediate bolus
delivery and extended delivery will cause a Warning W8 BOLUS
CANCELLED. Press f twice to confirm and turn off the alert.
See chapter 8 Warning W8: BOLUS CANCELLED.
92
You can review the actual bolus amount delivered before the
cancellation by looking at the bolus history. See section
5.4.1 Viewing your bolus history.
4
Note
If a Temporary Basal Rate is active at the same time, it is
also cancelled when your pump is put in STOP mode. The
Warning W8: BOLUS CANCELLED and a Warning W6: TBR
CANCELLED is displayed.
Press f twice to confirm and turn off the first Warning.
The second Warning appears on the display. Press f
twice to confirm and turn off the second Warning. Both
Warnings are recorded in the alarm history. See chapter
8 Warning W6: TBR CANCELLED and Warning W8: BOLUS
CANCELLED. Make sure the cancellation was intended
and then put the pump back in RUN mode and program a
new Multiwave Bolus (and / or Temporary Basal Rate), if
needed.
4.5	Programming a Temporary
Basal Rate (TBR)
Your pump allows you to temporarily increase or decrease your
basal rates. This enables you to match your changing insulin
needs due to increased or decreased activity level, illness, or
stress.
Typically, a basal rate is set to 100 %, but you can:
jj Increase it to 250 % for up to 24 hours
jj Decrease it to 0 % for up to 24 hours
When you increase or decrease your basal rate, each hourly
basal rate for the duration you program is increased or decreased automatically. The characteristic shape of your basal
rate profile remains and does not become a flat curve, if the
change is larger than 0 %. For 0 % the basal rate profile becomes
a flat line and no insulin (except boluses) is delivered during the
programmed duration.
Discuss programming a Temporary Basal Rate with your doctor
or healthcare team.
93
Note
A running Temporary Basal Rate increase or decrease
remains active, even if you have changed the basal rate
profile.
You can only program a Temporary Basal Rate when your pump
is in RUN mode.
Procedure for programming a Temporary Basal Rate
94
1.
2.
Press d to move to the Temporary
Basal Rate (TBR) screen.
Press f to select. The TBR PERCENTAGE
screen appears.
Note
If no Temporary Basal Rate is
currently active, the percentage is
set to 100 %. If a Temporary Basal
Rate is active, its duration and
percentage appear on the RUN
screen.
4
3.
Press a or s to increase or decrease
the basal rate.
4.
Tip: When you increase (or decrease) the
Temporary Basal Rate, the duration of
your previous Temporary Basal Rate
increase (or decrease) appears. However,
when you use your pump for the first
time, a default value appears.
Press d to move to the TBR DURATION
screen.
Press a or s to correct and set the
duration.
5.
Tip: You can switch between programming the basal rate percentage and
duration by pressing d.
When a Temporary Basal Rate is active,
the pump emits a beep and vibrates once
every hour.
Press f to save and exit.
The new Temporary Basal Rate is
immediately activated.
95
Note
During Temporary Basal Rate delivery, the increase or
decrease in percentage, the increased or decreased
hourly basal rate (hourly basal rate plus TBR percentage),
and the remaining time are displayed in the RUN screen.
An arrow pointing upward symbolizes a Temporary Basal
Rate increase; an arrow pointing downward symbolizes a
Temporary Basal Rate decrease.
Note
If an Extended Bolus or a Multiwave Bolus is active at the
same time, the remaining time and amount of the bolus
and the amount of the increased or decreased hourly
basal rate are displayed in the RUN screen.
Example: Extended Bolus running
Remaining duration
Extended Bolus symbol
96
TBR OVER Alert
At the end of a Temporary Basal Rate, a Warning W7: TBR OVER
is displayed. Press f twice to confirm and turn off the
Warning. See chapter 8 Warning W7: TBR OVER.
4
4.5.1 Cancelling a Temporary Basal Rate
During programming:
There are three ways to cancel a Temporary Basal Rate during programming:
j Do not press any key for 20 seconds. The pump returns to the RUN screen.
j E xit to the Temporary Basal Rate (TBR) screen by pressing a + d
simultaneously.
j Set the TBR percentage to 100 %. Press f to save and exit.
Pump continues to
deliver normal basal
rate.
During delivery:
There are two ways to cancel a Temporary Basal Rate during delivery:
j Set the TBR percentage to 100 %. Press f to save and exit. A Warning W6:
TBR CANCELLED is displayed.
j Or you can put your pump in STOP mode. The Temporary Basal Rate delivery
is cancelled, as well as any Extended or Multiwave Bolus that is currently
running. A Warning W6: TBR CANCELLED is displayed. Press f twice to
confirm and turn off the alert. Put your pump back in RUN mode.
Pump returns to
normal basal rate.
97
4.6 General safety information
Note
If an Extended Bolus or a Multiwave Bolus is active at the
same time, it is also cancelled when your pump is put into
STOP mode. A Warning W8: BOLUS CANCELLED and a
Warning W6: TBR CANCELLED are displayed.
Press f twice to confirm and turn off the first alert. The
second alert appears on the display. Press f twice to
confirm and turn off the second alert. Both alerts are
recorded in the alarm history. See chapter 8 Warning W6:
TBR CANCELLED and Warning W8: BOLUS CANCELLED.
Make sure that the cancellation was intended and put
your pump back in RUN mode and then program a new
Temporary Basal Rate (and /or an Extended or Multiwave
Bolus), if needed.
Warning
j Incorrect programming of your insulin pump may cause
inappropriate insulin delivery.
j Your insulin pump must be programmed with your personal
settings before starting insulin pump therapy.
j Do not operate your insulin pump without knowing your
personal settings.
j If you are not sure about your personal settings, or you are
less experienced, ask your doctor or healthcare team to
check your personal settings.
j Work with your doctor or healthcare team to determine the
timing, amount, and type of bolus you need to deliver.
j Make sure you know your personal carbohydrate-to-insulin
ratio and your correction factor.
Warning
When your pump is in STOP mode it does not deliver insulin.
Put the pump in RUN mode to continue insulin delivery.
98
5
Personalizing your pump
This chapter explains how to use the available menu options, and
to personalize your pump to match your level of experience with
insulin pump therapy.
5.1 Introduction
Using the four keys on the pump, and their combinations, you
can access the menu options and their relevant screens. This
enables you to, for example:
jj Program the pump
jj Perform a function
jj Change a setting
jj Store information
Note
5.1.1 User menus
Your Accu-Chek Spirit Combo insulin pump has been designed to
adapt to your level of experience in pump therapy – whether you
are a beginner or an experienced pump user. Your Accu-Chek
Spirit Combo insulin pump “grows” with you!
You can use one of three menus – STANDARD, ADVANCED or
CUSTOM – to access the functions and settings you will need
from day to day.
Your Accu-Chek Spirit Combo insulin pump has been
designed for use with the Meter. This “intelligent” blood
glucose meter enables you to communicate with the pump
using Bluetooth ® wireless technology.
99
Standard
100
This menu provides all the basic functions
you need for successful pump therapy. If
you are new to pump therapy, we recommend that you start with this menu. As you
become more experienced, you may wish
to change to the ADVANCED user menu.
ADVANCED
This menu provides the complete range
of the Accu-Chek Spirit Combo insulin pump
functions. It includes all the functions from
the STANDARD user menu, plus a wide
range of functions for the more experienced
user.
CUSTOM
Because the Accu-Chek Spirit Combo insulin
pump has so many features, you may want
to decide which screens are displayed when
you scroll through the menu choices. Using
appropriate PC software, this menu enables
you to hide screens of the ADVANCED user
menu and thereby customize your pump.
At the beginning of this User Guide, you will find fold-out
diagrams of the STANDARD, CUSTOM and ADVANCED user
menus.
Note
For your safety and convenience during programming,
your Accu-Chek Spirit Combo insulin pump returns to the
RUN or STOP screen if no key is pressed within 20 seconds.
The changes you made before your pump timed out will
not be saved.
5
5.2 Selecting a user menu
Note
For guidance in choosing the most suitable user menu,
see section 5.1.1 User menus. If you are still not sure
which menu to choose, discuss this with your doctor or
healthcare team.
Procedure for selecting a user menu
1.
2.
3.
Press d to move to the MENU SETTINGS
screen.
The SELECT USER MENU screen is
displayed.
Press f to confirm.
Press f to select.
Press a or s to select a user menu.
The selected basal rate profile and its
daily insulin total appear, or …
101
4.
5.
… if the previous basal rate profile is not
available from the selected user menu,
dashes appear instead.
Press a or s to select a basal rate
profile, if required.
Check the (new) basal rate profile and its
daily insulin total.
Press f to save and exit.
The new user menu and basal rate profile are active immediately.
Caution
A running increased or decreased Temporary Basal Rate will
remain active, even if you change the basal rate profile. The
Temporary Basal Rate is based on the new basal rate.
102
5
5.3 Standard user menu
The following is a list of menu options from the STANDARD user
menu. To view the order in which they appear on the display,
refer to the menu diagram below:
jj Press d to move forward
jj Press d + a simultaneously
to move backward
STOP
RUN
103
Some of the functions have already been described elsewhere in
this User Guide, as listed below. The remaining functions are
described following the list.
Quick Bolus
jj See section 4.2.1 Programming a Quick Bolus.
STANDARD BOLUS
jj See section 4.2 Programming a Standard Bolus.
TIME AND DATE SETTINGS
jj See section 2.4 Setting the time and date.
BASAL RATE PROGRAMMING
jj See section 2.5.1 Programming your basal rate profile.
CARTRIDGE CHANGE
jj See section 2.7 Inserting the cartridge.
Infusion set PRIMING
jj See section 2.8 Priming the infusion set.
START YOUR PUMP
jj See section 2.10 Starting insulin delivery.
STOP YOUR PUMP
jj See section 2.11 Stopping insulin delivery.
104
EXTENDED BOLUS
jj See section 4.3 Programming an Extended Bolus.
TEMPORARY BASAL RATE (TBR)
jj See section 4.5 Programming a Temporary Basal Rate (TBR).
MENU SETTINGS
jj See section 5.2 Selecting a user menu earlier in this chapter.
BLUETOOTH SETTINGS
jj See chapter 6 Using the Accu-Chek Spirit Combo insulin pump
with the Meter.
5
5.4 Viewing your pump data
The memory of your Accu-Chek Spirit Combo insulin pump stores
all the events (Warnings and Errors, programming operations and
insulin delivery records) up to 4500 events. This data corresponds
to about the last ninety days of use, and can be accessed on a
personal computer using Accu-Chek software products.
The following data can be reviewed directly on your Accu-Chek
Spirit Combo insulin pump:
Bolus history
last 30 boluses
Alarm history
last 30 Warnings and Errors
History of daily
insulin totals
last 30 daily totals of insulin
delivered
Temporary Basal
Rate history
last 30 increases and decreases in
basal rate
Pump timer
(“Backup” and loaner
pumps only)
remaining time in days until the
pump timer expires
105
5.4.1 Viewing your bolus history
The BOLUS DATA screen allows you to view up to the last
30 bolus deliveries, starting with the most recent entry.
Bolus amount / type
Date
Entry number
Bolus time
Each bolus data screen displays:
jj Bolus type (Standard, Extended or Multiwave Bolus)
jj Bolus duration ( – only displayed if an Extended or
Multiwave Bolus)
jj Time
jj Date
jj Entry number (01 is the most recent) of total entries
(example 01/30) of a delivered bolus
Tip: You can enter the BOLUS DATA screen also from the
QUICK INFO screen. See section 1.2.3 Display screens.
Procedure for viewing the bolus history
106
1.
2.
3.
Press d to move to the MY DATA
screen.
Press f to select.
Press a or s to view the entries.
The BOLUS DATA screen appears,
showing the most recent bolus information.
Press f to exit.
5
5.4.2 Viewing the Error and Warning history
The alarm data menu allows you to view up to the last
30 Warnings and Errors, starting with the most recent entry.
Each alarm data screen displays:
jj Number and type of the Warning or Error (for example, W6)
jj Warning or Error (for example, TBR CANCELLED)
jj Time
jj Date
jj Entry number (01 is the most recent) of total entries
(example 01/30) of a Warning or Error
Procedure for viewing the alarm history
1.
2.
3.
Press d to move to the MY DATA
screen.
Press d to move to the ERROR DATA
screen.
Press a or s to view the entries.
Press f to exit.
Press f to select.
107
5.4.3 Viewing the history of daily insulin totals
This function allows you to view up to the last 30 daily totals of
insulin delivered (from midnight to midnight; including basal rate
plus boluses), starting with the most recent entry.
Each screen displays:
jj Daily total of insulin delivered
jj Date
jj Entry number (01 is the most recent) of total entries
(example 01/04) of a daily insulin total
Procedure for viewing the daily insulin totals
1.
2.
3.
Press d to move to the MY DATA
screen.
Press d to move to the DAILY TOTALS
screen.
Press a or s to view the entries.
Press f to exit.
Press f to select.
108
5
5.4.4 Viewing the Temporary Basal Rate history
This option allows you to view up to the last 30 Temporary Basal
Rate (TBR) increases or decreases, starting with the most recent
entry.
Each TBR history screen displays:
jj TBR increase or decrease in percentage
jj TBR duration
jj Time
jj Date
jj Entry number (01 is the most recent) of total entries (example
01/30) of a delivered Temporary Basal Rate
Procedure for viewing the Temporary Basal Rate history
1.
2.
3.
Press d to move to the MY DATA
screen.
Press d to move to the TBR DATA
screen.
Press a or s to view the entries.
Press f to exit.
Press f to select.
