Index - ndd Medical Technologies

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Contents 5.4 FRC Quality Messages 80 5.5 System Interpretation 82 5.6 Retrospective Test Assessment, Entering Comments 82 5.7 Definition of Important Parameters 85 6 Switching the Device Off 88 7 Hygiene, Cleaning, Maintenance, Disposal 89 8 System Settings 99 9 Troubleshooting Tips 116 10 Specifications 117 11 Order Information 119 12 Appendix 120 12.1 Interpretation 120 12.2 Predicted Values 123 12.3 GDT Interface 124 12.4 Introduction to Adjustment of DLCO Measurements 130 12.5 How to interpret TLC from a single breath maneuver 132 12.6 Report Designer 134 12.7 Electromagnetic Compatibility (EMC) 138 12.8 Microsoft Software License Terms for Windows® XP Embedded Runtime 143 12.9 Quick Reference Guide to the Screen Displays 149 12.10 Literature 164 4 EasyOne Pro / EasyOne Pro LAB
1 Introduction 1.1 CE Marking Information Introduction � The product EasyOne Pro bears the CE marking CE-120 (notified body SGS) indicating its compliance with the provisions of the Council Directive 93/42/EEC about medical devices and fulfills the essential requirements of Annex I of this directive. � The flow sensor has been assigned to class IIa as specified in Annex IX of the Directive 93/42/EEC. � The device fulfills the requirements of standard EN 60601-1 "<strong>Medical</strong> electrical equipment, Part 1: General requirements for basic safety and essential performance" as well as the electromagnetic immunity requirements of standard EN 60601-1-2 "Electromagnetic compatibility – <strong>Medical</strong> electrical equipment". � The radio-interference emitted by EasyOne Pro is within the limits specified in EN 55011, class B. � The CE marking covers only the accessories listed in the Order Information chapter. � Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems, and cellular telephones are possible sources of interference as they may emit higher levels of electromagnetic radiation. Keep the equipment away from these devices and verify its performance before use. � The device is suitable for continuous operation. � The product fulfills the requiremens of the following standards: � EN ISO 14971 � IEC60601-1: 2005 � EN 60601-1: 2006 � EN 60601-1-2: 2007 � EN 60601-1-6: 2007 � The country of manufacture is indicated on the device label. EasyOne Pro / EasyOne Pro LAB 5
Page 1 and 2: EasyOne Pro EasyOne Pro LAB Operato
Page 3: Contents 1 Introduction 5 1.1 CE Ma
Page 7 and 8: Introduction accessories available
Page 9 and 10: Warning Shock Hazard— Introductio
Page 11 and 12: Introduction single patient use. Us
Page 13 and 14: Equipment Symbols 0120 Introduction
Page 15 and 16: Introduction 1.10 Components and Fu
Page 17 and 18: 1.12 Test Gas Requirements DLCO Tes
Page 19 and 20: Start-up and Initial Preparation 2
Page 21 and 22: Fig. 2-2 EasyOne Pro, rear panel g
Page 23 and 24: Start-up and Initial Preparation
Page 25 and 26: 2.4 Gas Supply DLCO Gas Start-up an
Page 27 and 28: Start-up and Initial Preparation If
Page 31 and 32: � Select the test to print. Start
Page 33 and 34: Fig. 2-18 Mains connection a Potent
Page 35 and 36: Start-up and Initial Preparation FR
Page 37 and 38: Start-up and Initial Preparation 2.
Page 41 and 42: Selecting the Patient Performing a
Page 43 and 44: Fig. 3-4 Smoking History tab Mergin
Page 45 and 46: Performing a Test 3.3 Forced Vital
Page 47 and 48: Measurement Performing a Test � I
Page 49 and 50: Performing a Test When three accept
Page 51 and 52: Performing a Test FVL Test (inspira
Page 53 and 54: Performing a Test The window with t
Page 55 and 56:
3.4 Vital Capacity (SVC) Performing
Page 57 and 58:
Performing a Test When three accept
Page 59 and 60:
3.6 Quick Test Fig. 3-23 Menu Perfo
Page 61 and 62:
Performing a Test � During exhala
Page 63 and 64:
Performing a Test With Collection B
Page 65 and 66:
Fig. 3-26 FRC Test a Tidal breathin
Page 67 and 68:
Performing a Test � Click the His
Page 69 and 70:
3.11 Trend View Performing a Test T
Page 71 and 72:
4 Editing Patient Data Editing Pati
Page 73 and 74:
FVC/FVL Quality Messages Quality Me
Page 75 and 76:
Quality Messages and Quality Grades
Page 77 and 78:
Low Inspiratory Volume Maneuver not
Page 79 and 80:
Page 81 and 82:
FRC(MBW) Error: No start of washout
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
FRC Quality Messages and Quality Gr
Page 89 and 90:
Hygiene, Cleaning, Maintenance, Dis
Page 91 and 92:
Data Backup on Memory Card Hygiene,
Page 93 and 94:
Technical Inspections Hygiene, Clea
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
8 System Settings System Settings M
Page 101 and 102:
System Settings Storage Tab This ta
Page 103 and 104:
System Settings Administrator Tab O
Page 105 and 106:
Test Tab System Settings The tab co
Page 107 and 108:
System Settings Note Additional inf
Page 109 and 110:
DLCO Tab System Settings On this ta
Page 111 and 112:
Device Tab System Settings The tab
Page 113 and 114:
Report Tab On the Report tab, you c
Page 115 and 116:
Environment Tab System Settings On
Page 117 and 118:
10 Specifications Specifications Di
Page 119 and 120:
11 Order Information Accessories Or
Page 121 and 122:
NLHEP Interpretation Appendix The f
Page 123 and 124:
Appendix System Interpretation Mess
Page 125 and 126:
Appendix Example: EMR Application "
Page 127 and 128:
3622 Height (in cm) 3623 Weight (in
Page 129 and 130:
Appendix 0436228PEF L/s 9.09 10.60
Page 131 and 132:
Adjustment for P AO2 or Altidue App
Page 133 and 134:
Appendix the decision. Note below,
Page 135 and 136:
Appendix � Select the Picture Box
Page 137 and 138:
Appendix Fig. 12-7: Windows, Report
Page 139 and 140:
Appendix Guidance and Manufacturer
Page 141 and 142:
Appendix a) Field strengths from fi
Page 143 and 144:
Appendix 12.8 Microsoft Software Li
Page 145 and 146:
Appendix � use the Remote Boot In
Page 147 and 148:
Appendix Medizintechnik AG's softwa
Page 149 and 150:
Appendix 12.9 Quick Reference Guide
Page 151 and 152:
Press the TAB or Enter key after ea
Page 153 and 154:
Appendix Viewing Ambient Conditions
Page 155 and 156:
Predicted values Selected patient F
Page 157 and 158:
FRC Test Result Measurement curve T
Page 159 and 160:
Trend Display Option buttons for se
Page 161 and 162:
Selected patient Configuration Menu
Page 163 and 164:
Selected patient Appendix Calibrati
Page 165 and 166:
Appendix [16] Wanger, J.L. Clausen
Page 167 and 168:
Index A Administrator tab . . . . .
Page 169 and 170:
Trend view . . . . . . . . . . . .
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