Compliance, 169 | Accu-Chek insulin pump manual

Technical Standards on Electromagnetic Emissions

The standard concerning electromagnetic compatibility of medical equipment (IEC 60601-1-2) requires the concrete specification of the corresponding levels which refer to specified electromagnetic interferences. The following is Guidance and manufacturer’s declaration on electromagnetic emissions.

Emissions Test	Compliance	Electromagnetic Environment – Guidance
RF emissions	Group 1	The ACCU-CHEK Spirit insulin pump uses RF
CISPR11		energy only for its internal function.
		Therefore, its RF emissions are very low
		and are not likely to cause any interference
		in nearby electronic equipment.

RF emissions	Class B	The ACCU-CHEK Spirit insulin pump is
CISPR11		suitable for use in establishments, including
		domestic establishments and those directly
		connected to the public low-voltage power
		supply network that supplies buildings used
		for domestic purposes.

Harmonic	Not applicable
emissions
IEC 61000-3-2

Voltage	Not applicable
fluctuations/
flicker emissions
IEC 61000-3-3

Appendixes

169

ACCU-CHEK Spirit Insulin Pump

Image 170

Accu-Chek insulin pump manual Technical Standards on Electromagnetic Emissions, Compliance, 169

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 E Vibrations Appendix F Symbols183 Appendix C Abbreviations This page left blank intentionally To malfunction ACCU-CHEK Spirit Insulin PumpDisplay Pump Support at 1-800-688-4578 immediately BacklightHint Key in areas of poor lighting as this will Keys and Key Combinations Exiting menus, function screens, One beep in Stop modeKey Combinations Information screens without saving RUN Screen Locking Keys Using KeyLock FeatureScreens Quick Info Screen Information, Function, and Setup ScreensStop Screen Status Screen Messages, Beeps, and Vibrations Follow the steps below to navigate through the screens To Turn Off the STOP-Warning Alarm SignalsSTOP-Warning Sterile Products Accessories and DisposablesOr void your warranty Out of the reach of children Cartridges Use only Recommended Possible Adapter Battery Battery Cover Always make sure that you remove the battery if your Battery Key Emergency Kit This page left blank intentionally Inserting or Changing the Battery 32 for more information Follow the steps below Press d to move to the Stop Your ACCU-CHEK screen Use the cover to gently push the battery all the way Pump begins its start-up process Insulin pump Put the pump in Stop mode ACCU-CHEK logo appearsSystem Check Start-Up Process 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 Insulin delivery Your Personal SettingsTeam to understand how to use the pump Your correction bolus ratio Your Basal Rate Profile Programming Your Basal Rate Profile Follow the steps below If you want to save the changes If you want to undo the changes Copying an Hourly Basal Rate Basal Rate and Bolus Always handle the items with clean hands Preparing the Cartridge Filling the Cartridge To fill a cartridge, have the following materials ready 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 Inserting the Cartridge Use a soft cloth to dry the compartment Follow the steps below Cartridge volume decreases accordingly on the display Press f after correctly inserting the cartridge Priming the Infusion Set To your body Stop Stopping the Priming Process Infusion Site Selection Infusion Site Preparation Getting Started Healthcare team Healthcare team’s recommendations During insulin pump therapy Before UsingWearing Your Pump 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 Mode to continue insulin delivery Stopping Insulin Delivery STOP-Warning Interruption of Insulin Pump Therapy Resuming Insulin Pump Therapy Put your pump in Stop modeShort Interruption 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 Inappropriate insulin delivery Personal settingsTeam check your personal settings 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 During programming the bolus amount blinks Using the a and s keys of your insulin pumpCancelling a Quick Standard Bolus No bolus is delivered Programming a Menu-Guided Scroll Standard Bolus Cancelling a Menu-Guided Scroll Standard Bolus Set the bolus amount to 0.0 units. Press f to