Accu-Chek | Spirit | User guide | Accu-Chek Spirit User guide

Accu-Chek Spirit User guide
Pump Therapy
MADE FOR YOU
Pump User Guide
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Dear ACCU-CHEK® Spirit insulin pump owner,
Thank you for choosing the ACCU-CHEK Spirit insulin pump.
This guide will help you to get the most from your ACCU-CHEK Spirit insulin
pump. Even if you have used an insulin pump before, it’s important that you
do these things before you use the ACCU-CHEK Spirit insulin pump:
왘 read this guide carefully
왘 work with your doctor or healthcare team to understand how to use
the pump
왘 test your blood glucose level often to find your personal settings and
to avoid getting the wrong dosage of insulin. (An ACCU-CHEK blood
glucose meter is one way to test blood glucose levels; talk to your
doctor or healthcare team to decide the best way for you.)
It’s a good idea to inform family members or friends about diabetes and pump
therapy so that they can help you in an emergency.
Disetronic Medical Systems is proud to help you manage your diabetes therapy.
However, Disetronic Medical Systems cannot recommend specific diabetes
therapy. Always follow the instructions given to you by your doctor or healthcare
team. If you have questions about your pump, or problems with it, refer to this
guide and talk to your doctor or healthcare team. We also invite you to contact
Pump Support at 1-800-688-4578.
Note:
Your insulin pump is a valuable medical device. Consider adding your
pump to your homeowner’s insurance policy to protect you in case it is
damaged or lost. Ask your insurance agent for details.
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How to use this guide
This guide is for version 2.XX of the ACCU-CHEK Spirit insulin pump.
Note:
This user guide presents you with sample screens. The screens in this
user guide may look slightly different from your pump screens. If you
have questions about what you see on your pump, contact Pump
Support at 1-800-688-4578.
When you become familiar with your pump, you can quickly refer to the back
of this user guide for tables and definitions that can help you to understand
pump alerts and warnings, and the symbols on the pump screen. There is also
a glossary at the back that defines terms used in this guide, and a table that
lists the technical specifications for your pump. All of this information can help
you and your doctor or healthcare team to understand the pump and use it to
best manage your insulin pump therapy.
Warnings and Cautions
Read all warnings and cautions in this guide before you use the pump. This
information is important to protect your health and the function of your pump.
If you have any questions about a warning or caution, contact Pump Support
at 1-800-688-4578. Warnings and Cautions are indicated by triangles.
▲
WARNINGS are indicated by a triangle and the word
WARNING.
▲
CAUTIONS are indicated by a triangle and the word
CAUTION.
!
WARNING
!
CAUTION
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Working safely with your ACCU-CHEK Spirit insulin pump
Your ACCU-CHEK Spirit insulin pump meets the safety requirements of national
medical device legislation and meets or exceeds the international standards for
Electromagnetic Compatibility regarding the pump’s use. This section introduces
you to the intended use of the ACCU-CHEK Spirit insulin pump, to its safety
features, and to warnings and safety information you need to know while using
your pump.
While your pump is in use, two internal safety systems monitor and control the
pump’s functioning. The pump performs more than nine million safety checks
every day. If your pump detects a change from its normal state, an alert or an
error message is delivered.
See the sections “Alerts and Errors” (page 147) and “Appendix A: Technical Data”
(page 165) for information on how to address errors and alerts.
Intended use of your ACCU-CHEK Spirit insulin pump
The ACCU-CHEK Spirit insulin pump is intended for the subcutaneous continuous
delivery of insulin, at set and variable rates, for the management of diabetes
mellitus in persons requiring insulin as prescribed by a physician.
The ACCU-CHEK Spirit insulin pump is intended for the use of U100 rapidacting insulin.
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Guarantee
Any changes or modifications to the ACCU-CHEK Spirit insulin pump that
are not expressly approved by Disetronic Medical Systems, Inc. could void
the pump warranty. Do not try to fix the device yourself.
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Contents
Chapter 1: Understanding Your New System _____________________9
The ACCU-CHEK Spirit Insulin Pump __________________________9
Display ________________________________________________9
Backlight______________________________________________10
Keys and Key Combinations _______________________________11
Screens _______________________________________________13
STATUS Screen Messages, Beeps, and Vibrations_______________15
Alarm Signals __________________________________________16
Accessories and Disposables ______________________________17
Emergency Kit __________________________________________23
Chapter 2: Getting Started __________________________________25
Inserting (or Changing) the Battery__________________________25
System Check Start-Up Process ____________________________28
Setting Time and Date____________________________________32
Your Personal Settings ___________________________________35
Your Basal Rate Profile ___________________________________36
Programming Your Basal Rate Profile ________________________37
Preparing the Cartridge___________________________________42
Connecting the Cartridge, Adapter, and Infusion Set_____________47
Inserting the Cartridge ___________________________________49
Priming the Infusion Set __________________________________53
Preparing the Infusion Site and Inserting the Infusion Set ________56
Chapter 3: Using Your Pump_________________________________59
Before Using ___________________________________________59
Wearing Your Pump______________________________________59
When Not to Wear Your Pump ______________________________61
Your Insulin Pump and Water ______________________________63
Starting Insulin Delivery __________________________________65
Stopping Insulin Delivery _________________________________66
Interruption of Insulin Pump Therapy ________________________68
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Changing the Infusion Set _________________________________70
Changing the Cartridge and Infusion Set _____________________73
Chapter 4: Boluses and Temporary Basal Rates__________________75
Understanding Boluses ___________________________________75
Programming a Standard Bolus ____________________________77
Programming an Extended Bolus ___________________________83
Programming a MultiWave Bolus ___________________________88
Programming a Temporary Basal Rate (TBR) __________________93
Chapter 5: User Menus _____________________________________99
Selecting a User Menu __________________________________100
STANDARD User Menu ___________________________________103
Data Transfer__________________________________________104
Setup for Data Transfer __________________________________105
Reviewing Pump Data ___________________________________107
SETUP MENU Standard __________________________________113
ADVANCED User Menu___________________________________122
Basal Rate Profiles _____________________________________123
Alarm Clock___________________________________________127
SETUP MENU Advanced __________________________________129
CUSTOM User Menu_____________________________________136
Chapter 6: Care and Maintenance ___________________________137
Care of Your ACCU-CHEK Spirit Insulin Pump _________________137
System Inspection Checklist_________________________________
137
What to Do When You Drop Your Pump ______________________139
Storing Your ACCU-CHEK Spirit Insulin Pump _________________140
Disposal _____________________________________________140
Maintenance __________________________________________141
Repair _______________________________________________142
Troubleshooting________________________________________143
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Chapter 7: Alerts and Errors ________________________________147
Confirming an Alert or Error ______________________________148
List of Alerts __________________________________________149
List of Errors __________________________________________154
Appendixes_____________________________________________165
Appendix A: Technical Data_______________________________165
Appendix B: Configuration Parameters ______________________177
Appendix C: Abbreviations _______________________________180
Appendix D: Beeps and Melodies __________________________181
Appendix E: Vibrations __________________________________182
Appendix F: Symbols____________________________________183
Appendix G: Sterile Products and Accessories ________________188
Appendix H: Glossary ___________________________________190
Warranty _____________________________________________194
Index _________________________________________________195
Diagram of User Menus ___________________________________198
Quick Reference Table for Alerts ____________________________199
Quick Reference Table for Errors ____________________________200
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Chapter 1: Understanding Your New System
The ACCU-CHEK Spirit Insulin Pump
Display
Menu key
Up key
Down key
Check key
Infusion set
Adapter
Cartridge
!
▲
CAUTION
Check your insulin pump and its sterile products, like an
infusion set and accessories, at least every three hours.
Immediately inspect your insulin pump if it is dropped.
Do not use your insulin pump if chips or cracks are visible.
Chips and cracks may allow water, dust, insulin, or other
foreign substances to enter your insulin pump and lead
to malfunction.
Display
Your insulin pump has a Liquid Crystal Display (LCD) screen that displays
important information. Check the display at least every three hours during
the day, before you go to sleep, and if you are not able to hear the beeps or
alerts or feel the vibrations. This is the only way you will be aware of important
changes in your pump.
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CAUTION
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If you discover incomplete characters, numbers, or symbols
on the display, put your insulin pump into STOP mode and
perform a system check by simply removing the battery for a
few seconds. When you reinsert the battery the system check
will occur. If the incomplete characters, numbers, or symbols
remain, your insulin pump may need to be returned since you
may not receive the correct information for operating your
pump. Put your insulin pump into STOP mode and contact
Pump Support at 1-800-688-4578 immediately.
Note:
To make the display easier to read, you can flip the display orientation
by 180° and adjust the display contrast lighter or darker. See the sections
“Display Orientation” (page 120) and “Display Contrast” (page 135) for
more information.
Backlight
The backlight helps you to see the display in poorly lighted areas. You can turn
on the backlight from the RUN screen, from the STOP screen, or when you are
browsing the menus. Press the a key to turn on the backlight. The backlight
turns itself on when an alert or an error message appears. The backlight turns
itself off after 30 seconds if no keys are pressed.
Hint:
Start programming with the a key in areas of poor lighting as this will
also turn on the backlight.
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Keys and Key Combinations
The pump will beep each time a key is pressed, unless the beep tone is set to 0.
▲
Never press any of the keys with a sharp or pointed item
such as the tip of your fingernail. This could damage the
casing of your insulin pump. Use the pad of your fingertip
instead to avoid puncturing the keys.
!
CAUTION
Single Keys
Each key has a specific function when it is pressed by itself. The following
table describes the function of each.
Key
Name
Function
d
Menu
f
Check
a
Up
s
Down
scrolling through menus, functions, and
information screens
• selecting a menu
• saving changes and exiting screen
• viewing the QUICK INFO screen
• increasing a setting
• moving forward in the information screens
• turning on the backlight
• decreasing a setting
• moving backward in the information screens
Either a or s can be used for programming or cancelling a Standard
bolus. Pressing either key for 3 seconds (until you hear a melody) will
also temporarily turn off the STOP-Warning.
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Note:
Increase or decrease the values by pressing the a or s keys. If
you want to make large changes to a value, in most cases you can do
this faster by pressing and holding down the a or s key (scrolling)
until the number you want is displayed. If needed, the value can still
be corrected by a single press of the s or a. Your pump will beep
once when you start scrolling.
Key Combinations
Keys can be pressed in pairs for additional functions. In the following table,
a plus symbol (+) between 2 keys means that both keys must be pressed
simultaneously.
Combination
Function
d+a
• exiting menus, function screens, and
information screens without saving
• moving backwards to a previous menu
unlocking the keys (press and hold both
keys until you hear three beeps in RUN mode
and one beep in STOP mode.)
copying an hourly basal rate to the next hour(s)
d+s
a+s
▲
If the keys on your pump are not functioning properly, or you
are not able to identify them correctly, disconnect your
WARNING insulin pump and contact Pump Support at 1-800-688-4578.
!
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Locking Keys Using KeyLock Feature
The KeyLock feature lets you lock all four keys on your pump as a safety measure
against accidentally activating functions. You may want to use this function
while sleeping, or during sports, for example. The KeyLock function is turned on
in the STANDARD SETUP MENU. All instructions in this user guide are given on
the assumption that the KeyLock is off. For more information see the section
“Turning KeyLock On or Off” (page 113).
Screens
Your pump displays various screens on its display for you to access information
and functions.
RUN Screen
basal rate current hourly
time basal rate
KeyLock locked
pump timer
cartridge low
battery low
active basal rate profile
During normal use, your pump is in RUN mode and insulin is delivered into
your body based on the basal rate you have programmed. The RUN screen is
the “home” screen and is displayed when the pump is in RUN mode. After you
program or review information, the pump returns to the RUN screen. This
screen shows the current time, the current basal rate profile, and the current
hourly basal rate in units per hour. The RUN screen will also display reminder
information (such as “cartridge low”) and special functions (such as KeyLock
locked or unlocked) in the form of symbols.
See the sections “Starting Insulin Delivery” (page 65) for instructions on starting
your pump and “Appendix F: Symbols” (page 183) for more information about
the symbols.
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STOP Screen
time
date
KeyLock unlocked
pump timer
cartridge low
battery low
The STOP screen shows the current time and date, the STOP symbol, reminder
information (such as “battery low”), and special functions (such as KeyLock locked
or unlocked). Some functions must be programmed while your pump is in STOP
mode, when insulin is not being delivered. Your pump must also be in STOP mode
before you can change cartridges. Additionally, always disconnect your pump from
the infusion site and place the pump in STOP mode when you prime the infusion
set and/or when you transfer data. See the section “Stopping Insulin Delivery”
(page 66) for instructions on stopping your pump.
QUICK INFO Screen
If you press the f key from the RUN or STOP
screen, your pump displays the remaining cartridge
content in units. Symbols for activated functions and
features (like the beep and vibration alarm signals) are displayed. Your pump will
return to the RUN or STOP screen after 8 seconds.
Information, Function, and Setup Screens
You will need to access various screens so you can view stored information,
program the pump, perform a function, or change a setting. You can reach
these screens from either the RUN or STOP screen.
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Follow the steps below to navigate through the screens.
1. Press the d key to move to a screen displaying your first choice. Think
of these screens as menu choices.
2. Press the d key again to see your next choice on the menu. After you
reach the last menu choice you will “loop” back to the first menu choice.
3. When you reach the screen displaying the choice you want (e.g., SET
THE TIME AND DATE), press f. The next set of screens are called
function screens. They all relate to the choice you made. There may be
only one function screen or multiple screens.
4. Press the a or s key to increase or decrease the selected value. Or,
press the d key again to move to the next function screen you want to
change. After you reach the last function screen you will “loop” back to
the first function screen.
5. Press f to save your changes. The pump returns to the RUN or STOP
screen and the changes are saved.
Note:
The menu choices that appear depend on the menu that is selected.
Your pump can display a Standard, Advance, or Custom user menu.
See the section “User Menus” (page 99) for more information.
Pressing d+ a simultaneously lets you move backwards in the
menu structure or to return to menus you just skipped. If you are
within a function screen, pressing d+a simultaneously lets you
move up to the corresponding menu without saving the current changes.
STATUS Screen Messages, Beeps, and Vibrations
Beeps, vibrations, and messages on the display inform you of the status of
your insulin pump. Beeps and/or vibrations are used as alarm signals. Your
insulin pump also beeps when a key is pressed unless the beep volume is
turned off. The beep volume can be turned up or down.
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▲
Check the display of your insulin pump at least every three
hours during the day and before you go to sleep, especially
WARNING if for any reason you are unable to hear the beeps or feel
the vibrations. This is the only way you will be notified of
changes in your insulin pump in a suitable amount of time.
!
Alarm Signals
Your pump gives alerts and errors using beeps and vibrations. You can turn off
either the beep or the vibrations but for your safety you cannot turn off both at
the same time for the initial alarm signal. See the sections “Alerts and Errors”
(page 147), “Adjusting the Beep Volume” (page 116), and “Setting Up Alarm
Signals” (page 117) for more information.
STOP-Warning
The STOP-Warning is turned on by the pump each time your pump switches from
RUN mode to STOP mode, and when a battery is inserted. The STOP-Warning
is a long beep and a vibration occurring 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 to turn off the STOP-Warning. A melody
plays indicating the STOP-Warning is turned off.
Note:
The volume of the STOP-Warning cannot be changed. It is independent
of the programmed beep volume.
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Accessories and Disposables
Sterile products and accessories are a crucial part of the ACCU-CHEK Spirit
insulin pump system and therapy. These products are designed for safe and
simple insulin pump therapy. Always follow the instructions given by your
doctor or healthcare team for the use of all system components.
Use your ACCU-CHEK Spirit insulin pump, sterile products, and accessories
for the first time in the presence of your doctor or healthcare team.
Sterile Products
Each sterile product should be used only once. Reusing these products could
lead to infection or could damage your pump. Do not use a sterile product if
the package is damaged or opened.
Sterility is guaranteed up to the indicated expiration date for all ACCU-CHEK
sterile products that are in the original, unopened packaging.
!
▲
Your insulin pump was designed for use with U100 insulin.
Only use sterile products and accessories that are designed
WARNING for use with your insulin pump. The proper functionality
of your insulin pump can only be guaranteed if you use
ACCU-CHEK brand sterile products and ACCU-CHEK Spirit
accessories. All ACCU-CHEK brand sterile products and
accessories designed for the ACCU-CHEK Spirit insulin pump
have been thoroughly tested and approved for use with
your insulin pump. Other sterile products and accessories
have not been tested for compatibility with your insulin
pump and, if used, may therefore endanger your health
or void your warranty.
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▲
Always have extra sterile products and accessories with you.
This allows you to exchange components when needed.
CAUTION Materials designed for single use (such as cartridges and
infusion sets) should not be reused due to the increased risk
of infections, malfunctions, and/or incorrect insulin delivery.
!
See Disetronic Medical Systems’ sterile products and accessories catalogs and
brochures for more information. Or, contact Pump Support at 1-800-688-4578.
▲
Your insulin pump and its sterile products and accessories
include small component pieces that could pose a choking
WARNING hazard to children. Keep sterile products and accessories
out of the reach of children.
!
Cartridges
Your pump is designed to use ACCU-CHEK 3.15 ml plastic cartridges to hold
insulin. Do not reuse a cartridge. Reusing sterile products could lead to infection
or could damage your pump.
ACCU-CHEK 3.15 ml plastic cartridges come with a protective cartridge cap,
as well as a filling needle and plunger rod to aid in filling.
cartridge
plunger rod
plunger
cartridge protective cap
filling needle with protective cap
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The cartridges are sterile products intended for single
use only.
WARNING
Infusion Set
An ACCU-CHEK infusion set connects your pump to your body to deliver insulin.
The insulin travels from the cartridge in your insulin pump through the infusion
set into your body. The cannula or needle of the infusion set is placed under
the skin, usually in the abdominal area.
Recommended
Possible
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Use only infusion sets that have a luer-lock connector. All current ACCU-CHEK
infusion sets have luer-lock connectors and are the preferred choice for use
with your ACCU-CHEK Spirit insulin pump. All ACCU-CHEK infusion sets are PVC
free, are skin-friendly, and do not affect insulin. The diameter of the ACCU-CHEK
infusion set tubing is small for fast priming and minimal waste of insulin.
ACCU-CHEK infusion sets come in a wide range of lengths from 60 cm (24 inches)
to 110 cm (43 inches). Choose your tubing length based on how you wear
your pump. Please refer to the infusion set instructions for proper usage and
priming volumes.
Adapter
Vents
Seal inside the adapter
Seal outside the adapter
The adapter connects the cartridge to the infusion set. It has two seals to keep
water from getting into the cartridge compartment. Two vents on the adapter
allow air pressure to equalize. The adapter will not work properly if the vents are
plugged, dirty, or if the seals are worn or missing.
Change the adapter with at least every 10th cartridge change. Also change the
adapter if the seals become worn, lost, or if the vents become plugged.
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Battery
Your pump runs on one AA battery. Use AA alkaline batteries that have a minimum
capacity of 2500 mAh. Do not use lithium, carbon zinc, or nickel cadmium (NiCd)
batteries. If you prefer to use rechargeable batteries, use NiMH batteries that
have a minimum capacity of 1500 mAh. If you use rechargeable batteries, always
use a battery charger recommended by the battery manufacturer. Keep extra
batteries on hand.
!
▲
CAUTION
Using batteries other than those recommended by Disetronic
Medical Systems may significantly reduce battery usage
time. Batteries other than those recommended could leak
and corrode the battery contacts within your insulin pump.
Therefore, using batteries not supplied or recommended
by Disetronic Medical Systems, Inc. may void the warranty.
The operating temperature of the battery must be between 41°F and 104°F
(+5°C and +40°C). The life of any battery is affected by how you use your
insulin pump, your personal settings, delivery rates, temperature and other factors.
With typical pump use [50 U/day using U100 insulin; operating temperature
72°F ± 6°F (22°C ± 3°C)], pump battery life is about four weeks using alkaline
batteries and one week using rechargeable batteries.
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Note:
You must set the battery type to match the kind of battery you are
using. If you do not set the correct battery type on your pump, the
alert A2: BATTERY LOW may not give you enough time to replace your
battery. If you change from using regular batteries to rechargeable
batteries, or from rechargeable batteries to regular batteries, you must
change the battery type setting in the Standard setup menu (SETUP
MENU STANDARD).
▲
!
CAUTION
Always make sure that you remove the battery if your
insulin pump is not in use for a long time period in order
to preserve the battery lifetime. To prevent water from
entering the casing, change the battery only in a dry area.
