About the Author |
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xxiii | |
Preface |
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xxv | |
Nomenclature |
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xxix | |
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Chapter 1 Diagnosis and therapy |
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5 | (40) |
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Medical device definitions |
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6 | (1) |
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7 | (1) |
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Medical devices versus medical instruments |
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7 | (6) |
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Instruments make measurements |
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7 | (3) |
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Input dynamic range and frequency response |
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10 | (1) |
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Accuracy, bias, and precision |
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11 | (2) |
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13 | (1) |
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13 | (10) |
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13 | (4) |
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17 | (3) |
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20 | (1) |
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21 | (2) |
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Patient and operator safety |
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23 | (2) |
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24 | (1) |
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Defibrillation protection |
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25 | (1) |
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25 | (3) |
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25 | (1) |
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26 | (2) |
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28 | (5) |
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30 | (3) |
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Medical electrical stimulators |
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33 | (4) |
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35 | (2) |
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37 | (1) |
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38 | (1) |
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39 | (2) |
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41 | (4) |
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Chapter 2 Electrocardiographs |
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45 | (28) |
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Cardiac electrical conduction |
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46 | (3) |
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46 | (1) |
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Spread of action potentials |
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46 | (3) |
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49 | (5) |
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54 | (2) |
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54 | (2) |
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56 | (1) |
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56 | (1) |
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56 | (3) |
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57 | (1) |
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Enabling technology: string galvanometer |
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58 | (1) |
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System description and diagram |
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59 | (6) |
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Arrhythmia detection accuracy |
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60 | (5) |
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Key features from engineering standards |
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65 | (3) |
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65 | (1) |
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65 | (2) |
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67 | (1) |
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67 | (1) |
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67 | (1) |
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68 | (1) |
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69 | (1) |
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70 | (3) |
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73 | (30) |
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74 | (5) |
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74 | (2) |
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76 | (3) |
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79 | (1) |
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Tissue response to stimulation voltage |
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79 | (1) |
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80 | (1) |
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80 | (3) |
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81 | (1) |
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Enabling technology: Ruben-Mallory zinc mercuric oxide battery |
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82 | (1) |
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System description and diagram |
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83 | (10) |
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84 | (3) |
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87 | (4) |
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91 | (1) |
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92 | (1) |
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Key features from engineering standards |
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93 | (3) |
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93 | (1) |
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Mechanical integrity of leads |
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94 | (1) |
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95 | (1) |
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95 | (1) |
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Minimum susceptibility to electromagnetic interference |
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96 | (1) |
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96 | (1) |
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97 | (1) |
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98 | (1) |
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99 | (4) |
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Chapter 4 External defibrillators |
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103 | (22) |
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104 | (3) |
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104 | (2) |
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106 | (1) |
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107 | (1) |
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Sudden cardiac arrest and cardiopulmonary resuscitation |
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107 | (1) |
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Defibrillation mechanism and threshold |
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108 | (2) |
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110 | (1) |
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110 | (6) |
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Early external defibrillator devices |
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111 | (1) |
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Enabling technology: Lown-Edmark waveform |
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111 | (3) |
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Early automated external defibrillator devices |
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114 | (1) |
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Enabling technology: biphasic truncated exponential waveform |
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115 | (1) |
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System description and diagram |
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116 | (3) |
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118 | (1) |
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Key features from engineering standards |
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119 | (2) |
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119 | (1) |
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Capacitor discharge accuracy |
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119 | (1) |
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120 | (1) |
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Rhythm recognition detection accuracy |
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120 | (1) |
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Recovery after defibrillation |
