Roche Diagnostics Diabetes Care 17 Accu-Chek Spirit Combo User Manual
Roche Diagnostics GmbH Diabetes Care Accu-Chek Spirit Combo Users Manual
Users Manual
User’s Manual
Accu-Chek® Spirit Combo Insulin pump
TW
BRIGANTC - Feb 12, 2018
f OK key
d Menu key
Your insulin pump
Adapter Luer-lock connector of the infusion setCartridge compartment with cartridge
a Up key
s Down key
Pump details and accessories
Cartridge plungerEnd platePiston rod
Adapter
BatteryBattery cover
Battery key
Cartridge
Infrared window
(next to battery cover)
Cartridge compartment
jPress d to move forwards
jPress d + a simultaneously to
move backwards
jPress f to select or save
jPress a to go up
jPress s to go down
BRP = Basal Rate Profile 2–4
Overview of the ADVANCED user menu
ff
BRP 4
BRP 3
BRP 2
BRP 4
BRP 3
BRP 2
RUN STOP
ff
RUN STOP
Accessible menus in the CUSTOM user
menu can be selected using the
appropriate Accu-Chek PC software
(sold separately).
jPress d to move forwards
jPress d + a simultaneously to
move backwards
jPress f to select or save
jPress a for up
jPress s for down
=
not accessible in the
STANDARD user menu
Overview of the STANDARD and CUSTOM user menus
Dear user of the Accu-Chek Spirit Combo insulin pump,
Your insulin pump is contraindicated for the delivery of
medication other than U100 short-acting regular human
insulin or rapid-acting insulin analogue.
Also consult the instructions for use coming with your insulin,
infusion set, and additional devices used for your insulin therapy.
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.
This User’s Manual is provided for you, as a person with
diabetes, and for healthcare professionals. It contains all the
necessary information for the safe and efficient use of your
Accu-Chek Spirit Combo insulin pump. Regardless of your level
of experience with pump therapy, please read this User’s Manual
carefully before beginning insulin pump therapy. Always refer to
this User’s Manual 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, we recommend that you
contact your local pump support. You will find the address on the
inside back cover of this manual.
Your Accu-Chek Spirit Combo insulin pump has been developed
exclusively for the continuous subcutaneous delivery of U100
short-acting insulin or fast-acting insulin analogue. Whether
insulin pump therapy is the appropriate way of treating your
diabetes must be decided by your healthcare professional.
The correct insulin type for the treatment of your insulin-
dependent diabetes mellitus will be prescribed by your doctor or
healthcare team. You should not begin pump therapy unless you
have attended the appropriate training course.
About this User’s Manual
To ensure the safe and convenient use of your new Accu-Chek
Spirit Combo insulin pump, some information in this User’s Manual
requires particular attention. This information is presented as
“WARNING”, “CAUTION” or “Note”.
jA “WARNING” informs you about risks to your health.
Neglecting this information may even lead to life-threatening
situations in some cases.
jA “CAUTION” informs you about risks to your device. Malfunction
or damage may result if you do not follow these instructions.
jA “Note” contains important information relating to the
efficient and smooth operation of your new Accu-Chek Spirit
Combo insulin pump.
1 Understanding your new system 1
1.1 Overview 1
1.2 Display and sounds 3
1.3 Keys and key combinations 9
1.4 Accessories and disposables 13
1.5 Emergency kit 16
1.6 General safety information 17
2 Getting started 19
2.1 Before you begin 19
2.2 Inserting the battery 19
2.3 Start-up process 23
2.4 Setting the time and date 26
2.5 Your basal rate profile 29
2.6 Connecting the cartridge, adapter and infusion set 36
2.7 Inserting the cartridge 38
2.8 Priming the infusion set 43
2.9 Positioning the infusion set 46
2.10 Starting insulin delivery 50
2.11 Stopping insulin delivery 51
2.12 General safety information 52
3 Using your pump in daily life 55
3.1 Wearing your pump 55
3.2 Interruption of insulin pump therapy 58
3.3 Your insulin pump and water 61
3.4 Changing the infusion set 63
3.5 Changing the cartridge and infusion set 67
3.6 General safety information 70
4 Boluses and Temporary Basal Rates 71
4.1 Understanding boluses 71
4.2 Programming a Standard Bolus 72
4.3 Programming an Extended Bolus 78
4.4 Programming a Multiwave Bolus 83
4.5 Programming a Temporary Basal Rate (TBR) 87
4.6 General safety information 92
5 Personalizing your pump 93
5.1 Introduction 93
5.2 Selecting a user menu 95
5.3 STANDARD user menu 97
5.4 Viewing your pump data 99
5.5 Transferring your data to a computer 105
5.6 Pump settings 107
5.7 ADVANCED user menu 114
5.8 Basal rate profiles 115
5.9 Setting a reminder 118
5.10 Therapy settings 120
5.11 CUSTOM user menu 124
6 Using the Accu-Chek Spirit Combo insulin
pump with the meter 127
6.1 Meter 127
6.2 Switching Bluetooth
® wireless technology ON and OFF 129
6.3 Pairing your pump with the meter 130
6.4 Troubleshooting the Bluetooth
® connection 133
7 Care and Maintenance 137
7.1 Inspecting your pump 137
7.2 Damage to your pump 139
7.3 Your insulin pump and water 140
7.4 Repair of your pump 142
7.5 Maintaining your pump 143
7.6 Storing your pump 144
7.7 Disposing of your pump 144
8 Warnings and errors 145
8.1 Confirming a warning or error 146
8.2 List of warnings 147
8.3 List of errors 153
8.4 List of reminders 164
9 Troubleshooting 165
9.1 Therapy-related issues 166
Appendix A: Technical data 169
Appendix B: Configuration parameters 185
Appendix C: Sterile products and accessories 188
Appendix D: Abbreviations 191
Appendix E: Beeps and melodies 192
Appendix F: Symbols 198
Appendix G: Warranty and Declaration of Conformity 204
Index 205
Glossary 209
Quick reference table for errors, warnings and reminders 214
Reminder 216
Bluetooth
® registration 217
1
1
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’s Manual the term “meter” always refers to
your Accu-Chek diabetes management device, which is
compatible with your Accu-Chek Spirit Combo insulin pump.
1.1.1 Summary of features
Interaction with the meter
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.
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 3 menus – STANDARD, ADVANCED or
CUSTOM – to access the functions and settings you will need
from day to day.
1 Understanding your new system
2
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.
See chapter 5 Personalizing your pump.
Five basal rate profiles
You can choose from 5 basal rate profiles in line with your
different daily routines.
Three bolus types
Your Accu-Chek Spirit Combo insulin pump enables you to program
3 bolus types, each corresponding to different situations you may
encounter, and this provides you with a lot of flexibility.
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.
Warnings and errors signalled in two ways
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.
Data transfer
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 personal computer.
Rotating display
Your pump’s display can be rotated by 180 degrees, and you can
also adjust its contrast. Combined with the backlight, these
features make the display easier to read.
3
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).
Key Lock
The Key Lock feature allows you to lock all 4 keys on your
Accu-Chek Spirit Combo insulin pump. This function prevents
you from accidentally activating your pump. For example, you
can use Key Lock 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 4 keys,
enables you to program the pump. It also shows important
information about the status of your pump.
w 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 notice changes or malfunctions in your pump.
4
1.2.1 Backlight
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.
The backlight turns on automatically when a reminder, warning
or error message is displayed, and turns off automatically after
10 seconds if no keys are pressed.
Tip: In poorly-lit areas, begin programming with the a.
1.2.2 Rotating display
Your pump’s display can be rotated by 180 degrees. See section
5.6.4 Display orientation.
Note that when you rotate the display, the s and a key
functions will be reversed.
c 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.
5
1
1.2.3 Display screens
The screens displayed by your pump relate to one of the
following modes:
jRUN
jSTOP
jQUICK INFO
The following screens are all accessed from the user menus (see
section 5.2 Selecting a user menu):
jInformation
jFunction
jSet-up
Note To save battery life, the screen of your Accu-Chek Spirit
Combo insulin pump goes blank if you do not press any key for
more than 20 seconds. When your pump shows a blank screen,
you have to press a key before any other operation can be
performed.
RUN screen
The screen is blank by default to save energy. The screen goes
blank again after 20 seconds if no key is pressed. 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.
Key Lock locked
Pump timer
Cartridge low
Battery low
Active basal rate profile
Time Current hourly basal rate
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.
6
The RUN screen also displays reminder information (such as
“cartridge low”) and special functions (such as Key Lock –
locked or unlocked) in the form of symbols (see Appendix F:
Symbols)
Note 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.
Key Lock unlocked
Pump timer
Cartridge low
Battery low
Time Date
The STOP screen also displays reminder information (such as
“battery low”) and special functions (such as Key Lock – locked
or unlocked) in the form of symbols.
Your pump must be in STOP mode in the following situations:
You are
jprogramming specific functions
jchanging the cartridge and / or the infusion set
jpriming the infusion set
jtransferring data to or from the pump
jchanging the battery
QUICK INFO screen
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.
7
1
By pressing f again you enter the BOLUS DATA function. You
can view the last 30 boluses by pressing a or s.
You can leave the QUICK INFO screen either 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.
1.2.4 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.
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 fkey.
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 key to save your changes.
8
You can move backwards through the main menu screens by
pressing the d key and a key simultaneously.
In any submenu the same key combination will move you back to
the main menu screen.
Note Changes that you made in the submenu will not be saved.
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 perceptibility 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 emits 2 beeps and vibrates once every minute. This warns
you that insulin delivery has been interrupted.
9
1
To turn off the STOP warning, press either a or s for 3
seconds. You then hear a melody, 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.
1.3 Keys and key combinations
You use the 4 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
Note Avoid pressing the keys with your fingernails or other
pointed objects. These can damage the rubber coating of the
keys, which can lead to consequential damage.
10
The following table lists the keys and their functions.
Key Name Function
d Menu jMove through menus, function screens
and information screens
f OK jSelect a menu
jSave changes and exit the function and
information screens
jView the QUICK INFO screen
a Up jMove forward in the information screens
jIncrease a setting
jTurn on the backlight
jProgram a Quick Bolus
jCancel a Quick Bolus
jTurn off the STOP warning (press and
hold 3 sec. until you hear a melody)
Key Name Function
s Down jMove backward in the information
screens
jDecrease a setting
jProgram a Quick Bolus
jCancel a Quick Bolus
jTurn off the STOP warning (press and
hold 3 sec. until you hear a melody)
c 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.
11
1
1.3.1 Combining keys
You can obtain additional functions by pressing 2 keys
simultaneously. In the following table, a plus symbol (+) indicates
that both keys must be pressed at the same time.
Combination Function
d + a jExits menus, function
screens and information
screens without saving your
changes.
jMoves you to a previous
menu.
d + s jUnlocks the keys. Press and
hold both keys until you hear
3 short beeps (RUN mode) or
3 long beeps (STOP mode).
a + s jCopies an hourly basal rate
to the following hour.
w WARNING
If the keys on your pump are not functioning properly,
disconnect your pump and contact your local pump support
(see inside back cover).
12
1.3.2 Scrolling
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.
When you begin scrolling, the pump beeps once.
1.3.3 Locking the keys
The Key Lock feature allows you to lock all 4 keys on your
Accu-Chek Spirit Combo insulin pump. This function prevents
you from accidentally activating your pump. For example, you
can use Key Lock while you are asleep or when playing sports.
You turn on the Key Lock function in the PUMP SETTINGS – See
section 5.6 Pump settings.
13
1
1.4 Accessories and disposables
w 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 sterile products with the Accu-Chek brand and genuine
Accu-Chek Spirit Combo insulin pump accessories.
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. The infusion set is the applied part.
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 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 a 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.
14
1.4.2 Adapter
vents
grip
seal
thread
The adapter connects the cartridge to the infusion set, and also
keeps the cartridge compartment watertight with 2 seals, one
inside and one outside the adapter. It holds the cartridge in place
and prevents the entry of air bubbles. The 2 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.
Note It is essential to change the adapter at least every 2
months. You must also change the adapter if the seals become
worn, are lost, or if the vents are blocked.
1.4.3 Battery
Your pump requires a 1.5 V AA alkaline (LR6) or lithium (FR6)
battery that has a mimimum capacity of 2500 mAh.
jAlkaline batteries: Only use high-quality alkaline LR6 batteries
that comply with IEC 60086-1. The Accu-Chek Spirit Combo
insulin pump was successfully tested with a Varta Power One
alkaline LR06, AA, 1.5 V battery which complies with IEC
60086-1.
jLithium batteries: Only use lithium batteries that comply with
IEC 60086-4. The Accu-Chek Spirit Combo insulin pump was
successfully tested with an Energizer Ultimate Lithium FR06,
AA, 1.5 V battery which complies with IEC 60086-4.
