MEDIANA D500 Operators Manual - ENG - Rev.11 2020.04 [PDF]

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OPERATOR’S MANUAL Defibrillator/Monitor D500



EU representative OBELIS S.A Bd. Général Wahis, 53, 1030 Brussels, Belgium



Manufacturer Mediana Co., Ltd. 132, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea Tel: (82) 2 542 3375 (82) 33 742 5400 Fax: (82) 2 542 7447 (82) 33 742 5483 Part Number: A7226-11 Revised Date: 2020-04



Copyright © 2020 All rights reserved.



Directive    



Copyright law allows no part of this instruction manual to be reproduced without permission. The content of this manual are subject to change without notice. The contents of this manual should be correct. If for some reason, there are any questionable points, please do not hesitate to contact our service center. The manual will be replaced if any pages are missing or collation is incorrect.



Warranty  



Please contact your local distributor about the warranty period. Device failure or damage related to the following situations during the guarantee period is not covered by this warranty:  Installation, transfer installation, maintenance and repairs by any person other than an authorized employee or technician by Mediana.  Damage sustained to the Mediana product(s) caused by product(s) from another company excluding products delivered by Mediana.  Damage – caused by mishandling and/or misuse – is the responsibility of the user.  Maintenance and repairs utilizing maintenance components that are not specified by Mediana.  Device modifications or use of accessories not recommended by Mediana.  Damage caused by accidents or natural disasters (earthquakes, flooding, etc.).  Damage resulting from usage where caution statements and operating instructions shown in this manual have not been followed.  Damage due to neglect of specified maintenance checks.  This warranty only covers the hardware of the D500. The warranty does not cover the following selections:  Whatever damage or loss results from the attachment of accessories or their operation.  In the event of a defect in the product, contact our sales outlet or EU representative as noted on the back cover.  The D500 conforms to the EMC standard IEC60601-1-2. Note that mobile phones should not be used in the vicinity of the D500. Note, however, any device not complying to the EMC standard that is used with the D500 renders the D500 as non-compliable to the EMC standard.



Trademark Product brand names shown in this manual are likely to be the trademark or registered trademark of the company concerned. This defibrillator/monitor is equipped with epoch-making ECG monitoring function incorporating the cutting edge software for analysis of electrocardiograms developed by the University of Glasgow in UK, which includes signal processing, diagnostic interpretation of electrocardiograms from individuals of all ages and analysis of cardiac rhythm.



CONTENTS CONTENTS ................................................................................................................................. i SAFETY INFORMATION ............................................................................................................ 7 General Safety Information .................................................................................................. 7 Warning ............................................................................................................................... 7 Cautions ............................................................................................................................ 12 INTRODUCTION ...................................................................................................................... 13 Intended Use for the D500 ................................................................................................. 13 Indications for Use ............................................................................................................. 13 About This Manual ............................................................................................................. 15 Identifying the D500 Configurations ................................................................................... 15 DESCRIPTION OF THE DEFIBRILLATOR/MONITOR ............................................................. 17 Front Panel Components ................................................................................................... 17 Top Panel Components ...................................................................................................... 19 Rear Panel Components .................................................................................................... 20 Left Panel Components...................................................................................................... 21 Right Panel Components ................................................................................................... 21 Displays ............................................................................................................................. 23 SETTING UP THE DEFIBRILLATOR/MONITOR...................................................................... 27 Unpacking and Inspection .................................................................................................. 27 List of Components ............................................................................................................ 28 Power Cable Connections.................................................................................................. 30 Measurement Cable Connections ...................................................................................... 32 BATTERY OPERATION ........................................................................................................... 35 Operating the defibrillator/monitor on Battery Power .......................................................... 36 Battery Status Indication .................................................................................................... 37 USING THE DEFIBRILLATOR/MONITOR................................................................................ 39 Turning On and Off the defibrillator/monitor ....................................................................... 40 Setting the Main Screen ..................................................................................................... 42 ALARMS AND LIMITS ............................................................................................................. 45 General .............................................................................................................................. 45 Alarm Priority and Messages ............................................................................................. 46 Visual Alarm Indication ....................................................................................................... 51 Audible Alarm Indication .................................................................................................... 51 Verifying Audible Alarm Indication ...................................................................................... 52 Changing Alarm Limits ....................................................................................................... 52 Audio Paused and OFF ..................................................................................................... 54 ECG MONITORING .................................................................................................................. 57 General .............................................................................................................................. 58 Setup Connections ............................................................................................................ 58 12-lead ECG ...................................................................................................................... 60 Preparing the 12 Lead ....................................................................................................... 64 Calculation Feature ............................................................................................................ 65 12 Lead Display ................................................................................................................. 68 Description of HR/PR Menu Functions ............................................................................... 69 AED(Automated External Defibrillator) MODE ...................................................................... 71 General .............................................................................................................................. 72 Preparing for Defibrillation.................................................................................................. 73 Operating the AED Mode of defibrillator/monitor ................................................................ 74 AHA/ERC guidelines (Rescue protocol) ............................................................................. 74 Summary of CPR Guidelines ............................................................................................. 75 Performing CPR................................................................................................................. 78 Description of AED Mode Menu Functions ......................................................................... 79 MANUAL MODE....................................................................................................................... 81 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General .............................................................................................................................. 81 Preparing for Defibrillation.................................................................................................. 82 Operating the Manual Mode of defibrillator/monitor ............................................................ 82 Defibrillating (async mode)................................................................................................. 83 Synchronized Cardioversion (sync mode) .......................................................................... 84 Description of Manual Mode Menu Functions .................................................................... 86 MONITOR MODE ..................................................................................................................... 93 General .............................................................................................................................. 93 Description of Pacing Mode Menu Functions ..................................................................... 93 PACING MODE ........................................................................................................................ 99 General .............................................................................................................................. 99 Demand Mode and Fixed Mode ....................................................................................... 100 Operating the Pacing Mode of defibrillator/monitor .......................................................... 100 Demand mode Pacing ..................................................................................................... 100 Fixed Mode Pacing .......................................................................................................... 101 Description of Pacing Mode Menu Functions ................................................................... 102 NIBP MONITORING ............................................................................................................... 107 General ............................................................................................................................ 108 Setup Connections .......................................................................................................... 108 Description of NIBP Menu Functions................................................................................ 110 Theory of Operation ......................................................................................................... 112 SpO2 MONITORING ............................................................................................................... 115 General ............................................................................................................................ 116 Setup Connections .......................................................................................................... 117 Description of SpO2 Menu Functions................................................................................ 118 Theory of Operation ......................................................................................................... 119 Clinical Studies ................................................................................................................ 121 RESPIRATION MONITORING ................................................................................................ 123 General ............................................................................................................................ 123 Setup Connections .......................................................................................................... 124 Description of Respiration Menu Functions ...................................................................... 124 Theory of Operation ......................................................................................................... 126 CAPNOGRAPHY MONITORING ............................................................................................ 127 General ............................................................................................................................ 128 Setup Connections .......................................................................................................... 129 Description of EtCO2 Menu Functions .............................................................................. 131 Theory of Operation ......................................................................................................... 133 TEMPERATURE MONITORING ............................................................................................. 135 General ............................................................................................................................ 135 Setup Connections .......................................................................................................... 135 Description of Temperature Menu Functions .................................................................... 135 Theory of Operation ......................................................................................................... 136 IBP MONITORING .................................................................................................................. 137 General ............................................................................................................................ 138 Setup Connections .......................................................................................................... 138 Description of IBP 1 Menu Functions ............................................................................... 139 Description of IBP 2 Menu Functions ............................................................................... 140 Theory of Operation ......................................................................................................... 142 SELF-TEST FUNCTION ......................................................................................................... 143 General ............................................................................................................................ 143 Functions to be tested in Self-test .................................................................................... 144 Self-test result transmission (if configured with Wireless module option).......................... 144 Self-test result printing ..................................................................................................... 144 External shock test........................................................................................................... 145 Trouble shooting .............................................................................................................. 146 EVENT.................................................................................................................................... 147 ii



General ............................................................................................................................ 147 Event Data List Display .................................................................................................... 147 Event Review Display ...................................................................................................... 148 12 Lead Record Display ................................................................................................... 149 ID# ................................................................................................................................... 149 REAL-TIME DATA .................................................................................................................. 151 General ............................................................................................................................ 151 Real-time data menu........................................................................................................ 151 Real-time data recording .................................................................................................. 152 MENU STRUCTURE .............................................................................................................. 155 PRINTING .............................................................................................................................. 165 General ............................................................................................................................ 165 Printer Settings ................................................................................................................ 165 Print-Out .......................................................................................................................... 167 EXTERNAL INTERFACE ....................................................................................................... 171 General ............................................................................................................................ 171 MAINTENANCE ..................................................................................................................... 173 Recycling and Disposal .................................................................................................... 173 Returning the defibrillator/monitor and System Components ............................................ 174 Service............................................................................................................................. 174 Periodic Safety Checks .................................................................................................... 174 Cleaning .......................................................................................................................... 174 Battery Maintenance ........................................................................................................ 175 Loading Printer Paper ...................................................................................................... 176 TROUBLESHOOTING ........................................................................................................... 177 General ............................................................................................................................ 177 Obtaining Technical Assistance ........................................................................................ 177 EMI (Electromagnetic Interference).................................................................................. 178 FACTORY DEFAULTS ........................................................................................................... 181 General ............................................................................................................................ 181 Parameter Ranges and Default Settings .......................................................................... 181 SPECIFICATION .................................................................................................................... 189 Display ............................................................................................................................. 189 Controls ........................................................................................................................... 189 Alarms ............................................................................................................................. 189 Physical Characteristics and Printer ................................................................................. 190 Electrical .......................................................................................................................... 190 Environmental Conditions ................................................................................................ 191 Tone Definition ................................................................................................................. 192 Measurement Parameters................................................................................................ 193 Event ............................................................................................................................... 199 Defibrillator (Technical Specification) ................................................................................ 200 Compliance ...................................................................................................................... 215 Manufacturer’s EMC Declaration ..................................................................................... 219



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Figures Figure 1. Front panel components ............................................................................................................................... 17 Figure 2. Top panel components .................................................................................................................................. 19 Figure 3. Rear panel components ................................................................................................................................ 20 Figure 4. Left panel components ................................................................................................................................. 21 Figure 5. Right panel components ............................................................................................................................... 21 Figure 6. Displays ........................................................................................................................................................ 23 Figure 7. AC Power Connection .................................................................................................................................. 30 Figure 8. DC Power Connection .................................................................................................................................. 31 Figure 9. Battery Placement ........................................................................................................................................ 36 Figure 10. Mode Select Knob ...................................................................................................................................... 40 Figure 11. Select Date/Time Menu .............................................................................................................................. 41 Figure 12. Setup: Display mode Menu ......................................................................................................................... 42 Figure 13. Normal Screen (4 waveform, Defibrillation mode, Full option) .................................................................... 43 Figure 14. Large Numeric Screen (2 waveform, Monitor mode, Full option) ................................................................ 43 Figure 15. Black-white Screen (4 waveform, Defibrillation mode, Full option) ............................................................. 44 Figure 16. Volume Menu Display ................................................................................................................................. 46 Figure 17. Alarm Limit Menu ........................................................................................................................................ 53 Figure 18. Standard 3 Electrode Placement ................................................................................................................ 58 Figure 19. 5 Electrode Placement................................................................................................................................ 59 Figure 20. Varying choice of baselines. ....................................................................................................................... 62 Figure 21. Baseline at the level of QRS onset as used by the Glasgow program. ....................................................... 62 Figure 22. Illustration of isoelectric segments I and K.................................................................................................. 62 Figure 23. Definitions for QRS end / ST junction ......................................................................................................... 63 Figure 24. 12 lead Placement ...................................................................................................................................... 64 Figure 25. Measurement Reference ............................................................................................................................ 65 Figure 26. 12-Lead ECG Preview Screen.................................................................................................................... 68 Figure 27. HR/PR Display ............................................................................................................................................ 69 Figure 28. ECG Waveform Display .............................................................................................................................. 69 Figure 29. HR/PR Menu .............................................................................................................................................. 69 Figure 30. AED Mode Menu ........................................................................................................................................ 79 Figure 31. ECG waveform display – ECG signal saturation (AED mode, Pads) .......................................................... 79 Figure 32. Patient Info: ID Menu .................................................................................................................................. 80 Figure 33. Manual Mode Screen.................................................................................................................................. 82 Figure 34. Shock Soft Key ........................................................................................................................................... 84 Figure 35. Manual Mode Menu .................................................................................................................................... 86 Figure 36. Setup Menu ................................................................................................................................................ 89 Figure 37. Alarm Limit Menu ........................................................................................................................................ 91 Figure 38. Patient Info: ID Menu .................................................................................................................................. 91 Figure 39. Monitor Mode Menu .................................................................................................................................... 93 Figure 40. Setup Menu ................................................................................................................................................ 96 Figure 41. Alarm Limit Menu ........................................................................................................................................ 97 Figure 42. Patient Info: ID Menu .................................................................................................................................. 98 Figure 43. Pacing mode screen ................................................................................................................................. 100 Figure 44. Pacing Mode Menu ................................................................................................................................... 102 Figure 45. Setup Menu .............................................................................................................................................. 104 Figure 46. Alarm Limit Menu ...................................................................................................................................... 106 Figure 47. Patient Info: ID Menu ................................................................................................................................ 106 Figure 48. NIBP Display............................................................................................................................................. 110 Figure 49. NIBP Menu Display ................................................................................................................................... 110 Figure 50. SpO2 Display ............................................................................................................................................ 118 Figure 51. SpO2 Waveform Display .......................................................................................................................... 118 Figure 52. SpO2 Menu Display .................................................................................................................................. 118 Figure 53. Oxyhemoglobin Dissociation Curve .......................................................................................................... 120 Figure 54. Modified Bland-Altman Plot ...................................................................................................................... 122 Figure 55. Respiration Display ................................................................................................................................... 124



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Figure 56. Respiration Waveform Display ................................................................................................................. 124 Figure 57. Respiration Menu Display ......................................................................................................................... 124 Figure 58. Connection for mainstream....................................................................................................................... 129 Figure 59. Connection for sidestream ........................................................................................................................ 130 Figure 60. EtCO2 Display .......................................................................................................................................... 131 Figure 61. EtCO2 Waveform Display ......................................................................................................................... 131 Figure 62. EtCO2 Menu Display ................................................................................................................................ 131 Figure 63. Temperature Display ................................................................................................................................. 135 Figure 64. Temperature Menu Display ....................................................................................................................... 135 Figure 65. IBP connections ........................................................................................................................................ 138 Figure 66. IBP 1 Display ............................................................................................................................................ 139 Figure 67. IBP 1 Waveform Display ........................................................................................................................... 139 Figure 68. IBP 1 Menu Display .................................................................................................................................. 139 Figure 69. IBP 2 Display ............................................................................................................................................ 140 Figure 70. IBP 2 Waveform Display ........................................................................................................................... 140 Figure 71. IBP 2 Menu Display .................................................................................................................................. 140 Figure 72. Auto Self-test display ................................................................................................................................ 144 Figure 73. External shock test ................................................................................................................................... 145 Figure 74. Event Data List Display............................................................................................................................. 147 Figure 75. Event Review Display ............................................................................................................................... 148 Figure 76. 12 Lead Record Display ........................................................................................................................... 149 Figure 77. Patient Info Menu ..................................................................................................................................... 149 Figure 78. Real-time data Menu ................................................................................................................................ 151 Figure 79. Real-time print (Header and Event messages) ......................................................................................... 152 Figure 80. Real-time print (Waveform, Shock info and Trend) ................................................................................... 153 Figure 81. Printer setting Menu ................................................................................................................................. 165 Figure 82. Print-out .................................................................................................................................................... 167 Figure 83. Print-out on shock ..................................................................................................................................... 167 Figure 84. Print-out on 12 lead ECG data .................................................................................................................. 168 Figure 85. Print-out on self-test result ........................................................................................................................ 168 Figure 86. Print-out on setting information ................................................................................................................. 169 Figure 87. Printer Paper Replacement ...................................................................................................................... 176 Figure 88. Biphasic Waveforms at 300 Joules and 360 Joules ................................................................................. 204 Figure 89. Biphasic Waveforms at 200 Joules ........................................................................................................... 204 Figure 90. Biphasic Waveforms at 175 Joules ........................................................................................................... 205 Figure 91. Biphasic Waveforms at 150 Joules ........................................................................................................... 205 Figure 92. Biphasic Waveforms at 125 Joules ........................................................................................................... 206 Figure 93. Biphasic Waveforms at 100 Joules ........................................................................................................... 206 Figure 94. Biphasic Waveforms at 75 Joules ............................................................................................................. 207 Figure 95. Biphasic Waveforms at 50 Joules ............................................................................................................. 207 Figure 96: Biphasic Waveforms at 40 Joules ............................................................................................................. 208 Figure 97. Biphasic Waveforms at 30 Joules ............................................................................................................. 208 Figure 98. Biphasic Waveforms at 20 Joules ............................................................................................................. 209 Figure 99. Biphasic Waveforms at 10 Joules ............................................................................................................. 209 Figure 100. Biphasic Waveforms at 9 Joules ............................................................................................................. 210 Figure 101. Biphasic Waveforms at 8 Joules ............................................................................................................. 210 Figure 102. Biphasic Waveforms at 7 Joules ............................................................................................................. 211 Figure 103. Biphasic Waveforms at 6 Joules ............................................................................................................. 211 Figure 104. Biphasic Waveforms at 5 Joules ............................................................................................................. 212 Figure 105. Biphasic Waveforms at 4 Joules ............................................................................................................. 212 Figure 106. Biphasic Waveforms at 3 Joules ............................................................................................................. 213 Figure 107. Biphasic Waveforms at 2 Joules ............................................................................................................. 213 Figure 108. Biphasic Waveforms at 1 Joules ............................................................................................................. 214



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Tables Table 1. The defibrillator/monitor controls .................................................................................................................... 18 Table 2. The defibrillator/monitor controls on paddle ................................................................................................... 19 Table 3. Panel and Label Symbols .............................................................................................................................. 22 Table 4. Display Symbols............................................................................................................................................. 24 Table 5. Display Colors Factory Defaults ..................................................................................................................... 25 Table 6. Standard Accessories..................................................................................................................................... 28 Table 7. Optional Accessories...................................................................................................................................... 29 Table 8. Front Panel Indications for Power Source ...................................................................................................... 36 Table 9. The defibrillator/monitor Battery Status Icon .................................................................................................. 37 Table 10. Date/Time Menu ........................................................................................................................................... 41 Table 11. High Priority Alarm........................................................................................................................................ 46 Table 12. Medium Priority Alarm .................................................................................................................................. 47 Table 13. Low Priority Alarm ........................................................................................................................................ 48 Table 14. Informative Messages .................................................................................................................................. 49 Table 15. Defibrillator Messages .................................................................................................................................. 49 Table 16. Visual Alarm Characteristics......................................................................................................................... 51 Table 17. Audible Alarm Characteristics ...................................................................................................................... 51 Table 18. Alarm Limits Ranges .................................................................................................................................... 53 Table 19. Bell Icon ....................................................................................................................................................... 55 Table 20. ECG Lead Colors ......................................................................................................................................... 59 Table 21. ECG Lead Pairs ........................................................................................................................................... 59 Table 22. Measurement Matrix .................................................................................................................................... 67 Table 23. HR/PR Menu ................................................................................................................................................ 69 Table 24. AED Mode Menu .......................................................................................................................................... 80 Table 25. Manual Mode Menu ..................................................................................................................................... 86 Table 26. Monitor Mode Menu ..................................................................................................................................... 93 Table 27. Pacing Mode Menu .................................................................................................................................... 102 Table 28. Cuff Size..................................................................................................................................................... 109 Table 29. NIBP Menu ................................................................................................................................................. 110 Table 30. SpO2 Sensors ............................................................................................................................................ 117 Table 31. SpO2 Menu ................................................................................................................................................ 118 Table 32. Demographic Data ..................................................................................................................................... 121 Table 33. SpO2 Accuracy for Nellcor™ Sensors ....................................................................................................... 122 Table 34. Respiration Menu ....................................................................................................................................... 125 Table 35. EtCO2 Menu .............................................................................................................................................. 131 Table 36. Temperature Sensors ................................................................................................................................. 135 Table 37. Temperature Menu ..................................................................................................................................... 136 Table 38. IBP 1 Menu ................................................................................................................................................ 139 Table 39. IBP 2 Menu ................................................................................................................................................ 141 Table 40. Self-test functions....................................................................................................................................... 144 Table 41. Trouble shooting of Self-test....................................................................................................................... 146 Table 42. Wireless Status Icon and Bed Number Icon ............................................................................................... 171 Table 43. Parameter Ranges and Factory Defaults ................................................................................................... 181 Table 44. Delivered Energy at Every Defibrillator Settings into a Range of Loads ..................................................... 203 Table 45. Electromagnetic Emissions (IEC60601-1-2)............................................................................................... 219 Table 46. Electromagnetic Immunity (IEC60601-1-2) ................................................................................................ 219 Table 47. Electromagnetic Immunity (IEC60601-2-4) ................................................................................................ 221 Table 48. Electro-surgical Unit Interference (IEC 60601-2-27, IEC 60601-2-30) ....................................................... 222 Table 49. Recommended Separation Distances ........................................................................................................ 222 Table 50. Immunity to proximity fields from RF wireless communications equipment (IEC 60601-1-2) ..................... 223 Table 51. Cables (IEC60601-1-2) .............................................................................................................................. 223



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SAFETY INFORMATION General Safety Information This section contains important safety information related to general use of the D500 defibrillator/monitor. Other important safety information appears throughout the manual. The D500 defibrillator/monitor will be referred to as the defibrillator/monitor throughout this manual. Important! Before use, read carefully the manual, accessory directions for use, all precautionary information and specifications.



Warning Warnings alert you to potential serious outcomes (death, injury, or adverse events) to the patient or user. Do not take or use the defibrillator/monitor in locations where highly combustible anesthetics or flammable gases are used or in highpressure oxygen rooms or inside oxygen tents, as this may cause a flammable explosion. Turn off the gas source or move the source away from patient during defibrillation. When using the defibrillator/monitor with anesthetics, nitrous oxide or high concentrations of oxygen, connect the gas outlet to a scavenger system. When using the defibrillator/monitor with a commercial electric power source, use the defibrillator/monitor with an electric power wall socket with a grounding wire for medical use. Not doing so could cause electric shock. Do not connect grounding wire to gas pipes. This could cause fire. Only doctors and officially certified personnel should use this defibrillator/monitor. Do not allow patients to touch the defibrillator/monitor. Allowing patients to touch the defibrillator/monitor could cause accidents. The defibrillator/monitor cannot be used when MRI is in progress. If MRI is in use, keep patient attachments away from patients to prevent accidents. The defibrillator/monitor conforms to the requirements of the EMC standard (IEC60601-1-2), and may therefore be used simultaneously with pacemakers and other electrical simulators. It should, however, be noted that the defibrillator/monitor may be affected by electrical scalpels and microwave therapeutic apparatus. Please check operation of the defibrillator/monitor during and after use of such equipment. Do not take mobile phones or transceivers into a room where this defibrillator/monitor is installed, as such devices may cause accidents. In order to avoid accidents, do not use any unauthorized accessories or options. Thoroughly read the instruction manuals supplied with accessories and options to ensure correct use. This instruction manual does not carry the caution selections for such equipment.



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Do not open cover or disassemble this defibrillator/monitor. Doing so could cause electric shock or fire. It is prohibited by law to modify the defibrillator/monitor without authorization. Do not use power source other than the specified voltage, (100240V~50/60Hz) as this may cause fire or electric shock. Pre-use inspection and preventive maintenance must be performed for safe use. The defibrillator/monitor equipment.



may



be



used



with



electrical



surgical



Follow the instruction manuals for medical instruments – notably electrosurgical and diathermy instruments – when used, as their high– frequency energy units may cause burns to patients via attachments. This defibrillator/monitor is protected against the discharge of a defibrillator. However, do not touch the defibrillator/monitor when a defibrillator is being discharged (electrified), as doing so may cause electric shock. The following cautions apply when connecting the defibrillator/monitor with other equipment. 1. Ensure that the connected equipment is in accordance with the IEC60601-1 or IEC safety standards, so that the system complies with IEC60601-1. 2. Employ additional protective measures (e.g. additional protective earthing) as necessary. Do not connect devices that do not meet medical safety standards (such as commercial PCs), as they may cause electric shock. This defibrillator/monitor meets the restricted level of leakage current required for medical devices. Therefore, this defibrillator/monitor cannot be connected to a device that would give a combined total of leakage current beyond the restricted level. Avoid connecting the patient to several devices at once. Leakage current limits may be exceeded. Do not use a second defibrillator on the patient while pacing with the defibrillator/monitor. Do not place anything on top of this defibrillator/monitor. If something is spilled over the defibrillator/monitor or gets into it, such spillage may cause fire or electric shock. If fluid spills on the defibrillator/monitor accidentally, disconnect power cord, wipe dry immediately, and have the defibrillator/monitor serviced to make sure that no hazard exists. Do not place heavy objects on the power cord, as doing so may cause fire or electric shock. Before conducting maintenance work, turn the power off and unplug the power cord from the wall socket to prevent electric shock. When the following occur, turn the power off immediately and unplug the power cord from the wall socket. Continued use in such situations may cause fire or electric shock.  There is smoke or a strange odor leaking out of the defibrillator/monitor.  The defibrillator/monitor has been dropped or impacted by an object.  Liquid or foreign matter gets inside the defibrillator/monitor.  Defibrillator/monitor failure has occurred. Also, when any of the above occurs, promptly do the following: 1. Check to see that the power cord has been unplugged from the



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wall socket. Place an “Out of Order” sign on the defibrillator/monitor and do not use it. 3. Have the defibrillator/monitor serviced to make sure that no hazard exists. Do not connect more than one patient to the defibrillator/monitor. Do not connect more than one defibrillator/monitor to a patient. 2.