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120 | (1) |
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121 | (1) |
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122 | (1) |
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123 | (2) |
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Chapter 5 Implantable cardioverter defibrillators |
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125 | (24) |
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126 | (4) |
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Pulse generator biocompatibility |
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129 | (1) |
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130 | (2) |
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132 | (3) |
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132 | (2) |
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Enabling technologies: transvenous defibrillation and integrated leads |
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134 | (1) |
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System description and diagram |
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135 | (4) |
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Defibrillation threshold tests |
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136 | (1) |
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137 | (2) |
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Key features from engineering standards |
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139 | (2) |
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139 | (1) |
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Mechanical integrity of leads |
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139 | (1) |
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Delivered voltage and energy |
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140 | (1) |
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Battery discharge and warning |
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140 | (1) |
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Arrhythmia detection accuracy |
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140 | (1) |
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FDA case study: Guidant ICD recall |
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141 | (3) |
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141 | (1) |
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142 | (1) |
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143 | (1) |
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143 | (1) |
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144 | (1) |
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144 | (1) |
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145 | (4) |
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149 | (30) |
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150 | (6) |
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151 | (2) |
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153 | (3) |
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156 | (1) |
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Mechanical valve biocompatibility |
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156 | (1) |
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157 | (1) |
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158 | (4) |
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159 | (1) |
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Enabling technology: ball and cage valve |
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159 | (1) |
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Enabling technology: glutaraldehyde treatment |
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160 | (2) |
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Enabling technology: transcatheter valve |
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162 | (1) |
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System description and diagram |
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162 | (4) |
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Comparison of velocities and turbulent shear stresses |
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164 | (2) |
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FDA case study: Bjork-Shiley heart valve |
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166 | (5) |
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168 | (1) |
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169 | (1) |
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170 | (1) |
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171 | (1) |
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Key features from engineering standards |
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171 | (2) |
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172 | (1) |
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172 | (1) |
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173 | (1) |
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Clinical study long-term follow-up |
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173 | (1) |
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173 | (1) |
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173 | (1) |
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174 | (1) |
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175 | (4) |
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Chapter 7 Blood pressure monitors |
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179 | (18) |
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Blood pressure propagation |
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179 | (3) |
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182 | (1) |
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182 | (1) |
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183 | (2) |
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183 | (1) |
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Enabling technology: auscultation |
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183 | (1) |
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Enabling technology: oscillometry |
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184 | (1) |
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System descriptions and diagrams |
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185 | (6) |
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189 | (1) |
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Consumer blood pressure monitor accuracy |
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189 | (2) |
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Key features from engineering standards |
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191 | (2) |
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192 | (1) |
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192 | (1) |
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Monitor accuracy with auscultatory method as reference standard |
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192 | (1) |
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Monitor accuracy with intraarterial method as reference standard |
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192 | (1) |
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193 | (1) |
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193 | (1) |
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194 | (1) |
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195 | (2) |
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Chapter 8 Catheters, bare metal stents, and synthetic grafts |
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197 | (32) |
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198 | (3) |
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Percutaneous coronary interventions |
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201 | (3) |
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204 | (1) |
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205 | (2) |
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207 | (2) |
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207 | (1) |
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Enabling technology: percutaneous transluminal coronary angioplasty |
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207 | (1) |
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Enabling technology: Vinyon "N" cloth |
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208 | (1) |
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System descriptions and diagrams |
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209 | (9) |
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Cardiac catheterization procedures |
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210 | (6) |
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216 | (1) |
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217 | (1) |
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FDA case study: Guidant Ancure endovascular graft system |
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218 | (4) |
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220 | (1) |