Do not use carbon zinc or nickel cadmium (NiCd) batteries.
If you prefer, you can use rechargeable batteries – in this case,
we recommend a Varta Rechargeable Accu Ready to Use NiMH,
HR06, AA, 1.2 V battery that complies with IEC 62133 and has a
mimium capacity of 2600 mAh. Only use a battery charger
officially recommended by the battery manufacturer. See
Appendix A: Technical Data, p. 170.
Contact your local pump support if you intend to use a different
type of battery to the one recommended.
15
1
c 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. They
could also lead to an electronic short circuit resulting in
dangerous heat development. 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 (e.g. damaged plastics isolation coating) 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 cover
The battery cover seals the battery compartment, and must be
changed at least every 2 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.
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.
16
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.
Consult the instructions for use coming with your medical
devices (e.g. lancing device), accessories and disposables.
Such an emergency kit should contain:
jAn Accu-Chek infusion set
jA new AA alkaline or lithium battery
jAn Accu-Chek Spirit 3.15 ml cartridge system
jAn insulin pen or syringe for alternative therapy
jA vial of insulin
jTreatment for low blood glucose levels
jBlood glucose monitoring equipment
(such as an Accu-Chek blood glucose meter)
jA disinfectant for skin
jA battery key
jA battery cover
jAn adapter
w 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.
17
1
1.6 General safety information
c 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.
w 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 hypoglycaemia. Too little insulin can lead to
a life-threatening ketoacidosis.
w 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.
18
19
2
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. If the power
is interrupted for a longer period of time (after more than 1 hour),
your pump will revert to the factory settings for the date and
time. 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).
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 (at least 4 times a 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.
w WARNING
This product contains small parts. There is a risk of suffocation
if small parts (e.g. covers, caps or similar objects) are
swallowed.
2 Getting started
20
Insert the battery, negative (–) end first,
positive (+) end up, into the battery
compartment.
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.
1.
Remove the battery cover.
Use the battery key to turn the battery
cover anticlockwise. Make sure that the
opening of the battery compartment and
the seal are clean and undamaged.
Where appropriate, remove the old
battery.
3.
Procedure for inserting and changing the battery
Remove or disconnect your infusion set
from the infusion site, to ensure that
there is no risk of accidental insulin
delivery.
2.
4.
2
21
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 section below).
If the pump does not begin the start-up process after inserting
the battery, make sure that the battery is inserted correctly
(negative end first).
c CAUTION
If your pump reverts to the factory settings for the date and
time immediately after the power supply is interrupted for a
short amount of time, please contact your customer support
to report this issue as it may be due to a component failure.
5. 6.
22
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 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.
w WARNING
It is important that you always check that the date and time
are set up correctly before you put your pump into RUN mode
after a battery change. Otherwise there is a risk that too
much or not enough insulin will be delivered because of a shift
of basal rate time blocks. Basal rates that are delivered at the
wrong time can lead to hyper- or hypoglycaemia.
23
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 the battery the whole start-up process is
performed.
When you … Then …
change only the
cartridge
the start-up process begins at the
SELF-TEST screen.
w 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.
The software version screen appears. The Accu-Chek logo appears. The SELF-TEST screen appears.
Start-up process sequence
1. 2. 3.
24
The display then shows a pattern. Check
that the pattern is even.
The BEEP TEST screen appears and your
pump beeps.
Listen for the beeps.
w 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)
The VIBRATION TEST screen appears and
your pump vibrates.
Check the vibrations.
w 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, stop using
the pump and contact your local pump
support. (See inside back cover)
The display then goes blank. Check that
the display is empty. (The backlight turns
on during this step.)
4. 5.
6. 7.
2
25
The display turns black. Check that the
display is completely black.
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.
To turn the STOP warning off, press a or
s until you hear a melody and / or feel a
vibration.
When you use your pump for the first time
or have not used it for a longer time, you
will be guided automatically to the TIME
AND DATE SETTINGS option after step 10
(see next page).
c CAUTION
Make sure that you choose the correct
battery type. Otherwise you may not be
informed about a low battery in time.
8. 9. 10.
11.
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.
Press f to save and exit.
26
2.4 Setting the time and date
w WARNING
jIncorrect 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.
jIf the power is interrupted for a longer period of time (after
more than 1 hour), your pump will revert to the factory
settings for the date and time.
jIn 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.
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,
make sure that the time and date are re-set correctly.
You can choose between American or European / Military time.
American Euro pean / Milit ary
12-hour clock 24-hour clock
month.day.year day.month.year
2
27
1. 2. 3.
Procedure for setting the time and date
Press d to move to the TIME AND DATE
SETTINGS screen.
Press f to select.
The HOUR screen is displayed.
Press a or s to set the hour.
Press d to move to the MINUTE screen.
Press a or s to set the minute.
4. 5. 6.
Press d to move to the YEAR screen.
Press a or s to set the year.
Press d to move to the MONTH screen.
Press a or s to set the month.
Press d to move to the DAY screen.
Press a or s to set the day.
28
8.7.
Press d to move to the TIME FORMAT
screen.
Press a or s to set the time format.
Press d to move to the DATE FORMAT
screen.
Press a or s to set the date format.
Press f to save and exit.
29
2
2.5 Your basal rate profile
Note 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.
An Accu-Chek Spirit Combo basal rate profile consists of up to
24different 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.
012345678910 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Time
Example: Basal rate profile for 18 U / 24 hours
Insulin delivery
[ U / h] Hourly basal rate
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.
2.5.1 Programming your basal rate profile
Your Accu-Chek Spirit Combo insulin pump delivers insulin
according to the programmed hourly basal rate, 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 5 different basal rate profiles to match
your changing insulin needs – for example: Monday to Friday,
Exercise Day or Sleeping Late Day.
30
Your basal rate profile should be reviewed:
jAfter any programming changes are made to your pump
jAfter a new battery is inserted
jAfter confirming the error E7: ELECTRONIC ERROR.
Note Insulin delivery does not stop or pause during basal rate
programming.
3.
Procedure for programming your basal rate profile
1. 2.
Press d to move to the BASAL RATE
PROGRAMMING 1 (2, 3, 4 or 5
accordingly) screen.
Press f to select.
The daily BASAL RATE TOTAL is displayed.
Press d to move to the first hour.
This is always 00:00–01:00
(12 AM–01 AM if the American time
format is used).
2
31
4. 5.
Press a or s or scroll to set the
hourly basal rate given by your doctor or
healthcare team.
Press d to move to the next hour.
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.
6. 7.
Press f to confirm.
The new daily BASAL RATE TOTAL is
displayed.
Press f to save the profile and exit.
Note 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
32
Press d to move to the BASAL RATE
PROGRAMMING 1 (2, 3, 4 or 5
accordingly) screen.
Press f to select.
The daily BASAL RATE TOTAL is
displayed.
Copying an hourly basal rate
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.
1.
3.
Press d to move to the hourly basal
rate you want to copy.
4. 5.
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.
If you want to copy the rate to multiple
hours, press a and s repeatedly or
press and hold a and s (scroll).
2.
2
33
Press f to confirm.
Check the new daily BASAL RATE TOTAL.
Press f to save and exit.
Note At any point in the programming of your basal rate, you have the following
options to exit.
If you want to … Then …
save the changes jPress f and check the new daily basal rate total.
jPress f again. Your pump returns to the RUN or STOP
screen.
undo the changes jWait for your Accu-Chek Spirit Combo insulin pump to
return to the RUN or STOP screen, or
jPress d and a simultaneously (exit feature) to exit the
Function screen.
6.
34
Selecting a basal rate profile
Press d to move to the BASAL RATE
SELECTION screen.
Press f to select.
The SELECT PROFILE for the current
basal rate profile is displayed.
Press a or s to select a basal rate
profile.
The SELECT PROFILE screen and its daily
basal rate total appear accordingly.
Press f to select the displayed profile.
The new basal rate profile is active
immediately.
4.
1. 2.
3.
When you have programmed more than
one basal rate profile (ADVANCED or
CUSTOM MENU), you can select the
required profile.
w WARNING
Make sure that you select an
appropriately programmed basal rate
profile. Otherwise there could be
inappropriate insulin delivery.
35
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:
jSelect the ADVANCED user menu, or
jAssign 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.
36
2.6 Connecting the cartridge, adapter and infusion set
Have the following materials ready:
jA 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)
jAn Accu-Chek Spirit Combo insulin pump adapter
jA new Accu-Chek infusion set
w WARNING
Ensure that the cartridge is at room temperature before use to
prevent from air bubbles.
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).
37
2
Procedure to connect the cartridge, adapter and infusion set
3.
Hold the adapter and twist the infusion
set luer-lock connection by hand,
clockwise into the adapter. Do not
over-tighten.
w 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.
Remove the protective cap from the
cartridge. (Do not touch the cartridge tip.)
1. 2.
4.
Push the adapter onto the cartridge tip all
the way until it stops.
Carefully prepare a new Accu-Chek
infusion set, following the instructions
supplied for use.
38
2.7 Inserting the cartridge
Have the following materials ready:
jA filled Accu-Chek Spirit 3.15 ml cartridge system with a
connected Accu-Chek Spirit Combo insulin pump adapter
jA new Accu-Chek infusion set
Procedure for inserting the cartridge
Press d to move to the STOP YOUR
PUMP screen.
Press f to select.
The pump displays the STOP screen, and
insulin delivery stops.
Disconnect the transfer set from the
headset to ensure that there is no risk of
accidental insulin delivery.
1. 2.
w WARNING
Do not use your pump for the delivery of medication other than
U100 short-acting regular human insulin or rapid-acting insulin
analogue.
3.
2
39
8.
Make sure your infusion set is
disconnected and the cartridge has been
removed.
Press and hold f for 3 seconds, until
you hear a melody.
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.
7.
6.
When the piston rod has returned
completely, the CARTRIDGE VOLUME
screen displays the maximum volume,
315 U.
Press d to move to the CARTRIDGE
CHANGE screen.
Press f to select.
5.
Remove the cartridge, if necessary.
Unscrew carefully. Do not pull the
cartridge out until it is completely
unscrewed.
c 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
cartridge compartment.
4.
40
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.
Make sure that the top edge of the
threaded part of the adapter is level with
the top of the cartridge compartment.
10.
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.
Tip: To prevent air bubbles move the
piston rod to at least 310 U.
12.11.
9.
see step 10
see step 11
2
41
The cartridge is correctly inserted when
the end plate of the piston rod is correctly
seated against the cartridge plunger.
16.
Position your insulin pump with the
opening of the cartridge compartment
pointing downwards. Insert the cartridge
into the cartridge compartment.
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 you
could cause damage to your pump.
Do not insert the cartridge into your
insulin pump without first connecting the
infusion set tubing.
Screw (do not push) the adapter closed in
a clockwise direction, until it is correctly
seated against the cartridge
compartment.
Do not hold your pump in an upright
position when inserting the cartridge.
15.
13. 14.
42
19.
Press f after correctly inserting the
cartridge.
Your pump performs a self-test. See
section 2.3 Start-up process.
When the self-test process is finished, the
INFUSION SET PRIMING screen is
displayed.
See section 2.8 Priming the infusion set. Start from step 4 in the
Procedure for priming the infusion set.
c CAUTION
If an empty cartridge is inserted into the pump (e.g. for training
purposes), the pump displays the programmed insulin deliveries
(infusion set priming, basal rate and bolus deliveries), even
though no insulin is being delivered due to the empty cartridge.
20.
Check that the infusion set luer-lock
connector is still correctly connected to
the adapter. Tighten the infusion set by
hand by screwing it in a clockwise
direction, until it sits tightly in the adapter.
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.
17. 18.
43
2
2.8 Priming the infusion set
w 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.
Your pump should be upright during priming, with the adapter
pointing upwards to help let air bubbles out of the cartridge and
infusion set.
w 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.
44
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.
Make sure your infusion set is
disconnected.
Press and hold f for 3 seconds, until
you hear a melody. The priming process
begins.
5.
Procedure for priming the infusion set
Press d to move to the STOP YOUR
PUMP screen.
Press f to select.
1. 2. 3.
The pump displays the STOP screen, and
insulin delivery stops.
Prepare the tubing or cannula for priming
according to the infusion set’s
instructions for use.
4.
Press d to move to the INFUSION SET
PRIMING screen.
Press f to select. The priming amount
of 25 units of insulin is shown on the
display.
6.
2
45
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.
46
2.9 Positioning the infusion set
Have the following materials ready:
jYour Accu-Chek Spirit Combo insulin pump
jA disinfectant for your skin
jA new Accu-Chek 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.
2
47
3.
Wash your hands thoroughly. Disinfect the infusion site and let it dry
completely.
