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ACCU-CHEK Spirit Combo
User Manual
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Roche ACCU-CHEK Spirit Combo User Manual

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Page 1
© 2015 Roche Diagnostics
User Guide
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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. Other trademarks and trade names are those of their respective owners.
ACCU-CHEK, ACCU-CHEK SPIRIT COMBO, ACCU-CHEK AVIVA COMBO, PERFORMA COMBO, ACCU-CHEK TENDERLINK, ACCU-CHEK FLEXLINK, ACCU-CHEK RAPIDLINK, ACCU-CHEK RAPID-D LINK and ACCU-CHEK ULTRAFLEX are trademarks of Roche.
In Canada, distributed by:
Roche Health Solutions Inc. Fishers, IN 46037, USA Toll Free 1-800-280-7801
Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.accu-chek.com
INSULIN PUMP
User Guide
en: 05957613001/E Last update: 12-2014 Master: 05184843001/K
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Your insulin pump
Your contact for assistance with and /or additional information about your Accu-Chek Spirit Combo insulin pump:
d Menu key
f OK key
a Up key
s Down key
United Kingdom
Distributed in the United Kingdom by: Roche Diabetes Care Limited Charles Avenue, Burgess Hill West Sussex, RH15 9RY, United Kingdom Accu-Chek Pump Careline UK Freephone number: 0800 731 22 91 ROI Freephone number: 1 800 88 23 51
1)
calls may be recorded for training purposes burgesshill.insulinpumps@roche.com www.accu-chek.co.uk www.accu-chek.ie
Australia
Accu-Chek Enquiry Line: 1800 251 816 Pump Support: 1800 633 457 www.accu-chek.com.au
New Zealand
Accu-Chek Enquiry Line: 0800 80 22 99 Pump Hotline: 0800 696 696 www.accu-chek.co.nz
1)
:
South Africa
Accu-Chek Customer Care Centre: 080-DIABETES (Dial 080-34-22-38-37) www.diabetes.co.za
India
Accu-Chek Customer Helpline: 1800 120 6020 (Toll-free) www.accu-chek.in
Canada
Accu-Chek Pump Support: 1-800-688-4578 (toll free) www.accu-chek.ca
Singapore
Accu-Chek ExtraCare line: 6272 9200 www.accu-chek.com.sg
Adapter
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Luer lock of infusion setCartridge compartment with cartridge
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Pump details and accessories
Battery Battery cover
Infrared window (next to Battery cover)
Battery key
Adapter
Cartridge Compartment
Cartridge
Cartridge plungerEnd platePiston rod
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Overview of ADVANCED user menu
j Press d to move forwards j Press d + a simultaneously
to move backwards
j Press f to select or save j Press a to go up j Press s to go down
BRP
= Basal Rate Prole 2–4
RUN
STOP
f
f
BRP 4
BRP 3
BRP 2
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BRP 4
BRP 3
BRP 2
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Overview of STANDARD and CUSTOM user menus
Accessible menus in CUSTOM user menu can be selected using Accu-Chek PC software (sold separately).
j Press d to move forwards j Press d + a simultaneously
to move backwards
j Press f to select or save j Press a for up j Press s for down
not accessible in STANDARD
=
user menu
RUN
STOP
f
f
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Dear Accu-Chek Spirit Combo insulin pump user,
This User Guide is provided for you, as a diabetes patient, and for healthcare professionals. It contains all the necessary information
for safe and efcient use of your Accu-Chek Spirit Combo insulin
pump. Regardless of your level of experience with pump therapy, please read this document carefully before beginning insulin
pump therapy. Always refer to this document rst, when you
have questions about or have problems using your insulin pump.
If you cannot nd the solution to your problem in this document,
then we recommend that you contact your local pump support.
You will nd 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 exact 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.
Do not use your pump for the delivery of medication other than U100 short-acting regular human insulin or rapid-acting insulin analogue.
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.
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About this User Guide
To ensure safe and convenient use of your new Accu-Chek Spirit Combo insulin pump, some information in this User Guide requires particular attention. This information is presented as “Warning”, “Caution” or “Note”.
j A “Warning” informs you about risks to your health. Neglecting
this information may even lead to life-threatening situations in some cases.
j A “Caution” informs you about risks to your device. Malfunction
or damage may result if you do not follow these instructions.
j A “Note” contains important information relating the efcient
and smooth operation of your new Accu-Chek Spirit Combo insulin pump.