Make sure that the seal of the battery cover is not worn
out or missing, and that the battery is properly inserted.
Battery Cover
open
Seal
The battery cover seals the battery compartment. Change the battery cover
with at least every 4th battery change.
• Remove the battery cover only in a dry area to prevent water from
getting inside the pump.
• Make sure that the seal is not worn or missing and that the battery
is properly inserted into the pump.
• Tighten or loosen the battery cover using only the ACCU-CHEK Spirit
insulin pump battery key. Knives, screwdrivers, or other sharp objects
may harm your pump.
• Do not over-tighten the battery cover. The battery cover is correctly
inserted and tightened when it is even with the pump casing.
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Battery Key
The battery key tightens and loosens the battery cover. It can also loosen the
luer-lock connection between the infusion set and adapter if it cannot be
loosened by hand. However, never use the battery key to attach or to tighten
an infusion set.
The battery key has a notch that fits all ACCU-CHEK infusion set luer-lock
connectors. The battery key should be replaced if it cracks, becomes worn,
or if it is lost.
Emergency Kit
It is a good idea to carry supplies in case of an emergency so that you can
exchange parts if you need to. An emergency kit might contain:
• A new ACCU-CHEK infusion set
• A new AA alkaline battery
• A new ACCU-CHEK 3.15 ml plastic cartridge
• A pen or syringe for alternate therapy
• A vial of insulin
• A filling aid
• Treatment for low blood glucose levels
• Blood glucose monitoring supplies (such as an ACCU-CHEK blood
glucose monitor)
• A disinfectant for skin
• A new site dressing
• The battery key
This list is only an example of what an emergency kit might contain. Ask your
doctor or healthcare team what supplies you should keep in your personal
emergency kit.
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Chapter 2: Getting Started
Inserting (or Changing) the Battery
Your pump turns on when you insert the battery. When you remove the battery,
your pump still tracks the time and date for about 1 hour. The pump will always
store your pump settings (such as the hourly basal rates, bolus increment and
active user menu) and event memory (bolus and alarm history, history of daily
insulin totals and Temporary Basal Rates) even if the battery power dies and no
matter how long your pump is without power.
See the section “Accessories and Disposables – Battery” (page 21) for information
on recommended batteries.
!
▲
Keep the Time/Date Settings Correct
Always check that the time and date of your insulin pump
WARNING are set correctly. The time and date are displayed on the
STOP screen. Incorrect programming of the time and date
may cause incorrect insulin delivery. If you, your doctor,
or healthcare team store and analyze your therapy data
electronically and the time and date of the devices used
are not set identically, the gathered data might not be
meaningful. See the section “Setting Time and Date”
(page 32) for more information.
▲
!
CAUTION
To prevent water from entering the casing, change the
battery only in a dry environment. Make sure that the
battery seal is not worn out or missing and that the
battery is properly inserted. Tighten or loosen the battery
cover with the ACCU-CHEK Spirit insulin pump battery key
(knives, screwdrivers or other sharp objects may harm
your insulin pump). Do not over-tighten as this may cause
damage to the battery cover and to the casing. The battery
cover is correctly inserted and tightened when the battery
cover is level with the insulin pump casing.
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Follow the steps below:
1. Press d to move to the STOP YOUR ACCU-CHEK screen.
Press f to select and put the pump in STOP
mode. Your pump returns to the STOP screen
and insulin delivery stops.
2. Remove or disconnect your infusion tube set from the headset so that insulin
cannot accidentally be delivered.
3. Remove the battery cover.
Use the battery key to turn the battery cover as
indicated by the arrow on the battery cover. Make
sure that the opening of the battery compartment
and the seal are clean and undamaged. Remove
the old battery if necessary.
4. Put the battery cover on the positive (+) end of the battery.
Hold the cover on the positive (+) end of the battery,
and insert the battery negative (-) end first into the
battery compartment.
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5. Use the cover to gently push the battery all the way in.
Turn the battery cover clockwise to tighten it.
The battery cover is correctly tightened when
the outside of it is even with the casing. Do not
over-tighten the battery cover.
The pump begins its start-up process.
Note:
If your pump was in RUN mode before you removed the battery, an
error E8: POWER INTERRUPT will occur when a new battery is inserted.
Press f twice to confirm and turn off the error. Check the time and
date in the STOP screen and correct them, if necessary. See the section
“Setting Time and Date” (page 32) for instructions. Put your pump into
RUN mode if necessary.
!
▲
CAUTION
Using AA batteries other than those recommended by
Disetronic Medical Systems may significantly reduce the
battery usage time. Batteries other than those recommended
may leak and corrode the battery contacts within your
insulin pump. Therefore, using batteries not recommended
by Disetronic Medical Systems may void the warranty. Do
not insert old or used batteries into your insulin pump as
this may cause a failure at the insulin pump start-up.
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System Check Start-Up Process
Your pump performs internal tests at start-up when you insert a battery and when
you change the cartridge. When you insert a battery the whole start-up process
is performed. When only the cartridge is changed, the start-up process begins
at the SELF-TEST screen.
▲
Do not interrupt the start-up process by pressing keys
or by handling the insulin pump. Interruption of the
WARNING start-up process may lead to malfunctions of your
insulin pump.
!
If your insulin pump does not beep and vibrate as
described, or if individual numbers, letters, symbols
or lines are shown incompletely or not at all, contact
Pump Support at 1-800-688-4578.
Note:
While you are using the pump, its safety system monitors it continuously.
If the safety system detects a change from the normal state, an alert
(warning instruction) or an error (error message) occurs.
1. Put the pump in STOP mode.
2. The ACCU-CHEK logo appears.
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3. SELF-TEST appears.
4. Your pump beeps and BEEP TEST appears.
Listen for the beeps.
!
▲
CAUTION
If you cannot hear the beeps from your insulin pump, you
may not be notified of changes with your insulin pump in
a suitable amount of time. If you cannot hear the beeps,
contact Pump Support at 1-800-688-4578.
5. Your pump vibrates and VIBRATION TEST appears.
Check for vibrations.
!
▲
CAUTION
If you cannot feel the vibration alert, you may not be
notified of any changes of your insulin pump in a suitable
amount of time. If you cannot feel the vibration alert,
contact Pump Support at 1-800-688-4578.
6. The display goes blank. Check that the display is empty. (The backlight turns
on during this step.)
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7. The display shows a pattern. Check that the pattern is even.
8. The display turns black. Check that the display is completely black.
9. You will also see an INFORMATION screen.
10. If your pump detects an alert or error during the start-up process, it
signals the error or alert at this point. See the section “Alerts and Errors”
(page 147) for more information.
11. A melody signals the end of the start-up process, and the pump shows
the STOP screen. The STOP-Warning occurs every minute by giving a
long beep and a vibration to remind you that no insulin is being delivered
in STOP mode. Press and hold a or s until you hear a melody to turn
the STOP-Warning off.
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Note:
If the voltage of the battery is too low, the start-up procedure
cannot finish.
Your pump beeps five tones and keeps restarting the start-up
procedure until you remove the battery or until the battery is dead.
▲
!
CAUTION
If you discover incomplete characters, numbers, or symbols
on the display, put your insulin pump into STOP mode and
perform a system check again by simply removing the battery
for a few seconds. When you reinsert the battery the system
check will occur. If the incomplete characters, numbers, or
symbols remain, your insulin pump may need to be returned
since you may not receive the correct information for
operating your pump. Put your insulin pump into STOP mode
and contact Pump Support at 1-800-688-4578 immediately.
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Setting Time and Date
Be careful to set the time and date correctly, because the basal rates and all
history information are stored on the basis of time and date set in the pump.
When you travel across time zones, make sure that the time and date are
set correctly.
The time format can be either American or European/Military Time.
American
12-hour clock
month/day/year
European/Military Time
24-hour clock
day/month/year
▲
Incorrect setting of time and date can lead to incorrect
insulin delivery. Make sure that the time and date of your
WARNING insulin pump is programmed correctly to ensure the
correct insulin delivery and data memory. Do not make
therapy decisions based upon a single result in the
insulin pump’s memory.
!
If you, your doctor, or healthcare team reviews your therapy
data electronically, it is essential that the time and date
of your insulin pump, your blood glucose measurement
system (such as an ACCU-CHEK blood glucose meter),
the PC, and other devices used are set identically. If they
are not, the gathered data might not be meaningful. Check
these devices regularly to ensure that the time and date
settings are identical.
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RUN
screen
8:44 AM
set the time
and date
Page 33
set the
hour
set the
minute
set the
year
set the
month
set the
day
Follow the steps below to set the Time and Date:
1. Press d to move to the SET TIME AND DATE screen.
Press f to select.
2. The SET HOUR screen displays.
Press a or s to set the hour.
3. Press d to move to the SET MINUTE screen.
Press a or s to set the minutes.
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4. Press d to move to the SET YEAR screen.
Press a or s to set the year.
5. Press d to move to the SET MONTH screen.
Press a or s to set the month.
6. Press d to move to the SET DAY screen.
Press a or s to set the day.
7. Press f to save and exit.
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Your Personal Settings
!
▲
Your new ACCU-CHEK Spirit insulin pump must be
programmed with your personal settings prior to starting
WARNING insulin pump therapy. Work with your doctor or healthcare
team to understand how to use the pump.
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 a new ACCU-CHEK Spirit insulin pump. Incorrect
programming of your insulin pump may cause incorrect
insulin delivery.
Do not operate your insulin pump without knowing your
personal settings. If you are not sure about your personal
settings or you are less experienced, have your doctor or
healthcare team check them. Work with your doctor or
healthcare team to determine the timing as well as the
amount and type of bolus you need to deliver. Make sure
you know your personal carbohydrate to insulin ratio and
your correction bolus ratio.
Change your personal settings only after consulting with your
doctor or healthcare team and always follow their instructions.
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Your Basal Rate Profile
Your pump delivers insulin every 3 minutes, in 20 equal doses each hour,
24 hours a day. This flow of insulin, measured in international units per hour
(U/h), is called the basal rate and is calculated to meet your basic insulin needs.
An ACCU-CHEK Spirit insulin pump basal rate profile consists of up to 24
different hourly basal rates. Each hourly rate may be changed independently.
The total of all 24 hourly basal rates in one basal rate profile is called the
(daily) basal rate total.
Your basal rate profile should be reviewed:
• after any programming changes are made to your pump,
• after a new battery is inserted, and
• after confirming an error E7: ELECTRONIC ERROR.
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Programming Your Basal Rate Profile
Note:
Insulin delivery does not stop or pause during basal rate programming.
The insulin amounts and other values used in this user guide are
examples only. Your personal values may differ.
RUN
screen
program
profile 1
daily basal
rate total
1st hour
2nd hour
…
24th hour
Note:
For your safety and convenience during programming, your insulin
pump returns itself to the RUN or STOP screen if no key is pressed
within 20 seconds. The changes you made before your insulin pump
“times out” will not be saved.
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Follow the steps below:
1. Press d to move to the PROGRAM BASAL RATE PROFILE 1 screen.
2. Press f to select.
The daily BASAL RATE TOTAL is displayed.
3. Press d to move to the first hour.
The first hour, which always begins at midnight,
00:00 – 01:00 (12:00 AM – 01:00 AM if the
American time format is used), is shown.
4. Press a or s or scroll to set the hourly basal rate given by your doctor
or healthcare team.
5. Press d to move to the next hour.
6. Continue using d and the a and s keys to set the hourly basal rates
for the remaining hours. This lets you program your individual basal rate
profile hour-by-hour. Continue until all 24 hours are programmed.
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7. Press f to confirm.
The new daily BASAL RATE TOTAL is displayed.
Check the new daily BASAL RATE TOTAL.
8. Press f to save and exit.
If the current active basal rate profile is the same as the new programmed
basal rate, it is active immediately.
Note:
At any screen you have three options to exit:
If you want to save the changes
• Press f. Check the new daily basal rate total.
• Press f. Your pump returns to the RUN screen.
If you want to undo the changes
• Wait for your ACCU-CHEK Spirit insulin pump to return to the RUN
screen (timeout), or
• Press d+a simultaneously (exit feature) to exit the function screen.
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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
programming by copying an hourly basal rate to one or more hours.
Follow the steps below:
1. Press d to move to the PROGRAM BASAL RATE PROFILE 1 screen.
2. Press f to select.
The daily BASAL RATE TOTAL is displayed.
3. Press d to move to the hourly basal rate you want to copy.
4. Press a+ s simultaneously.
A special beep confirms that you are pressing
the keys correctly. The same hourly basal rate
is copied to the next hour.
5. If you want to copy the rate to multiple hours, press a+ s repeatedly or
press and hold a+ s (scroll).
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6. Press f to confirm.
Check the new daily BASAL RATE TOTAL.
7. Press f to save and exit.
If the current active basal rate profile is the same as the new programmed
basal rate, it is active immediately.
Basal Rate and Bolus
During normal use, your pump is in RUN mode and insulin is continuously
delivered (basal rate).
A bolus can be programmed when it is needed. A bolus is the amount of insulin
delivered (in addition to the basal rate) to cover the intake of food and correct
high blood glucose levels. The bolus amount is determined by your doctor or
healthcare team’s guidelines, your blood glucose level, your food intake, and
your activity level as well as stress and illness. See the section “Understanding
Boluses” (page 75) for more information.
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Preparing the Cartridge
!
▲
Your insulin pump is designed to use an ACCU-CHEK
3.15 ml plastic cartridge. The cartridge is a sterile product
WARNING intended for single use only. Sterility is guaranteed for
unopened packaging up to the indicated expiration date.
• Do not use sterile products if the package is damaged.
• Do not reuse single use materials. Reusing single use
materials might lead to a malfunction of your insulin
pump and to incorrect insulin delivery and/or an infection.
• Always handle the items with clean hands.
• Use specified cartridges only. Using other cartridges
can endanger your health and may void the warranty.
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Filling the Cartridge
Note:
A filling aid, an optional accessory by Disetronic Medical Systems, helps
you fill an empty ACCU-CHEK 3.15 ml plastic cartridge from your vial of
insulin. Read the instructions that are included with the filling aid to learn
how to use it.
To fill a cartridge, have the following materials ready:
• A new 3.15 ml plastic cartridge with protective cap, plunger rod,
filling needle, and
• Insulin at room temperature to minimize formation of air bubbles
Follow the steps below:
1. Wash your hands.
2. Set the insulin vial on a hard, flat surface, such as a table.
Clean the rubber membrane of the vial using an
antiseptic wipe.
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3. Remove the cartridge, the cartridge protective cap, and the filling needle
with its protective cap from their packaging.
4. Place the filling needle with protective cap onto the cartridge tip and make
sure the connection is tight.
Move the plunger rod back and forth twice in the
cartridge to distribute the lubricant.
Pull the plunger back to fill the cartridge with air.
Plunger
Plunger rod
5. Remove the protective cap from the needle. Do not touch anything with
the needle.
Push the tip of the filling needle into the center
of the insulin vial’s rubber membrane.
Push the plunger rod down so that all air from
the cartridge enters the insulin vial.
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6. Hold steady pressure against the plunger rod with your thumb, and at the
same time turn the insulin vial over so that the filling needle and cartridge
are pointing upwards into the insulin vial.
Make sure that the tip of the filling needle stays in the insulin.
Slowly release the pressure against the plunger rod and
let the insulin flow into the cartridge.
Do not pull or push the plunger rod while it is moving on
its own (this could lead to air bubbles in the insulin).
Slowly pull the plunger rod straight down to fill the cartridge.
Remove any air bubbles by tapping on the cartridge. Push the
air bubbles back into the insulin vial using the plunger rod.
The cartridge is full when there are no air bubbles in it and
the plunger is at the bottom of the cartridge.
7. Remove the filling needle from the insulin vial.
8. Place the protective cap on the filling needle.
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Remove the plunger rod by turning it counter-clockwise
out of the plunger.
Remove the filling needle with its protective cap from the
cartridge by turning counter-clockwise. Dispose of properly.
Push the cartridge protective cap tightly onto the cartridge
tip until it clicks.
The cartridge is now ready to use.
Note:
Do not pull or push the plunger rod during removal.
▲
!
CAUTION
Air bubbles in the cartridge and infusion set may cause
the infusion of air instead of insulin. In this case, your body
does not receive the required amount of insulin and an
error E4: OCCLUSION may be displayed. Remove bubbles
while filling the cartridge and priming the infusion set and
without having the infusion set connected to your body.
Cold insulin may release air when warmed. Use only insulin
at room temperature when filling the cartridge and priming
the infusion set. Inspect the cartridge and the infusion set for
air bubbles at least every three hours during the day and
before you go to sleep. Remove any air bubbles and change
system components if needed.
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Connecting the Cartridge, Adapter, and Infusion Set
Note:
Before you change the cartridge, adapter, and infusion set, check
that your pump is in good, working order. See the section “System
Inspection Checklist” (page 137).
Insulin can flow freely 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 free flow
of insulin by correctly inserting the cartridge: move the piston rod to
the proper position and twist the adapter until the cartridge plunger
sits flush with the end plate of the piston rod.
Have the following materials ready:
• A filled ACCU-CHEK 3.15 ml plastic cartridge with a luer-lock connection
• An ACCU-CHEK Spirit insulin pump adapter
• A new ACCU-CHEK infusion set
▲
The cartridge and infusion set are sterile products intended
for single use only. Sterility is guaranteed for unopened
WARNING packaging up to the indicated expiration date. Do not use
sterile products if the packaging is damaged.
!
Do not reuse single use materials because this might lead
to a malfunction of your insulin pump, to incorrect insulin
delivery, and/or an infection. Always handle the 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.
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Follow the instructions below:
Remove the protective cap from the cartridge. Do not touch the cartridge tip.
b
Luer-lock connector
Push the adapter all the way onto the cartridge tip to
the stop (a).
a
Hold the adapter and twist the infusion set luer-lock
connection by hand, clockwise into the adapter (b).
Carefully prepare a new ACCU-CHEK infusion set for use,
priming and insertion, following its instructions for use.
Do not over-tighten.
▲
!
CAUTION
To avoid leakage, properly tighten the infusion set to the
adapter. Turn the infusion set luer-lock connector until it
stops. Do not turn it any further and do not use any auxiliary
tools as this may crack the infusion set luer-lock connector
and result in leakage.
Note:
Your pump cannot detect infusion set leakage. You must check all parts of
the infusion set at least every three hours during the day and before you go
to sleep. 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
actions according to your doctor’s or healthcare team’s instructions.
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Inserting the Cartridge
!
▲
CAUTION
Do not perform the CHANGE THE CARTRIDGE function if the
cartridge compartment is not completely dry. During the
rewinding of the piston rod, insulin or water might enter your
insulin pump and could lead to malfunction. If necessary,
use a soft cloth to dry the compartment.
STOP
screen
change the
cartridge
remove the
cartridge
3 sec.
returning
piston rod
cartridge volume
315 units
start-up
procedure
prime the
infusion set
Have the following materials ready:
• Your insulin pump
• A filled ACCU-CHEK 3.15 ml plastic cartridge with a connected
ACCU-CHEK Spirit insulin pump adapter
• A new ACCU-CHEK infusion set
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Follow the steps below:
1. Press d to move to the STOP YOUR ACCU-CHEK screen.
2. Press f to select and put the pump in STOP mode.
Your pump displays the STOP screen, and
insulin delivery stops.
3. Press d to move to the CHANGE THE CARTRIDGE screen.
4. Press f to select.
Remove the current cartridge, if there is one.
5. Press and hold f (for 3 seconds) until you hear a melody.
The piston rod begins its return. Do not touch or
disturb the piston rod while it is rewinding. Doing
so may potentially damage your pump.
When the piston rod returns completely, the
CARTRIDGE VOLUME screen displays the
maximum cartridge volume, 315U.
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6. Hold your pump upright. Hold the new filled cartridge so that the connected
adapter and infusion tube set point upwards, parallel, and close to the
cartridge compartment.
Make sure that the bottom edge of the colored
part of the adapter is level with the top of the
cartridge compartment.
Base plate of
piston rod
Cartridge plunger
7. Press a or s to move the plunger 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.
8. Position your insulin pump upright (with the adapter pointing upwards).
Insert the cartridge into the cartridge compartment.
9. Twist (do not push) the adapter clockwise until it sits flush with the cartridge
compartment.
It is not necessary to apply pressure. Twisting will
properly position the cartridge. Do not over-tighten
the adapter or it will be difficult to remove the
cartridge, adapter and cartridge plunger and may
potentially cause damage to your pump. The
cartridge is correctly inserted when the end plate
of the piston rod sits flush against the cartridge
plunger. This flush fit is an extra safety measure
to prevent the free flow of insulin and to minimize
occlusions (blockages).
