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Protect from heat and sunlight

For single use only

Does not contain pyrogen

Does not contain PVC

Recycling

Do not throw away

Do not use if the package is damaged

Flammable

See

Electronic device of type BF according to the standard IEC 60601-1. Protection against electrical shock.

Symbol for protection against the effect of temporary immersion in water [up to 60 minutes and 2.5 meters (8 feet)], according to IEC 60529.

Marking of conformity according to the European Medical Device Directive MDD 93/42/EEC with the number of the notified body.

Federal law (USA) restricts this device to sale by or on the order of a physician.

Federal Communications Commission, part 15 on radio frequency devices.

Manufacturer

Appendixes

ACCU-CHEK Spirit Insulin Pump

Page 185

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Contents

Pump User Guide Dear ACCU-CHEKSpirit insulin pump owner How to use this guide Intended use of your ACCU-CHEK Spirit insulin pump Guarantee Contents Boluses and Temporary Basal Rates Appendix C Abbreviations Appendix E Vibrations Appendix F Symbols183 This page left blank intentionally To malfunction ACCU-CHEK Spirit Insulin PumpDisplay Hint BacklightPump Support at 1-800-688-4578 immediately Key in areas of poor lighting as this will Keys and Key Combinations Key Combinations One beep in Stop modeExiting menus, function screens, Information screens without saving RUN Screen Locking Keys Using KeyLock FeatureScreens Quick Info Screen Information, Function, and Setup ScreensStop Screen Follow the steps below to navigate through the screens Status Screen Messages, Beeps, and Vibrations To Turn Off the STOP-Warning Alarm SignalsSTOP-Warning Sterile Products Accessories and DisposablesOr void your warranty Cartridges Out of the reach of children Recommended Possible Use only Adapter Battery Always make sure that you remove the battery if your Battery Cover Emergency Kit Battery Key This page left blank intentionally 32 for more information Inserting or Changing the Battery Press d to move to the Stop Your ACCU-CHEK screen Follow the steps below Pump begins its start-up process Use the cover to gently push the battery all the way System Check Start-Up Process Put the pump in Stop mode ACCU-CHEK logo appearsInsulin pump Pump Support at Contact Pump Support at Getting Started Since you may not receive the correct information for Insulin pump’s memory Setting Time and DateSettings are identical Follow the steps below to set the Time and Date Getting Started Team to understand how to use the pump Your Personal SettingsInsulin delivery Your correction bolus ratio Your Basal Rate Profile Programming Your Basal Rate Profile Follow the steps below If you want to undo the changes If you want to save the changes Copying an Hourly Basal Rate Basal Rate and Bolus Preparing the Cartridge Always handle the items with clean hands To fill a cartridge, have the following materials ready Filling the Cartridge Plunger Plunger rod Getting Started System components if needed These parts Connecting the Cartridge, Adapter, and Infusion SetHave the following materials ready Result in leakage Follow the instructions belowDo not over-tighten Use a soft cloth to dry the compartment Inserting the Cartridge Follow the steps below Cartridge volume decreases accordingly on the display Press f after correctly inserting the cartridge To your body Priming the Infusion Set Stop Stopping the Priming Process Infusion Site Preparation Infusion Site Selection Getting Started Healthcare team’s recommendations Healthcare team Wearing Your Pump Before UsingDuring insulin pump therapy Pocket knives, and coins Acceptable temperature range Pump if you have a cardiac pacemaker When Not to Wear Your PumpElectromagnetic Fields and Hazardous Areas If you have questions, contact Pump Support at Sports and ExerciseTraveling Accidental Contact with Water Your Insulin Pump and WaterDisconnect and take off your insulin pump Fog your display What to Do After Any Water ContactOther Liquids Starting Insulin Delivery Stopping Insulin Delivery Mode to continue insulin delivery STOP-Warning Interruption of Insulin Pump Therapy Short Interruption Put your pump in Stop modeResuming Insulin Pump Therapy For a long period of time Changing the Infusion Set Follow the steps below Using Your Pump Changing the Cartridge and Infusion Set Using Your Pump Standard Bolus Understanding BolusesYour pump can deliver three types of boluses Team check your personal settings Personal settingsInappropriate insulin delivery Insulin ratio and your correction bolus ratio Programming a Quick Standard Bolus Programming a Standard BolusThere are two ways to program a Standard Bolus RUN Cancelling a Quick Standard Bolus Using the a and s keys of your insulin pumpDuring programming the bolus amount blinks No bolus is delivered Programming a Menu-Guided Scroll Standard Bolus Set the bolus amount to 0.0 units. Press f to exit Cancelling a Menu-Guided Scroll Standard Bolus Boluses and