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1 Understanding your new system 7
1.1 Overview 7
1.2 Display and sounds 9
1.3 Keys and key combinations 15
1.4 Accessories and disposables 19
1.5 Emergency kit 22
1.6 General safety information 23
2 Getting started 25
2.1 Before you begin 25
2.2 Inserting the battery 25
2.3 Start-up process 29
2.4 Setting the time and date 32
2.5 Your basal rate prole 35
2.6 Connecting the cartridge, adapter and infusion set 42
2.7 Inserting the cartridge 44
2.8 Priming the infusion set 49
2.9 Positioning the infusion set 52
2.10 Starting insulin delivery 55
2.11 Stopping insulin delivery 56
2.12 General safety information 57
3 Using your pump in daily life 61
3.1 Wearing your pump 61
3.2 Interruption of insulin pump therapy 64
3.3 Your insulin pump and water 67
3.4 Changing the infusion set 69
3.5 Changing the cartridge and infusion set 73
3.6 General safety information 76
4 Boluses and Temporary Basal Rates 77
4.1 Understanding boluses 77
4.2 Programming a Standard Bolus 78
4.3 Programming an Extended Bolus 84
4.4 Programming a Multiwave Bolus 89
4.5 Programming a Temporary Basal Rate (TBR) 93
4.6 General safety information 98
5 Personalizing your pump 99
5.1 Introduction 99
5.2 Selecting a user menu 101
5.3 STANDARD user menu 103
5.4 Viewing your pump data 105
5.5 Transferring your data to a computer 111
5.6 Pump settings 113
5.7 ADVANCED user menu 120
5.8 Basal rate proles 121
5.9 Setting a Reminder 124
5.10 Therapy settings 126
5.11 CUSTOM user menu 130
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6 Using the Accu-Chek Spirit Combo insulin
pump with the Meter
6.1 Meter 133
6.2 Switching Bluetooth ® ON and OFF 135
6.3 Pairing your pump with the Meter 136
6.4 Troubleshooting the Bluetooth ® connection 139
133
7 Care and Maintenance 143
7.1 Inspecting your pump 143
7.2 Damage to your pump 145
7.3 Your insulin pump and water 146
7.4 Repair of your pump 148
7.5 Maintaining your pump 149
7.6 Storing your pump 150
7.7 Disposing of your pump 150
8 Warnings and Errors 151
8.1 Conrming a Warning or Error 152
8.2 List of Warnings 153
8.3 List of Errors 159
8.4 List of Reminders 170
Appendix A: Technical Data 175
Appendix B: Conguration parameters 189
Appendix C: Sterile products and accessories 192 Appendix D: Abbreviations 194 Appendix E: Beeps and melodies 195 Appendix F: Symbols 201 Appendix G: Warranty 207 Glossary 208 Index 213 Quick reference table for Errors, Warnings and Reminders 217 Reminder 219 Bluetooth ® registration 220 My notes 222
9 Troubleshooting 171
9.1 Therapy-related issues 172
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1 Understanding your new system
1.1 Overview
1
Your Accu-Chek Spirit Combo insulin pump has many helpful
features that help to ensure safe and efcient pump therapy.
Note In this User Guide the term “Meter” always refers to the
Accu-Chek Aviva Combo Blood Glucose Meter or Accu-Chek Performa Combo Blood Glucose Meter*.
1.1.1 Summary of features
Interaction with the Meter
The Accu-Chek Spirit Combo insulin pump is designed for use with the Meter. This new product is an intelligent blood glucose meter that can remote control the pump using Bluetooth wireless technology.
* The Accu-Chek Performa Combo Blood Glucose Meter has not been licensed
for sale in Canada.
®
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.
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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.
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.
CUSTOM The CUSTOM menu enables you to
ne-tune your pump according to your
personal needs and skill level.
See chapter 5 Personalizing your pump.
Five basal rate proles
You can choose from 5 basal rate proles, in line with your
different daily routines.
Four bolus types
Your Accu-Chek Spirit Combo insulin pump enables you to program 4 bolus types, each corresponding to different situations you
may encounter, and this provides you with a lot of exibility.
8
Dual signalling of Warnings and Errors
For your safety, Warnings and Errors are signalled using both audible beeps and vibration of the pump. In addition, the beep
tones are fully adjustable – from silent to loud.
Data transfer
The infrared port on the bottom of your Accu-Chek Spirit Combo insulin pump enables you to transfer information between your pump and a personal computer or handheld device.
Rotating display
Your pump’s display can be rotated through 180 degrees, and you can also adjust its contrast. Combined with the backlight, these features make the display easier to read.
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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 pump to prevent the accidental activation of functions. 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 be aware of changes or malfunctions in your pump.
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1.2.1 Backlight
1.2.2 Rotating display
The backlight helps you to read the information on the display in poorly-lit areas. You can turn on the backlight while in RUN or STOP mode, or when navigating through the menus, by pressing a.
The backlight turns on automatically when a Reminder, Warning or Error message is displayed, and turns off automatically after 10 seconds if no further keys are pressed.
Tip: In poorly-lit areas, begin programming with the a.
Your pump’s display can be rotated through 180 degrees. See section 5.6.4 Display orientation. Note that when you rotate the display, the s and a key functions are 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.
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1
1.2.3 Display screens
The screens displayed by your pump relate to one of following modes:
j RUN, STOP and Quick Info j Information j Function j Set-up
The Information, Function and Set-up screens are all accessed from the user menus. See section 5.2 Selecting a user menu.
Note To save battery life, the screen of your Accu-Chek
Spirit Combo insulin pump goes blank when you do not press any key for more than 20 seconds. As long as your pump is showing a blank screen, you have to press any key before any other operation can be performed.
RUN screen
By default the screen is blank, to save energy, and becomes blank again after 20 seconds. By pressing any key, the RUN screen is displayed when the pump is in RUN mode. This means that insulin is being delivered to your body according to the basal rate you have programmed.
Time
Active basal rate prole
The above screen shows all the possible symbols, including the current time, the current basal rate prole, and the current hourly basal rate in units per hour.
Current hourly basal rate
Key Lock locked
Pump timer
Cartridge low
Battery low
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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.