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If the end plate of the piston rod does not sit flush against the cartridge plunger,
remove the cartridge from the cartridge compartment. Hold the cartridge
and adapter next to the cartridge compartment. Press a or s to move
the piston rod forward until its base plate and the cartridge plunger are
level. The displayed cartridge volume decreases accordingly. Re-insert the
cartridge into the cartridge compartment.
– If needed, repeat this step until the cartridge is correctly inserted (the
end plate of the piston rod sits flush against the cartridge plunger).
10. Press f after correctly inserting the cartridge.
Your pump performs a self test. See the section
“System Check Start-Up Process” (page 28).
11. Check that the infusion set luer-lock connector is still correctly connected
to the adapter. Tighten the infusion set by hand clockwise until it sits tightly
in the adapter.
12. When the system check start-up process is finished, the PRIME THE INFUSION
SET screen is displayed.
See the section “Priming the Infusion Set” (page 53) for more information.
Start from the point in those instructions where the pump screen matches
the screen above.
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Priming the Infusion Set
▲
Never prime an infusion set that is connected to your body.
You risk uncontrolled insulin delivery into your body. Always
WARNING follow the instructions for the infusion set you are using.
!
The ACCU-CHEK Spirit insulin pump stops priming after 25 units of insulin. If no
insulin has emerged from the tube set needle after priming, repeat the priming
function. When insulin comes from the tip of the needle, press any pump key
to stop priming. The amount of insulin used in priming is not added to the pump’s
history of daily insulin totals.
During priming your pump should be upright, with the adapter pointing upwards
to help let air bubbles out of the cartridge and the infusion set.
▲
Air bubbles in the cartridge and infusion set may cause the
infusion of air instead of insulin. If this happens, your body
WARNING will not receive the required amount of insulin. Inspect the
cartridge and the infusion set for air bubbles at least every
three hours during the day and before you go to sleep.
Remove bubbles while filling the cartridge and priming the
infusion set and without having the infusion set connected
to your body.
!
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start-up
procedure
STOP
screen
prime the
infusion set
start
priming
3 sec. stop
priming
Follow the steps below:
1. Press d to move to the STOP YOUR ACCU-CHEK screen.
2. Press f to select and put the pump in STOP mode.
Your pump displays the STOP screen, and insulin
delivery stops.
3. Prepare the tubing or cannula/needle for priming per infusion set instructions
for use.
4. Press d to move to the PRIME THE INFUSION SET screen.
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5. Press f to select. The priming amount of 25 units of insulin is shown on
the display.
6. When START PRIMING is displayed, press and hold f until you hear a
melody and the piston rod moves forward.
The priming process begins and a count-up is
shown on the display. Your pump stops priming
after 25 units.
When the priming process is finished, your pump
returns to STOP.
The infusion tubing set is properly primed when
there are no air bubbles visible in the tubing and a drop of insulin has come
out of the connector or cannula.
Stopping the Priming Process
You can stop the priming process at any time by
pressing any key. Your pump displays the STOP
PRIMING screen.
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Preparing the Infusion Site and Inserting 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.
Infusion Site Selection
Your doctor or healthcare team will help you select 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 give you infusion site preparation guidelines.
Have the following materials ready:
• Your ACCU-CHEK Spirit insulin pump
• A disinfectant for your skin
• A new ACCU-CHEK infusion set
Follow the steps below:
1. Make sure your pump is correctly set up (including cartridge, adapter and
infusion set) and is programmed with your personal settings.
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2. Wash your hands thoroughly.
3. Disinfect the infusion site and let it dry completely.
4. Make sure your pump is in STOP mode.
5. Insert your ACCU-CHEK infusion set according to the instructions for its use.
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Note:
If you use a soft cannula-type infusion set, you must proceed with a bolus
to fill the air space in the cannula after removing the introducer needle
according to the instructions for the infusion set you are using. Failure to
do so could result in missed insulin dosing. See the section “Programming
a Standard Bolus” (page 77) for more information.
▲
!
CAUTION
Inspect your infusion site at least once or twice each day for
irritation or infection. Signs of infection may include, but
are not limited to, pain, lumps, redness, heat, or discharge.
If you see redness or swelling, change your infusion headset
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, your pump should now be ready to use. However, please
read the complete manual before starting.
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Chapter 3: Using Your Pump
Before Using
!
▲
CAUTION
Training and using your insulin pump requires the support of
an experienced doctor or healthcare team. Regular visits
to your doctor or healthcare team are absolutely essential
during insulin pump therapy.
Always follow the instructions given by your doctor or
healthcare team.
Successful insulin pump therapy requires you to check your blood glucose
levels often. It is a good idea to check your blood glucose (using an ACCU-CHEK
blood glucose monitor) at least four times a day, or as often as you are
directed by your doctor or healthcare team.
Wearing Your Pump
▲
!
CAUTION
When wearing your insulin pump make sure to prevent
any contact with objects that may damage or accidentally
press the keys of your insulin pump (e.g., keychains, keys,
pocket knives, and coins).
Attach your pump safely to your body or clothes to prevent damage. Special
carrying systems let you carry your pump on or under your clothes. All specified
accessories have been tested and approved for use with your ACCU-CHEK Spirit
insulin pump. The proper functioning of your pump can only be guaranteed if you
use it with ACCU-CHEK Spirit insulin pump accessories.
See Disetronic Medical Systems sterile products and accessories catalogs and
brochures for more information. Or, contact Pump Support at 1-800-688-4578.
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Wear your pump under your clothes or directly on your body in cold or rainy
weather. If you have concerns about the weather affecting your pump,
check the operating conditions of your pump and contact Pump Support at
1-800-688-4578. See the section “Appendix A: Technical Data” (page 165) for
more information on operating conditions.
▲
!
CAUTION
Do not place your insulin pump in direct sunlight. Overheating
of the insulin and your insulin 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 electronics of
your insulin pump and may cause a malfunction of the battery.
See the instructions for the insulin you are using to determine
the acceptable temperature range.
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When Not to Wear Your Pump
Electromagnetic Fields and Hazardous Areas
Do not use your pump around electromagnetic fields such as radar or antenna
installations, high-voltage sources, X-Ray sources, MRI, CAT scan, and all other
sources of electrical current as they may cause your pump not to work. Insulin
delivery may stop and an error E7: ELECTRONIC ERROR may occur.
Always stop and remove your pump before you enter these areas.
See “Appendix A: Technical Data” (page 165) for more information about
electromagnetic fields.
▲
Your insulin pump has not been tested with cardiac
pacemakers. Do not use the ACCU-CHEK Spirit insulin
WARNING pump if you have a cardiac pacemaker.
!
Your pump has been tested and complies with the regulations regarding
unintentional electromagnetic interference. Security systems in airports as
well as anti-theft monitoring devices, such as those in department stores,
should not affect the functioning of your pump.
Because there are so many devices, such as cellular phones, that give out
electromagnetic radiation, the influence of some such devices on your pump
cannot be ruled out. It is a good idea to keep your pump at least 4 inches
(10 cm) away from such devices while the other devices are turned on.
Do not use your pump in hyperbaric chambers and in hazardous areas of any
kind, such as areas where explosive or flammable gases or vapors could exist.
This could affect insulin delivery and/or lead to harm.
Your pump is designed to work in normal barometric conditions (from 700
to 1,060 mbar).
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Do not exceed 10,000 feet (3,000 meters) above sea level. Your pump has
not been tested for use above this level.
Always stop and remove your pump before you enter these areas. If you
have questions, contact Pump Support at 1-800-688-4578.
Sports and Exercise
Exercise is an important part of diabetes management. Disetronic Medical
Systems designed the ACCU-CHEK Spirit insulin pump to let you safely perform
many sporting activities while you wear your pump. It is important that you
protect your pump before you start exercise or sports activities. Do not wear
your pump during sports that involve body contact such as boxing, football,
or hockey since rough contact could damage your pump.
Consult our sterile products brochures and accessories catalog for more
information regarding carrying systems or contact Pump Support at
1-800-688-4578 for more information.
Traveling
Ask your doctor or healthcare team about any special actions you need to
take before you travel. Take extra blood-glucose testing and pump supplies
when you travel and find out where to get supplies while you are traveling.
When you travel across time zones, make sure that the time and date on
your pump are set correctly to the local time.
The ACCU-CHEK insulin pump has not been tested at altitudes in excess of
10,000 feet (3,000 meters) above sea level. If your travels take you to an area
in excess of 10,000 feet (3,000 meters) above sea level, stop and remove your
pump. This does not apply to use in airplanes with pressurized cabins.
If you have questions, contact Pump Support at 1-800-688-4578.
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Your Insulin Pump and Water
!
▲
CAUTION
Avoid deliberate contact with water. Check daily that your
insulin pump is not chipped, cracked, or damaged in any
way and that the battery cover and the adapter are correctly
closed. In the presence of chips and cracks, water, dust,
insulin, or other foreign substances may enter your insulin
pump and lead to malfunction. Prior to contact with water,
disconnect and take off your insulin pump.
Disconnect and remove your pump before entering a bathtub, Jacuzzi or
whirlpool, shower, or swimming pool. Avoid exposing your pump to high
humidity, such as in a sauna, as this could damage your pump. To make it
easy to remove your pump, use disconnectable ACCU-CHEK infusion sets.
Consult your doctor or healthcare team to find out how long your insulin pump
therapy can safely be interrupted.
Accidental Contact with Water
Your insulin pump is protected against accidental short-term water contact.
Examples of accidental short-term water contact include:
• rain, snow;
• water that splashes while you are biking, jogging, or hiking;
• accidental brief immersion into the sink or bathtub.
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What to Do After Any Water Contact
Put your pump into STOP mode. Disconnect the pump from your body before
inspecting it. Use a soft cloth to dry the outside of the pump. Check the battery
compartment and the cartridge compartment for water. If the battery compartment
or cartridge compartment are wet, turn your pump upside down to let the water
run out and let it air dry. Do not use warm air such as a hair dryer to dry the pump
as this could damage the pump’s electronics. Do not re-insert the battery or the
cartridge until the compartments are completely dry.
See the section “Cleaning Your ACCU-CHEK Spirit Insulin Pump” (page 141)
for more information.
Other Liquids
You do not have to worry about contact between your pump and:
• sweat
• saliva
You must check your pump immediately after contact with other liquids or
chemicals such as:
• cleaning solutions
• alcohol
• beverages
See the section “Cleaning Your ACCU-CHEK Spirit Insulin Pump” (page 141)
for more information.
▲
!
CAUTION
Avoid any contact of your insulin pump, the infusion set,
and the connecting parts of your insulin pump with health
and beauty items (for example, antiseptics, antibiotic
creams, soaps, perfumes, deodorants, body lotions, or any
other cosmetics). These items may discolor your pump or
fog your display.
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Starting Insulin Delivery
STOP
screen
start your
ACCU-CHEK
RUN
screen
Follow the steps below:
1. Start from the STOP screen.
2. Press d to move to the START YOUR ACCU-CHEK screen.
3. Press f to select. Your pump shows the RUN screen.
Insulin delivery begins within 3 minutes.
Note:
Check the amount of insulin remaining in the cartridge at least once a
day. If you press the f key from the RUN or STOP screen, your pump
displays the remaining cartridge content in units. Before going to sleep,
make sure that:
• the cartridge contains enough insulin to last through the night, and
• the time and date are set correctly.
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Stopping Insulin Delivery
▲
!
CAUTION
When your insulin pump is in STOP mode, it does not deliver
any insulin. You will need to put your insulin pump into RUN
mode to continue insulin delivery.
There are functions and actions, for your safety, that you can only perform
when the pump is in STOP mode. These functions and actions include:
• changing the cartridge
• connecting and disconnecting the adapter and/or infusion set, and
• priming the infusion set
Follow the steps below:
1. Press d to move to the STOP YOUR ACCU-CHEK screen.
2. Press f to select.
Your pump returns to the STOP screen and
insulin delivery stops.
3. Press f (QUICK INFO screen) to review activated functions and features
(like the beep and vibration alarm signals) indicated by icons and messages
on the screen.
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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, an alert
A6: TBR CANCELLED and/or an alert A8: BOLUS CANCELLED occur(s).
Press f twice for each appearing alert to confirm and turn off. See the
sections “Alert A6: TBR CANCELLED” (page 152) and “Alert A8: BOLUS
CANCELLED” (page 153) for more information.
STOP-Warning
The STOP-Warning is turned on by the pump each time your pump switches from
RUN mode to STOP mode, and when a battery is inserted. The STOP-Warning
is a long beep and a vibration occurring every minute. It warns you that insulin
delivery has stopped. If you are aware of the situation and don’t wish to be
reminded, you can turn off the STOP-Warning.
To Turn Off the STOP-Warning
Press either a or s for 3 seconds to turn off the STOP-Warning. A melody
plays indicating the STOP-Warning is turned off.
Note:
The volume of the STOP-Warning cannot be changed. It is independent of
the programmed beep volume.
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Interruption of Insulin Pump Therapy
Consult with your doctor or healthcare team about when and for how long your
insulin pump therapy can be interrupted.
Measure your blood glucose level regularly during any insulin interruption. Use
a syringe or insulin pen to inject insulin according to the instructions of your
doctor or healthcare team.
!
▲
WARNING
Since only rapid-acting insulin is used for insulin pump
therapy, there is only a small insulin reserve in the
body. If insulin is interrupted for any reason, such as:
• if you stop the pump
• there is a technical problem with the pump
• there is leakage in the cartridge
• there is occlusion in the infusion tube set or in the
infusion headset
• the cannula has slipped out of the infusion site
you must be ready to replace the missing insulin
immediately.
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.
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Short Interruption
1. Put your pump in STOP mode.
2. Remove or disconnect the infusion tube set from the infusion headset. When
using a disconnectable infusion set, disconnect it at your infusion site and
use the protective covers that came with the infusion set.
Resuming Insulin Pump Therapy
1. Attach a new ACCU-CHEK infusion set and prime it before inserting it.
2. Follow the instructions to prepare the infusion set you are using, and put your
pump into RUN mode.
Measure your blood glucose level within 2 hours of restarting pump therapy to
check the function of the system and to ensure insulin delivery.
Interruption of Use of Your Insulin Pump for a Long Period of Time
There may be times when you may need to interrupt your pump therapy for more
than one day. Follow the steps below.
!
▲
CAUTION
Contact your doctor or healthcare team for an alternate
therapy plan when you interrupt the insulin pump therapy
for a long period of time.
1. Put your pump into STOP mode.
2. Remove the cartridge, adapter, and infusion set.
3. Reinsert the adapter.
4. Remove the battery and reinsert the battery cover.
5. Store your pump properly. See the section “Storing Your ACCU-CHEK Spirit
Insulin Pump” (page 140) for more information.
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Changing the Infusion Set
When you change the infusion set, keep the following points and warnings in mind:
• Infusion sets are sterile products intended for single use only. Sterility is
guaranteed for unopened packaging up to the indicated expiration date.
Do not use sterile products if the package is damaged.
• Properly tighten the infusion set to 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 any auxiliary tools as this may crack the infusion set luer-lock
connector and result in leakage.
• Your pump cannot detect infusion set leakage. You must inspect all parts
of your infusion set at least every three hours during the day and before
you go to sleep. If there seems to be any loss of insulin and all parts are
correctly tightened, immediately replace the leaking component.
Immediately check your blood glucose level, because insulin delivery has
been interrupted. Take appropriate actions according to your doctor’s or
healthcare team’s instructions.
• Always disconnect your infusion set before changing a cartridge or
priming. You risk uncontrolled insulin delivery into your body. Always
follow the instructions for the infusion set you are using.
Have the following materials ready:
• Your ACCU-CHEK Spirit insulin pump
• A disinfectant for your skin
• A new ACCU-CHEK infusion set
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Follow the steps below:
1. Wash your hands thoroughly.
2. Make sure your pump is in STOP mode.
3. Remove the infusion tube set from the headset.
4. Remove the infusion tube set from the adapter and dispose of it properly.
Note:
The battery key has a notch that fits
all ACCU-CHEK infusion set luer-lock
connectors. You may use the battery
key to loosen the luer-lock connector
between your infusion set and adapter
if it cannot be loosened by hand.
5. Carefully prepare a new ACCU-CHEK infusion set for use.
6. Turn the ACCU-CHEK infusion set by hand clockwise into the adapter.
7. Properly tighten the luer-lock connector by hand.
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8. Prime the infusion set following all the instructions and warnings found in
the section “Priming the Infusion Set” (page 53).
9. Insert a new infusion set following the instructions found in the section
“Preparing the Infusion Site and Inserting the Infusion Set” (page 56).
10. Remove the old infusion headset and dispose of it properly.
11. Place the pump in RUN mode. See the section “Starting Insulin Delivery”
(page 65).
Note:
If you use a soft cannula-type infusion set, you must proceed with a
bolus to fill the air space in the cannula after removing the introducer
needle according to the instructions for the infusion set you are using.
Failure to do so could result in missed insulin dosing. See the section
“Programming a Standard Bolus” (page 77) for more information.
Inspect your infusion site at least once or 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 infusion headset according to the instructions for the infusion
set you are using and your doctor or healthcare team’s recommendations.
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Changing the Cartridge and Infusion Set
Have the following materials ready:
• Your ACCU-CHEK Spirit insulin pump
• A disinfectant for your skin
• A new ACCU-CHEK infusion set
• A filled ACCU-CHEK 3.15 ml plastic cartridge with a
luer-lock connection
• A new adapter (must be changed at least with every 10 th cartridge)
1. Wash your hands thoroughly.
2. Make sure your insulin pump is in STOP mode.
3. Remove your infusion tube set from the headset.
4. Remove the infusion tube set from the adapter and dispose of it properly.
Note:
The battery key has a notch that fits
all ACCU-CHEK infusion set luer-lock
connectors. You may use the battery
key to loosen the luer-lock connector
between your infusion set and adapter
if it cannot be loosened by hand.
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5. Hold your ACCU-CHEK Spirit insulin pump
with the adapter pointing downwards.
6. Remove the adapter and cartridge from your pump by unscrewing the
adapter from the pump casing. 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 Pump Support at
1-800-688-4578.
7. Remove the cartridge from the adapter and dispose of the cartridge properly.
8. Hold the adapter up to the light to check for signs of wear or dirt (especially
on the seals inside and outside of the adapter). It is recommended that you
replace the adapter at least every 10th insulin cartridge change.
9. If needed, clean the adapter using water and dry it. If it shows signs of
wear or dirt, replace it immediately.
10. Install a new cartridge and a new infusion set. See the following sections
for instructions: “Changing the Infusion Set” (page 70), “Preparing the
Cartridge” (page 42), “Connecting the Cartridge, Adapter, and Infusion Set”
(page 47), “Inserting the Cartridge” (page 49), “Priming the Infusion Set”
(page 53), “Preparing the Infusion Site and Inserting the Infusion Set”
(page 56), and “Starting Insulin Delivery” (page 65).
Note:
Check the amount of insulin remaining in the cartridge at least once
a day. Press the f key from the RUN or STOP screen to display
the remaining cartridge content in units. Before going to sleep, make
sure that:
• the cartridge contains enough insulin to last through the night, and
• that the time and date are set correctly.
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Chapter 4: Boluses and Temporary Basal Rates
Understanding Boluses
A bolus is the amount of insulin delivered (in addition to the basal rate) to cover
the intake of food and 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 and the amount and type of bolus you need with your
doctor or healthcare team. You can review the time, date, and amount of the
last 30 boluses in the bolus history. See the section “Review the Bolus History”
(page 107) for more information.
Your pump can deliver three types of boluses:
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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▲
• Incorrect programming of your insulin pump may cause
inappropriate insulin delivery.
WARNING • Your insulin pump must be programmed with your
personal settings prior to starting insulin pump therapy.
• Do not operate your insulin pump without knowing your
personal settings.
• If you are not sure about your personal settings or you
are less experienced, have your doctor or healthcare
team check your personal settings.
• Work with your doctor or healthcare team to determine
the timing, amount, and type of bolus you need to deliver.
• Make sure you know your personal carbohydrate to
insulin ratio and your correction bolus ratio.
!
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Programming a Standard Bolus
There are two ways to program a Standard Bolus:
“Quick” Standard Bolus
Using a and s on your
insulin pump, with bolus increments
determined by the user
“Scroll” Standard Bolus
Menu-guided using d and f
with a and s for
programming of the amount
The bolus amount per delivery is limited to 25 units using U100 insulin.