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220 | (1) |
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221 | (1) |
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221 | (1) |
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Key features from engineering standards |
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222 | (2) |
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Balloon rated burst pressure |
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222 | (1) |
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222 | (1) |
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223 | (1) |
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223 | (1) |
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223 | (1) |
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224 | (1) |
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225 | (1) |
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225 | (4) |
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Chapter 9 Hemodialysis delivery systems |
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229 | (28) |
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232 | (1) |
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Renal anatomy and physiology |
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233 | (3) |
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235 | (1) |
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Regulation of water and electrolyte balances |
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236 | (1) |
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Renal replacement therapies |
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236 | (3) |
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Dialysis adequacy through urea modeling |
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239 | (2) |
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241 | (2) |
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243 | (2) |
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243 | (1) |
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Enabling technology: external arteriovenous fistula |
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244 | (1) |
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System description and diagram |
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245 | (4) |
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246 | (1) |
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Hemodialysis delivery systems |
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247 | (2) |
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Key features from engineering standards |
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249 | (3) |
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250 | (1) |
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Blood circuit air protection |
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251 | (1) |
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251 | (1) |
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Ultrafiltration control system |
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251 | (1) |
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252 | (1) |
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252 | (1) |
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253 | (1) |
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254 | (3) |
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Chapter 10 Mechanical ventilators |
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257 | (24) |
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258 | (6) |
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258 | (2) |
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260 | (3) |
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263 | (1) |
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264 | (3) |
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267 | (1) |
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268 | (2) |
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268 | (2) |
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Enabling technology: positive-pressure ventilation |
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270 | (1) |
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System description and diagram |
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270 | (4) |
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Common modes of mechanical ventilation |
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271 | (1) |
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272 | (2) |
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Key features from engineering standards |
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274 | (2) |
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Protection from interruption of power supply |
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275 | (1) |
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Maximum pressure to patient |
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275 | (1) |
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Accuracy for pressure-controlled breath type |
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275 | (1) |
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276 | (1) |
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Protection from breathing system leakage |
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276 | (1) |
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276 | (1) |
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277 | (1) |
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278 | (3) |
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Chapter 11 Pulse oximeters |
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281 | (24) |
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Oxygen transport in blood |
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282 | (4) |
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282 | (1) |
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Oxyhemoglobin dissociation curve |
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282 | (3) |
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Carbon monoxide displacement |
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285 | (1) |
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286 | (2) |
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288 | (2) |
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290 | (1) |
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290 | (6) |
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290 | (2) |
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Enabling technology: calibration curve |
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292 | (1) |
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Enabling technology: adaptive filtering |
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292 | (4) |
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System description and diagram |
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296 | (2) |
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297 | (1) |
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Key features from engineering standards |
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298 | (2) |
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298 | (1) |
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Accuracy under conditions of motion |
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299 | (1) |
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Accuracy under conditions of low perfusion |
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299 | (1) |
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Signal inadequacy indication |
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299 | (1) |
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Protection from excessive temperatures |
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299 | (1) |
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300 | (1) |
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301 | (1) |
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301 | (1) |
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302 | (3) |
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305 | (22) |
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Thermoregulation physiology |
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306 | (5) |
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306 | (2) |
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308 | (2) |
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310 | (1) |
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Skin temperature versus core temperature |
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311 | (1) |
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311 | (1) |
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312 | (2) |
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312 | (1) |
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Enabling technology: six-inch mercury thermometer |
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312 | (2) |
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System descriptions and diagrams |
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314 | (4) |
