Accu-Chek Combo system User's Manual

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User’s Manual

Accu-Chek

®

Spirit Combo Insulin pump

PDF

Approved according to

SOP 04.07.08 – Anl. A, Vers. 02

The Signature will not be printed!

Kat. 04

LAN

ExA

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Your insulin pump

d

Menu key

f

OK key

a

Up key

s

Down key

Cartridge compartment with cartridge

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Adapter Luer-lock connector of the infusion set

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Pump details and accessories

Battery cover Battery

Infrared window

(next to battery cover)

Battery key

Adapter

Cartridge compartment

Cartridge plunger

Cartridge

Piston rod End plate

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Overview of the ADVANCED user menu

j Press d to move forward j Press d + a simultaneously to move backward j Press f to select or save j Press a to go up j Press s to go down

BRP = Basal Rate Profile 2–4

RUN f f

STOP

BRP

4

BRP 3

BRP

2

BRP 4

BRP

3

BRP 2

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Overview of the STANDARD and CUSTOM user menus

Accessible menus in the CUSTOM user menu can be selected using the appropriate Accu-Chek PC software

(sold separately).

j Press d to move forward j Press d + a simultaneously to move backward j Press f to select or save j Press a for up j Press s for down

= not accessible in the

STANDARD user menu

RUN f f

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Dear user of the Accu-Chek Spirit Combo insulin pump,

This User’s Manual is provided for you, as a person with diabetes, and for healthcare professionals. It contains all the necessary information for the safe and efficient use of your

Accu-Chek Spirit Combo insulin pump. Regardless of your level of experience with pump therapy, please read this User’s Manual carefully before beginning insulin pump therapy. Always refer to this User’s Manual first, when you have questions about or have problems using your insulin pump. If you cannot find the solution to your problem in this document, we recommend that you contact your Accu-Chek Customer Care. You will find the address and phone number on the inside back cover of this manual.

Intended Use of the Accu-Chek Spirit Combo insulin pump

The Accu-Chek Spirit Combo insulin pump is intended for the subcutaneous continuous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.

The Accu-Chek Spirit Combo insulin pump is intended for the use of U 100 rapid-acting insulin. Humalog ® (insulin lispro, rDNA origin)*, Apidra ® (insulin glulisine, rDNA origin)** and NovoLog ®

(insulin aspart)*** have been tested and found to be safe for use in the Accu-Chek Spirit Combo insulin pump.

Do not use your insulin pump for the delivery of medication other than U100 rapid-acting insulin. Before using a different insulin with the Accu-Chek Spirit Combo insulin pump, check the insulin label and accompanying documents to make sure it can be used with this device.

Also consult the instructions for use coming with your insulin, infusion set, and additional devices used for your insulin therapy.

Your Accu-Chek Spirit Combo insulin pump is a valuable medical device. We strongly encourage you to add your insulin pump to your home contents insurance policy to protect you in case of accidental damage or loss. Ask your insurance agent for details.

* Humalog ® is a registered trademark of Eli Lilly and Company.

** Apidra ® is a registered trademark of the sanofi-aventis group.

*** NovoLog ® is a registered trademark of Novo Nordisk A/S.

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About this User’s Manual

To ensure the safe and convenient use of your new Accu-Chek

Spirit Combo insulin pump, some information in this User’s Manual requires particular attention. This information is presented as

“Warning”, “Caution” or “Note”. j A “Warning” informs you about risks to your health. Neglecting this information may even lead to life-threatening situations in some cases.

j A “Caution” informs you about risks to your device. Malfunction or damage may result if you do not follow these instructions.

j A “Note” contains important information relating to the efficient and smooth operation of your new Accu-Chek Spirit

Combo insulin pump.

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1 Understanding your new system

1.1 Overview

1.2 Display and sounds

1.3 Keys and key combinations

1.4 Accessories and disposables

1.5 Emergency kit

1.6 General safety information

2 Getting started

2.1 Before you begin

2.2 Inserting the battery

2.3 Start-up process

2.4 Setting the time and date

2.5 Your basal rate profile

2.6 Connecting the cartridge, adapter and infusion set

2.7 Inserting the cartridge

2.8 Priming the infusion set

2.9 Positioning the infusion set

2.10 Starting insulin delivery

2.11 Stopping insulin delivery


3 Using your pump in daily life

3.1 Wearing your pump

3.2 Interruption of insulin pump therapy

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43

46

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26

29

50

51

52

55

55

58

13

16

3

9

17

1

1

3.3 Your insulin pump and water

3.4 Changing the infusion set

3.5 Changing the cartridge and infusion set


4 Boluses and Temporary Basal Rates

4.1 Understanding boluses

4.2 Programming a Standard Bolus

4.3 Programming an Extended Bolus

4.4 Programming a Multiwave Bolus

4.5 Programming a Temporary Basal Rate (TBR)


5 Personalizing your pump

5.1 Introduction

5.2 Selecting a user menu

5.3 STANDARD user menu

5.4 Viewing your pump data

5.5 Transferring your data to a computer

5.6 Pump settings

5.7 ADVANCED user menu

5.8 Basal rate profiles

5.9 Setting a reminder

5.11 CUSTOM user menu

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78

83

87

92

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67

70

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93

107

114

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118

124

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97

99

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6 Using the Accu-Chek Spirit Combo insulin pump with the Meter 127

6.1 Meter 127

6.2 Switching Bluetooth ® ON and OFF

6.3 Pairing your pump with the Meter

6.4 Troubleshooting the Bluetooth ® connection

129

130

133

7 Care and Maintenance

7.1 Inspecting your pump

7.2 Damage to your pump

7.3 Your insulin pump and water

7.4 Repair of your pump

7.5 Maintaining your pump

7.6 Storing your pump

7.7 Disposing of your pump

8 Warnings and errors

8.1 Confirming a warning or error

8.2 List of warnings

8.3 List of errors

8.4 List of reminders

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146

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153

164

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139

140

142

143

144

144

9 Troubleshooting

9.1 Therapy-related issues

165

166

Appendix A: Technical data

Appendix B: Configuration parameters

Appendix C: Sterile products and accessories

Appendix D: Abbreviations

Appendix E: Beeps and melodies

Appendix F: Symbols

Appendix G: Warranty and Declaration of Conformity

Glossary

Index 211

Quick reference table for errors, warnings and reminders 215

Bluetooth ® registration 218

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204

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1

Understanding your new system

1.1 Overview

Your Accu-Chek Spirit Combo insulin pump has many helpful features that help to ensure safe and efficient pump therapy.

Note In this User’s Manual the term “Meter” always refers to your Accu-Chek diabetes management device (diabetes manager), which is compatible with your Accu-Chek

Spirit Combo insulin pump.

Three user menus

Your Accu-Chek Spirit Combo insulin pump has been designed to adapt to your level of experience in pump therapy – whether you are a beginner or an experienced pump user. Your pump “grows” with you!

You can use one of 3 menus – STANDARD, ADVANCED or

CUSTOM – to access the functions and settings you will need from day to day.

1.1.1 Summary of features

Interaction with the Meter

The Accu-Chek Spirit Combo insulin pump is designed for use with the Meter. This new product is an intelligent blood glucose meter that can control the pump remotely using Bluetooth ® wireless technology.

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STANDARD

ADVANCED

CUSTOM

This is the most basic menu – designed for simplicity and comfort.

This menu helps you to adjust your therapy to a wider range of situations.

The CUSTOM menu enables you to fine-tune your pump according to your personal needs and skill level.

See chapter 5 Personalizing your pump.

Five basal rate profiles

You can choose from 5 basal rate profiles in line with your different daily routines.

Three bolus types

Your Accu-Chek Spirit Combo insulin pump enables you to program

3 bolus types, each corresponding to different situations you may encounter, and this provides you with a lot of flexibility.

Quick Bolus

You can program a Quick Bolus without looking at the display screen and check that it is correctly programmed by counting the beeps and vibrations. This is particularly useful when you want to program the bolus discreetly in public.

Warnings and errors signalled in two ways

For your safety, warnings and errors are signalled using both audible beeps and vibration of the pump. In addition, the beep tones are fully adjustable – from silent to loud.

Data transfer

The infrared port on the bottom of your Accu-Chek Spirit Combo insulin pump enables you to transfer information between your pump and a personal computer or handheld device.

Rotating display

Your pump’s display can be rotated by 180 degrees, and you can also adjust its contrast. Combined with the backlight, these features make the display easier to read.

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Reminder

As well as warnings and errors, your pump can signal reminders.

This works like an electronic alarm clock.

Choice of batteries

Your Accu-Chek Spirit Combo insulin pump can be powered by either disposable or rechargeable batteries. (If you decide to use rechargeable batteries, you will need a battery charger recommended by the battery manufacturer.)

Key Lock

The Key Lock feature allows you to lock all 4 keys on your pump to prevent functions from being activated accidentally. For example, you can use Key Lock while you are asleep or when playing sports.

1.2 Display and sounds

Your Accu-Chek Spirit Combo insulin pump has a Liquid Crystal

Display (LCD) screen. This display, together with the 4 keys, enables you to program the pump. It also shows important information about the status of your pump. w

WARNING

Changes in the status of your pump can be life-threatening. If for any reason you cannot hear the audible signals or feel the vibrations of your pump, looking at the display is the only way that you will notice changes or malfunctions in your pump.

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1.2.1 Backlight

The backlight helps you to read the information on the display in poorly-lit areas. You can turn on the backlight while in RUN or

STOP mode, or when navigating through the menus, by pressing a .

The backlight turns on automatically when a reminder, warning or error message is displayed, and turns off automatically after

10 seconds if no keys are pressed.

Tip: In poorly-lit areas, begin programming with the a.

1.2.2 Rotating display

Your pump’s display can be rotated by 180 degrees. See section

5.6.4 Display orientation.

Note that when you rotate the display, the s and a key functions will be reversed.

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CAUTION

If incomplete characters, numbers or symbols appear on the display, put your pump into STOP mode and remove the battery for a few seconds. When you reinsert the battery, the pump will perform a system check. If this does not resolve the problem, put your pump into STOP mode and contact your

Accu-Chek Customer Care. For details see inside the back cover.

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1.2.3 Display screens

The screens displayed by your pump relate to one of the following modes: j RUN j STOP j QUICK INFO

The following screens are all accessed from the user menus (see section 5.2 Selecting a user menu): j Information j Function j Set-up

Note To save battery life, the screen of your Accu-Chek

Spirit Combo insulin pump goes blank if you do not press any key for more than 20 seconds. When your pump shows a blank screen, you have to press a key before any other operation can be performed.

RUN screen

The screen is blank by default to save energy. The screen goes blank again after 20 seconds if no key is pressed. By pressing any key, the RUN screen is displayed when the pump is in RUN mode. This means that insulin is being delivered to your body according to the basal rate you have programmed.

Current hourly basal rate

Time

Key Lock locked

Pump timer

Cartridge low

Battery low

Active basal rate profile

The above screen shows all the possible symbols, including the current time, the current basal rate profile, and the current hourly basal rate in units per hour.

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The RUN screen also displays reminder information (such as

“cartridge low”) and special functions (such as Key Lock – locked or unlocked) in the form of symbols. (See Appendix F:

Symbols)

Note After you program or review information, the pump returns to the RUN screen.

STOP screen

The STOP screen is displayed when the pump is in STOP mode.

This means that insulin is no longer being delivered to your body.

The STOP screen shows the current time and date, and the STOP symbol.

Time Date

The STOP screen also displays reminder information (such as

“battery low”) and special functions (such as Key Lock – locked or unlocked) in the form of symbols.

Your pump must be in STOP mode in the following situations:

You are j programming specific functions j changing the cartridge and / or the infusion set j priming the infusion set j transferring data to or from the pump j changing the battery

QUICK INFO menu

You display the QUICK INFO screen by pressing the f key while in RUN or STOP mode. The QUICK INFO screen shows the remaining insulin content of the cartridge in units.

Key Lock unlocked

Pump timer

Cartridge low

Battery low

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By pressing f again you enter the BOLUS DATA function. You can view the last 30 boluses by pressing a or s.

You can leave the QUICK INFO screen either pressing f again or pressing no key for 20 seconds.

Information, Function and Set-up screens

You access these screens when you program the pump, perform a function, change a setting, or store or transfer information. You can reach these screens from either the RUN or STOP screen.

1.2.4 Navigating through the screens

The following procedure explains how to navigate through the screens. Think of these screens as menu choices. See section 1.2.3 Display screens.

1. Press the d key to select a screen of your choice.

2. Press the d key again to see the next available choice in the menu. (After you reach the last menu choice, you will return to the first menu choice.)

3. When you reach the screen of your choice, press the f button.

The next set of screens are called Function screens, and all relate to the choice you have just made. There may be one or several Function screens.

4. Press the s or a key to increase or decrease the displayed value, or press the d key again to move to the next Function screen to make further changes. (After you reach the last Function screen, you will return to the first

Function screen.)

5. Press the f button to save your changes.

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You can move backward through the main menu screens by pressing the d key and a key simultaneously.

In any submenu the same key combination will move you back to the main menu screen.

Note Changes that you made in the submenu will not be saved.

1.2.5 Status messages and alarm signals

Your Accu-Chek Spirit Combo insulin pump informs you of the status of your pump using audible beeps, vibrations and displayed messages. It is vital that you be able to hear and / or feel the beeps and vibrations. Be aware that some carrying pouches may hinder the perception of the signals.

You can turn off either beeps or vibrations, but for your safety you cannot turn off both at the same time for the initial alarm signal.

See chapter 8 Warnings and errors for a description of the full range of warnings and errors.

STOP warning

The STOP warning is triggered when your pump switches from

RUN mode to STOP mode, or when a battery is inserted. The pump beeps twice and vibrates once every minute. This warns you that insulin delivery has been interrupted.

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To turn off the STOP warning, press either a or s for 3 seconds. You then hear a melody, confirming that the STOP warning has been turned off. If you press the key too briefly, the

STOP warning will not be turned off.

Note For your safety, the volume of the STOP warning cannot be changed. It is independent of the programmed beep volume.

1.3 Keys and key combinations

You use the 4 keys on the Accu-Chek Spirit Combo insulin pump to program functions, access information, and set up the pump.

Each time you press a key the pump will beep, unless the beep tone is set OFF.

f OK key d Menu key

1 a Up key s Down key

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The following table lists the keys and their functions.

Key d f a

Name Function

Menu j Move through menus, function screens and information screens

OK j Select a menu j Save changes and exit the function and information screens j View the QUICK INFO screen

Up j Move forward in the information screens j Increase a setting j Turn on the backlight j Program a Quick Bolus j Cancel a Quick Bolus j Turn off the STOP warning (press and hold 3 sec. until you hear a melody)

Key s

Name Function

Down j Move backward in the information screens j Decrease a setting j Program a Quick Bolus j Cancel a Quick Bolus j Turn off the STOP warning (press and hold 3 sec. until you hear a melody) c CAUTION

Do not press the keys with a sharp or pointed item such as the tip of your fingernail, as this could damage the casing of your

Accu-Chek Spirit Combo insulin pump. Instead, use the pad of your fingertip to avoid puncturing the keys.

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1.3.1 Combining keys

You can obtain additional functions by pressing 2 keys simultaneously. In the following table, a plus symbol (+) indicates that both buttons must be pressed at the same time.

Combination d + a d + s a + s

Function j Exits menus, function screens and information screens without saving your changes. j Moves you to a previous menu.

j Unlocks the keys. Press and hold both buttons until you hear 3 short beeps (RUN mode) or 3 long beeps

(STOP mode).

j Copies an hourly basal rate to the following hour.

w WARNING

If the keys on your pump are not functioning properly, disconnect your pump and contact your Accu-Chek Customer

Care (see inside back cover).

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1.3.2 Scrolling

To enter larger or smaller values, the a and s keys must sometimes be pressed several times until the desired value is shown, with each press of the key changing the figure by a small increment. However, you can also press and hold the key

(scrolling function) to change the value faster. When programming boluses and hourly basal rates the increment of the value change increases if you keep the a or s key pressed.

When you begin scrolling, the pump beeps once.

1.3.3 Locking the keys

The Key Lock feature enables you to lock all 4 keys on your

Accu-Chek Spirit Combo insulin pump. This is a valuable safety measure that prevents you from accidentally activating your pump. For example, you can use Key Lock while you are asleep or when playing sports.

You turn on the Key Lock function in the PUMP SETTINGS –

See section 5.6 Pump settings.

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1.4 Accessories and disposables

High-quality sterile disposables and accessories are a vital part of the Accu-Chek Spirit Combo insulin pump system, and help to ensure safe pump therapy. (For a list of accessories and disposables tested and found to be safe with the Accu-Chek

Spirit Combo insulin pump, see Appendix C.) The infusion set is the applied part. Always follow the instructions provided by your doctor or healthcare team – as well as the printed instructions included with the product – relating to the use of these items.

Note Use your insulin pump, sterile disposables and accessories for the first time in the presence of your doctor or healthcare team.

1.4.1 Sterile disposables

Each sterile disposable, such as a cartridge or infusion set, should be used only once, as re-using these products could lead to infection or could damage your pump. Do not use a sterile product if the package has been damaged or opened.

w

WARNING

Your pump has been designed for use with rapid-acting U100 insulin. Humalog ® (insulin lispro, rDNA origin)*, Apidra ® (insulin glulisine, rDNA origin)** and NovoLog ® (insulin aspart)*** have been tested and found to be safe for use in the Accu-Chek

Spirit Combo insulin pump. Only use sterile disposables and accessories that are designed for use with your Accu-Chek

Spirit Combo insulin pump. The correct functioning of your pump can only be guaranteed if you use sterile products with the Accu-Chek brand and genuine Accu-Chek Spirit Combo insulin pump accessories.




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1.4.2 Adapter

vents grip seal thread

The adapter connects the cartridge to the infusion set, and also keeps the cartridge compartment watertight with 2 seals, one inside and one outside the adapter. It holds the cartridge in place and prevents the entry of air bubbles. The 2 small vents on the adapter allow air pressure to be equalized inside and outside the cartridge compartment. The adapter will not work properly if the vents are blocked or dirty, or if the seals are missing.

Note It is essential to change the adapter at least every 2 months. You must also change the adapter if the seals become worn, are lost, or if the vents are blocked.

1.4.3 Battery

Your pump requires a 1.5 V AA alkaline (LR6) or lithium (FR6) battery that has a mimimum capacity of 2500 mAh. j Alkaline batteries: Only use high-quality alkaline LR6 batteries that comply with IEC 60086-1. The Accu-Chek Spirit Combo insulin pump was successfully tested with a Varta Power One alkaline LR06, AA, 1.5 V battery which complies with IEC

60086-1. j Lithium batteries: Only use lithium batteries that comply with

IEC 60086-4. The Accu-Chek Spirit Combo insulin pump was successfully tested with an Energizer Ultimate Lithium FR06,

AA, 1.5 V battery which complies with IEC 60086-4.

Do not use carbon zinc or nickel cadmium (NiCd) batteries.

If you prefer, you can use rechargeable batteries – in this case, we recommend a Varta Rechargeable Accu Ready to Use NiMH,

HR06, AA, 1.2 V battery that complies with IEC 62133 and has a mimium capacity of 2600 mAh. Only use a battery charger officially recommended by the battery manufacturer. See

Appendix A: Technical Data, p. 170.

Contact your Accu-Chek Customer Care if you intend to use a different type of battery to the one recommended.

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c

CAUTION

Use of batteries other than those recommended may significantly reduce battery usage time. Such batteries may also leak and corrode the battery contacts in your pump. They could also lead to an electronic short circuit resulting in dangerous heat development. The use of batteries not supplied or recommended by Roche may void the warranty. Before inserting rechargeable batteries make sure that they are not damaged (e.g. damaged plastics isolation coating) or leaking as damaged or leaking batteries could damage your pump.

Battery key

The battery key tightens and loosens the battery cover. It is also designed to loosen the luer-lock connection between the infusion set and adapter if it cannot be loosened by hand, by using the notch on the side. However, never use the battery key to attach or tighten an infusion set. Using the battery key prevents possible damage to the battery cover.

If you lose the battery key, or if it becomes cracked or worn, order a replacement immediately, rather than using makeshift tools.

For a list of accessories and disposables tested and found to be safe with the Accu-Chek Spirit Combo insulin pump, see

Appendix C.

Note Always remember to remove the battery if your

Accu-Chek Spirit Combo insulin pump is not going to be used for a long period, in order to conserve the battery.

Battery cover

The battery cover seals the battery compartment, and must be changed at least every 2 months. You must remove and replace the battery cover using the battery key – do not use knives, screwdrivers or other sharp objects, as these may damage your pump.

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1.5 Emergency kit

It is highly recommended to keep accessories and disposables with you in case of an emergency. This enables you to change these items if necessary.

Consult the instructions for use coming with your medical devices (e.g. lancing device), accessories and disposables.

Such an emergency kit should contain: j An Accu-Chek infusion set (see Appendix C) j A new AA alkaline or lithium battery j An Accu-Chek Spirit 3.15 ml cartridge system j An insulin pen or syringe for alternative therapy j A vial of insulin j Treatment for low blood glucose levels j Blood glucose monitoring equipment

(such as an Accu-Chek blood glucose meter) j A disinfectant for skin j A battery key j A battery cover j An adapter w WARNING

Make sure that you have an alternative therapy plan, provided by your healthcare professional. Use this plan whenever you need to interrupt pump therapy.

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1.6 General safety information

w WARNING

Always make sure to accurately program your personal settings to avoid inappropriate insulin delivery. This phrase means that either too much or too little insulin is delivered. Too much insulin can lead to severe hypoglycemia. Too little insulin can lead to a life-threatening ketoacidosis.

w

WARNING

Your insulin pump has not been tested with cardiac pacemakers.

For information about the safe use of your Accu-Chek

Spirit Combo insulin pump with a cardiac pacemaker, contact the pacemaker manufacturer. For reference see Appendix A:

Tables 201–205.

c CAUTION

If you should drop your pump, immediately inspect it carefully for damage. Do not use your Accu-Chek Spirit Combo insulin pump if cracks or chips are visible – these may allow water, dust, insulin or other foreign substances to enter the pump and lead to malfunction.

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2

Getting started

This chapter explains how to prepare your pump and begin insulin pump therapy.

2.1 Before you begin

Successful insulin pump therapy requires you to check your blood glucose levels frequently. It is therefore recommended that you use an Accu-Chek blood glucose meter as often as directed by your doctor or healthcare team.