109
5.4.5 Viewing the time remaining (pump timer)
For loan pumps and “Backup” pumps, a pump timer limits the
operating time. When you begin using the pump, the timer starts
the countdown of the number of remaining days.
symbol appears in the RUN screen or STOP screen. When the
timer expires, an Error occurs, and your pump goes into STOP
mode. It can no longer be put into RUN mode.
See chapter 8 Warning W5: PUMP TIMER and Error E5: END OF
OPERATION .
Before the pump timer expires, a Warning will remind you that
the operating life of the pump is coming to an end, so that you
can arrange to get a new pump in good time. The pump timer
Procedure for viewing the time remaining
1.
2.
Press d to move to the MY DATA
screen.
Press d to move to the PUMP TIMER
screen.
The number of days remaining until the
pump timer expires is shown.
Press f to select.
Press f to exit.
110
Note
This setting is country-specific
and may not be visible on your
pump.
5
5.5 Transferring your data to a computer
The built-in infrared interface on the bottom of your Accu-Chek
Spirit Combo insulin pump enables you to transfer data between
your pump and a PC.
information management products (for details see the user
information provided with the software).
For availability of the appropriate software see Appendix C.
The memory of your Accu-Chek Spirit Combo insulin pump
stores all the events (Warnings and Errors, programming operations and insulin delivery records) up to a total of 4500 events.
This data corresponds to about the last ninety days of use, and
can be accessed on a personal computer using Accu-Chek
Procedure for transferring your data
1.
2.
3.
Put your pump in STOP mode.
Press d to move to the DATA TRANSFER
screen.
Press f. A melody signals that your
pump is ready to transfer data.
Press f to select.
111
4.
Set up your pump with a cartridge, adapter, and a new infusion
set, and put it in RUN mode if necessary.
Note
When the data transfer is complete,
press f to return to the STOP screen.
112
Your pump will return to STOP mode 15 minutes after the
last data transfer when the DATA TRANSFER screen is
selected.
You can press twice d and a simultaneously to exit
while data is being transferred. The data transfer is
interrupted, and the Error E12: DATA INTERRUPTED
occurs. See chapter 8.
5
5.6 Pump settings
5.6.1 Turning Keylock on and off
These settings relate to the practical use of the pump. For
settings relating to your therapy, see 5.10 Therapy settings later
in this chapter.
The Keylock function allows you to lock the four keys of your
Accu-Chek Spirit Combo insulin pump. This is an important
safety measure that prevents you from accidentally activating
functions, for example while sleeping or during contact sports.
If the Keylock is turned on and no key is pressed for 10 seconds
after your pump has returned to the RUN screen or STOP screen,
all four keys are locked.
Procedure for turning the Keylock on or off
1.
2.
3.
Press d to move to the PUMP
SETTINGS screen.
The current Keylock status (ON or OFF)
appears.
Press a or s to turn the Keylock ON
or OFF.
Press f to select.
Press f to save and exit.
113
Procedure for unlocking the Keylock
If you press any key while the screen is blank, the Keylock symbol
indicates that the keys are locked.
Note
The Keylock remains unlocked during fast bolus delivery of
Standard or Multiwave Bolus.
1.
2.
after three seconds to confirm that the
Keylock is unlocked.
From the blank screen, press and hold
d and s simultaneously for three
seconds.
You hear three beeps in RUN or STOP
mode when you press the keys and again
114
The Keylock remains unlocked during the
programming of the pump.
If no key is pressed for 10 seconds after
your pump has returned to the RUN or
STOP screen, all four keys are automatically locked.
5
5.6.2 Adjusting the sound volume
Your pump emits different acoustic signals in different handling
situations to facilitate handling e.g. for blind or partially-sighted
users. For details on the meaning of the sound patterns, see the
Appendix “Beeps and melodies”. You can adjust the volume of
the beeps according to your personal preference. There are five
volume levels available: off, low, medium, high and maximum.
Note
The volume of the STOP-Warning is independent of the
programmed beep volume – it always sounds at the
maximum level. If the beeps are turned off, and a Warning
or Error occurs, the beeps become active again to ensure
that you are aware of the Warning or Error. If the Warning
or Error is not cancelled, the beeps gradually increase in
volume until the maximum level is reached.
Procedure for adjusting the sound volume
1.
2.
Press d to move to the PUMP SETTINGS
screen.
Press d to move to the SOUND
VOLUME screen.
Press f to select.
Press a or s to adjust the sound
volume.
Press f to save and exit.
115
5.6.3 Changing signal settings
Beep only
The Accu-Chek Spirit Combo insulin pump enables you to choose
how you want your pump to alert you when a Warning or Error
occurs.
You have three options:
Vibrate only
Beep and vibrate
For your safety, if you do not respond to the vibration, the pump
starts beeping after one minute.
Procedure for changing the signal settings
1.
2.
Press d to move to the PUMP
SETTINGS screen.
Press d to move to the SIGNAL
SETTINGS screen.
Press f to select.
Press a or s to set the signals.
Press f to save and exit.
116
5
5.6.4 Display orientation
Note
Your pump allows you to turn the display by 180°, so that you
can view it more easily, depending on how you are wearing the
pump.
If you turn the display orientation of your pump by 180°,
the functions of the a or s keys are also reversed.
The functions of the d and f keys remains the same,
whichever screen orientation you choose.
Procedure for setting the display orientation
1.
2.
3.
Press d to move to the ORIENTATION
screen.
Press a or s to select the display
orientation.
The current orientation is displayed.
Press f to save and exit.
Press d to move to the PUMP
SETTINGS screen.
Press f to select.
117
5.6.5 Setting the display contrast
Your pump allows you to adjust the display contrast to suit your
preferences.
Procedure for setting the display contrast
118
1.
2.
Press d to move to the PUMP
SETTINGS screen.
Press d to move to the DISPLAY
CONTRAST screen.
Press f to select.
Press a or s to select the desired
contrast level.
Press f to save and exit.
5
5.6.6 Selecting the language
Your pump can display the information in several languages.
You can chose the language according to your preferences.
Procedure for setting the language
1.
2.
Press d to move to the PUMP
SETTINGS screen.
Press d to move to the LANGUAGE
screen.
Press f to select.
Press a or s to select a language.
Press f to save and exit.
119
5.7 ADVANCED user menu
The following is a list of additional menu options available in the
ADVANCED user menu. To view the order in which they appear
on the display, refer to the menu diagram below:
jj Press d to move forwards
jj Press d + a simultaneously
to move backwards
BRP
STOP
RUN
= Basal Rate profile 2 – 4
120
BRP
BRP 4
BRP
BRP
BRP 2
BRP
5
5.8 Basal rate profiles
Note
The ADVANCED user menu contains all the options from
the STANDARD user menu.
Some of the functions are described elsewhere in this
User Guide, as listed below. The remaining functions are
described in this chapter following the list.
Multiwave Bolus
See section 4.4 Programming a Multiwave Bolus.
Your pump has five different basal rate profiles to match your
changing insulin needs (for example, Monday to Friday or
Exercise Day or Sleeping Late Day). However, in the Standard
User menu only the basal rate profile 1 is accessible.
Discuss additional basal rate profiles with your doctor or
healthcare team. Also, consult with your doctor or healthcare
team before changing basal rate profiles, as this may affect how
you use your pump.
5.8.1 Programming additional basal rate profiles
WARNING
Your Accu-Chek Spirit Combo insulin pump must be programmed with your personal settings prior to starting insulin
pump therapy. Do not operate your pump without knowing
your personal settings. If you are not sure about your personal
settings or you are inexperienced, ask your doctor or
healthcare team to check your personal settings.
121
Procedure for Programming additional basal rate profiles
1.
2.
See section 2.5.1 Programming your
basal rate profile.
Press d to move to the BASAL RATE
PROGRAMMING (1, 2, 3, 4, 5) screen you
wish to program. Press f to select.
Note
122
The hourly basal rates for each additional
basal rate profile are set in the same way
as for basal rate profile 1.
Only basal rate profiles that are accessible in your current
user menu are available. If the basal rate profile
number(s) do(es) not appear, select the ADVANCED user
menu, or program the basal rate profile to an available
basal rate profile number.
5
5.8.2 Selecting a basal rate profile
1.
2.
Press d to move to the BASAL RATE
SELECTION screen.
Press a or s to select a basal rate
profile. The selected basal rate profile
and its daily insulin total appear.
Procedure for selecting a basal
rate profile
Press f to enter.
Press f to select.
The new basal rate profile is active immediately.
Note
Only basal rate profiles that are accessible in your current
user menu are available.
A running Temporary Basal Rate increase or decrease
stays active, even if you change the basal rate profile on
your pump.
123
5.9 Setting a Reminder
You can set both single and multiple Reminders on your pump.
Multiple Reminders are repeated at a set time every day. You can
use this feature to remind you, for example, when you need to
test your blood glucose.
Procedure for setting single or multiple Reminders
124
1.
2.
3.
Press d to move to the Reminder
SETTINGS screen.
Press f to select. The current Reminder
status and alarm time appear.
Press a or s to change the Reminder
setting to OFF, ONCE or EVERY DAY.
5
4.
5.
Press d to move to the HOUR screen.
Press d to move to the MINUTE screen.
Press a or s to set the hour.
Press a or s to set the minute.
Press f to save and exit.
Turning off the Reminder
When the Reminder sounds, the Reminder screen is diplayed.
Press f twice to snooze and confirm and return to RUN or
STOP mode (See also section 8.4 reminder).
125
5.10 Therapy settings
These settings relate to the therapeutic use of the pump. For
settings relating to the practical use of the pump, see Pump
settings earlier in this chapter.
your Accu-Chek Spirit Combo insulin pump is adjustable. It is
initially set to 0.5 units per key-press, but it can be changed
to 0.1, 0.2, 0.5, 1.0 or 2.0 units.
5.10.1 Adjusting the bolus increment
Designed for those patients who may need large or small
amounts of insulin, the bolus increment for the Quick Bolus of
Warning
The bolus increment determines the Quick Bolus amount per
key press using the a and s keys. Incorrect programming
of the bolus increment may cause inappropriate insulin
delivery.
Procedure for adjusting the bolus increment
126
1.
2.
Press d to move to the THERAPY
SETTINGS screen.
Press d to move to the BOLUS
INCREMENT screen.
Press f to select.
Press a or s to select a bolus
increment.
Press f to save and exit.
5
5.10.2 Adjusting the prime amount
The prime amount needed to fill an infusion set depends on the
length of the infusion set tubing. The shorter your infusion set
tubing, the less insulin will be required to prime the infusion set.
The default setting for the prime amount is 25 units of insulin.
Note
The amount of insulin used for the priming is not added to
the history of daily insulin totals.
Procedure for adjusting the prime amount
1.
2.
Press d to move to the THERAPY
SETTINGS screen.
Press d to move to the PRIME AMOUNT
screen.
Press f to select.
Press a or s to select a prime
quantity between 0.0 and 50.0 units.
Press f to save and exit.
127
5.10.3 Locking basal rate profiles
Your Accu-Chek Spirit Combo insulin pump allows you to adapt
your hourly basal rate profile as needed. You can then lock
your basal rate profiles to provide additional protection against
accidentally changing a basal rate during normal operation. If
the basal rate lock is set to ON, programming of the basal rate
profiles 1, 2, 3, 4 and 5 is blocked.
If you try to program a basal rate while the BASAL RATE LOCK is
turned ON, the key symbol in the BASAL RATE TOTAL screen
indicates that basal rate programming is locked.
The a and s functions are blocked.
However, you can still change between the different basal rate
profiles 1 to 5.
Procedure for locking the basal rate profiles
128
1.
2.
Press d to move to the THERAPY
SETTINGS screen.
Press d to move to the BASAL RATE
LOCK screen.
Press f to select.
Press a or s to turn the basal rate
lock ON or OFF.
Press f to save and exit.
5
5.10.4 Automatic Off
Automatic Off is a safety feature that stops insulin delivery and
triggers Error E3: AUTOMATIC OFF if no keys are pressed within
a programmed time period in RUN mode. This feature can either
be set to OFF or programmed up to 24 hours in 1-hour intervals.
The factory setting is OFF.
Discuss using the Automatic off function with your doctor or
healthcare team.
Procedure for using Automatic Off
1.
2.
3.
Press d to move to the THERAPY
SETTINGS screen.
Press d to move to the AUTOMATIC
OFF screen.
If you would like to set the Automatic Off
function to off, press s until “0 hours”
and OFF appear on the display.
Press f to select.
Press or scroll a to increase or s to
decrease the duration for the Automatic
Off in 1-hour intervals.
Press f to save and exit.
129
5.11 CUSTOM user menu
The CUSTOM user menu is designed to adapt your pump to your
special requirements and preferences. It allows you or your
doctor or healthcare team to display or hide screens and thereby
customize the individual user menus.
jj Press d to move forward
jj Press d + a simultaneously
to move backward
STOP
RUN
130
5
Note
By default, the CUSTOM user menu contains all of the
functions available except the following:
jj Multiwave Bolus
jj Basal rate profiles 3, 4 and 5
To change the CUSTOM user menu, you, your doctor,
or your healthcare team must use the appropriate Accu-Chek
PC software.
131
132
6
Using the Accu-Chek Spirit Combo insulin pump with the Meter
This chapter describes how the Accu-Chek Spirit Combo insulin
pump works with the Meter, and explains how to pair the two
devices using Bluetooth ® wireless technology.
Note In this User Guide the term “Meter” always refers to the
Accu-Chek Aviva Combo Blood Glucose Meter.
“Pairing” means to set up a connection between the two devices
using Bluetooth ® wireless technology. This is a secure connection, and there is no risk of your pump receiving signals from any
other device.