The defibrillator/monitor is a prescription device and is to be operated by qualified personnel only. As with any medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Never lift the defibrillator/monitor by the sensor cable, blood pressure hose, power cord, or any other accessory. Such accessories could detach, causing the defibrillator/monitor to fall on the patient. Do not make any clinical judgments defibrillator/monitor’s measurement only.



based



on



this



Emergency defibrillation should be performed only by appropriately trained, skilled and qualified personnel who are aware of the protocol for handling a patient in medical emergency such as cardiac arrest and have been certified in Advanced Cardiac Life Support (ACLS) or Basic Life Support (BLS). Synchronized electrical cardioversion should be performed only by skilled personnel trained in Advanced Cardiac Life Support (ACLS) and practiced in equipment operation. The precise cardiac arrhythmia must be determined prior to performing defibrillation. The defibrillator delivers up to 360 joules of electrical energy. Unless properly used as described in this manual, this electrical energy may cause serious injury or death. Do not attempt to operate this defibrillator/monitor unless thoroughly familiar with this manual and the function of all controls, indicators, connectors and accessories. Do not discharge standard paddles on top of pads or ECG electrodes. Do not allow standard paddles (or pads) to touch each other, ECG electrodes, lead wires, dressings, transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy away from the heart muscle. Discharging the defibrillator/monitor with the standard paddle surfaces shorted together can pit or damage the paddle electrode surface. Pitted or damaged paddle surfaces may cause patient skin burns during defibrillation. Discharge the defibrillator only as described in theses operating instructions. If a person is touching the patient, bed, or any conductive material in contact with the patient during defibrillation, the delivered energy may be partially discharged through that person. Clear everything away from contact with the patient, bed, and other conductive material before discharging the defibrillator/monitor. Do not discharge the defibrillator into the open air. To remove an unwanted charge, change the energy selection, or change the mode, or turn off the defibrillator/monitor. Conductive gel on the paddle handles can allow the electrical energy to be discharged through the operator during defibrillation. Completely



9



clean the paddle electrode surfaces, handles, and storage area after defibrillation. A gel pathway on the skin between the standard paddles will cause defibrillating energy to arc between paddles and delivery energy away from the heart muscle. Do not allow conductive gel (wet or dry) to become continuous between paddle sites. During defibrillation checks, the discharged energy passes through the cable connectors. Securely attach cable connectors to the simulator. Do not touch the patient or any equipment connected to the patient during defibrillation. Warn all persons around patient to DO NOT TOUCH THE PATIENT prior to defibrillation. The defibrillator/monitor should be out of contact with water (puddles or water spray). It may cause electrical shocks and defibrillator/monitor failure. Electrical safety of the defibrillator/monitor may not work properly when wet. Defibrillation may cause implanted devices to malfunction. Place standard paddles or pads away from implanted devices if possible. Check implanted device function after defibrillation. Implanted pacemakers may cause the heart rate meter to count the pacemaker rate during incidents of cardiac arrest or other arrhythmias. Pacemaker patients should be carefully observed. Check the patient’s pulse; do not rely solely on heart rate meters. Dedicated pacemaker detection circuitry may not detect all implanted pacemaker spikes. Patient history and physical exam are important in determining the presence of an implanted pacemaker. To ensure patient electrical isolation, connect only to other equipment with circuits that are electrically isolated. To avoid risk of electric shock, the defibrillator/monitor must only be connected to a supply mains with protective earth. The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: Use of the accessory in the PATIENT VICINITY. Evidence that the safety certification of the ACCESSORY has been performed in accordance with the appropriate IEC (EN) 60601-1 and/or IEC (EN) 60601-1-1 harmonized national standards. The defibrillator/monitor is equipped with RF telemetry module which transmits with 50dBm power in the 2.5GHz. The module has been tested and certified to be equipped safely. Check leakage levels prior to use. Leakage current may be excessive if more than one defibrillator/monitor or other piece of equipment is connected to the patient. Do not place or use the defibrillator/monitor when flammable gas presents in atmospheres or other flammable material exist near/around. Eg. Oxygenrich area, flammable anesthetic gases, gasoline and any flammable material or gas. Do not use the defibrillator/monitor near the place of a gasoline or other volatile substances spill may cause an explosion. Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high voltages may be present. Contact authorized service personnel for repair.



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Do not immerse any portion of this defibrillator in water or other fluids. Avoid spilling any fluids on defibrillator or accessories. Spilled liquids may cause the defibrillator and accessories to perform inaccurately or fail. Do not clean with ketones or other flammable agents. Do not autoclave or sterilize this defibrillator or accessories unless otherwise specified. Use care when operating this device close to oxygen sources (such as bag-valve-mask devices or ventilator tubing). Turn off gas source or move source away from patient during defibrillation. Check leakage levels prior to use. Leakage current may be excessive if more than one defibrillator/monitor or other piece of equipment is connected to the patient. If you are monitoring a patient and using the system connector, all equipment connected to the system connector must be battery powered or electrically isolated from AC power according to EN 60601-1. If in doubt, disconnect the patient from the defibrillator before using the system connector. Only use Mediana recommended data transmission cables. For more information, contact Mediana Technical Support. The defibrillator/monitor delivers up to 360 joules of electrical energy. When discharging the defibrillator, do not touch the paddle electrode surfaces or disposable paddle/pads electrodes. Do not attempt to perform this test unless you are qualified by training and experience and are thoroughly familiar with these operating instructions. Electric shock hazards exist internally. Do not remove assembly screws. Refer servicing to qualified personnel. Monitors, defibrillators, and their accessories (including electrodes and cables) contain ferromagnetic materials. As with all ferromagnetic equipment, these products must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging (MRI) device. The high magnetic field created by an MRI device will attract the equipment with a force sufficient to cause death or serious personal injury to persons between the equipment and the MRI device. This magnetic attraction may also damage the equipment. Skin burns will also occur due to heating of electrically conductive materials, such as patient leads and pulse oximeter sensors. Consult the MRI manufacturer for more information. Medical electrical equipment which does not incorporate defibrillator protection should be disconnected during defibrillation. Operating the defibrillator/monitor or its accessories in conditions outside the environmental specifications can result in device or accessory malfunction. The defibrillator/monitor should be allowed to stabilize within the operating temperature range prior to operation.



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Cautions Caution statements identify conditions or practices that could result in damage to the equipment or other property. Always check that the defibrillator/monitor functions properly and is in proper condition before use. Federal law restricts this device to sale by or on the order of a physician. The defibrillator/monitor may not operate properly if it is operated or stored at conditions outside the ranges stated in this manual, or subjected to excessive shock or dropping. When connecting the defibrillator/monitor to any instrument, verify proper operation before clinical use. Both the defibrillator/monitor and the instrument connected to it must be connected to a grounded outlet. Accessory equipment connected to the defibrillator/monitor’s data interface must be certified according to IEC60950 for data-processing equipment or IEC60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC60601-1-1 system requirements. Anyone who connects additional equipment to the signal input or signal output port configures a medical system and is therefore responsible that the system complies with the requirements of IEC 60601-1-1 and the electromagnetic compatibility system standard IEC60601-1-2. If in doubt, consult Mediana Technical Support Representative. Where the integrity of the external protective conductor in the installation or its arrangement is in doubt, equipment shall be operated from its internal electrical power source. Risk of explosion if battery is replaced by an incorrect type.



12



INTRODUCTION Patient conditions may result in erroneous readings. If the measurements are suspect, verify the reading using another clinically accepted measurement method.



Intended Use for the D500 The defibrillator/monitor is intended for use by trained medical technician, doctor, nurse or medical specialist in outdoor and indoor emergency care settings including air and ground ambulances within the environmental conditions specified. Manual and Automated external defibrillation, External pacing are intended for use on adult and pediatric (infantchild) patients. Diagnostic electrocardiography (12-lead ECG) are intended for use on adult and pediatric patients. The other monitoring functions (Electrocardiography (ECG, Heart Rate), Non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), respiration (RESP), temperature (TEMP) and invasive blood pressure (IBP)) are intended for use on adult, pediatric and neonatal patients. End tidal CO2 (EtCO2) are intended for use on adult, pediatric and infant patients.



Indications for Use Indications Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and ventricular tachycardia. Delivery of this energy in the synchronized mode is a method for treating atrial fibrillation, atrial flutter.



Contraindications Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as idioventricular or ventricular escape rhythms, and in the treatment if asystole. Defibrillation is not intended for patient who is conscious and has a palpable pulse and is contraindicated for use on neonates.



Automated External Defibrillation



AED mode is to be used only on patients in cardiopulmonary arrest. The patient who must be unconscious, pulseless and not breathing normally before using the defibrillator to analyze the patient’s ECG rhythm.



AED is not intended for patient who is conscious and has a palpable pulse and is contraindicated for use on neonates.



External Pacing



External pacing is indicated for symptomatic bradycardia in patients with a pulse. Increased heart rates in response to external pacing often suppress ventricular



External pacing is contraindicated for the treatment of ventricular fibrillation and asystole. External pacing in the presence of severe



Manual Defibrillation



13



14



Indications ectopic activity and may prevent tachycardia.



Contraindications hypothermia may be contraindicated and is contraindicated for use on neonates.



Electrocardiography



The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection.



No known contraindications



Noninvasive Blood Pressure



Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension and monitoring BP trends in patient conditions such as, but not limited to, shock, acute dysrhythmia, or major fluid imbalance.



Noninvasive Blood Pressure is not intended for use with severe arrhythmia. Noninvasive Blood Pressure is not intended for patients who are experiencing convulsion or tremors.



Pulse Oximetry



Pulse oximetry monitoring is intended to be used to monitor functional arterial oxygen saturation and pulse rate.



Pulse Oximetry is not intended for use with severe peripheral vascular disease and severe anemia (decreased Hemoglobin).



Invasive Blood Pressure



Invasive pressure monitor is indicated for use in measuring arterial, venous, intracranial and other physiological pressures using and invasive catheter system with a compatible transducer.



No known contraindications



End-Tidal CO2



EtCO2 monitoring is indicated for detection of trends in the level of expired CO2. It is used for monitoring breathing efficacy and treatment effectiveness in acute cardiopulmonary care.



No known contraindications



Temperature



Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.



No known contraindications



About This Manual This manual explains how to set up and use the defibrillator/monitor. Read the entire manual including the Safety Information section, before you operate the defibrillator/monitor.



Identifying the D500 Configurations The following table identifies D500 defibrillator/monitor configurations and how they are indicated. The reference number and serial number are located on the back of the product. All information in this manual, including the illustrations, is based on a device configured with the 12 lead ECG, SpO2 module, Temperature(TEMP) module, Capnography(EtCO2 and InCO2) (Mainstream or Sidestream) module, IBP module and Printer module. Product Code D500M-0 D500M-S D500M-L D500M-LS D500M-LSNT D500M-LSNTB D500M-SNTEM D500M-SNTES D500M-LSNTEM D500M-LSNTES D500M-LSNTBEM D500M-LSNTBES



Description Basic (Manual Defibrillation, Automated External Defibrillation, Pacing, ECG (3 lead, 5 lead), Respiration, Printer) Basic + SpO2 Basic + 12 lead ECG Basic + 12 lead ECG + SpO2 Basic + 12 lead ECG + SpO2 + NIBP/TEMP Basic + 12 lead ECG + SpO2 + NIBP/TEMP + 2CH IBP Basic + SpO2 + NIBP/TEMP + Capnography (Mainstream) Basic + SpO2 + NIBP/TEMP + Capnography (Sidestream) Basic + 12 lead ECG + SpO2 + NIBP/TEMP + Capnography (Mainstream) Basic + 12 lead ECG + SpO2 + NIBP/TEMP + Capnography (Sidestream) Basic + 12 lead ECG + SpO2 + NIBP/TEMP + 2CH IBP + Capnography (Mainstream) Basic + 12 lead ECG + SpO2 + NIBP/TEMP + 2CH IBP + Capnography (Sidestream)



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DESCRIPTION OF THE DEFIBRILLATOR/MONITOR Front Panel Components



1



12 13 - 16 17 18



2 3 4 5



19 - 21 22 23



6



24 - 25 7 8 9



26 - 30



10 11



31



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Figure 1. Front panel components 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16



Paddle NIBP connector LCD Temperature1 connector Temperature2 connector IBP1 connector IBP2 connector Soft key EtCO2 Connector SpO2 connector Printer Handle AC/DC in LED Battery A charging status LED Battery B charging status LED Service LED



17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32



MIC Mode select knob ANALYZE button CHARGE button Energy Level button SHOCK button Multi function knob RATE button mA button NIBP button PRINT button ALARM button LEAD button SIZE button ECG connector Paddle/Pads connector



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Symbols



Table 1. The defibrillator/monitor controls Description Mode select knob selects five modes of operation. (AED, Manual, Monitor, OFF and Pacing) ANALYZE button analyzes the patient’s ECG to determine whether or not to deliver a shock. CHARGE button charges to the desired energy level automatically. Energy Level button selects the defibrillation energy level. SHOCK button delivers a shock. Multi function knob provides user interaction with the defibrillator/monitor to control the functions. RATE button adjusts the rate of pacing waveform. mA button adjusts the current of pacing waveform. NIBP button toggles between starting and stopping NIBP measurements. PRINT button prints measured data. Alarm button pauses the audible alarm temporarily. turns off the audible alarm by pressing over 2 seconds. LEAD button selects to display the desired ECG lead on the screen. SIZE button adjusts and selects the amplitude of an ECG waveform.



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Top Panel Components 1



2



3



4 5



6



Figure 2. Top panel components 1 2 3



Symbols



Paddle Energy level button REC button



4 SHOCK button 5 CHARGE button 6 Charge Indicator



Table 2. The defibrillator/monitor controls on paddle Description CHARGE button charges to the desired energy level automatically. Charge Indicator lights up red when charging is completed. Energy Level button selects the defibrillation energy level. REC button prints the measured data.



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Rear Panel Components



1 2



3



4



5



6



7



Figure 3. Rear panel components 1 2 3 4



20



SMPS/battery push button DC input connector AC power inlet GND terminal



5 AC power supply (SMPS) 6 Speaker 7 Li-ion battery



Left Panel Components



1



1 Side Option Case Figure 4. Left panel components



Right Panel Components



1



2



1 Wireless(3G, Wi-Fi) module 2 USB/SD Card Slot Figure 5. Right panel components



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Symbols



Description AC indicator



Dust and water resistance



Direct current



CE mark



Battery indicator



22



Table 3. Panel and Label Symbols Symbols Description



charging



status



Prescription only device



Service indicator



Follow instructions for use



Type BF- Defibrillator Proof



Separate Collection



Type CF- Defibrillator Proof



EU representative



NIBP connector



Manufacturer



Temperature 1 connector



Date of manufacture



Temperature 2 connector



Reference number



IBP 1 connector



Serial number



IBP 2 connector



Environmental shipping/storage altitude limitations



EtCO2 connector



Environmental shipping/storage humidity limitations



SpO2 connector



Environmental shipping/storage temperature limitations



ECG connector



Fragile



AC power input rating



Keep dry



Equipotential terminal



This way up



Class II equipment



Single patient use only



Displays 1



2



3 4 5



6



7



12



8 9



10



11



13



14



Figure 6. Displays 1 2 3 4 5 6 7



Shock count number/icon Defibrillator message area Battery status icon Elapsed time (Power on) Wi-Fi/3G icon Title of numeric area ECG waveform message area



8 9 10 11 12 13 14



Title of waveform parameter Waveform area Waveform Alarm/Informative message area Numerical area Date/Time Soft key menu



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Symbols



Description



Table 4. Display Symbols Symbols Description



ECG source: Paddle



Temperature unit: Celsius



ECG source: Lead l



Temperature unit: Fahrenheit



ECG source: Lead ll



SpO2 unit or EtCO2 unit: %



ECG source: Lead lll



Respiration Icon



ECG source: Lead aVL ECG source: Lead aVR ECG source: Lead aVF



Pulse amplitude indicator



ECG source: Lead V



EtCO2 respiration: AW



ECG source: Lead V1



Thoracic impedance respiration: IM



ECG source: Lead V2



NIBP auto mode interval



ECG source: Lead V3



NIBP elapsed time



ECG source: Lead V4



HR/PR icon & unit



ECG source: Lead V5



Communication source: 3G



ECG source: Lead V6



Communication source: Wi-Fi



ECG source: Pads



Bed number icon



NIBP icon : Noninvasive Blood Pressure



Shock count number / icon



SpO2 waveform icon



Elapsed time (Power on) icon



Impedance respiration waveform icon EtCO2 icon : End-tidal carbon dioxide concentration InCO2 icon: Inspired carbon dioxide concentration



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NIBP or IBP or EtCO2 unit: mmHg NIBP or IBP or EtCO2 unit: kPa



Neonatal icon DC power input icon Battery status icon



IBP1 waveform icon



AC power input icon (Note: AC power input icon is displayed if the battery has been inserted.)



IBP1 waveform icon



Time display



IBP2 waveform icon



Alarm active



IBP2 waveform icon



Audio pause



IBP2 waveform icon



Audio off or Limit alarm pause



IBP2 waveform icon



Pacer pulse detection icon



Temperature 1 icon



ECG gain



Temperature 2 icon



Wi-Fi communication icon



Table 5. Display Colors Factory Defaults Function Color ECG Waveform Green SpO2 Waveform Cyan Respiration Waveform Light Blue EtCO2 Waveform Light Purple ECG Green NIBP White SpO2 Cyan Respiration Rate Light Blue EtCO2 Light Purple Temperature1 Pink Temperature2 Pink IBP 1 Red IBP 2 Yellow General background Black Alarm/Informative message Black background, Green font Defibrillator message Black background, White font Low priority alarm message Black background, Yellow font Medium priority alarm message Black background, Yellow font High priority alarm message Black background, Red font ECG alarm waveform message Green Battery status icon (normal) Green (refer to Table 9) Battery status icon (low battery) Yellow (refer to Table 9) Battery status icon (critically low battery) Red (refer to Table 9) Note: The display colors can only be changed by authorized personnel via the Service Menu. The detailed information is described in the service manual.



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SETTING UP THE DEFIBRILLATOR/MONITOR To ensure accurate performance and prevent defibrillator/monitor failure, do not expose the defibrillator/monitor to extreme moisture, including direct exposure to rain. Such exposure may cause inaccurate performance or device failure. Refer to Specification section. The defibrillator/monitor should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the defibrillator/monitor should be observed to verify normal operation in the configuration it is to be used. Make sure that the defibrillator/monitor speaker is not obstructed. Failure to do so could result in an inaudible alarm tone. Recharging the battery is strongly recommended when the battery has not been recharged for 6 or more months. Follow local government ordinances and recycling instructions regarding disposal or recycling of defibrillator/monitor components, including batteries. The use of accessories, cables, transducers and sensors sourced from manufacturers, which Mediana has not recommended may cause incorrect analysis. Electrical installation of the room or the building in which the defibrillator/monitor is to be used must comply with regulations specified by the country in which the equipment is to be used.



Unpacking and Inspection The defibrillator/monitor is shipped in one carton. Examine the carton carefully for evidence of damage. Contact Mediana Technical Support Representative immediately if any damage is discovered. Refer to the Maintenance section for instructions on returning damaged items. Note: Refer to the Performance Verification section in the service manual for detailed information. Set the defibrillator/monitor to the user’s intended position where the user can easily recognize the visual and audible monitoring conditions. Normally it is recommended to set at a distance of 1m from the user. Also the viewpoint is at any point within the base of a cone by an angle of 30° to the center of the monitoring display.



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List of Components The following items are standard in the package. Table 6. Standard Accessories Items D500 defibrillator/monitor Operator’s manual AC power cord Printer paper Defibrillation pads for adult Defibrillation pads for pediatric (infant-child) Pads extension cable ECG 3 leads cable (SNAP) SpO2 sensor



Qty 1 1 1 2 1 1 1 1 1



*Only when SpO2 option is installed.



SpO2 extension cable



1



*Only when SpO2 option is installed.



NIBP cuff for adult



1



*Only when NIBP option is installed.



NIBP cuff for pediatric



1



*Only when NIBP option is installed.



NIBP cuff hose for adult and pediatric



1



*Only when NIBP option is installed.



CAPNOSTAT 5 mainstream CO2 sensor



1



*Only when CO2 option is installed.



LoFlo airway adapter w/nafion, pediatric/adult



box/10ea



*Only when CO2 option is installed.



Single patient use adult airway adapter



box/1ea



*Only when CO2 option is installed.



Single patient use neonatal airway adapter



box/1ea



*Only when CO2 option is installed.



Cable holding clips



box/5ea



*Only when CO2 option is installed.



SMPS Li-ion battery



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1 1



Optional items may be ordered if needed. Contact your local supplier for pricing and ordering information. Table 7. Optional Accessories Items Paddle Defibrillation / external pacing pads for adult Defibrillation / external pacing pads for pediatric (infant-child) NIBP cuff for neonate NIBP cuff hose for neonate ECG 3 leads cable (GRAB) ECG 5 leads cable (SNAP) ECG 5 leads cable (GRAB) ECG 12 leads cable (SNAP) ECG 12 leads cable (GRAB) SpO2 disposable sensor LoFlo CO2 cannula-adult LoFlo CO2 nasal cannula-pediatric LoFlo CO2 nasal cannula-infant LoFlo CO2 nasal cannula w/O2-adult LoFlo CO2 nasal cannula w/O2-pediatric LoFlo CO2 nasal cannula w/O2-infant LoFlo CO2 oral/nasal cannula-adult LoFlo CO2 oral/nasal cannula-pediatric LoFlo CO2 oral/nasal cannula w/O2-adult LoFlo CO2 oral/nasal cannula w/O2-pediatric LoFlo airway adapter-pediatric/adult LoFlo airway adapter-pediatric/infant LoFlo airway adapter w/nafion, pediatric/infant Straight sampling line Straight sampling line w/nafion Module mounting bracket Single patient use adult airway adapter w/mouthpiece CAPNO2 mask-pediatric CAPNO2 mask-adult standard CAPNO2 mask-adult large Cable management straps Service manual (English) External DC-DC adaptor Carry bag Earth cable for ambulance



Qty -



box/10ea box/10ea box/10ea box/10ea box/10ea box/10ea box/10ea box/10ea box/10ea box/10ea box/10ea box/10ea box/10ea box/10ea box/10ea 1 box/10ea box/10ea box/10ea box/10ea box/10ea -



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Power Cable Connections Do not connect to an electrical outlet controlled by a wall switch or dimmer because the defibrillator/monitor may be accidentally turned off. If the integrity of the AC power source is in doubt, the defibrillator/monitor must be operated from its internal battery. AC Power Make sure that the AC outlet is properly grounded and supplies the specified voltage and frequency (100-240V~ 50/60 Hz).



Figure 7. AC Power Connection 1. 2. 3.



4.



Connect the female type connector end of the AC power cord to mains connector on the defibrillator/monitor’s rear panel. Plug the male type connector end of the AC power cord into a properly grounded mains outlet. If necessary, connect grounding wire. Connect the grounding wire connector to the equipotential terminal on the rear panel. Now attach the clip end of the grounding wire to the medical equipment grounding terminal on the wall. Verify that the Battery charging status LED and AC/DC in LED on the defibrillator/monitor’s front panel is lit.



Note: Battery A charging status LED indicates battery A is installed and being charged by the AC power. Note: Even if the defibrillator/monitor is not turned on, the Battery charging status LED is lit when the AC power cord is connected into a mains outlet. Note: Do not place the defibrillator/monitor so that it is difficult to disconnect the AC power cord.



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DC Power The external DC power source can be used, when the defibrillator/monitor is used for the emergency condition in the moving car.



Figure 8. DC Power Connection 1. 2.



Connect an external DC-DC adaptor (input: 12-16 Vdc output: 18Vdc) to defibrillator/monitor rear panel connecter identified with the DC power symbol. Verify that the DC power input icon appears on the screen, Battery charging status LED and AC/DC in LED on the defibrillator/monitor’s front panel is lit.



Note: Battery A charging status LED indicates battery A is installed and being charged by the AC power and Battery B charging status LED indicates battery B is installed and being charged by the AC or DC power. Note: Even if the defibrillator/monitor is not turned on, the Battery charging status LED is lit when the External DC-DC adaptor is connected into a DC input connector. Note: If the Battery charging status LED is not lit, check:  the power cord  the external DC-DC power cable  the AC input connector  the DC input connector  the power/ mains outlet  No Battery Note: If the Battery charging status LED still is not lit although no problem is found, contact qualified service personnel or your local supplier for assistance. Note: Do not connect the External DC-DC adapter and an AC power supply (SMPS) to the defibrillator/monitor together.



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Measurement Cable Connections For best product performance and measurement accuracy, use only accessories supplied or recommended by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. Use only accessories that have passed the recommended biocompatibility testing in compliance with ISO10993-1. Connect the sensor, probe, cuff/hose or transducer firmly into socket and do not use a damaged sensor, probe or cuff/hose. To avoid damage to the cable, always hold by the connector rather than the cable, when connecting or disconnecting either end. The sensor connector should not be connected to anything other than a sensor. Note: Both frequent checks by the operator on a daily basis and more comprehensive technical checks less frequently are covered by this requirement in order to detect mechanical damage and damage to cables, etc. ECG Cables and Leads 1.



Connect an ECG cable to the ECG connector making sure that the connector arrow is pointing panel (see Figure 1)



Defibrillator Paddle and Pads 1. 2. 3. 4.



Connect a paddle or pads to paddle / pads connector on the defibrillator/monitor’s front panel. (see Figure 1) Use LEAD button to select pads. (If paddle is connected, the mode is automatically changed to paddle.) Apply conductive material to paddles. Apply paddles or pads to patient’s bare skin.



NIBP Hoses and Cuffs (if configured with NIBP option) 1. 2. 3.



Select an appropriate size cuff for the patient. (Refer to the NIBP Monitoring section.) Connect the hose to the NIBP connector making sure to tighten the connector in the clockwise direction. (see Figure 1) Attach the cuff to the end of the hose.



SpO2 Cables and Sensors (if configured with SpO2 option) 1. 2. 3.



32



Select an appropriate sensor for the patient and desired application. (Refer to the SpO2 Monitoring section.) Connect the extension cable to the SpO2 connector on the defibrillator/monitor’s front panel. (see Figure 1) Attach the sensor to the end of the cable.



Temperature Probes (if configured with Temperature option) 1. 2.



Select the appropriate probe(s) for the desired application. (Refer to the Temperature Monitoring section.) Connect the temperature probes to the Temperature connector on the defibrillator/monitor’s side option case. (see Figure 1)



CO2 Sensor (if configured with CO2 option) 1. 2.



Select the appropriate CO2 sensor according to the operational mode. (Refer to the Capnography Monitoring section.) Connect Mainstream or Sidestream sensor to the CO 2 connector on the defibrillator/monitor’s side option case. (see Figure 1)



IBP Transducers (if configured with IBP option) 1.