Your Accu-Chek Spirit Combo insulin pump has been designed for use with the Meter. This intelligent blood glucose meter enables communication with your pump using Bluetooth ® wireless technology.

2.2 Inserting the battery

Your Accu-Chek Spirit Combo insulin pump turns on as soon as you insert the battery. When you remove the battery, your pump keeps track of the time and date for about one hour. If the power is interrupted for a longer period of time (after more than 1 hour), your pump will revert to the factory settings for the date and time. Your insulin pump settings (such as the hourly basal rates, bolus increment and active user menu) and the event memory

(bolus and alarm history, history of daily insulin totals and

Temporary Basal Rates) are always saved, regardless of battery condition or the amount of time your pump has been without a battery. See section 1.4.3 Battery for information on batteries

(both disposable and rechargeable types).

w WARNING

This product contains small parts. There is a risk of suffocation if small parts (e.g. covers, caps or similar objects) are swallowed.

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20

Procedure for inserting and changing the battery

1.

2.

Remove or disconnect your infusion set from the infusion site, to ensure that there is no risk of accidental insulin delivery.

Press d to move to the STOP YOUR

PUMP screen.

Press f to select. Your pump is now in

STOP mode and insulin delivery stops.

3.

4.

Remove the battery cover.

Use the battery key to turn the battery cover counter-clockwise. Make sure that the opening of the battery compartment and the seal are clean and undamaged.

Where appropriate, remove the old battery.

Insert the battery, negative (–) end first, positive (+) end up, into the compartment.

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5.

6.

Use the battery key to fully tighten the battery cover. You can verify that the battery cover is correctly tightened by checking that it is in line with the pump casing. Do not over-tighten.

Place the cover on the positive end and gently push the battery in, while turning the cover clockwise to partially tighten it.

After inserting the battery, the pump begins its start-up process

(see section below).

If the pump does not begin the start-up process after inserting the battery, make sure that the battery is inserted correctly

(negative end first).

c

CAUTION

If your pump reverts to the factory settings for the date and time immediately after the power supply is interrupted for a short amount of time, please contact your customer support to report this issue as it may be due to a component failure.

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c

CAUTION

To prevent water from entering the pump casing, only insert or change the battery in a dry environment. Make sure that the battery cover seal is not worn or missing, and that the battery is correctly inserted.

Note If your pump was in RUN mode before you removed the battery, the error E8: POWER INTERRUPT will occur when

the new battery is inserted. Press f twice to confirm and snooze the error. Check the time and date and correct them if necessary. Then put your pump into RUN mode.

See section 2.4 Setting the time and date. w

WARNING

It is important that you always check that the date and time are set up correctly before you put your pump into RUN mode after a battery change. Otherwise there is a risk that too much or not enough insulin will be delivered because of a shift of basal rate time blocks. Basal rates that are delivered at the wrong time can lead to hyper- or hypoglycemia.

22 man_05504929001_H_en-us.indb 22 01.06.2016 08:14:33

2.3 Start-up process

Your pump runs a start-up process when you insert a battery or when you change the cartridge. During this process, your pump performs a series of internal tests.

When you … change the battery

Then … the whole start-up process is performed.

When you … change only the cartridge

Then … the start-up process begins at the

SELF-TEST screen.

w WARNING

Do not interrupt the start-up process by pressing keys or otherwise handling the insulin pump. Interruption of the process may lead to malfunction of your pump.

Start-up process sequence

1.

2.

3.

2

The software version screen appears.

The Accu-Chek logo appears.

The SELF-TEST screen appears.

23

01.06.2016 08:14:33 man_05504929001_H_en-us.indb 23

24

4.

The BEEP TEST screen appears and your pump beeps.

Listen for the beeps.

w

WARNING

If you cannot hear the beeps from your

Accu-Chek Spirit Combo insulin pump, you may not be notified of changes within the pump in time to take action.

If you do not hear the beeps, stop using the pump and contact your

Accu-Chek Customer Care. (See inside back cover)

5.

The VIBRATION TEST screen appears and your pump vibrates.

Check the vibrations.

w

WARNING

If you cannot feel the vibrations, you may not be notified of changes within the pump in time to take action. If you do not feel the vibrations, stop using the pump and contact your Accu-Chek

Customer Care. (See inside back cover)

6.

7.

The display then goes blank. Check that the display is empty. (The backlight turns on during this step.)

The display then shows a pattern. Check that the pattern is even.

man_05504929001_H_en-us.indb 24 01.06.2016 08:14:34

2

8.

9.

10.

The display turns black. Check that the display is completely black.

If your pump detects a warning or an error during the start-up process, it signals the error or warning at this point.

See section 8.3 List of errors.

After the self-test, press a or s to select the type of battery you inserted.

Press f to save and exit.

11.

The end of the start-up process is signalled by a melody, and the pump displays the STOP screen.

The STOP warning occurs every minute.

To turn the STOP warning off, press a or s until you hear a melody and / or feel a vibration.

When you use your pump for the first time or have not used it for a longer time, you will be guided automatically to the TIME

AND DATE SETTINGS option after step 10

(see next page).

c CAUTION

Make sure that you choose the correct battery type. Otherwise you may not be informed about a low battery in time.

25 man_05504929001_H_en-us.indb 25 01.06.2016 08:14:34

2.4 Setting the time and date

It is essential to set the time and date correctly, because basal rates and history information are stored on the basis of the time and date set in the pump. When you travel across time zones, and for the change to and from daylight savings time, make sure that the time and date are re-set correctly.

You can choose between American or European / Military time.

American

12-hour clock month / day / year

European / Military

24-hour clock day / month / year w WARNING j Incorrect setting of the time and date can lead to incorrect basal insulin delivery. Make sure that the time and date of your pump are set correctly, to ensure correct delivery and data memory. Do not make therapy decisions based on a single result in the pump’s memory.

j If the power is interrupted for a longer period of time (after more than 1 hour), your pump will revert to the factory settings for the date and time.

j In addition, if you, your doctor, or healthcare team are reviewing your data electronically, it is essential that you synchronize the time and date of your pump with those of your blood glucose meter, your personal computer or handheld device. Otherwise, the resulting data might not be meaningful. Check these devices regularly to ensure that the settings remain synchronized.

26 man_05504929001_H_en-us.indb 26 01.06.2016 08:14:34

Procedure for setting the time and date

1.

2.

3.

Press d to move to the TIME AND DATE

SETTINGS screen.

Press f to select.

The HOUR screen is displayed.

Press a or s to set the hour.

Press d to move to the MINUTE screen.

Press a or s to set the minute.

2

4.

5.

6.

Press d to move to the YEAR screen.

Press a or s to set the year.

Press d to move to the MONTH screen.

Press a or s to set the month.

Press d to move to the DAY screen.

Press a or s to set the day.

man_05504929001_H_en-us.indb 27

27

01.06.2016 08:14:34

7.

8.

Press d to move to the TIME FORMAT screen.

Press a or s to set the time format.

Press d to move to the DATE FORMAT screen.

Press a or s to set the date format.


28 man_05504929001_H_en-us.indb 28 01.06.2016 08:14:34

2.5 Your basal rate profile

Your Accu-Chek Spirit Combo insulin pump must be programmed with your personal settings before you begin pump therapy. Your doctor or healthcare team can help you to understand how to use the pump.

2.5.1 Programming your basal rate profile

Your Accu-Chek Spirit Combo insulin pump delivers insulin according to the programmed hourly basal rate, 24 hours a day.

This flow of insulin, measured in international units per hour

(U / h), is called the basal rate profile and is calculated to meet your basic insulin needs.

The pump can store up to 5 different basal rate profiles to match your changing insulin needs – for example: Monday to Friday,

Exercise Day or Sleeping Late Day.

Note For your safety and convenience during programming, your Accu-Chek Spirit Combo insulin pump switches to

RUN or STOP screen if no key is pressed within

20 seconds. Any changes you have made before this

“time-out” occurs will not be saved.

An Accu-Chek Spirit Combo insulin pump basal rate profile consists of up to 24 different hourly basal rates. Each hourly rate may be changed independently. The total of all 24 basal rates in one basal rate profile is called the (daily) basal rate total.

Example: Basal rate profile for 18 U / 24 hours

Insulin delivery

[U / h]

Hourly basal rate

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Time

2

29 man_05504929001_H_en-us.indb 29 01.06.2016 08:14:34

Your basal rate profile should be reviewed: j After any programming changes are made to your pump j After a new battery is inserted j After confirming the error E7: ELECTRONIC ERROR.

Note Insulin delivery does not stop or pause during basal rate programming.

Procedure for programming your basal rate profile

1.

2.

3.

Press d to move to the BASAL RATE

PROGRAMMING 1 (2, 3, 4 or 5 accordingly) screen.

Press f to select.

The daily BASAL RATE TOTAL is displayed.

Press d to move to the first hour.

This is always 12 AM–01 AM.

30 man_05504929001_H_en-us.indb 30 01.06.2016 08:14:34

2

4.

Press a or s or scroll to set the hourly basal rate given by your doctor or healthcare team.

Note The increments shown depend on the programmed basal rate: it will be

0.01 U from 0.05 U to 1.00 U,

0.05 U from 1.00 U to 10.0 U and

0.1 U from 10.0 U to 25.0 U

5.

Press d to move to the next hour.

6.

Continue using d and a or s to set the hourly basal rates for the remaining hours. This allows you to program your individual basal rate profile on an hour-by-hour basis. Continue until all

24 hours are programmed.

7.

Press f to confirm.

The new daily BASAL RATE TOTAL is displayed.

Press f to save the profile and exit.

man_05504929001_H_en-us.indb 31

31

01.06.2016 08:14:34

Copying an hourly basal rate

If your basal rate is the same for multiple hours in a row, you can save time by copying an hourly basal rate to one or more hours.

1.


PROGRAMMING 1 (2, 3, 4 or 5 accordingly) screen.

2.

Press f to select.

The daily BASAL RATE TOTAL is displayed.

32

3.

4.

Press d to move to the hourly basal rate you want to copy.

Press a and s simultaneously.

A special beep confirms that you are pressing the keys correctly. The same hourly basal rate is copied to the next hour.

5.

If you want to copy the rate to multiple hours, press a and s repeatedly or press and hold a and s (scroll).

man_05504929001_H_en-us.indb 32 01.06.2016 08:14:34

6.

Press f to confirm.

Review the new daily BASAL RATE

TOTAL.


Note At any point in the programming of your basal rate, you have the following options to exit.

If you want to … Then … save the changes j Press f and check the new daily basal rate total.

j Press f again. Your pump returns to the RUN or STOP screen.

undo the changes j Wait for your Accu-Chek Spirit Combo insulin pump to return to the RUN or STOP screen, or

j Press d and a simultaneously (exit feature) to exit the Function screen.

2

33

01.06.2016 08:14:34 man_05504929001_H_en-us.indb 33

Selecting a basal rate profile

When you have programmed more than one basal rate profile (ADVANCED or

CUSTOM MENU), you can select the required profile.

1.


SELECTION screen.

2.

Press f to select.

The SELECT PROFILE for the current basal rate profile is displayed.

34

3.

4.

Press a or s to select a basal rate profile.

The SELECT PROFILE screen and its daily basal rate total appear accordingly.

Press f to select the displayed profile.

The new basal rate profile is active immediately.

w

WARNING

Make sure that you select an appropriately programmed basal rate profile. Otherwise there could be inappropriate insulin delivery.

man_05504929001_H_en-us.indb 34 01.06.2016 08:14:34

Note When you change your user menu for example from

ADVANCED to STANDARD, your current basal rate profile may not appear.

If the basal rate profile number(s) you want does not appear:

j Select the ADVANCED user menu, or

j Assign the basal rate profile to an available basal rate profile number

A running Temporary Basal Rate increase or decrease stays active, even if you change the basal rate profile on your pump.

Basal rate and bolus

During normal use, your pump is in RUN mode and insulin is continuously delivered to your body, according to the basal rate profile you have programmed.

A bolus can be programmed as required. A bolus is the amount of insulin delivered (in addition to the basal rate) to cover the intake of food and to correct high blood glucose levels. The bolus amount is determined by your doctor or healthcare team’s guidelines and depends on your blood glucose level, your food intake, and your activity level, as well as stress and illness. See section 4.1 Understanding boluses.

2

35

01.06.2016 08:14:34 man_05504929001_H_en-us.indb 35

2.6 Connecting the cartridge, adapter and infusion set

Before you change the cartridge, adapter or infusion set, check that your pump is in good working order.

See section 7.1.1 Checklist.

Insulin can flow uncontrolled from the cartridge or infusion set if the cartridge plunger and the piston rod are not properly connected and the pump is positioned at a higher level than the infusion site. Prevent leakage of insulin by correctly inserting the cartridge: move the piston rod to the correct position and twist the adapter until the cartridge plunger is aligned with the end plate of the piston rod. (See section 3.5 Changing the cartridge

and infusion set).

Have the following materials ready: j A filled Accu-Chek Spirit 3.15 ml cartridge system with a luer-lock connection (for filling instructions see the instructions for use provided with this product) j An Accu-Chek Spirit Combo insulin pump adapter j A new Accu-Chek infusion set w WARNING

Ensure that the cartridge is at room temperature before use to prevent air bubbles.

36 man_05504929001_H_en-us.indb 36 01.06.2016 08:14:34

2

Procedure to connect the cartridge, adapter and infusion set

1.

2.

3.

Remove the protective cap from the filled cartridge. (Do not touch the cartridge tip.)

Push the adapter all the way onto the cartridge tip, until it stops.

Carefully prepare a new Accu-Chek infusion set, following the instructions supplied for use.

4.

Hold the adapter and twist the infusion set luer-lock connection by hand, clockwise into the adapter. Do not over-tighten.

man_05504929001_H_en-us.indb 37 w

WARNING

To avoid leakage, tightly attach the infusion set to the adapter.

Turn the infusion set luer-lock connector until it stops. Do not over-tighten or use any auxiliary tools, as this may crack the infusion set luer-lock connector and result in leakage of insulin.

37

01.06.2016 08:14:35

2.7 Inserting the cartridge

Have the following materials ready: j A filled Accu-Chek Spirit 3.15 ml cartridge system with a connected Accu-Chek Spirit Combo insulin pump adapter j A new Accu-Chek infusion set

1.

2.

w WARNING

Do not use your pump for the delivery of medication other than

U100 rapid-acting insulin. Humalog ® (insulin lispro, rDNA origin)*, Apidra

NovoLog ®

® (insulin glulisine, rDNA origin)** and

(insulin aspart)*** have been tested and found to be safe for use in the Accu-Chek Spirit Combo insulin pump.

Before using a different insulin with the Accu-Chek Spirit

Combo insulin pump, you should check the insulin label to make sure it can be used with this device.




3.

38

Procedure for inserting the cartridge


PUMP screen.

Press f to select.

The pump displays the STOP screen, and insulin delivery stops.

Disconnect the infusion set from the infusion site to ensure that there is no risk of accidental insulin delivery.

man_05504929001_H_en-us.indb 38 01.06.2016 08:14:35

2

4.

5.

6.

Hold the pump with the adapter facing the ground. Remove the cartridge, if necessary. Unscrew carefully. Do not pull the cartridge out until it is completely unscrewed.

Press d to move to the CARTRIDGE

CHANGE screen.

Press f to select.

7.

8.

Make sure your infusion set is disconnected and the cartridge has been removed.

Press and hold f for 3 seconds, until you hear a melody.

The piston rod begins to return. Do not touch or otherwise disturb the piston rod while it is rewinding, as this could result in damage to your pump.

When the piston rod has returned completely, the CARTRIDGE VOLUME screen displays the maximum volume,

315 U.

c

CAUTION

Do not change the cartridge if the cartridge compartment is not completely dry. When the piston rod is rewinding, insulin could enter your pump and lead to malfunction. If necessary, use a soft cloth to dry the compartment.

39 man_05504929001_H_en-us.indb 39 01.06.2016 08:14:36

9.

11.

40 man_05504929001_H_en-us.indb 40 see step 10

Hold your pump upright. Hold the new filled cartridge so that the connected adapter and infusion set points upward, parallel, and close to the cartridge compartment.

see step 11

10.

Make sure that the top edge of the threaded part of the adapter is level with the top of the cartridge compartment.

Press a or s to move the piston rod forward until the end plate of the piston rod is level with the bottom of the cartridge plunger.

12.

The CARTRIDGE VOLUME decreases accordingly on the display.

Tip: To prevent air bubbles move the piston rod to at least 310 Units.

01.06.2016 08:14:36

2

13.

14.

Position your pump diagonally downwards

(with the adapter pointing down). Insert the cartridge into the cartridge compartment.

Do not insert the cartridge into your insulin pump without first connecting the infusion set tubing. If the tubing is not connected first, insulin may flow into the cartridge compartment, which may result in insulin entering your pump and causing damage to your pump.

Do not hold your pump upright when inserting the cartridge. Holding the pump upright may lead to insulin flowing into the cartridge compartment, which may block the piston rod and potentially cause an error.

15.

Twist (do not push) the adapter clockwise, until it is correctly seated against the cartridge compartment.

It is not necessary to apply pressure.

Do not over-tighten the adapter, otherwise it will be difficult to remove the cartridge, adapter and cartridge plunger, and you could cause damage to your pump.

16.

The cartridge is correctly inserted when the end plate of the piston rod is correctly seated against the cartridge plunger.

41 man_05504929001_H_en-us.indb 41 01.06.2016 08:14:37

17.

18.

19.

42

If the end plate of the piston rod is not correctly aligned with the cartridge plunger, remove the cartridge from the cartridge compartment and repeat steps

9 to 15.

Check that the infusion set luer-lock connector is still correctly connected to the adapter. Tighten the infusion set clockwise by hand, until it sits tightly in the adapter.

Press f after correctly inserting the cartridge.

Your pump performs a self-test. See section 2.3 Start-up process.

20.

When the self-test process is finished, the INFUSION SET PRIMING screen is displayed.

See section 2.8 Priming the infusion set. Start from step 4 in the

Procedure for priming the infusion set.

c CAUTION

If an empty cartridge is inserted into the pump (e.g. for training purposes), the pump displays the programmed insulin deliveries

(infusion set priming, basal rate and bolus deliveries), even though no insulin is being delivered due to the empty cartridge.

man_05504929001_H_en-us.indb 42 01.06.2016 08:14:38

2.8 Priming the infusion set

w WARNING

Never prime an infusion set that is connected to your body as you risk uncontrolled insulin delivery into your body. Always follow the instructions for the infusion set you are using.

The Accu-Chek Spirit Combo insulin pump stops priming at

25 units of insulin. If no insulin emerges from the needle or there are air bubbles in the tubing after priming, repeat the priming function until the infusion set is bubble-free and completely filled with insulin. When insulin appears at the tip of the needle, press f to stop priming. The amount of insulin used for priming is not added to the pump’s history of daily insulin totals.

Your pump should be upright during priming, with the adapter pointing upward to help let air bubbles out of the cartridge and infusion set.

w

WARNING

Air bubbles in the cartridge and infusion set may result in the infusion of air instead of insulin. If this happens, your body will not receive the required amount of insulin. Remove bubbles while filling the cartridge and priming the infusion set, and without having the infusion set connected to your body.

2

43

01.06.2016 08:14:38 man_05504929001_H_en-us.indb 43

Procedure for priming the infusion set

1.

2.

3.


PUMP screen.

Press f to select.

The pump displays the STOP screen, and insulin delivery stops.

Prepare the tubing or cannula for priming according to the infusion set’s instructions for use.

4.

5.

6.

44

Press d to move to the INFUSION SET

PRIMING screen.

Press f to select. The priming amount of 25 units of insulin is shown on the display.

Make sure your infusion set is disconnected.

Press and hold f for 3 seconds, until you hear a melody. The priming process begins.

To ensure that any air bubbles are removed always hold your pump upright and, gently tap it with the bottom in the palm of your hand.

man_05504929001_H_en-us.indb 44 01.06.2016 08:14:38

7.

A count-up is shown on the display. Your pump stops priming after 25 units.

You can stop the priming process at any time by pressing f.

The infusion set is properly primed when there are no air bubbles visible in the tubing and a drop of insulin has come out of the needle. When the priming process is complete, your pump returns to STOP.

2

45

01.06.2016 08:14:38 man_05504929001_H_en-us.indb 45

2.9 Positioning the infusion set

Always follow the instructions given to you by your doctor or healthcare team and the instructions for the infusion set you are using.

Change your infusion set as frequently as recommended by the manufacturer.

Have the following materials ready: j Your Accu-Chek Spirit Combo insulin pump j A disinfectant for your skin j A new Accu-Chek infusion set

2.9.1 Preparing the infusion site

Infusion site selection

Your doctor or healthcare team will help you choose your infusion site areas according to a planned rotation pattern. Avoid your waistline, bones, scar tissue, recent infusion sites, bruises and sores. Choose an infusion site at least one inch (2.5 cm) away from the navel and previous infusion sites.

Infusion site preparation

It is important to prepare the infusion site properly to reduce the risks of infection. Your doctor or healthcare team will provide you with infusion site preparation guidelines.

46 man_05504929001_H_en-us.indb 46 01.06.2016 08:14:39

2.9.2 Inserting the cannula

1.

2.

Make sure that your pump is properly connected (including cartridge, adapter and infusion set) and correctly programmed with your personal settings.

Make sure your pump is in STOP mode.

2

3.

4.

5.

Wash your hands thoroughly.

man_05504929001_H_en-us.indb 47

Disinfect the infusion site and let it dry completely.

Insert the cannula of your Accu-Chek infusion set according to the instructions.

47

01.06.2016 08:14:40

Note If you use an infusion set with a soft cannula, you must proceed with a bolus to fill the air space in the cannula and headset, according to the instructions for the infusion set you are using. Failure to do so could result

in missed insulin dosing. See section 4.2 Programming a Standard Bolus.

If you have read and followed all instructions, cautions, warnings and notes found in this chapter, you should now be ready to deliver insulin to your body using your Accu-Chek Spirit Combo insulin pump.

w

WARNING

Inspect your infusion site at least twice a day for irritation or infection. Signs of infection may include, but are not limited to: pain, lumps, redness, heat, or discharge.

If you see redness or swelling, change your infusion set and infusion site immediately and contact your doctor or healthcare team.

Change your infusion headset according to the instructions for the infusion set you are using and your doctor or healthcare team’s recommendations.