Note
6.1 Meter
The Meter is both a blood glucose meter and a remote-control
device for your Accu-Chek Spirit Combo insulin pump. Using the
Meter, you can program your pump without handling it, and also
receive bolus advice and review history information.
Note
Do not leave your Meter unattended as long as it is
connected to your pump. Otherwise your pump could be
manipulated remotely without your control (for example:
children playing with the Meter).
The pump may not communicate with the Meter using
Bluetooth ® wireless technology when the devices are
more than two meters (about six feet) apart.
133
6.1.1 Tasks that must be performed on the pump
The following tasks cannot be performed remotely using the
Meter:
jj Changing the cartridge
jj Priming the infusion set
jj Data transfer
jj Bluetooth ® settings
jj Display settings
All the other functions available on the Accu-Chek Spirit Combo
insulin pump can be performed using the Meter.
Before using your pump together with the Meter you must read
the documentation (Owner’s Booklet) provided with this product.
134
6
6.2 Switching Bluetooth ® ON and OFF
Warning
You must ensure that Bluetooth ® is switched off on both
devices before boarding an aircraft, as emissions from your
pump or the Meter could interfere with the electronics
systems of the aircraft.
To prolong the battery life and avoid accidental changes on your
pump, you should switch off Bluetooth ® wireless technology,
if the Meter is lost, stolen or, you plan not to carry it with you for
a longer period of time.
Procedure for switching Bluetooth ® ON and OFF
1.
Press d to move to the BLUETOOTH
SETTINGS screen.
2.
Press f to select to the ON/OFF screen.
Press a or s to switch on the
Bluetooth ® function.
Press f to save and exit.
135
6.3 Pairing your pump with the Meter
If you have already acquired the Meter together with the
Accu-Chek Spirit Combo insulin pump, the two devices will
already have been paired.
When pairing your Accu-Chek Spirit Combo insulin pump with
the Meter, place both devices on a table or desk, so that you can
see the displays of both devices clearly.
You should not perform the pairing process in crowded areas,
since the signals of other electronic devices could interfere with
the connection.
Procedure for Pairing
1.
2.
3.
Press d to move to the BLUETOOTH
SETTINGS screen.
Press f to select to the ON / OFF screen.
Press d to display the PAIRED DEVICE
screen.
Press a or s to switch on the
Bluetooth ® function.
136
6
Note
When Bluetooth ® is turned off,
you cannot access the Paired
Device menu.
4.
Pump screen
If the pump screen indicates that no
paired device is available, turn on the
Meter in pairing mode by holding down
* and simultaneously pressing +.
Meter screen
5.
6.
The pump begins searching and detects
the Meter, displaying its serial number
(This process may take several minutes).
Pump screen
Press the d key on the pump to see the
ADD DEVICE screen, and press f to
initiate pairing.
Press a or s to select the number,
which is also shown on your Meter
screen.
Press f on the pump to confirm that
you want to pair the Meter.
Meter screen
137
7.
8.
Pump screen
The pump begins the pairing process and
shows a 10-digit code. Enter the code on
the Meter display, using =, x and z
and then = to move to the next digit.
Confirm the complete code with ..
Meter screen
After the pairing is completed press + to
turn off the Meter.
Meter screen
138
9.
10.
The pump now shows the DEVICE PAIRED
screen. Press f to confirm the pairing.
The pump displays the PAIRED DEVICE
screen. You can return to the RUN screen
by pressing f.
If the pairing is not successful in a first
attempt, wait a few minutes before you
repeat the procedure in a safe or less
crowded environment.
6
6.4	Troubleshooting the Bluetooth ®
connection
In case of problems with the Buetooth connection or after the
appearance of the W10: BLUETOOTH FAULT, you have to repeat
the pairing procedure described in section 6.3 Pairing your pump
with the Meter.
Since only one Meter at a time can be paired with your pump,
you must delete the pairing before you can pair your pump with a
new Meter.
1.
2.
3.
Press d to move to the BLUETOOTH
SETTINGS screen.
Press f to enter the BLUETOOTH
ON / OFF screen.
Press d to move to the PAIRED DEVICE
screen.
139
4.
Press d to move to the DELETE DEVICE
screen.
Press f once to delete the pairing and
a second time to confirm.
6.4.1 Handling Warnings and Errors
The Accu-Chek Spirit Combo insulin pump and Meter behave in
the following ways when Warnings and Errors occur.
jj If both devices are switched on and paired you can enter the
Meter’s Pump menu and snooze and confirm the Warning or
Error through the Meter.
jj If the Meter is switched off, and you switch it on in response to
a Warning, Error or Reminder on the pump, the Meter switches
immediately to the Pump menu. All the functions available on
the pump are performed from the Pump menu of the Meter.
Note
Then repeat the pairing procedure described in section 6.3 Pairing
your pump with the Meter.
If the pairing is still not successful, contact local pump support
(details on inside back cover).
140
The above points do not apply in the case of E7:
ELECTRONIC ERROR.
6
6.4.2 Use in aircraft
Warning
You must ensure that Bluetooth ® is switched off on both
devices before boarding an aircraft, as emissions from your
pump or the Meter could interfere with the electronics
systems of the aircraft.
141
142
7
Care and Maintenance
This chapter explains how to take care of your pump and keep it
properly maintained.
Guarantee
Disetronic Medical Systems Inc. guarantees that your pump
functions according to its specifications only where all servicing
of your pump is carried out and  / or authorized by Disetronic
Medical Systems.
Caution
Do not perform any servicing or repair on your Accu-Chek
Spirit Combo insulin pump. For servicing or repair, contact
your local pump support (see inside back cover).
7.1 Inspecting your pump
Your pump must be properly maintained to guarantee accurate
insulin delivery.
Check the pump display regularly during the day and before you
go to sleep, and especially if for any reason you might not be
able to hear the beeps or feel the vibrations.
Accessories
Use only Accu-Chek sterile products and accessories designed
to be used with your pump. Replace and discard these items
according to your doctor’s or healthcare team’s recommendations and the instructions that come with these items.
143
7.1.1 Checklist
Check your pump daily, and make sure that:
jj The pump casing, the display, and the cartridge are not
chipped or cracked and that the display does not show
incomplete or abnormal letters or symbols.
jj You carefully inspect the cartridge. Make sure that the actual
amount of insulin in the cartridge equals the displayed
cartridge amount on the Quick Info screen.
jj You inspect all parts of your pump and infusion set regularly
during the day and before you go to sleep. If you detect any
loss of insulin, immediately replace the leaking component.
jj The battery cover is correctly tightened and positioned, in line
with the pump casing.
jj The adapter is correctly attached.
jj Your infusion set is primed, free of air bubbles, and tightly
connected to the adapter.
jj Your infusion set is inserted according to the instructions for
its use.
144
jj Your infusion site is secure, comfortable, and free of irritation
or infection.
jj The cartridge is free of air bubbles.
jj Your pump is in RUN mode.
jj The basal rates are set correctly according to your doctor’s or
healthcare team’s recommendations.
jj The time and date are set correctly.
jj The Temporary Basal Rate changes are set according to your
doctor’s or healthcare team’s recommendations.
jj The beeps and / or vibrations are set.
jj You have your personal emergency kit with you.
(See section 1.5 Emergency kit)
7
7.2 Damage to your pump
7.2.1 What to do if you drop your pump
If the pump is dropped it could be damaged, as well as the seal
that protects it against water. Use the specially designed pump
carrying system to help avoid dropping your pump. See
Disetronic Medical Systems sterile products and accessories
catalogs and brochures for more information, or contact your
local pump support (details on inside back cover).
If you drop your pump:
jj Check that all the connections in your infusion set are still
tight, and if they are not, reconnect or tighten them
jj Check your pump, its sterile products, and accessories for
chips and cracks
jj Change the cartridge if it is damaged
Note
If a Temporary Basal Rate, an Extended Bolus or a
Multiwave Bolus is active at the same time, it is cancelled
when your pump is put into STOP mode. A Warning W8:
BOLUS CANCELLED or a Warning W6: TBR CANCELLED is
displayed.
Press f twice to confirm and turn off the alert. The
alerts are recorded in the alarm history.
See chapter 8 Warning W6: TBR CANCELLED and
Warning W8: BOLUS CANCELLED.
Make sure that the cancellation was deliberate, put your
pump back in RUN mode and then program a new
Temporary Basal Rate (and  / or an Extended or Multiwave
Bolus), if needed.
Put your pump in STOP mode disconnect the infusion set, and
take out and reinsert the battery, so that the self-test is started
then put your pump back in RUN mode.
145
7.3 Your insulin pump and water
Caution
Immediately inspect your pump if it is dropped. Do not use
your Accu-Chek Spirit Combo insulin pump if chips, cracks
or other damages are visible. Otherwise water, dust, insulin
or other foreign substances may enter your pump and could
result in a malfunction.
If you have questions or are not sure whether your pump has
been damaged, contact your local pump support (details on
inside back cover).
146
Caution
Avoid contact with water. Check daily that your Accu-Chek
Spirit Combo insulin pump is not chipped, cracked or damaged
in any way, and that the battery cover and the adapter are
correctly closed. If the pump is chipped or cracked, water,
dust, insulin, or other substances may enter your pump and
lead to malfunction. Before any contact with water, disconnect
and take off your pump.
Disconnect and remove your pump before taking a bath, or
going into a whirlpool, shower, or swimming pool. Avoid
exposing your pump to high humidity, such as in a sauna, as
this could result in damage. To make it easy to remove your
pump, use disconnectable Accu-Chek infusion sets.
7
7.3.1 Accidental contact with water
Your Accu-Chek Spirit Combo insulin pump is IPX8 waterproof
when leaving the factory site. However hair-line cracks could
appear during use. Therefore we may only guarantee protection
against brief accidental water contact such as:
jj Rain
jj Water splashes while you are cycling, jogging or hiking
jj Accidental immersion in the sink, washbasin or bath
What to do after any water contact
Put your pump into STOP mode, disconnect the pump from your
body, and inspect it. Use a soft dry cloth to dry the outside of the
pump, and check the battery compartment and the cartridge
compartment for water. If the battery compartment or cartridge
compartment are wet, turn your pump upside down to let the
water run out and let it air dry. Do not use warm air such as a
hair dryer to dry the pump, as this could damage the pump’s
housing. Do not reinsert the battery or the cartridge until the
compartments are completely dry. See section 7.5.1 Cleaning
your pump.
Other liquids
You do not have to worry about contact between your pump and
perspiration or saliva. You must however check your pump
immediately after contact with other liquids or chemicals such as:
jj Cleaning solutions
jj Alcohol
jj Beverages
jj Oil or Fat
In case of contact with these substances, clean your pump
immediately. See section 7.5.1 Cleaning your pump.
Caution
Avoid any contact between your Accu-Chek Spirit Combo
insulin pump, the infusion set, and the connecting parts of
your insulin pump with health and beauty items (for example:
antiseptics, antibiotic creams, soaps, perfumes, deodorants,
body lotions, or any other cosmetics). These substances
could discolor your pump or fog the display.
147
7.4 Repair of your pump
Caution
Do not perform any servicing or repair on your pump. Do not
use any lubricants on the pump mechanism. If you have
questions, contact your local pump support (details on inside
back cover).
If you have problems with your pump, contact your local pump
support (details on inside back cover). Your local pump support
can answer many questions and resolve many problems over
the telephone. You may be requested to return your pump to
Disetronic Medical Systems for repair. For example, you may
need to return your pump if a Warning or Error could not be
cleared by following the procedures described in chapter
8 Warnings and Errors.
If you have to ship your pump, carefully pack the pump and the
used cartridge, battery, battery cover, adapter, and infusion set
to avoid damage during transportation. Place your pump back in
the shipping case and put the case in a package that will not rip
or tear. It is recommended to ship your pump using a company
that tracks the shipment for you.
148
When you return your pump, include the following:
jj your name and address
jj your daytime phone number
jj the serial number of your pump
jj any RMA (Return Material Authorization) number received from
your local pump support.
By returning your pump to Disetronic Medical Systems, you
authorize Disetronic Medical Systems to undertake any testing
on your insulin pump that is needed for a proper inspection,
and understand that your pump may not be returned to you.
(For the address, see inside the back cover.)
7
7.5 Maintaining your pump
7.5.1 Cleaning your pump
7.5.2 Batteries
The best time to clean your pump is when you change the
cartridge. Use a soft cloth to clean the outside of the pump. If
necessary, use a damp clean cotton cloth with water or, even
a damp soapy water cloth. If these measures are not successful,
contact your local pump support (details on inside back cover)
for more instructions. Also see section 7.3.1 Accidental contact
with water.
It is important to change your battery regularly and to keep spare
batteries available. The life of any battery is affected by how you
use your Accu-Chek Spirit Combo insulin pump, your personal
settings, delivery rates, temperature, and other factors.
For details about the battery lifetime see Appendix A for lifetime
of battery.
See section 1.4 Accessories and disposables or Appendix C for
more information on recommended batteries.
See section 2.2 Inserting the battery for instructions on how to
change your battery.
Caution
Always remove the cartridge and adapter, and put your pump
in STOP mode while cleaning. Avoid pressing the keys of your
Accu-Chek Spirit Combo insulin pump during cleaning, as this
may accidentally change your settings. Do not use alcohol,
solvents, strong detergents, bleaching agents, scouring pads
or sharp instruments for cleaning, as they may damage the
pump.
149
7.6 Storing your pump
Caution
When your pump will not be in use for a long period of time, it
must be properly stored to prevent any subsequent malfunction.