After you program a Standard Bolus there is a delay of 5 seconds before the
bolus delivery starts. This delay lets you cancel the bolus before delivery starts
by pressing the a or s key. Alert A8: BOLUS CANCELLED will occur. Press
f twice to confirm and turn off the alert. See the section “Alert A8: BOLUS
CANCELLED” (page 153) for more information.
Programming a “Quick” Standard Bolus
The following process involves only the a and s keys. You can start with
either key. The recommended steps below are those described with the first
key appearing without parenthesis, such as a. For the alternative step press
the key in the parenthesis, such as (s).
Note:
Because your pump beeps and vibrates to guide you safely through the
programming, you may program the “Quick” STANDARD Bolus using
one finger. After the bolus is programmed, you can count the beeps and
vibrations of your pump to verify the correct programming.
The bolus increment for the “Quick” Standard Bolus is initially set to
0.5 units.
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bolus
amount
if O unit
5 sec. delay
confirmation
of amount
5 sec. delay
A8: bolus cancelled
Follow the steps below:
1. From the RUN screen press and hold s (a) until you hear a beep
sequence and feel a vibration.
This activates the “Quick” STANDARD
BOLUS function.
Hint:
Start programming with the a key in areas of poor lighting, as this
will also turn on the backlight.
2. Press a (s) repeatedly until the bolus amount is reached.
Each press of the a (s) key adds one bolus
increment to the bolus amount. Your pump
beeps and vibrates simultaneously once for
each programmed bolus increment.
Five seconds after the last press of a (s), your pump confirms the total
bolus amount with one beep and vibration for each bolus increment programmed.
The Standard Bolus symbol (
start delay).
) blinks for 5 seconds (the bolus delivery
After this bolus delivery start delay, the pump beeps three times and then
begins to deliver the total bolus amount programmed. The countdown of the
remaining bolus amount appears on the display.
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▲
The bolus increment that can be programmed into your
insulin pump determines the Standard Bolus amount
WARNING using the a and s keys of your insulin pump.
Incorrect programming of the bolus increment may
cause inappropriate insulin delivery. See the section
“Bolus Increment” (page 131) for more information.
!
Cancelling a “Quick” Standard Bolus
– during programming (the bolus amount blinks):
• Press the key s or a you used to enter the “Quick” Standard
Bolus programming option. This will reset the bolus amount to 0.0
units. A melody will play. If no new bolus is programmed, your pump
returns to the RUN screen and beeps three times after five seconds.
No bolus is delivered.
– during confirmation (when the beeps and vibrations occur), or during the
start delay ( blinks):
• Press s or a. A melody plays. Your pump returns to the RUN
screen. An alert A8: BOLUS CANCELLED occurs. Press f twice to
confirm and turn off the alert. See the section “Alert A8: BOLUS
CANCELLED” (page 153) for more information.
No bolus is delivered.
– during bolus delivery (countdown of bolus amount):
• Press and hold s or a for 3 seconds until you hear a melody.
An alert A8: BOLUS CANCELLED occurs. Press f twice to confirm
and turn off the alert.
Bolus delivery is interrupted.
See the section “Alert A8: BOLUS CANCELLED” (page 153) for
more information.
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You can view the actual bolus amount delivered prior to the cancellation by
looking at the bolus history. See the section “Review the Bolus History” (page
107) for more information.
Make sure that the cancellation was intended, and then program a new Standard
Bolus, if needed.
Programming a Menu-Guided “Scroll” Standard Bolus
Regardless of the bolus increment setting, the bolus increments for the “Scroll”
Standard Bolus are fixed to 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.
Follow the steps below:
1. Press d to move to the STANDARD BOLUS screen.
2. Press f to select. The BOLUS AMOUNT screen appears.
3. Press or scroll a to increase or s to decrease the bolus amount.
4. Press f to confirm the bolus amount.
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The Standard Bolus symbol (
start delay).
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) blinks for five seconds (the bolus delivery
After this bolus delivery start delay, your pump beeps three times and begins to
deliver the total bolus amount programmed. The countdown of the remaining
bolus amount appears on the display.
Cancelling a Menu-Guided “Scroll” Standard Bolus
– during programming (the bolus amount blinks):
You have three options for cancelling a “Scroll” Standard Bolus during
programming:
• If you do not press any key for 20 seconds, your pump returns to the
RUN screen (timeout).
• Exit to the STANDARD BOLUS menu by pressing d+a simultaneously.
• Set the bolus amount to 0.0 units. Press f to exit.
No bolus is delivered.
– during the start delay (
is blinking):
• Press s or a. A melody plays. Your pump returns to the RUN screen.
An alert A8: BOLUS CANCELLED occurs. Press f twice to confirm
and turn off the alert.
No bolus is delivered.
Please refer to section “Alert A8: BOLUS CANCELLED” (page 153) for more
information.
– during bolus delivery (countdown of bolus amount):
• Press and hold s or a for 3 seconds until you hear a melody.
An alert A8: BOLUS CANCELLED occurs. Press f twice to confirm
and turn off the alert.
Bolus delivery is interrupted.
Please refer to section “Alert A8: BOLUS CANCELLED” (page 153) for
more information.
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You can view the actual bolus amount delivered prior to the cancellation
by looking at the bolus history. Please refer to the section “Review the
Bolus History” (page 107) for more information.
Make sure that the cancellation was intended and then program a new Standard
Bolus, if needed.
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Programming an Extended Bolus
The Extended Bolus is available in the ADVANCED and CUSTOM user menus. The
Extended Bolus function lets you 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
24 hours and begins immediately after confirmation.
Note:
You can add a Standard 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 want to program
a different Extended Bolus, put the pump in STOP mode to cancel the
current bolus and to program a new one.
RUN
screen
Extended
bolus
bolus
amount
stop your
ACCU-CHEK
bolus
duration
A8: bolus cancelled
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Follow the steps below:
1. Press d to move to the EXTENDED BOLUS screen.
2. Press f to select. The BOLUS AMOUNT screen appears.
3. Press a to increase or s decrease the bolus amount.
The duration of the last Extended Bolus
delivered appears, or when using your pump
for the first time, a default value appears.
4. Press d to move to the BOLUS DURATION screen.
Press a to increase or s decrease the
bolus duration.
Note:
Press d to loop between programming the bolus amount and
bolus duration.
5. Press f to confirm the bolus amount and duration. You will hear a melody
when the bolus delivery begins within the next 3 minutes.
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Note:
At any function screen you have three options to exit:
If you want to deliver the bolus
• Press f. Your pump returns to the RUN screen.
If you want to cancel the bolus
• Wait for your pump to return to the RUN screen (timeout), or
• Press d+a simultaneously (exit feature) to exit the function screen.
• Set the bolus amount to 0.0 units and press f.
Note:
During the entire bolus delivery, the remaining time and amount of the
Extended Bolus and the current hourly basal rate are displayed in the
RUN screen.
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.
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Cancelling an Extended Bolus
– during programming (the bolus amount or bolus duration blinks):
You have three options for cancelling an Extended Bolus during
programming:
• If you do not press any key for 20 seconds, your pump returns to the
RUN screen (timeout).
• Exit to the EXTENDED BOLUS menu by pressing d+a simultaneously.
• Set the bolus amount to 0.0 units and press f.
No bolus is delivered.
– during bolus delivery:
• If the Extended Bolus delivery has begun, it can be cancelled by putting
your pump into STOP mode. This cancels the bolus delivery and an alert
A8: BOLUS CANCELLED occurs. Press f twice to confirm and turn off
the alert. See the section “Alert A8: BOLUS CANCELLED” (page 153) for
more information.
Bolus delivery is interrupted.
The bolus amount delivered up to the cancellation can be reviewed in
the BOLUS HISTORY screen. See the section “Review the Bolus
History” (page 107) for more information.
!
▲
CAUTION
When your insulin pump is in STOP mode, it does not deliver
any insulin. Put the pump in RUN mode to continue the
insulin delivery.
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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. An alert A8: BOLUS CANCELLED
and an alert A6: TBR CANCELLED occur.
Press f twice to confirm and turn off the first alert. The second alert
appears on the display. Press f twice to confirm and turn off the second
alert. Both alerts are recorded in the alarm history.
See the sections “Alert A6: TBR CANCELLED” (page 152) and “Alert A8:
BOLUS CANCELLED” (page 153) for more information.
Make sure that the cancellation was intended and then program a new
Extended Bolus (and/or Temporary Basal Rate), if needed.
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Programming a MultiWave Bolus
The MultiWave Bolus function is available in the ADVANCED user menu. It is
designed to better simulate a body’s insulin delivery. It combines an immediate
bolus delivery followed by an Extended Bolus delivery. This function can be
helpful when you have meals that include both rapid and slowly absorbed
carbohydrates.
The duration of bolus delivery can be programmed in 15-minute intervals for
up to 24 hours.
Note:
• The MultiWave Bolus is available in the ADVANCED user menu.
• You can add a Standard Bolus to an ongoing MultiWave Bolus. If you
cancel the Standard Bolus, the MultiWave Bolus remains running.
• During the delivery of a MultiWave Bolus, the programming of a
second MultiWave Bolus or an Extended Bolus is blocked. If you
need a different MultiWave Bolus, put your pump in STOP mode
to cancel the current bolus and program a new one.
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3 sec.
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MultiWave
bolus
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bolus
amount
bolus
delivery
immediate
bolus
or
stop your
ACCU-CHEK
bolus
duration
5 sec. delay
A8: bolus cancelled
Follow the steps below:
1. Select the ADVANCED user menu or turn on the MULTIWAVE BOLUS menu
choice in the CUSTOM user menu. Also, your pump must be in RUN mode.
2. Press d to move to the MULTIWAVE BOLUS screen.
3. Press f to select.
The BOLUS AMOUNT screen appears.
4. Press a or s to increase or decrease the total bolus amount.
The first time you press a, the bolus duration of
the last MultiWave Bolus appears, except when
you are using your pump for the first time, in which
case, a default value appears.
As you increase or decrease the total bolus amount, the suggested immediate
bolus amount increases or decreases proportionally.
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5. Press d to move to the IMMEDIATE BOLUS screen.
Press a or s to correct and set the immediate
bolus amount.
6. 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 24 hours.
Note:
Press d to loop between programming the total bolus amount,
immediate bolus amount, and Extended Bolus duration.
7. Check the total and immediate bolus amounts and the extended bolus duration
programmed on the display. The set values can be viewed in the BOLUS
AMOUNT, IMMEDIATE BOLUS, and BOLUS DURATION screens.
8. Press f to confirm both bolus amounts and the bolus duration.
The MultiWave Bolus symbol (
start delay).
) blinks for 5 seconds (bolus delivery
The pump beeps three times and the immediate bolus delivery begins. The
countdown of the remaining bolus continues to appear on the display.
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Note:
Once the immediate bolus is delivered, the remaining time, bolus amount,
and the current hourly basal rate are displayed on the RUN screen.
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.
Cancelling a MultiWave Bolus
– during programming (a bolus amount or the bolus duration blinks):
There are three ways to cancel a MultiWave Bolus during programming:
• Do not press any key for 20 seconds. The pump returns to the RUN
screen (timeout).
• Exit to the MULTIWAVE BOLUS screen by pressing d+a simultaneously.
• Set the total bolus amount to 0.0 units and press f.
No bolus is delivered.
– during the start delay (
blinks):
• Press s or a. The pump beeps and vibrates.
The pump returns to the RUN screen.
An alert A8: BOLUS CANCELLED occurs. Press f twice to confirm
and turn off the alert.
No bolus is delivered.
See the section “Alert A8: BOLUS CANCELLED” (page 153) for more
information
– during bolus delivery:
• You can cancel the 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). An alert A8: BOLUS
CANCELLED occurs.
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Note:
If the alert A8: BOLUS CANCELLED does not occur, the bolus delivery
was not cancelled. Cancel the extended delivery (see below).
• You can cancel the extended delivery by putting the pump in STOP
mode. This cancels the Extended Bolus. An alert A8: BOLUS CANCELLED
occurs. Press f twice to confirm and turn off the alert.
Bolus delivery is interrupted.
See the section “Alert A8: BOLUS CANCELLED” (page 153) for
more information.
You can review the actual bolus amount delivered before the cancellation
by looking at the bolus history. See the section “Review the Bolus History”
(page 107) for more information.
▲
!
CAUTION
When your insulin pump is in STOP mode, it does not deliver
any insulin. Put your insulin pump in RUN mode to continue
the insulin delivery.
Note:
If a Temporary Basal Rate is active at the same time, it is also cancelled
when your pump is put in STOP mode. An alert A8: BOLUS CANCELLED
and an alert A6: TBR CANCELLED occur.
Press f twice to confirm and turn off the first alert. The second alert
appears on the display. Press f twice to confirm and turn off the second
alert. Both alerts are recorded in the alarm history.
See the sections “Alert A6: TBR CANCELLED” (page 152) and “Alert A8:
BOLUS CANCELLED” (page 153) for more information.
Make sure that the cancellation was intended and then program a new MultiWave
Bolus (and/or Temporary Basal Rate), if needed.
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Programming a Temporary Basal Rate (TBR)
Your pump lets you temporarily increase or decrease your basal rate. This lets
you match changing insulin needs from increased or decreased activity level,
illness, or stress.
▲
Incorrect programming of your insulin pump may cause
incorrect insulin delivery. Your insulin pump must be
WARNING programmed with your personal settings prior to starting
insulin pump therapy.
!
Do not operate your insulin pump without knowing your
personal settings. If you are not sure about your personal
settings or if you are less experienced, have your doctor
or healthcare team check your personal settings.
Typically, a basal rate is set to 100%, but you can:
• Increase it to 200% for up to 24 hours
• Decrease it to 0% for up to 24 hours
When you increase or decrease your basal rate, each hourly basal rate for the
duration you program is increased or decreased. The characteristic shape of
your basal rate profile remains and does not become a flat curve, if the change
is larger than 0%. For 0% the basal rate profile becomes a flat curve and no
insulin (except boluses) is delivered during the programmed duration.
Discuss programming a Temporary Basal Rate with your doctor or healthcare team.
Note:
A running Temporary Basal Rate increase or decrease remains active,
even if you changed the basal rate profile.
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screen
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temporary
basal rate
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precentage
duration
Follow the steps below:
1. Put your pump in RUN mode.
2. Press d to move to the TEMPORARY BASAL RATE (TBR) screen.
3. Press f to select.
The TBR PERCENTAGE screen appears.
Note:
If no Temporary Basal Rate is currently active, the percentage is set to
100%. If a Temporary Basal Rate is active, its duration and percentage
appear on the RUN screen.
4. Press a or s to increase or decrease the basal rate.
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Note:
When you increase (or decrease) the Temporary Basal Rate the duration of
your previous Temporary Basal Rate increase (or decrease) appears. When
you use your pump for the first time, a default value appears.
5. Press d to move to the TBR DURATION screen.
Press a or s to correct and set the duration.
Note:
Press d to loop between programming the basal rate percentage
and duration.
6. Press f to save and exit.
The new Temporary Basal Rate is immediately activated.
Note:
At any function screen you have three options to exit:
if you want to save the changes
• Press f. Your pump returns to the RUN screen.
if you want to undo the changes
• Wait for your pump to return to the RUN screen (timeout), or
• Press d+a simultaneously (exit feature) to exit the function screen.
• Set volume to 100% and press f.
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Note:
During the 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 up symbolizes a Temporary Basal Rate increase;
an arrow pointing down 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.
TBR OVER Alert
At the end of a Temporary Basal Rate, an alert A7: TBR OVER occurs. Press f
twice to confirm and turn off the alert. See the section “Alert A7: TBR OVER”
(page 153) for more information.
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Cancelling a Temporary Basal Rate
– during programming:
There are three ways to cancel a Temporary Basal Rate during programming:
• Do not press any key for 20 seconds. The pump returns to the
RUN screen (timeout).
• Exit to the TEMPORARY BASAL RATE (TBR) screen by pressing d+ a
simultaneously.
• Set the TBR percentage to 100%. Press f to save and exit.
No Temporary Basal Rate is delivered.
– during delivery:
There are two ways to cancel a Temporary Basal Rate during delivery:
• Set the TBR percentage to 100%:
1. Press d to move to the TEMPORARY BASAL RATE (TBR) screen.
2. Press f to select.
The TBR PERCENTAGE screen appears.
3. Press a or s to return the basal rate to 100%.
Press f to save and exit.
• Or, put your pump in STOP mode.
The Temporary Basal Rate delivery is interrupted.
An alert A6: TBR CANCELLED occurs. Press f twice to confirm and
turn off the alert.
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!
CAUTION
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When your insulin pump is in STOP mode, it does not deliver
any insulin. Put your insulin pump in RUN mode to continue
the insulin delivery.
Note:
If an Extended Bolus or a MultiWave Bolus is active at the same time,
it is also cancelled when your pump is put into STOP mode. An alert
A8: BOLUS CANCELLED and an alert A6: TBR CANCELLED occur.
Press f twice to confirm and turn off the first alert. The second alert
appears on the display. Press f twice to confirm and turn off the
second alert. Both alerts are recorded in the alarm history.
See the sections “Alert A6: TBR CANCELLED” (page 152) and “Alert A8:
BOLUS CANCELLED” (page 153) for more information.
Make sure that the cancellation was intended and then program a new
Temporary Basal Rate (and/or an Extended or MultiWave Bolus), if needed.
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Chapter 5: User Menus
You will need to access various screens so you can view stored information,
program the pump, perform a function, or change a setting. Your pump offers
a choice of three different user menus:
• The STANDARD User Menu
This menu offers all the functions you need for successful insulin pump
therapy and lets you change between the user menus. If you are new
to pump therapy, start with this menu. Later, as your comfort with
pump therapy grows, you may choose the features offered in the
ADVANCED user menu.
• The ADVANCED User Menu
This menu offers the full range of the ACCU-CHEK Spirit insulin pump
functions. It includes all functions from the STANDARD user menu, plus
a wide range of functions for the more experienced user.
• The CUSTOM User Menu
Because the ACCU-CHEK Spirit insulin pump has many features, you
may want to choose the screens that you see when you scroll through
the menu choices. This menu lets you display or hide other screens.
Note:
At the end of this user guide you will find diagrams for the STANDARD
and ADVANCED user menus.
For your safety and convenience during programming, your insulin pump
returns itself to the RUN or STOP screen if no key is pressed within 20
seconds. For your safety, the changes you made before your insulin
pump “times out” will not be saved.
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Selecting a User Menu
RUN
screen
select the
user menu
user
menu
select basal
rate profile
Note:
When you change the user menu, your current basal rate profile will not
appear if it is not activated. Make sure that your desired basal rate
profile number(s) is/are activated. This can be done through the previous
user menu or the ADVANCED user menu.
Follow the steps below:
1. Press d to move to the SELECT USER MENU screen.
Press f to select.
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2. The current user menu is selected on the SELECT USER MENU screen.
Press a or s to select a different user menu.
3. Press f to confirm.
The selected basal rate profile and its daily insulin
total appear,
or
if the previous basal rate profile is not available
from the selected user menu, dashes appear instead.
4. Press a or s to select a basal rate profile, if needed.
Check the (new) basal rate profile and its daily insulin total.
5. Press f to save and exit. The new user menu and basal rate profile are
active immediately.
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!
▲
CAUTION
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A running increased or decreased Temporary Basal
Rate will remain active, even if you changed the basal
rate profile. The temporary basal rate is based on the
new basal rate.
Note:
At any function screen you have three options to exit:
• If you want to confirm and save the changes press f until your
pump returns to the RUN screen,
• If you want to undo the changes
press d+ a simultaneously to exit the function screen, or
• Wait for your pump to return to the RUN screen (timeout).
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STANDARD User Menu
The following is a list of menu choices for the STANDARD user menu as they
are addressed in the manual. To view the order in which they appear on the
pump, refer to the menu diagrams at the back of the manual. Some of the
functions have already been described earlier in the manual. The remaining
functions are described following this list.
SET TIME AND DATE–See the section “Setting Time and Date” (page 32)
PROGRAM BASAL RATE PROFILE - See the section “Programming your
Basal Rate Profile” (page 37)
CHANGE THE CARTRIDGE–See the section “Inserting the Cartridge” (page 49)
PRIME THE INFUSION SET–See the section “Priming the Infusion Set”
(page 53)
START YOUR ACCU-CHEK–See the section “Starting Insulin Delivery”
(page 65)
STOP YOUR ACCU-CHEK–See the section “Stopping Insulin Delivery”
(page 66)
STANDARD BOLUS–See the section “Programming a Standard Bolus”
(page 77)
EXTENDED BOLUS–See the section “Programming an Extended Bolus”
(page 83)
TEMPORARY BASAL RATE (TBR)–See the section “Programming a
Temporary Basal Rate (TBR)” (page 93)
COMMUNICATION–See the section “Data Transfer” (page 104)
INFORMATION–See the section “Reviewing Pump Data” (page 107)
SETUP MENU STANDARD–See the section “SETUP MENU Standard”
(page 113)
SELECT USER MENU–See the section “Selecting a User Menu” (page 100)
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Data Transfer
The pump memory stores up to 4,500 pump events (about 90 days of usage).