48 man_05504929001_H_en-us.indb 48 01.06.2016 08:14:40

2.9.3 Connecting the insulin pump

1.

w

WARNING

Pay attention to the tubing of the infusion set connected to your body. There is a risk of strangulation if the tubing becomes wrapped around your neck. In case of doubt, use the shortest tubing length to minimise the risk of strangulation.

Attach the infusion set to the insulin pump and start insulin delivery. See section 2.10 Starting insulin delivery.

2

49

01.06.2016 08:14:41 man_05504929001_H_en-us.indb 49

2.10 Starting insulin delivery

Procedure for starting insulin delivery

1.

2.

Your pump is in STOP mode.

3.

Press d to move to the START YOUR

PUMP screen.

Press f to select. Your pump shows the

RUN screen.

Insulin delivery begins within 3 minutes.

50 man_05504929001_H_en-us.indb 50 01.06.2016 08:14:41

2.11 Stopping insulin delivery

For your safety, you must only perform certain functions and actions when the pump is in STOP mode. These functions and actions include: j changing the cartridge j connecting and disconnecting the adapter and / or infusion set j priming the infusion set j data transfer c

CAUTION

When your Accu-Chek Spirit Combo insulin pump is in STOP mode, no insulin is delivered to your body. You must put your pump into RUN mode to continue insulin delivery.

2

Procedure to stop insulin delivery

1.

2.


PUMP screen.

Press f to select. Your pump returns to the STOP screen.

Your pump is now in STOP mode.

No insulin is being delivered.

51

01.06.2016 08:14:41 man_05504929001_H_en-us.indb 51

STOP warning

The STOP warning is triggered when your pump switches from

RUN mode to STOP mode, or when a battery is inserted. The pump emits 2 short beeps and vibrates once every minute. This warns you that insulin delivery has been interrupted.

To turn off the STOP warning, press either a or s for 3 seconds. You then hear a melody and / or feel a vibration, confirming that the STOP warning has been turned off.

If you press the key too briefly, the STOP warning will not be turned off.

Note For your safety, the volume of the STOP warning cannot be changed. It is independent of the programmed beep volume.


w WARNING

The cartridge and infusion set are sterile products intended for single use only. Sterility is guaranteed for unopened packaging up to the indicated expiry date. Do not use sterile products if the packaging is damaged.

Do not re-use single-use materials because this might lead to a malfunction of your Accu-Chek Spirit Combo insulin pump, incorrect insulin delivery and / or infection. Always handle these items with clean hands. Avoid any contact of the infusion set and the connecting parts of your insulin pump with antiseptics, antibiotic creams, soaps, perfumes, deodorants, body lotions, or any other cosmetics. They may contaminate these parts.

52 man_05504929001_H_en-us.indb 52 01.06.2016 08:14:41

w

WARNING

Always check your personal settings before using your new pump, in order to avoid incorrect insulin delivery. Record your personal settings from your current insulin pump, and ensure that they are correctly programmed into your new Accu-Chek

Spirit Combo insulin pump. Incorrect programming of your pump may cause incorrect insulin delivery.

Do not use the pump without knowing your personal settings.

If you are not sure about your settings or you are inexperienced, ask your doctor or healthcare team to set or check them. Only change your settings after consulting your doctor or healthcare team.

w

WARNING

The support of a doctor or healthcare team is vital when training on and using your Accu-Chek Spirit Combo insulin pump. Regular visits to your doctor or healthcare team are also essential during insulin pump therapy. Always carefully follow instructions from the medical professionals responsible for your care.

Note When an Extended Bolus, a Multiwave Bolus and / or a

Temporary Basal Rate (TBR) is / are active and you put your pump into STOP mode, the warning W6: TBR

CANCELLED and / or the warning W8: BOLUS CANCELLED

occur(s). Press f twice for each warning to confirm and

turn them off. See section 8.2 List of warnings.

2

53

01.06.2016 08:14:41 man_05504929001_H_en-us.indb 53

Note Your pump cannot detect infusion set leakage. If you detect any loss of insulin and all parts are correctly tightened, immediately replace the leaking component.

Because insulin delivery has been interrupted, check your blood glucose level and take appropriate action according to your doctor’s or healthcare team’s instructions.

Note If the battery is too low, the start-up process may not be able to complete. In this case, the pump beeps five tones and keeps restarting the process until you remove the battery or until it is empty.

Note Check the amount of insulin remaining in the cartridge at

least once a day. If you press f from the RUN or STOP screen, your pump displays the remaining cartridge content in units.

Before going to sleep, make sure that:

j the cartridge contains enough insulin to last through the night

j the time and date are set correctly

54 man_05504929001_H_en-us.indb 54 01.06.2016 08:14:41

3

Using your pump in daily life

This chapter provides important guidelines on how to use your pump safely from day to day.

3.1 Wearing your pump

Attach your pump safely to your body or clothes to prevent damage. You can use one of our special carrying systems that enable you to carry your pump on or under your clothes. Wear your pump under your clothes or directly on your body to protect it from hot, cold or wet weather.

c

CAUTION

When wearing your pump, prevent any contact with objects that could damage it or accidentally press its keys (e.g. key chains, keys, pocket knives or coins).

3.1.1 When not to wear your pump

Electromagnetic fields and hazardous areas w

WARNING

Do not use your pump near strong electromagnetic fields.

Otherwise insulin delivery may stop and the error E7:

ELECTRONIC ERROR may occur. Follow the instructions below before you enter areas with electromagnetic fields: j Stop and remove your pump.

j Leave your pump outside these areas.

Strong electromagnetic fields such as radar or antenna installations, high-voltage sources, X-Ray sources, computer tomography, MRI, CAT scan and all other sources of electrical current, may cause your pump to fail. See Appendix A:

Technical data for more information about electromagnetic fields. If the error E7: ELECTRONIC ERROR occurs near areas with electromagnetic fields, contact your Accu-Chek

Customer Care.

3

55 man_05504929001_H_en-us.indb 55 01.06.2016 08:14:41

Your pump has been tested against, and complies with, the regulations on electromagnetic interference. Security systems in airports and anti-theft monitoring devices, such as those in department stores, should not normally affect the functioning of your pump.

Because there are so many devices, such as cellular phones, that emit electromagnetic radiation, the effect of such devices on your pump cannot be ruled out. It is therefore recommended to keep your pump at least 4 inches (10 cm) away from these devices while they are active.

Do not use your pump in hyperbaric chambers or in hazardous areas, such as areas where flammable gases or vapours could be present. This could cause an explosion.

Always stop and remove your pump before you enter these areas. If you have questions, contact your Accu-Chek Customer

Care (see inside back cover).

Your pump is designed to work in normal barometric conditions

(from 500 to 1060 mbar).

3.1.2 Sport and exercise

Exercise is an important part of diabetes management. Your

Accu-Chek Spirit Combo insulin pump is designed to enable you to safely perform a range of sporting activities while wearing your pump. It is important that you protect your pump before you begin exercise or sporting activities. Do not wear your pump for sports that involve body contact such as boxing, football or hockey, since rough contact could damage your pump.

Consult our sterile product brochures and accessories catalogue for more information about carrying systems or contact your

Accu-Chek Customer Care (see inside back cover) for more information.

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Note Rapid and extreme changes in air pressure, for example in an air plane that is taking off or when practicing sports like hang-gliding, can influence insulin delivery, especially if there are air bubbles in the cartridge or tubing. This also applies to rapid and extreme changes in temperature; for example, when leaving a heated room and going outside in cold weather.

We therefore recommend that you wear your pump close to your body, remove any air bubbles from the cartridge and tubing and also measure your blood sugar more frequently in such situations.

3.1.3 Travelling with your pump

Ask your doctor or healthcare team about any special steps you need to take before you travel. Take extra blood glucose testing and pump supplies with you, and find out where to obtain supplies while you are travelling.

When you travel across time zones, make sure that the time and date on your pump are set correctly to the local time.

If you have questions, contact your Accu-Chek Customer Care

(see inside back cover).

w

WARNING

You must ensure that the Bluetooth ® function is switched off before boarding an aircraft, as emissions from your pump or the Meter could interfere with the electronics systems of the aircraft. See section 6.2 Switching Bluetooth ® ON and OFF.

3

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3.2 Interruption of insulin pump therapy

Consult with your doctor or healthcare team about when and for how long your insulin pump therapy can be interrupted.

Measure your blood glucose level regularly during any insulin delivery interruption. Use a syringe or insulin pen to inject insulin according to the instructions of your doctor or healthcare team.

w WARNING

Because only rapid-acting insulin is used for insulin pump therapy, only a small amount of insulin is stored in the body. If insulin delivery is interrupted for any reason – such as: j If you stop the pump j There is a technical problem with the pump j The cartridge is leaking and /or the infusion set is leaking j There is an occlusion in the infusion set or in the headset j The cannula has slipped out of the infusion site – you must check your blood glucose level and replace the missing insulin immediately.

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3

3.2.1 Short interruptions

1.

2.

3.


PUMP screen.

Press f to put your pump in STOP mode.

Remove the infusion set or, when using a disconnectable infusion set, disconnect the transfer set from the headset and use the protective covers that came with it.

Resuming insulin delivery 1.

Reconnect your infusion set or insert a new one and put your pump into RUN mode.

Where appropriate, attach a new

Accu-Chek infusion set. (See section

3.4 Changing the infusion set).

Measure your blood glucose level within

2 hours of restarting pump therapy to check the function of the system and to ensure insulin delivery.

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3.2.2 Long interruptions

When you need to interrupt your pump therapy for more than one day, use the following procedure.

1.

Put your pump into STOP mode.

2.

Remove the cartridge, adapter, and infusion set.

3.

60

Remove the battery and reinsert the

battery cover.

Store your pump properly.

See section 7.6 Storing your pump.

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3.3 Your insulin pump and water

c CAUTION

Before any contact with water, disconnect and take off your

Accu-Chek Spirit Combo insulin pump. Check your pump daily to ensure that it is not chipped, cracked or damaged in any way, and that the battery cover and the adapter are correctly closed. Otherwise water, dust, insulin, or other substances may enter your pump and lead to malfunction.

Disconnect and remove your pump before taking a bath, or going into a whirlpool, shower or swimming pool. Avoid exposing your pump to high humidity, such as in a sauna, as this could result in damage. To make it easy to remove your pump, use disconnectable Accu-Chek infusion sets.

3.3.1 Accidental contact with water

Your Accu-Chek Spirit Combo insulin pump is protected against brief accidental contact with water. Examples of accidental water contact include: j Rain j Water splashes while you are cycling, jogging or hiking j Accidental immersion in the sink, washbasin or bath

3

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What to do after any water contact

Put your pump into STOP mode, disconnect the pump from your body, and inspect it. Use a soft cloth to dry the outside of the pump, and check the battery compartment and the cartridge compartment for water. If the battery compartment or cartridge compartment are wet, turn your pump upside down to let the water run out and leave it to dry. Do not use warm air such as a hair dryer to dry the pump, as this could damage the pump’s housing. Do not reinsert the battery or the cartridge until the compartments are completely dry. See section 7.5.1 Cleaning

your pump.

Other liquids

You do not need to worry about contact between your pump and perspiration or saliva. You must however check your pump immediately after contact with other liquids or chemicals such as: j Cleaning solutions j Alcohol j Beverages j Oil or fat

See section 7.5.1 Cleaning your pump.

c

CAUTION

Avoid any contact between your Accu-Chek Spirit Combo insulin pump, the infusion set, and the connecting parts of your insulin pump with health and beauty products (for example: antiseptics, antibiotic creams, soaps, perfumes, deodorants, body lotions, or other cosmetics). These substances could discolor your pump or fog the display.

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3.4 Changing the infusion set

When you change the infusion set, keep the following information in mind: j Infusion sets are sterile products intended for single use only.

Sterility is guaranteed for unopened packaging up to the indicated expiry date. Do not use sterile products if the package is damaged.

j Correctly tighten the infusion set onto the adapter to avoid leakage. Turn the infusion set luer-lock connector until it stops.

Do not turn it any further and do not use auxiliary tools, as this may crack the infusion set luer-lock connector and result in leakage.

j Your pump cannot detect infusion set leakage. You should inspect all parts of your infusion set regularly during the day and before you go to sleep. If there seems to be any loss of insulin and all parts are correctly tightened, look for and immediately replace a leaking component. Check your blood glucose level immediately, as insulin delivery has been interrupted. Take appropriate action according to your doctor’s or healthcare team’s instructions.

j Always disconnect your infusion set before changing a cartridge or priming the infusion set. Otherwise, you risk uncontrolled insulin delivery into your body. Always follow the instructions for the infusion set and cartridge system you are using.

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Procedure for changing the infusion set

Have the following materials ready: j Your Accu-Chek Spirit Combo insulin pump j A disinfectant for your skin j A new Accu-Chek infusion set

1.


2.


3.

4.

5.

64

Disconnect the transfer set from the headset.

Remove the infusion set from the adapter and dispose of it correctly.

all Accu-Chek infusion set luer-lock connectors. You can use this tool to loosen the luer-lock connector from the adapter if it cannot be loosened by hand.

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3

6.

7.

8.

Remove the used infusion headset and dispose of it correctly.

Carefully prepare a new Accu-Chek infusion set for use.

9.

10.

Screw the Accu-Chek infusion set clockwise into the adapter.

Carefully tighten the luer-lock connector by hand.

11.

Prime the infusion set following the instructions found in section 2.8 Priming the infusion set.

Prepare the infusion site and insert a new infusion set following the instructions in section 2.9 Positioning the infusion set.

Put the pump in RUN mode. See section 2.10 Starting insulin delivery.

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01.06.2016 08:14:44

Note If you use an infusion set with a soft cannula, you must begin with a bolus to fill the air space in the cannula and headset, according to the instructions for use for the infusion set you are using. Failure to do so could result in inadequate insulin dosing. See section 4.2 Programming a Standard Bolus. w

WARNING

Inspect your infusion site at least twice each day for irritation or infection. Signs of infection may include, but are not limited to: pain, lumps, redness, heat, or discharge. If you see redness or swelling, change the infusion headset and the infusion site immediately and contact your doctor or healthcare team.

Change the headset according to the instructions for the infusion set you are using and your doctor or healthcare team’s recommendations.

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3

3.5 Changing the cartridge and infusion set

Have the following materials ready: j Your Accu-Chek Spirit Combo insulin pump j A disinfectant for your skin j A new Accu-Chek infusion set j A filled Accu-Chek Spirit 3.15 ml cartridge system j A new adapter (this must be changed at least every

2 months)

Procedure for changing the cartridge and infusion set

1.

2.



3.

Remove the transfer set from the headset.

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01.06.2016 08:14:45 man_05504929001_H_en-us.indb 67

4.

5.

Hold your Accu-Chek Spirit Combo insulin pump with the adapter pointing downward.

Remove the adapter and cartridge from your pump by unscrewing the adapter from the pump casing.

Note Pulling the adapter from the pump casing without completely unscrewing it may result in the plunger staying attached to the piston rod. If this should happen, please call your Accu-Chek

Customer Care (see inside back cover).

6.

7.

68

Remove the transfer set from the adapter and dispose of it correctly.

Tip: The battery key has a notch that fits all Accu-Chek infusion set luer-lock connectors. You can use the battery key to loosen the luer-lock connector between your infusion set and adapter.

Remove the cartridge from the adapter and dispose of the cartridge properly.

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8.

9.

10.

Hold the adapter to the light to check for signs of wear or dirt (especially on the seals inside and outside of the adapter).

If necessary, clean the adapter using water and dry it. If it shows signs of wear or dirt, replace it immediately.

Insert a new cartridge and a new infusion set. See section 2.7 Inserting the cartridge.

3

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70


w WARNING

Always carry spare sterile products and accessories (infusion set, insulin cartridge, batteries), an insulin pen/syringe, and insulin. Without insulin, hyperglycemia or diabetic ketoacidosis may develop and may require in-patient hospital treatment.

c

CAUTION

Do not place your insulin pump in direct sunlight. Overheating of the insulin and the pump must be avoided. Protect your insulin pump from direct exposure to cold wind and temperatures over 104 °F (40 °C) and below 41 °F (5 °C).

These conditions may damage the insulin and the housing of your insulin pump, and could also cause a malfunction of the battery. See the instructions for the insulin you are using to determine the acceptable temperature range. Humalog ®

(insulin lispro, rDNA origin)*, Apidra ® (insulin glulisine, rDNA origin)** and NovoLog ® (insulin aspart)*** have been tested and found to be safe for use in the Accu-Chek Spirit Combo insulin pump.




Note Check the amount of insulin remaining in the cartridge at

least once a day. Press f from the RUN or STOP screen to display the remaining cartridge content in units. Before going to sleep, make sure that:

j The pump is in RUN mode

j The cartridge contains enough insulin to last through the night

j The battery level is OK

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4

Boluses and Temporary Basal Rates

4.1 Understanding boluses

Your pump can deliver 3 types of bolus:

A bolus is the amount of insulin delivered (in addition to the basal rate) to cover the intake of food and to correct high blood glucose levels. The bolus type and amount is determined by your doctor or healthcare team’s guidelines, your blood glucose level, your food intake, your health condition, and your activity level.

Discuss the timing, the amount and type of bolus you need with your doctor or healthcare team.

Standard Bolus

Extended Bolus

Multiwave Bolus fast delivery delivery over a programmed period of time combines fast delivery with delivery over a programmed period of time

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4.2 Programming a Standard Bolus

There are 2 ways to program a Standard Bolus:

Quick Bolus

Using Standard

Bolus menu

Using a and s on your insulin pump, with bolus increments determined by the user

Using d and f to enter the menu and then a and s to program the amount

The bolus amount per delivery is limited to 25 units.

After you program a Standard Bolus, there is a delay of 5 seconds before bolus delivery starts. This delay allows you to cancel the bolus by pressing the a or s key if desired. The warning W8:

BOLUS CANCELLED is displayed. Press f twice to confirm and turn off the alert. See chapter 8 Warning W8: BOLUS

CANCELLED.

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4.2.1 Programming a Quick Bolus

The following process uses only the a and s keys. You can start with either key. The recommended steps below are those described for the Down key s in step 1 and the Up key a in

Step 2. For the alternative step, you can use the Up key in step 1 and the Down key in step 2.

Because your pump beeps and vibrates to guide you through the programming steps, you can program the Quick Bolus without looking at the pump screen. After the bolus is programmed, you can count the beeps and vibrations of your pump to check the correct programming. For safety reasons, you should also check the display as long as you are less experienced with the pump.

The factory setting for the increment of the Quick Bolus is

0.5 units. You can set the increment to 0.1, 0.2, 0.5, 1.0 or 2.0 in your Therapy Settings. See section 5.10.1 Adjusting the bolus

increment.

Procedure for programming a Quick Bolus

1.

2.

3.

4

From the RUN screen, press and hold s until you hear a beep sequence and feel a vibration.

This activates the Quick Bolus function.

Press a once for each increment until the required bolus amount is reached.

You must not use the s key.

With each pressing of the key, your pump beeps and vibrates simultaneously; once for each programmed bolus increment.

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4.

5 seconds after the last press of a, your pump confirms the total bolus amount with one beep and vibration for each bolus increment programmed.

5.

The Standard Bolus symbol blinks for

5 seconds (the bolus delivery start delay).

6.

After the bolus delivery start delay, the pump beeps 3 times and vibrates and then begins to deliver the total bolus amount programmed. A countdown of the remaining bolus amount appears on the display.

74 w

WARNING

The bolus increment that can be programmed into your

Accu-Chek Spirit Combo insulin pump determines the Quick

Bolus amount using the a and s keys of your insulin pump.

Incorrect programming of the bolus increment may cause inappropriate insulin delivery.

See section 5.10.1 Adjusting the bolus increment.

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4.2.2 Cancelling a Quick Bolus

During programming

(the bolus amount blinks)

During confirmation

(when the beeps and vibrations occur), or

During start delay

(Standard Bolus symbol blinks)

During bolus delivery

(countdown of bolus amount)

Press the s or a key you used to enter the Quick Bolus programming option. This will reset the bolus amount to 0.0 units. You hear a melody.

If no new bolus is programmed, your pump returns to the RUN screen and beeps 3 times and vibrates after 5 seconds.

Press s or a. You hear a melody. Your pump returns to the RUN screen.

A warning W8: BOLUS CANCELLED occurs.

Press f twice to confirm and turn off the alert. See chapter 8 Warning W8:

BOLUS CANCELLED.

Press and hold s or a for 3 seconds until you hear a melody. A warning

W8: BOLUS CANCELLED is displayed.


BOLUS CANCELLED.

You can view the actual bolus amount delivered before the cancellation by looking at the bolus history. See section 5.4.1 Viewing your bolus history.

Note Make sure that the cancellation was deliberate, and then program a new bolus, if required.

No bolus is delivered.


Bolus delivery is interrupted.

4

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4.2.3 Programming a Standard Bolus using Standard bolus menu

Independent of the bolus increment setting, the bolus increments for the menu-guided Standard Bolus are fixed at 0.1 unit. You can program this bolus in the STANDARD BOLUS screen by holding the a or s key (scrolling) until the bolus amount is displayed.

1.

Press d to move to the STANDARD

BOLUS screen.

2.

3.

4.

Press f to select. The BOLUS AMOUNT screen appears.

Press or scroll a to increase or s to decrease the bolus amount.

Press f to confirm the bolus amount.

The Standard Bolus symbol blinks for 5 seconds (the bolus delivery start delay).

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After this bolus delivery start delay, your pump beeps 3 times and vibrates and begins to deliver the total bolus amount programmed. The countdown of the remaining bolus amount appears on the display.

4.2.4 Cancelling a Standard Bolus



During the start delay

(Standard Bolus symbol blinks)

During bolus delivery

(countdown of bolus amount)

You have 3 options for cancelling during programming: j If you do not press any key for 20 seconds after programming the bolus amount, your pump returns to the RUN screen. j Return to the Standard Bolus screen by pressing d + a simultaneously. j Set the bolus amount to 0.0 units. Press f to exit.

Press d + a, s or a. You hear a melody. Your pump returns to the RUN screen. A warning W8: BOLUS CANCELLED occurs.


BOLUS CANCELLED.

Press and hold s or a for 3 seconds until you hear a melody.

You can view the actual bolus amount delivered before the cancellation by looking at the bolus history. See section 5.4.1 Viewing your bolus history.




