Roche ACCU-CHEK Spirit Combo User Manual

© 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
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
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
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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24
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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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