Time
Date
Key Lock unlocked
Pump timer
Cartridge low
Battery low
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
j programming specic functions j changing the cartridge and / or the infusion set j priming the infusion set j transferring data to or from the pump j changing the battery
QUICK INFO menu
You display the QUICK INFO screen by pressing the f key while in RUN or STOP mode. The QUICK INFO screen shows the remaining insulin content of the cartridge in units.
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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 rst menu choice.)
3. When you reach the screen of your choice, press the
f button. The next set of screens are called Function screens, and all relate to the choice you have just made. There may be one or several Function screens.
4. Press the s or a key to increase or decrease the
displayed value, or press the d key again to move to the next Function screen to make further changes. (After you
reach the last Function screen, you will return to the rst
Function screen.)
5. Press the f button to save your changes.
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You can move backwards through the main menu screens by pressing the d key and a key simultaneously. In any sub-menu the same key combination will move you back to the main menu screen.
Note Changes that you made in the sub-menu 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.
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1
To turn off the STOP-Warning, press either a or s for 3 seconds. You then hear a melody, con rming that the STOP-
Warning has been turned off. If you press the key too brie y, 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
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The following table lists the keys and their functions.
Key Name Function
d Menu j Move through menus, function screens
and information screens
f OK j Select a menu
j Save changes and exit the function and
information screens
j View the QUICK INFO screen
a Up j Move forward in the information screens
j Increase a setting j Turn on the backlight j Program a Quick Bolus j Cancel a Quick Bolus j Turn off the STOP-Warning (press and
hold 3 sec. until you hear a melody)
Key Name Function
s Down j Move backward in the information
screens
j Decrease a setting j Program a Quick Bolus j Cancel a Quick Bolus j Turn 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 ngernail, as this could damage the casing of your
Accu-Chek Spirit Combo insulin pump. Instead, use the pad of
your ngertip to avoid puncturing the keys.
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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 buttons must be pressed at the same time.
Combination Function
d + a j Exits menus, function
screens and information screens without saving your changes.
j Moves you to a previous
menu.
d + s j Unlocks the keys. Press
and hold both buttons until you hear 3 short beeps (RUN mode) or 3 long beeps (STOP mode).
a + s j Copies 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).
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1.3.2 Scrolling
1.3.3 Locking the keys
To enter larger or smaller values, the a and s keys must sometimes be pressed several times until the desired value is
shown, with each press of the key changing the gure 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.
The Key Lock feature enables you to lock all 4 keys on your Accu-Chek Spirit Combo insulin pump. This is a valuable safety measure that prevents you from accidentally activating your pump. For example, you can use 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.
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1
1.4 Accessories and disposables
High-quality sterile disposables and accessories are a vital part of the Accu-Chek Spirit Combo insulin pump system, and help to ensure safe pump therapy. Always follow the instructions
provided by your doctor or healthcare team – as well as the printed instructions included with the product – relating to the
use of these items.
Note Use your insulin pump, sterile disposables and accesso-
ries for the rst time in the presence of your doctor or
healthcare team.
1.4.1 Sterile disposables
Each sterile disposable, such as cartridge or infusion set, should be used only once, as re-using these products could lead to infection or could damage your pump. Do not use a sterile product if the package has been damaged or opened.
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 Accu-Chek brand sterile products and genuine Accu-Chek Spirit Combo insulin pump accessories.
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1.4.2 Adapter
vents
grip
seal
thread
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 one AA 1.5 V battery in order to function. Use AA high-quality alkaline LR6 or lithium FR6 batteries that have a minimum capacity of 2500 mAh. Do not use carbon zinc or nickel cadmium (NiCd) batteries.
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
If you prefer, you can use rechargeable batteries – in this case,
use AA 1.2 V NiMH HR6 batteries with a minimum capacity of 2500 mAh. Always use a battery charger recommended by the
battery manufacturer. See Appendix A Technical Data p. 176. 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.
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1
c CAUTION
Use of batteries other than those recommended may signi­cantly 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.
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1.5 Emergency kit
It is highly recommended to keep accessories and disposables with you in case of an emergency. This enables you to change these items if necessary. Such an emergency kit should contain:
j An Accu-Chek infusion set j A new AA alkaline or lithium battery j An Accu-Chek Spirit 3.15 ml Cartridge System j An insulin pen or syringe for alternative therapy j A vial of insulin j Treatment for low blood glucose levels j Blood glucose monitoring equipment
(such as an Accu-Chek blood glucose meter)
j A disinfectant for skin j A battery key j A battery cover j An 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.
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1.6 General safety information
1
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 .
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.
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2 Getting started
2
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 communication with your pump using Bluetooth wireless technology.
®
2.2 Inserting the battery
Your Accu-Chek Spirit Combo insulin pump turns on as soon as you insert the battery. When you remove the battery, your pump keeps track of the time and date for about one hour. Your insulin pump settings (such as the hourly basal rates, bolus increment and active user menu) and the event memory (bolus and alarm history, history of daily insulin totals and Temporary Basal Rates) are always saved, regardless of battery condition or the amount of time your pump has been without a battery. See section
1.4.3 Battery for information on batteries (both disposable and rechargeable types).
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Procedure for inserting and changing the battery
1.
2.
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.
Remove or disconnect your infusion set from the infusion site, to ensure that there is no risk of accidental insulin delivery.
3.
4.
Remove the battery cover.
Use the battery key to turn the battery cover anti-clockwise. Make sure that the opening of the battery compartment and the seal are clean and undamaged. Where appropriate, remove the old battery.