Insert the cannula of your Accu-Chek
infusion set according to the instructions.
2.
5.
4.
2.9.2 Inserting the cannula
Make sure that your pump is properly
connected (including cartridge, adapter
and infusion set) and correctly
programmed with your personal settings.
1.
Make sure your pump is in STOP mode.
48
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.
Note If you use an infusion set with a soft cannula, you must
proceed with a bolus to fill the air space in the cannula and
headset, 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.
w 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.
49
2
2.9.3 Connecting the insulin pump
w WARNING
Pay attention to the tubing of the infusion set connected to
your body. There is a risk of strangulation if the tubing
becomes wrapped around your neck. In case of doubt, use
the shortest tubing length to minimise the risk of
strangulation.
Attach the infusion set to the insulin
pump and start insulin delivery. See
section 2.10 Starting insulin delivery.
1.
50
2.10 Starting insulin delivery
Procedure for starting insulin delivery
1. 2. 3.
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.
51
2
2.11 Stopping insulin delivery
c 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
Press d to move to the STOP YOUR
PUMP screen.
1. 2.
Press f to select. Your pump returns to
the STOP screen.
Your pump is now in STOP mode.
No insulin is being delivered.
For your safety, you must only perform certain functions and
actions when the pump is in STOP mode. These functions and
actions include:
jchanging the cartridge
jconnecting and disconnecting the adapter and / or infusion set
jpriming the infusion set
jdata transfer
52
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 2 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 3
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.
2.12 General safety information
w 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.
53
2
w WARNING
Always 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, ask your doctor or healthcare team to set or
check them. Only change your settings after consulting your
doctor or healthcare team.
w WARNING
The 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, the warning W6: TBR CANCELLED and / or the
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.
54
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:
jthe cartridge contains enough insulin to last through the night
jthe time and date are set correctly
55
3
This chapter provides important guidelines on how to use your
pump safely from day to day.
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. Wear
your pump under your clothes or directly on your body to protect
it from hot, cold or wet weather.
c 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).
3.1.1 When not to wear your pump
Electromagnetic fields and hazardous areas
w WARNING
Do not use your pump near strong electromagnetic fields.
Otherwise insulin delivery may stop and the error E7:
ELECTRONIC ERROR may occur. Follow the instructions below
before you enter areas with electromagnetic fields:
jStop and remove your pump.
jLeave your pump outside these areas.
Strong 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, may cause your pump to fail. See Appendix A:
Technical data for more information about electromagnetic
fields. If the error E7: ELECTRONIC ERROR occurs near areas
with electromagnetic fields, contact your local pump support.
3 Using your pump in daily life
56
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
(calculation based on standard atmosphere). During operation you
can use your pump at a barometric pressure from 50 to 106 kPa
(500 to 1060 mbar). These conditions also apply to transport and
storage in its shipping case. This equals an altitude of approx.
–300 to +5400 m. At sea level (0 m of height) the standard
atmosphere is defined with a barometric pressure of 101.325 kPa.
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 inside back cover) for more information.
57
3
Note Rapid and extreme changes in air pressure, for example
in an airplane that is taking off or when practising 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 glucose 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
inside back cover).
w WARNING
You must ensure that the Bluetooth ® wireless technology 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.
58
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
delivery interruption. Use a syringe or insulin pen to inject insulin
according to the instructions of your doctor or healthcare team.
w WARNING
Because only fast- or 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:
jIf you stop the pump
jThere is a technical problem with the pump
jThe cartridge is leaking and /or the infusion set is leaking
jThere is an occlusion in the infusion set or in the headset
jThe cannula has slipped out of the infusion site –
you must replace the missing insulin immediately.
3
59
1. 2.
3.2.1 Short interruptions
3.
Press d to move to the STOP YOUR
PUMP screen.
Press f to put your pump in STOP
mode. 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.
Resuming insulin delivery
Reconnect your infusion set or insert a
new one and put your pump into RUN
mode.
1. Where appropriate, attach a new
Accu-Chek infusion set. (See section
3.4 Changing the infusion set).
Measure your blood glucose level within
2hours of restarting pump therapy to
check the function of the system and to
ensure insulin delivery.
60
3.2.2 Long interruptions
When you need to interrupt your pump
therapy for more than one day, use the
following procedure.
1.
Put your pump into STOP mode.
Remove the cartridge, adapter, and
infusion set.
Reinsert the adapter.
2.
Remove the battery and reinsert the
battery cover.
Store your pump properly.
See section 7.6 Storing your pump.
4.3.
61
3
3.3 Your insulin pump and water
c 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.
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.
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
62
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:
jCleaning solutions
jBeverages
jOil or fat
See section 7.5.1 Cleaning your pump.
c 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
discolour your pump or fog the display.
63
3
3.4 Changing the infusion set
When you change the infusion set, keep the following information
in mind:
jInfusion 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.
jCorrectly 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.
jYour 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.
jAlways 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.
64
3.
Disconnect the transfer set from the
headset.
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 to loosen
the luer-lock connector from the adapter
if it cannot be loosened by hand.
4.
Procedure for changing the infusion set
Have the following materials ready:
jYour Accu-Chek Spirit Combo insulin
pump
jA disinfectant for your skin
jA new Accu-Chek infusion set
2.1.
Make sure your pump is in STOP mode.
Wash your hands thoroughly.
5.
3
65
7.
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.
6.
9. 10. 11.
Prime the infusion set following the
instructions found in section 2.8 Priming
the infusion set. Prepare the infusion site and insert a new
infusion set following the instructions in
section 2.9 Positioning the infusion set.
Put the pump in RUN mode. See
section2.10 Starting insulin delivery.
8.
66
Note If you use an infusion set with a soft cannula, you must
begin with a bolus to fill the air space in the cannula and headset,
according to the instructions for use 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.
w 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 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.
67
3
2.1. 3.
Make sure your pump is in STOP mode.
Wash your hands thoroughly. Remove the transfer set from the
headset.
Procedure for changing the cartridge and infusion set
3.5 Changing the cartridge and infusion set
Never reuse the Accu-Chek Spirit 3.15 ml cartridge system. This
can cause infections and blockages or occlusions. The cartridge
should be changed:
jBefore it is completely empty
jIf you believe the quality of the insulin is damaged or
compromised
jIn accordance with insulin manufacturers recommendations if
using the pre-filled Sanofi-Aventis Insuman Infusat glass
cartridges
jOr at least every 6 days when using the Accu-Chek Spirit
3.15ml cartridge system
Have the following materials ready:
jYour Accu-Chek Spirit Combo insulin pump
jA disinfectant for your skin
jA new Accu-Chek infusion set
jA filled Accu-Chek Spirit 3.15 ml cartridge system
jA new adapter (this must be changed at least every 2 months)
68
4. 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).
Hold your Accu-Chek Spirit Combo insulin
pump with the adapter pointing
downwards.
Remove the transfer set from the adapter
and dispose of it correctly. Remove the cartridge from the adapter
and dispose of the cartridge properly.
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 adapter and cartridge from
your pump by unscrewing the adapter
from the pump casing.
5.
6. 7.
3
69
Insert a new cartridge and a new infusion
set. See section 2.7 Inserting the
cartridge.
9.
Hold the adapter 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.
8. 10.
70
3.6 General safety information
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:
jThe cartridge contains enough insulin to last through the night
jThe battery level is OK
jThe time and date are set correctly
w WARNING
Always carry spare sterile products and accessories (infusion
set, insulin cartridge, batteries), an insulin pen/syringe, and
insulin. Without insulin, diabetic ketoacidosis may develop and
may require in-patient hospital treatment.
c 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.
71
4
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 3 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
Note If the connection between your pump and the meter is
interrupted while a bolus delivery is running note the following:
jStandard Bolus: The whole bolus will be delivered. In case you
do not manually stop the bolus delivery on your pump.
jExtended Bolus: The whole extended bolus will be delivered
during the programmed period of time. In case you do not
manually stop the bolus delivery on your pump.
jMultiwave Bolus: The whole bolus of fast delivered insulin
(Standard Bolus) and the whole bolus delivery for the
programmed period of time (Extended Bolus) will be delivered. In
case you do not manually stop the bolus delivery on your pump.
4 Boluses and Temporary Basal Rates
72
4.2 Programming a Standard Bolus
There are 2 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 using U100
insulin.
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. The warning W8: BOLUS
CANCELLED is displayed. Press f twice to confirm and turn off
the warning. See chapter 8 Warning W8: BOLUS CANCELLED.
Note You can not program a new Standard Bolus as long as
one Standard Bolus, Quick Bolus or the immediate part of a
Multiwave Bolus is running.
4
73
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 with the first key appearing without round brackets,
such as a. For the alternative step, press the key in the
parenthesis, such as (s).
Because your pump beeps and vibrates to guide you through the
programming steps, you can program the Quick Bolus without
1. 2.
Procedure for programming a Quick Bolus
From the RUN screen, press and hold s
(a) until you hear a sequence of beeps
and feel a vibration.
This activates the Quick Bolus function.
Press a (s) once for each increment
until the required bolus amount is
reached. You must not use the key you
pressed first.
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 reason, 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.
3.
With each pressing of the key, your pump
beeps and vibrates simultaneously; once
for each programmed bolus increment.
74
w 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.
5 seconds after last pressing a (s),
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).
6.
After the bolus delivery start delay, the
pump beeps 3 times and vibrates and
then begins to deliver the total bolus
amount programmed. A countdown of the
remaining bolus amount appears on the
display.
5.4.
75
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 3 times and vibrates after 5 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.
You can view the actual bolus amount delivered prior to the cancellation by
looking at the bolus history. See section 5.4.1 Viewing your bolus history.
Bolus delivery is
interrupted.
Note Make sure that the cancellation was deliberate, and then program a new bolus, if required.
76
4.2.3 Programming a Standard Bolus using Standard bolus menu
2. 3.
1.
Press d to move to the STANDARD
BOLUS screen.
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 5
seconds (the bolus delivery start delay).
4.
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.
77
4
After this bolus delivery start delay, your pump beeps 3 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 3 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 Return to the Standard Bolus screen 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 d + a, 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 prior to the cancellation by
looking at the bolus history. See section 5.4.1 Viewing your bolus history.
Bolus delivery is
interrupted.
78
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.
Cancellation during the start delay and during the bolus delivery
will cause a WARNING W8: BOLUS CANCELLED. Press f twice
to confirm and snooze the warning. See chapter 8 Warnings and
errors.
Check to see if any insulin was delivered: It is possible
that a small amount of insulin may have been delivered during
the cancel bolus process. In pump mode, press twice on
the meter to view the BOLUS DATA screen. If more insulin
was delivered than required for your therapy, you must eat
carbohydrates to compensate for that insulin. If you program a
new bolus you have to take into account any amount of insulin
already delivered during the cancel bolus process.
Note Make sure that the cancellation was deliberate and
program a new bolus, if needed.
4
79
1. 2. 3.
Procedure for programming an Extended Bolus
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.
Tip: You can add a Standard or Quick Bolus to an ongoing
Extended Bolus. 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”. The error message only appears on your
meter.
If you want to program a different Extended Bolus, put the pump
in STOP mode to cancel the current bolus and to program a new
one.
80
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.
4. 5.
Press d to move to the BOLUS
DURATION screen.
Press a to increase or s to decrease
the bolus duration.
Tip: Press d to switch between
programming the bolus amount and bolus
duration.
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.
81
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 the warning W8:
BOLUS CANCELLED is displayed. Press f twice to confirm and turn off the
alert. See chapter 8 Warning W8: BOLUS CANCELLED.
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.
Bolus delivery is
interrupted.
82
Note If a Temporary Basal Rate is active at the same time, it is
also cancelled when your pump is put into STOP mode. The
warning W8: BOLUS CANCELLED and the 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.
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.
83
4
4.4 Programming a Multiwave Bolus
When programming a Multiwave Bolus, make sure that you are
using the ADVANCED user menu and your pump is in RUN mode.
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 j The Multiwave Bolus is available only in the ADVANCED
user menu.
jYou can add a Standard Bolus to an ongoing Multiwave
Bolus. If you cancel the Standard Bolus, the Multiwave
Bolus remains running.
jDuring 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.
84
Procedure for programming a Multiwave Bolus
1. 2. 3.
5.
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. Press d to move to the IMMEDIATE
BOLUS screen.
Press a or s to correct and set the
immediate bolus amount.
Press d to move to the BOLUS
DURATION screen.
Press a or s to correct and set the
Extended Bolus duration in increments of
15 minutes for up to 12 hours.
4.
4
85
6.
Tip: Press d to loop between
programming the total BOLUS AMOUNT,
IMMEDIATE BOLUS and BOLUS
DURATION.
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).
8.
The pump beeps 3 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.
7.