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Cancellation during the start delay and during the bolus delivery will cause a WARNING W8: BOLUS CANCELLED. Press f twice to confirm and snooze the warning. See chapter 8 Warnings and

errors.

Note Make sure that the cancellation was deliberate and program a new bolus, if needed.

4.3 Programming an Extended Bolus

The Extended Bolus option enables you to program a bolus to be delivered over a period of time. This function is helpful during long meals, dinners, or receptions, or when you have meals that are digested slowly. The Extended Bolus may also be appropriate for people who have gastroparesis (delayed digestion).

The duration of bolus delivery can be programmed in 15-minute intervals up to 12 hours and begins immediately after confirmation. Throughout the bolus delivery, the remaining time and amount of the Extended Bolus and the current hourly basal rate are displayed in the RUN screen.

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4

Tip: You can program a Standard or Quick Bolus while an

Extended Bolus is ongoing. If you cancel the Standard Bolus, the

Extended Bolus continues to run.

During the delivery of an Extended Bolus, the programming of another Extended Bolus or a Multiwave Bolus is blocked. If you try to do this, you will receive the error message: “Bolus currently running”.

If you want to program a different Extended Bolus, put the pump in STOP mode to cancel the current bolus. Then put the pump in

RUN mode again to program a new Extended Bolus.

Procedure for programming an Extended Bolus

1.

2.

3.

Press d to move to the EXTENDED

BOLUS screen.


Press a to increase or s to decrease the bolus amount.

The duration of the last Extended Bolus delivered appears.

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4.

Press d to move to the BOLUS

DURATION screen.

Press a to increase or s to decrease the bolus duration.

Tip: Press d to switch between programming the bolus amount and bolus duration.

5.

Press f to confirm the bolus amount and duration. The pump returns to the

RUN screen. The bolus delivery begins within the next 3 minutes.

80

Note If a Temporary Basal Rate is active at the same time as the Extended Bolus, the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed in the RUN screen.

Time

Current basal rate

(including TBR where appropriate)

Bolus duration

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4.3.1 Cancelling an Extended Bolus


(the bolus amount or bolus duration blinks)

You can either: j wait for your pump to return to the RUN screen.

j press d and a simultaneously to exit the Function screen. j set the bolus amount to 0.0 units and press f.

During bolus delivery j If the Extended Bolus delivery has begun, it can be cancelled by putting your pump into STOP mode. This cancels the bolus delivery and the warning W8:

BOLUS CANCELLED is displayed. Press f twice to confirm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED. Put your pump back in RUN mode afterwards.

The bolus amount delivered up to the cancellation can be reviewed in the

BOLUS HISTORY screen. See section 5.4.1 Viewing your bolus history.



4

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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. The warning W8: BOLUS CANCELLED and the warning W6: TBR CANCELLED are displayed.

Press f twice to confirm and turn off the first warning.

The second alert appears on the display. Press f twice to confirm and turn off the second warning. Both alerts are recorded in the warnings history.

See chapter 8 Warning W6: TBR CANCELLED and Warning

W8: BOLUS CANCELLED. Make sure that the cancellation was deliberate and then program a new Extended Bolus

(and /or Temporary Basal Rate) if needed.

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4.4 Programming a Multiwave Bolus

The Multiwave Bolus option is available in the ADVANCED user menu. It is designed to better simulate the body’s insulin delivery, and combines an immediate bolus delivery followed by an

Extended Bolus delivery. This option can be helpful when you have meals that include both rapidly and slowly absorbed carbohydrates.

The duration of bolus delivery can be programmed in 15-minute intervals for up to 12 hours.

Note j The Multiwave Bolus is available only in the ADVANCED user menu.

j You can add a Standard Bolus to an ongoing Multiwave

Bolus. If you cancel the Standard Bolus, the Multiwave

Bolus remains running.

j During the delivery of a Multiwave Bolus, the 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.

When programming a Multiwave Bolus, make sure that you are using the ADVANCED user menu and your pump is in RUN mode.

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Procedure for programming a Multiwave Bolus

1.

2.

3.

Press d to move to the Multiwave Bolus screen.


Press a or s to increase or decrease the total bolus amount.

84

Note The first time you press a, the bolus duration of the last

Multiwave Bolus and a default immediate bolus amount appear.

The latter increases or decreases proportionally as you increase or decrease the total bolus amount.

4.

Press d to move to the IMMEDIATE

BOLUS screen.

Press a or s to correct and set the immediate bolus amount.

5.


DURATION screen.

Press a or s to correct and set the

Extended Bolus duration in increments of

15 minutes for up to 12 hours.

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6.

7.

Tip: Press d to loop between programming the total BOLUS AMOUNT,

IMMEDIATE BOLUS and BOLUS

DURATION.

Check the total and immediate bolus amounts and the Extended Bolus duration programmed on the screens.

Press f to confirm both bolus amounts and the bolus duration. The Multiwave

Bolus symbol blinks for 5 seconds (bolus delivery start delay).

4

8.

The pump beeps 3 times and vibrates.

The immediate bolus delivery begins. The countdown of the remaining bolus continues to appear on the display.

Note If a Temporary Basal Rate is active at the same time, the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed on the RUN screen.

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4.4.1 Cancelling a Multiwave Bolus



During the start delay

(Multiwave symbol blinks)

During immediate bolus delivery

During extended delivery

There are 3 ways to cancel a Multiwave Bolus during programming: j Do not press any key for 20 seconds. The pump returns to the RUN screen. j Return to the Multiwave Bolus screen by pressing d + a simultaneously. j Set the total bolus amount to 0.0 units and press f. j Press d + a, s or a. The pump beeps and vibrates. The pump returns to the RUN screen.



j You can cancel immediate delivery by pressing and holding s or a for

3 seconds until you hear a melody. This cancels the whole bolus (immediate and Extended Bolus delivery).

j You can cancel the extended delivery by putting the pump in STOP mode.

This cancels the Extended Bolus.



Cancellation of the bolus during start delay, immediate bolus delivery and extended delivery will cause the warning W8:

BOLUS CANCELLED. Press f twice to confirm and turn off the alert. See chapter 8 Warning W8: BOLUS CANCELLED.

You can review the actual bolus amount delivered before the cancellation by looking at the bolus history. See section

5.4.1 Viewing your bolus history.

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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 in STOP mode. The warning W8: BOLUS CANCELLED and the warning W6:

TBR CANCELLED are displayed.

Press f twice to confirm and turn off the first warning.

The second warning appears on the display. Press f twice to confirm and turn off the second warning. Both

warnings are recorded in the alarm history. See chapter

8 Warning W6: TBR CANCELLED and Warning W8: BOLUS

CANCELLED. Make sure the cancellation was intended and then put the pump back in RUN mode and program a new Multiwave Bolus (and / or Temporary Basal Rate), if needed.

4.5 Programming a Temporary

Basal Rate (TBR)

Your pump allows you to temporarily increase or decrease your basal rates. This enables you to match your changing insulin needs due to increased or decreased activity level, illness, or stress.

Typically, a basal rate is set to 100 %, but you can: j Increase it to 250 % for up to 24 hours j Decrease it to 0 % for up to 24 hours

When you increase or decrease your basal rate, each hourly basal rate for the duration you program is increased or decreased automatically. The characteristic shape of your basal rate profile remains and does not become a flat curve, if the change is larger than 0 %. For 0 % the basal rate profile becomes a flat line and no insulin (except boluses) is delivered during the programmed duration.

Discuss programming a Temporary Basal Rate with your doctor or healthcare team.

4

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Note A running Temporary Basal Rate increase or decrease remains active, even if you have changed the basal rate profile.

You can only program a Temporary Basal Rate when your pump is in RUN mode.

Procedure for programming a Temporary Basal Rate

1.

2.

Press d to move to the TEMPORARY

BASAL RATE (TBR) screen.

Press f to select. The TBR PERCENTAGE screen appears.

Note If no Temporary Basal Rate is currently active, the percentage is set to 100 %. If a Temporary Basal

Rate is active, its duration and percentage appear on the RUN screen.

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3.

Press a or s to increase or decrease the basal rate.

Tip: When you increase (or decrease) the

Temporary Basal Rate, the duration of your previous Temporary Basal Rate increase (or decrease) appears. However, when you use your pump for the first time, a default value appears.

4.

Press d to move to the TBR DURATION screen.

Press a or s to correct and set the duration.

Tip: You can switch between programming the basal rate percentage and duration by pressing d.

5.


The new Temporary Basal Rate is immediately activated.

When a Temporary Basal Rate is active, the pump emits a beep and vibrates once every hour.

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Note During Temporary Basal Rate delivery, the increase or decrease in percentage, the increased or decreased hourly basal rate (hourly basal rate plus TBR percentage), and the remaining time are displayed in the RUN screen.

An arrow pointing upward symbolizes a Temporary Basal

Rate increase; an arrow pointing downward symbolizes a

Temporary Basal Rate decrease.

Note If an Extended Bolus or a Multiwave Bolus is active at the same time, the remaining time and amount of the bolus and the amount of the increased or decreased hourly basal rate are displayed in the RUN screen.

Example: Extended Bolus running

TBR OVER Alert

At the end of a Temporary Basal Rate, the warning W7: TBR

OVER is displayed. Press f twice to confirm and turn off the warning. See chapter 8 Warning W7: TBR OVER.

Remaining duration

Extended Bolus symbol

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4.5.1 Cancelling a Temporary Basal Rate

During programming There are 3 ways to cancel a Temporary Basal Rate during programming: j Do not press any key for 20 seconds. The pump returns to the RUN screen. j Exit the Temporary Basal Rate (TBR) screen by pressing d + a simultaneously. j Set the TBR percentage to 100 %. Press f to save and exit.

During delivery There are 2 ways to cancel a Temporary Basal Rate during delivery: j Set the TBR percentage to 100 %. Press f to save and exit.

The warning W6: TBR CANCELLED is displayed.

j Or you can put your pump in STOP mode. The Temporary Basal Rate delivery is cancelled, as well as any Extended or Multiwave Bolus that is currently running. The warning W6: TBR CANCELLED is displayed. Press f twice to confirm and turn off the alert. Put your pump back in RUN mode.

Pump continues to deliver normal basal rate.

Pump returns to normal basal rate.

4

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Note If an Extended Bolus or a Multiwave Bolus is active at the same time, it is also cancelled when your pump is put into

STOP mode. The warning W8: BOLUS CANCELLED and the warning W6: TBR CANCELLED are displayed.

Press f twice to confirm and turn off the first alert. The

second alert appears on the display. Press f twice to confirm and turn off the second alert. Both alerts are

recorded in the alarm history. See chapter 8 Warning W6:

TBR CANCELLED and Warning W8: BOLUS CANCELLED.

Make sure that the cancellation was intended and put your pump back in RUN mode and then program a new

Temporary Basal Rate (and /or an Extended or Multiwave

Bolus), if needed. w WARNING j Incorrect programming of your insulin pump may cause inappropriate insulin delivery.

j Your insulin pump must be programmed with your personal settings before starting insulin pump therapy. j Do not operate your insulin pump without knowing your personal settings. j If you are not sure about your personal settings, or you are less experienced, ask your doctor or healthcare team to check your personal settings. j Work with your doctor or healthcare team to determine the timing, amount, and type of bolus you need to deliver. j Make sure you know your personal carbohydrate-to-insulin ratio and your correction factor.

w WARNING

When your pump is in STOP mode it does not deliver insulin.

Put the pump in RUN mode to continue insulin delivery.

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5

Personalizing your pump

This chapter explains how to use the available menu options, and to personalize your pump to match your level of experience with insulin pump therapy.

5.1 Introduction

Using the 4 keys on the pump, and their combinations, you can access the menu options and their relevant screens. This enables you to, for example: j Program the pump j Perform a function j Change a setting j Store information

Note Your Accu-Chek Spirit Combo insulin pump has been designed for use with the Meter. This blood glucose meter enables you to communicate with the pump using

Bluetooth ® wireless technology.

5.1.1 User menus

Your Accu-Chek Spirit Combo insulin pump has been designed to adapt to your level of experience in pump therapy – whether you are a beginner or an experienced pump user.

You can use one of 3 menus – STANDARD, ADVANCED or

CUSTOM – to access the functions and settings you will need from day to day.

5

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STANDARD

ADVANCED

CUSTOM

This menu provides all the basic functions you need for successful pump therapy. If you are new to pump therapy, we recommend that you start with this menu.

As you become more experienced, you may wish to change to the ADVANCED user menu.

This menu provides the complete range of the Accu-Chek Spirit Combo insulin pump functions. It includes all the functions from the STANDARD user menu, plus a wide range of functions for the more experienced user.

Because the Accu-Chek Spirit Combo insulin pump has so many features, you may want to decide which screens are displayed when you scroll through the menu choices. Using appropriate PC software, this menu enables you to hide screens of the ADVANCED user menu and thereby customize your pump.

At the beginning of this User’s Manual, you will find fold-out diagrams of the STANDARD, CUSTOM and ADVANCED user menus.

Note For your safety and convenience during programming, your Accu-Chek Spirit Combo insulin pump returns to the

RUN or STOP screen if no key is pressed within 20 seconds.

The changes you made before your pump timed out will not be saved.

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5

5.2 Selecting a user menu

Note For guidance in choosing the most suitable user menu,

see section 5.1.1 User menus. If you are still not sure which menu to choose, discuss this with your doctor or healthcare team.

Procedure for selecting a user menu

1.

2.

3.

Press d to move to the MENU SETTINGS screen.

Press f to select.

The SELECT USER MENU screen is displayed.

Press a or s to select a user menu.

Press f to confirm.

The selected basal rate profile and its daily insulin total appear, or … man_05504929001_H_en-us.indb 95

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4.

5.

… if the previous basal rate profile is not available from the selected user menu, dashes appear instead.

Press a or s to select a basal rate profile, if required.

Check the (new) basal rate profile and its daily insulin total.


The new user menu and basal rate profile are active immediately.

c CAUTION

A running increased or decreased Temporary Basal Rate will remain active, even if you change the basal rate profile. The

Temporary Basal Rate is based on the new basal rate.

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5.3 STANDARD user menu

The following is a list of menu options from the STANDARD user menu. To view the order in which they appear on the display, refer to the menu diagram below: j Press d to move forward j Press d + a simultaneously to move backward

RUN f f

STOP

5

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j j j j

Some of the functions have already been described elsewhere in this User’s Manual, as listed below. The remaining functions are described following the list.

TIME AND DATE SETTINGS

See section 2.4 Setting the time and date.

BASAL RATE PROGRAMMING

See section 2.5.1 Programming your basal rate profile.

CARTRIDGE CHANGE

See section 2.7 Inserting the cartridge.

INFUSION SET PRIMING

See section 2.8 Priming the infusion set.

START YOUR PUMP j See section 2.10 Starting insulin delivery.

STOP YOUR PUMP j See section 2.11 Stopping insulin delivery.

QUICK BOLUS j See section 4.2.1 Programming a Quick Bolus.

STANDARD BOLUS j See section 4.2 Programming a Standard Bolus.

EXTENDED BOLUS j See section 4.3 Programming an Extended Bolus.

TEMPORARY BASAL RATE (TBR) j See section 4.5 Programming a Temporary Basal Rate (TBR).

MENU SETTINGS j See section 5.2 Selecting a user menu earlier in this chapter.

BLUETOOTH SETTINGS j See chapter 6 Using the Accu-Chek Spirit Combo insulin pump

with the Meter.

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5.4 Viewing your pump data

The memory of your Accu-Chek Spirit Combo insulin pump stores all the events (warnings and errors, programming operations and insulin delivery records), up to 4500 events. This data corresponds to about the last 90 days of use, and can be accessed on a personal computer using the Accu-Chek software products.

The following data can be reviewed directly on your Accu-Chek

Spirit Combo insulin pump:

Bolus history

Alarm history

History of daily insulin totals

Temporary Basal

Rate history last 30 boluses last 30 warnings and errors last 30 daily totals of insulin delivered last 30 increases and decreases in basal rate

Pump timer

(“Backup” and loaner pumps only) remaining time in days until the pump timer expires

Note Once 30 history entries are in memory (e.g. bolus history, alarm history), adding a new entry deletes the oldest entry.

5

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5.4.1 Viewing your bolus history

The BOLUS DATA screen allows you to view up to the last

30 bolus deliveries, starting with the most recent entry.

Bolus amount / type

Bolus time

Date

Procedure for viewing the bolus history

1.

Entry number

2.

Each BOLUS DATA screen displays: j Bolus type (Standard, Extended or Multiwave Bolus) j Bolus duration (only displayed for an Extended or

Multiwave Bolus) j Time j Date j Entry number (01 is the most recent) of total entries

(example 01/30) of a delivered bolus

Tip: You can enter the BOLUS DATA screen also from the

QUICK INFO screen. See section 1.2.3 Display screens.

3.

100

Press d to move to the MY DATA screen.

Press f to select.

The BOLUS DATA screen appears, showing the most recent bolus information.

Press a or s to view the entries.

Press f to exit.

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5

5.4.2 Viewing the error and warning history

The alarm data menu allows you to view up to the last

30 warnings and errors, starting with the most recent entry.

Each alarm data screen displays: j Number and type of the warning or error (for example, W6) j warning or error (for example, TBR CANCELLED) j Time j Date j Entry number (01 is the most recent) of total entries

(example 01/30) of a warning or error

Procedure for viewing the alarm history

1.

2.

3.


Press f to select.

Press d to move to the ERROR DATA screen.


Press f to exit.

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5.4.3 Viewing the history of daily insulin totals

This function allows you to view up to the last 30 daily totals of insulin delivered (from midnight to midnight; including basal rate plus boluses), starting with the most recent entry.

Each screen displays: j Daily total of insulin delivered j Date j Entry number (01 is the most recent) of total entries

(example 01/04) of a daily insulin total

Procedure for viewing the daily insulin totals

1.

2.

3.

102


Press f to select.

Press d to move to the DAILY TOTALS screen.


Press f to exit.

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5.4.4 Viewing the Temporary Basal Rate history

This option allows you to view up to the last 30 Temporary Basal

Rate (TBR) increases or decreases, starting with the most recent entry.

Each TBR DATA screen displays: j TBR increase or decrease in percentage j TBR duration j Time j Date j Entry number (01 is the most recent) of total entries (example

01/30) of a delivered Temporary Basal Rate

5

Procedure for viewing the Temporary Basal Rate history

1.

2.

3.


Press f to select.

Press d to move to the TBR DATA screen.


Press f to exit.

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5.4.5 Viewing the time remaining (pump timer)

For loan pumps and “Backup” pumps, a pump timer limits the operating time. When you begin using the pump, the timer starts the countdown of the number of remaining days.

Before the pump timer expires, a Warning will remind you that the operating life of the pump is coming to an end, so that you can arrange to get a new pump in good time. The pump timer symbol appears in the RUN screen or STOP screen. When the timer expires, an Error occurs, and your pump goes into STOP mode. It can no longer be put into RUN mode.

See chapter 8 Warning W5: PUMP TIMER, Warning W9:

LOANTIME WARNING and Error E5: END OF OPERATION.

Procedure for viewing the time remaining

1.

2.

Note This setting is country-specific and may not be visible on your pump.

104


Press f to select.

Press d to move to the PUMP TIMER screen.

The number of days remaining until the pump timer expires is shown.

Press f to exit.

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5

5.5 Transferring your data to a computer

The built-in infrared interface on the bottom of your Accu-Chek

Spirit Combo insulin pump enables you to transfer data between your pump and a PC.

The memory of your Accu-Chek Spirit Combo insulin pump stores all the events (warnings and errors, programming operations and insulin delivery records) up to a total of 4500 events. This data corresponds to about the last 90 days of use, and can be accessed on a personal computer using the Accu-Chek information management products (for details see the user information provided with the software).

For availability of the appropriate software see Appendix C.

Procedure for transferring your data

1.

2.

3.

Put your pump in STOP mode.

Press d to move to the DATA TRANSFER screen.

Press f to select.

Press f. A melody signals that your pump is ready to transfer data.

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4.

When the data transfer is complete, 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 RUN mode if necessary.

Note Your pump will return to STOP mode 15 minutes after the last data transfer when the DATA TRANSFER screen is selected.

You can press d + a twice simultaneously to exit while data is being transferred. The data transfer is interrupted, and the error E12: DATA INTERRUPTED occurs. See chapter 8.

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5.6 Pump settings

These settings relate to the practical use of the pump. For settings relating to your therapy, see 5.10 Therapy settings later in this chapter.

5.6.1 Turning Key Lock on and off

The Key Lock function allows you to lock the 4 keys of your

Accu-Chek Spirit Combo insulin pump. This is an important safety measure that prevents you from accidentally activating functions, for example while sleeping or during contact sports.

If the Key Lock is turned on and no key is pressed for 10 seconds after your pump has returned to the RUN screen or STOP screen, all 4 keys are locked.

5

Procedure for turning the Key Lock on or off

1.

2.

3.

Press d to move to the PUMP

SETTINGS screen.

Press f to select.

The current Key Lock status (ON or OFF) appears.

Press a or s to turn the Key Lock ON or OFF.


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Procedure for unlocking the Key Lock

If you press any key while the screen is blank, the Key Lock symbol indicates that the keys are locked.

Note The Key Lock remains unlocked during fast bolus delivery of Standard or Multiwave Bolus.

108

1.

From the blank screen, press and hold d + s for 3 seconds.

You hear 3 beeps in RUN or STOP mode when you press the keys and again after

3 seconds to confirm that the Key Lock is unlocked.

2.

The Key Lock remains unlocked during the programming of the pump.

If no key is pressed for 10 seconds after your pump has returned to the RUN or

STOP screen, all 4 keys are automatically locked.

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5.6.2 Adjusting the sound volume

Your pump emits different acoustic signals in different handling situations to facilitate handling e.g. for blind or partially-sighted users. For details on the meaning of the sound patterns, see the

Appendix “Beeps and melodies”. You can adjust the volume of the beeps according to your personal preference. There are 5 volume levels available: off, low, medium, high and maximum.

Note The volume of the STOP warning is independent of the programmed beep volume – it always sounds at the maximum level. If the beeps are turned off, and a warning or error occurs, the beeps become active again to ensure that you are aware of the warning or error. If the warning or error is not cancelled, the beeps gradually increase in volume until the maximum level is reached.

5

Procedure for adjusting the sound volume

1.

2.

Press d to move to the PUMP SETTINGS screen.

Press f to select.

Press d to move to the SOUND

VOLUME screen.