Insert the battery, negative (–) end  rst,
positive (+) end up, into the compartment.
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2
5.
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). In case the pump does not begin the start-up process after inserting the battery, make sure that the battery is inserted
correctly (negative end  rst).
6.
Use the battery key to fully tighten the battery cover. You can verify that the battery cover is correctly tightened by checking that it is in line with the pump casing. Do not over-tighten.
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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 conrm 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.
28
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2
2.3 Start-up process
Your pump runs a start-up process when you insert a battery or when you change the cartridge. During this process, your pump performs a series of internal tests.
When you … Then …
change only the cartridge
the start-up process begins at the SELF-TEST screen.
w WARNING
When you … Then …
change the battery the whole start-up process is
performed.
Start-up process sequence
1. 2. 3.
The software version screen appears. The Accu-Chek logo appears. The SELF-TEST screen appears.
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.
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4. 5.
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 notied 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 notied 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)
30
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6. 7.
The display then goes blank. Check that the display is empty. (The backlight turns on during this step.)
The display then shows a pattern. Check that the pattern is even.
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8. 9. 10.
2
The display turns black. Check that the display is completely black.
11.
The end of the start-up process is signalled by a melody, and the pump displays the STOP screen.
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.
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 rst
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).
After the self-test, press a or s to select the type of battery you inserted.
Press f to save and exit.
c CAUTION
Make sure that you choose the correct battery type. Otherwise you may not be informed about a low battery in time.
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2.4 Setting the time and date
It is essential to set the time and date correctly, because basal rates and history information are stored on the basis of the time and date set in the pump. When you travel across time zones, make sure that the time and date are re-set correctly.
You can choose between American or European / Military time.
American European / Military
12-hour clock 24-hour clock
month / day / year day / month / year
w WARNING
Incorrect setting of the time and date can lead to incorrect basal insulin delivery. Make sure that the time and date of your pump are set correctly, to ensure correct delivery and data memory. Do not make therapy decisions based on a single result in the pump’s memory.
w WARNING
In addition, if you, your doctor, or healthcare team are reviewing your data electronically, it is essential that you synchronize the time and date of your pump with those of your blood glucose meter, your personal computer or handheld device. Otherwise, the resulting data might not be meaningful. Check these devices regularly to ensure that the settings remain synchronized.
32
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Procedure for setting the time and date
1. 2. 3.
2
Press d to move to the TIME AND DATE SETTINGS screen.
Press f to select.
4. 5. 6.
Press d to move to the YEAR screen.
Press a or s to set the year.
The HOUR screen is displayed.
Press a or s to set the hour.
Press d to move to the MONTH screen.
Press a or s to set the month.
Press d to move to the MINUTE screen.
Press a or s to set the minute.
Press d to move to the DAY screen.
Press a or s to set the day.
33
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8.7.
Press d to move to the TIME FORMAT screen.
Press a or s to set the time format.
34
Press d to move to the DATE FORMAT screen.
Press a or s to set the date format.
Press f to save and exit.
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2.5 Your basal rate prole
2
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 prole
Your Accu-Chek Spirit Combo insulin pump delivers insulin according to the programmed hourly basal rate, 24 hours a day.
This ow of insulin, measured in international units per hour (U / h), is called the basal rate prole and is calculated to meet
your basic insulin needs.
The pump can store up to 5 different basal rate proles to match your changing insulin needs – for example: Monday to Friday,
Exercise Day or Sleeping Late Day.
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 prole consists of up to 24 different hourly basal rates. Each hourly rate may be changed independently. The total of all 24 basal rates in one basal rate
prole is called the (daily) basal rate total.
Example: Basal rate prole for 18 U / 24 hours
Insulin delivery [U / h]
012345678910 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Hourly basal rate
Time
35
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Your basal rate prole should be reviewed:
j After any programming changes are made to your pump j After a new battery is inserted j After conrming the Error E7: ELECTRONIC ERROR.
Note Insulin delivery does not stop or pause during basal
rate programming.
Procedure for programming your basal rate prole
1. 2.
Press d to move to the BASAL R ATE
Press f to select.
3.
Press d to move to the rst hour.
PROGRAMMING 1 (2, 3, 4 or 5 accord­ingly) screen.
The daily BASAL RATE TOTAL is displayed.
This is always 00:00 – 01:00 (12 AM – 01 AM if the American time
format is used).
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2
4.
Press a or s or scroll to set the hourly basal rate given by your doctor or healthcare team.
6.
Continue using d and a or s to set the hourly basal rates for the remaining hours. This allows you to program your
individual basal rate prole on an
hour-by-hour basis. Continue until all 24 hours are programmed.
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
7.
Press f to conrm.
The new daily BASAL RATE TOTAL is displayed.
5.
Press d to move to the next hour.
Press f to save the prole and exit.
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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.
Press d to move to the BASAL R ATE PROGRAMMING 1 (2, 3, 4 or 5 accord­ingly) screen.
2.
Press f to select.
The daily BASAL RATE TOTAL is displayed.
3.
4. 5.
If you want to copy the rate to multiple hours, press a and s repeatedly or press and hold a and s (scroll).
Press d to move to the hourly basal
Press a and s simultaneously.
rate you want to copy.
A special beep conrms that you are
pressing the keys correctly. The same hourly basal rate is copied to the next hour.
38
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2
6.