Pump events include alerts and errors, programming operations, and insulin
delivery records. Some or all of the pump memory may be transferable to
compatible software.
The built-in infrared interface inside the bottom cover of your insulin pump
allows for wireless data transfer.
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Setup for Data Transfer
STOP
screen
communication
start data
transfer
stop data transfer
Follow the steps below:
1. Put your pump in STOP mode.
2. Press d to move to the COMMUNICATION screen.
3. Press f. The DATA TRANSFER screen appears and a melody signals that
your pump is ready to deliver data.
When the data transfer is finished, press f to return to the STOP screen.
Set up your pump with a cartridge, adapter, and a new infusion set and put
it in the RUN mode, if necessary.
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Note:
Your pump returns to STOP mode 15 minutes after the last data transfer
when the DATA TRANSFER screen is selected.
You may press d+ a simultaneously to exit while data is being
transferred. The data transfer is interrupted and an error E12: DATA
INTERRUPTED occurs. See the section, “Error E12: DATA INTERRUPTED”
(page 163) for more information.
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Reviewing Pump Data
The pump memory lets you review specific data such as:
• Bolus history
• Alarm history
• History of daily insulin totals
• Temporary Basal Rate history
• Maintenance (pump timer)
last 30 boluses
last 30 alerts and errors
last 30 daily totals of insulin delivered
last 30 increases and decreases
remaining time in days until the
pump timer expires
Review the Bolus History
The bolus history lets you review up to the last 30 boluses delivered beginning
with the most recent entry and working backward in time.
Each BOLUS HISTORY screen displays the:
• bolus type ( Standard Bolus, Extended Bolus or MultiWave Bolus),
• bolus duration ( only displayed if an Extended or a MultiWave Bolus),
• time ( )
• date ( ) and
• entry number (01 is the most recent) of total entries (example 01/30) of
a delivered bolus.
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bolus
history
alarm
history
daily
totalTBR
history
maintenance
1. Press d to move to the INFORMATION screen.
2. Press f to select.
The BOLUS HISTORY screen appears. The most
recent bolus information is displayed.
3. Press a or s to review the entries.
Press f to exit.
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Review the Alarm History
The alarm history lets you review the last 30 alerts or errors, beginning with
the most recent entry and working backward in time.
Each alarm history screen displays the:
• number and type of the alert or error (example A6),
• alert or error (example TBR CANCELLED),
• time ( ),
• date ( ) and
• entry number (01 is the most recent) of total entries (example: 01/30)
of an alert or error.
1. Press d to move to the INFORMATION screen.
Press f to select.
2. Press d to move to the ALARM HISTORY screen.
3. Press a or s to review the entries.
Press f to exit.
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Review the History of Daily Insulin Totals
This history lets you review the last 30 daily totals of insulin delivered (from
midnight to midnight; basal rate plus boluses), starting with the most recent
entry and working backward in time.
Each daily insulin total screen displays the following history:
• daily total of insulin delivered ( ),
• its date ( ), and
• entry number (01 is the most recent) of total entries (example 01/30)
of a daily insulin total.
Follow the steps below:
1. Press d to move to the INFORMATION screen.
Press f to select.
2. Press d to move to the DAILY TOTALS screen.
3. Press a or s to review the entries.
Press f to exit.
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Review the Temporary Basal Rate History
The Temporary Basal Rate (TBR) history lets you review the last 30 TBR
increases or decreases starting with the most recent entry and working
backward in time.
Each TBR history screen displays the:
• TBR increase ( ) or decrease ( ) in percentage,
• TBR duration ( ),
• time ( )
• date ( ) and
• entry number (01 is the most recent) of total entries (example 01/30)
of a delivered Temporary Basal Rate.
Follow the steps below:
1. Press d to move to the INFORMATION screen.
Press f to select.
2. Press d to move to the TBR HISTORY screen.
3. Press or scroll a or s to review the entries.
Press f to exit.
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Review the Time Remaining
Your pump is designed to be a highly reliable system that will give you worry-free
performance for a long time. For best performance, a pump timer limits the
operating time of the pump. This timer counts the number of days of operation
remaining for the ACCU-CHEK Spirit insulin pump.
Before the pump timer expires, an alert will remind you of the upcoming end of
operating time so that you can arrange to get a new one. The pump timer symbol
( ) appears in the RUN screen or STOP screen as a reminder. When the timer
expires, an error occurs and your pump goes into STOP mode. It can no longer
be put into RUN mode. See the sections “Alert A5: PUMP TIMER” (page 151)
and “Error E5: END OF OPERATION” (page 158) for more information.
Review the number of days left until the pump timer expires in the INFORMATION
menu.
Follow the steps below:
1. Press d to move to the INFORMATION screen.
Press f to select.
2. Press d to move to the PUMP TIMER screen.
The days until the pump timer expires is shown.
3. Press f to exit.
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SETUP MENU Standard
The SETUP MENU Standard should not be confused with the STANDARD user
menu. The SETUP MENU Standard is a menu choice that appears in STANDARD
and ADVANCED user menus. The SETUP MENU Standard allows you to “set up”
certain features and settings. The following features and settings can be
changed using the SETUP MENU Standard menu choice.
Turning KeyLock On or Off
The KeyLock function lets you lock the four keys of your pump and serves as an
extra safety measure against activating functions by accident (for example, while
sleeping, during contact sports). To use the KeyLock function, it must be turned on.
See the section “Keys and Key Combinations” (page 11) for more information.
RUN / STOP
screen
setup
standard
KeyLock
beep
volume
alarm
signals
automatic
off battery
typeorientation
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Follow the steps below:
1. Press d to move to the SETUP MENU STANDARD screen.
Press f to select.
2. The current KeyLock status (ON or OFF) appears.
3. Press a or s to turn the KeyLock ON or OFF.
Press f to save and exit.
If no key is pressed for 10 seconds after your pump has returned to the RUN
screen or STOP screen and if the KeyLock is turned on, all four keys are locked.
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Unlocking the KeyLock
RUN screen
locked
3 sec.
10 sec.
RUN screen
unlocked
Follow the steps below:
1. From the RUN or the STOP screen, press d+s simultaneously (you hear
three beeps in RUN mode one beep in STOP mode) and hold for 3 seconds
until you again hear three beeps (in RUN mode) one beep (in STOP mode) to
confirm that the KeyLock is unlocked.
2. If no key is pressed for 10 seconds after your pump has returned to the RUN
or the STOP screen, all four keys are automatically locked.
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Adjusting the Beep Volume
Your pump beeps when a key is pressed or when an alert or error occurs.
Follow the steps below:
1. Press d to move to the SETUP MENU STANDARD screen.
Press f to select.
2. Press d to move to the BEEP VOLUME screen.
The active beep volume is displayed.
3. Press a or s to adjust the beep volume.
There are five volume levels:
no beeps (beeps are turned off)
very low
low
normal
maximum
4. Press f to save and exit.
Note:
The volume of the STOP-Warning is independent of the programmed
beep volume. It always occurs at the maximum level. When the beeps
are turned off and an alert or error occurs, the beeps will become active
again after a short period of time to make sure that you are aware of
the alarm or error. These beeps will steadily increase in volume until
the maximum level is reached if the alert or error is not cancelled.
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Setting Up Alarm Signals
The ACCU-CHEK Spirit insulin pump lets you choose how you want your pump
to alert you when an alarm occurs.
You have three options:
beep only
vibrate only
beep and vibrate
Follow the steps below:
1. Press d to move to the SETUP MENU STANDARD screen.
Press f to select.
2. Press d to move to the ALARM SIGNALS screen.
The active alarm signals are displayed.
3. Press a or s to set the alarm signals.
4. Press f to save and exit.
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Automatic Off
▲
!
Discuss using the automatic off function with your doctor
or healthcare team.
CAUTION
Automatic off is a safety feature that stops insulin delivery and triggers an
error E3: AUTOMATIC OFF if no keys are pressed within a programmed time
period in RUN mode.
The automatic off can either be set to OFF or programmed up to 24 hours in
1-hour intervals in the SETUP MENU STANDARD screen.
Follow the steps below:
1. Press d to move to the SETUP MENU STANDARD screen.
Press f to select.
2. Press d to move to the AUTOMATIC OFF screen.
The current status is displayed at the bottom
left of the screen.
3. Press or scroll a to increase or s to decrease the duration for the
automatic off in 1-hour intervals.
4. If you would like to set the automatic off function to OFF, press or scroll s
until 0 hours and OFF appears on the display.
5. Press f to save and exit.
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Battery Type
▲
If you do not set the correct battery type on your insulin
pump, the alert A2: BATTERY LOW may not occur in time
WARNING to provide you sufficient warning to replace your battery.
!
Your pump lets you choose between using 1.5 volt AA alkaline batteries or
rechargeable AA NiMH batteries. If you change from one battery type to the
other, you must also change the battery type setting.
See the section “Accessories and Disposables–Battery” (page 21) for more
information on recommended batteries.
Follow the steps below:
1. Press d to move to the SETUP MENU STANDARD screen.
Press f to select.
2. Press d to move to the BATTERY TYPE screen.
The current battery type is displayed.
3. Press a or s to select the battery type ALKALINE or NiMH
(rechargeable) battery.
Press f to save and exit.
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Display Orientation
Your pump lets you flip the display orientation by 180° so that you can view it
more conveniently depending on how you are wearing the pump.
Follow the steps below:
1. Press d to move to the SETUP MENU STANDARD screen.
Press f to select.
2. Press d to move to the ORIENTATION screen.
3. Press a or s to select the display orientation.
4. Press f to save and exit.
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CAUTION
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If you flip the display orientation of your insulin pump
by 180°, the a and s keys will also reverse their
functions. In comparison to the display orientation, the
upper key will be the a and the lower key will be s.
This change applies for all a and s functions including
turning on the backlight. The d and f will not change
in their function, but will remain the same, regardless of
your screen orientation.
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ADVANCED User Menu
The ADVANCED user menu offers the full range of the ACCU-CHEK Spirit
insulin pump functions. The ADVANCED user menu includes all functions
from the STANDARD user menu, plus a wide range of functions for the more
experienced user.
The following is a list of additional menu choices that appear in the ADVANCED
user menu. Some of the functions have already been discussed earlier in the
manual. The remaining functions are described below.
EXTENDED BOLUS–See the section “Programming an Extended Bolus”
(page 83)
MULTIWAVE BOLUS–See the section “Programming a MultiWave Bolus”
(page 88)
CHANGE BASAL RATE PROFILE–See the section “Selecting a Basal
Rate Profile” (page 125)
PROGRAM BASAL RATE PROFILE–See the section “Programming
Additional Basal Sate Profiles” (page 124)
ALARM CLOCK–See the section “Alarm Clock” (page 127)
SETUP MENU ADVANCED–See the section “SETUP MENU Advanced”
(page 129)
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Basal Rate Profiles
Your pump can store up to five different basal rate profiles to match your
changing insulin needs (for example, Monday-Friday versus Exercise Day
versus Sleeping Late Day).
Discuss additional basal rate profiles with your doctor or healthcare team.
Consult with your doctor or healthcare team before changing basal rate profiles,
as this may change how you use your pump.
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Programming Additional Basal Rate Profiles
▲
Incorrect programming of your insulin pump may cause
incorrect insulin delivery. Your insulin pump must be
WARNING programmed with your personal settings prior to starting
insulin pump therapy. Do not operate your insulin pump
without knowing your personal settings. If you are not
sure about your personal settings or you are less
experienced, have your doctor or healthcare team
check your personal settings.
!
Follow the steps below:
1. Press d to move to the PROGRAM BASAL RATE PROFILE screen.
Note:
Only basal rate profiles that are accessible in your current user menu
are available.
2. The hourly basal rates for each additional basal rate profile are set in the
same way as for basal rate profile 1. See the section “Programming your
Basal Rate Profile” (page 37) for more information.
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Selecting a Basal Rate Profile
RUN
screen
change the
BR profile
BR profile
no. …
Follow the steps below:
1. Press d to move to the CHANGE BASAL RATE PROFILE screen.
2. Press f to select.
The current basal rate profile is displayed.
Note:
Only basal rate profiles that are accessible in your current user menu
are available.
3. Press a or s to select a basal rate profile. The selected basal rate profile
and its daily insulin total appear.
4. Press f to select. The new basal rate profile is active immediately.
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Note:
When you change your user menu your current basal rate profile may
not appear.
If the basal rate profile number(s) you want does not appear,
• Select the ADVANCED user menu, or
• Program the basal rate profile to an available basal rate profile number
A running Temporary Basal Rate increase or decrease stays active,
even if you change the basal rate profile on your pump.
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Alarm Clock
You can set the alarm clock for a single alarm or for multiple alarms. Multiple
alarms repeat at the set time every day. Alarms can be set to remind you of
blood glucose testing or other important events.
Set Single or Multiple Alarms
1. Press d to move to the ALARM CLOCK screen.
2. Press f to select. The current alarm clock status (OFF, ONCE, or EVERY
DAY) and alarm time appear.
3. Press a or s to change the alarm clock to OFF, ONCE (
DAY ( ).
), or EVERY
4. Press d to move to the SET ALARM HOUR screen.
Press a or s to set the hour.
5. Press d to move to the SET ALARM MINUTE screen.
Press a or s to set the minute.
6. Press f to save and exit.
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Turning Off the Alarm Clock
When the alarm clock goes off, an alert A4: ALARM CLOCK occurs. Press f
twice to confirm and turn off the alert.
See the section “Alert A4: ALARM CLOCK” (page 151) for more information.
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SETUP MENU Advanced
The SETUP MENU Advanced should not be confused with the ADVANCED user
menu. The SETUP MENU Advanced is a menu choice that appears in the
ADVANCED user menu. The SETUP MENU Advanced allows you to “set up” certain
features and settings. The following features and settings can be changed using
the SETUP MENU Advanced menu choice.
Time Format
You can set the time in either of the following formats:
American:
European/Military:
12-hour clock (AM/PM), example 1:39 PM
24-hour clock (00:00-23:59), example 13:39
Follow the steps below:
1. Press d to move to the SETUP MENU ADVANCED screen.
Press f to select.
2. The TIME FORMAT screen appears.
Press a or s to select a time format.
3. Press f to save and exit.
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Date Format
You can set the date in the following formats:
American:
European:
mm/dd/yyyy, example 04/26/06
dd.mm.yyyy, example 26.04.06
Follow the steps below:
1. Press d to move to the SETUP MENU ADVANCED screen.
Press f to select.
2. Press d to move to the DATE FORMAT screen.
Press a or s to select a date format.
3. Press f to save and exit.
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Bolus increment
▲
The bolus increment that can be programmed into your
insulin pump determines the “Quick” Standard Bolus
WARNING amount using the a and s keys of your insulin
pump. Incorrect programming of the bolus increment
may cause inappropriate insulin delivery.
!
To address patients who may need large or small amounts of insulin, the bolus
increment for the ACCU-CHEK Spirit insulin pump is adjustable. The “Quick”
Standard Bolus is initially set to 0.5 units per key press but can be changed
in the SETUP MENU ADVANCED to 0.1, 0.2, 0.5, 1.0, or 2.0 units. Units for the
scroll “Standard” bolus, which may be adjusted by simply holding down the
a or s keys, will move at a constant 0.1 units. See the section
“Programming a Standard Bolus” (page 77) for more information.
Follow the steps below:
1. Press d to move to the SETUP MENU ADVANCED screen.
Press f to select.
2. Press d to move to the BOLUS INCREMENT screen.
Press a or s to select a bolus increment.
3. Press f to save and exit.
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Prime Quantity
The prime quantity needed to fill an infusion set depends on the length of the
infusion set tubing being used. The shorter your infusion set tubing, the less
insulin will be required to prime the infusion set. The default setting for the
prime quantity is 25 units of U100 insulin.
Note:
The amount of insulin used for the priming is not added to the history of
daily insulin totals. You can press any of your pump’s keys to stop priming.
Follow the steps below:
1. Press d to move to the SETUP MENU ADVANCED screen.
Press f to select.
2. Press d to move to the PRIME QUANTITY screen.
Press a or s to select a prime quantity
between 0.0 and 30.0 units.
3. Press f to save and exit.
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Lock Basal Rate Profiles
Your pump lets you change your hourly basal rates as needed. You may lock
your basal rate profiles to provide extra protection against accidentally changing
a basal rate during normal operation. When this function is activated, your hourly
basal rates cannot be changed.
Follow the steps below:
1. Press d to move to the SETUP MENU ADVANCED screen.
Press f to select.
2. Press d to move to the BASAL RATE LOCK screen.
Press a or s to turn the basal rate lock ON
or OFF.
3. Press f to save and exit.
Note:
If the basal rate lock is set to ON (
), the programming of the basal
rate profiles 1, 2, 3, 4, and 5 is blocked. To check if the basal rate lock
is ON, press d to move to the PROGRAM BASAL RATE screen and
press f to select. The
symbol in the BASAL RATE TOTAL screen
indicates the lock of the basal rate programming. (The
symbol appears
in the BASAL RATE TOTAL screen only.) Press d to view the hourly
basal rates. The a and s functions are blocked.
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Language
Your pump is programmed in several languages. These languages include
Italian, English, German, French, Spanish, Portuguese, Czech, Dutch, Swedish,
Norwegian, Polish, and Greek.
To choose a language, do the following:
1. Press d to move to SETUP MENU ADVANCED screen.
Press f to select.
2. Press d to move to the LANGUAGE screen.
Press a or s to select a language.
3. Press f to save and exit.
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Display Contrast
Your pump lets you adjust the display contrast.
Follow the steps below:
1. Press d to move to the SETUP MENU ADVANCED screen.
Press f to select.
2. Press d to move to the DISPLAY CONTRAST screen.
Press a or s to select a contrast level.
3. Press f to save and exit.
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CUSTOM User Menu
The CUSTOM user menu contains the 11 most commonly used functions according
to a customer survey.
The following is a list of the functions included in the CUSTOM user menu. All
of these functions have been addressed in detail in STANDARD and ADVANCED
user menu sections.
– STANDARD BOLUS
– EXTENDED BOLUS
– TEMPORARY BASAL RATE (TBR)
– INFORMATION
– CHANGE BASAL RATE PROFILE
– PROGRAM BASAL RATE PROFILE 1
– PROGRAM BASAL RATE PROFILE 2
– ALARM CLOCK
– SET DATE AND TIME
– SETUP MENU STANDARD
– SELECT USER MENU
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Chapter 6: Care and Maintenance
Care of Your ACCU-CHEK Spirit Insulin Pump
▲
!
CAUTION
Do not perform any servicing or repair on your insulin
pump. For servicing or repairs contact Pump Support at
1-800-688-4578.
Disetronic Medical Systems, as the manufacturer, guarantees the functions of
your pump according to its specifications only if all servicing of your pump is
done and/or authorized by Disetronic Medical Systems.
System Inspection Checklist
Your pump must be well maintained to guarantee accurate insulin delivery.
Check the pump display at least every three hours during the day and before
you go to sleep, and especially if for any reason you might not be able to
hear the beeps or to feel the vibrations. Use only sterile products and
accessories designed to be used with your pump. Replace and discard these items
according to your doctor’s or healthcare team’s recommendations and the instructions that come with these items.
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Check your pump daily. Make sure that:
• The pump casing, the display, and the cartridge are not chipped or
cracked and that the display doesn’t show incomplete or abnormal
letters or symbols.
• You visually inspect the cartridge. Make sure that the actual amount of
insulin in the cartridge equals the displayed cartridge amount on the
QUICK INFO screen.
• You inspect all parts of your pump and infusion set at least every
three hours during the day and before you go to sleep. If you detect
any loss of insulin, immediately replace the leaking component.
• The battery cover is correctly tightened and positioned even with the
pump casing.
• The adapter is inserted properly.
• Your infusion set is primed, free of air bubbles, and tight in the adapter.
• Your infusion set is inserted according to the instructions for its use.
• Your infusion site is secure, comfortable, and free of irritation or infection.
• The cartridge is free of air bubbles.
• Your pump is in RUN mode.