2.



Connect the interface cable(s) for the transducer(s) to the “IBP” connector on the monitor’s side option case. An interface cable for the transducer has to be selected correctly as it depends on the transducer type. (see Figure 1, IBP Monitoring section) Set up the patient circuit according to the directions for use of the transducer, monitoring kit and IV set (6pin, red round connector).



Note: If leadwire cable, cuff/hose cable, sensor, probe and transducer are not connected firmly, the defibrillator/monitor could lose signal from patient.



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BATTERY OPERATION Do not disassemble, puncture, crush, heat above 100°C (212°F), or incinerate the battery. Be careful not to short the battery terminals because this could result in a fire hazard. Mediana has no information regarding the performance or effectiveness of its Mediana defibrillator/monitors if other manufacturers’ batteries or battery chargers are used. Using other manufacturers’ batteries or battery chargers may cause the defibrillator/monitor to perform improperly and invalidate the safety agency certifications. Use only Mediana’s battery or battery charger. Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “HOSPITAL ONLY” or “HOSPITAL GRADE”. If the grounding integrity of the line cord or AC receptacle is in doubt, operate on battery only. Recharging the battery is strongly recommended when it has not been fully recharged for 6 or more months. Do not install the battery into the defibrillator/monitor when storage may exceed 90 days. Battery damage may occur. When the voltage of the battery is very low, it is a possibility of not operating. Check for the battery-in-use indication when the defibrillator/monitor is operating on mains and apply corrective action. Do not operate the defibrillator/monitor without a battery. Keep a fully charged spare battery pack with the defibrillator/monitor at all times. Partial charge of battery results in a shortened service life. Storing at temperatures above 40°C (104°F) for extended periods of time will significantly reduce a battery’s life-expectancy. Using an improperly maintained battery to power the defibrillator/monitor may cause power failure without warning. Use the appropriate battery charger to charge batteries. Battery pins in the defibrillator/monitor may be damaged if batteries are dropped or forced into battery wells. Inspect pins routinely for signs of damage. Keep batteries installed at all times except when defibrillator/monitor is removed from service for storage. When storing the defibrillator/monitor for an extended period of time, the battery should be removed from the defibrillator/monitor. Stored batteries lose charge. Failure to charge a stored battery before use may cause device power failure without warning. Always charge a stored battery before placing it in active use. Note: It is recommended that keep AC power source connected to the defibrillator/monitor when not in use. This will ensure a fully charged battery whenever it is needed. Note: As the battery is used and recharged over a period of time, the amount of time between the onset of the low battery alarm and the defibrillator/monitor shut-off may become shorter. It is recommended for service personnel to check periodically or replace the battery if necessary.



35



Operating the defibrillator/monitor on Battery Power The defibrillator/monitor has the rechargeable battery that can be used to power the defibrillator/monitor when AC power source or external DC-DC adaptor is not available. The battery status icon appears on the screen when the defibrillator/monitor is on battery power. Note: The defibrillator/monitor can be powered with two batteries when a battery is inserted instead of AC power supply (SMPS). When the defibrillator/monitor is equipped with two batteries, two battery status icons appear on the screen.



Figure 9. Battery Placement 1. 2. 3.



Turn off the defibrillator/monitor. Push the AC power supply (SMPS)/battery push button. Insert the battery into the defibrillator/monitor carefully. Table 8. Front Panel Indications for Power Source Power Connections AC source DC source Battery



Front Panel Indications Battery charge icon is displayed on the screen. AC/DC in LED is lit. DC power input icon appears on the screen. AC/DC in LED is lit. Battery status icon appears on the screen.



The defibrillator/monitor cannot operate with a completely discharged battery. Before turning on the defibrillator/monitor with a battery that has been completely discharged, plug the defibrillator/monitor into an AC outlet to charge the battery for a minimum of 3 minutes. The defibrillator/monitor may then be powered on. A new, fully charged battery will provide 5 hours monitoring operation under the following conditions:     



Operation of ECG monitoring or in defibrillation mode (Standard option) No audible alarm condition No external communication operating No recording Ambient temperature at 25°C±5°C



Note: If there is the combination of battery A and B in the defibrillator/monitor, two new, fully charged batteries will provide 10 hours monitoring operation.



36



Battery Status Indication When operating on batteries, the battery status icon in the lower part of the display indicates the battery charge condition. See Table 9. Table 9. The defibrillator/monitor Battery Status Icon Battery Status Icons



Battery Status Icon Color Green (normal condition) Yellow (low battery) Red (critically low battery) White (charging)



A low priority alarm occurs when the remaining battery power is only enough for 15 minutes of operation. The “Low battery” message is displayed on the screen. Connect the AC power or replace the battery with a fully charged battery immediately when alarm occurs. This alarm cannot be paused while running on battery power. Connecting the defibrillator/monitor to AC power will stop the alarm. A high priority alarm occurs for about 5 minutes before the defibrillator/monitor shuts off. The “SYSTEM: Critically low-battery condition” message is displayed on the screen. Connect the defibrillator/monitor to an AC power source immediately to avoid any loss of trend data or settings. Note: The battery will not be charged for safety if the operating temperature exceeds 40°C.



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USING THE DEFIBRILLATOR/MONITOR Each time the defibrillator/monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. If different alarm presets are used for the same or similar equipment in any single area, e.g. an intensive care unit or cardiac operating room, a potential hazard can exist. Keep patients under close surveillance when monitoring. It is possible, although unlikely, that radiated electromagnetic signals from sources external to the patient and the defibrillator/monitor can cause inaccurate measurement readings. Do not rely entirely on the defibrillator/monitor readings for patient assessment. Be aware of patient cables, including ECG monitoring equipment when used with high frequency surgical equipment. When inaccurate analysis is suspected because of motion artifact do not analyze in a moving vehicle. Motion artifact may affect the ECG signal resulting in an inappropriate SHOCK or NO SHOCK ADVISED message. Motion detection may delay analysis. Stop vehicle and stand clear of patient during analysis. To avoid risk of electrical shock, do not touch gelled area of the pads while pacing or shock. When defibrillating with paddles use your thumbs to operate the SHOCK button in order to avoid inadvertent operator shock. No portion of the hand should be near the paddle plates. Pediatric (Infant-Child) defibrillation energy levels should be set based on site-specific clinical protocols. The metronome sounds do not indicate information regarding the patient’s condition. Because patient status can change in a short time, the patient should be assessed at all times. Do not perform CPR on a patient who is responsive or is breathing normally. Place the patient on a firm surface before performing CPR. Ventricular fibrillation may be induced with improper synchronization. Do not use the ECG from another monitor (slaving) to synchronize the defibrillator/monitor’s discharge. Always monitor the patient’s ECG directly through the defibrillator/monitor’s ECG cable or pad cable. Pitted or damaged paddles may cause patient skin burns during defibrillation. The ECG rhythm analysis function does not warn the operator of patient asystole, as it is not a shockable rhythm. Determination of electrical capture should only be performed by viewing the ECG on the screen with its ECG cable directly attached to the patient. Connect the device only to a three-wire, grounded, hospital grade receptacle. The three-conductor plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electrical code. Do not under any circumstances remove the grounding connector from the power plug. Do not use extension cords or adapters of any type. The power cord and plug must be intact and undamaged. If Select Energy Level button is not pressed when using defibrillation pads for adult or pediatric (infant-child) in Manual mode, defibrillator/monitor has default energy level setting for adult or pediatric (infant-child). Manually select the appropriate energy prior to 39



defibrillating the patient. Only use thumbs to depress the paddle SHOCK button. Failure to do so could result in the inadvertent depression of the energy select buttons, causing the defibrillator/monitor to disarm itself. Do not discharge the defibrillator/monitor except as indicated in the instructions. Do not permit gel to accumulate between the paddle electrodes on the chest wall (gel bridge). This could cause burns and reduce the amount of energy delivered to the heart. Changing the selected energy while the defibrillator/monitor is charging or charged will cause the defibrillator/monitor to disarm itself. Press the CHARGE button again to charge the defibrillator/monitor. If using defibrillation pads, make sure that the size of the pad is large enough to cover the entire paddle electrode area. Pads should be replaced after 8 hours of continuous pacing to ensure maximum patient benefit. Be sure to safely discharge external paddles.



Turning On and Off the defibrillator/monitor Before using the defibrillator/monitor, confirm that the defibrillator/monitor is working properly and is safe to use as described below. Look for display motion before accepting any displayed data as a current measurement. Note: If unusable sound like buzzer can be heard, do not use the defibrillator/monitor. Instead, please contact qualified service personnel or your local supplier. 1. 2.



Rotate Mode select knob to select one mode from AED, manual, monitor or pacing mode. The defibrillator/monitor is turned on in select mode.



Figure 10. Mode Select Knob  AED mode - to enable AED mode for semi-automated external defibrillation.  Manual mode - to enable manual mode for asynchronous or synchronous defibrillation.  Monitor mode - to enable monitor mode for 3- or 5-lead ECG monitoring, 12-lead ECG acquisition and vital signs trending, or monitoring of optional parameters.  Pacing mode - to enable pacing mode for Demand or Fixed mode pacing. Note: Monitor mode can be used in each mode. 3.



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To turn off the defibrillator/monitor, rotate Mode select knob to select Off mode. After selecting Off mode, the settings will be stored and the defibrillator/monitor will be turned off.



Setting Date and Time You may set the date and time displayed on the screen and printed on the reports. 1. Rotate the Multi function knob to highlight Date/Time, and then press the Multi function knob to select Date/Time Menu.



Figure 11. Select Date/Time Menu 2.



Soft key Menu will be changed to Date Format, Set Date, Set Time and Return. Rotate the Multi function knob to the desired format or number and then press the Multi function knob to select the desired format or number. When the soft key is pressed, the relevant Menu will appear.



Level 1 Menu DATE/TIME MENU Date Format



Set Date



Set Time



Table 10. Date/Time Menu Level 2 Menu or Response YY/MM/DD (Year/Month/Day) MM/DD/YY (Month/Day/Year) DD/MM/YY (Day/Month/Year) Return Year Month Day Return Hour Minute Second Return



Return



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Continued use This defibrillator/monitor retains the previous settings when the defibrillator/monitor is turned off for less than 10 seconds. And if the defibrillator/monitor was not turned off and less than 10 minutes have elapsed since the operation mode was last used, the defibrillator/monitor retains the previous settings of last operation mode.



Setting the Main Screen You may select the main screen to be displayed; 4 waveform screen, large numeric screen or Black-white invert screen. 1. 2. 3.



Press Setup soft key to change main screen (4 waveform screen) to large numeric screen or black-white invert screen. Select Display mode menu. Display mode menu will be displayed on screen. Rotate the Multi function knob to the desired display mode and then press the Multi function knob to select the desired display mode.



Note: Large numeric screen can only be selected in monitor mode.



Figure 12. Setup: Display mode Menu



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



4-ch Wave Screen: ECG + SpO2 + ABP + EtCO2



Figure 13. Normal Screen (4 waveform, Defibrillation mode, Full option)







Large Numeric Screen



Figure 14. Large Numeric Screen (2 waveform, Monitor mode, Full option)



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



Black-white Invert Screen (Mono-color screen)



Figure 15. Black-white Screen (4 waveform, Defibrillation mode, Full option)



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ALARMS AND LIMITS Each time the defibrillator/monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. If different alarm presets are used for the same or similar equipment in any single area, e.g. an intensive care unit or cardiac operating room, a potential hazard can exist. Always respond immediately to a system alarm since the patient may not be monitored during certain alarm conditions. Do not to cover the holes for the speaker which allows the alarm sound to exit the defibrillator/monitor. Also do not disable audible alarms when it is not appropriate to do so.



General When the defibrillator/monitor detects certain conditions that require user attention, the defibrillator/monitor enters an alarm state. The defibrillator/monitor response is indicated by:  Audible alarm indication  Physiological alarms including identification of out-of-limit vital signs  Technical alarms Note: The audible and visual alarms on the defibrillator/monitor, used in conjunction with clinical signs and symptoms, are the primary source for notifying medical personnel that a patient alarm condition exists. Note: Each key-control should result in some audible tone and that invalid key-controls are ignored. Have the defibrillator/monitor serviced if the key-controls fail. Changing Alarm Volume User can select an alarm volume level of 1 to 8. 1. 2. 3. 4. 5. 6. 7.



Select the Setup soft key and then the Setup menu will be displayed. Rotate the Multi function knob to highlight Volume and then press the Multi function knob to select Volume Menu. Rotate the Multi function knob to highlight desired menu. Selected menu is activated by pressing the Multi function knob. Rotate the Multi function knob to adjust the volume. Press the Multi function knob to save the desired volume and to select the other menu. Press the Return soft key. Then the current menu returns to the previous menu.



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Figure 16. Volume Menu Display



Alarm Priority and Messages There are three possible priorities for visual and audible alarms: High, Medium, and Low. The high, medium, low priority messages and informative messages are displayed in the alarm/informative message area and the defibrillator messages are displayed in the defibrillator message area. A message is displayed alternatively every 2 seconds when the defibrillator/monitor is in multiple alarm conditions. Refer to the Troubleshooting section for the recommended actions. High Priority High priority alarm indicates that immediate operator response is required. Table 11. High Priority Alarm Parameter ECG %SpO2 IBP EtCO2 Resp SYSTEM



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Condition Asystole V-FIB Loss of Pulse from SpO2 or No valid ECG and no motion artifact Loss of pulse from IBP APNEA Loss of Respiration Signal Critically Low-Battery condition



Messages ECG: Asystole ECG: V-FIB SpO2: Loss of Pulse {label}: Loss of pulse. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) EtCO2: APNEA RESP : Loss of respiration signal SYSTEM : Critically low-battery condition



Medium Priority Medium priority alarm indicates that prompt operator response is required. Table 12. Medium Priority Alarm Parameter HR/PR ECG %SpO2



Condition High Heart Rate/Pulse Rate limits violated Low Heart Rate/Pulse Rate limits violated ECG Signal Saturation High SpO2 limits violated Low SpO2 limits violated High Systolic blood pressure limits violated High Diastolic blood pressure limits violated High MAP blood pressure limits violated



NIBP



Low Systolic blood pressure limits violated Low Diastolic blood pressure limits violated Low MAP blood pressure limits violated



Resp



High Respiration Rate limits violated Low Respiration Rate limits violated IBP Over the systolic upper limit



IBP Under the systolic lower limit



IBP Over the diastolic upper limit



IBP



IBP Under the diastolic lower limit



IBP Over the mean upper limit



IBP Under the mean lower limit



Cable/Sensor disconnected.



EtCO2



Temp



High EtCO2 limits violated Low EtCO2 limits violated High InCO2 limits violated Low InCO2 limits violated High Temperature limits violated Low Temperature limits violated



Messages High Heart Rate/Pulse Rate limits violated Low Heart Rate/Pulse Rate limits violated ECG Signal Saturation High SpO2 limits violated Low SpO2 limits violated NIBP-High Systolic blood pressure limits violated NIBP-High Diastolic blood pressure limits violated NIBP-High MAP blood pressure limits violated NIBP-Low Systolic blood pressure limits violated NIBP-Low Diastolic blood pressure limits violated NIBP-Low MAP blood pressure limits violated High Respiration Rate limits violated Low Respiration Rate limits violated {label}: High systolic blood pressure limit violated. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) {label}: Low systolic blood pressure limit violated. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) {label}: High diastolic blood pressure limit violated. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) {label}: Low diastolic blood pressure violated. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) {label}: High MEAN blood pressure limit violated. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) {label}: Low MEAN blood pressure limit violated. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) {label}: Cable/Sensor disconnected. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) EtCO2 : High EtCO2 Limits violated EtCO2 : Low EtCO2 Limits violated EtCO2 : High InCO2 Limits violated EtCO2 : Low InCO2 Limits violated TEMP1 : High temperature limits violated TEMP2 : High temperature limits violated TEMP1 : Low temperature limits violated TEMP2: Low temperature limits violated



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Low Priority Low priority alarm indicates that operator awareness is required. Table 13. Low Priority Alarm Parameter ECG



Temp



Condition ECG Leads Off Chest Lead off Temperature Probe Disconnect Temperature – Out of range Abnormal Cuff Measurement Fail



NIBP Overpressure Artifact Artifact Time-Out Out of range Failed in zero calibration IBP



Out of range SpO2 - Technical Error



%SpO2



Resp



EtCO2



System



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SpO2 Cable/Sensor Disconnect Sensor Off from SpO2 Sensor Respiration Leads Off Adapter Calibration Failed Check Adapter Faulty Sensor Occlusion or Leak Out of Range Sample Line Disconnected Sensor Disconnected Printer out of paper Low Battery CMS disconnected



Messages ECG : Leads off ECG : Chest lead off TEMP1 : Probe disconnect TEMP2 : Probe disconnect TEMP1 : Out of range TEMP2 : Out of range NIBP : Abnormal cuff / EEE 11 NIBP : Abnormal cuff / EEE 21 NIBP : Measurement fail / EEE 12 NIBP : Measurement fail / EEE 14 NIBP : Measurement fail / EEE 15 NIBP : Measurement fail / EEE 18 NIBP : Measurement fail / EEE 20 NIBP : Overpressure / EEE 19 NIBP : Artifact / EEE 13 NIBP : Artifact / EEE 16 NIBP : Time-out / EEE 17 NIBP : Out of range. {label}: Unable to zero calibration. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) {label}: Out of range. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) SpO2 Error – EEE001 ~ SpO2 Error:EEE511 SpO2 : Module reset SpO2 : Reconnect / Replace SpO2 sensor SpO2 : Reposition / Replace SpO2 sensor SpO2 : Replace SpO2 Sensor SpO2 : Cable/Sensor disconnect SpO2 : Sensor off RESP : Leads off EtCO2 : Adapter Calibration Failed EtCO2 : Check Adapter EtCO2 : Faulty Sensor EtCO2 : Occlusion or Leak EtCO2 : Out of Range EtCO2 : Sample Line Disconnected EtCO2 : Sensor Disconnected SYSTEM : Printer out of paper SYSTEM : Low Battery SYSTEM : Connection to the CMS was disconnected



Informative Messages Informative messages indicate a system condition that needs operator’s acknowledgement and action if needed.



Condition



Table 14. Informative Messages Messages



ECG offset control SpO2 Pulse search SpO2 Motion interference IBP No zero reading



ECG: Signal calibration SpO2 : Pulse search SpO2 : Motion interference



IBP Zero cal in progress



{label}: Zero cal in progress (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) EtCO2 : Pressure Not Zeroed EtCO2 : Pressure Zero in Progress EtCO2 : Sensor Too Warm EtCO2 : Sensor Warming-up Copyright ⓒ 2011 All rights reserved. SYSTEM : Abnormally shut down last time SYSTEM : Audio off SYSTEM : Audio pause SYSTEM : Demo Mode SYSTEM : Printer is not available SYSTEM : Not enough memory (Event records) SYSTEM : Not enough memory (12 lead records) SYSTEM : Not enough memory (Internal memory) SYSTEM : Transmission (12 lead records)



{label}: No zero reading (ex. {label}: P1, P2, ABP, CVP, PAP, LAP)



EtCO2 - Pressure Not Zeroed EtCO2 - Pressure Zero in Progress EtCO2 - Sensor Too Warm EtCO2 - Sensor Warming-up Copyright ⓒ 2011 All rights reserved Abnormally shut down last time Audio Off Audio Pause Demo Mode Printer is not available Not Enough Memory – Event records Not Enough Memory – 12 lead records Not Enough Memory – Internal Memory Transmission – 12 lead records



Note: There may be other informative messages that are not listed above. Defibrillator message Defibrillator messages indicate a condition related to manual mode, AED mode and pacing mode. Note: Defibrillator messages are not displayed in monitor mode.



Condition Check for response Call for help Open the airway Check breathing Attach pads to bare chest



Check Pads



Table 15. Defibrillator Messages Messages Check response (Voice prompt: Check for response. Are you all right?) Call for help (Voice prompt: Call for help.) Open airway (Voice prompt: Open the airway.) Check breathing (Voice prompt: Check breathing.) Attach pads to bare chest (Voice prompt: Remove clothes from the patient's chest. Place pad exactly as shown in the picture. Press pads firmly to patient's bare chest.) Check Pads



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Condition Analyzing ECG



Do not touch the patient No Shock Advised Shock Advised Press Shock button



Press Paddle Shock button Shock button not pressed Shock Canceled Impedance is out of range Shock Delivered Shock not delivered It is Safe to touch the patient Begin CPR If needed, Begin CPR Press Charge button Remove Paddle Poor Pads Contact Poor Paddles Contact DEFIB Pads short DEFIB Paddles short Release shock Remove Sync to Analyze Analysis Halted ECG Lead Off ECG 12 Lead Acquiring Select BPM Select mA Pacing Paused Pacing out



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Messages Analyzing heart rhythm (Voice prompt: Analyzing heart rhythm. Do not touch the patient.) Do not touch the patient No Shock Advised (Voice prompt: Non Shock advised.) Shock Advised (Voice prompt: Shock advised.) Press Shock button (Voice prompt: Press the red flashing button now. Deliver shock now.) Press Paddle Shock Button Shock button not pressed (Voice prompt: Shock button not pressed.) Shock canceled (Voice prompt: Shock Cancelled.) Impedance is out of range (Voice prompt: Poor pads contact.) Shock Delivered (Voice prompt: Shock Delivered.) Shock not delivered (Voice prompt: Shock not delivered.) It is Safe to touch the patient (Voice prompt: It is Safe to touch the patient.) Begin CPR (Voice prompt: Begin CPR.) If needed, Begin CPR (Voice prompt: If needed, Begin CPR) Press Charge button Remove Paddle Poor Pads Contact Poor Paddle Contact DEFIB Pads short DEFIB Paddle short Release shock Remove Sync to Analyze Analysis Halted ECG Lead Off ECG 12 Lead Acquiring Select BPM Select mA Pacing Paused Pacer out ‘___’ mA



Visual Alarm Indication Alarm Category High priority Medium priority Low priority



Table 16. Visual Alarm Characteristics Color Flashing Period Duty Cycle Red 700ms (about 1.43Hz) 57% (On: 400ms / Off: 300ms) Yellow 2000ms (about 0.5Hz) 60% (On: 1200ms / Off: 800ms) Yellow 100% (Always On)



When a high priority alarm is activated, a non-flashing alarm message is displayed. The numerical area will flash red. When a medium priority alarm is activated, a non-flashing alarm message is displayed. The numerical area will flash yellow. When a low priority alarm is activated, a non-flashing alarm message is displayed. The numerical area will change to yellow.



Audible Alarm Indication Do not turn off the audible alarm or decrease its volume if patient safety could be compromised. Make sure that the defibrillator/monitor speaker is not obstructed. Failure to do so could result in an inaudible alarm tone.



Alarm Category High priority Medium priority Low priority



Table 17. Audible Alarm Characteristics Tone Pitch (IEC60601-1-8) Beep Rate (IEC60601-1-8) ~976 Hz 10 beeps in 15 sec ~697 Hz 3 beeps in 15 sec ~488 Hz 1 beeps in 30 sec



Note: Audible alarms may be decreased in volume or temporarily paused.



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Verifying Audible Alarm Indication If the defibrillator/monitor fails to perform as specified in this test, contact qualified service personnel or your local supplier for assistance. You can verify the alarm operation for all parameters like ECG, SpO2, NIBP, Temperature, EtCO2, IBP and Respiration by following the below procedures. 1. 2. 3.



Connect the defibrillator/monitor to an AC power source. Rotate the Mode select knob to turn on the defibrillator/monitor. Connect the simulator to the sensor input cable and connect cable to defibrillator/monitor. 4. Set the simulator to a smaller value than the lower alarm limit on the defibrillator/monitor. 5. Verify the following defibrillator/monitor reaction: a. The defibrillator/monitor begins to track the physiological signal from the simulator. b. After about 10 to 20 seconds, the defibrillator/monitor displays the value measured as specified by the simulator. Verify values are within the tolerances specified in the Specification section for each parameter. c. Audible alarm sounds. d. “Low limits violated” message is displayed. e. The numerical area flashes, indicating the parameter has violated default alarm limits. Note: The maximum mean time of the alarm delay is less than 10 seconds unless otherwise specified in this manual.



Changing Alarm Limits Each time the defibrillator/monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. If different alarm presets are used for the same or similar equipment in any single area, e.g. an intensive care unit or cardiac operating room, a potential hazard can exist. Do not set the alarm limits to extreme values that can cause the alarm to become useless. You can change alarm limits from default values, if necessary. Alarm limits or Limit Alarm Pause may be set in two ways:  



Via interaction with HR/PR, SpO2, NIBP, Respiration, EtCO2, IBP and Temperature Menu or Via interaction with the Alarm Limits Menu that presents the limits in all the parameters at one time.



Setting Alarm Limit via Alarm Limit Menu 1. 2. 3.



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Soft key is displayed on the lower of the normal screen. (Refer to figure 13.) Press the Alarm Limit soft key located lower right corner of the screen. Select the parameter menu to be changed by pressing the Multi function knob.



Figure 17. Alarm Limit Menu 4. 5. 6.



Change the alarm limit by rotating the Multi function knob. Selected parameter menu is returned to normal screen by pressing the Return soft key. When the menu is returned, the other menu can be selected.



Alarm Limits Ranges Table 18 describes the possible alarm limits. The defibrillator/monitor is shipped with factory default settings. Note: Authorized personnel can define the way to save the power default. The detailed information is described in the service manual.