86
4.4.1 Cancelling a Multiwave Bolus
During programming
(the bolus amount
blinks)
There are 3 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 Return 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 d + a, 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 or extended delivery will cause the warning W8: BOLUS
CANCELLED. Press f twice to confirm and turn off the alert.
See chapter 8 Warning W8: BOLUS CANCELLED.
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.
87
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 the warning W6: TBR
CANCELLED are 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 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 rate. 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:
jIncrease it to 250 % for up to 24 hours
jDecrease 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. 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.
88
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
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
89
4.
Press a or s to increase or decrease
the basal rate.
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.
3.
5.
Tip: You can switch between
programming the basal rate percentage
and duration by pressing d.
Press f to save and exit.
The new Temporary Basal Rate is
immediately activated.
When a Temporary Basal Rate is active,
the pump emits a beep once every hour.
90
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 upwards
symbolizes a Temporary Basal Rate increase; an arrow pointing
downwards 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
TBR OVER Alert
At the end of a Temporary Basal Rate, the warning W7: TBR
OVER is displayed. Press f twice to confirm and turn off the
warning. See chapter 8 Warning W7: TBR OVER.
91
4
During programming There are 3 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 Exit the Temporary Basal Rate (TBR) screen by pressing d + a
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 2 ways to cancel a Temporary Basal Rate during delivery:
j Set the TBR percentage to 100 %. Press f to save and exit. The 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. The warning W6: TBR CANCELLED is displayed. Press f twice to
confirm and turn off the alert.
Pump returns to
normal basal rate.
4.5.1 Cancelling a Temporary Basal Rate
92
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. The warning W8: BOLUS CANCELLED and the 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 then program a new Temporary Basal Rate (and /or
an Extended or Multiwave Bolus), if needed.
4.6 General safety information
w 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.
w WARNING
When your pump is in STOP mode it does not deliver insulin.
Put the pump in RUN mode to continue insulin delivery.
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5
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 4 keys on the pump, and their combinations, you can
access the menu options and their relevant screens. This enables
you to, for example:
jProgram the pump
jPerform a function
jChange a setting
jStore information
Note Your Accu-Chek Spirit Combo insulin pump has been
designed for use with the meter. This is intelligent blood glucose
meter that enables you to control your insulin pump using
Bluetooth
® wireless technology.
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 3 menus – STANDARD, ADVANCED or
CUSTOM – to access the functions and settings you will need
from day to day.
5 Personalizing your pump
94
STANDARD 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’s Manual, 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.
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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 provider.
2. 3.
Procedure for selecting a user menu
The SELECT USER MENU screen is
displayed.
Press a or s to select a user menu.
Press f to confirm.
The selected basal rate profile and its
daily insulin total appear, or …
1.
Press d to move to the MENU SETTINGS
screen.
Press f to select.
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5.
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.
c 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.
4.
… if the previous basal rate profile is not
available from the selected user menu,
dashes appear instead.
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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:
jPress d to move forwards
jPress d + a simultaneously
to move backwards
ff
RUN STOP
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Some of the functions have already been described elsewhere in
this User’s Manual, as listed below. The remaining functions are
described following the list.
TIME AND DATE SETTINGS
jSee section 2.4 Setting the time and date.
BASAL RATE PROGRAMMING
jSee section 2.5.1 Programming your basal rate profile.
CARTRIDGE CHANGE
jSee section 2.7 Inserting the cartridge.
INFUSION SET PRIMING
jSee section 2.8 Priming the infusion set.
START YOUR PUMP
jSee section 2.10 Starting insulin delivery.
STOP YOUR PUMP
jSee section 2.11 Stopping insulin delivery.
QUICK BOLUS
jSee section 4.2.1 Programming a Quick Bolus.
STANDARD BOLUS
jSee section 4.2 Programming a Standard Bolus.
EXTENDED BOLUS
jSee section 4.3 Programming an Extended Bolus.
TEMPORARY BASAL RATE (TBR)
jSee section 4.5 Programming a Temporary Basal Rate (TBR).
MENU SETTINGS
jSee section 5.2 Selecting a user menu earlier in this chapter.
BLUETOOTH SETTINGS
jSee chapter 6 Using the Accu-Chek Spirit Combo insulin pump
with the meter.
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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 90 days of use, and can be accessed on a
personal computer using the 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 remaining time in days until the
pump timer expires
Note Once 30 history entries are in memory (e.g. bolus history,
alarm history), adding a new entry deletes the oldest entry.
100
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 / t ype
Bolus time
Date Entry number
1. 2. 3.
Procedure for viewing the bolus history
Press d to move to the MY DATA
screen.
Press f to select.
The BOLUS DATA screen appears,
showing the most recent bolus
information.
Press a or s to view the entries.
Press f to exit.
Each BOLUS DATA screen displays:
jBolus type (Standard, Extended or Multiwave Bolus)
jBolus duration (only displayed for an Extended or
MultiwaveBolus)
jTime
jDate
jEntry number (01 is the most recent) of total entries
(example01/30) of a delivered bolus
Tip: You can enter the BOLUS DATA screen also from the
QUICKINFO screen. See section 1.2.3 Display screens.
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5.4.2 Viewing the error and warning history
The ERROR DATA menu allows you to view up to the last
30 warnings and errors, starting with the most recent entry.
1. 2. 3.
Procedure for viewing the error data history
Press d to move to the MY DATA
screen.
Press f to select.
Press d to move to the ERROR DATA
screen.
Press a or s to view the entries.
Press f to exit.
Each ERROR DATA screen displays:
jNumber and type of the warning or error (for example, W6)
jWarning or error (for example, TBR CANCELLED)
jTime
jDate
jEntry number (01 is the most recent) of total entries
(example 01/30) of a warning or error
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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.
1. 2. 3.
Procedure for viewing the daily insulin totals
Press d to move to the MY DATA
screen.
Press f to select.
Press d to move to the DAILY TOTALS
screen.
Press a or s to view the entries.
Press f to exit.
Each screen displays:
jDaily total of insulin delivered
jDate
jEntry number (01 is the most recent) of total entries
(example 01/04) of a daily insulin total
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3.
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.
1. 2.
Procedure for viewing the Temporary Basal Rate history
Press d to move to the MY DATA
screen.
Press f to select.
Press d to move to the TBR DATA
screen.
Press a or s to view the entries.
Press f to exit.
Each TBR DATA screen displays:
jTBR increase or decrease in percentage
jTBR duration
jTime
jDate
jEntry number (01 is the most recent) of total entries (example
01/30) of a delivered Temporary Basal Rate
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5.4.5 Viewing the time remaining (pump timer)
The pump timer function only occurs on a backup or loan pump.
Your backup pump has been provided for contingency use only.
It has a pre-set operating time of 180 days. When you first start
your backup or loan pump, it will begin to count down the
remaining days. Before the operating time expires, you will be
prompted with the warning W5: PUMP TIMER or W9: LOANTIME
WARNING message, and the pump timer symbol will be displayed
1. 2.
in the RUN and STOP screen. When the operating time has
expired, you will be prompted with the error E5 or E9: END OF
OPERATION, and the pump will turn to STOP mode.
After the error E5 or E9, the pump cannot be switched to RUN
mode again.
See chapter 8: Warning W5: PUMP TIMER, W9: LOANTIME
WARNING and Error E5, E9: END OF OPERATION
Procedure for viewing the time remaining
Press d to move to the MY DATA
screen.
Press f to select.
Press d to move to the PUMP TIMER
screen.
The number of days remaining until the
pump timer expires is shown.
Press f to exit.
Note This setting is country-specific
and may not be visible on your pump.
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105
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 personal computer.
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 90 days of use, and can be
accessed on a personal computer using the Accu-Chek
1. 2. 3.
Procedure for transferring your data
information management products (for details see the user
information provided with the software).
For availability of the appropriate software see Appendix C.
Put your pump in STOP mode. Press d to move to the DATA TRANSFER
screen.
Press f to select.
Press f. A melody signals that your
pump is ready to transfer data.
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4.
When the data transfer is complete,
pressf to return to the STOP screen.
Set up your pump with a cartridge, adapter, and a new infusion
set, and put it in RUN mode if necessary.
Note 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 + a to exit while data is being
transferred. The data transfer is interrupted, and the error E12:
DATA INTERRUPTED occurs. See chapter 8.
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107
5.6 Pump settings
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.
1. 3.
5.6.1 Turning Key Lock on and off
The Key Lock function allows you to lock the 4 keys of your
Accu-Chek Spirit Combo insulin pump. This function prevents
you from accidentally activating your pump. For example, you
can use Key Lock while you are asleep or when playing sports.
If the Key Lock is turned on and no key is pressed for 10 seconds
after your pump has returned to the RUN screen or STOP screen,
all 4 keys are locked.
Procedure for turning the Key Lock on or off
Press d to move to the PUMP
SETTINGS screen.
Press f to select.
2.
The current Key Lock status (ON or OFF)
appears.
Press a or s to turn the Key Lock ON
or OFF.
Press f to save and exit.
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1. 2.
From the blank screen, press and hold
d + s for 3 seconds.
You hear 3 beeps in RUN or STOP mode
when you press the keys and again after
3 seconds to confirm that the Key Lock is
unlocked.
If no key is pressed for 10 seconds after
your pump has returned to the RUN or
STOP screen, all 4 keys are automatically
locked.
Procedure for unlocking the Key Lock
If you press any key while the screen is blank, the Key Lock
symbol indicates that the keys are locked.
Note The Key Lock remains unlocked during fast bolus delivery
of Standard or Multiwave Bolus.
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109
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 E: Beeps and melodies. You can adjust the volume of
the beeps according to your personal preference. There are 5
volume levels available: off, low, medium, high and maximum.
1. 2.
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
Press d to move to the PUMP SETTINGS
screen.
Press f to select.
Press d to move to the SOUND
VOLUME screen.
Press a or s to adjust the sound
volume.
Press f to save and exit.
110
5.6.3 Changing signal settings
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 3 options:
Procedure for changing the signal settings
Beep only
Vibrate only
Beep and vibrate
For your safety, if you do not respond to the vibration, the pump
starts beeping after one minute.
1. 2.
Press d to move to the PUMP
SETTINGS screen.
Press f to select.
Press d to move to the SIGNAL
SETTINGS screen.
Press a or s to set the signals.
Press f to save and exit.
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111
5.6.4 Display orientation
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.
1. 2.
Procedure for setting the display orientation
Press d to move to the PUMP
SETTINGS screen.
Press f to select.
Press d to move to the ORIENTATION
screen.
The current orientation is displayed.
Press a or s to select the display
orientation.
Press f to save and exit.
Note If you turn the display orientation of your pump by 180°,
the functions of the a and s keys are also reversed. The
functions of the d and f keys remains the same, whichever
screen orientation you choose.
3.
INVERTED
112
1. 2.
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
Press d to move to the PUMP
SETTINGS screen.
Press f to select.
Press d to move to the DISPLAY
CONTRAST screen.
Press a or s to select the desired
contrast level.
Press f to save and exit.
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5
1. 2.
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
Press d to move to the PUMP
SETTINGS screen.
Press f to select.
Press d to move to the LANGUAGE
screen.
Press a or s to select a language.
Press f to save and exit.
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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:
BRP 4
BRP 3
BRP 2
BRP 4
BRP 3
BRP 2
ff
RUN STOP
jPress d to move forwards
jPress d + a simultaneously to
move backwards
BRP = Basal Rate profile 2–4
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5
Note The ADVANCED user menu contains all the options from
the STANDARD user menu.
Some of the functions are described elsewhere in this User’s
Manual, as listed below. The remaining functions are described in
this chapter following the list.
MULTIWAVE BOLUS
jSee section 4.4 Programming a Multiwave Bolus.
5.8 Basal rate profiles
Your pump has 5 different basal rate profiles to match your
changing insulin needs (for example, Monday to Friday or
Exercise Day or Sleeping Late Day).
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
w 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
healthcare provider to check your personal settings.
116
1. 2.
Procedure for Programming additional basal rate profiles
Press d to move to the BASAL RATE
PROGRAMMING (2, 3, 4, 5) screen you
wish to program.
Press f to select.
The hourly basal rates for each additional
basal rate profile are set in the same way
as for basal rate profile 1.
See section 2.5.1 Programming your
basal rate profile.
Note 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.
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117
1. 2.
5.8.2 Selecting a basal rate profile
Press a or s to select a basal rate
profile. The selected basal rate profile and
its daily insulin total appear.
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.
Press d to move to the BASAL RATE
SELECTION screen.
Press f to enter.
Procedure for selecting a basal rate
profile
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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.
1. 2. 3.
Procedure for setting single or multiple reminders
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.
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119
4.
Press d to move to the HOUR screen.
Press a or s to set the hour.
