User ManualTable of ContentsINTRODUCTION11Intended Use11Indications for Use11Contraindications11General Safety Information12Intended Operator12SYSTEM OVERVIEW14Prodigy Head Sensor14Prodigy Monitor15Power Supply16Use Environment17Duty Cycle17INSTRUCTIONS FOR USE18User Training18Preparation18Connecting to External Devices (optional)20Overview of Touch Screen Monitor20Overview of LED Indicator States21EEG Electrode Configurations22Four Electrode Configuration22Six Electrode Configuration23Eight Electrode Configuration23Frequently Used Functions24Starting the Sleep Study25Ending the Sleep Study33Special Instructions36Power Failure During Study36Resetting and Restarting the System36Replacing Head Sensor Batteries36Damaged Components37PC Application Software Installation Procedure38Instructions38Software Update Instructions46Data Retrieval52Wizards Mode52Advanced User Mode61Viewing Data65Combining Data67RE-PROCESSING72Pre-Cleaning73Cleaning73Disinfecting74Inspection74Programming75Wizards Mode75Advanced User Mode89Re-Packaging98Expected Service Life100TROUBLESHOOTING101TECHNICAL DESCRIPTION104Prodigy Head Sensor104Prodigy Monitor104Power Supply105ADDITIONAL INFORMATION106Equipment Classification106Technical Specification106Electromagnetic Compliance107Environmental Conditions112Components with High Integrity Characteristics112Risks112SYMBOLS USED FOR PRODIGY SLEEP MONITOR115Figure 1 – Prodigy Head Sensor Front View14Figure 2 – Prodigy Head Sensor Rear View15Figure 3 – Prodigy Monitor Front View15Figure 4 – Prodigy Monitor Rear View16Figure 5 – Monitor Power Supply17Figure 6 – Example EEG Electrodes19Figure 7 – 3.5mm Mono Cable for Monitor Outputs20Figure 8 – Touch Screen Monitor Overview21Figure 9 – Battery Status Indicator States21Figure 10 – Optimal 4 EEG Electrode Placement on Forehead23Figure 11 – Optimal 6 EEG Electrode Placement on Forehead23Figure 12 – Optimal 8 EEG Electrode Placement on Forehead24Figure 13 – Language Select Screen26Figure 14 – Name Selection Screen26Figure 15 – No Patient Found Screen (Support)27Figure 16 – No Patients Found Screen (Number Listed)27Figure 17 – Welcome Screen27Figure 18 – Instructions Screen28Figure 19 – Verification Screen30Figure 20 – Verification Fail Screen (batteries)30Figure 21 – Verification Fail Screen (electrodes)31Figure 23 – Verification Fail Screen (contact)31Figure 24 – Verification Fail Screen (off, contact)31Figure 22 – Verification Fail Screen (off, support)32Figure 25 – Verification Fail Screen (support)32Figure 26 – Verification Complete Screen32Figure 27 – Study Start Screen33Figure 28 – Study Finished Screen33Figure 29 – Evaluation Screen34Figure 30 – Sleep Study Complete Screen34Figure 32 – Sleep Study Incomplete Screen (contact)34Figure 31 – Sleep Study Incomplete Screen (support)35Figure 33 – Action required to remove battery cover from Head Sensor36Figure 34 – Head Sensor with Battery Cover Removed37Figure 35 – Head Sensor with Batteries37Figure 36 – Prodigy Sleep Monitor Application Icon for Installation38Figure 37 – Prodigy Sleep Monitor Application Installation Prompt Window38Figure 38 – Prodigy Sleep Monitor Application WinZip Self-Extractor Window39Window39Figure 40 – Prodigy Sleep Monitor Application Visual C++ 2010 Installation Prompt Window40Figure 41 – Prodigy Sleep Monitor Application Visual C++ 2010 License Terms Window40Figure 42 – Prodigy Sleep Monitor Application Installation Progress Window for Visual C++ 201041Figure 43 – Prodigy Sleep Monitor Application Visual C++ 2010 Installation Complete Window41Figure 44 – Prodigy Sleep Monitor Application Installation Progress Window for .NET Framework41Figure 45 – Prodigy Sleep Monitor Application Welcome Window42Figure 46 – Prodigy Sleep Monitor Application License Agreement Window42Figure 47 – Prodigy Sleep Monitor Application Select Installation Folder Window43Figure 48 – Prodigy Sleep Monitor Application Autostart Service Window43Figure 49 – Prodigy Sleep Monitor Application Confirm Installation Window44Figure 50 – Prodigy Sleep Monitor Application Installation Progress Window44Figure 51 – Prodigy Sleep Monitor Application When To Attach Your Device Notification Window44Figure 52 – Prodigy Sleep Monitor Application Installation Complete Window45Figure 53 – Prodigy Sleep Monitor Application Restart Window45Figure 54 – Prodigy Sleep Monitor Application Icon45Figure 55 – Windows PC Prodigy Application Screen With “Settings” Button Highlighted47Figure 56 – Windows PC Prodigy Application Screen With “Automatic Updates” Button Highlighted47Figure 57 – Windows PC Prodigy Application Login Screen48Figure 58 – Windows PC Prodigy Application Login Screen (Connecting Through Proxy