To store your pump, place it in STOP mode, then:
jj Remove the battery to preserve the battery life
jj Remove the cartridge
jj Insert the battery cover
jj Store your pump in its packaging
Storage conditions
150
Temperature
41 °F to 113 °F (+5 °C to +45 °C)
Air humidity
5 to 85 % relative air humidity
Barometric pressure
700 to 1060 mbar
7.7 Disposing of your pump
Since your Accu-Chek Spirit Combo insulin pump may come into
contact with blood during use, it may carry a risk of infection.
If you need to dispose of your Accu-Chek Spirit Combo insulin
pump, return it to Disetronic Medical Systems (address inside the
back cover) for professional disposal.
Battery
Correctly dispose of empty batteries, recycling them whenever
possible.
Cartridge, Infusion set, Adapter, and Accessories
Dispose of these items in your normal household waste or, for
the batteries, at the usual recycling point. Remember to dispose
of the introducer needle safely (using the needle container).
To prevent injury to others, replace the needle protective cap
or insert the needle of the infusion set into a disposable object,
or put it in a hard-shell container.
8
Warnings and Errors
A safety system monitors and controls the function of your
Accu-Chek Spirit Combo insulin pump. This safety system
performs more than 9 million safety checks every day. If it
detects a change from the pump’s normal state, it will trigger a
Warning or an Error message. Beeps, vibrations, and messages
on the pump screen indicate the cause of a Warning or Error.
Warnings and Errors are the only way you can be quickly notified
of any changes in your pump.
Caution
If you do not confirm a Warning or Error within 60 seconds, it will
be signalled again. Even when the beep is turned off or programmed at lower than maximum volume, the beep volume will
rise to the loudest volume level if not confirmed. Both the beep
and vibration will then continue at this level until confirmed.
Note
j The volume of the STOP-Warning is separate from the
programmed beep volume and cannot be changed.
It always occurs at the maximum level.
jj Keylock is unlocked by the system each time a Warning
or Error occurs.
Check the pump display regularly during the day, and before
you go to sleep, and especially if you might not be able to
hear the beeps or feel the vibrations for any reason.
Your pump signals Warnings and Errors using beeps and
vibrations. You can turn off either the beeps or the vibrations, but
for your safety you cannot turn off both at the same time for the
initial alarm signal.
151
8.1 Confirming a Warning or Error
When you confirm:
W1: CARTRIDGE LOW
E1: CARTRIDGE EMPTY
W2: BATTERY LOW
E2: BATTERY EMPTY
W5: PUMP TIMER (“Backup” pumps only)
E5: END OF OPERATION,
the symbol for that Warning or Error stays in the RUN screen or
STOP screen as a Reminder.
Battery low symbol
Pump timer symbol
Cartridge low symbol
Key lock symbol
When a Warning or an Error occurs:
jj Press f to turn off the beeps and vibrations. The Warning or
Error code stays on the display.
jj As soon as you understand the reason for the Warning or Error,
confirm by pressing f again.
jj Take appropriate action, as necessary.
jj If more than one Warning and /or Error occurs simultaneously,
press f twice for each Warning or Error to confirm them and
turn them off.
jj After a Warning or Error, make sure that you switch your pump
back to RUN mode where appropriate.
Note
For other Warnings or Errors, alarm information is cleared from
the display but stays in the alarm history and the event memory.
152
When you use your pump together with the Meter you can
also snooze and confirm an incoming Warning or Error
with the Meter. For further information see the Meter user
information.
8
8.2 List of Warnings
Warning
jj Press f twice to snooze and to confirm the Warning. Change
the cartridge before it is empty.
After a Warning occurs, your Accu-Chek Spirit Combo insulin
pump may be in STOP mode and insulin delivery may be
interrupted. In order to maintain insulin delivery, you must act
immediately according to the instructions given for each Error
code, or put your Accu-Chek Spirit Combo insulin pump in
RUN mode to continue the insulin delivery.
jj If necessary, put your pump in RUN mode.
Warning W1: CARTRIDGE LOW
The contents of the insulin cartridge have dropped to 20 units of
insulin. Be prepared to replace the cartridge as soon as possible.
The “cartridge low” symbol appears in the RUN or STOP screen
as a Reminder until you change the cartridge.
See section 3.5 Changing the cartridge and infusion set.
153
Warning W2: BATTERY LOW
The battery power is low. Be prepared for a battery change as
soon as possible. The battery low symbol appears in the RUN or
STOP screen as a Reminder until you change the battery.
Warning W3: REVIEW TIME
The pump has been without power for more than one hour. The
pump settings and history data are saved in memory regardless
of power loss. However, it may be necessary to set the time and
date again.
jj Press f twice to snooze and to confirm the Warning.
jj Press f twice to snooze and to confirm the Warning.
jj Replace the battery as soon as possible. Failure to change the
battery within a few hours of receiving the Warning could
result in additional Error messages.
jj If necessary, put your pump in RUN mode.
jj Review the time and date and correct them, if they are wrong.
jj If necessary, put your pump in RUN mode.
See section 2.4 Setting the time and date.
See section 1.4 Accessories and disposables on recommended
batteries. See section 2.2 Inserting the battery for instructions on
how to change the battery.
154
8
Warning W4: CALL FOR UPDATE
The pump is nearing six years of life. You may want to consider
updating to a new product. Contact your local pump support
(see inside back cover).
Warning W5: PUMP TIMER (“Backup” pumps only)
Your pump’s operating time will expire soon. When the Warning
W5: PUMP TIMER occurs, the pump will display the symbol to
remind you to check the timer.
jj Press f twice to snooze and to confirm the Warning.
jj Press f twice to snooze and to confirm the Warning.
jj Put your pump in RUN mode if necessary.
jj Put your pump in RUN mode.
jj Go to the MY DATA menu on your pump.
155
jj Move to the PUMP TIMER screen. The days until the pump
timer expires are shown.
Warning W6: TBR CANCELLED (Temporary Basal Rate
Cancelled)
A temporary increase or decrease in the basal rate has been
cancelled.
jj Press f twice snooze and to confirm the Warning.
When the PUMP TIMER reaches zero, the pump will change to
STOP mode and will no longer operate. An Error, E5: END OF
OPERATION, will appear on the display. Contact your local pump
support (details on inside back cover) to discuss the options for
further use of your Accu-Chek Spirit Combo insulin pump.
Note
156
The Warning W5: PUMP TIMER and the Error E5: END OF
OPERATION are based on running time (the total time the
pump is in RUN mode), and not on calendar years.
See section 5.4.5 Viewing the time remaining.
jj If necessary, put your pump in RUN mode.
jj Make sure that the cancellation was intended and then
program a new Temporary Basal Rate if necessary.
8
Warning W7: TBR OVER (Temporary Basal Rate Over)
A Temporary Basal Rate has ended. The original basal rate
(100 %) will resume automatically once the Warning has
occurred.
Warning W8: BOLUS CANCELLED
A bolus was cancelled during the start delay or after delivery
began.
jj Press f twice to snooze and to confirm the Warning.
jj Press f twice to snooze and confirm the Warning.
jj Decide whether a further Temporary Basal Rate change is
required. If necessary, program a new Temporary Basal Rate.
jj If necessary, put your pump in RUN mode.
jj Make sure that the cancellation was intended and then
program a new bolus if needed.
Note
The actual bolus amount that was delivered before the
cancellation can be reviewed in the bolus history. See
section 5.4.1 Viewing your bolus history.
157
Warning W9: LOANTIME WARNING (loan pumps only)
The pump is coming to the end of its loan period. In the MY DATA
menu, check the remaining loan time in the PUMP TIMER menu.
Make sure that you arrange for the replacement of the pump
within the scheduled loan time.
Warning W10: BLUETOOTH FAULT
You need to re-do the pairing procedure for the Accu-Chek
Spirit Combo insulin pump and Meter.
See section 6.3 Pairing your pump with the Meter.
Press f twice to snooze and to confirm the Warning.
jj Press f twice to snooze and to confirm the Warning.
jj Put your pump in RUN mode if necessary.
jj Put your pump in RUN mode if necessary.
jj Go to the MY DATA menu on your pump.
jj Move to the PUMP TIMER screen. The days until the loantime
expires are shown.
158
8
8.3 List of Errors
Warning
After the occurrence of an Error, your Accu-Chek Spirit Combo
insulin pump is in STOP mode and insulin delivery is interrupted. In order to maintain insulin delivery, you must act
immediately according to the instructions given for each
Error.
Error E1: CARTRIDGE EMPTY
The insulin cartridge is empty. You must change it immediately.
jj Press f twice to snooze and to confirm the Error.
jj Reconnect the infusion set at your infusion site.
jj Put your pump in RUN mode.
See section 3.5 Changing the cartridge and infusion set.
Error E2: BATTERY EMPTY
The battery is empty. You must replace it immediately.
Warning
After inserting a new battery, always check that the time and
date of your Accu-Chek Spirit Combo insulin pump are set
correctly. Incorrect programming of the time and /or date
may cause incorrect insulin delivery. If you, your doctor or
healthcare team store and analyze your therapy data
electronically and the time and date of the devices used are
not set identically, the resulting data might not be meaningful.
jj Disconnect or remove the infusion set from the infusion site.
jj Change the cartridge and prime the infusion set.
159
jj Press f twice to snooze and to confirm the Error.
Error E3: AUTOMATIC OFF
Automatic Off is a safety feature that stops insulin delivery and
triggers an Error E3: AUTOMATIC OFF if no keys are pressed
within a programmed time period in RUN mode.
jj Press f twice to snooze and to confirm the Error.
jj Replace the battery.
jj Put your pump in RUN mode.
Note
160
Your pump stores the settings you saved before the
battery power ran out. If your pump is without power for
more than one hour, check that the time and date are
still correct.
See section 1.4 Accessories and disposables on recommended batteries. See section 2.2 Inserting the battery
for instructions on how to change your battery.
jj Put your pump in RUN mode.
8
Error E4: OCCLUSION
Warning
If an Error E4: OCCLUSION (blockage) occurs, follow the
steps listed below:
jj Press f twice to turn off and to confirm the Error.
If the Error E4: OCCLUSION occurs, immediately check your
blood glucose level, and then check again about two hours
later, as insulin delivery has been interrupted. If your blood
glucose level is high, take appropriate action according to
your doctor’s or healthcare team’s instructions.
Insulin was not delivered. This may be due to:
jj a blocked infusion set
jj a damaged cartridge
jj a dirty or damaged piston rod
jj Disconnect or remove the infusion set from your infusion site.
jj Change the infusion set and prime it, as explained in chapter 2.
jj Reconnect the infusion set at your infusion site.
jj Put your pump in RUN mode.
161
In rare cases, the cartridge itself can be the cause of the
occlusion. If an Error E4: OCCLUSION occurs again, you
must change the cartridge. Follow the steps listed below:
jj Press f twice to turn off and to confirm the Error.
jj Disconnect or remove the infusion set from your infusion site.
jj Change the cartridge and prime the infusion set, as explained
in chapter 2.
jj Reconnect or insert a new infusion set at your infusion site.
jj Put your pump in RUN mode.
If the Error E4: OCCLUSION occurs again, prime your pump
without a cartridge. Follow the steps listed below:
jj Press f twice to turn off and to confirm the Error.
jj Disconnect or remove the infusion set from your infusion site.
jj Remove the cartridge, adapter and infusion set from your pump.
162
jj Carry out the Infusion set PRIMING function (See section
2.8 Priming the infusion set) without the cartridge, adapter,
and infusion set inserted.
jj Insert a new cartridge with the adapter and infusion set
connected.
jj Prime the infusion set.
jj Reconnect the or insert a new infusion set at your infusion
site.
jj Put your pump in RUN mode.
If the Error E4: OCCLUSION continues to occur, use the
alternative therapy plan provided by your doctor or
healthcare team. Contact your local pump support
(details on inside back cover) for more assistance.
8
Error E5: END OF OPERATION (“Backup” pumps only)
Your pump timer of your Backup pump has reached zero. The
pump changes to STOP mode and will no longer operate. An
Error E5: END OF OPERATION appears on the display. Before this
Error occurs, a Warning W5: PUMP TIMER will remind you to
replace your pump soon. If necessary, use the alternative therapy
plan provided by your doctor or healthcare team.
Note
The Warning W5: PUMP TIMER and the Error E5: END OF
OPERATION are based on running time (the total time
the pump is in RUN mode) and not on calendar years.
jj Press f twice to snooze and to confirm the Error.
jj Contact your local pump support (see inside back cover)
to discuss the options for further use of the Accu-Chek
Spirit Combo insulin pump.
163
Error E6: MECHANICAL ERROR
A mechanical Error has been discovered during a routine
automatic system check and insulin delivery has stopped.
jj Press f twice to snooze and to confirm the Error.
jj Remove or disconnect the infusion set from your infusion site.
jj Remove the cartridge, adapter, infusion set, and battery from
your pump. Insert a new battery.
jj Install a new cartridge and infusion set. It is essential that you
rewind the piston rod. (See section 2.7 Inserting the cartridge).
Prime the infusion set (See section 2.8 Priming the infusion set).
164
jj Reconnect the infusion set at your infusion site.
jj Put your pump in RUN mode.
If the Error E6: MECHANICAL ERROR occurs again, use the
alternative therapy plan provided by your doctor or healthcare
team. Contact your local pump support (details on inside back
cover) for more assistance.
Error E7: ELECTRONIC ERROR
An electronic Error has been discovered during a routine
automatic system check and insulin delivery has stopped.
Note
You cannot turn off and confirm an Error E7: ELECTRONIC
ERROR by pressing f. You must remove the battery
instead.