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314 | (1) |
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Digital electronic thermometer |
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314 | (2) |
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316 | (2) |
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Key features from engineering standards |
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318 | (3) |
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Electronic thermometer accuracy |
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318 | (2) |
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Maximum permissible laboratory error for ear IR thermometer |
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320 | (1) |
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Maximum permissible laboratory error for skin IR thermometer |
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320 | (1) |
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IR thermometer clinical accuracy |
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320 | (1) |
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Probe cover physical integrity |
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321 | (1) |
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FDA consensus standards for accuracy |
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321 | (2) |
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323 | (1) |
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323 | (1) |
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324 | (3) |
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Chapter 13 Electroencephalographs |
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327 | (22) |
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328 | (6) |
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329 | (2) |
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Generation of electroencephalograms |
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331 | (3) |
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334 | (3) |
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335 | (1) |
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336 | (1) |
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336 | (1) |
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337 | (3) |
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337 | (1) |
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338 | (2) |
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340 | (1) |
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340 | (1) |
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Enabling technology: double-coil galvanometer |
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340 | (1) |
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System description and diagram |
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341 | (1) |
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Key features from engineering standards |
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342 | (1) |
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Electrostatic discharge prevention |
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342 | (1) |
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342 | (1) |
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Bispectral index monitors |
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343 | (1) |
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344 | (1) |
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345 | (1) |
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346 | (3) |
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Chapter 14 Deep brain stimulators |
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349 | (24) |
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351 | (2) |
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352 | (1) |
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353 | (1) |
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353 | (3) |
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356 | (1) |
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356 | (2) |
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357 | (1) |
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Enabling technology: replacement of ablation by stimulation |
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357 | (1) |
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System description and diagram |
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358 | (7) |
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360 | (2) |
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Implantable pulse generator |
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362 | (1) |
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363 | (1) |
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363 | (2) |
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Key features from engineering standards |
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365 | (2) |
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Stimulation pulse characteristics |
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365 | (1) |
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365 | (1) |
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365 | (1) |
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Immunity from electromagnetic interference |
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366 | (1) |
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Protection from harm caused by magnetically-induced force |
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366 | (1) |
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367 | (1) |
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368 | (1) |
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369 | (4) |
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Chapter 15 Cochlear implants |
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373 | (24) |
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374 | (6) |
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374 | (4) |
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Sensorineural hearing loss |
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378 | (2) |
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380 | (1) |
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381 | (2) |
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383 | (3) |
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Early implantable devices |
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383 | (2) |
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Enabling technology: continuous interleaved sampling speech processing strategy |
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385 | (1) |
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System description and diagram |
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386 | (5) |
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386 | (2) |
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388 | (1) |
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389 | (1) |
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390 | (1) |
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Improvements in sound recognition |
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391 | (1) |
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Key features from engineering standards |
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391 | (2) |
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391 | (1) |
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Protection from harm caused by magnetically-induced force |
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392 | (1) |
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392 | (1) |
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393 | (1) |
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Effect of atmospheric pressure |
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393 | (1) |
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393 | (1) |
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394 | (1) |
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395 | (2) |
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Chapter 16 Functional electrical stimulators |
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397 | (26) |
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398 | (4) |
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399 | (2) |
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401 | (1) |
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402 | (3) |
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405 | (3) |
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408 | (1) |
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409 | (5) |
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409 | (1) |
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410 | (2) |
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412 | (2) |
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414 | (4) |
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Functional electrical stimulation and intracortical brain-computer interface |
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414 | (3) |