5.
Press d to move to the MINUTE screen.
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 displayed.
Press f twice to snooze and confirm and return to RUN or
STOP mode (See also chapter 8.4 Reminder R1).
120
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.
w 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.
1. 2.
Procedure for adjusting the bolus increment
Press d to move to the THERAPY
SETTINGS screen.
Press f to select.
Press d to move to the BOLUS
INCREMENT screen.
Press a or s to select a bolus
increment.
Press f to save and exit.
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.
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
5
121
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 U100
insulin.
Note The amount of insulin used for the priming is not added to
the history of daily insulin totals.
1. 2.
Procedure for adjusting the prime amount
Press d to move to the THERAPY
SETTINGS screen.
Press f to select.
Press d to move to the PRIME AMOUNT
screen.
Press a or s to select a prime
quantity between 0.0 and 50.0 units.
Press f to save and exit.
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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
1. 2.
Press d to move to the THERAPY
SETTINGS screen.
Press f to select.
Press d to move to the BASAL RATE
LOCK screen.
Press a or s to turn the basal rate
lock ON or OFF.
Press f to save and exit.
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123
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.
1. 2. 3.
Procedure for using Automatic Off
Press d to move to the THERAPY
SETTINGS screen.
Press f to select.
Press d to move to the AUTOMATIC
OFF screen.
Press or scroll a to increase or s to
decrease the duration for the Automatic
off in 1-hour intervals.
If you would like to set the Automatic Off
function to off, press s until “0 h” and
OFF appear on the display.
Press f to save and exit.
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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
healthcare provider to display or hide screens and thereby
customize the individual user menus.
jPress d to move forwards
jPress d + a simultaneously to
move backwards
ff
RUN STOP
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5
Note By default, the CUSTOM user menu contains all of the
functions available except the following:
jMultiwave Bolus
jBasal rate profiles 3, 4 and 5
jTherapy Settings
To change the CUSTOM user menu, you, your doctor, or your
healthcare provider must use the Accu-Chek 360° configuration
software.
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127
6
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 2
devices using Bluetooth
® wireless technology.
Note In this User’s Manual the term “meter” always refers to
your Accu-Chek diabetes management device, which is
compatible with your Accu-Chek Spirit Combo insulin pump.
“Pairing” means to set up a connection between the 2 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 The pump cannot communicate with the meter using
Bluetooth
® wireless technology when the devices are more than
2 meters apart.
6.1 Meter
The meter – available separately – 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).
128
6.1.1 Tasks that must be performed on the pump
The following tasks cannot be performed remotely using the
meter:
jChanging the cartridge
jPriming the infusion set
jData transfer
jBluetooth
® settings
jDisplay 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 (User’s Manual) provided with this product.
6
129
6.2 Switching Bluetooth
® wireless technology ON and OFF
1. 2.
Procedure for switching Bluetooth
® wireless technology ON and OFF
Press d to move to the BLUETOOTH
SETTINGS screen.
Press f to move to the ON / OFF screen.
Press a or s to switch the Bluetooth
®
wireless technology on or off.
Press f to save and exit.
w WARNING
You must ensure that Bluetooth ® wireless technology 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.
130
6.3 Pairing your pump with the meter
1. 2. 3.
Procedure for Pairing
Press d to move to the BLUETOOTH
SETTINGS screen.
Press f to move to the ON / OFF screen.
Press a or s to switch the Bluetooth
®
wireless technology on.
Press d to move to the PAIRED DEVICE
screen.
You should not perform the pairing process in crowded areas,
since the emissions of other electronic devices could interfere
with the connection.
If you have already acquired the meter together with the
Accu-Chek Spirit Combo insulin pump, the 2 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.
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131
6.
Pump screen
meter screen
4.
Pump screen
meter screen
5.
Note When Bluetooth
® is turned off,
you cannot access the Paired Device
menu.
If the pump screen indicates that no
paired device is available, turn on the
meter in pairing mode by holding down
* and simultaneously pressing +.
Press the d key on the pump to see the
ADD DEVICE screen, and press f to
initiate pairing.
The pump begins searching and detects
the meter, displaying its serial number
(This process may take several minutes).
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.
ADD DEVICE
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7.
9.
8.
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 ..
10.
Pump screen
meter screen
meter screen
After the pairing is completed press + to
turn off the meter.
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.
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133
6.4 Troubleshooting the Bluetooth
® connection
1. 2. 3.
Press d to move to the BLUETOOTH
SETTINGS screen.
Press f to move to the BLUETOOTH
ON / O FF screen.
Press d to move to the PAIRED DEVICE
screen.
In case of problems with the Bluetooth ® connection or after the
appearance of the warning 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.
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4.
Press d to move to the DELETE DEVICE
screen.
Press f once to delete the pairing and
a second time to confirm.
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).
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.
jIf 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.
jIf 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 The above points do not apply in the case of
E7: ELECTRONIC ERROR.
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6.4.2 Use in aircraft
w WARNING
You must ensure that Bluetooth ® wireless technology 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.
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7
This chapter explains how to take care of your pump and keep it
properly maintained.
c CAUTION
Do not perform any servicing or repair on your Accu-Chek
Spirit Combo insulin pump as this may void the guarantee. For
further information, 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 sterile products and accessories with the Accu-Chek
brand 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.
7 Care and Maintenance
138
7.1.1 Checklist
Check your pump daily, and make sure that:
jThe 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.
jYou 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.
jYou 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.
jThe battery cover is correctly tightened and positioned, in line
with the pump casing.
jThe adapter is correctly attached.
jYour infusion set is primed, free of air bubbles, and tightly
connected to the adapter.
jYour infusion set is inserted according to the instructions for
its use.
jYour infusion site is secure, comfortable, and free of irritation
or infection.
jThe cartridge is free of air bubbles.
jYour pump is in RUN mode.
jThe basal rates are set correctly according to your doctor’s or
healthcare team’s recommendations.
jThe time and date are set correctly.
jThe Temporary Basal Rate changes are set according to your
doctor’s or healthcare team’s recommendations.
jThe beeps and / or vibrations are set.
jYou have your personal emergency kit with you. (See section
1.5 Emergency kit)
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7.2 Damage to your pump
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. The warning W8: BOLUS
CANCELLED or the 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 and then program
a new Temporary Basal Rate (and / or an Extended or Multiwave
Bolus), if needed.
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. So be careful not to drop your
pump! Use the specially designed pump carrying system to help
avoid dropping your pump. See Roche sterile products and
accessories catalogues and brochures for more information, or
contact your local pump support (details on inside back cover).
If you drop your pump:
jCheck that all the connections of your infusion set are still
tight, and if they are not, reconnect or tighten them
jCheck your pump, its sterile products, and accessories for
chips and cracks
jChange the cartridge if it is damaged
Put your pump in STOP mode, and take out and reinsert the
battery, so that the self-test is started.
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c 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).
7.3 Your insulin pump and water
c 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.
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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:
jRain
jWater splashes while you are cycling, jogging or hiking
jAccidental 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:
jCleaning solutions
jBeverages
jOil or Fat
In case of contact with these substances, clean your pump
immediately. See section 7.5.1 Cleaning your pump.
c 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
discolour your pump or fog the display.
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7.4 Repair of your pump
c 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 Roche
for investigation. 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.
When you return your pump, include the following:
ja description of the reason for returning your pump
jyour name and address
jyour daytime phone number
jthe serial number of your pump
jany RMA (Return Material Authorization) number received from
your local pump support.
By returning your pump to Roche, you authorize Roche to
undertake any testing on your infusion 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.)
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7
7.5 Maintaining your pump
7.5.1 Cleaning your pump
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 clean cloth with alcohol (isopropanol or
ethanol). 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.
c 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 other
solvents, strong detergents, bleaching agents, scouring pads
or sharp instruments for cleaning, as they may damage the
pump.
7.5.2 Batteries
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 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.
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7.6 Storing your pump
c 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:
jRemove the battery to preserve the battery life
jRemove the cartridge
jInsert the battery cover and the adapter
jStore your pump in its packaging
Storage conditions
Temperature 41 °F to 113 °F (+5 °C to +45 °C)
Air humidity 5 to 85 % relative air humidity
Barometric pressure 500 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.
Therefore it falls outside the scope of the European Directive
2012/19/EU (Directive on waste electrical and electronic
equipment (WEEE)). If you need to dispose of your
Accu-ChekSpirit Combo insulin pump, return it to Roche
(address inside the back cover) for professional disposal.
Battery
Correctly dispose of empty batteries, recycling them wherever
possible.
Cartridge, Infusion set, Adapter, and Accessories
Dispose of the cartridge, infusion set, adapter, and accessories,
according to the instructions that came with the respective
product and according to local regulations.
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8
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.
c CAUTION
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.
If you do not confirm the 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.
All messages fall into the low-priority category according to
IEC60601-1-8:2006.
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.
jKey Lock is unlocked by the system each time a
warning or error occurs.
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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
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
Cartridge low symbol
Pump timer symbol
Key Lock symbol
For other warnings or errors, alarm information is cleared from
the display but stays in the alarm history and the event memory.
When a warning or an error occurs:
j Press f to turn off the beeps and vibrations. The warning or
error code stays on the display.
j As soon as you understand the reason for the warning or error,
confirm by pressing f again.
jTake appropriate action, as necessary.
j 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.
jAfter a warning or error, make sure that you switch your pump
back to RUN mode where appropriate.
Note 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.
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8.2 List of warnings
w WARNING
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.
Warning W1: CARTRIDGE LOW
The content of the insulin cartridge has 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.
j Press f twice to snooze and to confirm the warning. Change
the cartridge before it is empty.
jIf necessary, put your pump in RUN mode.
See section 3.5 Changing the cartridge and infusion set.
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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.
j Press f twice to snooze and to confirm the warning.
j 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.
jIf necessary, put your pump in RUN mode.
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.
Warning W3: REVIEW TIME
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.
jPress f twice to snooze and to confirm the warning.
jReview the time and date and correct them, if they are wrong.
jIf necessary, put your pump in RUN mode.
See section 2.4 Setting the time and date.
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Warning W4: CALL FOR UPDATE
Your pump has been in use for 6 years now. It is recommendable
to think about a new pump soon.
jPress f twice to snooze and to confirm the warning.
jPut your pump in RUN mode if necessary.
If, after the warning W4: CALL FOR UPDATE an E6 or E7 error
message appears, your pump is no longer able to operate.
Contact your local pump support in both situations (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, your pump has a remaining operating
time of 30 days.
jPress f twice to snooze and to confirm the warning.
jPut your pump in RUN mode.
jGo to the MY DATA menu on your pump.
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jMove to the PUMP TIMER screen. The days until the pump
timer expires are shown.
When the PUMP TIMER reaches zero, the pump will change to
STOP mode and will no longer operate. The 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 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.
Warning W6: TBR CANCELLED (Temporary Basal Rate
Cancelled)
A temporary increase or decrease in the basal rate has been
cancelled.
jPress f twice to snooze and to confirm the warning.
jIf necessary, put your pump in RUN mode.
jMake sure that the cancellation was intended and then
program a new Temporary Basal Rate if necessary.
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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.
jPress f twice to snooze and to confirm the warning.
jDecide whether a further Temporary Basal Rate change is
required. If necessary, program a new Temporary Basal Rate.
Warning W8: BOLUS CANCELLED
A bolus was cancelled during the start delay or after delivery
began.
jPress f twice to snooze and to confirm the warning.
jIf necessary, put your pump in RUN mode.
jMake 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.
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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.
jPress f twice to snooze and to confirm the warning.
jPut your pump in RUN mode if necessary.
jGo to the MY DATA menu on your pump.
jMove to the PUMP TIMER screen. The days until the loantime
expires are shown.
Note This setting is country-specific and may not be visible on
your pump.
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.
jPress f twice to snooze and to confirm the warning.
jPut your pump in RUN mode if necessary.
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8.3 List of errors
w 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.
jPress f twice to snooze and to confirm the error.
jDisconnect or remove the infusion set from the infusion site.
jChange the cartridge and prime the infusion set.
jReconnect the infusion set or insert a new one.
jPut 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.
w 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 analyse your therapy data
electronically and the time and date of the devices used are
not set identically, the resulting data might not be meaningful.
154
jPress f twice to snooze and to confirm the error.
jReplace the battery.
jPut your pump in RUN mode.
Note 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.
Error E3: AUTOMATIC OFF
Automatic Off is a safety feature that stops insulin delivery and
triggers the error E3: AUTOMATIC OFF if no keys are pressed
within a programmed time period in RUN mode.
jPress f twice to snooze and to confirm the error.
jPut your pump in RUN mode.