8
jj Remove or disconnect the infusion set from your infusion site.
Error E8: POWER INTERRUPT
A power interrupt Error occurs when you insert a new battery
without first placing the pump in STOP mode. See section
2.2 Inserting the battery for instructions on how to change the
battery. The Error can also occur if the pump has been dropped.
In this case, see section 7.2.1 What to do if you drop your pump.
jj Replace the battery in the pump (See section 2.2 Inserting the
battery).
jj Prime the infusion set.
jj Reconnect the infusion set at your infusion site.
jj Put your pump in RUN mode.
jj Press f twice to snooze and to confirm the Error.
After an Error E7: ELECTRONIC ERROR always check your
settings like e.g. basal rate profile, time and date.
If the Error E7: ELECTRONIC ERROR occurs again, contact your
local pump support (details on inside back cover) for assistance.
Use the alternative therapy plan provided by your doctor or
healthcare team.
jj Your pump goes into STOP mode.
jj Check the time and date and correct them if they are wrong.
See section 2.4 Setting the time and date.
jj Put your pump in RUN mode. Program a new bolus and /or
Temporary Basal Rate if necessary. See chapter 4 Boluses and
Temporary Basal Rates.
If an Error E8: POWER INTERRUPT occurs during programming,
check your settings.
165
166
Error E9: END OF OPERATION (loan pumps only)
Your pump timer has reached zero. The pump changes to STOP
mode and will no longer operate. An Error E9: END OF OPERATION appears on the display. Before this Error occurs, a Warning
W9: LOANTIME WARNING will remind you to replace your pump
soon. If necessary, use the alternative therapy plan provided by
your doctor or healthcare team.
Note
Error E10: CARTRIDGE ERROR
The CARTRIDGE CHANGE function was not correctly performed.
jj Press f twice to snooze and to confirm the Error.
jj Press f twice to snooze and to confirm the Error.
jj Contact your local pump support (details on inside back cover)
to discuss the options for further use of the Accu-Chek Spirit
Combo insulin pump.
jj Remove or disconnect the infusion set from your infusion site.
jj Remove the cartridge.
jj Reinsert the cartridge. (See section 2.7 Inserting the cartridge)
The Warning W9: LOANTIME WARNING and the Error E9:
END OF OPERATION are based on running time (the total
time the pump is in RUN mode) and not on calendar
years.
8
jj Prime the infusion set.
jj Reconnect the infusion set at your infusion site.
jj Put your pump into RUN mode.
jj If the Error E10: CARTRIDGE ERROR occurs during the
rewinding of the piston rod, insert a new battery in the pump
and repeat the procedure.
See sections 3.5 Changing the cartridge and infusion set and
2.8 Priming the infusion set.
Warning
Never prime an infusion set that is connected to your body.
You risk uncontrolled insulin delivery into your body. Always
follow the instructions provided with your infusion set.
Error E11: SET NOT PRIMED
The cartridge has been changed but the infusion set has not
been primed. The Error will be displayed when you try to put your
pump in RUN mode.
jj Press f twice to snooze and to confirm the Error.
jj Remove or disconnect the infusion set from your infusion site.
jj Prime the infusion set. (See section 2.8 Priming the infusion set)
jj Reconnect the infusion set at your infusion site.
jj Put your pump in RUN mode.
167
Error E12: DATA INTERRUPTED
Caution
If infrared data transfer between your pump and a compatible
device is disrupted in any way, the configuration may be
incomplete and the Error E12: DATA INTERRUPTED will occur.
The data transfer must be successfully completed before you
can put your Accu-Chek Spirit Combo insulin pump into RUN
mode.
Data transfer between your pump and the computer was
interrupted before it was completed.
168
jj Press f twice to snooze and to confirm the Error.
jj Restart the data transfer.
Before you can put your pump in RUN mode, the data transfer
must have been successfully performed.
See section 5.5 Transferring your data to a computer.
8
Error E13: LANGUAGE ERROR
The language setting needs to be checked.
jj Press f twice to snooze and to confirm the Error.
jj Follow the steps in section 5.6 Pump settings to change the
language.
jj Put your pump in RUN mode.
169
8.4 List of Reminders
Reminder R1: Reminder
A Reminder has been programmed on the pump.
jj Press f twice to snooze and to confirm the Reminder.
jj If necessary, put your pump in RUN mode.
Note
170
If you have set the Reminder occurrence to EVERY DAY,
the same Reminder occurs every 24 hours. Turn the
Reminder function OFF if you do not want the alarm to
go off again at that same time every day.
See section 5.9 Setting a Reminder.
9
Troubleshooting
This chapter describes problems that may occur when using
your Accu-Chek Spirit Combo insulin pump. Any problems that
generate a Warning or Error are described in chapter 8.
Note
The solutions provided in this chapter will normally enable
you to resolve the problem and continue with your pump
therapy. However, if the recommended action does not
resolve the problem, or if you have any concerns, do not
hesitate to contact your local pump support (see inside
back cover) or your doctor or healthcare team.
Note
Troubleshooting information relating to the Bluetooth ®
connection between the Meter and the Accu-Chek Spirit
Combo insulin pump is included in chapter 6 Using the
Accu-Chek Spirit Combo insulin pump with the Meter.
Also refer to the documentation (Owner’s Booklet) that
comes with the Meter.
Although your pump has an internal security check system, it
cannot for example detect if your infusion set is leaking or if the
insulin you are using has lost its effectiveness. These problems
can result in a rapid rise in your blood glucose level. Therefore,
it is essential to check your pump and blood glucose level during
the day.
171
9.1 Therapy-related issues
Many factors – such as alcohol consumption, medication, decreased activity, illness and stress – can affect your blood glucose level.
Contact your doctor or healthcare team for advice on how to manage these, or any other therapy-related issues.
172
Problem
Recommended Action
Individual characters, numbers, or symbols on the display
are shown incompletely or not at all.
Contact your local pump support (details on inside back cover).
Your Accu-Chek Spirit Combo insulin pump does not beep
or vibrate.
Check that the beep volume and alarm signals are turned on. Check the
battery and change it if necessary. If the pump still does not beep or
vibrate, contact your local pump support (details on inside back cover).
The self-test is not completed correctly (after an Error E7:
ELECTRONIC ERROR).
Remove the battery, wait a few seconds, and insert it again. If the
self-test is still not completed correctly, contact your local pump
support (details on inside back cover).
Insulin delivery is incorrect due to inaccurate time setting.
If the time setting is inaccurate, the correct hourly basal rate cannot be
delivered. Check and reset the time if necessary. Perform the same
check whenever you change the battery.
Insulin delivery is incorrect due to incorrect basal rate
programming.
Review any changes that you have made to your basal rate programming, to ensure that you are using the correct basal rate profile.
9
Problem
Recommended Action
There are air bubbles in the cartridge and /or infusion set.
Check your blood glucose level.
In the cartridge: Disconnect the infusion set from the headset and
re-prime the infusion set. If the air bubbles remain, replace the
cartridge. Always fill the cartridge with insulin that is at room temperature.
In the infusion set: Disconnect from the headset and prime your infusion
set. Reconnect the headset and ensure that all connections are tight and
secure.
The cartridge is empty.
Replace the cartridge. (Cartridges are for single use only.)
The infusion set is disconnected or dislodged.
Check your blood glucose level. Make sure that all the connections are
tight. Inspect the connections for leaking insulin. Change your infusion
set and infusion site.
173
174
Problem
Recommended Action
There is a leak in the system.
Check your blood glucose level. Check for leaking insulin at all the
connection points and on the skin. Change the infusion set, the infusion
site, the cartridge and the adapter.
There is an occlusion (blockage) in the system.
Check your blood glucose level. Follow the instructions in chapter
8 Error E4: OCCLUSION.
Priming was not completed (E11 or air bubbles in infusion
set).
Re-prime the infusion set. Always prime until a bubble-free insulin flow
emerges from the tip of the needle. Ensure that the tubing is free of air.
A
Appendix A: Technical Data
General Technical Data
Maximum dimensions
(without adapter)
Approx. 82.5 × 56 × 21 mm
(3.2 × 2.2 × 0.8 inches)
Weight
jj an empty insulin pump: approx. 80 g (2.8 ounces)
jj insulin pump inclusive battery, full plastic cartridge and infusion set:
approx. 110 g (3.9 ounces)
Pump casing
Shock- and scratch-resistant plastic, resistant to pharmaceuticals, all edges rounded
Temperature ranges*
During operation: +5 to +40 °C (+41 to +104 °F)
Storage in its shipping case: +5 to +45 °C (+41 to +113 °F)
During Transport: –20 to 50 °C (–4 to +122 °F)
Air humidity
During operation: 20 to 90 % relative humidity
Storage in its shipping case: 5 to 85 % relative humidity
During Transport: 5 to 95 % relative humidity
175
General Technical Data
Barometric pressure
During operation or storage in its shipping case: 70 to 106 kPA (700 to 1060 mbar) (do not
exceed 3000 meters [10 000 feet] above sea level)
During Transport: 50 to 106 kPA (500 to 1060 mbar)
176
Power supply
One 1.5 volt AA Alkaline (LR6) or Lithium (FR6) battery or one 1.2 volt rechargeable NiMH
AA (HR6) battery. Batteries should have a minimum capacity of 2500 mAh. Use only a
battery charger officially recommended by the battery manufacturer.
Lifetime of battery
If used in a typical usage pattern (50 U / day using U100 insulin; operating temperature 23 °C
±2 °C [73 °F ±4 °F]) the battery life is approximately:
Alkaline: 70 days for Bluetooth ® off; 30 days for Bluetooth ® on
Lithium: 200 days for Bluetooth ® off; 80 days for Bluetooth ® on
NiMH: 100 days for Bluetooth ® off; 40 days for Bluetooth ® on
Data storage time
The time and date are safely stored in the memory for about 1 hour after the battery has
been removed. Other insulin pump settings (the hourly basal rates, remaining cartridge
content, bolus increments and active user menu) and the event memory (bolus history,
history of daily insulin totals, Temporary Basal Rate history, alarm history) are saved,
regardless of battery voltage and the time your insulin pump has been without a battery.
A
General Technical Data
Delivery
1  /  20 of the current hourly basal rate in 3 minute intervals.
Basal rate
Min. 0.05 U / h, max. 50 U / h. There are 24 hourly basal rates adjustable in 0.01
(up to 1.00 U / h, 0.05 (up to 10.0 U / h) and 0.1 (up to 50.0 U / h) unit increments.
Bolus
The max. bolus amount per delivery is 50 insulin units. The bolus amount for the Quick
Bolus is adjustable in increments of 0.1, 0.2, 0.5, 1.0 and 2.0 units. For the Standard Bolus,
Extended Bolus and Multiwave Bolus, the amount is adjustable in fixed increments of
0.1 units. The duration of the Extended Bolus and the Multiwave Bolus is adjustable in
intervals of 15 minutes (15 minutes up to 24 hours).
Temporary Basal Rate
Adjustable in 10 % increments, 0 – 90 % for decreases, 110 – 250 % for increases. The
duration is adjustable in 15 minute intervals, up to a maximum of 24 hours. The last
programmed duration is given by default for the next Temporary Basal Rate change
­programmed.
177
General Technical Data
178
Maximum time for an Error
E4: OCCLUSION**
Plastic cartridges:
jj at medium basal rate 1.0 U / h: ≤ 2 h
jj at minimum basal rate 0.05 U / h: ≤ 24 h
Maximum volume before Error
E4: OCCLUSION**
Plastic cartridges: ≤ 1.5 U.
Maximum pressure
400 kPa (4.0 bar), for plastic and infusion sets.
Flow (delivery rate)
During infusion set priming and bolus 0.2 U / sec.
Maximum quantity delivered at
a single fault condition
≤ 1.0 U
Cartridge
Accu-Chek Spirit 3.15 ml Cartridge System and Accu-Chek 3.15 ml Plastic Cartridge with a
luer connection.
A
General Technical Data
Infusion sets
Accu-Chek infusion sets with a luer-lock connector.
Accu-Chek Infusion sets are PCV and latex free.
Data transfer
Infrared interface
Safety system
Alert system, beeps, information on the display, vibrations, dual microprocessors. Your
insulin pump is controlled by two microprocessors. The safety concept is based on one
processor (supervisor processor) supervising the other (main processor). Whenever a defect
or fault occurs in the main processor, it is identified by the supervisor processor. The motor
is immediately switched off and an Error E7: ELECTRONIC ERROR occurs. Conversely, the
main processor can also determine at any time whether the supervisor is working correctly.
The motor also constitutes an important safety component, as the combination of the main
and supervisor processor and brushless motor provides the best possible reliability and
accuracy in insulin delivery.
IPX8
Protected against the effects of temporary immersion in water under standardized conditions (up to 60 minutes and 2.5 meters [8 feet]).
*	See the instructions for use of the insulin you are using for information on the acceptable temperature range for storage and handling.
** Determined using measurement methods according to IEC 60601-2-24-1998.
179
Technical standards
Table 201: Electromagnetic emission
Guidance and manufacturer’s declaration – electromagnetic emissions
The Accu-Chek Spirit Combo is intended for use in the electromagnetic environment specified below. The customer or the user of the
Accu-Chek Spirit Combo should ensure that it is used in such an environment.
180
Emission test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 2
The Accu-Chek Spirit Combo must emit electromagnetic energy in
order to perform its intended function. Nearby electronic equipment
may be affected.