Press a or s to adjust the sound volume.


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5.6.3 Changing signal settings

The Accu-Chek Spirit Combo insulin pump enables you to choose how you want your pump to alert you when a warning or error occurs.

You have 3 options:

Beep only

Vibrate only

Beep and vibrate

For your safety, if you do not respond to the vibration, the pump starts beeping after one minute.

Procedure for changing the signal settings

1.

2.

110


SETTINGS screen.

Press f to select.

Press d to move to the SIGNAL

SETTINGS screen.

Press a or s to set the signals.


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5.6.4 Display orientation

Your pump allows you to turn the display by 180°, so that you can view it more easily, depending on how you are wearing the pump.

Note If you turn the display orientation of your pump by 180°,

the functions of the a and s keys are also reversed.

The functions of the d and f keys remains the same, whichever screen orientation you choose.

5

Procedure for setting the display orientation

1.

2.

3.


SETTINGS screen.

Press f to select.

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Press d to move to the ORIENTATION screen.

The current orientation is displayed.

Press a or s to select the display

orientation.


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5.6.5 Setting the display contrast

Your pump allows you to adjust the display contrast to suit your preferences.

Procedure for setting the display contrast

1.

2.

112


SETTINGS screen.

Press f to select.

Press d to move to the DISPLAY

CONTRAST screen.

Press a or s to select the desired contrast level.


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5

5.6.6 Selecting the language

Your pump can display the information in several languages.

You can chose the language according to your preferences.

Procedure for setting the language

1.

2.


SETTINGS screen.

Press f to select.

Press d to move to the LANGUAGE screen.

Press a or s to select a language.


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5.7 ADVANCED user menu

The following is a list of additional menu options available in the

ADVANCED user menu. To view the order in which they appear on the display, refer to the menu diagram below: j Press d to move forward j Press d + a simultaneously to move backward

RUN

BRP = Basal Rate profile 2–4 f f

STOP

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BRP 4

BRP 3

BRP 2

BRP 4

BRP 3

BRP

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Note The ADVANCED user menu contains all the options from the STANDARD user menu.

Some of the functions are described elsewhere in this

User’s Manual, as listed below. The remaining functions are described in this chapter following the list.

MULTIWAVE BOLUS j See section 4.4 Programming a Multiwave Bolus.

5.8 Basal rate profiles

Your pump has 5 different basal rate profiles to match your changing insulin needs (for example, Monday to Friday or

Exercise Day or Sleeping Late Day). However, in the Standard

User menu only the basal rate profile 1 is accessible.

Discuss additional basal rate profiles with your doctor or healthcare team. Also, consult with your doctor or healthcare team before changing basal rate profiles, as this may affect how you use your pump.

5.8.1 Programming additional basal rate profiles

w

WARNING

Your Accu-Chek Spirit Combo insulin pump must be programmed with your personal settings prior to starting insulin pump therapy. Do not operate your pump without knowing your personal settings. If you are not sure about your personal settings or you are inexperienced, ask your doctor or healthcare team to check your personal settings.

5

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Procedure for Programming additional basal rate profiles

1.

2.


PROGRAMMING (1, 2, 3, 4, 5) screen you wish to program.

Press f to select.

The hourly basal rates for each additional basal rate profile are set in the same way as for basal rate profile 1.

Note Only basal rate profiles that are accessible in your current user menu are available. If the basal rate profile number(s) do(es) not appear, select the ADVANCED user menu, or program the basal rate profile to an available basal rate profile number.

See section 2.5.1 Programming your

basal rate profile.

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5.8.2 Selecting a basal rate profile

Procedure for selecting a basal rate profile

1.


SELECTION screen.

Press f to enter.

2.

Press a or s to select a basal rate profile. The selected basal rate profile and its daily insulin total appear.

Press f to select.

5

The new basal rate profile is active immediately.

Note Only basal rate profiles that are accessible in your current user menu are available.

A running Temporary Basal Rate increase or decrease stays active, even if you change the basal rate profile on your pump.

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5.9 Setting a reminder

You can set both single and multiple reminders on your pump.

Multiple reminders are repeated at a set time every day. You can use this feature to remind you, for example, when you need to test your blood glucose.

Procedure for setting single or multiple reminders

1.

2.

3.

Press d to move to the REMINDER

SETTINGS screen.

Press f to select. The current REMINDER status and alarm time appear.

Press a or s to change the REMINDER setting to OFF, ONCE or EVERY DAY.

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5

4.

5.

Press d to move to the HOUR screen.

Press a or s to set the hour.

Press d to move to the MINUTE screen.

Press a or s to set the minute.


Turning off the reminder

When the reminder sounds, the reminder screen is displayed.

Press f twice to snooze and confirm and return to RUN or

STOP mode (See also section 8.4 Reminder R1).

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5.10 Therapy settings

These settings relate to the therapeutic use of the pump. For settings relating to the practical use of the pump, see pump settings earlier in this chapter.

5.10.1 Adjusting the bolus increment

Designed for those patients who may need large or small amounts of insulin, the bolus increment for the Quick Bolus of your Accu-Chek Spirit Combo insulin pump is adjustable. It is initially set to 0.5 units per key-press, but it can be changed to 0.1, 0.2, 0.5, 1.0 or 2.0 units. w

WARNING

The bolus increment determines the Quick Bolus amount per key press using the a and s keys. Incorrect programming of the bolus increment may cause inappropriate insulin delivery.

Procedure for adjusting the bolus increment

1.

2.

120

Press d to move to the THERAPY

SETTINGS screen.

Press f to select.


INCREMENT screen.

Press a or s to select a bolus increment.


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5.10.2 Adjusting the prime amount

The prime amount needed to fill an infusion set depends on the length of the infusion set tubing. The shorter your infusion set tubing, the less insulin will be required to prime the infusion set.

The default setting for the prime amount is 25 units of insulin.

Note The amount of insulin used for the priming is not added to the history of daily insulin totals.

5

Procedure for adjusting the prime amount

1.

2.


SETTINGS screen.

Press f to select.

Press d to move to the PRIME AMOUNT screen.

Press a or s to select a prime quantity between 0.0 and 50.0 units.


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5.10.3 Locking basal rate profiles

Your Accu-Chek Spirit Combo insulin pump allows you to adapt your hourly basal rate profile as needed. You can then lock your basal rate profiles to provide additional protection against accidentally changing a basal rate during normal operation. If the basal rate lock is set to ON, programming of the basal rate profiles 1, 2, 3, 4 and 5 is blocked.

If you try to program a basal rate while the BASAL RATE LOCK is turned ON, the key symbol in the BASAL RATE TOTAL screen indicates that basal rate programming is locked.

The a and s functions are blocked.

However, you can still change between the different basal rate profiles 1 to 5.

Procedure for locking the basal rate profiles

1.

2.

122


SETTINGS screen.

Press f to select.


LOCK screen.

Press a or s to turn the basal rate lock ON or OFF.


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5

5.10.4 Automatic Off

Automatic Off is a safety feature that stops insulin delivery and triggers error E3: AUTOMATIC OFF if no keys are pressed within a programmed time period in RUN mode. This feature can either be set to OFF or programmed up to 24 hours in 1-hour intervals.

The factory setting is OFF.

Discuss using the Automatic off function with your doctor or healthcare team.

Procedure for using Automatic Off

1.

2.

3.


SETTINGS screen.

Press f to select.

Press d to move to the AUTOMATIC

OFF screen.

Press or scroll a to increase or s to decrease the duration for the Automatic

Off in 1-hour intervals.

If you would like to set the Automatic Off function to off, press s until “0 hours” and OFF appear on the display.


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5.11 CUSTOM user menu

The CUSTOM user menu is designed to adapt your pump to your special requirements and preferences. It allows you or your doctor or healthcare team to display or hide screens and thereby customize the individual user menus.

RUN j Press d to move forward j Press d + a simultaneously to move backward f f

STOP

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5

Note By default, the CUSTOM user menu contains all of the functions available except the following:

j Multiwave Bolus

j Basal rate profiles 3, 4 and 5

j Therapy Settings

To change the CUSTOM user menu, you, your doctor, or your healthcare team must use the appropriate Accu-Chek PC software.

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6

Using the Accu-Chek Spirit Combo insulin pump with the Meter

6.1 Meter

This chapter describes how the Accu-Chek Spirit Combo insulin pump works with the Meter, and explains how to pair the 2 devices using Bluetooth ® wireless technology.

Note In this User’s Manual the term “Meter” always refers to your Accu-Chek diabetes management device (diabetes manager), which is compatible with your Accu-Chek

Spirit Combo insulin pump.

The Meter is both a blood glucose meter and a remote-control device for your Accu-Chek Spirit Combo insulin pump. Using the

Meter, you can program your pump without handling it, and also receive bolus advice and review history information.

“Pairing” means to set up a connection between the 2 devices using Bluetooth ® wireless technology. This is a secure connection, and there is no risk of your pump receiving signals from any other device.

Note Do not leave your Meter unattended as long as it is connected to your pump. Otherwise your pump could be manipulated remotely without your control (for example: children playing with the Meter). Therefore, it is recommended that the Key Lock feature be used.

Note The pump may not communicate with the Meter using

Bluetooth ® wireless technology when the devices are more than 2 meters (about six feet) apart.

6

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6.1.1 Tasks that must be performed on the pump

The following tasks cannot be performed remotely using the

Meter: j Changing the cartridge j Priming the infusion set j Data transfer j Bluetooth ® settings j Display settings

All the other functions available on the Accu-Chek Spirit Combo insulin pump can be performed using the Meter.

Before using your pump together with the Meter you must read the documentation (User’s Manual) provided with this product.

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6.2 Switching Bluetooth

®

ON and OFF

w WARNING

You must ensure that Bluetooth ® is switched off on both devices before boarding an aircraft, as emissions from your pump or the Meter could interfere with the electronics systems of the aircraft.

To prolong the battery life and avoid accidental changes on your pump, you should switch off Bluetooth ® wireless technology, if the Meter is lost, stolen or, you plan not to carry it with you for a longer period of time.

6

Procedure for switching Bluetooth ® ON and OFF

1.

2.

Press d to move to the BLUETOOTH

SETTINGS screen.

Press f to select to the ON / OFF screen.

Press a or s to switch on the

Bluetooth ® function.


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6.3 Pairing your pump with the Meter

Your Accu-Chek Spirit Combo insulin pump and your Meter will already have been paired by default. If you need to replace one of the devices for any reason you need to redo the pairing.

When pairing your Accu-Chek Spirit Combo insulin pump with the

Meter, place both devices on a table or desk, so that you can see the displays of both devices clearly.

You should not perform the pairing process in crowded areas, since the signals of other electronic devices could interfere with the connection.

Procedure for Pairing

1.

2.

3.

130


SETTINGS screen.

Press f to select the ON / OFF screen.

Press a or s to switch on the

Bluetooth ® function.

Press d to display the PAIRED DEVICE screen.

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If the pump screen indicates that no paired device is available, turn on the

Meter in pairing mode by holding down

* and simultaneously pressing +.

6

Note When Bluetooth ® is turned off, you cannot access the Paired

Device menu.

4.

Pump screen

5.

6.

Meter screen

Press the d key on the pump to see the

ADD DEVICE screen, and press f to initiate pairing.

Pump screen

Meter screen man_05504929001_H_en-us.indb 131

The pump begins searching and detects the Meter, displaying its serial number

(This process may take several minutes).

Press a or s to select the number, which is also shown on your Meter screen.

Press f on the pump to confirm that you want to pair the Meter.

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7.

Pump screen

8.

The pump begins the pairing process and shows a 10-digit code. Enter the code on the Meter display, using = , x and z and then = to move to the next digit.

Confirm the complete code with .

.

Meter screen

After the pairing is completed press + to turn off the Meter.

9.

Meter screen

10.

The pump now shows the DEVICE PAIRED screen. Press f to confirm the pairing.

The pump displays the PAIRED DEVICE screen. You can return to the RUN screen by pressing f.

If the pairing is not successful in a first attempt, wait a few minutes before you repeat the procedure in a safe or less crowded environment.

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6

6.4 Troubleshooting the Bluetooth

®

connection

In case of problems with the Bluetooth ® connection or after the appearance of the warning W10: BLUETOOTH FAULT, you have to repeat the pairing procedure described in section 6.3 Pairing

your pump with the Meter.

Since only one Meter at a time can be paired with your pump, you must delete the pairing before you can pair your pump with a new Meter.

1.

2.

3.


SETTINGS screen.

Press f to enter the BLUETOOTH

ON / OFF screen.

Press d to move to the PAIRED DEVICE screen.

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4.

Press d to move to the DELETE DEVICE screen.

Press f once to delete the pairing and a second time to confirm.

Then repeat the pairing procedure described in section 6.3 Pairing your pump with the Meter.

If the pairing is still not successful, contact Accu-Chek Customer

Care (details on inside back cover).

6.4.1 Handling warnings and errors

The Accu-Chek Spirit Combo insulin pump and Meter behave in the following ways when warnings and errors occur.

j If both devices are switched on and paired you can enter the

Meter’s pump menu and snooze and confirm the warning or error through the Meter. j If the Meter is switched off, and you switch it on in response to a warning, error or reminder on the pump, the Meter switches immediately to the pump menu. All the functions available on the pump are performed from the pump menu of the Meter.

Note The above points do not apply in the case of

E7: ELECTRONIC ERROR.

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6

6.4.2 Use in aircraft

w WARNING

You must ensure that Bluetooth ® is switched off on both devices before boarding an aircraft, as emissions from your pump or the Meter could interfere with the electronics systems of the aircraft. man_05504929001_H_en-us.indb 135

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7

Care and Maintenance

This chapter explains how to take care of your pump and keep it properly maintained.

c

CAUTION

Do not perform any servicing or repair on your Accu-Chek

Spirit Combo insulin pump as this may void the guarantee. For further information, contact your Accu-Chek Customer Care

(see inside back cover).

7.1 Inspecting your pump

Your pump must be properly maintained to guarantee accurate insulin delivery.

Check the pump display regularly during the day and before you go to sleep, and especially if for any reason you might not be able to hear the beeps or feel the vibrations.

Accessories

Use only sterile products and accessories with the Accu-Chek brand designed to be used with your pump. Replace and discard these items according to your doctor’s or healthcare team’s recommendations and the instructions that come with these items. For a list of recommended accessories and disposables, see Appendix C.

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7.1.1 Checklist

Check your pump daily, and make sure that: j The pump casing, the display, and the cartridge are not chipped or cracked and that the display does not show incomplete or abnormal letters or symbols.

j You carefully inspect the cartridge. Make sure that the actual amount of insulin in the cartridge equals the displayed cartridge amount on the QUICK INFO screen. j You inspect all parts of your pump and infusion set regularly during the day and before you go to sleep. If you detect any loss of insulin, immediately replace the leaking component. j The battery cover is correctly tightened and positioned, in line with the pump casing. j The adapter is correctly attached. j Your infusion set is primed, free of air bubbles, and tightly connected to the adapter. j Your infusion set is inserted according to the instructions for its use. j Your infusion site is secure, comfortable, and free of irritation or infection. j The cartridge is free of air bubbles. j Your pump is in RUN mode. j The basal rates are set correctly according to your doctor’s or healthcare team’s recommendations. j The time and date are set correctly. j The Temporary Basal Rate changes are set according to your doctor’s or healthcare team’s recommendations. j The beeps and / or vibrations are set. j You have your personal emergency kit with you.

(See section 1.5 Emergency kit)

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7.2 Damage to your pump

7.2.1 What to do if you drop your pump

If the pump is dropped it could be damaged, as well as the seal that protects it against water. Use the specially designed pump carrying system to help avoid dropping your pump. See Roche

Diabetes Care, Inc. sterile products and accessories catalogs and brochures for more information, or contact your Accu-Chek

Customer Care (details on inside back cover).

If you drop your pump: j Check that all the connections of your infusion set are still tight, and if they are not, reconnect or tighten them j Check your pump, its sterile products, and accessories for chips and cracks j Change the cartridge if it is damaged

Put your pump in STOP mode, disconnect the infusion set, and take out and reinsert the battery, so that the self-test is started then put your pump back in RUN mode.

Note If a Temporary Basal Rate, an Extended Bolus or a

Multiwave Bolus is active at the same time, it is cancelled when your pump is put into STOP mode. The warning W8:

BOLUS CANCELLED or the warning W6: TBR CANCELLED is displayed.

Press f twice to confirm and turn off the alert. The alerts are recorded in the alarm history.

See chapter 8 Warning W6: TBR CANCELLED and Warning

W8: BOLUS CANCELLED.

Make sure that the cancellation was deliberate, put your pump back in RUN mode, and then program a new

Temporary Basal Rate (and / or an Extended or Multiwave

Bolus), if needed.

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c CAUTION

Immediately inspect your pump if it is dropped. Do not use your Accu-Chek Spirit Combo insulin pump if chips, cracks or other damages are visible. Otherwise water, dust, insulin or other foreign substances may enter your pump and could result in a malfunction.

If you have questions or are not sure whether your pump has been damaged, contact your Accu-Chek Customer Care

(details on inside back cover).

7.3 Your insulin pump and water

c CAUTION

Avoid contact with water. Check daily that your Accu-Chek

Spirit Combo insulin pump is not chipped, cracked or damaged in any way, and that the battery cover and the adapter are correctly closed. If the pump is chipped or cracked, water, dust, insulin, or other substances may enter your pump and lead to malfunction. Before any contact with water, disconnect and take off your pump.

Disconnect and remove your pump before taking a bath, or going into a whirlpool, shower, or swimming pool. Avoid exposing your pump to high humidity, such as in a sauna, as this could result in damage. To make it easy to remove your pump, use disconnectable Accu-Chek infusion sets.

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7.3.1 Accidental contact with water

Your Accu-Chek Spirit Combo insulin pump is IPX8 waterproof when leaving the factory site. However hair-line cracks could appear during use. Therefore we may only guarantee protection against brief accidental water contact such as: j Rain j Water splashes while you are cycling, jogging or hiking j Accidental immersion in the sink, washbasin or bath

What to do after any water contact

Put your pump into STOP mode, disconnect the pump from your body, and inspect it. Use a soft dry cloth to dry the outside of the pump, and check the battery compartment and the cartridge compartment for water. If the battery compartment or cartridge compartment are wet, turn your pump upside down to let the water run out and let it air dry. Do not use warm air such as a hair dryer to dry the pump, as this could damage the pump’s housing. Do not reinsert the battery or the cartridge until the compartments are completely dry. See section 7.5.1 Cleaning

your pump.

Other liquids

You do not have to worry about contact between your pump and perspiration or saliva. You must however check your pump immediately after contact with other liquids or chemicals such as: j Cleaning solutions j Beverages j Oil or Fat

In case of contact with these substances, clean your pump immediately. See section 7.5.1 Cleaning your pump.

c CAUTION

Avoid any contact between your Accu-Chek Spirit Combo insulin pump, the infusion set, and the connecting parts of your insulin pump with health and beauty items (for example: antiseptics, antibiotic creams, soaps, perfumes, deodorants, body lotions, or any other cosmetics). These substances could discolour your pump or fog the display.

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142

7.4 Repair of your pump

c CAUTION

Do not perform any servicing or repair on your pump. Do not use any lubricants on the pump mechanism. If you have questions, contact your Accu-Chek Customer Care (details on inside back cover).

If you have problems with your pump, contact your Accu-Chek

Customer Care (details on inside back cover). Your Accu-Chek

Customer Care can answer many questions and resolve many problems over the telephone. You may be requested to return your pump to Roche Diabetes Care, Inc. for investigation. For example, you may need to return your pump if a warning or error could not be cleared by following the procedures described in chapter 8 Warnings and errors.

If you have to ship your pump, carefully pack the pump and the used cartridge, battery, battery cover, adapter, and infusion set to avoid damage during transportation. Place your pump back in the shipping case and put the case in a package that will not rip or tear. It is recommended to ship your pump using a company that tracks the shipment for you.

When you return your pump, include the following: j your name and address j your daytime phone number j the serial number of your pump j any RMA (Return Material Authorization) number received from your Accu-Chek Customer Care.

By returning your pump to Roche Diabetes Care, Inc., you authorize Roche Diabetes Care, Inc. to undertake any testing on your insulin pump that is needed for a proper inspection, and understand that your pump may not be returned to you.

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7.5 Maintaining your pump

7.5.1 Cleaning your pump

The best time to clean your pump is when you change the cartridge. Use a soft cloth to clean the outside of the pump.

If necessary, use a clean cloth with alcohol (isopropanol or ethanol). If these measures are not successful, contact your

Accu-Chek Customer Care (details on inside back cover) for more instructions. Also see section 7.3.1 Accidental contact with water.

7.5.2 Batteries

It is important to change your battery regularly and to keep spare batteries available. The life of any battery is affected by how you use your Accu-Chek Spirit Combo insulin pump, your personal settings, delivery rates, temperature, and other factors.

For details about the battery lifetime see Appendix A.

See section 1.4 Accessories and disposables or Appendix C for more information on recommended batteries.

See section 2.2 Inserting the battery for instructions on how to change your battery.

c CAUTION

Always remove the cartridge and adapter, and put your pump in STOP mode while cleaning. Avoid pressing the keys of your

Accu-Chek Spirit Combo insulin pump during cleaning, as this may accidentally change your settings. Do not use other solvents, strong detergents, bleaching agents, scouring pads or sharp instruments for cleaning, as they may damage the pump.

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7.6 Storing your pump

c CAUTION

When your pump will not be in use for a long period of time, it must be properly stored to prevent any subsequent malfunction.

To store your pump, place it in STOP mode, then: j Remove the battery to preserve the battery life j Remove the cartridge j Insert the battery cover j Store your pump in its packaging

Storage conditions

Temperature

Air humidity

41 °F to 113 °F (+5 °C to +45 °C)

5 to 85 % relative air humidity

Barometric pressure 500 to 1060 mbar

7.7 Disposing of your pump

Since your Accu-Chek Spirit Combo insulin pump may come into contact with blood during use, it may carry a risk of infection. If you need to dispose of your Accu-Chek Spirit Combo insulin pump, please call Accu-Chek Customer Care for instruction (see inside back cover for phone number).

Battery

Correctly dispose of empty batteries, recycling them wherever possible.

Cartridge, Infusion set, Adapter, and Accessories

Dispose of these items in your normal household waste or, for the batteries, at the usual recycling point. Remember to dispose of the introducer needle safely (using the needle container).