Parameters



Table 18. Alarm Limits Ranges Upper Limit, Default Lower Limit, Default



HR/PR (BPM) Adult/Pediatric 25 ~ 300 BPM, 120 BPM NIBP Systolic (mmHg, kPa) 35 ~ 270 mmHg, 160 mmHg Adult/Pediatric (4.7 ~ 36.0 kPa, 21.3 kPa) 45 ~ 130 mmHg, 90 mmHg Neonatal (6.0 ~ 17.3 kPa, 12.0 kPa) NIBP Diastolic (mmHg, kPa) 15 ~ 250 mmHg, 90 mmHg Adult/Pediatric (2.0 ~ 33.3 kPa, 12.0 kPa) 25 ~ 90 mmHg, 60 mmHg Neonatal (3.3 ~ 12.0 kPa, 8.0 kPa) NIBP MAP (mmHg, kPa) 25 ~ 260 mmHg, 110 mmHg Adult/Pediatric (3.3 ~ 34.7 kPa, 14.7 kPa) 35 ~ 110 mmHg, 70 mmHg Neonatal (4.7 ~ 14.7 kPa, 9.3 kPa) SpO2 (%)



Resolution



20 ~ 295 BPM, 50 BPM



5 BPM



30 ~ 265 mmHg, 90 mmHg (4.0 ~ 35.3 kPa, 12.0 kPa) 40 ~ 125 mmHg, 40 mmHg (5.3 ~ 16.7 kPa, 5.3 kPa)



5 mmHg (0.6 or 0.7 kPa) 5 mmHg (0.6 or 0.7 kPa)



10 ~ 245 mmHg, 50 mmHg (1.3 ~ 32.7 kPa, 6.7 kPa) 20 ~ 85 mmHg, 20 mmHg (2.7 ~ 11.3 kPa, 2.7 kPa)



5 mmHg (0.6 or 0.7 kPa) 5 mmHg (0.6 or 0.7 kPa)



20 ~ 255 mmHg, 60 mmHg (2.7 ~ 34.0 kPa, 8.0 kPa) 30 ~ 105 mmHg, 30 mmHg (4.0 ~ 14.0 kPa, 4.0 kPa)



5 mmHg (0.6 or 0.7 kPa) 5 mmHg (0.6 or 0.7 kPa)



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Parameters



Upper Limit, Default



Adult/Pediatric 21 ~ 100 %, 100 % Respiration (BPM) Adult/Pediatric 4 ~ 120 BPM, 30 BPM Temperature1 (°C, °F) 0.1 ~ 50.0°C, 39.0 °C Adult/Pediatric (32.1 ~ 122.0°F, 102.2°F) Temperature2 (°C, °F) 0.1 ~ 50.0°C, 39.0 °C Adult/Pediatric (32.2 ~ 122.0°F, 102.2°F) EtCO2 (mmHg, kPa, %) 1 ~ 80 mmHg, 80 mmHg Adult/Pediatric (0.1 ~ 10.7 kPa, 10.7 kPa) (0.1 ~ 10.5 %, 10.5%) InCO2 (mmHg, kPa, %) 1 ~ 20 mmHg, 20 mmHg Adult/Pediatric (0.1 ~ 2.7 kPa, 2.7 kPa) (0.1 ~ 2.6 %, 2.6 %) P1 Systolic (mmHg, kPa) -45 ~ 300 mmHg, 120mmHg Adult/Pediatric (-6.0 ~ 40.0 kPa, 16.0 kPa) P1 MEAN (mmHg, kPa) -45 ~ 300 mmHg, 90 mmHg Adult/Pediatric (-6.0 ~ 40.0 kPa, 12.0 kPa) P1 Diastolic (mmHg, kPa) -45 ~ 300 mmHg, 70 mmHg Adult/Pediatric (-6.0 ~ 40.0 kPa, 9.3 kPa) P2 Systolic (mmHg, kPa) -45 ~ 300 mmHg, 120mmHg Adult/Pediatric (-6.0 ~ 40.0 kPa, 16.0 kPa) P2 MEAN (mmHg, kPa) -45 ~ 300 mmHg, 90 mmHg Adult/Pediatric (-6.0 ~ 40.0 kPa, 12.0 kPa) P2 Diastolic (mmHg, kPa) -45 ~ 300 mmHg, 70 mmHg Adult/Pediatric (-6.0 ~ 40.0 kPa, 9.3 kPa)



Lower Limit, Default



Resolution



20 ~ 99 %, 90 %



1%



3 ~ 119 BPM, 8 BPM



1 BPM



0.0 ~ 49.9 °C, 36.0 °C (32.0 ~ 121.8°F, 96.8°F )



0.1°C (0.1°F or 0.2°F)



0.0 ~ 49.9 °C, 36.0 °C (32.0 ~ 121.8°F, 96.8°F )



0.1°C (0.1°F or 0.2°F)



0 ~ 79 mmHg, 0 mmHg (0 ~ 10.5 kPa, 0 kPa) (0 ~ 10.4%, 0%)



1 mmHg (0.13 kPa) (0.13%)



0 ~ 19 mmHg, 0 mmHg (0 ~ 2.5 kPa, 0 kPa) (0 ~ 2.5 %, 0%)



1 mmHg (0.13 kPa) (0.13%)



-50 ~ 295 mmHg, 70 mmHg (-6.7 ~ 39.3 kPa, 9.3 kPa)



5 mmHg (0.6 or 0.7 kPa)



-50 ~ 295 mmHg, 50 mmHg (-6.7 ~ 39.3 kPa, 6.7 kPa)



5 mmHg (0.6 or 0.7 kPa)



-50 ~ 295 mmHg, 40 mmHg (-6.7 ~ 39.3 kPa, 5.3 kPa)



5 mmHg (0.6 or 0.7 kPa)



-50 ~ 295 mmHg, 70 mmHg (-6.7 ~ 39.3 kPa, 9.3 kPa)



5 mmHg (0.6 or 0.7 kPa)



-50 ~ 295 mmHg, 50 mmHg (-6.7 ~ 39.3 kPa, 6.7 kPa)



5 mmHg (0.6 or 0.7 kPa)



-50 ~ 295 mmHg, 40 mmHg (-6.7 ~ 39.3 kPa, 5.3 kPa)



5 mmHg (0.6 or 0.7 kPa)



Audio Paused and OFF Do not pause the audio or decrease its volume if patient safety could be compromised. If an alarm condition occurs while in the Audio Off state, the only alarm indication on the defibrillator/monitor will be visual displays related to the alarm condition. Default startup setup is with Audio off on Power ON. If Audio Alarms are required, make sure to activate audio alarm ON for the patient being monitored. Check the audible alarm silence duration before temporarily silencing the audible alarms. When an alarm occurs, you can pause the audio for the audio pause time (30 sec, 60 sec, 90 sec, 120 sec) selected via Service menu. However, visual alarms continue during this time. The factory default for audio pause time is 30 seconds.



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Table 19. Bell Icon Alarm Active



Audio paused



Audio Off



Limit alarm pause



To pause an audio: 1. Press the Alarm button to immediately pause the alarm tone. The alarm resumes after the audio paused period if the alarm condition has not been corrected. 2. Check the patient and provide appropriate care. During the audio paused period, you can press the Alarm button again to re-enable the audio tones. Also, if another alarm occurs during the audio paused period, the audio tones will be automatically re-enabled. You can pause the audio tones for that another alarm by pressing the Alarm button. Note: The audio paused by some technical errors may be canceled by pressing the Alarm button. However, battery failure and physiological alarms cannot be canceled until the alarm condition is corrected. To off an audio: 1. 2.



To initiate an audible alarm off, press the Alarm button and hold it for at least 2 seconds. To cancel an audible alarm off condition, press the Alarm button for 2 seconds again.



This action disables audible alarms for a user-defined audio off period (3 min, 5 min, 10 min or Indefinite) selected via the Service menu. If audio off period is set to 3, 5 or 10 minutes, the audible alarm is not activated for the specified time interval and the Audio Off icon is displayed. Note: You may disable limit violation alarms of each vital sign via the HR/PR, SpO2, NIBP, Respiration, EtCO2, IBP, Temperature or Alarm limit menus. Note: The periods can only be changed by authorized personnel via the Service menu. Note: Alarm Off may disable the visual alarm manifestation if sensors, probes, or modules are intentionally disconnected by operator.



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ECG MONITORING For best product performance and measurement accuracy, use only accessories supplied or recommended by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. It may cause burns to the patients or defibrillator/monitor failure to use of pacing/defibrillation pads or adapters from sources other than Mediana. Line isolation defibrillator/monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. Such transients may be minimized by proper electrode and cable placement, as specified in this manual and electrode directions for use. Do not use damaged ECG leads. Do not immerse ECG leads completely in water, solvents, or cleaning solutions. Do not sterilize ECG leads by irradiation, steam, or ethylene oxide. Follow the manufacturer’s directions for use. Do not use ECG electrodes with expired dates. Do not use defective ECG electrodes. These might cause improper performance. ECG cables may be damaged if they are connected to a patient during defibrillation. Cables that have been connected to a patient during defibrillation should be checked for functionality before using again. It is possible for the patient to receive a burn due to an improperly connected electrosurgical unit. Additionally, the defibrillator/monitor could be damaged or measurement errors could occur. Place the ECG cable and leads as far as possible from the site of the electrosurgical unit and from the electrosurgical cables. This will minimize interference and the risk of burns to the patient. For pacemaker patients, the defibrillator/monitor may continue to count pacemaker rate during occurrences of cardiac arrest or some arrhythmias. To reduce the likelihood of this, ensure that the Pacer Detect setting is On in the ECG waveform Menu when monitoring such patients. Do not rely entirely upon the defibrillator/monitor alarms. Keep pacemaker patients under close surveillance. To ensure patient safety, the conductive parts of the ECG electrodes (including associated connectors) and other patient-applied parts should not contact other conductive parts, including earth ground, at any time. Correct the electrode placement. Improper electrode placement may cause incorrect result. User must be aware of proper defibrillator/monitor operation. Use only high quality ECG electrodes. ECG electrodes are for rhythm acquisition only. Do not attempt to defibrillate or pace through ECG electrodes. Precordial lead electrodes and lead wires may interfere with the placement of standard paddles or pads. Before defibrillation, remove any interfering precordial lead electrodes and lead wires. The defibrillator/monitor may be used in conjunction with and must not be damaged by typical electrosurgical equipment operation. The defibrillator/monitor is not suitable for direct cardiac application.



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General The process of depolarization and repolarization of the myocardium generates electric potentials that are sensed by ECG electrodes on the skin surface. These electrodes are typically attached to the patient’s right arm, left arm, and left leg. The defibrillator/monitor processes and amplifies these signals and presents the ECG waveform on the screen. Also, the defibrillator/monitor computes the minute heart rate at least every second by moving average. In addition to the acquisition of the QRS complex, the circuitry performs a number of other functions. The defibrillator/monitor can display:  Heart rate in beats per minute  Detection of a “lead off” condition if an electrode is disconnected or poorly connected  Detection of the presence of pacemaker signals within the ECG waveform complex Note: Occasionally, electromagnetic interference beyond the range guaranteed from the manufacturer’s EMC declaration may cause the defibrillator/monitor to display a "Check ECG Leads & Electrodes" alarm. This occurrence is rare, and duration should be short. When the interference ceases, the defibrillator/monitor removes the "Check ECG Leads & Electrodes" alarm. Refer to the Specification section.



Setup Connections Note: Mediana recommends the use of silver/silver chloride electrodes (Ag/AgCl). When dissimilar metals are used for different electrodes, the electrodes may be subject to large offset potentials due to polarization, which may be severe enough to prevent obtaining an ECG trace. Using dissimilar metals may also increase recovery time after defibrillation. 1.



Select the electrodes to be used. Use only one type of electrode on the same patient to avoid variations in electrical resistance. Prepare the electrode sites according to the electrode manufacturer’s instructions. See Figure 18 and 19 for electrode placement configurations.



Figure 18. Standard 3 Electrode Placement



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Figure 19. 5 Electrode Placement Note: One of 5-1 to 5-6 Lead electrode placement sites for the fifth lead. 2. 3. 4.



Connect the ECG lead. Connect the ECG lead to the ECG connector on the defibrillator/monitor’s front panel. Attach the leads to the electrodes, and then apply the electrodes to the patient, using the color-code guide in Table 17. Verify that the desired Lead Selection is active in the ECG waveform area. Refer to Table 18. Lead II is best suited for most monitoring situations. Table 20. ECG Lead Colors Lead 1. Right arm 2. Left arm 3. Left leg 4. Right leg 5-1 to 5-6. V (Chest)



AAMI White (RA) Black (LA) Red (LL) Green (RL) Brown (V)



IEC Red (R) Yellow (L) Green (F) Black (N) White (C)



Table 21. ECG Lead Pairs Lead-Selection I II III V (Chest) aVR aVL aVF



Electrode Differential (AAMI) RA LA RA LL LA LL (RA+LA+LL)/3 Chest (V) – (Lead I + Lead III/2) (Lead I – Lead III)/2 (Lead II + Lead III)/2



Electrode Differential (IEC) R L R F L F (R+L+F)/3 Chest (C) – (Lead I + Lead III/2) (Lead I – Lead III)/2 (Lead II + Lead III)/2



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12-lead ECG Using previously unpackaged electrodes or electrodes past the Use by date may impair ECG signal quality. Remove electrodes from a sealed package immediately before use and follow the procedure for applying the electrodes. Computerized ECG interpretive statements should not be used withholds or prescribes patient treatment without review of the ECG data by qualified medical personnel. Always confirm interpretive statements by over-reading the ECG data. General The optional 12 lead ECG function, using the GLA algorithm, is available in Monitor Mode and allows you to Acquire, Setup, 12 lead On and Patient Info. In addition, the 12 lead function provides computerized ECG analysis. A report with measurements and interpretive statements from the analysis is displayed, stored and printed, as configured. Patient age and gender are used to define normal limits for heart rate, axis deviation, time intervals, and voltage values, for interpretation accuracy in tachycardia, bradycardia, prolongation or shortening of PR and QT intervals, hypertrophy, early repolarization, myocardial infarction and culprit artery detection. In a 12-lead ECG using 10 electrodes, an electrode is placed on the right arm, left arm, right leg and left leg. Six V/C electrodes are placed on the chest as shown in Figure 24. The right leg electrode is the standard. This defibrillator/monitor is equipped with epoch-making ECG monitoring function incorporating the cutting edge software for analysis of electrocardiograms developed by the University of Glasgow in UK, which includes signal processing, diagnostic interpretation of electrocardiograms from individuals of all ages and analysis of cardiac rhythm. ECG Wave Recognition The methodology for ECG waveform measurement is described in general terms in an earlier publication from the Glasgow Laboratory. 10s of ECG data is input to the software for analysis and all leads require to have been acquired simultaneously. Processing Initially, a 50Hz or 60Hz notch filter is applied to remove any AC interference, if such a filter has not already been applied within the acquiring device. The first stage of the analysis is to compute any missing limb leads from the minimum of two leads that need to be provided. The ECG data is then filtered to minimize the effects of noise. The next step in the analysis is to calculate a form of spatial velocity combining the first difference of each lead. From this function, the approximate locations of all the QRS complexes are derived. Allowance has to be made for pacemaker stimuli, which are ideally detected by the front end equipment and passed to the program in the form of a list of “spike” locations. Given the QRS locations, it is then possible to check the quality of the recording for noise and baseline drift. If the drift is excessive, it is removed by using a cubic spline technique to obtain, for each lead affected, the baseline trend, which is then subtracted from the original data. If the noise is excessive, it is possible to remove a whole lead from the analysis or alternatively, 5 seconds of all leads are removed either from the first or second half of the recording. 60



QRS typing Thereafter, the various QRS complexes are typed according to their morphology. An iterative process is used. Effectively, the first complex in lead I is compared with the second using first differences of each cycle. The comparison takes the form of moving one beat over the other and when the difference is minimal, optimal alignment is present. This alignment point is used for averaging as discussed below. If the difference between beats is less than a threshold value, they are deemed to belong to the same class. The procedure is repeated with the third beat being compared with the second and so on. If a new morphology is detected, i.e. if the threshold is exceeded, a new class is established. The procedure continues with five leads being used in the typing process. Selection of Required QRS Class If more than one class of beat is present, then a decision has to be made as to which morphology will be used for the averaging procedure, i.e. the cycle to be interpreted has to be selected. A complex logic is used for this purpose. It has to allow for a single normally conducted beat in the midst of demand pacemaker beats for example. It also needs to take account of the QRS durations of different beat classes, RR intervals to exclude extrasystoles, and to a limited extent, the number of beats in each morphological class. The net effect is to choose one class of beats, of a similar morphology, that are regarded as being conducted in the normal sequence through the ventricles. Averaging All beats in the selected class are averaged so that 12 such beats, one from each lead, are then available. The “average” beat can be computed in several ways. Common to this are the alignment points detected when wave typing was undertaken. They are used as reference points in the averaging process. The average beat can be a straight average of all corresponding aligned points, it can be a median calculated from the same points or it can be a weighted average – the so called modal beat introduced into the program in 1977. In practice, the program forms the straight average, which is compared to individual beats in the same class. If there is a significant difference at any point, then the median beat is used. The modal beat is regarded as being computationally excessive, though it is undoubtedly the best approach to use.



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Wave Measurement From the 12 average beats, a single combined function is formed and a provisional overall QRS onset and termination is determined by thresholding techniques. The provisional onset and termination are then used as starting points for a search for QRS onset and termination within each individual lead. Basically the approach conforms to the recommendations of the CSE working party (of which one of the Glasgow team was a member), which were published in 1985.



Figure 20. Varying choice of baselines.



Figure 21. Baseline at the level of QRS onset as used by the Glasgow program.



In each individual lead, the QRS onset is taken as the baseline and hence Q, R, S, R' waves are measured with respect to the QRS onset as shown in the accompanying figures from the CSE paper (see Figures 30-33).



Figure 22. Illustration of isoelectric segments I and K. Isoelectric segments at the beginning of a QRS complex, i.e. a flat segment between the provisional overall onset and the onset of an individual lead are excluded from the first component (Q or R) of the QRS complex as recommended by the CSE group. Similar considerations apply at the end of the QRS complex (see Figure 32). A sorting algorithm is then applied to all 12 onsets to determine the global QRS onset as follows. The earliest onset is excluded and the next onset that also lies within 20 ms of the next again is then selected as the overall onset. This ensures that any true outliers are excluded. The reverse process is used to find the overall QRS termination.



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QRS Components Within the QRS complex, the amplitude and duration of the various Q, R, S, R’ waves are then measured. In keeping with the CSE recommendations, the minimum wave acceptable has to have a duration >8 ms and an amplitude >20 V. With respect to global QRS duration, the Glasgow program measures QRS duration from the global QRS onset to the global QRS termination. This means that an isoelectric segment within one particular QRS complex by definition will lead to a shorter QRS duration for that lead compared to the global QRS duration.



Figure 23. Definitions for QRS end / ST junction ST segment The ST segment has several measurements made. Figure 19 shows the J point as used in the diagnosis of ST elevation myocardial infarction. However, measurements are also made at equal intervals throughout the ST segment, e.g. 1/8 ST-T, 2/8 ST-T etc. P and T waves A search for the P wave is made in the interval preceding the QRS complex. A P wave may not always be found in certain arrhythmias. P onset and termination are found using a method involving second differences but the same P onset and termination is used over all 12 leads in view of the difficulty in detecting low amplitude P waves in many leads. P wave amplitude is determined with respect to the same baseline as for Q, R, S amplitudes, namely the QRS onset. This was found to be more reliable than fitting a straight line between P onset and P termination even in cases where the P wave was superimposed on the T wave in the case of a tachycardia. T end is determined for each lead using a template method. The global T end is derived in a similar fashion to the global QRS offset. The other components of the ECG waveform, namely the ST and T wave amplitudes, are also measured with respect to QRS onset. Thus, the ST junction and the various ST amplitude measurements, such as ST 60 and ST 80 as well as the positive and negative components of the T wave, are all measured with respect to the QRS onset. The reason for this is that it is the most straightforward approach to measurement.



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Interval Measurement With respect to intervals, the global QT interval is measured from the global QRS onset to the global T end. On the other hand, because the P onset is taken as being simultaneous in all 12 leads, the global PR interval measurement is from the P onset to the global QRS onset. Normal Limits The above methods were used to determine the normal limits of QRS waveforms from an adult database of over 1,500 normal, published in Comprehensive Electrocardiology, 1989 and a pediatric database derived from 1750 neonates, infants and children, published in part in 1989 and 1998 and which will be published in much more detail in the next edition of Comprehensive Electrocardiology. These normal limits are essentially an integral part of the diagnostic software.



Figure 24. 12 lead Placement



Preparing the 12 Lead Proper skin preparation and electrode placement are the most important elements in producing a high quality 12 lead ECG. The patient should be supine and relaxed when an ECG is acquired. In preparation for acquiring the ECG: 1. 2. 3. 4. 5. 6.



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Attach the electrodes to the patient as above Figure 24. Attach the 12 lead cable lead wires to the electrodes on the patient. Attach the 12 lead cable to the defibrillator/monitor’s front panel. Turn on the manual mode of defibrillator/monitor by rotating the Mode select knob to Manual Mode. Enter patient information. Check the patient’s pulse.



Calculation Feature



Figure 25. Measurement Reference Figure 25 shows the parameters obtained in ECG waveform to analyze the ECG. Overall P onset, P offset, QRS onset, QRS offset and T termination are determined from all 12 leads. Individual lead wave amplitudes are then obtained. P+, P-, Q, R, S, R’, S’, T+ and T- amplitudes are measured with respect to a horizontal line through the lead QRS onset. Durations are measured between relevant points. Areas are measured in units of millivolts x milliseconds (mV x ms). Units of measure are not specified when an area measurement appears in the criteria. Isoelectric components between the overall QRS onset and an individual lead onset are not included in a Q or R duration. ECG analysis results were categorized and categories include: PRELIMINARY COMMENTS, measurement, Results on QRS wave analysis, Results on ST and T wave analysis, MISCELLANEOUS, RHYTHM STATEMENTS. And the results in diagnosis will be printed. Preliminary Comments Preliminary comments includes the effects to the statement of ECG input signal and diagnosis.  LEAD REVERSAL/DEXTROCARDIA  RESTRICTED ANALYSIS  MISCELLANEOUS PRELIMINARY STATEMENTS Measurement Parameter Measurement parameters are fundamentally obtained after ECG analysis.  HEART RATE  INTERVALS  ATRIAL ABNORMALITIES  QRS AXIS DEVIATION



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Results on QRS Wave Analysis Results on QRS wave analysis shows diagnosis results of QRS waveform and measurement values.  CONDUCTION DEFECTS WOLFF-PARKINSON-WHITE PATTERN BRUGADA PATTERN  HYPERTROPHY LEFT VENTRICULAR HYPERTROPHY RIGHT VENTRICULAR HYPERTROPHY BIVENTRICULAR HYPERTROPHY Results on ST And T Wave Analysis Results on ST and T wave analysis shows diagnosis results of ST and T waveform and measurement values.  MYOCARDIAL INFARCTION INFERIOR INFARCTION LATERAL INFARCTION ANTEROSEPTAL INFARCTION ANTERIOR INFARCTION SEPTAL INFARCTION POSTERIOR INFARCTION ANTEROLATERAL INFARCTION EXTENSIVE INFARCTION  ST ABNORMALITIES  ST-T ABNORMALITIES (ISCHAEMIA ETC). Rhythm Statements Rhythm statements includes diagnosis results according to occurrence of beats, etc.  DOMINANT RHYTHM  SUPPLEMENTARY RHYTHM



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Measurement Matrix The electrocardiographs can be programmed so that the Measurement Matrix is written out after the analysis report. The Measurement Matrix consists of 12 columns which contain measurements for the twelve standard leads. These columns are labelled I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6. Table 22. Measurement Matrix Measurement PON PDUR QRSON QRSDUR QDUR RDUR SDUR RPDUR SPDUR P+DUR QRSDEF P+AMP P-AMP QRSP2P QAMP RAMP SAMP RPAMP SPAMP STAMP 1/8STT 2/8STT 3/8STT T+AMP T-AMP QRSAR TMORPH RWNCH DWCON STSLOP TON



Meaning Time in milliseconds from the beginning of recording to the beginning of the first P wave. P wave duration in milliseconds. Time in milliseconds from the beginning of recording to the beginning of the QRS complex. QRS duration in milliseconds. Q wave duration in milliseconds. R wave duration in milliseconds. S wave duration in milliseconds. R' wave duration in milliseconds. S' wave duration in milliseconds. P+ wave duration in milliseconds. Intrinsicoid deflection time. P+ wave amplitude in microvolts. P- wave amplitude in microvolts. Peak to peak amplitude of the QRS complex. Q wave amplitude in microvolts. R wave amplitude in microvolts. S wave amplitude in microvolts. R' wave amplitude in microvolts. S' wave amplitude in microvolts. ST wave amplitude in microvolts. Amplitude in microvolts at a point which is 1/8 of the ST-T interval. Amplitude in microvolts at a point which is 2/8 of the ST-T interval. Amplitude in microvolts at a point which is 3/8 of the ST-T interval. T+ wave amplitude in microvolts. T- wave amplitude in microvolts. Total area of the QRS complex in microvolts/millisecond. T wave morphology. R wave notch count. Probability (in %) of the presence of a delta wave. ST slope in degrees. Time in milliseconds from the beginning of the recording to the beginning of the T wave.



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12 Lead Display The 12 lead display allows you to see real-time 12 lead ECG data and verify signal quality before acquiring the ECG. As shown in Figure 21, it displays patient information and approximately 2.5 seconds of each of the 12 leads acquired. Waveforms are presented at a rate of 25mm/sec and the configured wave size. A dashed line is displayed if a lead cannot be derived. The message (Lead-Wire) Lead Off is displayed if an electrode is not making adequate contact with the patient. The Patient info menu of 12 lead mode includes ID, name, age and gender. The Event ID is displayed until you enter the patient’s ID. Age and sex are displayed once entered. Although waveforms for monitored parameters such as ECG, SpO 2, Invasive Pressures and EtCO2 are not visible on the Preview Screen, related alarms, measurements and alarm messages remain active and are reported in Parameter Blocks 1 and 2 and the general status area.