RF emissions
CISPR 11
Class B
The Accu-Chek Spirit Combo is suitable for use in all establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
–
Voltage fluctuations / flicker Not applicable
emissions
IEC 61000-3-3
–
A
Table 202: Electrostatic discharge (ESD) and power frequency magnetic fields (all devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
The Accu-Chek Spirit Combo is intended for use in the electromagnetic environment specified below. The customer or the user of
Accu-Chek Spirit Combo should assure that it is used in such an environment.
Immunity test standard IEC 60601 test level * Compliance level
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Electrical fast
transient / burst
IEC 61000-4-4
± 2 kV for power
supply lines
Not applicable
Surge
IEC 61000-4-5
± 1 kV line to line
± 2 kV line to earth
Not applicable
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30 %.
181
Immunity test standard IEC 60601 test level * Compliance level
Voltage dips, short
interruptions and voltage
variations on power
supply lines
IEC 61000-4-11
Note
< 5 % UT (0,5 cycle)
40 % UT (5 cycles)
70 % UT (25 cycles)
< 5 % UT for 5s
Not applicable
UT is the A.C. mains voltage prior to application of the test level.
Immunity test standard IEC 60601 test level * Compliance level
Power frequency
(50 / 60 Hz)
magnetic field
IEC 61000-4-8
400 A / m
* Test levels acc. to IEC / EN 60601-2-24
182
Electromagnetic environment – guidance
400 A / m
Electromagnetic environment – guidance
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
A
Table 203: Immunity electromagnetic fields (life-supporting devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
The Accu-Chek Spirit Combo is intended for use in the electromagnetic environment specified below. The customer or the user of the
Accu-Chek Spirit Combo should assure that it is used in such an environment.
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of the Accu-Chek Spirit Combo, including
cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Immunity test standard IEC 60601 test level
Compliance level
Recommended separation distance c)
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
V1 = 10 Vrms
150 kHz to 80 MHz
d = 1.2 
150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
10 V / m
80 MHz to 800 MHz
E1 = 10 V / m
80 MHz to 800 MHz
d = 1.2 
80 MHz to 800 MHz
Radiated RF
IEC 61000-4-3
10 V / m
800 MHz to 2,5 GHz
d)
da = 11.7 
2.3 GHz to 2.5 GHz
db = 2.3 
800 MHz to 2.3 GHz and
2.5 GHz to 2.7 GHz
E2a = 2 V / m for
2.3 GHz to 2.5 GHz
e)
E2b = 10 V / m for
800 MHz to 2.3 GHz
and 2.5 to 2.7
183
Guidance and manufacturer’s declaration – electromagnetic immunity
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters. as determined by an electromagnetic site survey, a) should be less than the compliance
level in each frequency range. b)
Interference may occur in the vicinity of equipment marked with the following symbol:
Note
At 80 MHz and 800 MHz, the higher frequency range applies.
Note
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a ) Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the Accu-Chek Spirit Combo is used exceeds the
applicable RF compliance level above, the Accu-Chek Spirit Combo or the device, which contains it should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the device containing the Accu-Chek Spirit Combo.
b ) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V / m.
c ) Possible shorter distances outside ISM bands are not considered to have a better applicability of this table.
d ) Exclusion band for Bluetooth ® ISM 2.4 GHz communication channel
e ) Compliance band for the system equipment
184
A
Table 205: Recommended separation distances (life-supporting devices)
Recommended separation distances between portable and mobile RF communications equipment and the
Accu-Chek Spirit Combo.
The Accu-Chek Spirit Combo is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the Accu-Chek Spirit Combo can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the Accu-Chek Spirit Combo as recommended below, according to the maximum output power of the communication equipment.
Rated maximum output Separation distance according to frequency of transmitter (m)
power of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.3 GHz
(W)
d = 1.2 
d = 1.2 
db = 2.3 
2.3 GHz to 2.5 GHz
da = 11.7 
   0.01
12 cm
12 cm
23 cm
118 cm
   0.1
38 cm
38 cm
73 cm
373 cm
   1
1.2 m
1.2 m
2.3 m
11.8 m
10
3.8 m
3.8 m
7.3 m
37.3 m
100
12 m
12 m
23 m
118 m
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation
applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
185
186
Note
At 80 MHz and 800 MHz, the separation distance for the
higher frequency range applies.
Note
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
Note
An additional factor of 10 / 3 is used in calculating the
recommended separation distance to decrease the
likelihood that mobile / portable communications equipment could cause interference if it is inadvertenly
brought into the vicinity of the user.
A
Accuracy of flow rate for both
Accu-Chek 3.15 ml Plastic Cartridges
and Accu-Chek Spirit 3.15 ml Cartridge
System
Trumpet curve plotted from data after the end of the
stabilization period
The trumpet curve shows the accuracy of the delivery rate in
relation to the observation period.
minimum measured variation
maximum measured variation
overall percentage Error
20
percentage Error of flow (%)
15
10
3 81
0 82
0 22
0 18
0 81
1 02
3 17
2 58
2 18
1 97
1 79
A= 1 38
8 17
10
15
20
60
120
180
240
300
360
420
480
840
600
660
720
780
840
900
960
observation window duration (min)
The maximum deviation of the delivered amount (overall mean
percentage flow Error) for U100 insulin is ≤ ± 5 %*.
*	The measurements were made at a medium basal rate of 1.0 U / h
according to IEC 60601-2-24:1998 with an Accu-Chek Ultraflex infusion
set PC 16 / 110 at room temperature.
187
Start-up graph over the stabilization period
The start-up graph shows changes in the flow rate over the
stabilization time.
real flow
target flow
0 012
flow rate (ml / h)
0 010
0 008
0 006
0 004
0 002
0 000
0.01 ml is equivalent
to 1IU (U100 insulin)
120
240
360
480
600
720
840
960
1080
1200
1320
1440
time (min)
Influence of height on delivery accuracy
The maximum deviation of the delivered amount (overall mean
percentage flow Error) for U100 insulin is ≤ ± 10 %* where your
Accu-Chek Spirit Combo insulin pump is located ≤ 1 m (3.3 feet)
above / below the infusion site.
188
Bolus
For U100 insulin the maximum deviation of a maximum bolus is
≤ ± 5 % and the maximum deviation of a minimum bolus is
≤ ± 30 %**.
*	The measurements were made at a medium basal rate of 1.0 U / h
according to IEC 60601-2-24:1998 with an Accu-Chek Ultraflex infusion
set PC 16 / 110 at room temperature.
**	The measurements were made according to IEC 60601-2-24:1998 with a
Accu-Chek Ultraflex infusion set PC 16 / 110 at room temperature.
B
Appendix B: Configuration parameters
Typical range available on
the pump and standard
parameter settings*
Maximum parameter
range adjustable with the
appropriate Accu-Chek
PC Software
62.5 U / h
max. amount: 0 – 250.0 U / h
0.01 (up to 1.00 U / h),
0.05 (up to 10.0 U / h) and
0.1 (up to 50.0 U / h)
0.0, 0.05 U / h– 50.0 U / h
Hourly basal rates
25.0 U / h
max. amount: 0 – 50.0 U / h
Temporary Basal Rate
TBR increases or decrease in increments of
TBR duration
TBR duration increments
0 – 250 %
10 %
max. 24 h
15 min
0 – 500 %
10 %
15 min – 50 h
15 min, 30 min, 1 h
Basal rate profiles available
Basal rate lock
off
1– 5
on or off
Basal rate
 ourly basal rate + max. TBR
(hourly basal rate combined with temporary
basal rate, max. increase)
Hourly basal rates increment
* Note: These factory settings may vary in some countries and depend on the
changes you, your doctor or healthcare team make using your insulin pump or
pump programming software for healthcare professionals.
189
190
Typical range available on
the pump and standard
parameter settings*
Maximum parameter
range adjustable with the
appropriate Accu-Chek
PC Software
Bolus
Bolus amount per bolus delivery
25.0 U
max. amount: 0 –  50.0 U
bolus amount increments for Quick Bolus
bolus amount increments for Standard Bolus
bolus duration (Extended Bolus, Multiwave Bolus)
bolus duration increments
0.5 U
0.1 U
max. 12 h
15 min
0.1, 0.2, 0.5, 1.0 or 2.0 U
Prime volume
25.0 U
max. amount: 0 – 50.0 U
Display orientation
standard or inverted
Display contrast
7 steps
User menus
3 (STANDARD, ADVANCED or
CUSTOM)
Volumes (for beeps)
off, 4 steps
Alarm signals turned on
beeps, vibrations or both
15 min – 50 h
15 min, 30 min, 1 h
B
Typical range available on
the pump and standard
parameter settings*
Battery type
AA (LR6) ALKALINE, AA (FR6)
LITHIUM or AA (HR6) NiMH
rechargeable battery
Keylock
turned on or off
Automatic off
turned on (1 – 24 h) or off (0 h)
Reminder
turned on or off
when on: once or every day’s
occurrence
Time format
European (24 h) or
American (12 h, am / pm)
Date format
European (dd.mm.yy) or
American (mm / dd / yy)
Bluetooth
on or off
* Note: These factory settings may vary in some countries and depend on the
changes you, your doctor or healthcare team make using your insulin pump or
pump programming software for healthcare professionals.
Maximum parameter
range adjustable with the
appropriate Accu-Chek
PC Software
191
Appendix C: Sterile products and accessories
Cartridges
Accu-Chek infusion sets
Name
Comments
Name
Comments
Accu-Chek Spirit 3.15 ml
Cartridge System
Accu-Chek 3.15 ml Plastic
Cartridge
Plastic cartridges are single-use
items only. Do not re-use cart­ridges.
Refer to the instructions for use
of the insulin you are using for
information on the acceptable
temperature range for storage and
handling.
Accu-Chek Tender
Accu-Chek Ultraflex
Accu-Chek Rapid-D
All Accu-Chek infusion sets are
available in various tubing and
needle lengths. All Accu-Chek
branded Infusion Sets are
compatible with the Accu-Chek
Spirit Combo insulin pump.
Discuss with your doctor and /or
healthcare team to find the
infusion set that fits you best.
For recommendations on how long
you may use the same infusion set
see the information material
provided with this product.
192
C
Accessories
Name
Comments
Name
Comments
Adapter
Battery Cover
Adapter and Battery Cover are part
of the Accu-Chek Spirit Combo
Service Pack and Accu-Chek Spirit
Combo Service Pack small.
Replace your adapter every
two months.
Carrying Systems
Batteries
One 1.5 volt AA (LR6)
Alkaline or AA (FR6)
Lithium battery with a
minimum capacity of
2500 mAh.
For battery lifetime see p. 176
Lifetime of battery
All Accu-Chek Spirit Combo and
Accu-Chek Spirit Carrying systems
are compatible with the Accu-Chek
Spirit Combo insulin pump.
Disetronic Medical Systems offers
a wide range of carrying system
solutions to best fit your lifestyle.
Accu-Chek PC
Configuration Software
Check with your local pump
support for the availability of
appropriate pump programming
software.
Rechargeable Batteries
One 1.2 volt AA (HR6)
NiMH rechergeable battery
with a minimum capacity
of 2500 mAh.
For battery lifetime see p. 176
Lifetime of battery
Rechargeable batteries are not
provided by Disetronic Medical
Systems. Use only a battery
charger officially recommended by
the battery manufacturer.
Accu-Chek Spirit Combo
Quick Reference Guide
This is a convenient pocket size
reference that you may take with
you to assist with your insulin
pump questions.
Battery Cover
Replace your battery cover
every two months.
193
Appendix D: Abbreviations
194
Abbreviation
Meaning
Abbreviation
Meaning
approx.
Approximately
NiMH
BR
Basal Rate
Nickel Metal Hydrid (used with rechargeable
batteries)
BRP
Basal rate profile
rel.
Relative
Hour (s)
sec.
Seconds
IEC
International Electrotechnical Commission
TBR
Temporary Basal Rate
incl.
Inclusive or including
See I.U.
IR
Infrared
U/h
Amount of International Units of insulin
delivered per hour
I.U., U
International Units in context with biological
effectiveness of certain insulin amount
U100
kPa
Kilo pascals
This is the insulin concentration. Each
milliliter of liquid contains 100 International
Units of insulin
LCD
Liquid Crystal Display
dd.mm.yy
European date format:
day.month.year
LED
Light Emitting Diode for infrared communication with e.g. a PC
mm.dd.yy
American date format:
month.day.year
E
Appendix E: Beeps and melodies
Acoustic Signals
All of the functions of the Accu-Chek Spirit Combo insulin pump
are supported by acoustic signals. The acoustic signals are
beeps.