TBRs Programming an Extended Bolus Follow the steps below If you want to deliver the bolus If you want to cancel the bolusAt any function screen you have three options to exit During bolus delivery Cancelling an Extended Bolus Boluses and TBRs Programming a MultiWave Bolus ACCU-CHEK Boluses and TBRs Set the total bolus amount to 0.0 units and press f Cancelling a MultiWave Bolus When your insulin pump is in Stop mode, it does not deliver Typically, a basal rate is set to 100%, but you can Programming a Temporary Basal Rate TBRInsulin pump therapy Press a or s to increase or decrease the basal rate If you want to save the changes TBR Over Alert Temporary Basal Rate delivery is interrupted Cancelling a Temporary Basal RateNo Temporary Basal Rate is delivered Insulin delivery Custom User Menu Advanced User Menu 100 Selecting a User Menu 101 102 New basal rate 103 Standard User Menu 104 Data Transfer 105 Setup for Data Transfer 106 Review the Bolus History Reviewing Pump DataEach Bolus History screen displays 107 108 Press d to move to the Information screen Press f to selectPress a or s to review the entries Press f to exit 109 Review the Alarm History 110 Review the History of Daily Insulin Totals 111 Review the Temporary Basal Rate History 112 Review the Time Remaining 113 Setup Menu StandardTurning KeyLock On or Off 114 115 116 Adjusting the Beep Volume 117 Setting Up Alarm SignalsBeep and vibrate 118 Automatic OffOr healthcare team 119 Battery Type 120 Display Orientation 121 By 180, the a and s keys will also reverse theirYour screen orientation 122 Alarm Clock See the section Alarm ClockAdvanced User Menu 123 Basal Rate Profiles 124 Check your personal settingsProgramming Additional Basal Rate Profiles 125 Selecting a Basal Rate Profile 126 127 Alarm ClockSet Single or Multiple Alarms 128 Turning Off the Alarm Clock 129 Setup Menu AdvancedTime Format You can set the date in the following formats American Date FormatEuropean 130 131 Bolus incrementMay cause inappropriate insulin delivery 132 Prime Quantity 133 Lock Basal Rate Profiles 134 LanguageTo choose a language, do the following 135 Your pump lets you adjust the display contrastDisplay Contrast 136 Custom User Menu 137 System Inspection ChecklistCare of Your ACCU-CHEK Spirit Insulin Pump 138 139 What to Do When You Drop Your Pump Disposal Storing Your ACCU-CHEK Spirit Insulin Pump Cleaning Your ACCU-CHEK Spirit Insulin Pump MaintenanceBattery Information Damage the pump 142 Repair 143 Troubleshooting 144 Therapy-Related IssuesTroubleshooting Table Problem Recommended Actions 145 Problem Recommended ActionsSingle use only 146 147 Alerts and Errors When you confirm A1 Cartridge LOW , E1 Cartridge Empty Confirming an Alert or ErrorFollow the steps below to confirm an alert or error 148 149 List of AlertsAlert A1 Cartridge LOW 150 Alert A2 Battery LOWAlert A3 Review Time and Date See the section Alarm Clock page 127 for more information Alert A4 Alarm ClockAlert A5 Pump Timer 151 152 Alert A6 TBR Cancelled Temporary Basal Rate Cancelled 153 Alert A8 Bolus CancelledAlert A7 TBR Over Temporary Basal Rate Over 154 List of ErrorsError E1 Cartridge Empty Battery is out of power. Replace it immediately Error E2 Battery DepletedGathered data might not be meaningful 155 Error E4 Occlusion Error E3 Automatic OFFYour doctor’s or healthcare team’s instructions 156 157 158 Error E5 END of Operation 159 Error E6 Mechanical Error 160 Error E7 Electronic Error 161 Error E8 Power Interrupt 162 Error E10 Cartridge ErrorError E11 SET not Primed 163 Error E12 Data Interrupted 164 Error E13 Language ErrorSee the section Data Transfer page 104 for more information 165 Appendix a Technical DataGeneral Technical Data 166 167 168 169 Technical Standards on Electromagnetic EmissionsCompliance KHz to 80 MHz MHz to E1 in V/m100 170 IEC Compliance Electromagnetic Technical Standards on Electromagnetic ImmunityTest Level 171 172 173 Accuracy of Flow Rate for Plastic Cartridges 174 Start-up graph over the stabilization period 175 176 Bolus≤ 177 Appendix B Configuration Parameters Basal Rate Maximum ParameterBolus 178 179 Typical Range Maximum Parameter Parameter Settings 180 Appendix C Abbreviations 181 Appendix D Beeps and MelodiesEach press 182 Appendix E VibrationsYour ACCU-CHEK Spirit insulin pump vibrates when 183 Appendix F SymbolsGeneral Symbols 184 185 Symbol Definition 186 187 188 Appendix G Sterile Products and AccessoriesName Comments 189 Appendix H Glossary Headset also known as cannula housing Factory settingsDaily insulin total Diabetes Data Management DDM RUN mode Luer-lock connectorInfusion site Insulin Stop mode SettingsTimeout Scrolling 194 Limited FOUR-YEAR Warranty 195 Index KeyLock 77-80Turning On 80-82 Turning Off 196 No. Error What You Need to Do Quick Reference Table for Errors200 197 No. Alert What You Need to Do Diagram of User MenusQuick Reference Table for Alerts Disetronic Medical Systems AG

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Models: insulin pump

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