Press f to conrm.
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 j Press f and check the new daily basal rate total.
j Press f again. Your pump returns to the RUN or STOP
screen.
undo the changes j Wait for your Accu-Chek Spirit Combo insulin pump to
return to the RUN or STOP screen, or
j Press d and a simultaneously (exit feature) to exit
the Function screen.
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Selecting a basal rate prole
When you have programmed more than
one basal rate prole (ADVANCED or
CUSTOM MENU), you can select the
required prole.
1. 2.
Press d to move to the BASAL R ATE SELECTION screen.
Press f to select.
The SELECT PROFILE for the current
basal rate prole is displayed.
3.
Press a or s to select a basal rate
prole.
The SELECT PROFILE screen and its daily basal rate total appear accordingly.
40
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4.
Press f to select the displayed prole. The new basal rate prole is active
immediately.
w WARNING
Make sure that you select an appropri-
ately programmed basal rate prole.
Otherwise there could be inappropriate insulin delivery.
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2
Note When you change your user menu for example from
ADVANCED to STANDARD, your current basal rate prole
may not appear.
If the basal rate prole number(s) you want does not appear:
j Select the ADVANCED user menu, or j Assign the basal rate prole to an available basal rate
prole number
A running Temporary Basal Rate increase or decrease
stays active, even if you change the basal rate prole 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
prole 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.
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2.6 Connecting the cartridge, adapter
and infusion set
Before you change the cartridge, adapter or infusion set, check that your pump is in good working order. See section 7.1.1 Checklist.
Insulin can ow 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).
Have the following materials ready:
j A lled Accu-Chek Spirit 3.15 ml Cartridge System with a
luer-lock connection (for lling instructions see the instructions
for use provided with this product)
j An Accu-Chek Spirit Combo insulin pump adapter j A new Accu-Chek infusion set
w WARNING
Ensure that the cartridge is at room temperature before use to prevent from air bubbles.
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Procedure to connect the cartridge, adapter and infusion set
2
1. 2.
Remove the protective cap from the cartridge. (Do not touch the cartridge tip.)
4.
Hold the adapter and twist the infusion set luer-lock connection by hand, clockwise into the adapter. Do not over-tighten.
Push the adapter all the way onto the cartridge tip, to the stop.
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.
3.
Carefully prepare a new Accu-Chek infusion set, following the instructions supplied for use.
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2.7 Inserting the cartridge
Have the following materials ready:
j A  lled Accu-Chek Spirit 3.15 ml Cartridge System with a
connected Accu-Chek Spirit Combo insulin pump adapter
j A new Accu-Chek infusion set
Procedure for inserting the cartridge
1. 2.
Press d to move to the STOP YOUR PUMP screen.
Press f to select.
The pump displays the STOP screen, and insulin delivery stops.
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.
Disconnect the infusion set.
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2
4.
Remove the cartridge, if necessary. Unscrew carefully. Do not pull the cartridge out until it is completely unscrewed.
7.
The piston rod begins to return. Do not touch or otherwise disturb the piston rod while it is rewinding, as this could result in damage to your pump.
5.
Press d to move to the CARTRIDGE CHANGE screen.
Press f to select.
8.
When the piston rod has returned completely, the CARTRIDGE VOLUME screen displays the maximum volume, 315 U.
6.
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.
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 compartment.
45
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Page 50
9.
10.
Hold your pump upright. Hold the new
see step 10
 lled cartridge so that the connected
adapter and infusion set points upwards, parallel, and close to the cartridge compartment.
46
see step 11
Make sure that the top edge of the threaded part of the adapter is level with the top of the cartridge compartment.
12.11.
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 Units.
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13. 14.
Position your insulin pump upright (with the adapter pointing upwards). Insert the cartridge into the cartridge compartment.
Twist (do not push) the adapter clockwise until it is correctly seated against the cartridge compartment.
2
It is not necessary to apply pressure. Do not over-tighten the adapter, other-
wise it will be dif cult to remove the
cartridge, adapter and cartridge plunger, and could cause damage to your pump.
15.
The cartridge is correctly inserted when the end plate of the piston rod is correctly seated against the cartridge plunger.
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16.
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.
Check that the infusion set luer-lock connector is still correctly connected to the adapter. Tighten the infusion set clockwise by hand until it sits tightly in the adapter.
47
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18.
19.
See section 2.8 Priming the infusion set. Start from step 4 in the Procedure for priming the infusion set.
Press f after correctly inserting the cartridge.
Your pump performs a self-test. See section 2.3 Start-up process.
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.
48
When the self-test process is nished, the INFUSION SET PRIMING screen is displayed.
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2.8 Priming the infusion set
2
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 lled
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 lling the cartridge and priming the infusion set, and without having the infusion set connected to your body.
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Procedure for priming the infusion set
1. 2. 3.
Press d to move to the STOP YOUR PUMP screen.
Press f to select.
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.
50
The pump displays the STOP screen, and insulin delivery stops.
5.
Make sure your infusion set is discon­nected.
Press and hold f for 3 seconds, until you hear a melody. The priming process begins.
Prepare the tubing or cannula for priming according to the infusion set’s instruc­tions for use.
6.
To ensure that any air bubbles are removed always hold your pump upright and, gently tap it with the bottom in the palm of your hand.
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7.
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.
2
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.