• The basal rates are set correctly according to your doctor’s or healthcare
team’s recommendations.
• The time and date are set correctly.
• The Temporary Basal Rate changes are set according to your doctor’s
or healthcare team’s recommendations.
• The beeps and/or vibrations are set.
• You have your personal emergency kit.
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What to Do When You Drop Your Pump
If the pump is dropped it could be harmed or the seal that protects it against water
could be damaged. Be careful not to drop your pump. Use the proper ACCU-CHEK
Spirit insulin pump carrying system to help avoid dropping your pump. See
Disetronic Medical Systems sterile products and accessories catalogs and
brochures for more information. Or, contact Pump Support at 1-800-688-4578.
If your pump is dropped:
• Check that all connections in your infusion set are still tight, and if
they are not, reconnect or tighten them
• Check your pump, its sterile products, and accessories for chips and
cracks, and
• Change the cartridge if it is damaged.
▲
!
CAUTION
Check your insulin pump and its sterile products and
accessories at least every three hours. Immediately inspect
your insulin pump if it is dropped. Do not use your insulin
pump if chips or cracks are visible. Chips and cracks may
allow water, dust, insulin, or other foreign substances to
enter your insulin pump and lead to malfunction.
If you have questions or are not sure whether your pump has been damaged,
contact Pump Support at 1-800-688-4578.
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Storing Your ACCU-CHEK Spirit Insulin Pump
!
▲
When your insulin pump will not be in use for a long period of
time, it should be properly stored, to prevent a malfunction.
CAUTION
To store your pump, place in STOP mode, then:
• Remove the battery to preserve the battery life
• Remove the cartridge
• Insert the battery cover and the adapter
• Store your pump in its shipping case
Storage Conditions
Temperature
Air humidity
Barometric pressure
41°F to 113°F (+5°C to +45°C)
5 to 85% relative air humidity
700 to 1060 mbar
Disposal
Your ACCU-CHEK Spirit Insulin Pump
If you need to dispose of your insulin pump, return it to Disetronic Medical
Systems for professional disposal.
Battery
Properly dispose of dead batteries.
Cartridge, Infusion Set, Adapter, and Accessories
Dispose of these items in your normal garbage. Remember to dispose of the
introducer needle safely (needle container). To prevent injury to others, replace
the needle protective cap or insert the needle of the infusion set into a disposable
object, or put it in a hard shell container.
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Maintenance
Cleaning Your ACCU-CHEK Spirit Insulin Pump
The best time to clean your pump is when you change the cartridge. Use a
soft, dry cloth for cleaning. If the pump compartments are very dirty, contact
Pump Support at 1-800-688-4578 for more instructions.
▲
!
CAUTION
Always remove the cartridge and adapter and place your
insulin pump in STOP mode while cleaning. Avoid pressing
the keys of your insulin pump during cleaning, as this may
accidentally change your settings. Do not use alcohol,
solvents, strong detergents, bleaching agents, scouring
pads, or sharp instruments for cleaning as they may
damage the pump.
Battery Information
It is important to change your battery regularly and to have spare batteries ready.
The life of any battery is affected by how you use your insulin pump, your personal
settings, delivery rates, temperature, and other factors. With typical pump use
[50 U/day using U100 insulin; operating temperature 72°F ± 6°F (22°C ± 3°C)],
pump battery life is about four weeks using alkaline batteries and one week
using rechargeable batteries. See the section “Accessories and Disposables–
Battery” (page 21) for more information on recommended batteries. See the
section “Inserting (or Changing) the Battery” (page 25) for instructions on how to
change your battery.
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Repair
!
▲
CAUTION
Do not perform any servicing or repair on your insulin pump.
Do not use any lubricants on the pump mechanism. If you
have questions, contact Pump Support at 1-800-688-4578.
If you have problems with your pump, contact Pump Support at 1-800-688-4578.
Pump Support can help you and answer many questions over the telephone.
Pump Support may direct you to return your pump to Disetronic Medical Systems
for repair. For example, you might need to return your pump if an alert or error
could not be cleared by following the procedures described in “Alerts and Errors.”
(page 147). If Pump Support directs you to return your pump, they will give you
a Return Material Authorization (RMA) number that you must include with the
pump when you send it.
If you must ship your pump, carefully pack the pump and the used cartridge,
battery, battery cover, adapter, and infusion set to avoid damage to them during
transportation. Place your pump back in the shipping case and put the case in a
package that will not rip or tear. It is best to send your pump using a shipping
method and carrier that tracks the shipment.
When you return your pump, include the following:
• a description of the reason for returning your pump
• your name and address
• your daytime phone
• the serial number of your pump, and
• any RMA (Return Material Authorization) number received from
Pump Support.
By returning your pump to Disetronic Medical Systems, you allow Disetronic
Medical Systems to undertake any testing on your infusion pump that is needed for
a proper inspection, and understand that your pump may not be returned to you.
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Troubleshooting
This section describes problems that may occur while using your ACCU-CHEK
Spirit insulin pump. See “Alerts and Errors” (page 147) for more information.
Note:
The solutions in this guide are only suggestions. Do not use these
procedures without approval of your doctor or healthcare team. Always
follow your doctor’s or healthcare team’s recommendations, and
contact them if you have any concerns about your insulin pump therapy.
You need to know that the interruption of insulin delivery (due to a leak,
occlusion, or loss of insulin potency, for example) or the malfunction of
your insulin pump can result in a rapid rise of your blood glucose level.
Although your pump has an internal security check system, it cannot
alert you if your infusion set is leaking or if the insulin you are using
has lost its potency.
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Therapy-Related Issues
Many factors, such as alcohol consumption, medications other than insulin,
ineffective or expired insulin, decreased activity, illness, and stress can affect
blood glucose levels. Contact your doctor or healthcare team for advice on how
to manage these or any other therapy related issues.
Troubleshooting Table
Problem
Recommended Actions
Individual characters, numbers, or
symbols on the display are shown
incompletely or not at all.
Contact Pump Support at
1-800-688-4578.
Your insulin pump does not beep
or vibrate.
Check that the beep volume and alarm
signals are turned on. Check and
change the battery. If your insulin pump
still does not beep or vibrate, contact
Pump Support at 1-800-688-4578.
Self-test incomplete (after an error
E7: ELECTRONIC ERROR).
Remove the battery, wait a few
seconds, and insert it again. If the
self-test remains incomplete, contact
Pump Support at 1-800-688-4578.
Incorrect insulin delivery due to
incorrect time setting.
The correct hourly basal rate cannot be
delivered if the time is not set correctly.
Check and reset the time if it is wrong.
Do the same check when you change
the battery.
Incorrect insulin delivery due to
incorrect basal rate programming.
Always review changes made in basal
rate programming. Confirm that you are
using your correct basal rate profile.
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Problem
Recommended Actions
Air bubbles in the cartridge
and/or infusion set
Check blood glucose level. In the
cartridge: Disconnect the infusion tube
set from the headset and re-prime your
infusion tube set. If the air bubbles
remain, replace the cartridge. Make sure
to fill the cartridge with insulin at room
temperature. In the infusion set:
Disconnect and prime your infusion set.
Reconnect and make sure all connections
are tight and secure.
Blood in the infusion set tubing Change your infusion set and infusion site.
Empty cartridge
Replace the cartridge. Cartridges are for
single use only.
Disconnected or dislodged
infusion set
Make sure all connections are tight. Inspect
connections for leaking insulin. Check your
blood glucose level. Change your infusion
set and infusion site.
Leak in system
Check for leaking insulin at all connections
and on the skin. Change your infusion set,
infusion site, cartridge, and adapter. Check
your blood glucose level.
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Problem
Recommended Actions
Occlusion in system
Disconnect and re-prime your infusion
set. Check your blood glucose. If the
occlusion remains, prime the pump
without the cartridge inserted. See the
section “Error E4: OCCLUSION” (page 156).
Failure to complete prime
Re-prime the infusion set. Always prime
until a bubble-free insulin flow emerges
from the tip of the needle. Make sure the
tubing is free of air.
Poor absorption of insulin
Choose infusion sites that do not have
scar tissue, bruises, or tissue build-up.
Do not use the same infusion set or
infusion site longer than your doctor or
healthcare team recommends.
Infusion site becomes sore,
red, or swollen.
Change your infusion headset and infusion
site immediately. Use proper insertion
technique. Check blood glucose level.
Follow the planned infusion site rotation
pattern and advice given by your doctor or
healthcare team.
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Chapter 7: Alerts and Errors
A safety system monitors and controls the function of your pump. This safety
system performs more than 9 million safety checks every day. If it detects a
change from the pump’s normal state, it will trigger an alert (warning instruction)
or an error (error message). Beeps, vibrations, and messages on the pump
display indicate the cause of an alert or error. Alerts and errors are the only
way you will be quickly notified of any changes in your pump.
▲
!
CAUTION
Check the pump display at least every three hours during
the day, and before you go to sleep, and especially if you
might be not be able to hear the beeps or feel the vibrations.
Your pump gives alerts and errors using beeps and vibrations. You can turn off
either the beeps or the vibrations, but for your safety you cannot turn off both
at the same time for the initial alarm signal.
If you do not confirm an alert or error within 60 seconds, it will signal again.
When the beep is turned off or programmed at lower than maximum volume
level, the beep volume will rise to the loudest volume level if not confirmed.
The beep and vibration will continue at this level until confirmed.
Note:
The volume of the STOP-Warning is separate from the programmed beep
volume and cannot be changed. It always occurs at the maximum level.
KeyLock is unlocked by the system each time an alert or error occurs.
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Confirming an Alert or Error
When you confirm A1: CARTRIDGE LOW
, E1: CARTRIDGE EMPTY,
A2: BATTERY LOW , E2: BATTERY DEPLETED, A5: PUMP TIMER
or E5:
END OF OPERATION, the symbol for that alert or error stays in the RUN screen
or STOP screen as a reminder. For other alerts or errors, alarm information is
cleared from the display but stays in the alarm history and the event memory.
Follow the steps below to confirm an alert or error:
1. Press f to turn off the beeps and vibrations.
The alert or error code stays on the display.
2. As soon as you understand the reason for the alert, error code, or message,
confirm by pressing f again.
3. Take the appropriate action, if any.
4. If more than one alert and/or error occurs simultaneously, press f twice
for each alert or error to confirm and turn each off.
5. After an alert or error, make sure that your pump is returned to RUN mode.
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List of Alerts
!
▲
After an alert occurs, your insulin pump may be in STOP
mode and the insulin delivery may be interrupted. In order
WARNING to maintain insulin delivery, you must act immediately
according to the instructions given for each error code
or put your insulin pump in RUN mode to continue the
insulin delivery.
Alert A1: CARTRIDGE LOW
The contents of the insulin cartridge have dropped to 20 units of insulin. Be
prepared to replace the cartridge as soon as possible. The cartridge low symbol
(
) appears in the RUN or STOP screen as a reminder until you change
the cartridge.
1. Press f twice to turn off and to confirm the alert.
Change the cartridge before it is empty.
2. If necessary, put your pump in RUN mode.
See the section “Changing the Cartridge and Infusion Set” (page 73) for more
information.
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Alert A2: BATTERY LOW
The battery power is low. Be prepared for a battery change as quickly as possible.
The battery low symbol (
) appears in the RUN or STOP screen as a reminder
until you change the battery.
1. Press f twice to turn off and to confirm the alert.
Replace the battery as soon as possible (within a
few hours). Failure to change the battery within a
few hours of receiving the alert could result in
additional error messages.
2. If necessary, put your pump in RUN mode.
See the section “Accessories and Disposables–Battery” (page 21) for more
information on recommended batteries. See the section “Inserting (or Changing)
the Battery” (page 25) for instructions on how to change your battery.
Alert A3: REVIEW TIME AND DATE
The pump was without power for more than one hour. The ACCU-CHEK Spirit
insulin pump settings and history data are saved in memory regardless of
power loss. However, it may be necessary to enter the time and date again.
1. Press f twice to turn off and to confirm the alert.
Review the time and date and correct them,
if they are wrong.
2. If necessary, put your pump in RUN mode.
See the section “Setting Time and Date” (page 32) for more information.
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Alert A4: ALARM CLOCK
An alarm clock reminder was programmed into the pump.
1. Press f twice to turn off and to confirm the alert.
2. If necessary, put your pump in RUN mode.
Note:
If you have set the alarm occurrence to EVERY DAY, the same alert occurs
every 24 hours. Turn the alarm clock function OFF if you do not want
the alarm to go off again at that same time every day.
See the section “Alarm Clock” (page 127) for more information.
Alert A5: PUMP TIMER
Your pump’s operating time will expire soon. It is recommended that you replace
your pump after a period of four years of running time. After the alert A5: PUMP
TIMER occurs, the ACCU-CHEK Spirit insulin pump will display the symbol ( )
to remind you to check the timer.
1. Press f twice to turn off and to confirm the alert.
2. Put your pump in RUN mode.
3. Go to the INFORMATION screen on your pump.
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4. Move to the PUMP TIMER screen.
The days until the pump timer expires are shown.
When the PUMP TIMER reaches zero, the pump will change to STOP mode and
no longer operate. An error, E5: END OF OPERATION, will appear on the display.
Contact Pump Support at 1-800-688-4578 to discuss your options for further
use of your ACCU-CHEK Spirit insulin pump.
Note:
The alert A5: PUMP TIMER ALERT and the error E5: END OF OPERATION
are based on running time (the total time the pump is in RUN mode)
and not calendar years. However, the warranty is based on the date the
pump was purchased.
See the section “Review the Time Remaining” (page 112) for more information.
Alert A6: TBR CANCELLED (Temporary Basal Rate Cancelled)
A temporary increase or decrease of the basal rate has been cancelled.
1. Press f twice to turn off and to confirm the alert.
2. If necessary, put your pump in RUN mode.
3. Make sure that the cancellation was intended and then program a new
Temporary Basal Rate if needed.
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Alert A7: TBR OVER (Temporary Basal Rate Over)
A Temporary Basal Rate has ended. The original basal rate (100%) will resume
automatically once the alert has been confirmed.
1. Press f twice to turn off and confirm the alert.
2. Decide whether a further Temporary Basal Rate change is needed. If necessary,
program a new Temporary Basal Rate.
Alert A8: BOLUS CANCELLED
A bolus was cancelled during the start delay or after delivery began.
1. Press f twice to turn off and to confirm the alert.
2. If necessary, put your pump in RUN mode.
3. Make sure that the cancellation was intended and then program a new
bolus if needed.
Note:
The actual bolus amount that was delivered before the cancellation can be
reviewed in the bolus history. See the section “Review the Bolus
History” (page 107) for more information.
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List of Errors
!
▲
After the occurrence of an error, your insulin pump will be in
STOP mode and the insulin delivery is interrupted. In order
WARNING to maintain insulin delivery, you must act immediately
according to the instructions given for each error code.
Error E1: CARTRIDGE EMPTY
The insulin cartridge is empty. Change the cartridge immediately.
1. Press f twice to turn off and to confirm the error.
2. Disconnect or remove the infusion set from your infusion site.
3. Change the cartridge and prime the infusion set.
4. Reconnect the infusion set at your infusion site.
5. Put your pump in RUN mode.
See the section “Changing the Cartridge and Infusion Set” (page 73) for more
information.
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Error E2: BATTERY DEPLETED
The battery is out of power. Replace it immediately.
▲
After inserting a new battery, always check that the time
and date of your insulin pump are set correctly. Incorrect
WARNING programming of the time and date may cause incorrect
insulin delivery. If you, your doctor, or healthcare team
store and analyze your therapy data electronically and the
time and date of the devices used are not set identically,
the gathered data might not be meaningful.
!
1. Press f twice to turn off and to confirm the error.
2. Replace the battery.
3. Put your pump in RUN mode.
Note:
Your pump stores the settings you saved before the battery power ran
out. If your pump is without power for more than one hour, check the
time and date.
See the section “Accessories and Disposables–Battery” (page 21) for more
information on recommended batteries. See the section “Inserting (or changing)
the Battery” (page 25) for instructions on how to change your battery.
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Error E3: AUTOMATIC OFF
Automatic off is a safety feature that stops insulin delivery and triggers an
error E3: AUTOMATIC OFF if no keys are pressed within a programmed time
period in RUN mode.
1. Press f twice to turn off and to confirm the error.
2. Put your pump in RUN mode.
Error E4: OCCLUSION
▲
If an error E4: OCCLUSION occurs, immediately check your
blood glucose level, and check again in about 2 hours,
WARNING because insulin delivery has been interrupted. If your blood
glucose level is high, take appropriate actions according to
your doctor’s or healthcare team’s instructions.
!
Insulin (a maximum of 3.5 units of U100 insulin) was not delivered. This may
be due to:
• a blocked infusion set,
• a reused cartridge, or
• a dirty or damaged piston rod.
Note:
The display of this error depends on several factors including your current
hourly basal rate and boluses. For example, a blocked infusion set with
a basal rate of 2.0 U/h (U100 insulin and no additional boluses) would
trigger an error E4: OCCLUSION in approximately three hours or less,
depending on the type and severity of the blockage.
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If the occlusion (blockage) was inside your infusion set, follow the
steps below.
1. Press f twice to turn off and to confirm the error.
2. Disconnect or remove the infusion set from your infusion site.
3. Change the infusion set and prime it.
4. Reconnect the infusion set (tubing) at your infusion site.
5. Put your pump in RUN mode.
In rare cases, the cartridge itself can be the cause of the occlusion. If an
error E4: OCCLUSION occurs again, you must change the cartridge. Follow
the steps below:
1. Press f twice to turn off and to confirm the error.
2. Disconnect or remove the infusion set from your infusion site.
3. Change the cartridge and prime the infusion set.
4. Reconnect the infusion set (tubing) at your infusion site.
5. Put your pump in RUN mode.
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If the error E4: OCCLUSION occurs again, prime your pump without a
cartridge. Follow the steps below:
1. Press f twice to turn off and to confirm the error.
2. Disconnect or remove the infusion set from your infusion site.
3. Remove the cartridge, adapter and infusion set from your pump.
4. Carry out the PRIME THE INFUSION SET function without the cartridge,
adapter, and infusion set inserted.
5. Insert a new cartridge with connected adapter and infusion set.
6. Prime the infusion set.
7. Reconnect the infusion set (tubing) at your infusion site.
8. Put your pump in RUN mode.
If the error E4: OCCLUSION continues to occur, contact your doctor or
healthcare team for an alternate therapy plan. Contact Pump Support at
1-800-688-4578 for more assistance.
Error E5: END OF OPERATION
Your pump timer has reached zero. The pump will change to STOP mode and will
no longer operate. An error E5: END OF OPERATION will appear on the display. It
is recommended that you replace your pump after four years. Before this error
occurs, an alert A5: PUMP TIMER will remind you to replace your pump soon.
1. Press f twice to turn off and to confirm the error.
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2. Contact Pump Support at 1-800-688-4578 to discuss your options for further
use of the ACCU-CHEK Spirit insulin pump.
Note:
The alert A5: PUMP TIMER ALERT and the error E5: END OF OPERATION
are based on running time (the total time the pump is in RUN mode)
and not calendar years. However, the warranty is based on the date the
pump was purchased.
Error E6: MECHANICAL ERROR
A mechanical error was discovered during a routine automatic system check
and insulin delivery has stopped.
1. Press f twice to turn off and to confirm the error.
2. Remove or disconnect the infusion set from your infusion site.
3. Remove the cartridge, adapter, infusion set (tubing), and battery from
your pump. Insert a new battery.
4. Rewind the piston rod.
5. Install a new cartridge and infusion set.
6. Prime the infusion set.
7. Reconnect the infusion set (tubing) at your infusion site.
8. Put your pump in RUN mode.
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If the error E6: MECHANICAL ERROR occurs again in spite of these actions,
contact your doctor or healthcare team for an alternate therapy plan. Contact
Pump Support at 1-800-688-4578 for more assistance.
Error E7: ELECTRONIC ERROR
An electronic error was discovered during a routine automatic system check
and the insulin delivery has stopped. You cannot turn off and confirm an error
E7: ELECTRONIC ERROR by pressing f. You must remove the battery instead.
1. Remove or disconnect the infusion set from your infusion site.
2. Insert a new battery into the pump.
3. Prime the infusion set.
4. Reconnect the infusion set (tubing) at your infusion site.
5. Put your pump in RUN mode.
If an error E7: ELECTRONIC ERROR occurs during programming (i.e., basal rate,
time and date) check your settings.
If the error E7: ELECTRONIC ERROR occurs again, contact Pump Support at
1-800-688-4578 for assistance. Contact your doctor or healthcare team if
you need an alternate therapy plan.