To prevent injury to others, replace the needle protective cover or insert the needle of the infusion set into a disposable object, or put it in a hard-shell container.

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8

Warnings and errors

A safety system monitors and controls the function of your

Accu-Chek Spirit Combo insulin pump. This safety system performs more than 9 million safety checks every day. If it detects a change from the pump’s normal state, it will trigger a warning or an error message. Beeps, vibrations, and messages on the pump screen indicate the cause of a warning or error.

Warnings and errors are the only way you can be quickly notified of any changes in your pump.

c

CAUTION

Check the pump display regularly during the day, and before you go to sleep, and especially if you might not be able to hear the beeps or feel the vibrations for any reason.

Your pump signals warnings and errors using beeps and vibrations. You can turn off either the beeps or the vibrations, but for your safety you cannot turn off both at the same time for the initial alarm signal.

If you do not confirm the warning or error within 60 seconds, it will be signalled again. Even when the beep is turned off or programmed at lower than maximum volume, the beep volume will rise to the loudest volume level if not confirmed. Both the beep and vibration will then continue at this level until confirmed.

All messages fall into the low-priority category according to

IEC 60601-1-8:2006.

Note j The volume of the STOP warning is separate from the

programmed beep volume and cannot be changed.

It always occurs at the maximum level.

j Key Lock is unlocked by the system each time a warning or error occurs.

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146

8.1 Confirming a warning or error

When you confirm:

W1: CARTRIDGE LOW

E1: CARTRIDGE EMPTY

W2: BATTERY LOW

E2: BATTERY EMPTY

W5: PUMP TIMER (“Backup” pumps only)

E5: END OF OPERATION (“Backup” pumps only) the symbol for that warning or error stays in the RUN screen or

STOP screen as a reminder.

When a warning or an error occurs: j Press f to turn off the beeps and vibrations. The warning or error code stays on the display.

Battery low symbol Pump timer symbol

Cartridge low symbol Key Lock symbol

For other warnings or errors, alarm information is cleared from the display but stays in the alarm history and the event memory.

j As soon as you understand the reason for the warning or error, confirm by pressing f again. j Take appropriate action, as necessary. j If more than one warning and /or error occurs simultaneously, press f twice for each warning or error to confirm them and turn them off. j After a warning or error, make sure that you switch your pump back to RUN mode where appropriate.

Note When you use your pump together with the Meter you can also snooze and confirm an incoming warning or error with the Meter. For further information see the Meter user information.

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8.2 List of warnings

w WARNING

After a warning occurs, your Accu-Chek Spirit Combo insulin pump may be in STOP mode and insulin delivery may be interrupted. In order to maintain insulin delivery, you must act immediately according to the instructions given for each error code, or put your Accu-Chek Spirit Combo insulin pump in

RUN mode to continue the insulin delivery.

j Press f twice to snooze and to confirm the warning. Change the cartridge before it is empty.

Warning W1: CARTRIDGE LOW

The content of the insulin cartridge has dropped to 20 units of insulin. Be prepared to replace the cartridge as soon as possible.

The “cartridge low” symbol appears in the RUN or STOP screen as a reminder until you change the cartridge. j If necessary, put your pump in RUN mode.

See section 3.5 Changing the cartridge and infusion set.

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Warning W2: BATTERY LOW

The battery power is low. Be prepared for a battery change as soon as possible. The battery low symbol appears in the RUN or

STOP screen as a reminder until you change the battery.

j Press f twice to snooze and to confirm the warning.

Warning W3: REVIEW TIME

The pump has been without power for more than one hour. The pump settings and history data are saved in memory regardless of power loss. However, it may be necessary to set the time and date again. j Press f twice to snooze and to confirm the warning. j Replace the battery as soon as possible. Failure to change the battery within a few hours of receiving the warning could result in additional error messages. j If necessary, put your pump in RUN mode.

See section 1.4 Accessories and disposables on recommended batteries. See section 2.2 Inserting the battery for instructions on how to change the battery. j Review the time and date and correct them, if they are wrong.

j If necessary, put your pump in RUN mode.


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Warning W4: CALL FOR UPDATE

Your pump has been in use for 6 years now. You may want to consider updating to a new product.


Warning W5: PUMP TIMER (“Backup” pumps only)

Your pump’s operating time will expire soon. When the warning

W5: PUMP TIMER occurs, the pump will display the symbol to remind you to check the timer.

j Press f twice to snooze and to confirm the warning. j Put your pump in RUN mode if necessary.

If, after the warning W4: CALL FOR UPDATE an E6 or E7 error message appears, your pump is no longer able to operate.

Contact your Accu-Chek Customer Care in both situations (see inside back cover). j Put your pump in RUN mode. j Go to the MY DATA menu on your pump.

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j Move to the PUMP TIMER screen. The days until the pump timer expires are shown.

Warning W6: TBR CANCELLED (Temporary Basal Rate

Cancelled)

A temporary increase or decrease in the basal rate has been cancelled. j Press f twice snooze and to confirm the warning.

When the PUMP TIMER reaches zero, the pump will change to

STOP mode and will no longer operate. The error, E5: END OF

OPERATION, will appear on the display. Contact your Accu-Chek

Customer Care (details on inside back cover) to discuss the options for further use of your Accu-Chek Spirit Combo insulin pump.

Note The warning W5: PUMP TIMER and the error E5: END OF

OPERATION are based on running time (the total time the pump is in RUN mode), and not on calendar years.

See section 5.4.5 Viewing the time remaining. j If necessary, put your pump in RUN mode. j Make sure that the cancellation was intended and then program a new Temporary Basal Rate if necessary.

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Warning W7: TBR OVER (Temporary Basal Rate Over)

A Temporary Basal Rate has ended. The original basal rate

(100 %) will resume automatically once the warning has occurred. j Press f twice to snooze and confirm the warning. j

Warning W8: BOLUS CANCELLED

A bolus was cancelled during the start delay or after delivery began.

Press f twice to snooze and to confirm the warning. j Decide whether a further Temporary Basal Rate change is required. If necessary, program a new Temporary Basal Rate.

j If necessary, put your pump in RUN mode. j Make sure that the cancellation was intended and then program a new bolus if needed.

Note The actual bolus amount that was delivered before the cancellation can be reviewed in the bolus history. See

section 5.4.1 Viewing your bolus history.

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Warning W9: LOANTIME WARNING (loan pumps only)

The pump is coming to the end of its loan period. In the MY DATA menu, check the remaining loan time in the PUMP TIMER menu.

Make sure that you arrange for the replacement of the pump within the scheduled loan time.


Warning W10: BLUETOOTH FAULT

You need to re-do the pairing procedure for the Accu-Chek

Spirit Combo insulin pump and Meter.

See section 6.3 Pairing your pump with the Meter. j Press f twice to snooze and to confirm the warning.

j Put your pump in RUN mode if necessary. j Go to the MY DATA menu on your pump.

j Move to the PUMP TIMER screen. The days until the loantime expires are shown.

j Put your pump in RUN mode if necessary.

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Note This setting is country-specific and may not be visible on your pump.

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8.3 List of errors

w WARNING

After the occurrence of an error, your Accu-Chek Spirit Combo insulin pump is in STOP mode and insulin delivery is interrupted. In order to maintain insulin delivery, you must act immediately according to the instructions given for each error.

j Reconnect the infusion set or insert a new one. j Put your pump in RUN mode.

See section 3.5 Changing the cartridge and infusion set.

Error E1: CARTRIDGE EMPTY

The insulin cartridge is empty. You must change it immediately. j Press f twice to snooze and to confirm the error. j Disconnect or remove the infusion set from the infusion site. j Change the cartridge and prime the infusion set.

Error E2: BATTERY EMPTY

The battery is empty. You must replace it immediately.

w WARNING

After inserting a new battery, always check that the time and date of your Accu-Chek Spirit Combo insulin pump are set correctly. Incorrect programming of the time and /or date may cause incorrect insulin delivery. If you, your doctor or healthcare team store and analyse your therapy data electronically and the time and date of the devices used are not set identically, the resulting data might not be meaningful.

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j Press f twice to snooze and to confirm the error. j Replace the battery. j 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 that the time and date are still correct.

See section 1.4 Accessories and disposables on

recommended batteries. See section 2.2 Inserting the battery for instructions on how to change your battery.

Error E3: AUTOMATIC OFF

Automatic Off is a safety feature that stops insulin delivery and triggers the error E3: AUTOMATIC OFF if no keys are pressed within a programmed time period in RUN mode. j Press f twice to snooze and to confirm the error.

j Put your pump in RUN mode.

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Error E4: OCCLUSION w WARNING

If the error E4: OCCLUSION occurs, immediately check your blood glucose level, and then check again about 2 hours later, as insulin delivery has been interrupted. If your blood glucose level is high, take appropriate action according to your doctor’s or healthcare team’s instructions.

Insulin was not delivered. This may be due to: j a blocked infusion set j a damaged cartridge j a dirty or damaged piston rod

If the error E4: OCCLUSION (blockage) occurs, follow the steps listed below: j Press f twice to turn off and to confirm the error. j Disconnect or remove the infusion set from your infusion site. j Change the infusion set and prime it, as explained in chapter 2. j Put your pump in RUN mode.

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In rare cases, the cartridge itself can be the cause of the occlusion. If the error E4: OCCLUSION occurs again, you must change the cartridge. Follow the steps listed below: j Press f twice to turn off and to confirm the error. j Disconnect or remove the infusion set from your infusion site. j Change the cartridge and prime the infusion set, as explained in chapter 2.

j Reconnect or insert a new infusion set at your infusion site. j Put your pump in RUN mode.

If the error E4: OCCLUSION occurs again, prime your pump without a cartridge. Follow the steps listed below: j Press f twice to turn off and to confirm the error. j Disconnect or remove the infusion set from your infusion site. j Remove the cartridge, adapter and infusion set from your pump. j Carry out the INFUSION SET PRIMING function (See section

2.8 Priming the infusion set) without the cartridge, adapter, and infusion set inserted. j Rewind the piston rod.

j Insert a new cartridge with the adapter and infusion set connected. j Prime the infusion set. j Reconnect or insert a new infusion set at your infusion site. j Put your pump in RUN mode.

If the error E4: OCCLUSION continues to occur, use the alternative therapy plan provided by your doctor or healthcare team. Contact your Accu-Chek Customer Care

(details on inside back cover) for more assistance.

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Error E5: END OF OPERATION (“Backup” pumps only)

The pump timer of your Backup pump has reached zero. The pump changes to STOP mode and will no longer operate. The error E5: END OF OPERATION appears on the display. Before this error occurs, the warning W5: PUMP TIMER will remind you to replace your pump soon. If necessary, use the alternative therapy plan provided by your doctor or healthcare team.

j Press f twice to snooze and to confirm the error.

Note The warning W5: PUMP TIMER and the error E5: END OF

OPERATION are based on running time (the total time the pump is in RUN mode) and not on calendar years.

8 j Contact your Accu-Chek Customer Care (see inside back cover) to discuss the options for further use of the Accu-Chek

Spirit Combo insulin pump.

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j

Error E6: MECHANICAL ERROR

A mechanical error has been discovered during a routine automatic system check and insulin delivery has stopped.

Press f twice to snooze and to confirm the error. j Reconnect the infusion set at your infusion site. j Put your pump in RUN mode.

If the error E6: MECHANICAL ERROR occurs again, use the alternative therapy plan provided by your doctor or healthcare team. Contact your Accu-Chek Customer Care (details on inside back cover) for more assistance. j Remove or disconnect the infusion set from your infusion site. j Remove the cartridge, adapter, infusion set, and battery from your pump. Insert a new battery.

j It is essential that you rewind the piston rod. Install a new cartridge and infusion set. (See section 2.7 Inserting the

cartridge). Prime the infusion set (See section 2.8 Priming the

infusion set).

Error E7: ELECTRONIC ERROR

An electronic error has been discovered during a routine automatic system check and insulin delivery has stopped.

Note You cannot turn off and confirm the error E7: ELECTRONIC

ERROR by pressing f. You must remove the battery instead.

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j Remove or disconnect the infusion set from your infusion site. j Replace the battery in the pump (See section 2.2 Inserting the

battery). j Prime the infusion set. j Reconnect the infusion set at your infusion site. j Put your pump in RUN mode.

After the error E7: ELECTRONIC ERROR always check your settings like e.g. basal rate profile, time and date.

If the error E7: ELECTRONIC ERROR occurs again, contact your

Accu-Chek Customer Care (details on inside back cover) for assistance. Use the alternative therapy plan provided by your doctor or healthcare team.

j j j

Error E8: POWER INTERRUPT

A power interrupt error occurs when you insert a new battery without first placing the pump in STOP mode. See section

2.2 Inserting the battery for instructions on how to change the battery. The error can also occur if the pump has been dropped.

In this case, see section 7.2.1 What to do if you drop your pump. j Press f twice to snooze and to confirm the error.

Your pump goes into STOP mode.

Check the time and date and correct them if they are wrong.


Put your pump in RUN mode. Program a new bolus and /or

Temporary Basal Rate if necessary. See chapter 4 Boluses and

Temporary Basal Rates.

If the error E8: POWER INTERRUPT occurs during programming, check your settings.

8

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Error E9: END OF OPERATION (loan pumps only)

Your pump timer has reached zero. The pump changes to STOP mode and will no longer operate. The error E9: END OF

OPERATION appears on the display. Before this error occurs, the warning W9: LOANTIME WARNING will remind you to replace your pump soon. If necessary, use the alternative therapy plan provided by your doctor or healthcare team.


Note This setting is country-specific and may not be visible on your pump.

The warning W9: LOANTIME WARNING and the error E9:

END OF OPERATION are based on running time (the total time the pump is in RUN mode) and not on calendar years.

Error E10: CARTRIDGE ERROR

The CARTRIDGE CHANGE function was not correctly performed.

j Press f twice to snooze and to confirm the error. j Contact your Accu-Chek Customer Care (details on inside back cover) to discuss the options for further use of the Accu-Chek


j Remove or disconnect the infusion set from your infusion site. j Remove the cartridge. j Reinsert the cartridge. (See section 2.7 Inserting the cartridge)

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8 j Prime the infusion set. j Reconnect the infusion set at your infusion site. j Put your pump into RUN mode. j If the error E10: CARTRIDGE ERROR occurs during the rewinding of the piston rod, insert a new battery in the pump and repeat the procedure.

Error E11: SET NOT PRIMED

The cartridge has been changed but the infusion set has not been primed. The error will be displayed when you try to put your pump in RUN mode.


See sections 3.5 Changing the cartridge and infusion set and

2.8 Priming the infusion set. w WARNING

Never prime an infusion set that is connected to your body.

You risk uncontrolled insulin delivery into your body. Always follow the instructions provided with your infusion set.

j Remove or disconnect the infusion set from your infusion site.

j Prime the infusion set. (See section 2.8 Priming the infusion set).

j Reconnect the infusion set at your infusion site. j Put your pump in RUN mode.

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Error E12: DATA INTERRUPTED c CAUTION

If infrared data transfer between your pump and a compatible device is disrupted in any way, the configuration may be incomplete and the error E12: DATA INTERRUPTED will occur.

The data transfer must be successfully completed before you can put your Accu-Chek Spirit Combo insulin pump into RUN mode.

Data transfer between your pump and the computer was interrupted before it was completed.

j Press f twice to snooze and to confirm the error. j Restart the data transfer.

Before you can put your pump in RUN mode, the data transfer must have been successfully performed.

See section 5.5 Transferring your data to a computer.

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8

Error E13: LANGUAGE ERROR

The language setting needs to be checked.

j Press f twice to snooze and to confirm the error. j Follow the steps in section 5.6 Pump settings to change the language. j Put your pump in RUN mode.

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8.4 List of reminders

Reminder R1: REMINDER

A reminder has been programmed on the pump. j Press f twice to snooze and to confirm the reminder. j If necessary, put your pump in RUN mode.

Note If you have set the reminder occurrence to EVERY DAY,

the same reminder occurs every 24 hours. Turn the reminder function OFF if you do not want the alarm to go

off again at that same time every day. See section

5.9 Setting a reminder.

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9

Troubleshooting

This chapter describes problems that may occur when using your Accu-Chek Spirit Combo insulin pump. Any problems that generate a warning or error are described in chapter 8.

Note The solutions provided in this chapter will normally enable you to resolve the problem and continue with your pump therapy. However, if the recommended action does not resolve the problem, or if you have any concerns, do not hesitate to contact your Accu-Chek Customer Care (see inside back cover) or doctor or healthcare team.

Note Troubleshooting information relating to the Bluetooth ® connection between the Meter and the Accu-Chek

Spirit Combo insulin pump is included in chapter 6 Using the Accu-Chek Spirit Combo insulin pump with the Meter.

Also refer to the documentation (Owner's Booklet) that comes with the Meter.

Although your pump has an internal security check system, it cannot, for example, detect if your infusion set is leaking, if an empty cartridge has been inserted instead of a filled cartridge or if the insulin you are using has lost its effectiveness. These problems can result in a rapid rise in your blood glucose level.

Therefore, it is essential to check your pump and blood glucose level during the day.

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9.1 Therapy-related issues

Many factors – such as alcohol consumption, medication, decreased activity, illness and stress – can affect your blood glucose level.

Contact your doctor or healthcare team for advice on how to manage these, or any other, therapy-related issues.

Problem

Individual characters, numbers, or symbols on the display are shown incompletely or not at all.

Your Accu-Chek Spirit Combo insulin pump does not beep or vibrate.

The self-test is not completed correctly (after an error E7:

ELECTRONIC ERROR).

Recommended Action

Contact your Accu-Chek Customer Care (details on inside back cover).

Check that the beep volume and alarm signals are turned on. Check the battery and change it if necessary. If the pump still does not beep or vibrate, contact your Accu-Chek Customer Care (details on inside back cover).

Remove the battery, wait a few seconds, and insert it again. If the self-test is still not completed correctly, contact your Accu-Chek

Customer Care (details on inside back cover).

Insulin delivery is incorrect due to inaccurate time setting.

If the time setting is inaccurate, the correct hourly basal rate cannot be delivered. Check and reset the time if necessary. Perform the same check whenever you change the battery.

Insulin delivery is incorrect due to incorrect basal rate programming.

Review any changes that you have made to your basal rate programming, to ensure that you are using the correct basal rate profile.

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Problem Recommended Action

There are air bubbles in the cartridge and /or infusion set.

Check your blood glucose level.

In the cartridge: Disconnect the infusion set from the headset and re-prime the infusion set. If the air bubbles remain, replace the cartridge. Always fill the cartridge with insulin that is at room temperature.

The cartridge is empty.

In the infusion set: Disconnect from the headset and prime your infusion set. Reconnect the headset and ensure that all connections are tight and secure.

Replace the cartridge. (Cartridges are for single use only.)

The infusion set is disconnected or dislodged.

Check your blood glucose level. Make sure that all the connections are tight. Inspect the connections for leaking insulin. Change your infusion set and infusion site.

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Problem

There is a leak in the system.

There is an occlusion (blockage) in the system.

Priming was not completed (E11 or air bubbles in infusion set).

Recommended Action

Check your blood glucose level. Check for leaking insulin at all the connection points and on the skin. Change the infusion set, the infusion site, the cartridge and the adapter.

Check your blood glucose level. Follow the instructions in chapter 8 Error E4: OCCLUSION.

Disconnect from the headset and re-prime the infusion set. Always prime until a bubble-free insulin flow emerges from the tip of the needle. Ensure that the tubing is free of air. Reconnect to the headset.

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Appendix A: Technical data

General Technical Data

Maximum dimensions

(without adapter)

Weight

Pump casing

Approx. 82.5 × 56 × 21 mm

(3.2 × 2.2 × 0.8 inches) j empty insulin pump: approx. 80 g (2.8 ounces) j insulin pump including battery, full plastic cartridge and infusion set: approx. 110 g (3.9 ounces)

Shock- and scratch-resistant plastic, resistant to pharmaceuticals, all edges rounded

Temperature ranges*

Air humidity

Barometric pressure

During operation: +5 to +40 °C (+41 to +104 °F)

During storage in its shipping case: +5 to +45 °C (+41 to +113 °F)

During transport: -20 to +50 °C (-4 to +122 °F)

During operation: 20 to 90 % relative humidity

During storage in its shipping case: 5 to 85 % relative humidity

During transport: 5 to 95 % relative humidity

During operation or storage in its shipping case: 50 to 106 kPA (500 to 1060 mbar) (do not exceed 3000 meters [10 000 feet] above sea level)

During transport: 50 to 106 kPa (500 to 1060 mbar)

A

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Power supply

Lifetime of battery

Lifetime of insulin pump

Data storage time

One 1.5 V AA Alkaline (LR6) or Lithium (FR6) battery or one 1.2 V rechargeable NiMH AA

(HR6) battery. Batteries should have a minimum capacity of 2500 mAh. Do not use alkaline batteries that do not comply with IEC 60086-1. Do not use lithium batteries that do not comply with IEC 60086-4. Do not use carbon zinc or nickel cadmium (NiCd) batteries.

Rechargeable batteries should have a minimum capacity of 2600 mAh. Only use a battery charger officially recommended by the battery manufacturer. Do not use rechargeable batteries that do not comply with IEC 62133.

Contact your Accu-Chek Customer Care if you intend to use a different type of battery or rechargeable battery to the one recommended.

If used in a typical usage pattern (50 U/day using U100 insulin; operating temperature

23 °C ±2 °C [73 °F ±4 °F] at minimum/intermediate/maximum basal rate), the battery life is approximately:

Alkaline: 70 days with Bluetooth ® off; 30 days with Bluetooth ® on

Lithium: 200 days with Bluetooth ® off; 80 days with Bluetooth ® on

NiMH: 100 days with Bluetooth ® off; 40 days with Bluetooth ® on

6 years

The time and date are safely stored in the memory for about 1 hour after the battery has been removed. Other insulin pump settings (the hourly basal rates, remaining cartridge content, bolus increments, active user menu and alarm settings) and the event memory (bolus history, history of daily insulin totals, Temporary Basal Rate history and alarm history) are saved, regardless of battery voltage and the time your insulin pump has been without a battery.

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Delivery

Basal rate

Bolus

Temporary Basal Rate

Bolus delivery speed

Priming speed

Sound pressure

Your Accu-Chek Spirit Combo insulin pump delivers insulin according to the programmed hourly basal rate, 24 hours a day.

j Minimum dose: 1/20 of the hourly basal rate, delivered a maximum of 20 times per hour.

j Test interval: every 3 minutes.