Figure 26. 12-Lead ECG Preview Screen



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Description of HR/PR Menu Functions The calculated Heart Rate/Pulse Rate may be derived from different sources (ECG, SpO2, NIBP or IBP) as shown by the icon in the HR/PR numerical area. 1 2 3 4 5



1 2 3 4



6



HR/PR icon HR/PR source icon Pacer pulse detection icon ECG size



5 6 7



7



HR/PR unit HR/PR value Bell icon



Figure 27. HR/PR Display 3 1



2



1 2



ECG waveform icon ECG waveform



3



ECG lead pair



Figure 28. ECG Waveform Display HR/PR source



Pacer Detect



Filter Select



Alarm Limit



Return



Figure 29. HR/PR Menu Table 23. HR/PR Menu Level 1 Menu HR/PR MENU HR/PR Source



Pacer Detect



Filter Select



Alarm Limit Limit Alarm Pause Return



Level 2 Menu or Response Auto HR PR Return Enable Disable Return 0.5Hz ~ 21Hz 0.05Hz ~ 40Hz 1Hz ~ 21Hz Return HR/PR Upper Limit adjust HR/PR Lower Limit adjust On, Off



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HR/PR Source You may select Auto, HR, PR to decide the source of the heart rate or pulse rate. The HR/PR tone volume can be adjusted in the Setup menu. Auto If you select Auto, the defibrillator/monitor automatically derives the heart rate or pulse rate from one of the monitoring parameters in this order of priority: ECG, IBP, SpO2 or NIBP. Note: When ECG lead off occurs, HR becomes “zero”. In this case, HR display is automatically switched to PR from SpO2, if SpO2 is being measured. HR When HR is selected, the heart rate (HR) is measured from ECG. PR When PR is selected, the pulse rate (PR) is measured from IBP, SpO 2 or NIBP. The color of the HR/PR icon and HR/PR source icon will be changed according to the current source. If the pulse rate is derived from NIBP, the value will be displayed for only 180 minutes after the NIBP measurement, then the value will be changed to “---”. Note: If the ECG signal is in saturation state or the normal QRS is not detected due to noise, ‘---’ shall be displayed in heart rate measurement value. Pacer Detect Pacer detect should always be Enable for patients with pacemakers (refer to the warning in this section). When Pacer detect is Enable, the defibrillator/monitor detects and filters pacemaker-generated signals so that they will not be calculated in determining a patient’s heart rate. When monitoring patients without pacemakers, Pacer detect should be set to Disable to avoid misdiagnosis. Filter Select The defibrillator/monitor can filter ECG waveform noise with different ranges of frequency response: 0.5 Hz to 21 Hz: Expands the range to display very low frequencies down to 0.05 Hz. 0.05 Hz to 40 Hz: Choose this mode to see just the ECG waveform monitoring. 1 Hz to 21 Hz: Generally called a filter mode, it reduces ECG waveform noise. Note: The sub-clause 50.102.8 Frequency and impulse response and sub-clause 50.102.15 Heart rate range, accuracy and QRS detection range of IE60601-2-27 are tested only for Monitor (0.05Hz to 40Hz) of ECG filter. Limit Alarm Pause When the Limit Alarm Pause is set to On, the audible alarm for HR/PR limit violation is paused. Note: When the measurement value is an invalid, ‘---’ shall be displayed.



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AED(Automated External Defibrillator) MODE The defibrillator/monitor will only administer a shock if it is needed. A voice prompt will tell you when to press the SHOCK button to administer defibrillation therapy. The defibrillator/monitor should not be used on someone who is responsive when shaken or breathing normally. Do not use pads if the adhesive gel is dried or damaged. Pads that are dried out or damaged may cause electrical arcing and patient skin burns during defibrillation. Do not use pads that have been removed from foil package for more than 24 hours. Do not use electrodes beyond expiration date. Check that pads adhesive is intact and undamaged. Do not reuse disposable pads that are labeled for single patient use. Do not use pediatric (infant-child) pads on adults or larger children. Delivery of defibrillation energies equal to or greater than 100 joules (typically used on adults) through these smaller pads increases the possibility of skin burns. Do not use paddles for AED mode. AED mode is enabled only with pads. Disconnect non-defibrillation proof electronic devices or equipment from patient before defibrillation. Do not administer a shock using the electrode monitoring cable. Do not place adult pads in the anterior-posterior position when operating this defibrillator/monitor in AED mode. A shock or no shock advised decision may be inappropriately advised. The shock advisory algorithm requires the electrodes to be placed in the anterior-lateral (Lead II) position. The adult pads must be used on patients older than 8 years old. The pediatric (infant-child) pads must be used on patients between 1 and 8 years old or less than 25 kg (55lb). Do not use the defibrillator/monitor in AED mode on patient younger than 1 years old. Do not delay therapy to determine patient’s exact age or weight. Be sure that the electrodes do not come in contact with other conductive materials, especially when connecting or disconnecting the electrodes to or from the patient. Heart rate alarms are temporarily paused in AED Mode. Heart rate alarms are also paused while the defibrillator/monitor is charging for defibrillation and delivering a shock. The AED Mode of defibrillator/monitor is designed for the treatment of sudden cardiac arrest (SCA). It should only be used to treat someone who may be a victim of a SCA and is:  unresponsive to stimulus,  not breathing,  exhibiting no signs of life. If the person is unresponsive but you are unsure that they have suffered from a SCA begin CPR. When it is appropriate to treat, apply the defibrillator/monitor and follow the audible instructions.



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General Defibrillation therapy is the definitive method for termination of a variety of potentially fatal arrhythmias. The defibrillator/monitor’s Automated External Defibrillation (AED) Mode is designed to guide you through standard treatment algorithms for cardiac arrest. The defibrillator/monitor provides therapy through the application of a brief biphasic pulse of electricity to the cardiac muscle. This electrical energy is transferred through disposable multifunction pads applied to the patient’s bare chest. Configuration choices allow you to customize AED Mode to better meet the unique needs of your organization or resuscitation team. This chapter describes how to use AED Mode. It explains the prompts that guide you through the defibrillation process and describes how prompts vary depending upon the condition of the patient and the configuration of your device. Sudden Cardiac Arrest (SCA) Sudden cardiac arrest is a condition in which the heart suddenly stops pumping effectively due to a malfunction of the heart's electrical system. Often victims of SCA have no prior warning signs or symptoms. SCA can also occur in people with previously diagnosed heart conditions. Survival for an SCA victim depends on immediate cardiopulmonary resuscitation (CPR). The use of an external defibrillator within the first few minutes of collapse can greatly improve the patients' chances of survival. Heart attack and SCA are not the same, though sometimes a heart attack can lead to a SCA. If you are experiencing symptoms of a heart attack (pain, pressure, shortness of breath, squeezing feeling in chest or elsewhere in the body) seek emergency medical attention immediately. Heart Rhythm The normal electrical rhythm by which the heart muscle contracts to create blood flow around the body is known as Normal Sinus Rhythm (NSR). Ventricular Fibrillation (VF) caused by chaotic electrical signals in the heart is often the cause of SCA, but a shock can be administered to re-establish normal sinus rhythm. This treatment is called defibrillation. The AED Mode is designed to automatically detect ventricular fibrillation (VF) and perform defibrillation on victims of sudden cardiac arrest. Detecting Fibrillation The electrical rhythm by which the heart muscle contracts can be detected and used for medical diagnosis and the resulting reading is called an Electrocardiogram (ECG). The AED Mode is designed to analyze a patient’s ECG in order to detect ventricular fibrillation (VF) in the heart. If ventricular fibrillation (VF) is detected, the defibrillator/monitor will deliver a carefully engineered electrical shock designed to stop the chaotic electrical activity experienced within the heart muscle during SCA. This may allow the victim's heart to return to a normal sinus rhythm. Rhythm Recognition Performance The ECG database for validation of rhythm recognition performance includes ventricular fibrillation (VF) rhythms of varying amplitudes, ventricular tachycardia (VT) rhythms of varying rates and QRS width, various sinus rhythms including supraventricular tachycardias, atrial fibrillation and atrial flutter, sinus rhythms with PVC (premature ventricular contraction), asystole, and pacemaker rhythms.



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Preparing for Defibrillation The AED algorithm is not designed to handle erratic spiking problems caused by a properly or improperly functioning pacemaker. In patients with cardiac pacemakers, the defibrillator/monitor may have reduced sensitivity and not detect all shockable rhythms. 1.    2.



3. 4. 5.



Confirm that the patient is: unresponsive to stimulus, not breathing, exhibiting no signs of life. Remove clothing to expose the patient’s chest. Wipe moisture from the patient’s chest and if the patient has an excessively hairy chest, shave the area where the electrodes are about to be applied. Make sure the pads packaging is intact and within the expiration date shown. Apply pads to the patient as directed on the pads package. Use the anterioranterior (anterior-lateral) pads placement. If not pre-connected, insert the pads cable into paddle/pads connector located on the front panel of the device. Push until you hear it click into place.



Note: Successful resuscitation is dependent on many variables specific to the patient’s physiological state and the circumstances surrounding the patient incident. Failure to have a successful patient outcome is not a reliable indicator of defibrillator/monitor performance. The presence or absence of a muscular response to the transfer of energy during electrical therapy is not a reliable indicator of energy delivery or device performance.



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Operating the AED Mode of defibrillator/monitor Do not let the multifunction pads touch each other or other monitoring electrodes, lead wires, dressings, transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillation current away from the heart. During defibrillation, air pockets between the skin and multifunction pads can cause patient skin burns. To help prevent air pockets, make sure defibrillation pads completely adhere to the skin. Do not use driedout multifunction pads. Aggressive handling of multifunction pads in storage or prior to use can damage the pads. Discard the pads if they become damaged. Note: Impedance is the resistance between the defibrillator’s pads or paddles that the defibrillator must overcome to deliver an effective discharge of energy. The degree of impedance differs from patient to patient and is affected by several factors including the presence of chest hair, moisture, and lotions or powders on the skin. The low-energy biphasic waveform is an impedance-compensating waveform that is designed to be effective across a wide range of patients. However, if you receive a "Poor Pads Contact" message, check that the patient’s skin has been washed and dried and that any chest hair has been clipped. If the message persists, change the pads and/or the pads cable.



AHA/ERC guidelines (Rescue protocol) The AED rescue protocol is consistent with the guidelines recommended by the AHA/ERC 2015 Guidelines for Resuscitation and Emergency Cardiac Care. The AED rescue protocol is subject to be upgradeable in order to be consistent with and optimized for the guidelines recommended by the latest version of AHA/ERC Guidelines for Resuscitation and Emergency Cardiac Care. Please contact your Mediana service representative for more information. Note: AHA is the abbreviation for ‘American Heart Association’ and ERC is the abbreviation for ‘European Resuscitation Council’. Note: This section is described in accordance with ERC Guidelines. Differences for ERC Guidelines and AHA Guidelines are described with Note format.



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Summary of CPR Guidelines This “Guidelines Highlights” publication summarizes the AHA/ERC 2015 Guidelines. This is easy reference material for both lay rescuer and healthcare provider. Before installing the defibrillator/monitor, it is recommended that the expected AED user should be trained to provide CPR and use the AED. Note: The recommended procedure in below table is intended for the trained user. It is recommended that the untrained user calls the emergency service and follows the instruction directed by dispatcher. Ensure scene safety.



Make sure you, the victim and any bystanders are safe.



Check the victim for a response.



Gently shake victim’s shoulders and ask loudly: “Are you all right?”



Open the airway, Check for breathing.



Open the airway. Look, listen and feel for normal breathing. Note: AHA 2015 Guidelines recommends that untrained user should call for help before checking for breathing and trained rescuers are encouraged to simultaneously perform ‘checking for pulse’ step. Person not responsive? Not breathing normally?



After call for help, Send for AED.



Ask a helper to call the emergency services if possible otherwise call them yourself. Stay with the victim when making the call if possible. Send someone to find and bring an AED if available. If you are on your own, do not leave the victim, start CPR. Note: AHA 2015 Guidelines indicates that helper gets AED if there is an AED nearby. Start chest compressions.



30 Compressions 2 Breaths UNTIL EMC ARRIVE.



After 30 compressions open the airway again and deliver two rescue breaths. Note: If untrained or unable to do rescue breaths, give chest compressions only CPR. Continue CPR until an AED is available or arrival of emergency physician. If the AED available, turn on and follow instructions. ANALYSIS SHOCK DECISION YES



Repeat every 2 minutes.



NO



DELIVER SHOCK.



Continue CPR for about 5 cycles. (approximately 2minutes)



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Using AED Mode 1. 2.



Turn on the AED Mode of defibrillator/monitor by rotating the Mode select knob. Verify the AED Mode of defibrillator/monitor is activated normally and follow audio guidance and STEP icon.



Note: It will take about 4 seconds to initialize AED mode. STEP 1 Check for response. Are you all right? Call for help. If pads are connected to defibrillator/monitor during STEP1, defibrillator/monitor will go on to STEP4 directly.



STEP 2 Open the airway. Check Breathing. If pads are connected to defibrillator/monitor during STEP2, defibrillator/monitor will go on to STEP4 directly.



STEP 3 Begin CPR [Beep] Give two breaths. Stop CPR. If pads are connected to defibrillator/monitor during STEP3, defibrillator/monitor will go on to STEP4 directly. STEP 4 Remove clothes from the patient’s chest. Place pads exactly as shown in the picture. Press pads firmly to patient’s bare chest.



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STEP 5 Analyzing heart rhythm. Do not touch the patient. Shock advised. Charging. or No shock advised.



Note: The Step 5 should be performed at first when the AED Mode of defibrillator/monitor is turned on and the pads are attached correctly to the patient. STEP 6



Press the SHOCK button now. Shock delivered.



Note: The SHOCK button on the third soft key as shown in Figure 34 appears only when SHOCK button on the front side is not pressed within 10 seconds in fully charged state. This button is just an auxiliary function. If there is a fail of the SHOCK button on the front side, it should be repaired. STEP 7 It is safe to touch the patient. Begin CPR [Beep] or If needed, Begin CPR [Beep] Give two breaths. Stop CPR.



Note: If you hear following voice while the AED Mode of defibrillator/monitor is analyzing you should perform the following actions: 











SHOCK button not pressed or Shock cancelled: Move to Step 7 → ECG analyzing again → non-shockable rhythm → move to Step 7 or Critically low battery, Replace new battery: Move to Step 1 after replace the new battery or connect AC power, External DCDC adaptor. Resume analyzing: Pressing the Resume analyzing button at the bottom of the defibrillator/monitor, CPR will be stopped. → Move to Step 5.



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Performing CPR After the electric shock is delivered, the following voice prompt would be emitted.  



It is safe to touch the patient. Begin CPR.



Follow the voice prompts to properly perform the CPR. When performing CPR, use the metronome sound from the defibrillator/monitor in AED mode for compression rate – the defibrillator/monitor emits a tone at a rate of 100 beats per minute. Also, action icon of the defibrillator/monitor will be flashing at a same rate of metronome sound. Rescuer performs 5 cycles of CPR, each cycle include 30 times of chest compression and 2 times of rescue breaths. Or perform the chest compression without rescue breath, if untrained or unable to do rescue breaths. The defibrillator/monitor will remain in CPR mode for 5 cycles (approximately 2 minutes). After CPR mode you will hear the following voice prompt: 



Stop CPR.



The defibrillator/monitor in AED mode will then return to analyzing procedure. Continue to follow this instruction until emergency physician arrives and the hand over patient to emergency physician. Note: In accordance with AHA/ERC 2015 Guidelines, - the recommended compression rate is 100 ~ 120 beats per minute, - the recommended compression depth is at least 2 inches (5 cm), but not more than 2.4 inches (6 cm), - the recommended compression ventilation ratio is 30:2, - the recommended duration is 5 cycles (30:2 x 5 cycles). Note: Your Mediana dealer will have trained you in the particular SCA treatment protocol you have chosen. In all cases follow the voice prompts and visual instructions given by the defibrillator/monitor in AED mode.



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Description of AED Mode Menu Functions



Figure 30. AED Mode Menu



Figure 31. ECG waveform display – ECG signal saturation (AED mode, Pads) Note: If 1 channel ECG input from pads is saturated, waveform is displayed as shown as Figure 31 in AED mode.



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Level1 Level 2 Menu Menu or Response Patient Info ID Confirm Return Name Confirm Return Age Confirm Return Gender Male Female Event Data review records ID#



Real-time data



Table 24. AED Mode Menu Level 3 Menu or Response



Level 4 Menu or Response



Print Return ID Name Age Gender Return



Return Print Download Return



Return



Patient Info ID, Name, Age or Gender of patients can be entered in this menu. ID and Name can be up to 14 characters long, Age can be up to 3 digit numbers and Gender can be selected between Male and Female.



Figure 32. Patient Info: ID Menu More details for Data Review and ID# in Event Records menu, please refer to Event Section. Select the Real-time data Menu to identify real-time data in Patient Info menu. More details for Real-time data, please refer to Real-time Data Section.



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MANUAL MODE Make sure that the ECG signal quality is good and that sync marks are correctly displayed above each QRS complex prior to performing synchronized defibrillation (cardioversion). Artifact introduced by paddle movement may resemble an R-wave and trigger a defibrillation shock when performing synchronized defibrillation (cardioversion). Disconnect non-defibrillation-proof electronic devices or equipment from patient before defibrillation. The defibrillator/monitor has a mechanism to inhibit its output when the impedance of human body which can be measured by paddle is out of range between 15 and 250 ohm. Whenever possible, Mediana recommended that user performs synchronized defibrillation (cardioversion) procedures while directly monitoring the patient through the defibrillator’s electrodes or lead inputs. This section explains how to prepare for and perform asynchronous defibrillation and synchronous defibrillation (cardioversion) using multifunction electrode pads, external paddles.



General Defibrillation therapy is the definitive method for termination of a variety of potentially fatal arrhythmias. The defibrillator/monitor provides this therapy through the application of a brief biphasic waveform of electricity to the cardiac muscle. This electrical energy is transferred through attached paddles or disposable multifunction pads applied to the patient’s bare chest. In manual mode, you must assess the ECG, decide if defibrillation or cardioversion is indicated, select the appropriate energy setting, charge the defibrillator/monitor, and deliver the shock. The entire defibrillation process is under your control. Voice prompts are not present. However, text messages on the display provide relevant information throughout the process. It is important to be attentive to these messages when displayed. Note: Defibrillation is always performed through paddles or pads. However, during defibrillation you may choose to monitor the ECG using an alternate ECG source (3-, 5-, or 12- lead monitoring electrodes). Note: Defibrillating asystole can inhibit the recovery of natural pacemakers in the heart and completely eliminate any chance of recovery. Asystole should not be routinely shocked. Note: Successful resuscitation is dependent on many variables specific to the patient’s physiological state and the circumstances surrounding the patient event. Failure to have a successful patient outcome is not a reliable indicator of defibrillator/monitor performance. The presence or absence or a muscular response to the transfer of energy during electrical therapy is not a reliable indicator of energy delivery or device performance.



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Preparing for Defibrillation Using adult paddles 1. External paddles are placed on the device. 2. Remove the paddles from the paddle tray by pulling the paddles straight up and out of the paddle tray. 3. Apply conductive matter to the paddle electrodes. Do not distribute conductive matter by rubbing the paddle electrodes together. 4. Apply paddles to the patient’s bare chest. Using pediatric paddles 1. The defibrillator/monitor external paddles come with pediatric paddles included. 2. Depress the latch at the front of the external paddles while pulling forward on the adult paddle plate. 3. Apply paddle to the patient’s bare chest. Note: The paddle is an assembled product which is intended to use for adult patient. Remove the plate of paddle for adult, and there is the paddle for pediatric patient.



Operating the Manual Mode of defibrillator/monitor 1. 2.



Select manual mode of defibrillator/monitor by rotating the Mode select knob. When the manual mode of defibrillator/monitor is activated normally, the energy select display will be displayed on the top of the screen and other parameter information will be displayed.



Figure 33. Manual Mode Screen Note: Defibrillation is always performed through paddles or pads. However, during defibrillation you may choose to monitor the ECG using an alternate ECG source (3-, 5-, or 12- lead monitoring electrodes). Note: Defibrillating asystole can inhibit the recovery of natural pacemakers in the heart and completely eliminate any chance of recovery. Asystole should not be routinely shocked.



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Defibrillating (async mode) If the device and paddles are prepared for defibrillation, perform the following steps; 1. To select the energy setting, press the Select Energy Level button and rotate the Multi function knob to the desired energy level. Energy choices range from 1 to 200J. (To choose higher value than 200J, enter the Service Menu by using extra passcode) Note: If Select Energy Level button is not pressed, defibrillator/monitor has default energy level setting. To change default setting, enter the Service Menu. Note: Clinicians must select an appropriate energy level for defibrillation according to patient type. 2.



To charge the energy, press the CHARGE button. If using external paddles, the CHARGE buttons on the paddle or on the front panel can be used. When charging is completed, Charge Indicator on the paddles lights up red. Before Step 3, check the Charge Indicator.



Note: You may increase or decrease the selected energy at any time during charging or after charging is complete. 3.



There are two ways to shock the energy. a. Press the SHOCK button which is placed on the front side of defibrillator/ monitor. b. Press the SHOCK button located on the external paddles. c. Press the SHOCK button appeared on the third soft key menu. (Refer to Figure 34)



Note: If paddles are used, the SHOCK button on the front side does not work. Only the SHOCK button on the paddles works. Note: Defibrillation current can cause operator or bystander injury. Do not touch the patient, or equipment connected to the patient, during defibrillation.



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Figure 34. Shock Soft Key Note: The SHOCK button on the third soft key as shown in Figure 34 appears only when SHOCK button on the front side is not pressed within 10 seconds in fully charged state. This button is just an auxiliary function. If there is a fail of the SHOCK button on the front side, it should be repaired.



Synchronized Cardioversion (sync mode) Synchronized Cardioversion allows you to synchronize delivery of the shock with the Rwave of the ECG being monitored in Wave Sector 1. You may choose to perform synchronized cardioversion through either multifunction pads, or external paddles. When using paddles, you should defibrillator/monitor the ECG through monitoring electrodes connected to a 3-, 5- or 12- lead ECG cable or a defibrillator/monitor. You may choose to defibrillator/monitor through an alternate source when using pads, as well. During cardioversion, energy shock is still delivered through either pads or paddles. If the defibrillator/monitor and paddles are prepared for defibrillation, perform the following steps; 1. 2. 3.



To activate Sync mode, press the Sync soft key located lower right corner of the screen. Confirm that the Sync marker appears with each R-wave. To select the energy setting, rotate the Multi function knob to the desired Energy Level button and press it. Energy choices range from 1 to 200J. (To choose higher value than 200J, enter the Service Menu by using extra passcode)



Note: Clinicians must select an appropriate energy level for defibrillation according to patient type.



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4.



To charge the energy, press the CHARGE button. If using external paddles, the CHARGE button on the paddles may be used instead. When charging is completed, Charge Indicator on the paddles lights up red. Before Step 5, check the Charge Indicator.



Note: You may increase or decrease the selected energy at any time during charging or after charging is complete. 5.



There are two ways to shock the energy. a. Press the SHOCK button which is placed on the front side of defibrillator/ monitor. b. Press the SHOCK button located on the external paddles. The shock will be delivered when the next R-wave is detected. c. Press the SHOCK button appeared on the third soft key menu. (Refer to Figure 34)



Note: It is important to continue to hold the SHOCK button (or the paddle SHOCK button) until the shock is delivered. The defibrillator shocks with the next detected R-wave. Note: Defibrillation current can cause operator or bystander injury. Do not touch the patient, or equipment connected to the patient, during defibrillation. If additional synchronized shocks are indicated, perform the following steps; 6. 7.



Make sure the Sync function is still enabled, as indicated by the presence of the Sync message in the upper right corner of the Wave Sector 1. Repeat Steps 4-5 under “Delivering a Synchronized Shock”.



To turn off the Sync function of the defibrillator/monitor, Press the Sync soft key. Note: The maximum time delay between synchronization pulse and delivery of energy is not exceeded 60ms. Note: The SHOCK button on the third soft key as shown in Figure 34 appears only when SHOCK button on the front side is not pressed within 10 seconds in fully charged state. This button is just an auxiliary function. If there is a fail of the SHOCK button on the front side, it should be repaired.



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Description of Manual Mode Menu Functions



Figure 35. Manual Mode Menu



Level 1 Menu 12 Lead Acquire Setup



Level 2 Menu or Response



Filter



Table 25. Manual Mode Menu Level 3 Menu or Response



0.05Hz ~ 40Hz 0.05Hz ~ 150Hz Return



Transmission Return 12 lead ON / OFF Patient info



ID Name Age Gender



12 lead records



Confirm Return Confirm Return Confirm Return Male Female Return Print Transmission ID #



Return Return 86



ID Name Age Gender



Level 4 Menu or Response



Level 1 Menu Setup Volume



Printer Setting



Level 2 Menu or Response Alarm Beep Button Charging alarm Voice prompt CPR metronome Pacing alarm Return Print on alarm Print on charge Print on shock Print on mark Print on BP Print on self-test 12 lead auto printing Analyze auto printing



Erase data



Return Erase 12 lead records Erase event records Erase internal memory



Waveform setting



Level 3 Menu or Response



Level 4 Menu or Response



On Off On Off On Off On Off On Off On Off On Off On Off Yes No Yes No Yes No



Return 2nd Waveform



ECG



3rd Waveform



SpO2 RESP IBP1 IBP2 EtCO2 Return ECG



4th Waveform



SpO2 RESP IBP1 IBP2 EtCO2 Return ECG



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads



SpO2 87



Level 1 Menu



Display Mode Clinical action list Manual self-test Button test Service menu Return Alarm Limit ▲ ▼ Patient Info ID Name Age Gender



Event records



Level 2 Menu or Response



Return Large numeric display Black-white Invert Mode Clinical Action List 1 ~ 10 Return



(Display 3 digit code) Return



Upper Alarm Limit Lower Alarm Limit Confirm Return Confirm Return Confirm Return Male Female Return Data review ID#



Real-time data Return Sync On/Off



88



Level 3 Menu or Response RESP IBP1 IBP2 EtCO2 Return



Return Print Download Return



Print Return ID Name Age Gender Return



Level 4 Menu or Response



12 Lead Acquire To acquire the 12 lead ECG data from patient, press the Acquire soft key. Setup This menu allows you to set Filter and Transmission. Filter can be selected between 0.05Hz~40Hz and 0.05Hz~150Hz. 12 lead ECG is transmitted to external devices via wireless communication from the defibrillator/monitor. To transmit the result of 12 lead ECG diagnosis, press the Transmission soft key. 12 lead ON / OFF This menu allows you to set 12 lead display. Patient info ID, Name, Age or Gender of patients can be entered in this menu. ID and Name can be up to 14 characters long, Age can be up to 3 digit numbers and Gender can be selected between Male and Female. Setup



Figure 36. Setup Menu Volume The Volume options allow you to adjust the volume of Alarm, Beep, Button, Charging alarm, Voice prompt, CPR metronome and Pacing alarm. Alarm volume, Charging alarm and Voice prompt can be set at level 1 to 8 and Beep volume, Button volume, CPR metronome and Pacing alarm can be set at level 1 to 7 or Off. 1. 2. 3. 4.



