IEC Compliance Electromagnetic, Test Level | Accu-Chek insulin pump

Technical Standards on Electromagnetic Immunity

Guidance and manufacturer’s declaration – electromagnetic immunity

The ACCU-CHEK Spirit insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the ACCU-CHEK Spirit insulin pump should assure that it is used in such an environment.

	IEC 60601	Compliance	Electromagnetic
Immunity Test	Test Level	Level	Environment – Guidance

Electrostatic	± 6 kV contact	± 8 kV contact	Avoid any contact with
discharge (ESD)	± 8 kV air	± 15 kV air	synthetic materials. A
IEC 61000-4-2		(IEC 60601-2-24) relative humidity of 10% will
			allow ESD to be more likely.

Power frequency	3 A/m 400 A/m	400 A/m	Power frequency magnetic
(50/60Hz)			fields should be at levels
magnetic field			characteristic of a typical
IEC 61000-4-8		(IEC 60601-2-24)	location in a typical
			commercial or hospital
			environment.

Conducted RF	3 Vrms	Not applicable
IEC 61000-4-8	150 kHz to
	80 MHz

Appendixes

171

ACCU-CHEK Spirit Insulin Pump

Image 172

Accu-Chek insulin pump Technical Standards on Electromagnetic Immunity, IEC Compliance Electromagnetic, Test Level, 171