Min. 0.05 U / h, max. 25 U / h. There are 24 hourly basal rates adjustable in increments of

0.01 U / h (up to 1.00 U / h), 0.05 U / h (up to 10.0 U / h) and 0.1 U / h (up to 25.0 U / h).

The maximum bolus amount per delivery is 25 insulin units. The bolus amount for the Quick

Bolus is adjustable in increments of 0.1 U / h, 0.2 U / h, 0.5 U / h, 1.0 U / h and 2.0 U / h. For the

Standard Bolus, Extended Bolus and Multiwave Bolus, the amount is adjustable in fixed increments of 0.1 U / h. The duration of the Extended Bolus and the Multiwave Bolus is adjustable in intervals of 15 minutes (15 minutes up to 12 hours).

Adjustable in 10 % increments, 0–90 % for decreases, 110–250 % for increases. The duration is adjustable in 15 minute intervals, up to a maximum of 24 hours. The last programmed duration is used by default for the next Temporary Basal Rate change.

12 U/min

12 U/min

In addition to tactile notification, the pump generates on average a sound pressure of at least 45 dB.

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Maximum time before the error

E4: OCCLUSION** occurs

Maximum missing volume before the error E4: OCCLUSION** occurs

Maximum system occlusion alarm threshold

Maximum alarm threshold

Maximum pressure

Plastic cartridges: j at medium basal rate 1.0 U / h: ≤ 2 h j at minimum basal rate 0.05 U / h: ≤ 24 h

Plastic cartridges: ≤ 2.0 U

< 400 kPa (4.0 bar)

< 400 kPa (4.0 bar)

400 kPa (4.0 bar), for plastic cartridges and infusion sets.

Flow (delivery rate) During infusion set priming and bolus: 0.2 U / sec.

Maximum quantity delivered at a single fault condition

Cartridge

≤ 1.0 U

The Accu-Chek Spirit 3.15 ml cartridge system and the Accu-Chek 3.15 ml plastic cartridge with a luer-lock connection. Sanofi Aventis Insuman Infusat cartridges*** have been evaluated and approved for use with the Accu-Chek Spirit Combo insulin pump.

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Infusion sets The Accu-Chek infusion sets with a luer-lock connector (see Appendix C).

Data transfer between pump and a PC Infrared interface

Safety system

IPX8

The safety concept is based on a control system which consists of two microprocessors

(1 main processor and 1 supervisor processor). Whenever a defect or fault occurs in the main processor, it is identified by the supervisor processor. If, for example, overdelivery occurs, the motor is immediately switched off and the error E7: ELECTRONIC ERROR occurs. The main processor and supervising processor signal the error E7 with beeps and vibrations. In addtion, the main processor shows the specific error E7 number on the pump display. Conversely, the main processor can also determine at any time whether the supervisor processor is working correctly.

Protected against the effects of temporary immersion in water under standardized conditions (up to 60 minutes and 2.5 meters [8 feet]).

Electric shock protection The Accu-Chek Spirit Combo insulin pump and the Accu-Chek infusion sets are applied parts of the type BF.

* See the instructions for use of the insulin you are using for information on the acceptable temperature range for operation, storage and handling.

** Determined using measurement methods according to IEC 60601-2-24-1998.

A

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Technical standards

Table 201: Electromagnetic emission

Guidance and manufacturer’s declaration – electromagnetic emissions

The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Accu-Chek Spirit Combo insulin pump should ensure that it is used in such an environment.

Emission test Compliance Electromagnetic environment – guidance

RF emissions

CISPR 11

Group 1

RF emissions

CISPR 11

Class B

The Accu-Chek Spirit Combo insulin pump must emit electromagnetic energy in order to perform its intended function. In rare cases, nearby electronic equipment may be affected.

The Accu-Chek Spirit Combo insulin pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

– Harmonic emissions

IEC 61000-3-2

Not applicable

Voltage fluctuations / flicker emissions

IEC 61000-3-3

Not applicable –

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Table 202: Electrostatic discharge (ESD) and power frequency magnetic fields (all devices)

Guidance and manufacturer’s declaration – electromagnetic immunity

The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of Accu-Chek Spirit Combo insulin pump should ensure that it is used in such an environment.

Immunity test standard IEC 60601 test level * Compliance level Electromagnetic environment – guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast transient / burst

IEC 61000-4-4

Surge

IEC 61000-4-5

± 8 kV contact

± 15 kV air

± 2 kV for power supply lines

± 1 kV line to line

± 2 kV line to earth

± 8 kV contact

± 15 kV air

Not applicable

Not applicable

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

A

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Immunity test standard IEC 60601 test level * Compliance level

Voltage dips, short interruptions and voltage variations on power supply lines

IEC 61000-4-11

< 5 % UT (0.5 cycle)

40 % UT (5 cycles)

70 % UT (25 cycles)

< 5 % UT for 5s

Not applicable

Note UT is the A.C. mains voltage prior to application of the test level.

Electromagnetic environment – guidance

Immunity test standard IEC 60601 test level * Compliance level ** Electromagnetic environment – guidance

Power frequency

(50 / 60 Hz) magnetic field

IEC 61000-4-8

3 A / m 3 A / m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

* Test levels acc. to IEC/EN 60601-1-2:2007

** Successfully tested by the manufacturer with 400 A/m

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Table 203: Immunity electromagnetic fields (life-supporting devices)


The Accu-Chek Spirit Combo insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Accu-Chek Spirit Combo insulin pump should assure that it is used in such an environment.

Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Accu-Chek Spirit Combo insulin pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Immunity test standard IEC 60601 test level Compliance level

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz

V1 = 10 Vrms

150 kHz to 80 MHz

Radiated RF

IEC 61000-4-3

10 V / m

80 MHz to 800 MHz

Recommended separation distance d = 1.2 P 150 kHz to 80 MHz

E1 = 10 V / m

80 MHz to 800 MHz d = 1.2 P 80 MHz to 800 MHz c)

Radiated RF

IEC 61000-4-3

10 V / m

800 MHz to 2.5 GHz d) E2a = 2 V / m for

2.3 GHz to 2.5 GHz e) E2b = 10 V / m for

800 MHz to 2.3 GHz and 2.5 to 2.7

da = 11.7 P 2.3 GHz to 2.5 GHz db = 2.3 P 800 MHz to 2.3 GHz and

2.5 GHz to 2.7 GHz

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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)

Interference may occur in the vicinity of equipment marked with the following symbol:

Note At 80 MHz and 800 MHz, the higher frequency range applies.

Note These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a ) Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Accu-Chek Spirit Combo insulin pump is used exceeds the applicable RF compliance level above, the Accu-Chek Spirit Combo insulin pump or the device, which contains it should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device containing the Accu-Chek


b ) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V / m.

c ) Possible shorter distances outside ISM bands are not considered to have a better applicability of this table.

d ) Exclusion band for Bluetooth ® ISM 2.4 GHz communication channel e ) Compliance band for the system equipment

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Table 205: Recommended separation distances (life-supporting devices)

Recommended separation distances between portable and mobile RF communications equipment and the

Accu-Chek Spirit Combo insulin pump.

The Accu-Chek Spirit Combo insulin pump is intended for use in electromagnetic environments in which radiated RF disturbances are controlled. The customer or the user of the Accu-Chek Spirit Combo insulin pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Accu-Chek

Spirit Combo insulin pump as recommended below, according to the maximum output power of the communication equipment.

Rated maximum output power of transmitter

(W)

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHz d = 1.2 P

80 MHz to 800 MHz d = 1.2 P

800 MHz to 2.3 GHz db = 2.3 P

2.3 GHz to 2.5 GHz da = 11.7 P

0.01

0.1

1

10

100

12 cm

38 cm

1.2 m

3.8 m

12 m

12 cm

38 cm

1.2 m

3.8 m

12 m

23 cm

73 cm

2.3 m

7.3 m

23 m

118 cm

373 cm

11.8 m

37.3 m

118 m

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

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Note At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Note An additional factor of 10 / 3 is used in calculating the recommended separation distance to decrease the likelihood that mobile / portable communications equipment could cause interference if it is inadvertenly brought into the vicinity of the user.

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Accuracy of flow rate for the Accu-Chek 3.15 ml plastic cartridges and the Accu-Chek Spirit 3.15 ml cartridge system

Trumpet curve plotted from data after the end of the stabilization period

The trumpet curve shows the accuracy of the delivery rate in relation to the observation period.

minimum measured variation

maximum measured variation

overall percentage error

20

15

10

–10

–15

5

0

–5

3.81

0.82

0.22

A= –1.38

–3.17

–2.58

–8.17

–20

0

–0.18

–2.18

–0.81

–1.97

-1.02

-1.79

60 120 180 240 300 360 420 480 540 600 660 observation window duration (min)

720 780 840 900 960

The maximum deviation of the delivered amount (overall mean percentage error of flow rate) for U100 insulin is ≤ ±5 %*, where your Accu-Chek Spirit Combo insulin pump is located ≤ 1 m (3.3 feet) above / below the infusion site.

* The measurements were made at a medium basal rate of 1.0 U / h according to IEC 60601-2-24:2012 with an Accu-Chek Tender infusion set PC 17 / 110 at room temperature.

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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.

real flow

target flow

0.012

0.010

0.008

0.006

0.004

0.002

0.000

0 120 240 360 480 600 720 time (min)

840 960 1080

0.01 ml is equivalent to 1 U (U100 insulin)

1200 1320 1440

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Accuracy of flow rate for the Accu-Chek 3.15 ml plastic cartridges and the Accu-Chek Spirit 3.15 ml cartridge system at minimum hourly basal rate of 0,05 U/h

Trumpet curve plotted from data after the end of the stabilization period.

The trumpet curve shows the accuracy of the delivery rate in relation to the observation period.

minimum measured variation

maximum measured variation

overall percentage error

0

–50

–100

100

50

68.0000

22.0000

11.2000

–86.0000

–39.2000

5.0909

–20.7273

2.3158

–12.4211

–8.0000

–150

–200

–250

–300

–292.0000

–350

0 60 120 180 240 300 360 420 480 540 600 660 observation window duration (min)

720 780 840 900 960

The maximum deviation of the delivered amount (overall mean percentage error of flow rate) for 100U insulin is ≤ 30%*.

It is in the responsibility of the health care professional to decide whether the accuracy of the flow rate is sufficient for the according patient.

* The measurements were made at the minimum rate of 0,05U/h according to IEC 60601-2-24:2012 with an Accu-Chek Tender infusion set PC 17 / 110 at room temperature.

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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.

real flow

target flow

0.002

Bolus

For U100 insulin the maximum deviation of a maximum bolus (25 U and 50 U) is ≤ ±5 % and the maximum deviation of a minimum bolus (0.1 U) is ≤ ±30 %*.

0.000

–0.002

0.01 ml is equivalent to 1 U (U100 insulin)

1455 1485 1515 1545 1575 1605 1635 1665 1695 1725 1755 1785 1815 1845 1875 1905 1935 1965 1995 2025 2055 2085 2115 2145 2175 2205 2235 2265 2295 2325 2355 2385 2415 2445 2475 2505 2535 2565 2595 2625 2655 2685 2715 2745 2775 2805 2835 2865 2895 2925 time (min)

184 * The measurements were made according to IEC 60601-2-24:2012 with an Accu-Chek Rapid-D Link infusion set 12 / 100 at room temperature.

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Appendix B: Configuration parameters

Typical range available on the pump and standard parameter settings*

Basal rate

Hourly basal rate + max. TBR

(hourly basal rate combined with temporary basal rate, max. increase)

Default basal rate

Hourly basal rate increment

62.5 U / h

0 U/h

0.01 U/h (up to 1.00 U / h),

0.05 U/h (up to 10.0 U / h) and

0.1 U/h (up to 25.0 U / h)

Hourly basal rates


TBR increases or decrease in increments of

TBR duration

TBR duration increments

Basal rate profiles available

Basal rate lock

* Note: These factory settings may vary in some countries and depend on the changes you, your doctor or healthcare team make using your insulin pump or pump programming software for healthcare professionals.

25.0 U / h

0–250 %

10 % max. 24 h

15 min

5 off

Maximum parameter range adjustable with the appropriate Accu-Chek PC software max. amount: 0–250.0 U / h

0–50 U/h

0.0 U/h, 0.05 –25.0 U / h max. amount: 0–25.0 U / h

0–500 %

10 %

15 min–50 h

15 min, 30 min, 1 h

1–5 on or off

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Bolus

Bolus amount per bolus delivery bolus amount increments for Quick Bolus bolus amount increments for Standard Bolus bolus duration (Extended Bolus, Multiwave Bolus) bolus duration increments

Prime volume

Display orientation

Display contrast

User menus

Volumes (for beeps)

Alarm signals turned on


Maximum parameter range adjustable with the appropriate Accu-Chek PC software

25.0 U

0.5 U

0.1 U max. 12 h

15 min

25.0 U standard or inverted

7 steps

3 (STANDARD, ADVANCED or

CUSTOM) off, 4 steps beeps, vibrations or both max. amount: 0–25.0 U

0.1 U, 0.2 U, 0.5 U, 1.0 U or 2.0 U

15 min–50 h

15 min, 30 min, 1 h max. amount: 0–50.0 U

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Battery type

Key Lock

Automatic off

Reminder

Time format

Date format

Bluetooth ®

* Note: These factory settings may vary in some countries and depend on the changes you, your doctor or healthcare team make using your insulin pump or pump programming software for healthcare professionals.

man_05504929001_H_en-us.indb 187


AA (LR6) ALKALINE, AA (FR6)

LITHIUM or AA (HR6) NiMH rechargeable battery

On or Off

On (1–24 h) or Off (0 h)

On or Off

If On: occurs once or every day

European (24 h) or

American (12 h, am / pm)

European (dd.mm.yy) or

American (mm / dd / yy)

On or Off

Maximum parameter range adjustable with the appropriate Accu-Chek PC software

B

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188

Appendix C: Sterile products and accessories

Cartridges

Name

Accu-Chek Spirit 3.15 ml cartridge system

Accu-Chek 3.15 ml plastic cartridge

Comments

Plastic cartridges are single-use items only. Do not re-use cart ridges.

Refer to the instructions for use of the insulin you are using for information on the acceptable temperature range for storage and handling.

The insulin remains stable in the cartridge:

Humalog ® : 6 days

Apidra ® : 2 days

NovoLog ® : 6 days




Accu-Chek infusion sets

Name

Accu-Chek Tender

Accu-Chek Ultraflex

Accu-Chek Rapid-D

Comments

All Accu-Chek infusion sets are available with various tubing and cannula lengths. All infusion sets listed on the left are compatible with the Accu-Chek Spirit Combo insulin pump. Discuss with your doctor and /or healthcare team to find the infusion set that fits you best.

For recommendations on how long you may use the same infusion set see the information material provided with this product.

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C

Accessories

Name

Adapter

Battery cover

Comments

Adapter and battery cover are part of the Accu-Chek Spirit Combo service pack and the Accu-Chek

Spirit Combo service pack small.

Replace your adapter and battery cover every 2 months.

Name Comments

Batteries

One 1.5 V, AA alkaline

(LR6) battery compliant with IEC 60086-1 or one lithium (FR6) battery compliant with IEC

60086-4. The Accu-Chek

Spirit Combo insulin pump was successfully tested with a Varta Power One alkaline LR6, AA, 1.5 V battery which complies with IEC 60086-1 and with an Energizer Ultimate

Lithium FR6, AA, 1.5 V battery which complies with IEC 60086-4. The battery should have a minimum capacity of 2500 mAh.

For battery lifetime see p. 170

Lifetime of battery

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Name Comments

Rechargeable batteries

One 1.5 V, AA alkaline

(LR06) battery compliant with IEC 60086-1 or one lithium (FR06) battery compliant with IEC

60086-4. The Accu-Chek

Spirit Combo insulin pump was successfully tested with a Varta Power One alkaline LR06, AA, 1.5 V battery which complies with IEC 60086-1 and with an Energizer Ultimate

Lithium FR06, AA, 1.5 V battery which complies with IEC 60086-4. The battery should have a minimum capacity of 2500 mAh.

For battery lifetime see p. 170

Lifetime of battery

Rechargeable batteries are not provided by Roche Diabetes Care,

Inc. Only use a battery charger officially recommended by the battery manufacturer.

Name

Carrying systems

Accu-Chek PC configuration software

Accu-Chek Spirit Combo quick reference guide

Comments

All Accu-Chek Spirit Combo and

Accu-Chek Spirit carrying systems are compatible with the Accu-Chek

Spirit Combo insulin pump. Roche

Diabetes Care, Inc. offers a wide range of carrying system solutions to best fit your lifestyle.

Check with your Accu-Chek

Customer Care for the availability of appropriate pump programming software.

This is a convenient pocket size reference that you may take with you to assist with your insulin pump questions.

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Appendix D: Abbreviations

Abbreviation Meaning approx.

Approximately

BRP Basal rate profile h

IEC

IR kPa

LCD

LED

NiMH

PC

Hour (s)

International Electrotechnical Commission

Infrared

Kilopascal

Liquid Crystal Display

Light Emitting Diode for infrared communication with e.g. a PC

Nickel Metal Hydrid (used with rechargeable batteries)

Personal Computer

Abbreviation Meaning sec.

Seconds

TBR

U

U / h

U100 dd.mm.yy

mm.dd.yy


International Units in context with biological effectiveness of a certain insulin amount

Amount of International Units of insulin delivered per hour

This is the insulin concentration. Each milliliter of liquid contains 100 International

Units of insulin

European date format: day.month.year

American date format: month.day.year

D

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192

Appendix E: Beeps and melodies

Acoustic Signals

All of the functions of the Accu-Chek Spirit Combo insulin pump are supported by acoustic signals. The acoustic signals are beeps.

Sound Function

Duration for very short sound = 31.25 ms ±20 %

Duration for short sound = 62.5 ms ±20 %

Duration for medium sound = 93.75 ms ±20 %

Duration for long sound = 125.0 ms ±20 %

Duration for short pause = 125.0 ms ±20 %

Duration for medium pause = 218.75 ms ±20 %

Duration for long pause = 500.0 ms ±20 %

UP KEY

Frequency: 3131 Hz ±5 %

Duration: Short sound

Sound Function

DOWN KEY



MENU KEY



NAVIGATION BACKWARD

(MENU + UP KEY)



EXECUTE FUNCTION (OK KEY)

Frequency: 2090 Hz ±5 %, 2486 Hz ±5 %

Duration: 2 × short sound

CANCEL FUNCTION

Frequency: 2486 Hz ±5 %, 2090 Hz ±5 %

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Sound Function

BASE STATE RUN (KEYS UNLOCKED)


Duration: Short sound, short pause, short sound, short pause, short sound

BASE STATE RUN (KEYS LOCKED)


Duration: Short sound, short pause, short sound, short pause, short sound

BASE STATE STOP (KEYS UNLOCKED)


Duration: Long sound, short pause, long sound, short pause, long sound

BASE STATE STOP (KEYS LOCKED)


Duration: Long sound, short pause, long sound, short pause, long sound

Sound

+

+

Function

CARTRIDGE CONTENT ≤20 U

Frequency: f1 = 2090 Hz ±5 %, f2 = 2486 Hz ±5 %, f3 = 2789 Hz ±5 %

Duration: f1 short sound, f2 short sound, long pause, f3 medium sound, short pause, f3 medium sound, short pause, f3 medium sound

20 U < CARTRIDGE CONTENT ≤50 U


Duration: f1 short sound, f2 short sound, long pause, f3 medium sound, short pause, f3 medium sound

E

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Sound

+

+

Function

50 U < CARTRIDGE CONTENT ≤100 U


Duration: f1 short sound, f2 short sound, long pause, f3 medium sound

100 U < CARTRIDGE CONTENT


Duration: f1 short sound, f2 short sound, long pause, f3 long sound

SYSTEM TEST SUCCESSFUL

Frequency: 1043 Hz ±5 %, 1314 Hz ±5 %,

1563 Hz ±5 %,

2090 Hz ±5 %

Duration: 4 × long sound

Sound Function

COPY BASAL RATE

Frequency: 2486 Hz ±5 %, 3131 Hz ±5 %,

2486 Hz ±5 %


TEMPORARY BASAL RATE ACTIVE


Duration: Short sound, short pause, short sound

STOP WARNING


Duration: Long sound, short pause, long sound

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Sound Function

Reminder (REPEATING SEQUENCE)

Frequency: f1 = 1043 Hz ±5 %, f2 = 1850 Hz ±5 %

Duration: f1 medium sound, short pause, f2 medium sound, short pause, f1 medium sound, medium pause, f2 medium sound

Repeating

Interval: 3000.0 ms ±20 %

WARNING (REPEATING SEQUENCE)


Duration: f1 medium sound, short pause, f2 medium sound, short pause, f1 medium sound, medium pause, f2 medium sound, short pause, f2 medium sound

Repeating


Sound Function

ERROR (REPEATING SEQUENCE)


Duration: f1 medium sound, short pause, f2 medium sound, short pause, f1 medium sound, medium pause, f2 medium sound, short pause, f2 medium sound, short pause, f2 medium sound

Repeating


UPPER LIMIT REACHED

Frequency: 2486 Hz ±5 %, 3131 Hz ±5 %,

2486 Hz ±5 %, 3131 Hz ±5 %


LOWER LIMIT REACHED

Frequency: 2090 Hz ±5 %, 2486 Hz ±5 %,

2090 Hz ±5 %, 2486 Hz ±5 %


E

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Sound

+

+

+

+

+

Function

OK KEY PRESSED



CHANGED TO BASE STATE RUN BY OK KEY

(KEYS UNLOCKED)

Sequence: A12, long pause, A14

CHANGED TO BASE STATE RUN BY OK KEY

(KEYS LOCKED)


CHANGED TO BASE STATE STOP BY OK

KEY (KEYS UNLOCKED)


CHANGED TO BASE STATE STOP BY OK

KEY (KEYS LOCKED)


CHANGED TO BASE STATE STOP BY

CANCELLATION OF FUNCTION


Sound Function

INITIAL POINT (SUBMENU, VALUE)


Duration: Short sound, short pause, short sound

SUPERVISOR SEQUENCE (GENERATED BY

SUPERVISOR)

Frequency: 2630 Hz ±10 %, 95 ms ±10 %

Pause: 95 ms ±10 %

Frequency: 2630 Hz ±10 %, 95 ms ±10 %

Pause: 95 ms ±10 %

Frequency: 2630 Hz ±10 %, 95 ms ±10 %

Pause: 200 ms ±10 %

Frequency: 2630 Hz ±10 %, 95 ms ±10 %

Pause: 95 ms ±10 %

Frequency: 2630 Hz ±10 %, 95 ms ±10 %

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Tactile Signals

Dedicated functions of the Accu-Chek Spirit Combo insulin pump are supported by tactile signals additionally. The tactile signals are vibrations which are generated by a vibra motor.