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417 | (1) |
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417 | (1) |
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Key features from engineering standards |
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418 | (1) |
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418 | (1) |
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419 | (1) |
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420 | (3) |
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Chapter 17 Intraocular lens implants |
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423 | (28) |
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424 | (4) |
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424 | (4) |
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428 | (1) |
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428 | (6) |
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428 | (4) |
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432 | (2) |
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434 | (1) |
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435 | (3) |
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435 | (1) |
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Enabling technology: poly(methyl methacrylate) lens |
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436 | (1) |
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Enabling technology: phacoemulsification |
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437 | (1) |
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System description and diagram |
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438 | (5) |
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438 | (2) |
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Intraocular lens complications |
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440 | (2) |
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442 | (1) |
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Key features from engineering standards |
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443 | (4) |
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Dynamic fatigue durability |
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443 | (1) |
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Recovery of properties following simulated surgical manipulation |
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444 | (1) |
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445 | (1) |
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Effect of Nd-YAG laser exposure |
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445 | (1) |
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445 | (2) |
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447 | (1) |
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448 | (1) |
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449 | (2) |
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Chapter 18 Total hip prostheses |
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451 | (32) |
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452 | (6) |
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452 | (3) |
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Articular cartilage and synovial joint capsule |
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455 | (1) |
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455 | (3) |
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458 | (2) |
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459 | (1) |
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460 | (1) |
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461 | (2) |
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461 | (1) |
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Enabling technologies: low friction and PMMA cement |
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461 | (2) |
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System descriptions and diagrams |
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463 | (6) |
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463 | (5) |
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468 | (1) |
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Key features from engineering standards |
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469 | (7) |
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Femoral component fatigue without torsion |
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471 | (1) |
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Femoral component fatigue with torsion |
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472 | (1) |
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Femoral component corrosion |
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473 | (1) |
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473 | (1) |
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473 | (3) |
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476 | (1) |
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477 | (1) |
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478 | (1) |
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479 | (4) |
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Chapter 19 Drug-eluting stents |
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|
483 | (20) |
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484 | (1) |
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Drug delivery using coatings |
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485 | (4) |
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489 | (1) |
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|
490 | (2) |
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Drug-eluting stent requirements |
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|
492 | (1) |
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System descriptions and diagrams |
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|
492 | (6) |
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493 | (1) |
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|
493 | (3) |
|
|
496 | (2) |
|
Key features from engineering standards |
|
|
498 | (1) |
|
Pre-clinical in vitro evaluation of the device part-related attributes |
|
|
498 | (1) |
|
|
498 | (1) |
|
|
499 | (1) |
|
|
500 | (3) |
|
Chapter 20 Artificial pancreas |
|
|
503 | (38) |
|
|
504 | (4) |
|
|
505 | (1) |
|
|
506 | (1) |
|
|
507 | (1) |
|
|
508 | (7) |
|
|
508 | (2) |
|
Minimal model of insulin sensitivity |
|
|
510 | (3) |
|
Plasma interstitial glucose equilibration model |
|
|
513 | (2) |
|
|
515 | (1) |
|
|
516 | (3) |
|
Ideal artificial pancreas system |
|
|
516 | (1) |
|
|
517 | (2) |
|
Artificial pancreas requirements |
|
|
519 | (5) |
|
|
520 | (3) |
|
|
523 | (1) |
|
System description and diagram |
|
|
524 | (4) |
|
Key features from engineering standards |
|
|
528 | (3) |
|
|
528 | (1) |
|
|
528 | (1) |
|
Sensor threshold alarm accuracy |
|
|
529 | (1) |
|
|
530 | (1) |
|
|
531 | (1) |
|
|
532 | (2) |
|
|
534 | (7) |
|
|
|
Chapter 21 ECG electrode verification testing lab |
|
|
541 | (4) |
|
|
541 | (1) |
|
|
542 | (2) |
|
|
543 | (1) |
|
|
544 | (1) |
|
|
544 | (1) |
|
|
544 | (1) |
|
Chapter 22 Electrocardiograph design lab |
|
|
545 | (4) |
|
|
545 | (1) |
|
|
546 | (1) |
|
|
547 | (1) |
|
|
547 | (1) |
|
|
548 | (1) |
|
|
548 | (1) |
|
Chapter 23 Electrocardiograph filtering lab |
|
|
549 | (6) |
|
|
550 | (1) |
|
Introduction to wavelet filters |
|
|
550 | (2) |
|
|
552 | (1) |
|
|
552 | (1) |
|
|
553 | (1) |
|
|
554 | (1) |
|
|
554 | (1) |
|
Chapter 24 Pacemaker programming lab |
|
|
555 | (6) |
|
|
555 | (1) |
|
|
555 | (4) |
|
|
557 | (1) |
|
|
558 | (1) |
|
|
558 | (1) |
|
|
559 | (1) |
|
|
559 | (2) |
|
Chapter 25 Echocardiography lab |
|
|
561 | (8) |
|
|
561 | (1) |
|
|
562 | (6) |
|
|
562 | (3) |
|
|
565 | (1) |
|
|
566 | (2) |
|
|
568 | (1) |
|
|
568 | (1) |
|
|
568 | (1) |
|
Chapter 26 Patient monitoring lab |
|
|
569 | (6) |
|
|
569 | (1) |
|
|
570 | (1) |
|
Motion artifact and false alarms |
|
|
570 | (1) |
|
|
571 | (2) |
|
|
571 | (2) |
|
|
573 | (1) |
|
|
573 | (1) |
|
|
573 | (2) |
|
Chapter 27 Thermometry accuracy lab |
|
|
575 | (4) |
|
|
575 | (1) |
|
|
576 | (2) |
|
|
577 | (1) |
|
|
578 | (1) |
|
|
578 | (1) |
|
|
578 | (1) |
|
Chapter 28 Energy balance lab |
|
|
579 | (10) |
|
|
579 | (1) |
|
Personal comfort in a building |
|
|
580 | (5) |
|
|
581 | (1) |
|
|
582 | (1) |
|
Radiation calculated from energy balance of the entire system |
|
|
583 | (2) |
|
|
585 | (2) |
|
|
585 | (1) |
|
|
586 | (1) |
|
|
587 | (1) |
|
|
587 | (1) |
|
|
587 | (2) |
|
Chapter 29 Surface characterization lab |
|
|
589 | (6) |
|
|
589 | (1) |
|
|
590 | (1) |
|
|
590 | (1) |
|
|
591 | (2) |
|
|
591 | (2) |
|
|
593 | (1) |
|
|
593 | (1) |
|
|
593 | (2) |
|
Chapter 30 Entrepreneurship lab |
|
|
595 | (6) |
|
|
595 | (1) |
|
|
596 | (1) |
|
Crossing the Chasm background |
|
|
596 | (2) |
|
|
598 | (1) |
|
Report structure and grading |
|
|
598 | (1) |
|
Crossing the Chasm discussion lecture |
|
|
599 | (1) |
|
|
599 | (2) |
|
Chapter 31 Engineering ethics lab |
|
|
601 | (6) |
|
|
601 | (1) |
|
|
602 | (1) |
|
Engineering ethics background |
|
|
602 | (1) |
|
|
603 | (3) |
|
Assignment structure and grading |
|
|
605 | (1) |
|
|
606 | (1) |
Index |
|
607 | |