Server)48Figure 59 – Windows PC Prodigy Application Screen With “YES” Button Highlighted49Figure 60 – Prodigy Sleep Monitor Application Automatic Updates Notification49Figure 61 – Prodigy Sleep Monitor Application Updates Ready Window49Figure 62 – Prodigy Sleep Monitor Application Automatic Update Window50Figure 63 – Prodigy Sleep Monitor Application Gathering Information Window50Figure 64 – Prodigy Sleep Monitor Application Close USB Service Window50Figure 65 – Prodigy Sleep Monitor Application Prompt Window 551Figure 66 – Prodigy Sleep Monitor Application Setup Wizard Window51Figure 67 – Prodigy Sleep Monitor Application Final Status Window52Figure 68 – Windows PC Prodigy Application Start Screen (Connected)53Figure 69 – Windows PC Prodigy Application Start Screen (No Device)53Figure 70 – Windows PC Prodigy Application Start Screen (Disconnected)54Figure 71 – Windows PC Prodigy Application Screen With “Download Study” Button Highlighted54Figure 72 – Windows PC Prodigy Application Introduction Screen (Download Study Wizard)55Figure 73 – Windows PC Prodigy Application Patient Information Screen (Download Study Wizard)55Figure 74 – Windows PC Prodigy Application Study Selection Screen (Download Study Wizard)56Figure 75 – Windows PC Prodigy Application File Save As Screen56Figure 76 – Windows PC Prodigy Application Download Progress Screen (Download Study Wizard)57Figure 78 – Windows PC Prodigy Application Combine Study Screen (Download Study Wizard)58Wizard)58Figure 80 – Windows PC Prodigy Application File Open Screen59Wizard)60Figure 83 – Windows PC Prodigy Application Data Screen (Download Study Wizard)60Figure 84 – Windows PC Prodigy Application Download Complete Screen (Download Study Wizard)61Figure 85 – Windows PC Prodigy Application User Interface Screen (General Settings)62(General Settings)62Patients)63Figure 88 – Windows PC Prodigy Application Download Study Screen (Manage Studies)63Figure 89 – Windows PC Prodigy Application Download Progress Screen (Manage Studies)64Figure 90 – Windows PC Prodigy Application Successful Download Screen (Manage Studies)64Highlighted65Figure 94 – Windows PC Prodigy Application Study Data Screen (Review Study Wizard).67(Manage Patients)68Figure 97 – Windows PC Prodigy Applications Screen With File 1 Uploaded (Combine Studies)69Figure 99 – Windows PC Prodigy Application Files Selected Fail To Overlap (Combine Studies)70Figure 100 – Windows PC Prodigy Application Files Selected Overlap (Combine Studies)70Figure 101 – Windows PC Prodigy Application Combination Progress Screen (Combine Studies)71Figure 102 – Windows PC Prodigy Application Successful Combination Screen (Combine Studies)71Figure 103 – Windows PC Prodigy Application Screen With “Manage Patients” Button Highlighted75Management Wizard)77Figure 107 – Windows PC Prodigy Application No Patients Screen (Patient Management Wizard)77(Patient Management Wizard)78Wizard)78Figure 110 – Windows PC Prodigy Application Edit Screen (Device Settings)79Figure 111 – Windows PC Prodigy Application Support Number Override Screen (Device Settings)80(Device Settings)80Figure 114 – Prodigy Sleep Monitor Calibration Screen81(Create Patient Wizard)82Wizard)83Wizard)84Wizard)84Figure 121 – Windows PC Prodigy Application Search Status Failure Screen (Create Patient Wizard)85Wizard)85Wizard)88Wizard)88Patient Wizard)89(Manage Patients)90(Manage Studies)90Figure 131 – Windows PC Prodigy Application Studies Deleted Screen (Manage Studies)91(Manage Patients)91Patients)92Figure 134 – Windows PC Prodigy Application Screen With Patient Deleted (Manage Patients)92Patients)93Figure 136 – Windows PC Prodigy application Screen No Patients (Manage Patients)93(Manage Patients)94Figure 139 – Windows PC Prodigy Application Erase Sleep Monitor Screen (Manage Devices)95Devices)95(Manage Devices)96Figure 143 – Windows PC Prodigy Application Introduction Screen (Manage Patients)97(Manage Patients)97Figure 145 – Windows PC Prodigy Application Successful Patient Addition Screen98Table 1 – Expected Service Life of Accessories100Table 2 – Shelf Life of Accessories100Table 3 – Equipment Classification106Table 4 – Technical Specification of Prodigy Sleep Monitor107Table 5 – IEC 60601-1-2:2007 Table 1 Requirements107Table 6 – Table 5 – IEC 60601-1-2:2007 Table 2 Requirements109Table 7 – IEC 60601-1-2:2007 Table 4 Requirements110Table 8 – IEC 60601-1-2:2007 Table 6 Requirements111Table 9 – Electromagnetic Compliance111Table 10 – Transport and Storage Conditions112Table 11 – Operating Conditions112Table 12 – Regulatory Symbols115Table 13 – Electrical Symbols116Table 14 – Packaging Symbols116Size: 3.22 MBPages: 118Language: EnglishOpen manual