Signal Function

SHORT VIBRATION

Duration short vibration =

109.375 ms ±5 %

MEDIUM VIBRATION

Duration medium vibration =

203.125 ms ±5 %

LONG VIBRATION

Duration long vibration = 281.25 ms ±5 %

Signal Function

WARNING AND REMINDER

(REPEATING SEQUENCE)

Duration vibration = 1062.5 ms ±5 %

Duration pause = 2125.0 ms ±5 %

(Repeating interval = 3187.5 ms ±5 %)

ERROR (REPEATING SEQUENCE)

Duration vibration = 531.25 ms ±5 %

Duration pause = 1062.5 ms ±5 %

(Repeating interval = 1593.75 ms ±5 %)

E

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198

Appendix F: Symbols

Display Symbols

Icon Meaning

Basal Lock OFF

Basal Lock ON

Basal Rate

Basal Rate Total

Battery Empty

Battery Low

Beep Volume

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Icon Meaning

Bluetooth ® ON

Bluetooth ® Settings

Bluetooth ® in Remote control mode

Beep Test

Cartridge Empty

Cartridge Full

Cartridge Low

OK

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Icon Meaning

Clock

Data Transfer menu

Data Transfer (to start screen)

Data Transfer running

Date

Date Format EU

Date Format US

Display contrast

Extended Bolus

Key Lock OFF

Icon man_05504929001_H_en-us.indb 199

F

Meaning

Key Lock ON

Pump timer (Call for update)

Menu Settings

Multiwave Bolus

Multiwave Bolus Immediate

My Data

Pairing Failed

Pairing Successful

Priming

Progress Bar

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Icon

200 man_05504929001_H_en-us.indb 200

Meaning

Pump Settings

Reminder

Reminder Everyday

Reminder OFF

Reminder Settings

Reminder Single

Display orientation

Beep

Beep and Vibration

Standard Bolus

Icon Meaning

Stop

Total


Therapy Settings

Time and Date Settings

Units

Units per hour

Vibrations

Error

Warning

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General Symbols

Icon Meaning

Consult instructions for use

Caution, refer to safety-related notes in the instructions for use accompanying this product.

Follow instructions for use

Temperature limitation (store at)

Use only once

Use by

Sterilized using ethylene oxide

Sterilized using irradiation

Icon man_05504929001_H_en-us.indb 201

Meaning

Sterilized using aseptic processing techniques

Manufacturer

Date of manufacture

Catalogue number

Batch code

Serial number

Global Trade Item Number

Recommended battery

201

F

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Icon

202 man_05504929001_H_en-us.indb 202

Meaning

Keep away from sunlight

Keep dry

Do not use if package is damaged

Recycling

Do not throw away

Flammable

Admissible humidity range

Admissible air pressure range

Fragile – handle with care!

Icon Meaning

Bluetooth ® wireless technology

Electronic device of type BF according to the standard

IEC 60601-1. Protection against electrical shock.

Non-ionizing radiation

The FCC ID (Federal

Communications Commission

Identification) indicates that the radio frequency equipment has passed the equipment authorization process for the

United States of America.

Federal law (USA) restricts this device to sale by or on the order of a physician.

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F

Icon Meaning

Symbol for protection against the effect of temporary immersion in water (up to 60 minutes and

2.5 meters [8 feet]), according to

IEC 60529.

Admissible temperature range during operation

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203

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Appendix G: Warranty and Declaration of Conformity

Limited Four-Year Warranty

Roche Diabetes Care, Inc. warrants the ACCU-CHEK ® Spirit

Combo insulin pump (“insulin pump”) against defects in materials and workmanship for a period of four (4) years from the date of purchase. Proof of purchase date may be required. This warranty does not include supplies and accessories, including but not limited to, cartridges, batteries, or infusion sets. During the warranty period, Roche Diabetes Care, Inc. will 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 replacement. This warranty applies only to new devices. In the event an insulin pump is replaced, the warranty period will not be extended.

Declaration of Conformity

Roche hereby declares that the Accu-Chek Spirit Combo insulin pump conforms with the basic requirements and other relevant regulations of the European Directive 1999/5/EC on radio and telecommunications terminal equipment (R&TTE). The conformity declaration may be found at the following Internet address: http://declarations.accu-chek.com

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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 Roche Diabetes Care, Inc.

3. If damage results from a force majeure or other event beyond the control of Roche Diabetes Care, Inc.; 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 ROCHE

DIABETES CARE, INC. 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.

No warranty of merchantability or fitness for a particular purpose, if any is implied from the sale of the insulin pump, shall exist for a longer duration than four years from the date of purchase.

Some jurisdictions do not allow limitations on how long an implied warranty will last or the exclusion of incidental or consequential damages, so the above limitation and exclusion may not apply to you. This warranty gives you specific legal rights, which may vary by jurisdiction.

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Glossary

Adapter

The adapter connects the cartridge and infusion set. It has 2 seals and forms an efficient seal for the cartridge compartment of your Accu-Chek Spirit Combo insulin pump. The 2 small vents on the adapter allow the equalization air pressure.

Automatic Off

Automatic Off is a safety feature that stops insulin delivery and triggers an error if no keys are pressed within a programmed time period in RUN mode. See the entry in chapter 5 Persona- lizing your pump.

Basal rate

This is the amount of insulin delivered per hour that is required to cover your basic insulin needs. In insulin pump therapy, your basal rate is determined together with your doctor or healthcare team and can be adjusted to meet your individual physiological needs throughout the day. Your basal rate is delivered by your

Accu-Chek Spirit Combo insulin pump according to the curve of your personal basal rate profile or profiles.

Basal rate profile

Your Accu-Chek Spirit Combo insulin pump offers you the option of delivering up to 5 different basal rate profiles in order to easily meet your changing insulin needs (for example during the week rather than at the weekend). A basal rate profile consists of

24 programmed hourly basal rates.

Basal rate total

The sum of all 24 hourly basal rates in one basal rate profile is called the (daily) basal rate total.

Bluetooth ® wireless technology

The term Bluetooth ® refers to a wireless technology that allows digital devices to transfer data at high speed. This technology is common in many portable devices such as portable PCs, Personal

Digital Assistants and mobile telephones.

Bolus

The amount of insulin delivered (in addition to the basal rate) to cover the intake of food and to correct high blood glucose levels.

The bolus amount is determined by your doctor or healthcare team’s guidelines, your blood glucose level, your food intake and your activity level.

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Carrying system

A wide variety of carrying systems made of different materials are specially designed to suit your individual needs while wearing your Accu-Chek Spirit Combo insulin pump.

Cartridge

The insulin reservoir of your Accu-Chek Spirit Combo insulin pump. It holds 3.15 ml (315 U) of rapid-acting insulin.

Cartridge compartment

The chamber in your Accu-Chek Spirit Combo insulin pump for the cartridge.

Daily insulin total

The total amount of insulin delivered (basal rate plus boluses) delivered in a 24-hour day, beginning at midnight. This amount does not include any insulin needed for the priming of infusion sets.

Diabetes manager

This is a diabetes management device that enables you to measure your blood glucose level, manage your blood glucose data, and get bolus advice. It also enables remote control of your

Accu-Chek Spirit Combo insulin pump, using Bluetooth ® wireless technology.

Factory settings

Your Accu-Chek Spirit Combo insulin pump is provided by Roche

Diabetes Care, Inc. with a standard configuration (factory settings). These settings can be adapted to your individual needs directly on your Accu-Chek Spirit Combo insulin pump or by using the Accu-Chek insulin pump configuration software.

Hourly basal rate

An hourly basal rate is the amount of insulin delivered by your

Accu-Chek Spirit Combo insulin pump for each hour.

Infusion set

Infusion sets connect your Accu-Chek Spirit Combo insulin pump to your body. The insulin is delivered from the cartridge through the infusion set tubing and cannula or needle into your subcutaneous tissue. Infusion sets can be disconnectable or non-disconnectable.

Infusion site

The place where the infusion set cannula or needle is inserted into your subcutaneous tissue to deliver insulin.

Insulin

A hormone that helps cells transform glucose into energy. Insulin is produced in the beta cells of the pancreas (also called islets of

Langerhans).

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Insulin (rapid-acting)

A type of insulin created using recombinant DNA technology.

The onset time of insulin analogue is shorter than the onset time of regular insulin.

IPX8 according to IEC 60529

Protection against the effects of temporary immersion in water.

Ingress of water in quantities causing damage is not possible when the device is temporarily immersed in water under standardized conditions (maximal 60 minutes a day and

2.5 meters [8 feet]).

Luer-lock connector

A standardized fitting at the end of the infusion set which allows to tightly connect the infusion set and cartridge through the adapter.

Meter

See Diabetes manager.

Occlusion

An occlusion is a blockage which prevents the insulin from flowing correctly from the insulin pump into the body.

Personal settings

Your Accu-Chek Spirit Combo insulin pump must be programmed with your personal settings prior to starting insulin pump therapy.

Personal settings include the basal rate profile(s), the correct time and date and all other variable values which can be tailored to your individual needs on your Accu-Chek Spirit Combo insulin pump. Your personal settings can also be programmed using the

Accu-Chek 360° configuration software.

Priming

Process of filling the tubing with insulin and pushing any air bubbles out.

Rapid-acting insulin

See Insulin (rapid-acting).

RUN

During normal use, your Accu-Chek Spirit Combo insulin pump is in RUN mode and insulin is continuously delivered. Boluses,

Temporary Basal Rates and almost all functions can be programmed from RUN mode.

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RUN screen

The RUN screen is the starting point for all functions which can be accessed while your Accu-Chek Spirit Combo insulin pump delivers insulin. Your Accu-Chek Spirit Combo insulin pump displays the RUN screen during normal use when no programming is being performed. The time, current hourly basal rate, selected basal rate profile and all currently activated functions appear on the RUN screen.

Settings

Settings are individually programmable values and parameters that affect the way your Accu-Chek Spirit Combo insulin pump works.

Scrolling

Scrolling allows a fast and easy programming of a range of values.

STOP

When your Accu-Chek Spirit Combo insulin pump is in STOP, it does not deliver any insulin. The insulin delivery is only stopped if an error occurs or if your Accu-Chek Spirit Combo insulin pump is put into a necessary STOP, (e.g. when changing the cartridge, adapter or infusion set or for data transfer). Functions such as

Extended Bolus or Temporary Basal Rate are interrupted by putting your Accu-Chek Spirit Combo insulin pump into STOP.

STOP screen

The STOP screen is the starting point for all functions that require that your Accu-Chek Spirit Combo insulin pump does not deliver insulin.

Temporary Basal Rate

Temporary increase or decrease of your basal rate profile in percentages (from 0–250 %) to match changing insulin needs due to increased or decreased activity level, illness or stress.

U100

This is the insulin concentration. Each milliliter of liquid contains

100 International Units of insulin. Your insulin pump has been developed exclusively for delivery of U100 rapid-acting insulin.

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Index

A

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14, 144, 189

ADVANCED user menu . . . . . . . . . . . . . . . . . . . . . . . . . . 94, 114

Air bubbles . . . . . . . . . . . . . . . . . . . . . . . . . . 14, 36, 43, 44, 167

Aircraft . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57, 129, 135

Alarm data menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Alarm signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 110, 166

Automatic Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123, 154

B

Basal rate profile . . . . . . . . . . . . . . . . . . . . . 115, 125, 185, 191

Battery . . . . . . . . . . . . . . . 14, 20, 148, 170, 187, 189, 190, 198

Battery cover . . . . . . . . . . . . . . . . . . . . . . . . . . . 15, 20, 60, 189

Battery key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Beeps and melodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Beep volume . . . . . . . . . . . . . . . . . . . . . . . . 9, 52, 109, 145, 166

Blood glucose levels . . . . . . . . . . . . . . . . . . . . . . . 16, 19, 35, 71

Bluetooth ® connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Bluetooth ® function . . . . . . . . . . . . . . . . . . . . . . . . 57, 129, 130

Bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Bolus history . . . . . . . . . . . . . . . . . . . . 75, 77, 86, 100, 151, 170

Bolus increment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

C

Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Cleaning your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

Configuration parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

Contact with water . . . . . . . . . . . . . . . . . . . . . . . . . 61, 140, 141

CUSTOM user menu . . . . . . . . . . . . . . . . . . . . . . . . . . . 124, 125

D

Damage to your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . 39, 41

Display contrast . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Display orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

Display screens

Function screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Information screens . . . . . . . . . . . . . . . . . . . . . . . . . 7, 10, 11 navigating through . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

QUICK INFO screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 100

RUN screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

STOP screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Disposing of your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

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212

E

Electromagnetic immunity . . . . . . . . . . . . . . . . . . . . . . . . . . 177

Electromagnetic radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Emergency kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16, 138

Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29, 56, 115

Extended Bolus . . . . . . . . . 71, 78, 79, 81, 82, 92, 171, 186, 199

F

Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1, 2, 94

H

History of daily insulin totals . . . . . . . . . . . 19, 43, 102, 121, 170

Hourly basal rate . . . . . . . . . . . . . . . 5, 11, 31, 32, 166, 185, 207

I

Infection . . . . . . . . . . . . . . . . . . . . . 13, 46, 48, 52, 66, 138, 144

Infusion set . . . . . . . . . . . . . . . . . . . . . . 6, 42, 43, 44, 46, 51, 63

Inspecting your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Insulin delivery starting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 stopping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51, 98

K

Keylock . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3, 12, 107, 108, 187

Keys combining . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

L

Language selecting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95, 113

Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36, 37, 54, 63

Luer-lock connector . . . . . . . . . . . . . 37, 42, 63, 64, 65, 68, 173

M

Meter interaction with . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 pairing your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Multiwave Bolus . . . . . . . 71, 83, 84, 86, 92, 115, 171, 186, 199

P

Personalizing your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 93

Personal settings . . . . . . . . . . . . . . 17, 29, 47, 53, 92, 115, 143

Prime amount . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Priming . . . . . . . . . . . . . . . . . . . . . . . 43, 44, 121, 128, 168, 199

Pump settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Pump therapy interruption of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Q

Quick Bolus . . . . . . . . . 2, 10, 72, 73, 74, 75, 79, 120, 171, 186 man_05504929001_H_en-us.indb 212 01.06.2016 08:14:56

R

Reminders list of 164, 217

Reminder Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118, 200

Repair of your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

Rotating display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 4

S

Safety system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Scrolling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12, 76

Sport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Standard Bolus . . . 71, 72, 74, 75, 76, 77, 79, 83, 171, 186, 200

Status messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Status of your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3, 8

Sterile disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Sterile products . . . . . . . . . . . . . . . . . . 13, 52, 63, 70, 137, 139

STOP-warning confirming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 30, 52 turning off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Storing your pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Swimming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61, 140

Symbols

Display Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198

General Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

T

Tactile signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

Temporary Basal Rate . . . 87, 88, 89, 90, 91, 92, 150, 151, 171,

185, 191, 200, 216

Temporary Basal Rate history viewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Therapy settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Time and Date

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Time remaining (pump timer) . . . . . . . . . . . . . . . . . . . . . . . . 104

Transferring Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6, 105

Travelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Troubleshooting therapy-related issues . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

U

Unlocking Keylock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

W

Warning history viewing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

Warnings list of 147

213 man_05504929001_H_en-us.indb 213 01.06.2016 08:14:56

Warnings and errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 confirming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Wearing your pump carrying systems . . . . . . . . . . . . . . . . . . . . . . . . . 55, 56, 190 in hazardous areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

214 man_05504929001_H_en-us.indb 214 01.06.2016 08:14:56

Quick reference table for errors, warnings and reminders

Errors

No Error What you have to do

E1 CARTRIDGE EMPTY Change the cartridge.

E2

E3

E4

BATTERY EMPTY

AUTOMATIC OFF

OCCLUSION

Change the battery.

Put your Accu-Chek Spirit

Combo insulin pump into RUN if necessary.

Change the cartridge and infusion set. See section 2.6 to

2.9.

E5 END OF OPERATION

(“Backup” pumps only)

Arrange for immediate replacement of your Accu-Chek


Contact your healthcare professional for alternative insulin therapy options.

No Error What you have to do

E6 MECHANICAL ERROR See chapter 8.

E7 ELECTRONIC ERROR See chapter 8.

E8 POWER INTERRUPT See chapter 8.

E9 END OF OPERATION

(loan pumps only)

Arrange for immediate replacement of your Accu-Chek


Contact your healthcare professional for alternative insulin therapy options.

E10 CARTRIDGE ERROR See chapter 8.

E11 SET NOT PRIMED Prime your infusion set.

E12 DATA INTERRUPTED Restart the data transfer.

E13 LANGUAGE ERROR See chapter 8.

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Warnings

No Warning

W1

W2

CARTRIDGE LOW

BATTERY LOW

What you have to do

Change cartridge before it is completely empty.

Replace the battery as soon as possible.

Set the time and date.

W3 REVIEW TIME

W4 CALL FOR UPDATE Contact your Accu-Chek

Customer Care.

W5 PUMP TIMER

(“Backup” pumps only)

In the MY DATA menu check for the remaining operation time under the menu PUMP TIMER.

Arrange for replacement of pump within the scheduled pump operation time.

No Warning What you have to do

W6

W7

TBR CANCELLED

TBR OVER


Combo insulin pump into RUN if necessary. Ensure the cancellation was intended and program a new Temporary

Basal Rate if necessary.

Decide whether a further

Temporary Basal Rate change is appropriate and program one if necessary.

W8 BOLUS CANCELLED Put your Accu-Chek Spirit

Combo insulin pump into RUN if necessary. Ensure that the cancellation was intended and program a new bolus if necessary.

216 man_05504929001_H_en-us.indb 216 01.06.2016 08:14:56

No Warning What you have to do

W9 LOANTIME WARNING In the MY DATA menu, check for the remaining insulin pump loan time under the menu PUMP

TIMER. Arrange for replacement of pump within the scheduled pump loan time.

W10 BLUETOOTH FAULT Re-do pairing procedure for insulin pump and Meter. See section 6.4 Troubleshooting the

Bluetooth ® connection in the

User’s Manual for detailed information.

Reminder

No Reminder

Reminder

What you have to do


Combo insulin pump into RUN if necessary.

Some reminders and warnings are country specific and may never occur on your pump.

217

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Bluetooth ® registration

Please note that in Italy and France Bluetooth ® wireless technology is for indoor use only.

RAH3

This device complies with part 15 of the FCC Rules. Operation is subject to the following 2 conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the

FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio / TV technician for help. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

218 man_05504929001_H_en-us.indb 218 01.06.2016 08:14:56

man_05504929001_H_en-us.indb 219

219

01.06.2016 08:14:56

220 man_05504929001_H_en-us.indb 220 01.06.2016 08:14:56

Your contact for assistance with and/or additional information about your Accu-Chek Spirit Combo insulin pump:

In US, distributed by:

Roche Diabetes Care, Inc.

Indianapolis, IN 46256, USA

Toll Free: 1-800-280-7801

ACCU-CHEK Customer Care Service Center: 1-800-688-4578 www.accu-chek.com

man_05504929001_H_en-us.indb 3 01.06.2016 08:14:56

The Bluetooth ® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by

Roche is under license. Other trademarks and trade names are those of their respective owners.

ACCU-CHEK, ACCU-CHEK SPIRIT COMBO, ACCU-CHEK TENDERLINK,

ACCU-CHEK FLEXLINK, ACCU-CHEK RAPID-D and ULTRAFLEX are trademarks of Roche.

© 2016 Roche Diabetes Care

In US, distributed by:

Roche Diabetes Care, Inc.

Indianapolis, IN 46256, USA

Toll Free: 1-800-280-7801

Manufacturer:

Roche Diabetes Care GmbH

Sandhofer Strasse 116

68305 Mannheim, Germany www.accu-chek.com

made in Germany man_05504929001_H_en-us.indb 4 01.06.2016 08:14:56

Accu-Chek Combo system User's Manual

User’s Manual

Accu-Chek

®

Spirit Combo Insulin pump

Your insulin pump

Menu key

OK key

Up key

Down key

Cartridge compartment with cartridge

Adapter Luer-lock connector of the infusion set

Pump details and accessories

Battery cover Battery

Infrared window

(next to battery cover)

Battery key

Adapter

Cartridge compartment

Cartridge plunger

Cartridge

Piston rod End plate

Overview of the ADVANCED user menu

Overview of the STANDARD and CUSTOM user menus

Dear user of the Accu-Chek Spirit Combo insulin pump,

1 Understanding your new system

2 Getting started

3 Using your pump in daily life

19

55

1

4 Boluses and Temporary Basal Rates

5 Personalizing your pump

71

93

6 Using the Accu-Chek Spirit Combo insulin pump with the Meter 127

7 Care and Maintenance

8 Warnings and errors

145

137

9 Troubleshooting

165

Understanding your new system

1.1 Overview

1.1.1 Summary of features

1.2 Display and sounds

1.2.1 Backlight

1.2.2 Rotating display

1.2.3 Display screens

1.2.4 Navigating through the screens

1.2.5 Status messages and alarm signals

1.3 Keys and key combinations

1.3.1 Combining keys

1.3.2 Scrolling

1.3.3 Locking the keys

1.4 Accessories and disposables

1.4.1 Sterile disposables

1.4.2 Adapter

1.4.3 Battery

1.5 Emergency kit

1.6 General safety information

Getting started

2.1 Before you begin

2.2 Inserting the battery

2.3 Start-up process

2.4 Setting the time and date

2.5 Your basal rate profile

2.5.1 Programming your basal rate profile

2.6 Connecting the cartridge, adapter and infusion set

2.7 Inserting the cartridge

2.8 Priming the infusion set

2.9 Positioning the infusion set

2.9.1 Preparing the infusion site

2.9.2 Inserting the cannula

2.9.3 Connecting the insulin pump

2.10 Starting insulin delivery

2.11 Stopping insulin delivery

2.12 General safety information

Using your pump in daily life

3.1 Wearing your pump