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2.9 Positioning the infusion set
Always follow the instructions given to you by your doctor or healthcare team and the instructions for the infusion set you are using.
Change your infusion set as frequently as recommended by the manufacturer.
2.9.1 Preparing the infusion site
Infusion site selection
Your doctor or healthcare team will help you choose your infusion site areas according to a planned rotation pattern. Avoid your waistline, bones, scar tissue, recent infusion sites, bruises and sores. Choose an infusion site at least one inch (2.5 cm) away from the navel and previous infusion sites.
Infusion site preparation
It is important to prepare the infusion site properly to reduce the risks of infection. Your doctor or healthcare team will provide you with infusion site preparation guidelines.
Have the following materials ready:
j Your Accu-Chek Spirit Combo insulin pump j A disinfectant for your skin j A new Accu-Chek infusion set
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2.9.2 Inserting the cannula
2
1.
Make sure that your pump is properly connected (including cartridge, adapter and infusion set) and correctly pro­grammed with your personal settings.
3.
Wash your hands thoroughly. Disinfect the infusion site and let it dry
4.
completely.
2.
Make sure your pump is in STOP mode.
5.
Insert the cannula of your Accu-Chek infusion set according to the instructions.
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Note If you use a soft-cannula type infusion set, you must
proceed with a bolus to ll 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.
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.
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2.10 Starting insulin delivery
Procedure for starting insulin delivery
1. 2. 3.
2
Your pump is in STOP mode. Press d to move to the START YOUR
PUMP screen.
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Press f to select. Your pump shows the RUN screen.
Insulin delivery begins within 3 minutes.
55
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2.11 Stopping insulin delivery
For your safety, you must only perform certain functions and actions when the pump is in STOP mode. These functions and actions include:
j changing the cartridge j connecting and disconnecting the adapter and / or infusion set j priming the infusion set j data transfer
Procedure to stop insulin delivery
1. 2.
Press d to move to the STOP YOUR PUMP screen.
Press f to select. Your pump returns to the STOP screen.
Your pump is now in STOP mode. No insulin is being delivered.
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.
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2.12 General safety information
2
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,
conrming that the STOP-Warning has been turned off.
If you press the key too briey, 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.
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.
57
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Page 62
w WARNING
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.
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, a Warning W6: TBR CAN­CELLED and / or a Warning W8: BOLUS CANCELLED occur(s). Press f twice for each Warning to conrm and turn them off. See section 8.2 List of Warnings.
58
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Page 63
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 ve 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:
j the cartridge contains enough insulin to last through
the night
j the time and date are set correctly
2
59
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3 Using your pump in daily life
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 elds and hazardous areas
w WARNING
Do not use your pump near electromagnetic elds such as
radar or antenna installations, high-voltage sources, X-Ray sources, computer tomography, MRI, CAT scan, and all other sources of electrical current, as they may cause your pump to fail. Insulin delivery may stop and an Error E7: ELECTRONIC ERROR may occur.
Always stop your pump, remove and leave it outside these areas. See Appendix A: Technical Data for more information
about electromagnetic elds.
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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 ammable gases or vapours could
be present. This could cause an explosion.
Always stop and remove your pump before you enter these areas. If you have questions, contact your local pump support (see inside back cover).
Your pump is designed to work in normal barometric conditions (from 500 to 1060 mbar).
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.
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3
Note Rapid and extreme changes in air pressure, for example
in an air plane that is taking off or when practising sports
like hang-gliding, can inuence insulin delivery, especially
if there are air bubbles in the cartridge or tubing. This also applies to rapid and extreme changes in temperature; for example, when leaving a heated room and going outside in cold weather.
We therefore recommend that you wear your pump close to your body, remove any air bubbles from the cartridge and tubing and also measure your blood sugar more frequently in such situations.
3.1.3 Travelling with your pump
Ask your doctor or healthcare team about any special steps you need to take before you travel. Take extra blood glucose testing
and pump supplies with you, and nd 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 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.
function is switched off
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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:
j If you stop the pump j There is a technical problem with the pump j The cartridge is leaking and /or the infusion set is leaking j There is an occlusion in the infusion set or in the headset j The cannula has slipped out of the infusion site –
you must replace the missing insulin immediately.
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3.2.1 Short interruptions
1. 2.
3
3.
Press d to move to the STOP YOUR PUMP screen.
Resuming insulin delivery
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.
1.
Reconnect your infusion set or insert a new one and put your pump into RUN mode.
Where appropriate, attach a new Accu-Chek infusion set. (See section
3.4 Changing the infusion set).
Measure your blood glucose level within 2 hours of restarting pump therapy to check the function of the system and to ensure insulin delivery.
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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.
4.3.
2.
Remove the cartridge, adapter, and infusion set.
Reinsert the adapter.
Remove the battery and reinsert the battery cover.
Store your pump properly. See section 7. 6 Storing your pump.
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3.3 Your insulin pump and water
3
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
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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:
j Cleaning solutions j Alcohol j Beverages j Oil 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.
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3.4 Changing the infusion set
3
When you change the infusion set, keep the following information in mind:
j Infusion sets are sterile products intended for single use only.