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Error E8: POWER INTERRUPT
A power interrupt error occurs when you insert a new battery without first placing
the pump in STOP mode. See the section “Inserting (or Changing) the Battery”
(page 25) for instructions on how to change your battery. The error can also occur
if the pump was dropped. If the pump was dropped, see the section “What to Do
When You Drop Your Pump” (page 139) for more information.
1. Press f twice to turn off and to confirm the error.
2. Your pump goes in STOP mode.
3. Check the time and date and correct them if they are wrong. See the section
“Setting Time and Date” (page 32) for more information.
4. If a bolus and/or a Temporary Basal Rate was interrupted by the error,
review the bolus and/or the Temporary Basal Rate history for the delivered
amount and duration. See the section “Reviewing Pump Data” (page 107)
for instructions.
5. Put your pump in RUN mode.
6. Program a new bolus and/or Temporary Basal Rate if you need them. See
“Boluses and Temporary Basal Rates” (page 75).
If an error E8: POWER INTERRUPT occurs during programming, check your settings.
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Error E10: CARTRIDGE ERROR
The CHANGE THE CARTRIDGE function was not correctly carried out.
1. Press f twice to turn off and to confirm the error.
2. Remove or disconnect the infusion set from your infusion site.
3. Start the CHANGE THE CARTRIDGE menu.
4. Prime the infusion set.
5. Reconnect the infusion set (tubing) at your infusion site.
6. Put your pump into RUN mode.
7. If an error E10: CARTRIDGE ERROR occurs during the winding of the piston
rod, insert a new battery into the pump and repeat steps 1-6.
Error E11: SET NOT PRIMED
▲
Never prime an infusion set that is connected to your body.
You risk uncontrolled insulin delivery into your body. With
WARNING detachable infusion sets, make sure you have disconnected
the tubing from your site prior to priming. Always follow
the instructions provided with your infusion set.
!
The cartridge was changed but the infusion set was not primed. The error will
display when you try to put your pump in RUN mode.
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1. Press f twice to turn off and to confirm the error.
2. Remove or disconnect the infusion set from your infusion site.
3. Prime the infusion set.
4. Reconnect the infusion set (tubing) at your infusion site.
5. Put your pump in RUN mode.
See the sections “Changing the Cartridge and Infusion Set” (page 73) and
“Priming the Infusion Set” (page 53) for more information.
Error E12: DATA INTERRUPTED
▲
!
CAUTION
If data transfer between compatible software and your
insulin pump is disrupted in any way, the configuration
may be incomplete and an error E12: DATA INTERRUPTED
occurs. The data transfer must be completed successfully
before you can put your insulin pump into RUN mode.
Data transfer between your pump and a PC was interrupted before it was
completed.
1. Press f twice to turn off and to confirm the error.
2. Restart the data transfer.
Before you can put your pump in RUN mode, the data transfer must be successful.
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See the section “Data Transfer” (page 104) for more information.
Error E13: LANGUAGE ERROR
The language setting needs to be checked.
1. Press f twice to turn off and to confirm the error.
2. Follow the steps in the section “SETUP MENU Advanced–Language”
(page 134) to change the language.
3. Put your pump in RUN mode.
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Appendixes
Appendix A: Technical Data
General Technical Data
Air humidity
• During operation: 20 to 90%
relative humidity
• Stored in its shipping case:
5 to 85% relative humidity
Barometric pressure
During operation or stored in its
shipping case: 700 to 1,060
mbar [do not exceed 10,000 feet
(3,000 meters) above sea level].
Basal rate
Minimum 0.1 U/h; maximum 25 U/h
There are 24 hourly basal rates
adjustable in 0.1 unit increments.
Battery life
If used in a typical usage pattern
[50 U/day using U100 insulin;
operating temp. of 72°F ± 6°F
(22°C ± 3°C)] the battery life is
approx. four weeks for alkaline
and one week for rechargeable
batteries.
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Bolus
The max. bolus amount per delivery
is 25 units when using U100 insulin.
The bolus amount for the “Quick”
Standard Bolus is adjustable in
increments of 0.1, 0.2, 0.5, 1.0,
and 2.0 units. For the “Scroll”
Standard Bolus, the Extended
Bolus, and the MultiWave Bolus,
the amount is adjustable in fixed
increments of 0.1 units. The
duration of the Extended Bolus and
the MultiWave Bolus is adjustable in
intervals of 15 minutes (15 minutes
up to 24 hours).
Cartridge
ACCU-CHEK 3.15 ml plastic
cartridge with luer-lock connection.
Data storage time
The time and date is safely stored
in the memory for about 1 hour
after the battery has been removed.
Your insulin pump’s settings (the
hourly basal rates, remaining
cartridge content, bolus increments,
and active user menu) and the event
memory (bolus history, history of
daily insulin totals, Temporary
Basal Rate history, alarm history)
are saved, regardless of battery
voltage and time the insulin pump
has been without a battery.
Data transfer
Infrared interface
Delivery
1/20th of the current hourly basal
rate in 3-minute intervals.
Dimensions (maximum)
without adapter
Approx. 3.2 x 2.2 x 0.8 inches
(81 x 55 x 20 mm)
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Flow (delivery rate)
Page 167
0.2 U/sec during infusion set
priming and bolus when using
U100 insulin.
ACCU-CHEK infusion sets with
luer-lock connector.
Infusion sets
IPX 8
Protected against the effects of
temporary immersion in water
under standardized conditions
[up to 60 minutes and 8 feet
(2.5 meters)].
Maximum time for an error
E4: OCCLUSION
Plastic cartridges*
• at med. basal rate 1.0 U/h using
U100 insulin
≤ 5h
• at min. basal rate 0.1 U/h using
U100 insulin
≤ 50h
Maximum volume* before error
U100 insulin
Maximum pressure
400kPa (4.0 bar)
Maximum quantity delivered at
a single fault condition
U100 insulin
Power supply
One 1.5 volt AA Alkaline battery
or one rechargeable Nickel Metal
Hydride (NiMH) AA battery. Alkaline
batteries should have a minimum
capacity of 2500 mAh and NiMH
AA rechargeable batteries a
minimum capacity of 1500 mAh.
Use only a battery charger
officially recommended by the
battery manufacturer.
Pump casing
Shock, scratch, pharmaceutical
resistant plastic. All edges are
rounded.
≤ 3.5 U
≤ 1.0 U
*Determined using measurement methods according to IEC 60601-2-24-1998.
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Safety system
Alert system, beeps, information
on the display, vibrations, dual
microprocessor. The insulin pump is
controlled by two microprocessors.
The safety concept is based on one
processor (supervisor processor)
supervising the other (main
processor). Whenever a defect or
fault occurs in the main processor,
as identified by the supervisor
processor, the motor is immediately
switched off and an error E7:
ELECTRONIC ERROR occurs.
Conversely, the main processor
can also determine at any time
whether the supervisor is working
correctly. The brushless motor also
constitutes an important safety
component. It provides the best
possible reliability and accuracy in
insulin delivery.
Temperature ranges
• During operation: 41°F to 104°F
(5°C to 40° C)
• Stored in its shipping case:
41°F to 113°F (5°C to 45° C)
Temporary Basal Rate
Adjustable in 10% increments,
0-90% for decreases, 110-200%
for increases. The duration is
adjustable in 15-minute intervals,
up to a maximum of 24 hours. The
last programmed duration is given
by default for the next temporary
basal rate change programmed.
Weight
• Empty: approx. 2.8 oz. (80 g)
• Pump w/battery, full plastic
cartridge, and infusion set:
approx. 4 oz. (110 g)
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Technical Standards on Electromagnetic Emissions
The standard concerning electromagnetic compatibility of medical equipment
(IEC 60601-1-2) requires the concrete specification of the corresponding levels
which refer to specified electromagnetic interferences. The following is
Guidance and manufacturer’s declaration on electromagnetic emissions.
Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF emissions
CISPR11
Group 1
The ACCU-CHEK Spirit insulin pump uses RF
energy only for its internal function.
Therefore, its RF emissions are very low
and are not likely to cause any interference
in nearby electronic equipment.
RF emissions
CISPR11
Class B
The ACCU-CHEK Spirit insulin pump is
suitable for use in establishments, including
domestic establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings used
for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Not applicable
Voltage
Not applicable
fluctuations/
flicker emissions
IEC 61000-3-3
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Note 1
At 80 and 800 MHz, the higher frequency range applies.
Note 2
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects and people.
Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast, cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the
ACCU-CHEK Spirit insulin pump is used exceeds the applicable RF
compliance level above, the ACCU-CHEK Spirit insulin pump should be
observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting
or relocating the ACCU-CHEK Spirit insulin pump.
a
b
Over the frequency range 150 kHz to 80 MHz, field strengths
should be less than 10 V/m.
V1 in V:
10.00
E1 in V/m:
Rated maximum 150 kHz to 80 MHz
output power
out of ISM (Industrial,
of transmitter W Scientific, Medical Band)
10.00
80 MHz to
800 MHz
80 MHz to
2.5 GHz
Separation distance according to frequency of transmitter m
0.01
0.1
1
10
100
Appendixes
0.04
0.11
0.35
1.11
3.50
0.04
0.11
0.35
1.11
3.50
170
0.07
0.22
0.70
2.21
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Technical Standards on Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The ACCU-CHEK Spirit insulin pump is intended for use in the electromagnetic
environment specified below. The customer or the user of the ACCU-CHEK
Spirit insulin pump should assure that it is used in such an environment.
IEC 60601
Immunity Test Test Level
Compliance
Level
Electromagnetic
Environment – Guidance
Electrostatic
± 6 kV contact ± 8 kV contact
Avoid any contact with
discharge (ESD) ± 8 kV air
± 15 kV air
synthetic materials. A
IEC 61000-4-2
(IEC 60601-2-24) relative humidity of 10% will
allow ESD to be more likely.
Power frequency 3 A/m 400 A/m 400 A/m
(50/60Hz)
magnetic field
IEC 61000-4-8
(IEC 60601-2-24)
Conducted RF
IEC 61000-4-8
Appendixes
3 Vrms
150 kHz to
80 MHz
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Not applicable
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IEC 60601
Immunity Test Test Level
Compliance
Level
Radiated RF
10 V/m
3 V/m
IEC 61000-4-3 80 MHz to
2.5 GHz
Page 172
Electromagnetic
Environment – Guidance
Portable and mobile RF
communications equipment
80 MHz
should be used no closer to
2.5 GHz
any part of the ACCU-CHEK
Spirit insulin pump, includ(IEC 60601-2-24) ing cables, than the recommended separation distance
calculated from the equation
applicable to the frequency
of the transmitter.
Recommended separation
distance:
Ҁ
d = 0.4 .앀P 80 MHz
to 800 MHz
Ҁ
d = 0.7 .앀P 800 MHz
to 2.5 GHz
where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic site
survey (a), should be less
than the compliance level in
each frequency range (b).
Interface may occur in the
vicinity of equipment
marked with the following
symbol:
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Accuracy of Flow Rate for Plastic Cartridges
Trumpet curve plotted from data after the end of the stabilization period
The trumpet curve shows the accuracy of the delivery rate in relation to the
observation period.
The measurements were made at a medium basal rate of 1.0 U/h according to
IEC 60601-2-24:1998 with a Disetronic Classic infusion set PC 16/110 at room
temperature.
The average deviation of the delivered amount (overall mean percentage flow
error) for U100 insulin is ≤ ± 5%.
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Start-up graph over the stabilization period
The start-up graph shows changes in the flow rate over the stabilization time.
The measurements were made at a medium basal rate of 1.0 U/h according to
IEC 60601-2-24:1998 with a Disetronic Classic infusion set PC 16/110 at room
temperature.
Influence of height on delivery accuracy
The average deviation of the delivered amount (overall mean percentage flow
error) for U100 insulin is ≤ ± 10% when your ACCU-CHEK Spirit insulin pump is
located 3.3 feet (1 m) above/below the level of infusion site.
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Trumpet curve plotted from data after the end of the stabilization period
The trumpet curve shows the accuracy of the delivery rate in relation to the
observation period.
The measurements were made at a medium basal rate of 0.1 U/h according to
IEC 60601-2-24:1998 with a Disetronic Classic infusion set PC 16/110 at room
temperature.
The average deviation of the delivered amount (overall mean percentage flow
error) for U100 insulin is ≤ ± 20%.
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Start-up graph over the stabilization period
The start-up graph shows changes in the flow rate over the stabilization time.
The measurements were made at a medium basal rate of 0.1 U/h according to
IEC 60601-2-24:1998 with a Disetronic Classic infusion set PC 16/110 at room
temperature.
Bolus
For U100 insulin the delivery accuracy of a maximum bolus is ≤ ± 5% and the
delivery accuracy of a minimum bolus is ≤ ± 30%.
The measurements were made according to IEC 60601-2-24:1998 with a
Disetronic Classic infusion set PC 16/110 at room temperature.
Delivery Mode
Delivery Rate/Volume
Accuracy
Range
Basal
Bolus
0.1 U/h
0.1 U
±20%
±30%
0.08 - 0.12 U/h
0.07 - 0.13 U
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Appendix B: Configuration Parameters
Your pump is built by Disetronic Medical Systems with a standard configuration
(factory settings). A list containing the important factory settings is added to the
original insulin pump package when your pump is first shipped. You may need
to adapt the factory settings to meet your individual needs. Set the configuration
parameters directly on your insulin pump. Always consult your doctor or
healthcare team before changing parameters.
The list on the next two pages gives you the full range for the adjustable
configuration parameters on your pump. Also included are examples of typical
range and parameter settings.
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Typical Range and
Parameter Settings
Basal Rate
– hourly basal rate +
max. TBR
(hourly basal rate
combined with temporary
basal rate, max. increase)
U100: 62.5 IU/h
– hourly basal rates
increment
0.1 U
– hourly basal rates
U100: 10.0 IU/h
– temporary basal rate
– TBR increase or decrease
in increments of
– TBR duration
– TBR duration increments
– bolus amount increments
for “Quick” and “Scroll”
Standard Bolus
– bolus duration (Extended
bolus, MultiWave bolus)
– bolus duration increments
Appendixes
Insulin Type Max. Amount
U100 0 – 62.50 IU/h
Insulin Type
U100
Max. Amount
0 – 25.0 IU/h
100%
0 – 200%
10%
max. 24 h
15 min
10%
15 min – 24 h
15 min, 30 min, 1 h
5
off
1–5
on or off
– basal rate profiles available
– basal rate lock
Bolus
– bolus amount per
bolus delivery
Maximum Parameter
Range
U100: 25.0 IU/h
Insulin Type
U100
Max. Amount
0 – 25.0 U
0.5U
0.1, 0.2, 0.5, 1.0 or 2.0 U
max. 24 h
15 min – 24 h
15 min
15 min, 30 min, 1h
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Typical Range and
Parameter Settings
Prime volume
Display orientation
Display contrast
U100: 25.0 U
Maximum Parameter
Range
Insulin Type
U100
Max. Amount
0 – 25.0 IU/h
standard
medium
standard or inverted
13 steps
STANDARD
3 (STANDARD, ADVANCED
or CUSTOM)
Volume (for beeps)
maximum
Alarm signals turned on beeps and vibrations
off, 1 – 4 steps
beeps, vibrations or both
User menus
Battery type
AA battery
AA Alkaline or
AA NiMH rechargeable battery
KeyLock
off
turned on or off
Automatic off
off
turned on or off
0.1 – 24h
Alarm clock
off
turned on or off
when on: once or every
day’s occurrence
Time format
American (12 h am/pm) or
European (24 h)
Date format
American (mm/dd/yy) or
European (dd.mm.yy)
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Appendix C: Abbreviations
approx.
Approximately
BR
Basal rate
BRP
Basal rate profile
DDM
Diabetes Data Management
h
Hour(s)
IEC
International Electrotechnical Commission
incl.
Inclusive
IR
Infrared
I.U., IU
International Units in context with biological effectiveness of
a certain insulin amount
kPa
Kilo pascals
LCD
Liquid Crystal Display
LED
Light Emitting Diode for infrared communication with, for
example, a personal computer (PC)
NiMH
Nickel Metal Hydride (used with rechargeable batteries)
rel.
Relative
sec.
Second(s)
TBR
Temporary Basal Rate
U
see I.U.
U/h
Amount of International Units of insulin delivered per hour
U100
Each milliliter of liquid contains 100 International Units of insulin
mm/dd/yy
American date format: month/day/year
dd.mm.yy
European date format: day.month.year
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Appendix D: Beeps and Melodies
You can turn off either the pump beeps or the vibrations, but not both
simultaneously. Please refer to sections “Adjust the Beep Volume”(page 116),
and “Setting Up Alarm Signals” (page 117) for more information.
Each press of
Each press of
Each press of
confirms each programmed bolus
increment when programming a “Quick” Standard Bolus
Each press of
confirms the STOP-Warning
Temporary Basal Rate is active
Unlock the KeyLock in RUN mode, enter the RUN or INFO
screen, start a Temporary Basal Rate
Lock the KeyLock in RUN mode
Unlock the KeyLock in STOP mode, enter STOP screen
Lock the KeyLock in STOP mode
Exit a screen
Cancel a running bolus or stop priming
Start-up procedure successful
Copy an hourly basal rate
Alert and error
Maximum amount reached
Minimum amount reached
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Appendix E: Vibrations
Your pump signals alerts and errors using beeps and vibrations. You can turn off
either the beeps or the vibrations, but you cannot turn off both simultaneously.
When you program a “Quick” Standard Bolus, your ACCU-CHEK Spirit insulin pump
confirms all programming by vibrating. You cannot turn off these vibrations.
Your ACCU-CHEK Spirit insulin pump vibrates when
l (Short vibration)
Your ACCU-CHEK Spirit insulin pump performs a
start-up procedure
(Medium vibration)
Your ACCU-CHEK Spirit insulin pump confirms
the programmed bolus amount of the “Quick”
Standard bolus
(Long vibration)
You reset the “Quick” Standard Bolus amount to
zero, you cancel the “Quick” Standard Bolus, or
when the STOP-Warning occurs
See the sections “Programming a Standard Bolus” (page 77) and “Setting Up
Alarm Signals” (page 117) for more information.
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Appendix F: Symbols
General Symbols
Read user guide
Sterilized using ethylene oxide
Sterilized using radiation
Sterilized using antiseptics
Year of manufacture
Batch number
Expiration date
Item number
Serial number
Admissible temperature range during operation
Admissible temperature range
Admissible humidity range
Admissible air pressure range
Fragile – handle with care
Protect against moisture
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Protect from heat and sunlight
For single use only
Does not contain pyrogen
Does not contain PVC
Recycling
Do not throw away
Do not use if the package is damaged
Flammable
See
Electronic device of type BF according to the standard
IEC 60601-1. Protection against electrical shock.
Symbol for protection against the effect of temporary immersion
in water [up to 60 minutes and 2.5 meters (8 feet)], according
to IEC 60529.
Marking of conformity according to the European Medical
Device Directive MDD 93/42/EEC with the number of the
notified body.
Federal law (USA) restricts this device to sale by or on the
order of a physician.
Federal Communications Commission, part 15 on radio
frequency devices.
Manufacturer
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Symbol Definition
Start your ACCU-CHEK Spirit insulin pump
STOP screen and Stop insulin delivery
Time, and Set the time and date menu
Date
Locked keys when the KeyLock function is turned on
Unlocked keys when the KeyLock function is turned on
Change the cartridge menu and cartridge content
Cartridge low warning
Empty cartridge
Low battery
Empty battery
Alkaline AA battery
Rechargeable AA battery
Amount of International Units of insulin delivered per hour
Basal rate profile
Temporary Basal Rate
TBR percentage
Daily basal rate total
Basal rate programming unlocked
Basal rate programming locked
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Standard Bolus and Bolus increment programming
Extended Bolus and Extended delivery of the MultiWave Bolus
MultiWave Bolus
Immediate bolus delivery of MultiWave Bolus
Decreased Temporary Basal Rate (0–90%)
Increased Temporary Basal Rate (110–200%)
Remaining duration of an ongoing Extended Bolus, MultiWave
Bolus, TBR, or automatic off
Daily total of insulin delivered (basal rate plus boluses)
Prime the infusion set (menu)
Alert or error occurring
Alert
Error
Information menu
Pump timer
Select the user menus STANDARD, ADVANCED or CUSTOM
SETUP MENU STANDARD menu
SETUP MENU ADVANCED menu
Beeps turned on
Vibrations turned on
Beeps and vibrations turned on
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Set beep volume
Screen orientation
European date format
American date format
Alarm clock turned on
Alarm clock turned off
Single alarm when setting an alarm clock
Every day repeat alarm when setting an alarm clock
PC communication
Set beep volume
Check key
Up key
Down key
Timeout of a menu
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Appendix G: Sterile Products and Accessories
Sterile Products
Cartridges
Name
Comments
Empty ACCU-CHEK
3.15ml Plastic Cartridge
Plastic cartridges are single-use
items. Do not reuse cartridges.