exit 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 Cancelling an Extended Bolus During bolus delivery Boluses and TBRs Programming a MultiWave Bolus ACCU-CHEK Boluses and TBRs Cancelling a MultiWave Bolus Set the total bolus amount to 0.0 units and press f 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 Advanced User Menu Custom User Menu Selecting a User Menu 100 101 New basal rate 102 Standard User Menu 103 Data Transfer 104 Setup for Data Transfer 105 106 Each Bolus History screen displays Reviewing Pump DataReview the Bolus History 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 Review the Alarm History 109 Review the History of Daily Insulin Totals 110 Review the Temporary Basal Rate History 111 Review the Time Remaining 112 113 Setup Menu StandardTurning KeyLock On or Off 114 115 Adjusting the Beep Volume 116 117 Setting Up Alarm SignalsBeep and vibrate 118 Automatic OffOr healthcare team Battery Type 119 Display Orientation 120 121 By 180, the a and s keys will also reverse theirYour screen orientation 122 Alarm Clock See the section Alarm ClockAdvanced User Menu Basal Rate Profiles 123 124 Check your personal settingsProgramming Additional Basal Rate Profiles Selecting a Basal Rate Profile 125 126 127 Alarm ClockSet Single or Multiple Alarms Turning Off the Alarm Clock 128 129 Setup Menu AdvancedTime Format European Date FormatYou can set the date in the following formats American 130 131 Bolus incrementMay cause inappropriate insulin delivery Prime Quantity 132 Lock Basal Rate Profiles 133 134 LanguageTo choose a language, do the following 135 Your pump lets you adjust the display contrastDisplay Contrast Custom User Menu 136 137 System Inspection ChecklistCare of Your ACCU-CHEK Spirit Insulin Pump 138 What to Do When You Drop Your Pump 139 Storing Your ACCU-CHEK Spirit Insulin Pump Disposal Battery Information MaintenanceCleaning Your ACCU-CHEK Spirit Insulin Pump Damage the pump Repair 142 Troubleshooting 143 144 Therapy-Related IssuesTroubleshooting Table Problem Recommended Actions 145 Problem Recommended ActionsSingle use only 146 Alerts and Errors 147 Follow the steps below to confirm an alert or error Confirming an Alert or ErrorWhen you confirm A1 Cartridge LOW , E1 Cartridge Empty 148 149 List of AlertsAlert A1 Cartridge LOW 150 Alert A2 Battery LOWAlert A3 Review Time and Date Alert A5 Pump Timer Alert A4 Alarm ClockSee the section Alarm Clock page 127 for more information 151 Alert A6 TBR Cancelled Temporary Basal Rate Cancelled 152 153 Alert A8 Bolus CancelledAlert A7 TBR Over Temporary Basal Rate Over 154 List of ErrorsError E1 Cartridge Empty Gathered data might not be meaningful Error E2 Battery DepletedBattery is out of power. Replace it immediately 155 Your doctor’s or healthcare team’s instructions Error E3 Automatic OFFError E4 Occlusion 156 157 Error E5 END of Operation 158 Error E6 Mechanical Error 159 Error E7 Electronic Error 160 Error E8 Power Interrupt 161 162 Error E10 Cartridge ErrorError E11 SET not Primed Error E12 Data Interrupted 163 164 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 100 E1 in V/mKHz to 80 MHz MHz to 170 Test Level Technical Standards on Electromagnetic ImmunityIEC Compliance Electromagnetic 171 172 Accuracy of Flow Rate for Plastic Cartridges 173 Start-up graph over the stabilization period 174 175 Bolus≤ 176 Appendix B Configuration Parameters 177 Bolus Maximum ParameterBasal Rate 178 Typical Range Maximum Parameter Parameter Settings 179 Appendix C Abbreviations 180 181 Appendix D Beeps and MelodiesEach press 182 Appendix E VibrationsYour ACCU-CHEK Spirit insulin pump vibrates when 183 Appendix F SymbolsGeneral Symbols 184 Symbol Definition 185 186 187 188 Appendix G Sterile Products and AccessoriesName Comments 189 Appendix H Glossary Daily insulin total Factory settingsHeadset also known as cannula housing Diabetes Data Management DDM Infusion site Luer-lock connectorRUN mode Insulin Timeout SettingsStop mode Scrolling Limited FOUR-YEAR Warranty 194 Index 195 Turning On 80-82 Turning Off 77-80KeyLock 196 200 Quick Reference Table for ErrorsNo. Error What You Need to Do 197 No. Alert What You Need to Do Diagram of User MenusQuick Reference Table for Alerts Disetronic Medical Systems AG