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Error E4: OCCLUSION
w WARNING
If the error E4: OCCLUSION occurs, immediately check your
blood glucose level, and then check again about 2 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:
ja blocked infusion set
ja damaged cartridge
ja dirty or damaged piston rod
If the error E4: OCCLUSION (blockage) occurs, follow the
steps listed below:
jPress f twice to turn off and to confirm the error.
jDisconnect or remove the infusion set from your infusion site.
jChange the infusion set and prime it, as explained in chapter 2.
jPut your pump in RUN mode.
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In rare cases, the cartridge itself can be the cause of the
occlusion. If the error E4: OCCLUSION occurs again, you
must change the cartridge. Follow the steps listed below:
jPress f twice to turn off and to confirm the error.
jDisconnect or remove the infusion set from your infusion site.
jChange the cartridge and prime the infusion set, as explained
in chapter 2.
jReconnect or insert a new infusion set at your infusion site.
jPut your pump in RUN mode.
If the error E4: OCCLUSION occurs again, prime your
infusion set without a new cartridge. Follow the steps listed
below:
jPress f twice to turn off and to confirm the error.
jDisconnect or remove the infusion set from your infusion site.
jRemove the cartridge, adapter and infusion set from your pump.
jCarry out the INFUSION SET PRIMING function (See section
2.8 Priming the infusion set) without the cartridge, adapter,
and infusion set inserted.
jRewind the piston rod.
jInsert a new cartridge with the adapter and infusion set
connected.
jPrime the infusion set.
jReconnect or insert a new infusion set at your infusion site.
jPut 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.
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8
Error E5: END OF OPERATION (backup pumps only)
The pump timer of your Backup pump has reached zero. The
pump changes to STOP mode and will no longer operate. The
error E5: END OF OPERATION appears on the display. Before this
error occurs, the 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.
jPress f twice to snooze and to confirm the error.
jContact your local pump support (see inside back cover) to
discuss the options for further use of the Accu-Chek
Spirit Combo insulin pump.
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.
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Error E6: MECHANICAL ERROR
A mechanical error has been discovered during a routine
automatic system check and insulin delivery has stopped.
jPress f twice to snooze and to confirm the error.
jRemove or disconnect the infusion set from your infusion site.
jRemove the cartridge, adapter, infusion set, and battery from
your pump. Insert a new battery.
jIt is essential that you rewind the piston rod. Install a new
cartridge and infusion set. (See section 2.7 Inserting the
cartridge). Prime the infusion set (See section 2.8 Priming the
infusion set).
jReconnect the infusion set at your infusion site.
jPut 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 the error E7: ELECTRONIC
ERROR by pressing f. You must remove the battery instead.
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8
jRemove or disconnect the infusion set from your infusion site.
jReplace the battery in the pump (See section 2.2 Inserting the
battery).
jPrime the infusion set.
jReconnect the infusion set at your infusion site.
jPut your pump in RUN mode.
After the 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.
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.
jPress f twice to snooze and to confirm the error.
jYour pump goes into STOP mode.
jCheck the time and date and correct them if they are wrong.
See section 2.4 Setting the time and date.
jPut 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 the error E8: POWER INTERRUPT occurs during programming,
check your settings.
160
Error E9: END OF OPERATION (loan pumps only)
The pump timer of your Loaner pump has reached zero. The
pump changes to STOP mode and will no longer operate. The
error E9: END OF OPERATION appears on the display. Before this
error occurs, the 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.
jPress f twice to snooze and to confirm the error.
jContact your local pump support (details on inside back cover)
to discuss the options for further use of the Accu-Chek Spirit
Combo insulin pump.
Note This setting is country-specific and may not be visible on
your pump.
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.
Error E10: CARTRIDGE ERROR
The cartridge change function was not correctly performed.
jPress f twice to snooze and to confirm the error.
jRemove or disconnect the infusion set from your infusion site.
jRemove the cartridge.
jReinsert the cartridge. (See section 2.7 Inserting the cartridge)
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8
jPrime the infusion set.
jReconnect the infusion set at your infusion site.
jPut your pump into RUN mode.
jIf the error E10: CARTRIDGE ERROR occurs during the
rewinding of the piston rod, insert a new battery in the pump
and repeat the procedure.
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.
jPress f twice to snooze and to confirm the error.
jRemove or disconnect the infusion set from your infusion site.
jPrime the infusion set (See section 2.8 Priming the infusion set).
jReconnect the infusion set at your infusion site.
jPut your pump in RUN mode.
See sections 3.5 Changing the cartridge and infusion set and
2.8 Priming the infusion set.
w 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.
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Error E12: DATA INTERRUPTED
c 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 PC was interrupted
before it was completed.
jPress f twice to snooze and to confirm the error.
jRestart 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.
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8
Error E13: LANGUAGE ERROR
The language setting needs to be checked.
jPress f twice to snooze and to confirm the error.
jFollow the steps in section 5.6 Pump settings to change the
language.
jPut your pump in RUN mode.
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8.4 List of reminders
Reminder R1: REMINDER
A reminder has been programmed on the pump.
jPress f twice to snooze and to confirm the reminder.
jIf necessary, put your pump in RUN mode.
Note 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.
Reminder R2: END OF WARRANTY
The 4-year warranty covering your insulin pump has expired. For
any questions and concerns about the warranty, contact your
local pump support (see inside back cover).
jPress f twice to snooze and to confirm the reminder.
jPut your pump in RUN mode if necessary.
165
9
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 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 (User’s Manual) coming with the meter.
Although your pump has an internal security check system, it
cannot, for example, detect if your infusion set is leaking, if an
empty cartridge has been inserted instead of a filled cartridge or
if the insulin you are using has lost its efficacy. 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.
166
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.
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.
167
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.
168
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).
Disconnect from the headset and 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. Reconnect to the headset.
169
A
Appendix A: Technical data
General Technical Data
HVIN Accu-Chek Spirit Combo
Maximum dimensions
(without adapter)
Approx. 82.5 × 56 × 21 mm
(3.2 × 2.2 × 0.8 inches)
Weight jempty insulin pump: approx. 80 g (2.8 ounces)
jinsulin pump including 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)
During 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
During storage in its shipping case: 5 to 85 % relative humidity
During transport: 5 to 95 % relative humidity
Barometric pressure
(simplified calculation based on
standard atmosphere)
Altitude: approx. –300 to +5400 m
During operation: 50 to 106 kPa (500 to 1060 mbar)
During transport or storage in its shipping case: 50 to 106 kPa (500 to 1060 mbar)
170
General Technical Data
Power supply One 1.5 V AA Alkaline (LR6) or Lithium (FR6) battery or one 1.2 V rechargeable NiMH AA
(HR6) battery. Batteries should have a minimum capacity of 2500 mAh. Do not use alkaline
batteries that do not comply with IEC 60086-1. Do not use lithium batteries that do not
comply with IEC 60086-4. Do not use carbon zinc or nickel cadmium (NiCd) batteries.
Rechargeable batteries should have a minimum capacity of 2600 mAh. Only use a battery
charger officially recommended by the battery manufacturer. Do not use rechargeable
batteries that do not comply with IEC 62133.
Contact your local pump support if you intend to use a different type of battery or
rechargeable battery to the one recommended.
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] at minimum/intermediate/maximum basal rate), the battery life is
approximately:
Alkaline: 70 days with Bluetooth ® off; 30 days with Bluetooth ® on
Lithium: 200 days with Bluetooth ® off; 80 days with Bluetooth ® on
NiMH: 100 days with Bluetooth ® off; 40 days with Bluetooth ® on
Lifetime of insulin pump 6 years
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, active user menu and alarm settings) and the event memory (bolus history,
history of daily insulin totals, Temporary Basal Rate history and alarm history) are saved,
regardless of battery voltage and the time your insulin pump has been without a battery.
171
A
General Technical Data
Delivery Your Accu-Chek Spirit Combo insulin pump delivers insulin according to the programmed
hourly basal rate, 24 hours a day.
jMinimum dose: 1/20 of the hourly basal rate, delivered a maximum of 20 times per hour.
jTest interval: every 3 minutes.
Basal rate Min. 0.05 U / h, max. 50 U / h. There are 24 hourly basal rates adjustable in increments of
0.01 U / h (up to 1.00 U / h), 0.05 U / h (up to 10.0 U / h) and 0.1 U / h (up to 50.0 U / h).
Bolus The maximum bolus amount per delivery is 50 insulin units. The bolus amount for the Quick
Bolus is adjustable in increments of 0.1 U / h, 0.2 U / h, 0.5 U / h, 1.0 U / h and 2.0 U / h. For the
Standard Bolus, Extended Bolus and Multiwave Bolus, the amount is adjustable in fixed
increments of 0.1 U / h. The duration of the Extended Bolus and the Multiwave Bolus is
adjustable in intervals of 15 minutes (15 minutes up to 12 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 used by default for the next Temporary Basal Rate change.
Bolus delivery speed 12 U/min
Priming speed 12 U/min
Sound pressure In addition to tactile notification, the pump generates on average a sound pressure of at
least 45 dB.
172
General Technical Data
Maximum time before the error
E4: OCCLUSION** occurs
Plastic cartridges:
jat medium basal rate 1.0 U / h: ≤ 2 h
jat minimum basal rate 0.05 U / h: ≤ 24 h
Sanofi-Aventis Insuman Infusat glass cartridges***:
jat medium basal rate 1.0 U / h: ≤ 8 h
jat minimum basal rate 0.05 U / h: ≤ 120 h
Maximum missing volume before the
error E4: OCCLUSION** occurs
Plastic cartridges: ≤ 2.0 U
Sanofi-Aventis Insuman Infusat glass cartridges***: ≤ 8.0 U
Maximum system occlusion alarm
threshold
< 400 kPa (4.0 bar)
Maximum alarm threshold < 400 kPa (4.0 bar)
Maximum pressure 400 kPa (4.0 bar), for plastic and Sanofi-Aventis Insuman Infusat glass cartridges*** 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 The Accu-Chek Spirit 3.15 ml cartridge system and the Accu-Chek 3.15 ml plastic cartridge
with a luer-lock connection. Sanofi-Aventis Insuman Infusat cartridges*** have been
evaluated and approved for use with the Accu-Chek Spirit Combo insulin pump.
173
A
General Technical Data
Infusion sets The Accu-Chek infusion sets with a luer-lock connector.
Data transfer between pump and a PC Infrared interface
Safety system The safety concept is based on a control system which consists of two microprocessors
(1main processor and 1 supervisor processor). Whenever a defect or fault occurs in the
main processor, it is identified by the supervisor processor. If, for example, overdelivery
occurs, the motor is immediately switched off and the error E7: ELECTRONIC ERROR occurs.
The main processor and supervising processor signal the error E7 with beeps and
vibrations. In addtion, the main processor shows the specific error E7 number on the pump
display. Conversely, the main processor can also determine at any time whether the
supervisor processor is working correctly.
IPX8 Protected against the effects of temporary immersion in water under standardized
conditions (up to 60 minutes and 2.5 meters [8 feet]).
Electric shock protection The Accu-Chek Spirit Combo insulin pump and the Accu-Chek infusion sets are applied
parts of the type BF.
* See the instructions for use of the insulin you are using for information on the acceptable temperature range for operation, storage and transport.
** Determined using measurement methods according to IEC 60601-2-24:2012.
*** Insuman® Infusat produced by Sanofi-Aventis Deutschland GmbH is a registered trademark of the Sanofi group.
174
Technical standards
Table 201: Electromagnetic emission
Guidance and manufacturer’s declaration – electromagnetic emissions
The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specified below. The customer or
the user of the Accu-Chek Spirit Combo insulin pump should ensure that it is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The Accu-Chek Spirit Combo insulin pump must emit electro-
magnetic energy in order to perform its intended function. In rare
cases, nearby electronic equipment may be affected.
RF emissions
CISPR 11
Class B The Accu-Chek Spirit Combo insulin pump 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
emissions
IEC 61000-3-3
Not applicable –
175
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 insulin pump is intended for use in the electromagnetic environment specified below. The customer or
the user of Accu-Chek Spirit Combo insulin pump should ensure that it is used in such an environment.
Immunity test standard IEC 60601 test level * Compliance level Electromagnetic environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete or ceramic tile. If floors
are covered with synthetic material, the relative humidity
should be at least 30 %.
Electrical fast
transient / bur st
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
176
Immunity test standard IEC 60601 test level * Compliance level Electromagnetic environment – guidance
Voltage dips, short
interruptions and voltage
variations on power
supply lines
IEC 61000-4-11
< 5 % UT (0.5 cycle)
40 % UT (5 cycles)
70 % UT (25 cycles)
< 5 % UT for 5s
Not applicable
Note UT is the A.C. mains voltage prior to application of the test level.