Refer to the instructions of the
insulin you are using for information
of proper use and acceptable
temperature range for storage
and handling.
ACCU-CHEK infusion sets
Name
Comments
ACCU-CHEK Ultraflex
The ACCU-CHEK Ultraflex infusion
set has a specially tapered cannula
and reversible connector for easy,
comfortable insertion and wearing
convenience.
ACCU-CHEK Tender
Variable insertion angle and choice
of cannula for maximum control
and comfort.
ACCU-CHEK Rapid-D
Ultra-fine stainless needle inserts
easily with one hand and is a great
option for new pumpers or those
with vision or dexterity issues.
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Accessories
Name
Comments
Adapter
Replace your adapter with every
10th cartridge.
Battery
One 1.5 AA alkaline battery with a
minimum capacity of 2500mAh
If used in a typical usage pattern
[50 U/day using U100 insulin;
operating temp. of 72°F ± 6°F
(22°C ± 3°C)] the battery life is
approx. four weeks for alkaline.
Rechargeable Battery
One AA NiMH rechargeable battery with
a minimum capacity of 1500 mAh
If used in a typical usage pattern
[50 U/day using U100 insulin;
operating temp. of 72°F ± 6°F
(22°C ± 3°C)] the battery life is
approx. one week for rechargeable
batteries.
Battery Cover
Replace your battery cover with
every 4th battery.
Carrying Systems
Disetronic Medical Systems offers
a wide range of carrying system
solutions to best fit your lifestyle.
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Appendix H: Glossary
Adapter
The adapter connects the cartridge and infusion set. It has two seals for the
cartridge compartment of your insulin pump. The two small vents on the
adapter let air pressure equalize.
Basal rate
The amount of insulin needed to cover your own basic insulin needs. In insulin
pump therapy, your basal rate is determined by your doctor or healthcare team
and can be adjusted to meet your body’s specific needs throughout the day.
Your basal rate is delivered by your insulin pump according to your personal
basal rate profile or profiles.
Basal rate profile
Your pump can be set to deliver up to five different basal rate profiles to match
changing insulin needs (for example, during the week and on the weekend). A
basal rate profile consists of 24 programmed hourly basal rates.
Basal rate total
The sum of all 24 hourly basal rates in one basal rate profile is called the (daily)
basal rate total.
Bolus
The amount of insulin delivered (in addition to the basal rate) to cover the
intake of food and correct high blood glucose levels. The bolus amount is
determined by your doctor or healthcare team’s guidelines, your blood glucose
level, your food intake, and your activity level.
Carrying system
A variety of special carrying systems made of different materials are designed
to suit your individual needs while wearing your pump.
Cartridge
The insulin reservoir of your pump. It holds 3.15 ml of rapid-acting insulin analog.
When using U100 insulin, 3.15 ml is equal to 315 International Units of insulin.
Cartridge compartment
The opening in your pump for the cartridge.
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Daily insulin total
The total amount of insulin delivered (basal rate plus boluses) in a 24-hour day,
beginning at midnight. This amount does not include any insulin needed for the
priming of infusion sets.
Diabetes Data Management (DDM)
Diabetes Data Management is the recording of the therapy-relevant data
gained from your insulin delivery system and your blood glucose measurement
system (such as an ACCU-CHEK blood glucose monitor) in order to analyze and
illustrate this data on a PC or other communication device.
Factory settings
The standard configuration (“factory settings”) on a new pump. These settings
can be adapted to your individual needs directly on your pump.
Filling aid
An accessory that can be used to help you fill an empty ACCU-CHEK 3.15 ml
plastic cartridge from your vial of insulin.
Free flow
Free flow of insulin from the infusion set may occur when two conditions are
met: first, if the cartridge with a connected infusion set and the piston rod of
your pump are not correctly coupled and second, if you position your pump at
a higher level than the infusion site.
Headset (also known as cannula housing)
The part of an infusion set that includes the soft cannula or needle. The
infusion set tubing connects either directly to the headset, or connects to a
shorter length of tubing permanently attached to the headset.
Hourly basal rate
The amount of insulin delivered by your pump in 3-minute intervals for a
given hour.
Infusion set
Connects your pump to your body. The insulin is delivered from the cartridge
through the infusion set tubing and cannula or needle into your subcutaneous
tissue.
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Infusion site
The place where the infusion set cannula or needle is inserted into your
subcutaneous tissue to deliver insulin.
Insulin
A hormone that helps cells turn glucose into energy. Insulin is produced in the
beta cells of the pancreas (also called islets of Langerhans).
Insulin, rapid-acting (insulin analog)
A type of insulin created using recombinant DNA technology. The onset time
of insulin analog is 5 to 15 minutes.
IPX8 according to IEC 60529
Protection against the effects of temporary immersion in water. Ingress of water
in quantities causing harmful effects is not possible when the device is temporarily
immersed in water under standardized conditions [maximum of 60 minutes a
day and 8 feet (2.5 meters) depth].
Luer-lock connector
A standardized fitting at the end of the infusion set, the cartridge, and the adapter
that lets them be locked together without leaking.
Personal settings
Your pump must be programmed with your personal settings prior to starting
insulin pump therapy. Personal settings include the basal rate profile(s), the
correct time and date, and all other variable values that can be tailored to
your individual needs on your pump.
RUN mode
During normal use, your pump is in RUN mode and insulin is continuously
delivered. Boluses, Temporary Basal Rates, and almost all functions can be
programmed from RUN mode.
RUN screen
The RUN screen is the starting point for all functions that can be accessed
while your pump delivers insulin. Your pump displays the RUN screen during
normal use when no programming is currently being performed. The time,
current hourly basal rate, basal rate profile, and all functions currently
activated appear on the RUN screen.
Appendixes
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Settings
Settings are individually programmable values and parameters that affect the
way your pump works.
Scrolling
Scrolling allows fast and easy programming of larger values.
STOP mode
When your pump is in STOP mode, it does not deliver any insulin. The insulin
delivery is only stopped if an error occurs or if your pump is put into STOP
mode (for example, when changing the cartridge, adapter or infusion set, or
for data transfer). Functions such as Extended Bolus or Temporary Basal Rate
are interrupted by putting your pump into STOP mode.
STOP screen
The STOP screen is the starting point for all functions that require that your
pump does not deliver insulin.
Temporary Basal Rate
Temporary increase or decrease of your basal rate profile in percentages (from
0 – 200%) to match changing insulin needs due to increased or decreased
activity level, illness, or stress.
Timeout
For your safety and convenience, your pump returns to the RUN or STOP
screen if no key is pressed within a certain time. Any changes made are not
saved.
U100
Each milliliter of liquid contains 100 International Units of insulin. Your pump
was developed only to use U100 rapid-acting insulin analogs.
Appendixes
193
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LIMITED FOUR-YEAR WARRANTY
DISETRONIC MEDICAL SYSTEMS, INC. (“DISETRONIC”) WARRANTS THE ACCU-CHEK SPIRIT
INSULIN PUMP (“INSULIN PUMP”) AGAINST DEFECTS IN MATERIALS AND WORKMANSHIP FOR A
PERIOD OF FOUR (4) YEARS FROM THE DATE OF PURCHASE. PROOF OF PURCHASE DATE MAY
BE REQUIRED. THIS WARRANTY DOES NOT INCLUDE SUPPLIES AND ACCESSORIES, INCLUDING
BUT NOT LIMITED TO, CARTRIDGES, BATTERIES, OR INFUSION SETS.
DURING THE WARRANTY PERIOD, DISETRONIC WILL REPAIR OR REPLACE, IN ITS SOLE
DISCRETION, ANY INSULIN PUMP THAT DOES NOT WORK PROPERLY BECAUSE OF A DEFECT IN
MATERIALS OR WORKMANSHIP. THE PURCHASER’S SOLE AND EXCLUSIVE REMEDY WITH
RESPECT TO THE INSULIN PUMP SHALL BE REPAIR OR REPLACEMENT. THIS WARRANTY APPLIES
ONLY TO NEW DEVICES. IN THE EVENT A PUMP IS REPAIRED OR REPLACED, THE WARRANTY
PERIOD WILL NOT BE EXTENDED.
THIS WARRANTY IS VALID ONLY IF THE INSULIN PUMP IS USED IN ACCORDANCE WITH THE USER
INSTRUCTIONS. THIS WARRANTY WILL NOT APPLY:
1. IF DAMAGE RESULTS FROM CHANGES OR MODIFICATIONS MADE TO THE INSULIN PUMP BY
THE USER OR THIRD PERSONS AFTER THE DATE OF MANUFACTURE;
2. IF DAMAGE RESULTS FROM SERVICE OR REPAIRS PERFORMED BY ANY PERSON OR ENTITY
OTHER THAN DISETRONIC.
3. IF DAMAGE RESULTS FROM A FORCE MAJEURE OR OTHER EVENT BEYOND THE CONTROL OF
DISETRONIC; OR
4. IF DAMAGE RESULTS FROM NEGLIGENCE OR IMPROPER USE, INCLUDING BUT NOT LIMITED
TO IMPROPER STORAGE, PHYSICAL ABUSE SUCH AS DROPPING, OR OTHERWISE.
THIS WARRANTY SHALL BE PERSONAL TO THE ORIGINAL PURCHASER. ANY SALE, RENTAL, OR
OTHER TRANSFER OR USE OF THE INSULIN PUMP COVERED BY THIS WARRANTY TO OR BY A
USER OTHER THAN THE ORIGINAL PURCHASER SHALL CAUSE THIS WARRANTY TO IMMEDIATELY
TERMINATE.
THIS WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED INCLUDING
WITHOUT LIMITATION THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. IN NO EVENT SHALL DISETRONIC OR ITS SUPPLIERS OR DISTRIBUTORS
BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL OR PUNITIVE DAMAGES
ARISING FROM OR IN ANY WAY CONNECTED WITH THE PURCHASE OR USE OF THE INSULIN
PUMP.
Appendixes
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ACCU-CHEK Spirit Insulin Pump
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Index
Cartridge; 9, 18
Changing; 73-74
Connecting; 47-48
Filling; 43-46
Inserting; 49-52
Low; 149, 185
CHECK Key; 9, 187
Cleaning; 141
Copying Hourly Basal Rate; 40-41
Accessories; 17-23, 189
Adapter; 9, 20, 47-48, 190
Advanced User Menu; 99, 122-128
Air Bubbles; 45, 53, 145
Alarm Clock; 127-128, 151
Alarm History; 109
Alarm Signals; 16, 117
Alcohol Consumption; 144
Alerts and Errors; 147-164, 199-200
Automatic Off; 118, 156
Data Interrupted; 163
Data Transfer; 104
Date; 32-34, 150
Date Format; 130
Daily Insulin Totals; 110, 191
Display; 9-10
Contrast; 135
Orientation; 120, 187
Disposal; 140
DOWN Key; 9, 187
Backlight; 10
Basal Rate Profile; 36, 123, 126, 190
Lock; 133
Programming; 37-41, 124
Selecting; 125
Temporary; 93-96
Battery; 21, 141
Cover; 22
Depleted; 155
Inserting or changing; 25-27
Key; 23, 71
Life; 165, 189
Low; 150, 185
Type; 119, 167
Beeps; 15, 116, 181, 186-187
Bolus; 75
Extended; 83-87
History; 107-108
MultiWave; 88-92
“Quick” Standard; 77-80
“Scroll” Standard; 80-82
Index
Page 3
Electromagnetic; 61, 169-172
Electronic Error; 160
Emergency Kit; 23
Errors; 147-148, 154-164
Exit Options; 102
Filling Aid; 43
Guarantee; 4
History; 107
Alarm; 109
Bolus; 107-108
Daily Insulin; 110
Temporary Basal Rate; 111
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Immunity; 171-172
Infusion Set; 9, 19-20
Changing the; 70-72
Not Primed; 162-163
Priming; 53-55
Infusion Site; 56-57, 72
Insulin Delivery;
Starting; 65
Stopping; 66
Insulin Pump Therapy;
Interruption of; 68-69
Resuming; 69
Power Interrupt; 161
Prime Quantity; 132
Priming; 53-55
Products, Sterile; 17-18, 188
Profile, See Basal Rate Profile
Programming;
Additional Basal Rate
Profile; 124
Basal Rate Profile; 37
Extended Bolus; 83-87
MultiWave Bolus; 88-92
“Quick” Standard Bolus;
77-80
“Scroll” Standard Bolus;
80-82
Temporary Basal Rate; 93-96
Pump; 9
Stopping; 66
Storing; 140
Wearing; 59-60
KeyLock; 13
Turning On; 113-114
Turning Off; 113-114
Unlocking; 181, 185
Keys; 11
Key Combinations; 12
Language; 134
Language Error; 164
Liquids; 64
Luer-Lock; 192
Quick Info Screen; 14
Quick Information; 30
Repair; 142
RUN Screen; 13, 192
Maintenance; 141
Mechanical Error; 159-160
Menus; 99-102
Advanced; 122
Custom; 136
Standard; 103
MultiWave Bolus;
Programming; 88-91
Cancelling; 91-92
Safety System; 147, 168
Screen; 9-10
Scrolling; 193
Setup Menu;
Advanced; 129, 186
Standard; 113, 186
Standard User Menu; 99, 103
Start-Up; 28-31
Status Screen; 15
Sterile; 17, 188
Stop-Warning; 16, 67
Occlusion; 146
Error; 156-158, 167
Orientation; 120
Index
Page 4
196
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Quick Reference Table for Errors
No. Error
What You Need to Do
E1
CARTRIDGE EMPTY
Change the cartridge.
E2
BATTERY DEPLETED
Change the battery.
E3
AUTOMATIC OFF
If necessary, put your ACCU-CHEK Spirit in
RUN mode.
E4
OCCLUSION
Immediately check your blood glucose level,
because insulin delivery has been interrupted.
If your blood glucose level is high, take
appropriate actions according to your doctor’s
or healthcare team’s instructions. See the
section “Error E4: OCCLUSION.”
E5
END OF OPERATION
Arrange for immediate replacement of your
insulin pump. Contact Pump
Support at
1-800-688-4578 to discuss your options for further use of the
ACCU-CHEK Spirit insulin pump. Contact
your healthcare professional for alternative
insulin therapy options.
E6
MECHANICAL ERROR
See the section “Error E6: MECHANICAL
ERROR.”
E7
ELECTRONIC ERROR
See the section “Error E7: ELECTRONIC
ERROR.”
E8
POWER INTERRUPT
See the section “Error E8: POWER INTERRUPT.”
E10
CARTRIDGE ERROR
See the section “Error E10: CARTRIDGE
ERROR.”
E11
SET NOT PRIMED
Prime your infusion set.
E12
DATA INTERRUPTED
Restart the data transfer.
E13
LANGUAGE ERROR
See the section “Error E13: LANGUAGE
ERROR.”
Quick Reference Table for Errors
200
ACCU-CHEK Spirit Insulin Pump
Stopping;
Insulin Delivery; 66
Priming; 55
System Check; 28-31
Temporary Basal Rate;
Cancelling; 97
History; 111
Over; 96, 153
Programming; 93-96
Time and Date; 32
American; 32, 130
European; 32, 130
Time and Date, Review; 150
Time Remaining; 112
Troubleshooting; 143-146
Tubing; 20, 132
UP Key; 9, 187
User Menu; 99-102
Advanced; 122
Custom; 136
Standard; 103
Water; 63
Contact with; 63
After Contact with; 64
IndexIndex
1 197
ACCU-CHEK
Insulin
ACCU-CHEK
SpiritSpirit
Insulin
PumpPump
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Quick Reference Table for Alerts
Diagram of User Menus
In all cases, turn off and confirm the alert prior to addressing the issue.
Your Insulin pump STANDARD MENU
No. Alert
What You Need to Do
A1
CARTRIDGE LOW
Change cartridge before it is completely
empty.
A2
BATTERY LOW
Replace the battery as soon as possible.
A3
REVIEW TIME AND DATE Set the time and date.
A4
ALARM CLOCK
Put your ACCU-CHEK Spirit in RUN mode,
if necessary.
A5
PUMP TIMER
Your pump’s operating time will expire
soon. Go to the INFORMATION screen on
your pump, then move to the PUMP TIMER
screen. The days until the pump timer
expires is shown. Make arrangements for
replacement of the pump before the timer
reaches zero days.
A6
TBR CANCELLED
Put your ACCU-CHEK Spirit insulin pump in
RUN mode, if necessary. Ensure the cancellation was intended and program a new
Temporary Basal Rate, if necessary.
A7
TBR OVER
Decide whether a further Temporary Basal
Rate change is appropriate and program
one, if necessary.
A8
BOLUS CANCELLED
Put your ACCU-CHEK Spirit insulin pump in
RUN mode, if necessary. Ensure that the
cancellation was intended and program a
new bolus, if necessary.
KeyLock
Standard
bolus
quick info
KeyLock
quick info
«Scroll» Standard bolus
bolus
amount
temporary
basal rate
stop your
Accu-Chek
percentage
change the
cartridge
start your
Accu-Chek
duration
prime the
infusion set
communication
information
menu
program
profile no.1
set the time
and date
setup menu
standard
select the
user menu
bolus
history
daily basal
rate total
set the
hour
KeyLock
user menu
alarm
history
1st hour
set the
minute
beep
volume
BR profile
no.…
fill volume
315 units
daily insulin
totals
2nd hour
set the
year
alarm
signals
start-up
procedure
TBR history
…
set the
month
automatic
off
maintenance
24th hour
set the
day
battery
type
remove the
cartridge
start
priming
returning the
piston rod
stop
priming
data transfer
to PC
Standard
bolus
(A) «Quick»
Standard bolus
with direct access from the RUN screen
using the a and s keys of your
insulin pump.
(B) «Scroll»
Standard bolus
menu-guided using the STANDARD BOLUS
menu and the scroll function of the a and s
keys for programming the bolus amount.
For a complete review of your insulin pump features as well as
the warnings and precautions associated with its use, please
refer to your ACCU-CHEK Spirit Insulin Pump User Guide.
display
orientation
Your Insulin pump ADVANCED MENU
KeyLock
Standard
bolus
quick info
KeyLock
quick info
«Scroll» Standard bolus
bolus
amount
Extended
bolus
MultiWave
bolus
temporary
basal rate
bolus
amount
bolus
amount
percentage
bolus
duration
immediate
bolus
duration
stop your
Accu-Chek
start your
Accu-Chek
bolus
duration
change the
cartridge
prime the
infusion set
communication
information
menu
change your
BR profile
program
program
program
program
program
profile
profile
no.
profile
profile
1no.profile
no.
2 no.
3 no.
4 5
alarm clock
set the time
and date
setup menu
standard
setup menu
advanced
select the
user menu
remove the
cartridge
start
priming
data transfer
to PC
bolus
history
BR profile
no. …
daily basal
rate total
alarm
occurance
set the
hour
KeyLock
time
format
user menu
returning the
piston rod
stop
priming
alarm
history
1st hour
alarm
hour
set the
minute
beep
volume
date
format
BR profile
no.…
fill volume
315 units
daily insulin
totals
2nd hour
alarm
minute
set the
year
alarm
signals
bolus
increment
start-up
procedure
TBR history
…
set the
month
automatic
off
prime
quantity
maintenance
24th hour
set the
day
battery
type
basal
rate lock
display
orientation
language
display
contrast
Index
198
ACCU-CHEK Spirit Insulin Pump
Quick Reference Table for Alerts
199
ACCU-CHEK Spirit Insulin Pump
Manufactured by:
Disetronic Medical Systems AG
CH-3401 Burgdorf, Switzerland
Distributed by:
Disetronic Medical Systems Inc.
11800 Exit 5 Parkway, Suite 120
Fishers, IN 46037
Phone
866-703-3476
Fax
888-810-0758
For technical assistance, call Pump Support at 800-688-4578.
accu-chek.com
ACCU-CHEK, ACCU-CHEK SPIRIT, LIVE LIFE THE WAY YOU WANT and PUMP THERAPY MADE FOR YOU are
trademarks of Roche.
©2008 Disetronic Medical Systems Inc. All rights reserved. 04632753001/V03/05.08
Swiss made
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