Rotate the Multi function knob to highlight Alarm volume, Beep volume or Button volume. Press the Multi function knob. Levels of Alarm volume, Beep volume or Button volume will appear. Rotate the Multi function knob to select a volume level. Press the Multi function knob to enter a desired volume into the defibrillator/monitor.



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Printer setting This menu allows you to set Print on alarm, Print on charge, Print on shock, Print on mark, Print on BP, Print on self-test, 12 lead auto printing or Analyze auto printing. 1.



2.



Rotate the Multifunction knob to highlight Print on alarm, Print on charge, Print on shock, Print on mark, Print on BP, Print on self-test, 12 lead auto printing or Analyze auto printing. Press the Multifunction knob. Multifunction knob toggles between On and Off.



Erase data To clear Erase 12 lead records, Erase event records or Erase internal memory in the defibrillator/monitor, set Erase data to Yes Waveform setting The defibrillator/monitor automatically detects the attached lead. For example, lead type is selected to only Lead I, II and III when 3 leads are attached. You can select the desired ECG lead type. Display Mode This menu allows the user to change a display format of Black-white invert mode. Large numeric screen can only be selected in monitor mode. Clinical Action List This menu indicates the information of drug administration. Only authorized personnel are allowed to set the Clinical Action List in the Service Menu. Refer to the service manual for instructions. Manual self-test This menu allows the user to perform a Self-test manually. Refer to the Self test function section. Button test The user can check buttons for proper functioning. It can be performed by ‘Button Test’ function in the Setup Menu. Service Menu Only authorized personnel are allowed to change the Service Menu settings. The 3 digit code is required for access. Refer to the service manual for instructions.



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Alarm Limit



Figure 37. Alarm Limit Menu Press the Multi function knob to select Alarm limits. The defibrillator/monitor will display all alarm limits that are currently in effect for all monitored parameters. Select the alarm limits to set Patient Info ID, Name, Age or Gender of patients can be entered in this menu. ID and Name can be up to 14 characters long, Age can be up to 3 digit numbers and Gender can be selected between Male and Female.



Figure 38. Patient Info: ID Menu More details for Data Review and ID# in Event Records Menu, please refer to Event Section. Select the Real-time data Menu to identify real-time data in Patient Info. More details for Real-time data, please refer to Real-time Data Section. Sync On/Off Press the Sync On/Off soft key to operate the sync mode. When pressing Sync On soft key, Sync On soft key will be changed to Sync off soft key.



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MONITOR MODE General In monitor mode, you can monitor Electrocardiography (ECG) acquired a 3-. 5-, or 10lead ECG electrodes. Optional monitoring of functional arterial oxygen saturation (SpO2), respiration (RESP), temperature (TEMP), invasive blood pressure (IBP), noninvasive blood pressure (NIBP), and end tidal CO2 (EtCO2), invasive blood pressure (IBP) are also available. Measurements from these parameters are presented on the display and alarms are available to alert you to changes in the patient’s condition. Monitor mode also provides display format of large numeric screen. However, monitor mode cannot provide the defibrillator function including select the delivered energy, analyze, charge, deliver the shock and appear defibrillator messages on the display.



Description of Pacing Mode Menu Functions



Figure 39. Monitor Mode Menu Table 26. Monitor Mode Menu Level 2 Menu Level 3 Menu or Response or Response



Level1 Menu 12 Lead Acquire Setup



Filter



Level 4 Menu or Response



0.05Hz ~ 40Hz 0.05Hz ~ 150Hz Return



Transmission Return 12 lead ON / OFF Patient info



ID Name Age



Confirm Return Confirm Return Confirm 93



Level1 Menu



Level 2 Menu or Response Gender



12 lead records



Level 3 Menu or Response Return Male Female Return Print Transmission ID #



Level 4 Menu or Response



ID Name Age Gender Return



Return Return Setup Volume



Printer Setting



Alarm Beep Button Charging alarm Voice prompt CPR metronome Pacing alarm Return Print on alarm Print on charge Print on shock Print on mark Print on BP Print on self-test 12 lead auto printing Analyze auto printing



Erase data



Return Erase 12 lead records Erase event records Erase internal memory



Waveform setting



Return 2nd Waveform



On Off On Off On Off On Off On Off On Off On Off On Off Yes No Yes No Yes No ECG SpO2 RESP IBP1 IBP2



94



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads



Level1 Menu



Level 2 Menu or Response



3rd Waveform



Level 3 Menu or Response EtCO2 Return ECG



4th Waveform



SpO2 RESP IBP1 IBP2 EtCO2 Return ECG



Level 4 Menu or Response



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads



SpO2 RESP IBP1 IBP2 EtCO2 Return Display Mode Clinical action list Manual self-test Button test Service menu Return Alram Limit ▲ ▼ Patient Info ID Name Age Gender Event records



Return Large numeric display Black-white Invert Mode Clinical Action List 1 ~ 10 Return



(Display 3 digit code) Return



Upper Alarm Limit Lower Alarm Limit Confirm Return Confirm Return Confirm Return Male Female Data review ID#



Real-time data



Print Return ID Name Age Gender Return



Return Print Download Return



Return 95



12 Lead Acquire To acquire the 12 lead ECG data, press the Acquire soft key. Setup This menu allows you to set Filter and Transmission. Filter can be selected between 0.05Hz~40Hz and 0.05Hz~150Hz. To transmit the result of 12 lead ECG diagnosis, press the Transmission soft key. 12 lead ON This menu allows you to set 12 lead display. Patient info ID, Name, Age, Gender of patients or 12 lead records setting can be entered in this menu. ID and Name can be up to 14 characters long, Age can be up to 3 digit numbers and Gender can be selected between Male and Female. Setup



Figure 40. Setup Menu Volume The Volume options allow you to adjust the volume of Alarm, Beep, Button, Charging alarm, Voice prompt, CPR metronome, Pacing alarm. Alarm volume, Charging alarm and Voice prompt can be set at level 1 to 8 and Beep volume, Button volume, CPR metronome and Pacing alarm can be set at level 1 to 7 or Off. 1. 2. 3. 4.



Rotate the Multi function knob to highlight Alarm volume, Beep volume or Button volume. Press the Multi function knob. Levels of Alarm volume, Beep volume or Button volume will appear. Rotate the Multi function knob to select a volume level. Press the Multi function knob to enter a desired volume into the defibrillator/monitor.



Printer setting This menu allows you to set Print on alarm, Print on charge, Print on shock, Print on mark, Print on BP, Print on self-test, 12 lead auto printing or Analyze auto printing. 1.



2.



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Rotate the Multifunction knob to highlight Printer on alarm, Print on charge, Print on shock, Print on mark, Print on BP, Print on self-test,12 lead auto printing or Analyze auto printing. Press the Multifunction knob. Multifunction knob toggles between On and Off.



Erase data To clear Erase 12 lead records, Erase event records or Erase internal memory in the defibrillator/monitor, set Erase data to Yes. Waveform setting The defibrillator/monitor automatically detects the attached lead. For example, lead type is selected to only Lead I, II and III when 3 leads are attached. You can select the desired ECG lead type. Display Mode This menu allows the user to change a display format of Large numeric screen or Blackwhite invert mode. Clinical Action List This menu indicates the information of drug administration. Only authorized personnel are allowed to set the Clinical Action List in the Service Menu. Refer to the service manual for instructions. Manual self-test This menu allows the user to perform a Self-test manually. Refer to the Self test function section. Button test The user can check buttons for proper functioning. It can be performed by ‘Button Test’ function in the Setup Menu. Service Menu Only authorized personnel are allowed to change the Service Menu settings. A 3 digit code is required for access. Refer to the service manual for instructions. Alarm Limit



Figure 41. Alarm Limit Menu Press the Multi function knob to select Alarm limits. The defibrillator/monitor will display all alarm limits that are currently in effect for all monitored parameters. Select the alarm limits to set.



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Patient Info ID, Name, Age or Gender of patients can be entered in this menu. ID and Name can be up to 14 characters long, Age can be up to 3 digit numbers and Gender can be selected between Male and Female.



Figure 42. Patient Info: ID Menu More details for Data Review and ID# in Event Records Menu, please refer to Event Section. Select the Real-time data Menu to identify real-time data in Patient Info. More details for Real-time data, please refer to Real-time Data Section. Sync On/Off Press the Sync On/Off soft key to operate the sync mode. When pressing Sync On soft key, Sync On soft key will be changed to Sync off soft key.



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PACING MODE Use sync mode pacing whenever possible. Use Fixed mode pacing when motion artifact or other ECG noise makes R-wave detection unreliable. Observe the patient continuously while the pacemaker is in use. Patient response to pacing therapy (for example, capture threshold) may change over time. Prolonged invasive pacing may cause patient skin irritation and burns, especially with higher pacing current levels. Discontinue noninvasive pacing if skin becomes burned and another method of pacing is available. The ECG size must be properly adjusted so that the patient’s own beats are detected. If ECG size is set too high or too low, pacing pulses may not be delivered when required. Adjust ECG size so that pacing pulse mark is placed on the patient’s QRS complexes. If you are using the pacing function with battery power and the low battery appears, plug the device into AC power. When the device powers back up, pacing is no longer activated. Press Pacer to reactivate the pacing function. Using other manufacturers’ combination pads with this device could cause a decrease in pacing efficacy or the inability to pace because of unacceptably high impedance levels and invalidate the safety agency certifications. Use only the pads that are specified in these operating instructions. Use of other ECG monitoring devices may provide misleading information due to the presence of pace artifacts. Under certain conditions it may not be possible to properly defibrillator/monitor or pace while electrosurgical apparatus is operating. When poor pads contact, dry skin and/or skin with hair causes excessively high impedance, which restrain the generation of the selected pacing current, and that close surveillance is essential to avoid any risk caused by high impedance if it occurs, the “Pacer out ___ mA” warning message is provided on the screen. Monitor the patient condition continuously through other physiological measurements or mechanical captures when pacing is activated.



General Pacing therapy is used to deliver pace pulses to the heart. Pace pulses are delivered through multifunction pads that are applied to the patient’s bare chest. Note: Use only approved lead sets when pacing with the defibrillator/monitor. Note: Waveforms, ECG monitoring, measurements, and most alarms remain active and retain their settings when you convert from manual mode or monitor mode to pacing mode.



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Demand Mode and Fixed Mode The defibrillator/monitor can deliver pace pulses in either Demand mode or Fixed mode. 1. 2.



In Demand mode, the defibrillator/monitor only delivers pace pulses when the patient’s heart rate is lower than the selected pacing rate. In Fixed mode, the defibrillator/monitor delivers pace pulses at the selected rate.



Note: Use Demand mode pacing whenever possible. Use Fixed mode pacing when motion artifact or other ECG noise makes R-wave detection unreliable or when monitoring electrodes are not available. The defibrillator/monitor requires a 3-, 5-, 12- lead ECG cable and monitoring electrodes as the source of the ECG during standard pacing. Pace pulses are delivered through the multifunction pads. However, the pads cannot be used to monitoring the ECG and deliver pace pulses simultaneously.



Operating the Pacing Mode of defibrillator/monitor Align the Mode select knob to ‘Pacer’ to select the pacing mode. When the pacing mode of defibrillator/monitor is activated normally, the pace rate and current value will be displayed on the top of the screen and other parameter information will be displayed.



Figure 43. Pacing mode screen



Demand mode Pacing When the pacing mode is turned on by selecting ‘Pacer’ mode, the Demand mode operates automatically. 1. 2.



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When the RATE button is pressed, each color of pulse rate value is changed and it can be modified. The ‘Select BPM’ defibrillator message is displayed.



3.



4. 5. 6.



7.



Rotate the Multi function knob to the desired value of pace pulse per minute and then press the Multi function knob to select the desired value of pace pulse per minute. The value is changed by 2 bpm. When the mA button is pressed, each color of output value is changed and the output value can be modified. The ‘Select mA’ defibrillator message is displayed. Rotate the Multi function knob to the desired output value and then press the Multi function knob to select the desired output value. The value is changed by 2 mA. When selected value of pace pulse per minute or below are detected, relevant current (mA) is delivered to patient.



Note: The setting becomes effective only after color of values returns to white from yellow. Note: The pulse rate value in bpm unit is modified between 30 bpm and 180 bpm and the output value is modified between 0 mA and 140 mA. Note: When pacing in demand mode, the ECG cable must be directly connected from the patient to the defibrillator/monitor. Note: If you are using the pacing function with battery power and the low battery alarm is annunciated, connect the device to external power or insert a fully charged battery.



Fixed Mode Pacing Pacing rate should be set higher than the patient’s heart rate. Close patient surveillance is required because ventricular fibrillation could be induced when pacing pulse is activated on T-wave under fixed mode. Note: The amount of energy needed to induce ventricular fibrillation is approximately 12 times the amount needed to pace the heart in canine studies. Although the pace stimulus is applied to the T-wave, the risk of inducing VF during precordial pacing is small. After the pacing mode is turned on by selecting ‘Pacer’ mode, press the Fixed soft key to operate the Fixed mode pacing. 1.



When the RATE button is pressed, each color of Pulse rate value is changed and it can be modified. 2. The ‘Select BPM’ defibrillator message is displayed. 3. Rotate the Multi function knob to the desired value of pace pulse per minute and then press the Multi function knob to select the desired value of pace pulse per minute. The value is changed by 2 bpm. 4. When the mA button is pressed, each color of output value is changed and the output value can be modified. 5. The ‘Select mA’ defibrillator message is displayed. 6. Rotate the Multi function knob to the desired output value and then press the Multi function knob to select the desired output value. The value is changed by 2 mA. 7. The set current value is delivered continuously. Note: To pause pacing, press Pause Pacing soft key and to resume pacing, press Pause Pacing soft key again. 101



Description of Pacing Mode Menu Functions



Figure 44. Pacing Mode Menu



Level 2 Menu Level1 Menu or Response Pause/Resume Pacing Setup Volume Alarm Beep Button Charging alarm Voice prompt CPR metronome Pacing alarm Return Printer Print on alarm Setting Print on charge Print on shock Print on mark Print on BP Print on self-test 12 lead auto printing Analyze auto printing Return 102



Table 27. Pacing Mode Menu Level 3 Menu or Response



On Off On Off On Off On Off On Off On Off On Off On Off



Level 4 Menu or Response



Level1 Menu Erase data



Level 2 Menu or Response Erase 12 lead records Erase event records Erase internal memory



Waveform setting



Level 3 Menu or Response



Level 4 Menu or Response



Yes No Yes No Yes No



Return 2nd Waveform



ECG



3rd Waveform



SpO2 RESP IBP1 IBP2 EtCO2 Return ECG



4th Waveform



SpO2 RESP IBP1 IBP2 EtCO2 Return ECG



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads



SpO2 RESP IBP1 IBP2 EtCO2 Return Display Mode Clinical action list Manual selftest Button test Service menu Return Alarm Limit ▲ ▼ Patient Info ID Name Age



Return Large numeric display Black-white Invert Mode Clinical Action List 1 ~ 10 Return



(Display 3 digit code) Return



Upper Alarm Limit Lower Alarm Limit Confirm Return Confirm Return Confirm Return 103



Level 2 Menu or Response



Level1 Menu Gender



Male Female Data review



Event records



ID#



Level 3 Menu or Response



Level 4 Menu or Response



Print Return ID Name Age Gender Return



Return Print Download Return



Real-time data Return Demand/Fixed Pause Pacing



When the Pause Pacing soft key is pressed, if pacing is operating, pacing will be paused, if pacing is not operating, pacing will be resumed. Setup



Figure 45. Setup Menu Volume The Volume options allow you to adjust the volume of Alarm, Beep, Button, Charging alarm, Voice prompt, CPR metronome and Pacing alarm. Alarm volume, Charging alarm and Voice prompt can be set at level 1 to 8 and Beep volume, Button volume, CPR metronome and Pacing alarm can be set at level 1 to 7 or Off. 1. 2. 3. 4.



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Rotate the Multifunction knob to highlight Alarm volume, Beep volume or Button volume. Press the Multifunction knob. Levels of Alarm volume, Beep volume or Button volume will appear. Rotate the Multi function knob to select a volume level. Press the Multi function knob to enter a desired volume into the defibrillator/monitor.



Printer setting This menu allows you to set Print on alarm, Print on charge, Print on shock, Print on mark, Print on BP, Print on self-test, 12 lead auto printing or Analyze auto printing. 1.



2.



Rotate the Multi function knob to highlight Print on alarm, Print on charge, Print on shock, Print on mark, Print on BP, Print on self-test, 12 lead auto printing or Analyze auto printing. Press the Multi function knob. Multi function knob toggles between On and Off.



Erase data To clear Erase 12 lead records, Erase event records or Erase internal memory in the defibrillator/monitor, set Erase data to Yes. Waveform setting The defibrillator/monitor automatically detects the attached lead. For example, lead type is selected to only Lead I, II and III when 3 leads are attached. You can select the desired ECG lead type. Display Mode This menu allows the user to change a display format of Black-white invert mode. Large numeric screen can only be selected in monitor mode. Clinical Action List This menu indicates the information of drug administration. Only authorized personnel are allowed to set the Clinical Action List in the Service Menu. Refer to the service manual for instructions. Manual Self-test This menu allows the user to perform a Self-test manually. Refer to the Self test function section. Button Test The user can check buttons for proper functioning. It can be performed by ‘Button Test’ function in the Setup Menu. Service Menu Only authorized personnel are allowed to change the Service Menu settings. A 3digit code is required for access. Refer to the service manual for instructions.



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Alarm Limit



Figure 46. Alarm Limit Menu Press the Multi function knob to select Alarm limits. The defibrillator/monitor will display all alarm limits that are currently in effect for all monitored parameters. Select the alarm limits to set. Patient Info ID, Name, Age or Gender of patients can be entered in this menu. ID and Name can be up to 14 characters long, Age can be up to 3 digit numbers and Gender can be selected between Male and Female.



Figure 47. Patient Info: ID Menu More details for Data Review and ID# in Event Records Menu, please refer to Event Section. Select the Real-time data Menu to identify real-time data in Patient Info. More details for Real-time data, please refer to Real-time Data Section. Fixed Press the Fixed soft key to operate the Fixed mode pacing. When pressing the Fixed soft key, Fixed soft key will be changed to Demand soft key.



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NIBP MONITORING For best product performance and measurement accuracy, use only accessories supplied or recommended by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. Inaccurate measurements may be caused by incorrect cuff application or use. This can include placing the cuff too loosely on the patient, using the incorrect cuff size, or not placing the cuff at the same level as the heart, leaky cuff or hose or excessive patient motion. In some cases, rapid, prolonged cycling of an oscillometric, the cuff has been associated with any or all of the followings: ischemia, purpura, or neuropathy. Periodically observe the patient’s limb to make sure that the circulation is not impaired for a prolonged period of time. Also make sure the cuff is placed according to directions in this manual and the cuff directions for use. Do not place the cuff, the catheter or SpO2 sensor on an extremity being used for intravenous infusion or any area where circulation is compromised or has the potential to be compromised. As with all automatically inflatable blood pressure devices, continual cuff measurements can cause injury to the patient being monitored. Weigh the advantages of frequent measurement and/or use of CONT mode against the risk of injury. Ensure the patient is quiet with minimal movement during NIBP readings; minimize the patient’s shivering. Never place the cuff on an extremity being used for intravenous infusion or any area where circulation is compromised or has the potential to be compromised. Never fit NIBP system with Luer Lock adapters. Never use an adult monitor setting or cuff for an NIBP measurement on a neonatal patient. Adult inflation limits can be excessive for neonatal patients, even if a neonatal cuff is used. Do not pull the cable because pulling the cable could cause the disconnection of the cable from the defibrillator/monitor and can cause the error for the measurement. Noninvasive pacing may cause patient skin irritation and burns, especially with higher pacing current levels. Inspect underlying skin of the electrode frequently after 30 minutes of continuous pacing. Discontinue pacing if skin burn develops and another method of pacing is available. On cessation of pacing, immediately remove or replace electrodes with new ones. Do not place the cuff over a wound as this could cause further injury when pressurized. Application of the cuff to any limb where intravascular access or therapy or an arterio-venous (A-V) shunt is present could result in injury due to the temporary interference of blood flow during pressurization. The application of the cuff to the arm on the same side as a mastectomy should be avoided. Any blood pressure reading can be affected by the measurement site, the position of the patient, exercise, or the patient’s physiologic condition. Environmental or operational factors which can affect the performance of the defibrillator/monitor and/or its blood pressure reading are common arrhythmias such as atrial or ventricular premature



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beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, age, pregnancy, pre-eclampsia, renal diseases, patient motion, trembling, and shivering. In the automatic mode, the defibrillator/monitor displays results of the last blood pressure measurement until another measurement starts. If a patient’s condition changes during the time interval between measurements, the defibrillator/monitor will not detect the change or indicate an alarm condition. Any excessive patient motion may cause inaccurate measurements of non-invasive blood pressure. Minimize motion to improve blood pressure measurements. Do not apply the blood pressure cuff to the same extremity as the one to which the SpO2 sensor is attached. Cuff inflation can disrupt SpO2 monitoring and lead to nuisance alarms. Make sure that heavy objects are not placed on the cuff hose. Avoid crimping or undue bending, twisting, or entanglement of the hose. The sensor disconnect error message and associated alarm indicate the sensor is either disconnected or the wiring is faulty. Check the sensor connection and, if necessary, replace the sensor. A compressed or kinked hose connection may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient. Note: Blood pressure measurements can be affected by the position of the patient, the patient’s physiological condition and other factors. Note: Blood pressure measurements determined with the defibrillator/monitor are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed by the American National Standard for manual, electronic, and automated sphygmomanometers.



General The defibrillator/monitor performs Non-Invasive Blood Pressure measurements using the oscillometric measuring technique. A motorized pump inflates the cuff to initially blocking the flow of blood in the extremity. Then, under defibrillator/monitor control, the pressure in the cuff is gradually reduced, while a pressure transducer detects air pressure and transmits a signal to the NIBP circuitry. When the cuff pressure is still above systolic pressure, small pulses or oscillations in the cuff pressure begin to be sensed by the transducer. As the cuff continues to deflate, oscillation amplitude increases to a maximum and then decreases. When maximum oscillation amplitude occurs, the cuff pressure at that time is measured as mean arterial pressure (MAP). The systolic and diastolic pressures are calculated based on analysis of the oscillation amplitude profile.



Setup Connections 1.



2. 3.



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Measure the patient’s limb and select a proper size cuff. As a general rule, cuff width should span approximately two-thirds of the distance between the patient’s elbow and shoulder. Connect the cuff hose to the connector on the defibrillator/monitor’s side option case and turn to right to lock (see Figure 2). Connect a cuff to the cuff hose and turn the connector to right to lock the hoses together. Firm connection must be made.



4. 5. 6.



7.



Patient should be seated with back comfortably and arms supported. Patient should have their legs uncrossed, feet flat on the floor with their back and arms supported. Wrap the cuff around a hare arm or around an arm covered in thin clothing. Thick clothing or a rolled up sleeve will cause a major discrepancy in the blood pressure reading. Wrap the cuff around the patient’s arm so that the center of the cuff’s rubber bladder sits on the artery of the upper arm. The hose should be brought out from the peripheral side without bending (The Brachial artery is located on the inside of the patient’s upper arm.) At this time, check that the index line on the edge of the cuff sits inside the range. Use a different sized cuff if the index line is outside of the range because this will cause a major discrepancy in blood pressure reading. The adult cuff should be wrapped around the arm tightly enough so that only two fingers can be inserted under it, above and below the cuff. Refrain from talking during the measurement procedure, and at least 5 minutes should elapse before the first reading is taken.



8. 9.



Maintain the height of the cuff-wrapped upper arm artery to that of the heart’s right ventricle during measurement. Follow the cuff directions for use when applying the cuff to the arm.



Note: Obtaining NIBP readings can be more difficult in patients with arrhythmias. These arrhythmias increase the beat-to-beat pressure fluctuations, which increases the variability of the NIBP readings. Temporarily verify pressure using another method if it becomes difficult to obtain readings in the presence of arrhythmias. Table 28. Cuff Size Neonate



Pediatric



Adult



Model Number Cuff No.10 Cuff No.11 Cuff No.13 HEM-CS23 HXA-GCUFF-SSLA HXA-GCUFF-SLA HEM-CR23 HEM-CL23 HEM-CX23 HXA-GCUFF-MLA HXA-GCUFF-LLA HXA-GCUFF-XLLA



Arm circumference (cm) 3.5 to 6 5.0 to 7.5 8.5 to 13 13 to 22 12 to 18 17 to 22 22 to 32 32 to 42 42 to 50 22 to 32 32 to 43 42 to 50



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Description of NIBP Menu Functions 2



3



4



5



1



6



1 2 3 4 5



NIBP icon NIBP unit NIBP auto mode interval NIBP elapsed time Bell icon



7



6 7 8 9 10



8 9 10



Systolic pressure value MAP value Initial pressure value Diastolic pressure value Neonatal icon



Figure 48. NIBP Display



Figure 49. NIBP Menu Display Table 29. NIBP Menu Level 1 Menu NIBP MENU Inflate Pressure



Auto Interval Patient Type



Alarm Limit ▲ ▼ ▲ ▼ ▲ ▼ (Limit Alarm Pause) Return



Level 2 Menu or Response 120, 140, 160, 180, 200, 220, 240, 260, 280 (mmHg) (Adult/Pediatric) 80, 100, 120, 140 (mmHg) (Neonatal) Return OFF, Cont, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 (min) Return Adult/Pedi Neonatal Return SYS Upper Limit Adjust SYS Lower Limit Adjust MAP Upper Limit Adjust MAP Lower Limit Adjust DIA Upper Limit Adjust DIA Lower Limit Adjust On, Off



Note: Initial Inflate Pressures shown above are for Adult patient mode. In order to set alarm limits to Neonatal mode, change Patient type via the Setup Menu. Note: The NIBP unit can only be changed by authorized personnel via the Service Menu.



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Inflate Pressure The inflating pressure can be set from 120 to 280 mmHg for adult and pediatric, or from 80 to 140 mmHg for neonatal. Note: Measurement was stopped because measurement time exceeded and then blood pressure measurement might be repeated up to 2 times. Auto Interval The NIBP measurement interval can be selected as Off, Cont, 1, 2.5, 3, 5, 10, 15, 30, 60 or 90 min. Continuous (Cont) mode can measure blood pressure as many measurement as possible within a 5 minutes period. The measurement time will be integral multiple of the selected interval starting from 0 minute. Patient Type The patient type can be selected as Adult/Pedi or Neonatal. Limit Alarm Pause When the Limit Alarm Pause is set to On, the audible alarm for NIBP systolic, MAP and diastolic limit violation is paused.