Immunity test standard IEC 60601 test level * Compliance level ** Electromagnetic environment – guidance
Power frequency
(50 / 60 Hz)
magnetic field
IEC 61000-4-8
3 A / m
30 A / m
3 A / m
30 A / m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.
* Test levels acc. to IEC/EN 60601-1-2:2007 and IEC 60601-1-2:2014
** Successfully tested by the manufacturer with 400 A/m
177
A
Table 203: Immunity electromagnetic fields (life-supporting devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specified below. The customer or
the user of the Accu-Chek Spirit Combo insulin pump 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 insulin
pump, 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 a)
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
V1 = 10 Vrms
150 kHz to 80 MHz d = 1.2 P 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 P 80 MHz to 800 MHz
Radiated RF
IEC 61000-4-3
10 V / m
800 MHz to 2.5 GHz
b) E2a = 2 V / m for
2.3 GHz to 2.5 GHz
c) E2b = 10 V / m for
800 MHz to 2.3 GHz
and 2.5 GHz to 2.7 GHz
da = 11.7 P 2.3 GHz to 2.5 GHz
db = 2.3 P 800 MHz to 2.3 GHz and
2.5 GHz to 2.7 GHz
178
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 meters (m).
Field strengths from fixed RF transmitters as determined by an electromagnetic site survey, d) should be less than the compliance
level in each frequency range. e)
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 ) Possible shorter distances outside ISM bands are not considered to have a better applicability of this table.
b
) Exclusion band for Bluetooth ® ISM 2.4 GHz communication channel
c ) Compliance band for the system equipment
d ) 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 insulin pump is used
exceeds the applicable RF compliance level above, the Accu-Chek Spirit Combo insulin pump 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.
e ) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V / m.
179
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 insulin pump.
The Accu-Chek Spirit Combo insulin pump is intended for use in electromagnetic environments in which radiated RF disturbances are
controlled. The customer or the user of the Accu-Chek Spirit Combo insulin pump can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Accu-Chek
Spirit Combo insulin pump as recommended below, according to the maximum output power of the communication equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1.2 P
80 MHz to 800 MHz
d = 1.2 P
800 MHz to 2.3 GHz
db = 2.3 P
2.3 GHz to 2.5 GHz
da = 11.7 P
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.
180
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 or portable communications equipment could cause
interference if it is inadvertenly brought into the vicinity of the
user.
181
A
Accuracy of flow rate for the Accu-Chek 3.15 ml plastic cartridges and the
Accu-Chek Spirit 3.15 ml cartridge system
* The measurements were made at a medium basal rate of 1.0 U / h according to IEC 60601-2-24:2012 with an Accu-Chek TenderLink infusion set 17 / 110 at room
temperature.
The maximum deviation of the delivered amount (overall mean
percentage error of flow rate) for U100 insulin is ≤ ±5 %*, where
your Accu-Chek Spirit Combo insulin pump is located ≤ 1 m (3.3
feet) above / below the infusion site.
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.
percentage error of flow rate (%)
20
0
–
10
–
15
–
20
060 120 180 300 660 780 960240 360 540 600 840
10
5
420 480 720 900
–5
15
– 8.17
–3.17 –2.58 –2.18
– 0.18
0.22
0.82
3.81
–1.97
– 0.81
-1.79
-1.02
A= –1.38
observation window duration (min)
minimum measured variation
maximum measured variation
overall percentage error
182
Start-up graph over the stabilization period
The start-up graph shows changes in the flow rate over the
stabilization time.
flow rate (ml / h)
0.012
0.006
0.004
0.002
0.000
0 120 240 360 600 1080 1200 1
440
480 720 840 960 1320
0.010
0.008
time (min)
real flow
target flow
0.01 ml is equivalent
to 1 U (U100 insulin)
183
A
Accuracy of flow rate for the Accu-Chek 3.15 ml plastic
cartridges and the Accu-Chek Spirit 3.15 ml cartridge
system at minimum hourly basal rate of 0.05 U/h
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.
percentage error of flow rate (%)
50
100
–
150
–250
–300
–350
060 120 180 300 660 780 960240 360 540 600 840
–50
–
100
420 480 720 900
–
200
0
– 292.0000
–86.0000
–39.2000
– 20.7273 – 12.4211 – 8.0000
68.0000
22.0000 11.2000 5.0909 2.3158
observation window duration (min)
minimum measured variation
maximum measured variation
overall percentage error
The maximum deviation of the delivered amount (overall mean
percentage error of flow rate) for U100 insulin is ≤ 30%*.
It is in the responsibility of the health care professional to
decide whether the accuracy of the flow rate is sufficient
for the according patient.
* The measurements were made at the minimum rate of 0.05U/h according to IEC 60601-2-24:2012 with an Accu-Chek TenderLink Infusion set 17/110 at room
temperature.
184
Start-up graph over the stabilization period
The start-up graph shows changes in the flow rate over the
stabilization time.
flow rate (ml / h)
1455
1485
1515
1545
1575
1605
1635
1665
1695
1725
1755
1785
1815
1845
1875
1905
1935
1965
1995
2025
2055
2085
2115
2145
2175
2205
2235
2265
2295
2325
2355
2385
2415
2445
2475
2505
2535
2565
2595
2625
2655
2685
2715
2745
2775
2805
2835
2865
2895
2925
0.002
0.000
–0.002
time (min)
real flow
target flow
0.01 ml is equivalent
to 1 U (U100 insulin)
Bolus
For U100 insulin the maximum deviation of
a maximum bolus (25 U and 50 U) is ≤ ±5 % and
the maximum deviation of a minimum bolus (0.1 U) is ≤ ±30 %*.
* The measurements were made according to IEC 60601-2-24:2012 with an Accu-Chek Rapid-D Link infusion set 12 / 100 at room temperature.
185
B
Appendix B: Configuration parameters
Typical range available on the
pump and standard
parameter settings*
Maximum parameter range
adjustable with the
Accu-Chek 360° configuration
software
Basal rate
Hourly basal rate + max. TBR
(hourly basal rate combined with temporary basal rate, max.
increase)
62.5 U / h max . amount : 0 – 250.0 U / h
Default basal rate 0 U/h 0–50 U/h
Hourly basal rate increment 0.01 U/h (up to 1.00 U / h),
0.05 U/h (up to 10.0 U / h) and
0.1 U/h (up to 50.0 U / h) 0.0 U/h, 0.05 – 50.0 U / h
Hourly basal rates 25.0 U / h max. amount: 0 – 5 0.0 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
5
off
1–5
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.
186
Typical range available on the
pump and standard
parameter settings*
Maximum parameter range
adjustable with the
Accu-Chek 360° configuration
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 U, 0.2 U, 0.5 U, 1.0 U or 2.0 U
15 min–50 h
15 min, 30 min, 1 h
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
* 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.
187
B
Typical range available on the
pump and standard
parameter settings*
Maximum parameter range
adjustable with the
Accu-Chek 360° configuration
software
Battery type AA (LR6) ALKALINE, AA (FR6)
LITHIUM or AA (HR6) NiMH
rechargeable battery
Key Lock On or Off
Automatic off On (1–24 h) or Off (0 h)
Reminder On or Off
If On: occurs once or every day
Time format European (24 h) or
America n (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.
188
Cartridges
Name Comments
Accu-Chek Spirit 3.15 ml
cartridge system
Accu-Chek 3.15 ml plastic
cartridge
Sanofi-Aventis Insuman
Infusat Prefilled 3.15 ml
Glass Cartridges* (U100)
Plastic cartridges are single-use
items only. Do not re-use cart ridges.
Refer to the instructions for use of
the insulin you are using for
information on the acceptable
temperature range for storage and
handling.
* Insuman® Infusat produced by Sanofi-Aventis Deutschland GmbH is a
registered trademark of the Sanofi group.
Accu-Chek infusion sets
Name Comments
Accu-Chek Rapid-D
Accu-Chek Rapid-D Link
Accu-Chek Tender
Accu-Chek TenderLink
Accu-Chek FlexLink
Accu-Chek Ultraflex
All Accu-Chek infusion sets are
available with various tubing and
cannula lengths. All infusion sets
listed on the left 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.
Appendix C: Sterile products and accessories
189
C
Accessories
Name Comments
Adapter
Battery cover
Adapter and battery cover are part
of the Accu-Chek Spirit Combo
service pack and the Accu-Chek
Spirit Combo service pack small.
Replace your adapter and battery
cover every 2 months.
Batteries One 1.5 V, AA alkaline (LR6)
battery compliant with IEC
60086-1 or one lithium (FR6)
battery compliant with IEC
60086-4. The Accu-Chek Spirit
Combo insulin pump was
successfully tested with a Varta
Power One alkaline LR6, AA, 1.5 V
battery which complies with IEC
60086-1 and with an Energizer
Ultimate Lithium FR6, AA, 1.5 V
battery which complies with IEC
60086-4. The battery should have
a minimum capacity of 2500 mAh.
For battery lifetime see p. 170
Lifetime of battery
Name Comments
Rechargeable batteries Rechargeable batteries are not
provided by Roche. Only use a
battery charger officially
recommended by the battery
manufacturer.
One 1.5 V, AA alkaline (LR06)
battery compliant with IEC
60086-1 or one lithium (FR06)
battery compliant with IEC
60086-4. The Accu-Chek Spirit
Combo insulin pump was
successfully tested with a Varta
Power One alkaline LR06, AA, 1.5
V battery which complies with IEC
60086-1 and with an Energizer
Ultimate Lithium FR06, AA, 1.5 V
battery which complies with IEC
60086-4. The battery should have
a minimum capacity of 2500 mAh.
For battery lifetime see p. 170
Lifetime of battery
190
Name Comments
Carrying systems All Accu-Chek Spirit Combo and
Accu-Chek Spirit carrying systems
are compatible with the Accu-Chek
Spirit Combo insulin pump. Roche
offers a wide range of carrying
system solutions to best fit your
lifestyle.
Accu-Chek 360°
configuration software
Check with your local pump
support for the availability of
appropriate pump programming
software.
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.
191
D
Appendix D: Abbreviations
Abbreviation Meaning
approx. Approximately
BRP Basal rate profile
hH our (s)
IEC International Electrotechnical Commission
IR Infrared
kPa Kilopascal
LCD Liquid Crystal Display
NiMH Nickel Metal Hydrid (used with rechargeable
batteries)
PC Personal Computer
sec. Seconds
Abbreviation Meaning
TBR Temporary Basal Rate
UInternational Units in context with biological
effectiveness of a certain insulin amount
U / h Amount of International Units of insulin
delivered per hour
U100 This is the insulin concentration. Each
millilitre of liquid contains 100 International
Units of insulin
dd.mm.yy European date format:
day.month.year
mm.dd.yy American date format:
month.day.year
192
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.
jDuration for very short sound = 31.25 ms ±20 %
jDuration for short sound = 62.5 ms ±20 %
jDuration for medium sound = 93.75 ms ±20 %
jDuration for long sound = 125.0 ms ±20 %
jDuration for short pause = 125.0 ms ±20 %
jDuration for medium pause = 218.75 ms ±20 %
jDuration for long pause = 500.0 ms ±20 %
Sound Function
UP KEY
Frequency: 3131 Hz ±5 %
Duration: Short sound
DOWN KEY
Frequency: 2486 Hz ±5 %
Duration: Short sound
Sound Function
MENU KEY
Frequency: 2820 Hz ±5 %
Duration: Short sound
NAVIGATION BACKWARDS
(MENU + UP KEY)
Frequency: 2763 Hz ±5 %
Duration: Short sound
EXECUTE FUNCTION (OK 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
193
E
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
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
194
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
SYSTEM TEST SUCCESSFUL
Frequency: 1043 Hz ±5 %, 1314 Hz ±5 %,
1563 Hz ±5 %,
2090 Hz ±5 %
Duration: 4 × long sound
Sound Function
COPY BASAL RATE
Frequency: 2486 Hz ±5 %, 3131 Hz ±5 %,
2486 Hz ±5 %
Duration: 3 × 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
195
E
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 %
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
196
Sound Function
OK KEY PRESSED
Frequency: 2789 Hz ±5 %
Duration: Short sound
+
CHANGED TO BASE STATE RUN BY OK KEY
(KEYS UNLOCKED)
Sequence: A12, long pause, A14
+
CHANGED TO BASE STATE RUN BY OK KEY
(KEYS LOCKED)
Sequence: A12, long pause, A15
+
CHANGED TO BASE STATE STOP BY OK
KEY (KEYS UNLOCKED)
Sequence: A12, long pause, A16
+
CHANGED TO BASE STATE STOP BY OK
KEY (KEYS LOCKED)
Sequence: A12, long pause, A17
+
CHANGED TO BASE STATE STOP BY
CANCELLATION OF FUNCTION
Sequence: A13, long pause, A16
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 %
197
E
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 %
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 %)
198
Display Symbols
Icon Meaning
Basal Lock OFF
Basal Lock ON
Basal Rate
Basal Rate Total
Battery Empty
Battery Low
Beep Volume
Bluetooth
® OFF
Icon Meaning
Bluetooth
® ON
Bluetooth
® Settings
Bluetooth
® in Remote control
mode
Beep Test
Cartridge Empty
Cartridge Full
Cartridge Low
OK
Appendix F: Symbols
199
F
Icon Meaning
Clock
Data Transfer menu
Data Transfer (to start screen)
Data Transfer running
Date
Date Format EU
Date Format US
Display contrast
Extended Bolus
Key Lock OFF
Icon Meaning
Key Lock ON
Pump timer (Call for update)
Menu Settings
Multiwave Bolus
Multiwave Bolus Immediate
My Data
Pairing Failed
Pairing Successful
Priming
Progress Bar
200
Icon Meaning
Pump Settings
Reminder
Reminder Every Day
Reminder OFF
Reminder Settings
Reminder Single
Display orientation
Beep
Beep and Vibration
Standard Bolus
Icon Meaning
Stop
Total
Temporary Basal Rate
Therapy Settings
Time and Date Settings
Units
Units per hour
Vibrations
Error
Warning
201
F
General Symbols
Icon Meaning
Consult instructions for use
Caution, refer to safety-related
notes in the instructions for use
accompanying this product.