Sterility is guaranteed for unopened packaging up to the indicated expiry date. Do not use sterile products if the package is damaged.
j Correctly tighten the infusion set onto the adapter to avoid
leakage. Turn the infusion set luer-lock connector until it stops. Do not turn it any further and do not use auxiliary tools, as this may crack the infusion set luer-lock connector and result in leakage.
j Your pump cannot detect infusion set leakage. You should
inspect all parts of your infusion set regularly during the day and before you go to sleep. If there seems to be any loss of insulin and all parts are correctly tightened, look for and immediately replace a leaking component. Check your blood glucose level immediately, as insulin delivery has been interrupted. Take appropriate action according to your doctor’s or healthcare team’s instructions.
j Always disconnect your infusion set before changing a
cartridge or priming the infusion set. Otherwise, you risk uncontrolled insulin delivery into your body. Always follow the instructions for the infusion set and cartridge system you are using.
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Procedure for changing the infusion set
Have the following materials ready:
j Your Accu-Chek Spirit Combo insulin
pump
j A disinfectant for your skin j A new Accu-Chek infusion set
3.
Disconnect the transfer set from the headset.
Make sure your pump is in STOP mode.
4.
Remove the infusion set from the adapter and dispose of it correctly.
2.1.
Wash your hands thoroughly.
5.
Tip: The battery key has a notch that  ts
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.
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3
6.
Remove the used infusion headset and dispose of it correctly.
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
7.
Carefully prepare a new Accu-Chek infusion set for use.
infusion set following the instructions in section 2.9 Positioning the infusion set.
8.
Screw the Accu-Chek infusion set clockwise into the adapter. Carefully tighten the luer-lock connector by hand.
Put the pump in RUN mode. See section 2.10 Starting insulin delivery.
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Note If you use a soft-cannula type infusion set, you must
begin with a bolus to ll 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 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 the infusion headset and the infusion site immediately and contact your doctor or healthcare team.
Change the headset according to the instructions for the infusion set you are using and your doctor or healthcare team’s recommendations.
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3.5 Changing the cartridge and infusion set
Have the following materials ready:
j Your Accu-Chek Spirit Combo insulin pump j A disinfectant for your skin j A new Accu-Chek infusion set j A  lled Accu-Chek Spirit 3.15 ml Cartridge System j A new adapter (this must be changed at least every
2 months)
Procedure for changing the cartridge and infusion set
2.1. 3.
Make sure your pump is in STOP mode.
3
Wash your hands thoroughly. Remove the transfer set from the
headset.
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4 .
5.
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.
6.
Remove the adapter and cartridge from your pump by unscrewing the adapter from the pump casing.
7.
Tip: The battery key has a notch that
Remove the transfer set from the adapter and dispose of it correctly. Remove the cartridge from the adapter
 ts all Accu-Chek infusion set luer-lock
connectors. You can use the battery key to loosen the luer-lock connector
and dispose of the cartridge properly.
between your infusion set and adapter.
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3
8.
Hold the adapter to the light to check for signs of wear or dirt (especially on the seals inside and outside of the adapter).
9.
If necessary, clean the adapter using water and dry it. If it shows signs of wear or dirt, replace it immediately.
10.
Insert a new cartridge and a new infusion set. See section 2.7 Inserting the
cartridge.
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3.6 General safety information
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.
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:
j The cartridge contains enough insulin to last through
the night
j The battery level is OK j The time and date are set correctly
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4 Boluses and Temporary Basal Rates
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
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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
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.
Using Standard Bolus menu
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 conrm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED.
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Using d and f to enter the menu and then a and s to program the amount
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4.2.1 Programming a Quick Bolus
4
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  rst 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
Procedure for programming a Quick Bolus
1. 2.
From the RUN screen, press and hold s (a) until you hear a beep sequence 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  rst.
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.
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5.4.
The Standard Bolus symbol blinks for
5 seconds after the last press of a (s), your pump con rms the total bolus amount with one beep and vibration for each bolus increment programmed.
5 seconds (the bolus delivery start delay).
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.
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.
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4.2.2 Cancelling a Quick Bolus
4
During programming
(the bolus amount blinks):
During conrmation (when the beeps and vibrations occur), or During start delay (Standard Bolus symbol blinks):
During bolus delivery (countdown of bolus amount):
Note Make sure that the cancellation was deliberate, and then program a new bolus, if required.
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.
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 conrm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED.
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 conrm 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.
No bolus is delivered.
No bolus is delivered.
Bolus delivery is interrupted.
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4.2.3 Programming a Standard Bolus using Standard bolus menu
Independent of the bolus increment setting, the bolus increments for the menu-guided Standard Bolus are xed 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.
1.
Press d to move to the STANDARD BOLUS screen.
2. 3.
Press f to select. The BOLUS AMOUNT screen appears.
Press or scroll a to increase or s to decrease the bolus amount.
4.
Press f to conrm the bolus amount. The Standard Bolus symbol blinks for 5 seconds (the bolus delivery start delay).
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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
4
During programming
(the bolus amount blinks):
During the start delay (Standard Bolus symbol blinks):
During bolus delivery (countdown of bolus amount):
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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.
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 conrm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED.
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.
No bolus is delivered.
No bolus is delivered.
Bolus delivery is interrupted.
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Cancellation during the start delay and during the bolus delivery will cause a WARNING W8: BOLUS CANCELLED. Press f twice to conrm and snooze the Warning. See chapter 8.
Note Make sure that the cancellation was deliberate and
program a new bolus, if needed.