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Theory of Operation Overview The oscillometric technique does not use Korotkoff sounds to determine blood pressure. The oscillometric technique monitors the changes in cuff pressure caused by the flow of blood through the artery. The defibrillator/monitor inflates the cuff to a pressure that occludes the artery. Even when the artery is occluded, the pumping of the heart against the artery can cause small pressure pulses in the cuff baseline pressure. The defibrillator/monitor lowers cuff pressure at a controlled rate. As the cuff pressure goes down, blood starts to flow through the artery. The increasing blood flow causes the amplitude of the pressure pulses in the cuff to increase. These pressure pulses continue to increase in amplitude with decreasing cuff pressure until they reach a maximum amplitude at which point they begin to decrease with decreasing cuff pressure. The cuff pressure at which the pulse amplitude is the greatest is known as Mean Arterial Pressure (MAP). The manner in which the pulse amplitudes vary is often referred to as the pulse envelope. The envelope is an imaginary line that connects the peak of each pressure pulse and forms an outline. The shape of the envelope is observed by the defibrillator/monitor using a variety of techniques to determine the diastolic and systolic blood pressure.



● Oscillometric Response (Pressure Pulses)



MAP Distole Systole



Systole



Distole



● Cuff Pressure



MAP Distole



TIME



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MAP



Systole



TIME



Overall Accuracy Discussion Overall system accuracy shall be determined by considering various influences of the pressure sensor accuracy, motion artifacts, other artifact created by pressure valve, technical errors of electrical components, and the origin error of oscillometric method. The origin error of oscillometric comes from the basic theory of that the MAP is determined by the pulse. Therefore, there might be an error of the time between two pulses. In another words, the greatest amplitude point of pulses could not represent the MAP point exactly. On clinical trial perspective, overall system accuracy is not easy to be determined. The clinical trial test protocols have been tried and have been described in many treatises, and international standards. So, there are many methods to determine the overall system accuracy of Automated Sphygmomanometer using the oscillometric method. But, there are no absolute test protocols to determine the overall system accuracy of the Automated Sphygmomanometer using oscillometric method. Normally, the Gold standards of Blood pressure for the reference are the intra-arterial pressure and the auscultatory method. The popular standard for the overall system accuracy is AAMI, SP-10 2002+A1;2003 (Electronic or automated sphygmomanometers). The main test conditions are as follow: A. Data comparing the Intra-arterial or the auscultatory by the clinical experts with the automated sphygmomanometer. B. For data collection and the data analysis, Bland-Altman Plot is used. C. On the systolic, diastolic, and MAP, the Deltas of all measurements shall be met under +/- 5mmHg of mean difference (MD), and +/- 8mmHg of standard deviation (SD). (Delta = Intra-arterial or Auscultatory – Automated sphygmomanometer)



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Oscillometric Method The blood pressure values are determined by measuring the small oscillations (changes) in the cuff pressure caused by the heart’s contractions as the pressure in the cuff is released. Mediana’s measurement technology utilizes a unique deflation technique, Dynamic Linear Deflation. This cuff deflation technique allows the Mediana monitor to measure each small change in the cuff pressure oscillations that directly correspond to the measurement’s systolic, mean and diastolic blood pressure values. The cuff is first increased in pressure until it reaches a pressure above arterial occlusion. As the cuff starts to deflate, the pulse rate of the patient is determined and the deflation speed of the cuff is modified to create a patient specific deflation speed. As the pressure decreases, small cuff pressure oscillations are recorded that correspond to the applied pressure of the blood under the cuff as the heart contracts. These oscillations increase in strength as the cuff pressure approaches the systolic blood pressure value. A sudden increase in oscillation amplitude indicates that the patient’s systolic blood pressure is now able to push blood completely through beneath the cuff. The oscillation amplitude continues to increase as the pressure in the cuff is decreases until the mean blood pressure value is reached. The oscillation strength then starts to diminish and finally drop off as the diastolic blood pressure value is reached. The oscillometric method does not determine an instantaneous blood pressure reading like the auscultatory method employing a microphone-type auto blood pressure defibrillator/monitor but, as described above, determines blood pressure from an uninterrupted changing curve, which means that the oscillometric method is not easily effected by external noise and electrosurgical instruments. Note: This equipment is suitable for use in the presence of electro-surgery.



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SpO2 MONITORING For best product performance and measurement accuracy, use only accessories manufactured by Nellcor® or supplied by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. Tissue damage can be caused by incorrect application or use of an SpO2 sensor. Harm can be caused, for example, by wrapping the sensor too tightly, by applying supplemental tape, or by leaving a sensor on too long in one place. Inspect the sensor site as directed in the sensor directions for use to ensure skin integrity, correct positioning, and adhesion of the sensor. Do not use damaged SpO2 sensors. Do not use an SpO2 sensor with exposed optical components. Do not immerse sensor completely in water, solvents, or cleaning solutions because the sensor and connectors are not waterproof. Do not sterilize SpO2 sensors by irradiation, steam or ethylene oxide. Refer to the cleaning instructions in the directions for use for reusable SpO2 sensors. Inaccurate measurements may be caused by:  incorrect sensor application or use  significant levels of dysfunctional hemoglobin (such as carboxyhemoglobin or methemoglobin)  intravascular dyes such as indocyanine green or methylene blue  exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight  excessive patient movement  high-frequency electrosurgical interference and defibrillators  venous pulsations  placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line  patient conditions such as hypotension, severe vasoconstriction, severe anemia, hypothermia, cardiac arrest, or shock  arterial occlusion proximal to the sensor  environmental conditions  unspecified length of the extension cable Do not attach any cable to the sensor port connector that is intended for computer use. Do not pull the cable because pulling the cable could cause the disconnection of the cable from the defibrillator/monitor and can cause the error for the measurement. Do not use a damaged sensor or cable. Do not alter the sensor or cable in any way. Alternations or modification may affect performance and/or accuracy. Never use more than one cable between the pulse oximeter and the sensor to extend the length. Sensors exposed to ambient light when incorrectly applied to a patient may exhibit inaccurate saturation readings. Securely place the sensor on the patient and check the sensor’s application frequently to help ensure accurate readings. Do not rely solely on SpO2 reading: assess the patient at all times. SpO 2 readings may be inaccurate in the presence of significant levels of carboxyhemoglobin or methemoglobin, in patients with restricted blood



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flow to the extremities (such as those in severe shock or hypothermia), or in the presence of excessive motion. Failure to apply the sensor properly may reduce the accuracy of the SpO2 measurement. Inspection the sensor application site at least every two hours for changes in skin quality, correct optical alignment, and proper sensor application. If skin quality is compromised, change the sensor site. Change the application site at least every four hours. More frequent checking may be required due to individual patient’s condition. Severe anemia, methemoglobin, intravascular dyes that change usual blood pigmentation, excessive patient movement, venous pulsations, electrosurgical interference, exposure to irradiation and placement of the sensor on an extremity that has a blood pressure cuff, intravascular line, or externally applied coloring(such as nail polish) may interfere with oximeter performance. The operator should be thoroughly familiar with the operation of the oximeter of the oximeter prior to use. The pulsations from intra-arotic ballon support can be additive to the pulse rate on the oximeter pulse rate display. Verify patient’s pulse rate against the ECG heart rate. Prolonged, continuous use of a sensor may cause irritation, blistering, or pressure necrosis of the skin. Check the sensor site regularly based on patient condition and type of sensor. Change the sensor site if skin changes occur. Do not use tape to hold the sensor in place as this may cause inaccurate readings or damage to the sensor or skin. Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Carboxyhemoglobin and methemoglobin may erroneously increase SpO2 readings. The amount that SpO2 increases is approximately equal to the amount of carboxyhemoglobin or methemoglobin that is present. The sensor disconnect error message and associated alarm indicate the sensor is either disconnected or the wiring is faulty. Check the sensor connection and, if necessary, replace the sensor, extension cable or both. Reusable sensors may be used on the same site for a maximum of 4 hours, provided the site is inspected routinely to ensure skin integrity and correct positioning.



General The defibrillator/monitor uses pulse oximetry to measure functional oxygen saturation in the blood. Because a measurement of SpO2 is dependent upon light from the SpO 2 sensor, excessive ambient light can interfere with this measurement. SpO2 and Pulse rate are updated every second. This defibrillator/monitor measures functional saturation oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin.



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Setup Connections When selecting a sensor, consider the patient’s weight and activity, adequacy of perfusion, availability of sensor sites, need for sterility, and anticipated duration of monitoring. Refer to Table 30, or contact Nellcor® or Mediana sales department for ordering information. 1. 2. 3. 4.



Select the proper sensor for the patient. Connect the extension cable to the SpO 2 connector on the defibrillator/monitor’s front panel and lock it. Connect the sensor to the extension cable and lock it. Carefully apply the sensor to the patient, as described in the sensor directions for use. Observe all warnings and cautions in the directions for use.



Note: Refer to directions for use to ensure the proper placement for various types of SpO2 sensors. Note: Periodically check to see that the sensor remains properly positioned on the patient and that skin integrity is acceptable. Refer to the sensor directions for use. Table 30. SpO2 Sensors Sensor Model OXIMAX® oxygen transducer (Sterile, single- MAX-N use only) MAX-I MAX-P MAX-A MAX-AL MAX-R OXIMAX Oxiband® oxygen transducer OXI-A/N (Reusable with disposable non-sterile OXI-P/I adhesive) OXIMAX Durasensor® Oxygen transducer DS-100A (Reusable, non-sterile) OXIMAX OxiCliq® oxygen transducers P (Sterile, single-use only) N I A OXIMAX Dura-Y® multisite oxygen transducer D-YS (Reusable, non-sterile) For use with the Dura-Y sensor: Ear clip (Reusable, non-sterile) D-YSE Pedi-CheckTM pediatric Spot Check clip (Reusable, non-sterile) D-YSPD OXIMAX MAX-FAST® adhesive reflectance MAXoxygen transducer FAST



Patient Size 40 kg 3 to 20 kg 10 to 50 kg >30 kg >30 kg >50 kg 40 kg 3 to 40 kg >40 kg 10 to 50 kg 40 kg 3 to 20 kg >30 kg >1 kg



>30 kg 3 to 40 kg >40 kg



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Description of SpO2 Menu Functions 1 3 4



2



1 2



SpO2 icon Pulse amplitude indicator



3 4



SpO2 value Bell icon



Figure 50. SpO2 Display



1



2



1



SpO2 waveform icon



2



SpO2 waveform



Figure 51. SpO2 Waveform Display Pulse Amplitude Indicator The pulse amplitude indicator is the segmented display within the SpO 2 numerical area that shows the relative strength of the detected pulse. A stronger pulse causes a larger amplitude indicator.



Alarm Limit



Return



Figure 52. SpO2 Menu Display Table 31. SpO2 Menu Level 1 Menu SpO2 MENU (Alarm Limit) ▲ ▼ (Limit Alarm Pause) Return



Level 2 Menu or Response



% SpO2 Upper Alarm Limit % SpO2 Lower Alarm Limit On, Off



Limit Alarm Pause When the Limit Alarm Pause is set to On, the audible alarm for SpO2 limit violation is paused.



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Theory of Operation The defibrillator/monitor uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by applying a Nellcor™ pulse oximetry sensor to a pulsating arteriolar vascular bed, such as a finger or toe. The sensor contains a dual light source and a photodetector. Bone, tissue, pigmentation, and venous vessels normally absorb a constant amount of light over time. The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations. The ratio of light absorbed is translated into a measurement of functional oxygen saturation ( SpO2). Ambient conditions, sensor application, and patient conditions can influence the ability of the pulse oximeter to accurately measure SpO2. Pulse oximetry is based on two principles: oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (measured using spectrophotometry), and the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (registered using plethysmography). A defibrillator/monitor determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared low-voltage light-emitting diodes (LED) in the sensor serve as light sources; a photo diode serves as the photo detector. Since oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation. The defibrillator/monitor uses the pulsatile nature of arterial flow to identify the oxygen saturation of arterial hemoglobin. During systole, a new pulse of arterial blood enters the vascular bed, and blood volume and light absorption increase. During diastole, blood volume and light absorption reach their lowest point. The defibrillator/monitor bases its SpO2 measurements on the difference between maximum and minimum absorption (measurements at systole and diastole). By doing so, it focuses on light absorption by pulsatile arterial blood, eliminating the effects of nonpulsatile absorbers such as tissue, bone, and venous blood. Functional versus Fractional Saturation This defibrillator/monitor measures functional saturation where oxygenated hemoglobin expressed as a percentage of the hemoglobin that can transport oxygen. It does not detect significant amounts of dysfunctional hemoglobin, such as carboxyhemoglobin or methemoglobin. In contrast, hemoximeters such as the IL482 report fractional saturation where oxygenated hemoglobin expressed as a percentage of all measured hemoglobin, including measured dysfunctional hemoglobin. To compare functional saturation measurements to those from an instrument that measures fractional saturation, fractional measurements must be converted using the listed equation. functional saturation =



fractional saturation × 100 100 – (%carboxyhemoglobin + %methemoglobin)



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Measured versus Calculated Saturation When calculating saturation from a blood gas partial pressure of oxygen (PO 2), the calculated value may differ from the SpO2 measurement of a defibirillator/monitor. This usually occurs when saturation calculations exclude corrections for the effects of variables such as pH, temperature, the partial pressure of carbon dioxide (PCO 2), and 2,3-DPG, that shift the relationship between PO2 and SpO2.



Figure 53. Oxyhemoglobin Dissociation Curve 1 % Saturation Axis 2 PO2 (mmHg) Axis



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3 Increased pH; Decreased temperature, PCO2, and 2,3-DPG 4 Decreased pH; Increased temperature, PCO2, and 2,3-DPG



Clinical Studies Clinical studied conducted for the Nellcor™ Sensors Overview This appendix contains data from clinical studies conducted for the Nellcor™ sensors used with the defibrillator/monitor. One (1) prospective, controlled hypoxia clinical study was conducted to demonstrate the accuracy of Nellcor™ sensors when used in conjunction with the defibrillator/monitor. The study was performed with healthy volunteers at a single clinical laboratory. Accuracy was established by comparison to CO-oximetry. Methods Data from 11 healthy volunteers were included in the analysis. Sensors were rotated on digits and brow to provide a balanced study design. SpO 2 values were continuously recorded from each instrument while inspired oxygen was controlled to produce five steady state plateaus at target saturations of approximately 98, 90, 80, 70 and 60%. Six arterial samples were taken 20 seconds apart at each plateau resulting in a total of approximately 30 samples per subject. Each arterial sample was drawn over two (2) respiratory cycles (approximately 10 seconds) while SpO 2 data were simultaneously collected and marked for direct comparison to CO 2. Each arterial sample was analyzed by at least two of the three IL CO-oximeters and a mean SaO2 was calculated for each sample. End tidal CO2, respiratory rate, and respiratory pattern were continuously monitored throughout the study. Study Population Table 32. Demographic Data Type Gender



Race



Age Weight Skin pigment



Class Male Female Caucasian Hispanic African American Asian Very light Olive Dark olive/Medium black Extremely dark/Blue black



Total 5 people 6 people 8 people 2 people 1 people 0 people 19 ~ 48 years 108 ~ 250 lb 2 people 5 people 3 people 1 people



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Study Results Accuracy was calculated using the root mean square difference (RMSD). Table 33. SpO2 Accuracy for Nellcor™ Sensors SpO2 Decade 60-70 70-80 80-90 90-100



MAX-A Data Points 71 55 48 117



MAX-N Arms 3.05 55 1.84 1.23



Data Points 71 55 48 117



Arms 2.89 2.32 1.73 1.68



MAX-FAST Data Arms Points 71 2.22 55 1.28 48 1.48 117 0.98



Figure 54. Modified Bland-Altman Plot 1



Test Sensor: Avg CO-oximeter value 70-100% SpO2 Oximetry board with MAX-A sensor



2



Avg CO-oximeter value 70-100% SpO2 Trendline of MAX-A sensor



Oximetry board with MAX-N sensor



Trendline of MAX-N sensor



Oximetry board with MAX-FAST sensor



Trendline of MAX-FAST sensor



Adverse Events or Deviations The study was conducted as expected with no adverse events and no deviations from the protocol. Conclusion The pooled results indicate that for a saturation range of 60-80% for SpO2, the acceptance criterion was met for the defibrillator/monitor when tested with MAX-A, MAX-N and MAXFAST sensors. The pooled results indicate that for a saturation range of 70-100% for SpO2, the acceptance criterion was met.



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RESPIRATION MONITORING For best product performance and measurement accuracy, use only accessories supplied or recommended by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. The defibrillator/monitor does not detect apnea when the respiration signal is measured by trans-thoracic impedance. Keep patients under close surveillance when monitoring respiration. Respiration signals are relatively more sensitive to interference from radiated electromagnetic signals. Thus, it is possible, although unlikely, that radiated electromagnetic signals from sources external to the patient and defibrillator/monitor can cause inaccurate respiration readings. Do not rely entirely on the defibrillator/monitor respiration readings for patient assessment. If measured waveforms are not appropriate readings, check external conditions to ensure there is no equipment causing electromagnetic interference. Impedance respiration technology is very sensitive to any of artifacts. If impedance respiration is doubtful due to artifacts, it is not recommended to assess the clinical state of patient only with impedance respiration parameter.



General The patient’s respiration is detected by using two of the three leads of the ECG electrodes and cable. Real-time respiratory information is presented as a waveform and numeric data; Impedance respiration source (IM). The airway respiration measurement uses gases coming into the airway adapter in case of the CO2 equipped. The defibrillator/monitor detects respiration rate by computing each breath cycle form the continuous EtCO2 waveform; Airway respiration source (AW). The respiration monitoring is designed to use the variation of this thoracic impedance. The chest contains various materials, ranging from bone to air. Each of these materials has different electrical properties and is located in a different portion of the chest. The materials of the chest vary in electrical resistivity (the amount of electrical resistance between opposite faces of a cube of that material), which is an important determinant of electrical impedance in the body.



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Setup Connections Refer to the ECG Monitoring section for how to acquire the respiration signal by patient impedance using the ECG electrodes, leads and cable. The performance of impedance respiration can be improved by the particular placement of the Left arm (LA) and Right arm (RA) electrodes. (See Standard ECG electrode placement in Figure 14.) Refer to the Capnography Monitoring section to detect the respiration signal by the airway adapter in case that the CO2 equipped. Note: Impedance respiration monitoring is active only if the paddles are not connected to the defibrillator/monitor or if pads are not connected to pads cable. In case pads or paddles are connected, the respiration rate is displayed as “---” and waveform of respiration is not displayed on the screen.



Description of Respiration Menu Functions 1 4 2 3 5



1 2 3



Respiration rate icon Respiration rate source icon Bell icon



4 Respiration icon 5 Measurement Value



Figure 55. Respiration Display



1



2



1



Respiration waveform icon



2



Respiration waveform



Figure 56. Respiration Waveform Display



Respiration



Respiration Setting



Apnea time setting



Alarm Limit



Figure 57. Respiration Menu Display



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Return



Table 34. Respiration Menu Level 1 Menu RESPIRATION MENU RR Source Size Apnea time setting (Alarm Limit) ▲ ▼ (Limit Alarm Pause) Return



Level 2 Menu or Response Auto (Airway > Impedance), Impedance, Airway, Return X 0.5, X 1, X 1.5, X 2 Off, 10 seconds, 20 seconds, 30 seconds, 40 seconds, 50 seconds, 60 seconds, Return RR Upper Limit Adjust RR Lower Limit Adjust On, Off



RR Source User can select either Airway or Impedance for source of the respiration rate. If the Auto is selected, the defibrillator/monitor will automatically drive the respiration rate from one of the monitoring parameters in this order of priority; Airway and Impedance. Note: You can select Airway as the source when CO2 module is installed. Size Size allows you to adjust the waveform size. Size can be selected as X 0.5, X 1, X 1.5 or X 2.0. Apnea time setting When the patient’s breath is not detected from the airway measurement for the selected time setting, the defibrillator/monitor will activate an apnea alarm. When 60 is selected, the defibrillator/monitor will generate two tones after 20 seconds from no breath. Then three tones are generated again after 20 seconds, and then an apnea alarm will be activated after another 20 seconds. If Off is selected, the defibrillator/monitor does not detect an apnea alarm. When the defibrillator/monitor does not detect a respiration signal from the impedance measurement for 40 seconds, the defibrillator/monitor will activate a loss of respiration alarm. Check the condition of the patient, then check the connections of the patient cables. Limit Alarm Pause When Limit Alarm Pause is set to On, the audible alarm for respiration rate limit violation is paused.



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Theory of Operation The respiration monitoring is designed to use the variation of this thoracic impedance. The chest contains various materials, ranging from bone to air. Each of these materials has different electrical properties and is located in a different portion of the chest. The materials of the chest vary in electrical resistivity (the amount of electrical resistance between opposite faces of a cube of that material), which is an important determinant of electrical impedance in the body. Two of the major components of the chest, blood and air, are at opposite ends of the scale. Furthermore, the volume of each of these materials varies with time over the cardiac and breathing cycles. The variation of the thoracic impedance is caused by the difference between air and blood in the thoracic impedance. Blood has relatively low resistivity, which varies over the cardiac cycle owing to changing blood volumes in the heart and in the vascular compartment. Air, on the other hand, has high electrical resistivity and hence impedance, and it undergoes wide volume changes in the lungs during normal breathing. i.e. the impedance of blood is 150 ohm/cm and the one of air is 5=000 ohm/cm. The patient’s respiration is detected by using two of the three leads of the ECG electrodes (RA and LA, or RA and LL) and cable. The electrical impedance between a pair of electrodes is determined by dividing the voltage difference between the two electrodes by the current that passes between them. When the electrodes are placed on the actual structure, respective structures change. A low-level excitation signal is applied to these leads, and the variation of the thoracic impedance caused by the breathing is sensed and processed for display and measurement. This variation is processed to the voltage value for the measurement. In order to transfer the thoracic impedance by a transformer, it is used a minimum constant current of the sine wave carrier signal. The transferred thoracic impedance is changed to the voltage signal by using bridge circuit and differential amplifier. Then, ECG signal is removed by filter, and carrier frequency is removed by full wave rectifier and filter in order to extract only thoracic impedance in amplifying at the definite level of signal. This extracted thoracic impedance signal is used to measure the respiration by digital signal processing.



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CAPNOGRAPHY MONITORING For best product performance and measurement accuracy, use only accessories supplied or recommended by Mediana. Use accessories according to your facility’s standards and the manufacturer’s recommendation. Always refer to the manufacturer’s Directions for Use for instruction about operation, cleaning, and replacement. The EtCO2 readings do not always correlate closely with blood gas values, especially in patients with pulmonary disease, pulmonary embolism or inappropriate ventilation. If uncertain about the accuracy of any measurement, first check the patient’s vital signs by alternate means, and then make sure the defibrillator/monitor is functioning correctly. The defibrillator/monitor should not be used as an apnea monitor. To ensure patient safety, do not place the defibrillator/monitor in any position that might cause it to fall on the patient. To ensure accurate performance and prevent defibrillator/monitor failure, do not expose the defibrillator/monitor to extreme moisture, such as rain. The use of accessories, transducers, sensors and cables other than those specified may result in increased emission and/or decreased immunity of the equipment and/or system. CO2 readings and respiratory rate can be affected by sensor application errors, certain ambient environmental conditions, and certain patient conditions. The defibrillator/monitor is a prescription device and is to be operated by qualified healthcare personnel only. Ensure that the components of the airway are secure. If they become loose, external air may be sucked in the tube and the sampling gas will be diluted, causing incorrect measurement values. Ensure that selection of a volatile anesthetic is done carefully. If an improper selection is made, the measurement values may be incorrect. Do not use accessories other than which are specified. Different sampling tube lengths or inside diameters may have an effect on the measurement. The mainstream/sidestream capnography module should not be used in the presence of flammable anesthetics or other flammable gases. Use of this device in such an environment may present an explosion hazard. Do not use device without rectifying a gas calibration failure, as correct measurement readings will not be obtained. Do not use device on patients that cannot tolerate the withdrawal of 50 cc/min ±10cc /min from airway. CO2 should not be measured in the presence of aerosolized pharmaceuticals. Do not use a damaged airway adapter. To ensure accurate performance and prevent the defibrillator/monitor failure, do not connect the exhaust tube to the ventilator circuit. Flow-related readings may significantly affected by a gas leak, such as that caused by an un-cuffed endotracheal tube or a damaged sidestream sensor and mainstream sensor. In high-altitude environments, EtCO2 values may be lower than values observed at sea level, as described by Dalton's law of partial pressures. 127



When using the defibrillator/monitor in high-altitude environments, it is advisable to consider adjusting EtCO2 alarm settings accordingly. Do not operate the Capnostat sensor when it is wet. Do not immerse the device in water. Do not operate the Capnostat sensor if it appears to have been damage or if it fails to operate properly. If the patient’s airway is configured with a closed suctioning system, make sure the airway adapter is placed closed to the suctioning system (on the ventilator side). This will help ensure that the sampling adapter is not impaired during and after suctioning. The disposable airway adapter, nasal and nasal/oral sampling cannulas, and the airway adapter kit are intended for single patient use. Do not reuse or sterilize these disposable adapters, because system performance will be compromised. Do not insert any object other than the sidestream sample cell into the inlet port of the CO2 module. Inspect the mainstream CO2 sensor and airway adapter connection to ensure correct positioning. Position sidestream airway adapter with the tubing in an upright position. This help keep patient secretions from pooling into the tubing. To prevent moisture from during into the mainstream airway or into the sidestream airway adapter tubing, do not place the adapter in a gravity dependent position. It is recommended that the mainstream airway adapter and the sidestream airway adapter be removed from the circuit whenever an aerosolized medication is delivered. The increased viscosity of the medication may contaminate the sensor windows, causing the sensor to fail prematurely.



General The defibrillator/monitor capnography option supports mainstream and sidestream gas analysis designed to measure the concentration of carbon dioxide in a gas mixture and to aid in determining the patient’s ventilatory, circulatory, and metabolic status. Mainstream (nondiverting) and sidestream (diverting) capnography are highly accurate methods of measuring respiratory gas values. When monitoring capnography, the defibrillator/monitor automatically compensates for the ambient barometric pressure to ensure accurate readings.