Follow instructions for use
Temperature limitation (store at)
Use only once
Use by
Sterilized using ethylene oxide
Sterilized using irradiation
Icon Meaning
Manufacturer
Date of manufacture
Catalogue number
Batch code
Serial number
Global Trade Item Number
This product fulfils the
requirements of the European
Directive 93 / 42 / EE C on medical
devices.
202
Icon Meaning
This product also fulfils the
requirements of:
jEuropean Directive 1999/5/EC
on radio and telecommunications
terminal equipment (R&TTE).
jEuropean Directive 2011/65/EU
on the restriction of the use of
certain hazardous substances in
electrical and electronic
equipment (RoHS II).
Recommended battery
Keep away from sunlight
Keep dry
Do not use if package is damaged
Recycling
Icon Meaning
Do not throw away
Admissible humidity range
Admissible air pressure range
Fragile – handle with care!
Bluetooth
® wireless technology
Electronic device of type BF
according to the standard
IEC 60601-1. Protection against
electrical shock.
Non-ionizing radiation
203
F
Icon Meaning
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 compliance mark indicates
that the product complies with the
applicable standard and
establishes a traceable link
between the equipment and the
manufacturer, importer or their
agent responsible for compliance
and for placing it on the Australian
and New Zealand market.
Federal law (USA) restricts this
device to sale by or on the order of
a physician.
Icon Meaning
Symbol for protection against the
effect of temporary immersion in
water (up to 60 minutes and
2.5 meters [8 feet]), according to
IEC 60529.
Warning against device use in
electromagnetic or high electrical
field or environments
204
Appendix G: Warranty and Declaration of Conformity
Warranty
Any changes or modification to the devices not expressly
approved by Roche could void your operating warranty for the
Accu-Chek Spirit Combo insulin pump.
Declaration of Conformity
Roche hereby declares that the Accu-Chek Spirit Combo insulin
pump conforms with the basic requirements and other relevant
regulations of the European Directive 2014/53/EU. The currently
valid conformity declaration may be found at the following
website: http://declarations.accu-chek.com
Radio Frequency Connectivity
Bluetooth® wireless technology operating in the frequency band
of 2.400 GHz to 2.4835 GHz.
Maximum Transmitted Power
Accu-Chek Spirit Combo insulin pump: 20 mW
205
Index
A
Abbreviations .................................... 191
Accessories ...................................... 13
Adapter .................................. 14, 144, 189
ADVANCED user menu .......................... 94, 114
Air bubbles ....................... 14, 36, 40, 43, 44, 167
Alarm signals .............................. 8, 110, 166
Automatic Off ................................ 123, 154
B
Basal rate profile ..................... 115, 125, 185, 191
Battery ................... 14, 20, 148, 170, 187, 189, 198
Battery cover ........................... 15, 20, 60, 189
Battery key ....................................... 20
Beeps and melodies ............................... 192
Beep volume ........................ 9, 52, 109, 145, 166
Blood glucose levels ....................... 16, 19, 35, 71
Bluetooth
® wireless technology .............. 129, 130, 165
Bolus ........................................... 71
Bolus history .................... 75, 77, 86, 100, 151, 170
Bolus increment .................................. 120
C
Cartridge ........................................ 38
Cleaning your pump ............................... 143
Configuration parameters ........................... 185
Contact with water ......................... 61, 140, 141
CUSTOM user menu ........................... 124, 125
D
Damage to your pump ........................... 39, 41
Display contrast .................................. 112
Display orientation ................................ 111
Display screens
Function screens ................................. 7
Information screens ......................... 7, 10, 11
navigating through ................................ 4
QUICK INFO screen ............................ 6, 100
RUN screen ..................................... 5
STOP screen .................................... 6
Disposing of your pump ............................ 144
206
E
Electromagnetic immunity .......................... 177
Electromagnetic radiation ............................ 56
Emergency kit ................................. 16, 138
Exercise .................................. 29, 56, 115
Extended Bolus ......... 71, 78, 79, 81, 82, 92, 171, 186, 199
F
Features ..................................... 1, 2, 94
H
History of daily insulin totals ........... 19, 43, 102, 121, 170
Hourly basal rate ............... 5, 11, 31, 32, 166, 185, 210
I
Infection ..................... 13, 46, 48, 52, 66, 138, 144
Infusion set ...................... 6, 42, 43, 44, 46, 51, 63
Inspecting your pump .............................. 137
Insulin delivery
starting ....................................... 98
stopping .................................... 51, 98
K
Keylock ............................ 3, 12, 107, 108, 187
Keys
combining ..................................... 11
L
Language
selecting .................................. 95, 113
Leakage ................................ 36, 37, 54, 63
Luer-lock connector ............. 37, 42, 63, 64, 65, 68, 173
M
Meter
interaction with .................................. 1
pairing your pump .............................. 130
Multiwave Bolus ....... 71, 83, 84, 86, 92, 115, 171, 186, 199
P
Personalizing your pump ........................... 2, 93
Personal settings .............. 17, 29, 47, 53, 92, 115, 143
Prime amount .................................... 121
Priming ....................... 43, 44, 121, 128, 168, 199
Pump settings .................................... 107
Pump therapy
interruption of .................................. 58
Q
Quick Bolus ......... 2, 10, 72, 73, 74, 75, 79, 120, 171, 186
207
R
Reminders
list of 164, 216
Reminder Settings ............................ 118, 200
Repair of your pump ............................... 142
Rotating display .................................. 2, 4
S
Safety system .................................... 145
Scrolling ...................................... 12, 76
Sport ........................................... 56
Standard Bolus ... 71, 72, 74, 75, 76, 77, 79, 83, 171, 186, 200
Status messages ................................... 8
Status of your pump ............................... 3, 8
Sterile disposables ................................. 13
Sterile products .................. 13, 52, 63, 70, 137, 139
STOP-warning
confirming ................................ 9, 30, 52
turning off ..................................... 52
Storing your pump ................................ 144
Swimming ................................... 61, 140
Symbols
Display Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
General Symbols ............................... 201
T
Tactile signals .................................... 197
Technical Data ................................... 169
Temporary Basal Rate ... 87, 88, 89, 90, 91, 92, 150, 151, 171,
185, 191, 200, 215
Temporary Basal Rate history
viewing ...................................... 103
Therapy settings .................................. 120
Time and Date
Settings ....................................... 27
Time remaining (pump timer) ........................ 104
Transferring Data ............................... 6, 105
Travelling ........................................ 57
Troubleshooting
therapy-related issues ........................... 166
U
Unlocking Keylock ................................ 108
W
Warning history
viewing ...................................... 101
Warnings
list of 147
208
Warnings and errors ............................... 145
confirming .................................... 146
handling ...................................... 134
Warranty ..................................... 15, 204
Wearing your pump
carrying systems ......................... 55, 56, 190
in hazardous areas ............................... 56
209
Glossary
Adapter
The adapter connects the cartridge and infusion set. It has 2
seals and forms an efficient seal for the cartridge compartment
of your Accu-Chek Spirit Combo insulin pump. The 2 small vents
on the adapter allow the equalization 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 Personalizing 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 5 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.
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.
210
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 short-acting insulin or fast-
acting insulin analogue.
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.
Diabetes manager
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.
Factory settings
Your Accu-Chek Spirit Combo insulin pump is provided by Roche
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 360° configuration software.
Hourly basal rate
An hourly basal rate is the amount of insulin delivered by your
Accu-Chek Spirit Combo insulin pump 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).
211
Insulin analogue (rapid-acting)
A type of insulin created using recombinant DNA technology.
The offset time of insulin analogue is shorter than the offset time
of regular insulin.
Insulin, regular (short-acting or fast-acting)
Insulin that has the same chemical structure as insulin produced
by the human pancreas. The offset time of regular insulin is 30 to
45 minutes.
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 Diabetes manager.
Occlusion
An occlusion is a blockage which prevents the insulin from
flowing correctly from the insulin pump into the body.
Priming
Process of filling the tubing with insulin and pushing any air
bubbles out.
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. Your personal settings can also be programmed using the
Accu-Chek 360° configuration software.
212
Rapid-acting insulin analogue
See Insulin analogue (rapid acting).
Regular insulin (short-acting or fast-acting)
See Insulin, regular (short-acting or fast-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.
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.
213
Temporary Basal Rate
Temporary increase or decrease of your basal rate profile in
percentages (from 0–500 %) to match changing insulin needs
due to increased or decreased activity level, illness or stress.
U100
This is the insulin concentration. Each millilitre of liquid contains
100 International Units of insulin. Your insulin pump has been
developed exclusively for delivery of U100 short-acting insulin or
rapid-acting insulin analogue.
214
Errors
No Error What you have to do
E1 CARTRIDGE EMPTY Change the cartridge.
E2 BATTERY EMPTY Change the battery.
E3 AUTOMATIC OFF Put your Accu-Chek Spirit
Combo insulin pump into RUN if
necessary.
E4 OCCLUSION Change the cartridge and
infusion set. See section 2.6 to
2.9.
E5 END OF OPERATION Arrange for immediate
replacement of your Accu-Chek
Spirit Combo insulin pump.
Contact your healthcare
professional for alternative
insulin therapy options.
No Error What you have to do
E6 MECHANICAL ERROR See chapter 8.
E7 ELECTRONIC ERROR See chapter 8.
E8 POWER INTERRUPT See chapter 8.
E9 END OF OPERATION 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.
Quick reference table for errors, warnings and reminders
215
Warnings
No Warning What you have to do
W1 CARTRIDGE LOW Change cartridge before it is
completely empty.
W2 BATTERY LOW Replace the battery as soon as
possible.
W3 REVIEW TIME Set the time and date.
W4 CALL FOR UPDATE Contact your local pump
support.
W5 PUMP TIMER In the MY DATA menu check for
the remaining operation time
under the menu PUMP TIMER.
Arrange for replacement of
pump within the scheduled
pump operation time.
No Warning What you have to do
W6 TBR CANCELLED 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.
W7 TBR OVER 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.
216
No Warning What you have to do
W9 LOANTIME WARNING 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 Re-do pairing procedure for
insulin pump and meter. See
section 6.4 Troubleshooting the
Bluetooth
® connection in the
User’s Manual for detailed
information.
Reminder
No Reminder What you have to do
Reminder Put your Accu-Chek Spirit
Combo insulin pump into RUN if
necessary.
END OF WARRANTY Contact your local pump
support.
Some reminders and warnings are country specific and may
never occur on your pump.
217
Bluetooth
® registration
Please note that in Italy and France Bluetooth ® wireless
technology is for indoor use only.
V WI-17
This device complies with part 15 of the FCC Rules. Operation is
subject to the following 2 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. 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.
218
219
220
Your contact for assistance with and/or additional information about your Accu-Chek Spirit Combo insulin pump:
05184843001/M Last update: 2018-02
The Bluetooth
® word mark and logos are registered trademarks
owned by Bluetooth SIG, Inc. and any use of such marks by Roche
is under license.
All other product names and trademarks are the property of their
respective owners.
ACCU-CHEK, ACCU-CHEK SPIRIT COMBO, ACCU-CHEK 360°,
ACCU-CHEK TENDERLINK, ACCU-CHEK FLEXLINK,
ACCU-CHEK RAPID-D LINK and ULTRAFLEX are trademarks of
Roche.
© 2018 Roche Diabetes Care
Roche Diabetes Care GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
www.accu-chek.com