Sound
Function
Duration for very short sound = 31.25 ms ±20 %
Duration for short sound = 62.5 ms ±20 %
Duration for medium sound = 93.75 ms ±20 %
Duration for long sound = 125.0 ms ±20 %
Duration for short pause = 125.0 ms ±20 %
Duration for medium pause = 218.75 ms ±20 %
Duration for long pause = 500.0 ms ±20 %
UP KEY
Frequency: 3131 Hz ±5 %
Duration: Short sound
Sound
Function
DOWN KEY
Frequency: 2486 Hz ±5 %
Duration: Short sound
MENU KEY
Frequency: 2820 Hz ±5 %
Duration: Short sound
NAVIGATION BACKWARDS
(MENU + UP KEY)
Frequency: 2763 Hz ±5 %
Duration: Short sound
EXECUTE FUNCTION (CHECK KEY)
Frequency: 2090 Hz ±5 %, 2486 Hz ±5 %
Duration: 2 × short sound
CANCEL FUNCTION
Frequency: 2486 Hz ±5 %, 2090 Hz ±5 %
Duration: 2 × short sound
195
Sound
Function
BASE STATE RUN (KEYS UNLOCKED)
Frequency: 2789 Hz ±5 %
Duration:	Short sound, short pause,
short sound, short pause,
short sound
BASE STATE RUN (KEYS LOCKED)
Frequency: 2763 Hz ±5 %
Duration:	Short sound, short pause,
short sound, short pause,
short sound
BASE STATE STOP (KEYS UNLOCKED)
Frequency: 2789 Hz ±5 %
Duration:	Long sound, short pause,
long sound, short pause,
long sound
BASE STATE STOP (KEYS LOCKED)
Frequency: 2763 Hz ±5 %
Duration:	Long sound, short pause,
long sound, short pause,
long sound
196
Sound
Function
CARTRIDGE CONTENT <= 20 U
Frequency:	f1 = 2090 Hz ±5 %,
f2 = 2486 Hz ±5 %,
f3 = 2789 Hz ±5 %
Duration:	f1 short sound, f2 short sound,
long pause,
f3 medium sound, short
pause, f3 medium sound,
short pause, f3 medium sound
20 U < CARTRIDGE CONTENT <= 50 U
Frequency:	f1 = 2090 Hz ±5 %,
f2 = 2486 Hz ±5 %,
f3 = 2789 Hz ±5 %
Duration:	f1 short sound, f2 short sound,
long pause, f3 medium sound,
short pause,
f3 medium sound
E
Sound
Function
50 U < CARTRIDGE CONTENT <= 100 U
Frequency:	f1 = 2090 Hz ±5 %,
f2 = 2486 Hz ±5 %,
f3 = 2789 Hz ±5 %
Duration:	f1 short sound, f2 short sound,
long pause, f3 medium sound
100 U < CARTRIDGE CONTENT
Frequency:	f1 = 2090 Hz ±5 %,
f2 = 2486 Hz ±5 %,
f3 = 2789 Hz ±5 %
Duration:	f1 short sound, f2 short sound,
long pause, f3 long sound
Sound
Function
COPY BASAL RATE
Frequency:	2486 Hz ±5 %, 3131 Hz ±5 %,
2486 Hz ±5 %
Duration: 3 x short sound
Temporary Basal Rate ACTIVE
Frequency: 2789 Hz ±5 %
Duration:	Short sound, short pause,
short sound
STOP WARNING
Frequency: 2789 Hz ±5 %
Duration:	Long sound, short pause,
long sound
SYSTEM TEST SUCCESSFUL
Frequency:	1043 Hz ±5 %, 1314 Hz ±5 %,
1563 Hz ±5 %, 		
2090 Hz ±5 %
Duration: 4 x long sound
197
Sound
Function
Reminder (REPEATING SEQUENCE)
Frequency:	f1 = 1043 Hz ±5 %,
f2 = 1850 Hz ±5 %
Duration:	f1 medium sound, short
pause, f2 medium sound,
short pause, f1 medium
sound, medium pause,
f2 medium sound
Repeating
Interval:
3000.0 ms ±20 %
WARNING (REPEATING SEQUENCE)
Frequency:	f1 = 1043 Hz ±5 %,
f2 = 1850 Hz ±5 %
Duration:	f1 medium sound, short
pause, f2 medium sound,
short pause, f1 medium
sound, medium pause,
f2 medium sound, short
pause, f2 medium sound
Repeating
Interval:
3000.0 ms ±20 %
198
Sound
Function
ERROR (REPEATING SEQUENCE)
Frequency:	f1 = 1043 Hz ±5 %,
f2 = 1850 Hz ±5 %
Duration:	f1 medium sound, short
pause, f2 medium sound,
short pause, f1 medium
sound, medium pause,
f2 medium sound, short
pause, f2 medium sound,
short pause, f2 medium sound
Repeating
Interval:
3000.0 ms ±20 %
UPPER LIMIT REACHED
Frequency:	2486 Hz ±5 %, 3131 Hz ±5 %,
2486 Hz ±5 %, 3131 Hz ±5 %
Duration: 4 × short sound
LOWER LIMIT REACHED
Frequency:	2090 Hz ±5 %, 2486 Hz ±5 %,
2090 Hz ±5 %, 2486 Hz ±5 %
Duration: 4 × short sound
E
Sound
Function
CONFIRMATION KEY PRESSED
Frequency: 2789 Hz ±5 %
Duration: Short sound
CHANGED TO BASE STATE RUN BY CHECK
KEY (KEYS UNLOCKED)
Sequence: A12, long pause, A14
CHANGED TO BASE STATE RUN BY CHECK
KEY (KEYS LOCKED)
Sequence: A12, long pause, A15
CHANGED TO BASE STATE STOP BY CHECK
KEY (KEYS UNLOCKED)
Sequence: A12, long pause, A16
CHANGED TO BASE STATE STOP BY CHECK
KEY (KEYS LOCKED)
Sequence: A12, long pause, A17
Sound
Function
INITIAL POINT (SUBMENU, VALUE)
Frequency: 2820 Hz ±5 %
Duration:	Short sound, short pause,
short sound
SUPERVISOR SEQUENCE (GENERATED BY
SUPERVISOR)
Frequency: 2630 Hz ±10 %, 95 ms ±10 %
Pause:
95 ms ±10 %
Frequency: 2630 Hz ±10 %, 95 ms ±10 %
Pause:
95 ms ±10 %
Frequency: 2630 Hz ±10 %, 95 ms ±10 %
Pause:
200 ms ±10 %
Frequency: 2630 Hz ±10 %, 95 ms ±10 %
Pause:
95 ms ±10 %
Frequency: 2630 Hz ±10 %, 95 ms ±10 %
CHANGED TO BASE STATE STOP BY
CANCELLATION OF FUNCTION
Sequence: A13, long pause, A16
199
Tactile Signals
Dedicated functions of the Accu-Chek Spirit Combo insulin pump
are supported by tactile signals additionally. The tactile signals
are vibrations which are generated by a vibra motor.
Signal
Function
SHORT VIBRATION
Duration short vibration =
109.375 ms ±5 %
MEDIUM VIBRATION
Duration medium vibration =
203.125 ms ±5 %
LONG VIBRATION
Duration long vibration = 281.25 ms ±5 %
200
Signal
Function
WARNING AND Reminder
(REPEATING SEQUENCE)
Duration vibration = 1062.5 ms ±5 %
Duration pause = 2125.0 ms ±5 %
(Repeating interval = 3187.5 ms ±5 %)
ERROR (REPEATING SEQUENCE)
Duration vibration = 531.25 ms ±5 %
Duration pause = 1062.5 ms ±5 %
(Repeating interval = 1593.75 ms ±5 %)
F
Appendix F: Symbols
Display Symbols
Icon
Meaning
Icon
Meaning
Basal Lock OFF
Bluetooth ® ON
Basal Lock ON
Bluetooth ® Settings
Basal Rate
Bluetooth ® in Remote control
mode
Basal Rate Total
Beep Test
Battery Empty
Cartridge Empty
Battery Low
Cartridge Full
Beep Volume
Cartridge Low
Bluetooth ® OFF
OK
201
Icon
202
Meaning
Icon
Meaning
Clock
Key Lock ON
Data Transfer menu
Pump timer (Call for update)
Data Transfer (to start screen)
Menu Settings
Data Transfer running
Multiwave Bolus
Date
Multiwave Bolus Immediate
Date Format EU
My Data
Date Format US
Pairing Failed
Display contrast
Pairing Successful
Extended Bolus
Priming
Key Lock OFF
Progress Bar
F
Icon
Meaning
Icon
Meaning
Pump Settings
Stop
Reminder
Total
Reminder Everyday
Temporary Basal Rate
Reminder OFF
Therapy Settings
Reminder Settings
Time and Date Settings
Reminder Single
Units
Screen Orientation
Units per hour
Beep
Vibrations
Beep and Vibration
Error
Standard Bolus
Warning
203
General Symbols
Icon
Meaning
Caution. Please refer to safetyrelated notes in the manual
accompanying this device.
Consult instructions for use
Sterilized using ethylene oxide
Sterilized using radiation
Sterilized using antiseptics
Year of manufacture
Lot number
204
Icon
Meaning
Expiry date
Catalogue number
Serial number
Admissible temperature range
during operation
Store at
Admissible humidity range
Admissible air pressure range
F
Icon
Meaning
Icon
Meaning
Fragile – handle with care
Do not use if the package is
damaged
Protect against moisture
Flammable
Protect from heat and sunlight
Bluetooth ® wireless technology
Electronic device of type BF
according the standard
IEC 60601-1. Protection against
electrical shock.
For single use only
Does not contain pyrogen
IPX8
Does not contain PVC
Recycling
Do not throw away
Symbol for protection against the
effect of temporary immersion of
water (up to 60 minutes and
2.5 meters [8 feet]), according to
IEC 60529.
Marking of conformity according to
the European Medical Device
Directive MDD 93 / 42 / EEC with the
number of the notified body.
Includes also RTTE DIRECTIVE
1999 / 5 / EC.
205
Icon
Meaning
FCC ID
IC ID
The FCC ID (Federal Communications Commission Identification)
indicates that the radio frequency
equipment has passed the
equipment authorization process
for the United States of America.
The IC ID (Industry Canada
Identification) indicates that the
radio frequency equipment has
passed the equipment authorization process for Canada.
Federal law (USA) restricts this
device to sale by or on the order
of a physician.
Manufacturer
Non-ionizing radiation
Recommended battery
206
Appendix G: Warranty
Limited Four-Year Warranty
Disetronic Medical Systems Inc. (“Disetronic”) warrants the
ACCU-CHEK® Spirit Combo insulin pump (“insulin pump”) against
defects in materials and workmanship for a period of four (4)
years from the date of purchase. Proof of purchase date may be
required. This warranty does not include supplies and accessories,
including but not limited to, cartridges, batteries, or infusion
sets.
During the warranty period, Disetronic will repair or replace, in
its sole discretion, any insulin pump that does not work properly
because of a defect in materials or workmanship. The purchaser’s
sole and exclusive remedy with respect to the insulin pump shall
be repair or replacement. This warranty applies only to new
devices. In the event an insulin pump is repaired or replaced,
the warranty period will not be extended.
G
This warranty is valid only if the insulin pump is used in accordance with the user instructions. This warranty will not apply:
1. If damage results from changes or modifications made to the
insulin pump by the user or third persons after the date of
manufacture;
2. If damage results from service or repairs performed by any
person or entity other than Disetronic.
3. If damage results from a force majeure or other event beyond
the control of Disetronic; or
4. If damage results from negligence or improper use, including
but not limited to improper storage, physical abuse such as
dropping, or otherwise.
No warranty of merchantability or fitness for a particular
purpose, if any is implied from the sale of the insulin pump,
shall exist for a longer duration than four years from the
date of purchase.
Some jurisdictions do not allow limitations on how long an
implied warranty will last or the exclusion of incidental or
consequential damages, so the above limitation and exclusion
may not apply to you. This warranty gives you specific legal
rights, which may vary by jurisdiction.
This warranty shall be personal to the original purchaser. Any
sale, rental, or other transfer or use of the insulin pump covered
by this warranty to or by a user other than the original purchaser
shall cause this warranty to immediately terminate.
THIS WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES,
EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION THE
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR
A PARTICULAR PURPOSE. IN NO EVENT SHALL DISETRONIC
OR ITS SUPPLIERS OR DISTRIBUTORS BE LIABLE FOR ANY
INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL OR
PUNITIVE DAMAGES ARISING FROM OR IN ANY WAY CONNECTED
WITH THE PURCHASE OR USE OF THE INSULIN PUMP.
207
208
Glossary
Accu-Chek Aviva Combo Meter
This is an “intelligent” diabetes management device that enables
you to measure your blood glucose level, manage your blood
glucose data, and get bolus advice. It also enables remote
control of your Accu-Chek Spirit Combo insulin pump, using
Bluetooth ® wireless technology.
Adapter
The adapter connects the cartridge and infusion set. It has two
seals and forms an efficient seal for the cartridge compartment
of your Accu-Chek Spirit Combo insulin pump. The two small
vents on the adapter allow the equalization of air pressure.
Automatic Off
Automatic Off is a safety feature that stops insulin delivery and
triggers an Error if no keys are pressed within a programmed
time period in RUN mode. See the entry in chapter 5 Persona­
lizing your pump.
Basal rate
This is the amount of insulin delivered per hour that is required
to cover your basic insulin needs. In insulin pump therapy, your
basal rate is determined together with your doctor or healthcare
team and can be adjusted to meet your individual physiological
needs throughout the day. Your basal rate is delivered by your
Accu-Chek Spirit Combo insulin pump according to the curve of
your personal basal rate profile or profiles.
Basal rate profile
Your Accu-Chek Spirit Combo insulin pump offers you the option
of delivering up to five different basal rate profiles in order to
easily meet your changing insulin needs (for example during the
week rather than at the weekend). A basal rate profile consists of
24 programmed hourly basal rates.
Basal rate total
The sum of all 24 hourly basal rates in one basal rate profile is
called the (daily) basal rate total.
209
Bluetooth ® wireless technology
The term “Bluetooth” refers to a wireless technology that allows
digital devices to transfer data at high speed. This technology is
common in many portable devices such as portable PCs, Personal
Digital Assistants and mobile telephones.
Bolus
The amount of insulin delivered (in addition to the basal rate) to
cover the intake of food and to correct high blood glucose levels.
The bolus amount is determined by your doctor or healthcare
team’s guidelines, your blood glucose level, your food intake and
your activity level.
Carrying system
A wide variety of carrying systems made of different materials
are specially designed to suit your individual needs while wearing
your Accu-Chek Spirit Combo insulin pump.