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 Display ACCU-CHEK Spirit Insulin PumpTo malfunction Backlight HintPump Support at 1-800-688-4578 immediately Key in areas of poor lighting as this will Keys and Key Combinations One beep in Stop mode Key CombinationsExiting menus, function screens, Information screens without saving Screens Locking Keys Using KeyLock FeatureRUN Screen Stop Screen Information, Function, and Setup ScreensQuick Info Screen Status Screen Messages, Beeps, and Vibrations Follow the steps below to navigate through the screens STOP-Warning Alarm SignalsTo Turn Off the STOP-Warning Or void your warranty Accessories and DisposablesSterile Products 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 Put the pump in Stop mode ACCU-CHEK logo appears System Check Start-Up ProcessInsulin pump Pump Support at Contact Pump Support at Getting Started Since you may not receive the correct information for Settings are identical Setting Time and DateInsulin pump’s memory Follow the steps below to set the Time and Date Getting Started Your Personal Settings Team to understand how to use the pumpInsulin delivery 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 Have the following materials ready Connecting the Cartridge, Adapter, and Infusion SetThese parts Do not over-tighten Follow the instructions belowResult in leakage 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 Before Using Wearing Your PumpDuring insulin pump therapy Pocket knives, and coins Acceptable temperature range Electromagnetic Fields and Hazardous Areas When Not to Wear Your PumpPump if you have a cardiac pacemaker Traveling Sports and ExerciseIf you have questions, contact Pump Support at Disconnect and take off your insulin pump Your Insulin Pump and WaterAccidental Contact with Water Other Liquids What to Do After Any Water ContactFog your display Starting Insulin Delivery Mode to continue insulin delivery Stopping Insulin Delivery STOP-Warning Interruption of Insulin Pump Therapy Put your pump in Stop mode Short InterruptionResuming 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 Your pump can deliver three types of boluses Understanding BolusesStandard Bolus Personal settings Team check your personal settingsInappropriate insulin delivery Insulin ratio and your correction bolus ratio There are two ways to program a Standard Bolus Programming a Standard BolusProgramming a Quick Standard Bolus RUN Using the a and s keys of your insulin pump Cancelling a Quick Standard BolusDuring programming the bolus amount blinks 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 At any function screen you have three options to exit If you want to cancel the bolusIf you want to deliver the bolus 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 Insulin pump therapy Programming a Temporary Basal Rate TBRTypically, a basal rate is set to 100%, but you can Press a or s to increase or decrease the basal rate If you want to save the changes TBR Over Alert No Temporary Basal Rate is delivered Cancelling a Temporary Basal RateTemporary Basal Rate delivery is interrupted 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 Reviewing Pump Data Review the Bolus HistoryEach Bolus History screen displays 107 Press a or s to review the entries Press f to exit Press d to move to the Information screen Press f to select108 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 Turning KeyLock On or Off Setup Menu Standard113 114 115 Adjusting the Beep Volume 116 Beep and vibrate Setting Up Alarm Signals117 Or healthcare team Automatic Off118 Battery Type 119 Display Orientation 120 Your screen orientation By 180, the a and s keys will also reverse their121 Advanced User Menu Alarm Clock See the section Alarm Clock122 Basal Rate Profiles 123 Programming Additional Basal Rate Profiles Check your personal settings124 Selecting a Basal Rate Profile 125 126 Set Single or Multiple Alarms Alarm Clock127 Turning Off the Alarm Clock 128 Time Format Setup Menu Advanced129 Date Format You can set the date in the following formats AmericanEuropean 130 May cause inappropriate insulin delivery Bolus increment131 Prime Quantity 132 Lock Basal Rate Profiles 133 To choose a language, do the following Language134 Display Contrast Your pump lets you adjust the display contrast135 Custom User Menu 136 Care of Your ACCU-CHEK Spirit Insulin Pump System Inspection Checklist137 138 What to Do When You Drop Your Pump 139 Storing Your ACCU-CHEK Spirit Insulin Pump Disposal Maintenance Cleaning Your ACCU-CHEK Spirit Insulin PumpBattery Information Damage the pump Repair 142 Troubleshooting 143 Troubleshooting Table Problem Recommended Actions Therapy-Related Issues144 Single use only Problem Recommended Actions145 146 Alerts and Errors 147 Confirming an Alert or Error When you confirm A1 Cartridge LOW , E1 Cartridge EmptyFollow the steps below to confirm an alert or error 148 Alert A1 Cartridge LOW List of Alerts149 Alert A3 Review Time and Date Alert A2 Battery LOW150 Alert A4 Alarm Clock See the section Alarm Clock page 127 for more informationAlert A5 Pump Timer 151 Alert A6 TBR Cancelled Temporary Basal Rate Cancelled 152 Alert A7 TBR Over Temporary Basal Rate Over Alert A8 Bolus Cancelled153 Error E1 Cartridge Empty List of Errors154 Error E2 Battery Depleted Battery is out of power. Replace it immediatelyGathered data might not be meaningful 155 Error E3 Automatic OFF Error E4 OcclusionYour doctor’s or healthcare team’s instructions 156 157 Error E5 END of Operation 158 Error E6 Mechanical Error 159 Error E7 Electronic Error 160 Error E8 Power Interrupt 161 Error E11 SET not Primed Error E10 Cartridge Error162 Error E12 Data Interrupted 163 See the section Data Transfer page 104 for more information Error E13 Language Error164 General Technical Data Appendix a Technical Data165 166 167 168 Compliance Technical Standards on Electromagnetic Emissions169 E1 in V/m KHz to 80 MHz MHz to100 170 Technical Standards on Electromagnetic Immunity IEC Compliance ElectromagneticTest Level 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 Maximum Parameter Basal RateBolus 178 Typical Range Maximum Parameter Parameter Settings 179 Appendix C Abbreviations 180 Each press Appendix D Beeps and Melodies181 Your ACCU-CHEK Spirit insulin pump vibrates when Appendix E Vibrations182 General Symbols Appendix F Symbols183 184 Symbol Definition 185 186 187 Name Comments Appendix G Sterile Products and Accessories188 189 Appendix H Glossary Factory settings Headset also known as cannula housingDaily insulin total Diabetes Data Management DDM Luer-lock connector RUN modeInfusion site Insulin Settings Stop modeTimeout Scrolling Limited FOUR-YEAR Warranty 194 Index 195 77-80 KeyLockTurning On 80-82 Turning Off 196 Quick Reference Table for Errors No. Error What You Need to Do200 197 Quick Reference Table for Alerts Diagram of User MenusNo. Alert What You Need to Do Disetronic Medical Systems AG