4.3 Programming an Extended Bolus
The Extended Bolus option enables you to program a bolus to be delivered over a period of time. This function is helpful during long meals, dinners, or receptions, or when you have meals that are digested slowly. The Extended Bolus may also be appropriate for people who have gastroparesis (delayed digestion).
The duration of bolus delivery can be programmed in 15-minute intervals up to 12 hours and begins immediately after conrma­tion. 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.
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4
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”.
Procedure for programming an Extended Bolus
1. 2. 3.
Press d to move to the EXTENDED BOLUS screen.
Press f to select. The BOLUS AMOUNT screen appears.
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.
Press a to increase or s to decrease the bolus amount.
The duration of the last Extended Bolus delivered appears.
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4. 5.
Tip: Press d to switch between
programming the bolus amount and bolus duration.
Press d to move to the BOLUS DURATION screen.
Press a to increase or s to decrease the bolus duration.
Note If a Temporary Basal Rate is active at the same time as
the Extended Bolus, the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed in the RUN screen.
86
Press f to conrm the bolus amount and duration. The pump returns to the RUN screen. The bolus delivery begins within the next 3 minutes.
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4.3.1 Cancelling an Extended Bolus
4
During programming
(the bolus amount or bolus duration blinks):
During bolus delivery j If the Extended Bolus delivery has begun, it can be cancelled by putting your
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.
pump into STOP mode. This cancels the bolus delivery and a Warning W8: BOLUS CANCELLED is displayed. Press f twice to conrm 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.
No bolus is delivered.
Bolus delivery is interrupted.
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Note If a Temporary Basal Rate is active at the same time,
it is also cancelled when your pump is put into STOP mode. A Warning W8: BOLUS CANCELLED and a Warning W6: TBR CANCELLED are displayed. Press f twice to conrm and turn off the rst Warning. The second alert appears on the display. Press f twice
to conrm 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.
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4.4 Programming a Multiwave Bolus
4
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.
j You can add a Standard Bolus to an ongoing Multiwave
Bolus. If you cancel the Standard Bolus, the Multiwave Bolus remains running.
j During the delivery of a Multiwave Bolus, the program-
ming 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.
When programming a Multiwave Bolus, make sure that you are using the ADVANCED user menu and your pump is in RUN mode.
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Procedure for programming a Multiwave Bolus
1. 2. 3.
Press d to move to the Multiwave Bolus screen.
Note The rst 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.
90
Press f to select. The BOLUS AMOUNT screen appears.
4.
Press d to move to the IMMEDIATE BOLUS screen.
Press a or s to correct and set the immediate bolus amount.
Press a or s to increase or decrease the total bolus amount.
5.
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.
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4
Tip: Press d to loop between program-
ming the total BOLUS AMOUNT, IMMEDI­ATE BOLUS and BOLUS DURATION.
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.
6.
Check the total and immediate bolus amounts and the Extended Bolus duration programmed on the screens.
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.
Press f to conrm both bolus amounts and the bolus duration. The Multiwave Bolus symbol blinks for 5 seconds (bolus delivery start delay).
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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.
During the start delay (Multiwave symbol
j Press d + a, s or a. The pump beeps and vibrates. The pump
returns to the RUN screen.
blinks):
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).
During extended delivery
j You can cancel the extended delivery by putting the pump in STOP mode.
This cancels the Extended Bolus.
Cancellation of the bolus during start delay, immediate bolus delivery and extended delivery will cause a Warning W8: BOLUS CANCELLED. Press f twice to conrm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED.
No bolus is delivered.
No bolus is delivered.
Bolus delivery is interrupted.
Bolus delivery is interrupted.
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.
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4
Note If a Temporary Basal Rate is active at the same time, it is
also cancelled when your pump is put in STOP mode. The Warning W8: BOLUS CANCELLED and a Warning W6: TBR CANCELLED is displayed. Press f twice to conrm and turn off the rst Warning. The second Warning appears on the display. Press f
twice to conrm 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:
j Increase it to 250 % for up to 24 hours j Decrease it to 0 % for up to 24 hours
When you increase or decrease your basal rate, each hourly basal rate for the duration you program is increased or de-
creased. The characteristic shape of your basal rate prole remains and does not become a at curve, if the change is larger than 0 %. For 0 % the basal rate prole becomes a at line and
no insulin (except boluses) is delivered during the programmed duration.
Discuss programming a Temporary Basal Rate with your doctor or healthcare team.
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Note A running Temporary Basal Rate increase or decrease
remains active, even if you have changed the basal rate
prole.
You can only program a Temporary Basal Rate when your pump is in RUN mode.
Procedure for programming a Temporary Basal Rate
1. 2.
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
Press d to move to the TEMPORARY BASAL RATE (TBR) screen.
Press f to select. The TBR PERCENTAGE screen appears.
screen.
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4
3.
Press a or s to increase or decrease the basal rate.
Tip: You can switch between program­ming the basal rate percentage and duration by pressing d.
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 rst
time, a default value appears.
5.
Press f to save and exit.
The new Temporary Basal Rate is immediately activated.
4.
Press d to move to the TBR DURATION screen.
Press a or s to correct and set the duration.
When a Temporary Basal Rate is active, the pump emits a beep once every hour.
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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
TBR OVER Alert
At the end of a Temporary Basal Rate, a Warning W7: TBR OVER is displayed. Press f twice to conrm and turn off the Warning. See chapter 8 Warning W7: TBR OVER.
Extended Bolus symbol
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