Cartridge
The insulin reservoir of your Accu-Chek Spirit Combo insulin
pump. It holds 3.15 ml (315 U) of rapid-acting insulin.
210
Cartridge compartment
The chamber in your Accu-Chek Spirit Combo insulin pump for
the cartridge.
Daily insulin total
The total amount of insulin delivered (basal rate plus boluses)
delivered in a 24-hour day, beginning at midnight. This amount
does not include any insulin needed for the priming of infusion
sets.
Factory settings
Your Accu-Chek Spirit Combo insulin pump is provided by
Disetronic Medical Systems with a standard configuration
(factory settings). These settings can be adapted to your
individual needs directly on your Accu-Chek Spirit Combo insulin
pump or by using the Accu-Chek Insulin Pump Configuration
Software.
Hourly basal rate
An hourly basal rate is the amount of insulin delivered by your
Accu-Chek Spirit Combo insulin pump in three-minute intervals
for each hour.
Infusion set
Infusion sets connect your Accu-Chek Spirit Combo insulin pump
to your body. The insulin is delivered from the cartridge through the
infusion set tubing and cannula or needle into your subcutaneous
tissue. Infusion sets can be disconnectable or non-disconnectable.
Infusion site
The place where the infusion set cannula or needle is inserted
into your subcutaneous tissue to deliver insulin.
Insulin
A hormone that helps cells transform glucose into energy. Insulin
is produced in the beta cells of the pancreas (also called islets of
Langerhans).
Insulin (rapid-acting)
A type of insulin created using recombinant DNA technology.
The onset time of insulin analogue is shorter than the onset time
of regular insulin.
IPX8 according to IEC 60529
Protection against the effects of temporary immersion in water.
Ingress of water in quantities causing damage is not possible
when the device is temporarily immersed in water under
standardized conditions (maximal 60 minutes a day and
2.5 meters [8 feet]).
Luer-lock connector
A standardized fitting at the end of the infusion set which allows
to tightly connect the infusion set and cartridge through the
adapter.
Meter
See Accu-Chek Aviva Combo.
Occlusion
An occlusion is a blockage which prevents the insulin from
flowing correctly from the insulin pump into the body.
211
Personal settings
Your Accu-Chek Spirit Combo insulin pump must be programmed
with your personal settings prior to starting insulin pump therapy.
Personal settings include the basal rate profile(s), the correct
time and date and all other variable values which can be tailored
to your individual needs on your Accu-Chek Spirit Combo insulin
pump or using Accu-Chek Insulin Pump Configuration Software.
Rapid-acting Insulin
See Insulin (rapid acting).
RUN
During normal use, your Accu-Chek Spirit Combo insulin pump
is in RUN mode and insulin is continuously delivered. Boluses,
Temporary Basal Rates and almost all functions can be programmed from RUN mode.
RUN screen
The RUN screen is the starting point for all functions which can
be accessed while your Accu-Chek Spirit Combo insulin pump
delivers insulin. Your Accu-Chek Spirit Combo insulin pump
displays the RUN screen during normal use when no programming
is being performed. The time, current hourly basal rate, selected
basal rate profile and all currently activated functions appear on
the RUN screen.
Settings
Settings are individually programmable values and parameters
that affect the way your Accu-Chek Spirit Combo insulin pump
works.
Scrolling
Scrolling allows a fast and easy programming of a range of
values.
STOP
When your Accu-Chek Spirit Combo insulin pump is in STOP, it
does not deliver any insulin. The insulin delivery is only stopped
if an Error occurs or if your Accu-Chek Spirit Combo insulin pump
is put into a necessary STOP, (e.g. when changing the cartridge,
adapter or infusion set or for data transfer). Functions such as
Extended Bolus or Temporary Basal Rate are interrupted by
putting your Accu-Chek Spirit Combo insulin pump into STOP.
212
STOP screen
The STOP screen is the starting point for all functions that
require that your Accu-Chek Spirit Combo insulin pump does
not deliver insulin.
Temporary Basal Rate
Temporary increase or decrease of your basal rate profile in
percentages (from 0 – 250 %) to match changing insulin needs
due to increased or decreased activity level, illness or stress.
U100
This is the insulin concentration. Each milliliter of liquid contains
100 International Units of insulin. Your insulin pump has been
developed exclusively for delivery of U100 rapid-acting insulin.
213
214
Index
Abbreviations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  194
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1, 19
Accu-Chek Aviva Combo. . . . . . . . . . . . . . . . . . . . . . . . . .  7, 133
Adapter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1, 20, 150, 193
ADVANCED user menu . . . . . . . . . . . . . . . . . . . . . . . . .  100, 120
Air bubbles. . . . . . . . . . . . . . . . . . . . . . . . . . . 20, 42, 49, 50, 173
Aircraft. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  63, 135, 141
Alarm data menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  107
Alarm signals. . . . . . . . . . . . . . . . . . . . . . . . . . . . .  14, 116, 172
Automatic Off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  129, 160
Basal rate profile . . . . . . . . . . . . . . . . . . . . .  121, 131, 189, 194
Battery. . . . . . . . . . . . . . . . . . 1, 20, 26, 154, 176, 191, 193, 201
Battery cover . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 21, 26, 66, 193
Battery key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1, 26
Beeps and melodies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  195
Beep volume. . . . . . . . . . . . . . . . . . . . . . . . 15, 57, 115, 151, 172
Blood glucose levels. . . . . . . . . . . . . . . . . . . . . . .  22, 25, 41, 77
Bluetooth ® connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . .  171
Bluetooth ® function. . . . . . . . . . . . . . . . . . . . . . . .  63, 135, 136
Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  77
Bolus history. . . . . . . . . . . . . . . . . . . . . 81, 83, 92, 106, 157, 176
bolus increment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  126
Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  14, 17
Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  42, 44, 73
Cleaning your pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  149
Configuration parameters. . . . . . . . . . . . . . . . . . . . . . . . . . .  189
Contact with water. . . . . . . . . . . . . . . . . . . . . . . . .  67, 146, 147
CUSTOM user menu. . . . . . . . . . . . . . . . . . . . . . . . . . .  130, 131
Damage to your pump . . . . . . . . . . . . . . . . . . . . . . . . . . .  45, 47
Display contrast. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  118
Display orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  117
Display screens
Function screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  13
Information screens. . . . . . . . . . . . . . . . . . . . . . . . . . .  16, 17
QUICK INFO screen. . . . . . . . . . . . . . . . . . . . . . . . . . .  12, 106
RUN screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  11
STOP screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  12
Disposing of your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . .  150
215
E
Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . .  183
Electromagnetic radiation. . . . . . . . . . . . . . . . . . . . . . . . . . . .  62
Emergency kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  22, 144
Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  159
Exercise. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  35, 62, 121
Extended Bolus. . . . . . . . . . 77, 84, 85, 87, 88, 98, 177, 190, 202
Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  7, 8, 100
History of daily insulin totals. . . . . . . . . . . . 25, 49, 108, 127, 176
Hourly basal rate. . . . . . . . . . 11, 17, 37, 38, 172, 177, 189, 209
Infection. . . . . . . . . . . . . . . . . . . . . . 19, 52, 54, 57, 72, 144, 150
Infusion set. . . . . . . . . . . . . . . . . . . . . . 12, 48, 49, 50, 52, 56, 69
Inspecting your pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  143
Insulin delivery
starting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  55, 104
stopping. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  56, 104
216
Keylock. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 18, 113, 114, 191
Keys
combining. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  17
Language
selecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  119
Leakage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  42, 43, 59, 69
Luer-lock connector. . . . . . . . . . . . . . 43, 47, 69, 70, 71, 74, 179
Maintaining your pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . .  149
Meter
interaction with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  7
pairing your pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  136
Multiwave Bolus. . . . . . . . 77, 89, 90, 92, 98, 121, 177, 190, 202
Personalizing your pump. . . . . . . . . . . . . . . . . . . . . . . . . . .  8, 99
Personal settings . . . . . . . . . . . . . . . 23, 35, 53, 58, 98, 121, 149
Prime amount. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  127
Priming. . . . . . . . . . . . . . . . . . . . . . . . 49, 50, 127, 134, 174, 202
Pump data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  105
Pump settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  113
Pump therapy
interruption of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  64
Quick Bolus . . . . . . . . . . 8, 16, 78, 79, 80, 81, 85, 126, 177, 190
R
Reminders
list of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  170, 221
Reminder Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . .  124, 203
Repair of your pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  148
Rotating display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  8, 10
Safety system. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  151
Scrolling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  18, 82
Sport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  62
Standard Bolus. . . . 77, 78, 80, 81, 82, 83, 85, 89, 177, 190, 203
Start-up process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  29
Status messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  14
Status of your pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  9, 14
Sterile disposables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  19
Sterile products . . . . . . . . . . . . . . . . . . . 19, 57, 69, 76, 143, 145
STOP-Warning
confirming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  15, 36, 57
turning off. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  57
Storing your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  150
Swimming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  67, 146
Symbols
Display Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201
General Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  201
Tactile signals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  200
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  61, 175
Temporary Basal Rate . . . . 93, 94, 95, 96, 97, 98, 156, 157, 177,
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189, 194, 203, 220
Temporary Basal Rate history
viewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  109
Therapy settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  126
Time and Date
Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  32, 33
Time remaining (pump timer). . . . . . . . . . . . . . . . . . . . . . . .  110
Transferring Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  12, 111
Travelling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  63
Troubleshooting
therapy-related issues. . . . . . . . . . . . . . . . . . . . . . . . . . .  172
Unlocking Keylock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  114
User menu
selecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  101
Warning history
viewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  107
Warnings
list of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
217
Warnings and Errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  151
confirming. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  152
handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  140
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  21, 170, 206
Wearing your pump
carrying systems. . . . . . . . . . . . . . . . . . . . . . . . .  61, 62, 193
in hazardous areas. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  62
218
Quick reference table for Errors, Warnings and Reminders
Errors
No
Error
What you have to do
No
Error
What you have to do
E1
CARTRIDGE EMPTY
Change the cartridge.
E6
MECHANICAL ERROR
See chapter 8.
E2
BATTERY EMPTY
Change the battery.
E7
ELECTRONIC ERROR
See chapter 8.
E3
AUTOMATIC OFF
Put your Accu-Chek Spirit
Combo insulin pump into RUN if
necessary.
E8
POWER INTERRUPT
See chapter 8.
E9
END OF OPERATION
(loaner pumps only)
Arrange for immediate replacement of your Accu-Chek
Spirit Combo insulin pump.
Contact your healthcare
professional for alternative
insulin therapy options.
E10
CARTRIDGE ERROR
See chapter 8.
E11
SET NOT PRIMED
Prime your infusion set.
E12
DATA INTERRUPTED
Restart the data transfer.
E13
LANGUAGE ERROR
See chapter 8.
E4
OCCLUSION
Change the cartridge and
infusion set. See section 2.6 to
2.9.
E5
END OF OPERATION
(“Backup” pumps
only)
Arrange for immediate replacement of your Accu-Chek Spirit
Combo insulin pump. Contact
your healthcare professional for
alternative insulin therapy
options.
219
Warnings
220
No
Warning
What you have to do
No
Warning
What you have to do
W1
CARTRIDGE LOW
Change cartridge before it is
completely empty.
W6
TBR CANCELLED
W2
BATTERY LOW
Replace the battery as soon as
possible.
W3
REVIEW TIME
Set the time and date.
Put your Accu-Chek Spirit
Combo insulin pump into RUN if
necessary. Ensure the cancellation was intended and program
a new Temporary Basal Rate if
necessary.
W4
CALL FOR UPDATE
Contact your local pump
support.
W7
TBR OVER
W5
PUMP TIMER
(“Backup” pumps
only)
In the MY DATA menu check for
the remaining operation time
under the menu PUMP TIMER.
Arrange for re-placement of
pump within the scheduled
pump operation time.
Decide whether a further
Temporary Basal Rate change is
appropriate and program one if
necessary.
W8
BOLUS CANCELLED
Put your Accu-Chek Spirit
Combo insulin pump into RUN
if necessary. Ensure that the
cancellation was intended and
program a new bolus if
necessary.
Reminder
No
Warning
What you have to do
W9
LOANTIME WARNING
(loaner pumps only)
In the MY DATA menu, check for
the remaining insulin pump loan
time under the menu PUMP
TIMER. Arrange for replacement
of pump within the scheduled
pump loan time.
W10 BLUETOOTH FAULT
No
Reminder
What you have to do
Reminder
Put your Accu-Chek Spirit Combo
insulin pump into RUN if
necessary.
Some Reminders and Warnings are country specific and may
never occur on your pump.
Re-do pairing procedure for
insulin pump and Meter. See
section 6.4 Troubleshooting the
Bluetooth ® connection in the
User Guide for detailed
information.
221
My notes
222
Bluetooth ® registration
Please note that in Italy and France Bluetooth ® wireless
technology is for indoor use only.
FCC ID RAH3
IC ID 7937A-3
This Class B digital apparatus complies with Canadian ICES-003.
Cet appareil numérique de la classe B est conforme à la norme
NMB-003 du Canada.
This device complies with part 15 of the FCC Rules. Operation
is subject to the following two conditions: (1) This device may
not cause harmful interference, and (2) this device must accept
any interference received, including interference that may
cause undesired operation.
Note: This equipment has been tested and found to comply with
the limits for a Class B digital device, pursuant to part 15 of the
FCC Rules. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance
with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one
or more of the following measures: Reorient or relocate the
receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a
circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio / TV technician for
help. Changes or modifications not expressly approved by the
party responsible for compliance could void the user’s authority
to operate the equipment.
223
224

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