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Contents1 IntroductionIntended User of this Product ................................................................... 13Indications for Use.................................................................................... 13Contraindications ..................................................................................... 14Prescription Device Statement ................................................................. 14Regulatory and Safety Information........................................................... 14Safety Conventions .................................................................................. 14Safety Hazards........................................................................................ 15Classification of Medical Device ................................................................... 17Certification Information............................................................................ 17Recording ECGs During Defibrillation............................................................. 17Accuracy of Input Signal Reproduction........................................................... 18Modulating Effects in Digital Systems ............................................................ 18EMI/EMC/RF Safety Information ................................................................... 18Biocompatibility....................................................................................... 19Legal Notice ........................................................................................... 19Supplies and Accessories........................................................................... 19Responsibility of the Manufacturer................................................................ 20Responsibility of the Purchaser/Customer....................................................... 20Product and Packaging Information.............................................................. 20Training................................................................................................. 28Equipment Identification........................................................................... 28Product Label ......................................................................................... 29Serial Number Format............................................................................... 29Device Address Label and Rating Plate........................................................... 30Product Codes ........................................................................................ 30Service Information................................................................................... 31Service Requirements ............................................................................... 31Warranty Information ............................................................................... 31Additional Assistance................................................................................ 31Manual Information.................................................................................. 31Manual Purpose ...................................................................................... 31Document Conventions ............................................................................. 312 Product OverviewProduct Description .................................................................................. 33Hardware Overview .................................................................................. 33Front View ............................................................................................. 34Rear View .............................................................................................. 34Side View............................................................................................... 35Internal View .......................................................................................... 362053535-003C MAC™ 2000 ECG Analysis System 9 PreviousNext |