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Setup Connections The defibrillator/monitor has one capnography sensor receptacle which may be used for a mainstream capnography sensor or a sidestream capnography sensor. Note: Capnograpy is not analyzed during unit warm-up however, the capnography does display to indicate that the defibrillator/monitor is working properly. Note: The typical initial warm-up period can take up to two minutes. This time varies based of the temperature of the sensor at the start of the initial warm-up. Note: The airway adapter may require cleaning or replacement if the capnograph is used on patients that emit excessive mucous. Calibrating the CO2 Sensor You must calibrate the CO2 sensor the first time it is connected to the defibrillator/monitor, when the CO2 sensor is changed. You do not need to calibrate the sensor when you power on the defibrillator/monitor. Once calibrated, the sensor may be disconnected and reconnected without calibration. Note: To maintain optimum performance of the sensor and capnograph, you should perform a sensor calibration verification at least once a week. Mainstream Operation Mainstream monitoring uses an external, self-calibrating CO2 sensor to ensure continuous monitoring without interruption of connection. Reusable, lightweight, or single-use airway adapters are available for both adult and neonatal (low dead space) patients. Respiration can be monitored via an airway adapter and endotracheal or tracheostomy tube using the mainstream function of the module. The external capnography device includes a small, lightweight sensor that continuously measures the end-tidal and minimum carbon dioxide levels in the patient’s airway. The sensor head contains a small infrared transducer that accurately measures the CO 2 in the airway. The sensor is connected to the airway by a disposable or reusable airway adapter. These adapters are available in adult and neonatal size.



Figure 58. Connection for mainstream 1 2 3



Y-piece Airway adapter Patient connector (Adult/Pedi)



4 5



Elbow Mainstream CO2 sensor



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Sidestream Operation Sidestream monitoring uses an external, sidestream sensor that plug into the capnography port on the defibrillator/monitor. Adult, pediatric, or infant sampling lines are then plugged into the sensor receptacle. Respiration can be monitored for intubated or non-intubated patients via an airway adapter, nasal cannula, or nasal/oral cannula using the sidestream function of the module. Sidestream monitoring diverts patient gases at a rate of 50 ml/min (±10ml/min). The sidestream sampling lime consists of a sample cell on one end that into the sidestream sensor receptacle on the defibrillator/monitor. The other end of sampling line is connected to the patient either via a cannula or a sample-T, as shown in Figure 59. Note: For connection method for exhaust tube, follow the instruction in the directions for use of sidestream sensor.



Figure 59. Connection for sidestream 1 2



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Cannula Sampling cell



3 4



Sampling-T Sidestream CO2 sensor



Description of EtCO2 Menu Functions 1



5



2



6



3



7



4



1 2 3 4



EtCO2 icon EtCO2 value InCO2 icon InCO2 value



5 6 7



EtCO2 unit Bell icon InCO2 unit



Figure 60. EtCO2 Display



1



2



1



EtCO2 waveform icon



2



EtCO2 waveform



Figure 61. EtCO2 Waveform Display



Figure 62. EtCO2 Menu Display



Menu EtCO2 MENU EtCO2



EtCO2 Setting



Table 35. EtCO2 Menu Level 2 Menu or Response Level 3 Menu or Response On Off Return N2O Gas



O2 Gas



Calibration Scale



(Alarm Limit) ▲ ▼



On Off Return On Off Return Enter Return



0 ~ 40 mmHg 0 ~ 60 mmHg 0 ~ 80 mmHg Auto Return EtCO2 Upper Limit Adjust EtCO2 Lower Limit Adjust 131



▲ ▼ (Limit Alarm Pause) Return



InCO2 Upper Limit Adjust InCO2 Lower Limit Adjust On, Off



Note: The EtCO2 unit can only be changed by authorized personnel via the Service Menu. EtCO2 When the capno measurement is On, EtCO2, InCO2 and capno waveform measurement are activated. EtCO2 Setting O2 Gas As the N2 in the sample gas is replaced by O2, the effect is a decrease in IR absorption. This results in a lower than actual measured CO2 value (CO2 measured). It is recommended O2 Gas is set to On to correct for the O 2 effect when the O2 concentration is greater than 50%. At O2 levels equal to or less than 50%, the correction should not be used. N2O Gas As the N2O in the sample gas, an assumption is made: if N 2O is administered to the patient, then the remaining balance of the administered mixture is O 2. The combined effect of these gases is two-fold: O2 presence decreases IR absorption, and N2O presence increases absorption. Though N2O does not directly absorb the filtered IR energy, it cause the CO2 molecule to absorb and pass along some of it energy to the N2O molecule of similar molecular weight. By passing off some of this energy, the CO 2 molecule is free to absorb even more energy which leads to an increase in absorption. Since the increased absorption effect due to N 2O presence is greater than the decrease due to O2 presence, an optimal administered mixture of 25% N2O and 75% O2 effectively cancels the combined effect. The effect of desflurane on the CO 2 measurement is similar to the effect of N2O. It is recommended N2O Gas is set to On when N 2O or desflurane concentrations is above 12%. Calibration When the calibration is set to Enter, the EtCO2 calibration will be performed automatically. Scale The user can select the scale of capno waveform. When Auto is selected, the defibrillator/monitor will automatically set the scale upon the measurement value. Limit Alarm Pause When Limit Alarm Pause is set to On, the audible alarm for EtCO2 or InCO2) limit violation is paused.



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Theory of Operation The CO2 sensor measures CO2 by using the infrared technique. The principle is based on the fact that CO2 molecules absorb infrared (IR) light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO 2 concentration. When an IR beam is passed through a gas sample containing CO2, the electronic signal from the photodetector (which measures the remaining light energy) is measured. This signal is then compared to the energy of the IR source and adjusted to accurately reflect CO 2 concentration in the sample. The CO2 sensor’s response to a known concentration of CO 2 is stored at the factory in the sensor’s memory. A reference channel accounts for optical changes in the sensor, allowing the system to remain in calibration without user intervention.



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TEMPERATURE MONITORING For best product performance and measurement accuracy, use only YSI 400 and 700 series temperature probes recommended by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards.



General Measurement of patient temperature is accomplished by processing the signal from a probe containing a resistance element whose impedance is temperature dependent. These devices are called thermistors. The measuring time required to obtain accurate readings at the specific body site is about 20 seconds.



Setup Connections The defibrillator/monitor is designed to accept signals from the temperature probes, YSI 400 series and 700 series for skin, rectal or etc. 1. 2.



Insert a body temperature probe into the temperature connector on the defibrillator/monitor’s side option case. (see Figure 1). Follow the directions for use accompanying the temperature probe. Table 36. Temperature Sensors



YSI sensors



Sensor YSI 401 or compatible YSI 409 or compatible YSI 701 or compatible YSI 709 or compatible



Description Mono, rectal type Mono, skin type Stereo, rectal type Stereo, skin type



Description of Temperature Menu Functions



1 2 3 4



1



5



2



6



3



7



4



7



Temperature1 icon 2 Temperature1 value Temperature2 icon Temperature2 value



5 6 7



Temperature1 unit Bell icon Temperature2 unit



Figure 63. Temperature Display Alarm Limit



Return



Figure 64. Temperature Menu Display



135



Menu TEMPERATURE MENU (Alarm Limit) ▲ ▼ ▲ ▼ (Limit Alarm Pause) Return



Table 37. Temperature Menu Level 2 Menu or Response



Temperature1 Upper Limit Adjust Temperature1 Lower Limit Adjust Temperature2 Upper Limit Adjust Temperature2 Lower Limit Adjust On, Off



Note: The temperature unit can only be changed by authorized personnel via the Service Menu. Limit Alarm Pause When the Limit Alarm Pause is set to On, the audible alarm for Temperature limit violation is paused.



Theory of Operation Temperature measurement used by the defibrillator/monitor based on a thermistor whose resistance is inversely proportional to its temperature. By measuring the thermistor’s resistance, its temperature can be calculated. The resistance of the thermistor is measured by passing a current through it and measuring the voltage developed across it. The defibrillator/monitor is designed to accept the signals from electrically isolated a range of temperature probes from YSI-400 and YSI-700 series. The probes may be used for skin or rectal temperature measurement. Probes are furnished with a standard 10-feet lead; extension leads are available. The signal from the probe is conditioned by the defibrillator/monitor input circuitry, processed, and used to drive the numeric display.



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IBP MONITORING Proper measurements may not be possible,  If improper zero calibration was performed.  If air bubbles are mixed into the patient circuit. If the height of the three-way tap for zero calibration and the right auricle have changed. If the pressure transducer has been dropped or subjected to strong physical shock, check for faults before use. Be sure to thoroughly read the instruction manuals for each item-such as the transducer, monitoring kit and transfusion set-that are used in invasive blood pressure measurements before using them. The cautions and warnings for such items are not included in this manual. Use a CE certified transducer with a sensitivity of 5μV/V/mmHg at an excitation voltage of 5 VDC, and a measurement range of -50 to 300mmHg. Do not reuse disposable (single use) transducers. Check the time limit on the package not to use transducers with expired dates. Ensure that reusable transducers are sufficiently sterilized. To ensure patient safety, do not contact any conductive parts to the applied part. Never install or remove the IBP module while the defibrillator/monitor is powered on. It is likely to break when installing or removing it while powered on. Do not perform the pressure zero setting while measuring the patient. If air bubbles appear in the pressure line or transducer, flush the system with the solution to be infused again. Invasive pressure alarms (and pulse alarm, if there are being derived from the invasive pressure) are turned off while the transducer is zeroing. The alarms turn back on 30 seconds after the zeroing is finished. Make sure the correct label has been selected before you set the alarm limits The alarm limits you set are valid only for labels in the current group. Changing the label could change the alarm limits. The sensor disconnect error message and associated alarm indicate the sensor is either disconnected or the wiring is faulty. Check the sensor connection and, if necessary, replace the sensor. Zeroing is necessary before IBP monitoring can begin. Verify the IBP zero (per hospital procedures) and alarm at least once daily and whenever the patient’s position changes to ensure that IBP measurements are accurate. Zero the pressure transducer to atmospheric pressure to ensure pressure readings are accurate.



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General The invasive blood pressure measurement measures the systolic pressure, mean pressure, diastolic pressure and pulse rate for up to 2 blood pressure line channels using blood pressure transducers, and displays the blood pressure waveform.



Setup Connections 1.



2.



Connect the interface cable for the transducer to the IBP connector (6pin, red round connector) on the defibrillator/monitor’s side option case. An interface cable for the transducer has to be selected correctly as it depends on the each transducer type. Set up the patient circuit according to the directions for use of the transducer, monitoring kit and IV set.



The drawing below shows the example.



Figure 65. IBP connections 1 2



138



Pressure bag Transducer



3 4



Interface cable To patient



Description of IBP 1 Menu Functions 1



4 5



2



6



3



1 IBP 1 label icon 2 Systolic value 3 Mean arterial pressures value 4



4 IBP 1 unit 5 Diastolic value 6 Bell icon



Figure 66. IBP 1 Display



1



2



1 IBP 1 label icon



2 IBP 1 waveform



Figure 67. IBP 1 Waveform Display



Zero Setting



Scale



Label



Alarm Limit



Return



Figure 68. IBP 1 Menu Display Table 38. IBP 1 Menu Menu IBP 1 MENU Zero Setting Scale Label



(Alarm Limit) ▲ ▼ ▲ ▼ ▲ ▼ (Limit Alarm Pause) Return



Level 2 Menu or Response Enter Return 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~ 300mmHg, Auto, Return P1 ABP Return SYS Upper Limit Adjust SYS Lower Limit Adjust MEAN Upper Limit Adjust MEAN Lower Limit Adjust DIA Upper Limit Adjust DIA Lower Limit Adjust On, Off



139



Zero Setting When Zero Setting is set to Enter, IBP 1 channel is calibrated. Scale The user-selectable pressure waveform scale allows you to adjust the scale of a pressure waveform. The scale can be selected as 0 to 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~ 300mmHg or Auto. Label The label can be selected as P1 or ABP. Limit Alarm Pause When the Limit Alarm Pause is set to On, the audible alarm for IBP 1 limit violation is paused.



Description of IBP 2 Menu Functions 1



4



2



5



3



6



1 IBP 2 label icon 2 Systolic value 3 Mean arterial pressures value 4



4 IBP 2 unit 5 Diastolic value 6 Bell icon



Figure 69. IBP 2 Display



1



2



1 P2 (CVP, PAP, LAP) icon



2 P2 waveform



Figure 70. IBP 2 Waveform Display



Zero Setting



Scale



Label



Alarm Limit



Figure 71. IBP 2 Menu Display



140



Return



Table 39. IBP 2 Menu Level 1 Menu IBP 2 MENU Zero Setting



Level 2 Menu or Response



Label



Enter Return 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~ 300mmHg, Auto, Return P2 CVP PAP LAP Return



(Alarm Limit) ▲ ▼ ▲ ▼ ▲ ▼ (Limit Alarm Pause) Return



SYS Upper Limit Adjust SYS Lower Limit Adjust MEAN Upper Limit Adjust MEAN Lower Limit Adjust DIA Upper Limit Adjust DIA Lower Limit Adjust On, Off



Scale



Zero Setting When Zero Setting is set to Enter, IBP 2 channel is calibrated. Scale The user-selectable pressure waveform scale allows you to adjust the scale of a pressure waveform. The scale can be selected as 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~ 300mmHg or Auto. When the Auto is selected, the defibrillator/monitor automatically set the scale upon the IBP measurement value. Label The label can be selected as P2, CVP, PAP or LAP. Limit Alarm Pause When the Limit Alarm Pause is set to On, the audible alarm for IBP 2 limit violation is paused.



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Theory of Operation The pressure transducer is connected to a pressure line which, by means of a catheter is invasively connected to the patient blood stream. The force of movement of the blood in the patient vessels in transported by the fluid column in the pressure line to the transducer. This movement cause an electrical signal to be generated which is then amplified to display the pressure wave and the numeric for the systolic, diastolic and mean pressure values. The blood pressure is influenced by the respiratory system. This occurs in spontaneous breathing patients, but is more apparent in positive pressure ventilated patients. To reduce this respiration artifact the module uses a variable weight filter technique in the processing of the pressure values.



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SELF-TEST FUNCTION General This defibrillator/monitor incorporates a Self-test function. The defibrillator/monitor should be checked at regular intervals so that it will always be ready-to-use for emergency situations. There are three modes: Manual Self-test, Auto Self-test and Button test. Additionally, the external shock test should be performed prior to use. Manual Self-test If the user wants to perform a High-voltage module alive test, Body impedance test, ECG circuit and algorithm test, internal shock test, internal pacing output test, pads/paddle connection test, system ROM test, system RAM test, real time clock test, installed module alive test and battery test, it can be performed by ‘Manual Self-test’ function in Setup Menu. Auto Self-test When the defibrillator/monitor has been turned off, Auto Self-test (or scheduled Self-test) is operated automatically according to the user’s setting. The Self-test interval can be selected as Off, 24, 48, and 72 hours. If the residual of battery power is less than 60% without using the AC or DC, the Self-test will not be performed. If the defibrillator/monitor is in use at the time of a scheduled Auto Self-test, the Auto Selftest will be canceled. If the defibrillator/monitor is turned on when the Auto Self-test is in process, the Auto Self-test will be canceled and the defibrillator/monitor will be operated normally. Note: The setting of the Auto self-test (time and interval) can only be changed by authorized personnel via the Service Menu. Button test The defibrillator/monitor has the button test function. User can check buttons that are working correctly. It can be performed by ‘Button Test’ function in Setup Menu. Button test is to check button is working correctly by pressing the denotative buttons. Button test can be divided into two types, Front panel and paddles. ‘Shock’, ‘Charge’, ‘Analyze’, ‘Energy Select’, ‘BPM’, and ‘mA’ buttons can be checked on the front panel, and ‘Shock’, ‘Charge’, ‘Energy Up’, ‘Energy Down’, and ‘Recording’ buttons can be checked on the paddles. Note: It is recommended to run ‘Button test’ manually once a week.



143



Functions to be tested in Self-test The defibrillator/monitor Self-test performs 11 test steps. Lists and descriptions of the tests are indicated below.



Figure 72. Auto Self-test display



No. 1 2 3 4 5 6 7 8 9 10 11



Table 40. Self-test functions Description To check if the High-Voltage module is operational and available to communicate. To check impedance of internal fixed resistance from 25Ω to 175Ω ECG circuit and algorithm To check the result of diagnosis for normal sinus test rhythm and Ventricular Fibrillation for ECG input. Internal Shock test To check the energy accuracy for discharge of set energy to internal discharge resistance. Internal Pacing output test To check the normal condition of pacing output of fixed value of current and bmp. Pads/Paddle connection test To check if paddles or pads are connected correctly. System ROM test To check if the internal program is normal. System RAM test To check if the Read/Write performance of RAM is normal. Real time clock test To check the accuracy of the time. Installed module alive test To check if installed measurement parameter modules are operational and working correctly. Battery test To check the status of the battery. Test High-Voltage module operational test Body Impedance test



Self-test result transmission (if configured with Wireless module option) The result of the Self-test can be transmitted to a hospital biomedical engineer by using the 3G/Wi-Fi module and can also be printed out by the printer module.



Self-test result printing Printing the result of a Self-test can be set as On or Off in the Service menu by authorized personnel as described in the service manual.



144



External shock test The user must verify the ability to deliver defibrillation energy once a week.



Figure 73. External shock test 1.



2. 3. 4. 5. 6. 7. 8.



Make sure the paddles and the paddle tray are thoroughly clean and there is no residue including the conductive material on electrode surfaces of the paddle and paddle tray. Place the paddles on the paddle tray. (see Figure 73). Turn on the defibrillator/monitor. Select the defibrillation energy by pressing the Energy level button on paddle. Press the CHARGE button on paddle to charge the selected energy. When charging is completed, Charge Indicator lights up red. Before Step 7, check the Charge Indicator. Press the SHOCK button on paddle. Confirm the energy level on the display.



145



Trouble shooting After finish the auto self-test, the defibrillator/monitor will be turned off itself again. If there was no fail, the service LED will be blinking. But if any fail was detected, service LED and buzzer sound will be generated. (when the defibrillator/monitor is using the AC or DC power, the result of auto self-test will be displayed). But when the residual of battery power has dropped less than 60 %, those LED and buzzer will be turned off for saving the power.



LED condition LED OFF



LED Blink LED Fixed



146



Table 41. Trouble shooting of Self-test Situation To do Possibility 1: The self-test has not Turn on the defibrillator/monitor been performed. (Connect the AC or DC power if it is Possibility 2: The self-test has been not connected) and perform the performed but the residual of battery manual self-test via setup menu. was dropped less than 60%, it turned off the LED and buzzer itself. The self-test was finished, and no Turn on the defibrillator/monitor and failure was detected. use it safely. The self-test was finished and any If AC or DC power is connected, check failure was detected. If AC or DC the failed item of self-test and contact power is connected, self-test result qualified service personnel or your will be displayed, and buzzer sound local supplier. will be generated. If the If the device is using battery power defibrillator/monitor is using battery only, turn on the defibrillator/monitor power only, the buzzer sound will be and can check the failed item. After generated without display screen. then, contact qualified service personnel or your local supplier.



EVENT General Event data in either graphical or tabular format may be displayed on 3rd and 4th waveform display area. 1. 2.



Press the Patient Info soft key. Rotate the Multi function knob to Event records on the screen and press the Multi function knob to display.



The event data is stored in memory. When the defibrillator/monitor turns on and starts to measure vital signs, the defibrillator/monitor saves data of elapsed time before and after 10 seconds from the point of event generation. The events are including Defibrillation, Pacer mode, Heart rate alarm, and VF alarm. Also, the defibrillator/monitor saves all NIBP measurements events. The data remains even if the defibrillator/monitor is powered off. After the defibrillator/monitor has stored 250 event data, “SYSTEM: Not enough memory” message or “SYSTEM : Not enough memory(Internal memory)” message is displayed on the screen.



Event Data List Display The defibrillator/monitor presents event information in tabular format for all monitored parameters. Event type, Patient ID, name, age, gender and time are displayed. The newest data appears at the top of tabular events. To scroll the event data list, rotate the Multi function knob when the event data list is displayed. For the NIBP event may display the latest measurement.



Figure 74. Event Data List Display



147



Event Review Display Event information in graphical format for ECG data is displayed in a graph. The defibrillator/monitor displays the event information through recent 10sec after and before event occurred. When printing the event information, all the parameters like ECG, SpO2, NIBP, Temp, EtCO2, IBP and Respiration are printed. The event review display of each parameter is indicated by the symbols specified in table. The vertical range of a graphical event is presented with fixed value, and the horizontal range is 20 seconds. The newest data appears at the right of graphical event. Use the scroll function to view more data.



Figure 75. Event Review Display



148



12 Lead Record Display The 12 lead data is displayed in tabular format as shown in Figure 76. Patient ID, name, age, gender and time are displayed. The newest data appears at the top of tabular events. To scroll the event data list, rotate the Multi function knob when the 12 lead data list is displayed.



Figure 76. 12 Lead Record Display



ID# To display ID Menu, press the ID soft key on the lower side of Event records. ID Menu is displayed equal to Patient Info menu. Refer to Figure 77.



Figure 77. Patient Info Menu



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REAL-TIME DATA General This defibrillator/monitor is designed to print the Real-time data and download to Realtime data in SD card.



Real-time data menu List of Real-time data shows a maximum of 18 data in Real-time data menu as shown in Figure 75. When the Real-time data has been exceeded 18 data, user can identify the exceeded 18 data. Data were identified when to press the previous icon or next icon, which located in the upper-left corner. The Start time and Date duration of Real-time data and data reading in memory(%) is displayed on the table. The newest data appears at the top of tabular events.



Figure 78. Real-time data Menu



151



Real-time data recording Real-time data contains header(print case, patient info and device info), event messages, waveform, shock information and trend in real time. In order to write by user, the comments, weight, height, device type and operator are left blank. Header recording The defibrillator/monitor prints case, patient info and defibrillator/monitor info in header as shown in Figure 76. Case Case contains Date/time when the real-time data is stored, and comments for the realtime data. Patient info Patient info contains patient ID, patient name, patient gender, patient age, patient weight, patient height, number of shock, pacing time and number of 12-lead ECG diagnosis. Device info The device info contains device type, operator, serial number. Event messages recording The event messages contain event time, event message and ECG number as shown in Figure 76. The event of ECG, V-FIB, Shock, Pacing and ECG sequentially is assigned number. The table is displayed time, event message and ECG number from left to right. When above event occurred at the same time, the time displayed only once. Table contains maximum 20 data. When exceeding 20 data, data is displayed next table. Case ---------------------------------------------------------------------Start time: 2014-12-26 15:18:49 Data duration : 00:01:55 Comments:



Patient Info. ---------------------------------------------------------------------Patient ID: Patient name: Gender: Age: Weight: Height: Total Shocks: 3 Total time paced: 00:00:00 Total 12-Lead ECG: 0



Device Info. ---------------------------------------------------------------------Device type: Operator: Serial number: 000000000000



Time Event ECG-Nr. ----------------------------------------------------------------------------------------------------------15:18:49 Power on AED mode Start ECG 1 15:18:50 Adult pads 15:18:52 Analyzing heart rhythm 15:18:54 Low heart rate limits violated 15:19:02 ECG: V-FIB 2 Shock advise 15:19:04 Charging (125J) 15:19:08 Shock ready 15:19:11 Shock delivered (1, 125J, 51ohm) 3 15:19:13 CPR 15:20:14 Manual mode: NO SYNC 15:20:15 Charging (125J) 15:20:19 Shock ready 15:20:20 Shock delivered (2, 125J, 51ohm) 4 15:20:30 Charging (125J) 15:20:33 Shock ready 15:20:37 Shock delivered (3, 125J, 51ohm) 5 15:20:43 Power off



Figure 79. Real-time print (Header and Event messages)



152



Waveform recording Waveform which the event occurred is displayed. Waveform contains ECG, V-FIB, shock and pacing event as shown in Figure 80. Shock information recording Shock info displays the shock event among all events. Shock info contains shock time, number of shock and energy as shown in Figure 80. The time, number of shock and energy is displayed from left to right. Table contains maximum 20 data. When exceeding 20 data, data is displayed next table. Trend recording auto print. Parameter alarm event among trend event prints out. Trend contains parameter alarm event time, parameter value and alarm as shown in Figure 77. The time, HR/PR, respiration, SpO2, temperature, NIBP, IBP1, IBP2 and CO2 is displayed from left to right. The newest data appears at the top of table. Table is displayed up to 10 data on a screen. When exceeding 10 data, data is displayed next screen. Time Shock# Energy -------------------------------------15:19:11 1 125J 15:20:20 2 125J 15:20:37 3 125J



I



ECG-Nr. 1 15:18:49 25mm/s 10mm/mV



Time HR/PR RR SpO2 TEMP NIBP -------------------------------------------------------------15:18:54 0↓ --- --- ---.- ---/--(---) 15:19:02 51 --- --- ---.- ---/--(---)



15:18:44 Pads



15:18:44



Figure 80. Real-time print (Waveform, Shock info and Trend) Download When download begins, ‘Check SD card’ message is displayed. After inserting the SD card, this defibrillator/monitor identifies the SD card, if the SD card was inserted, the realtime data is downloaded. At this time, ‘Downloading Real-time Data’ message is displayed on the screen. If the SD card were not inserted, the downloading will be stopped. At this time, 'SD card - Not Insert' message is displayed on the screen. Note: When pressing the Return icon, return to Screen mode. Print Setting After selecting the data, press the Print menu icon. The defibrillator/monitor prints the event massages all occurred events. If the print is not available, ‘Printer is not available’ message is displayed. When a printer runs out of paper, ‘Out of paper’ message is displayed.



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154



MENU STRUCTURE MANUAL MODE MENU -



12 lead Setup -



-



-



Acquire Setup Filter 0.05Hz ~ 40Hz / 0.05Hz ~ 150Hz / Return Transmission Return 12 lead ON/OFF Patient info ID Confirm / Return Name Confirm / Return Age Confirm / Return Gender Male / Female / Return 12 lead records Print / Transmission / ID # / Return Return Volume



Alarm / Beep / Button / Charging alarm / Voice prompt / CPR metronome / Pacing alarm / Return



Printer setting Print on alarm On / Off Print on charge On / Off Print on shock On / Off Print on mark On / Off Print on BP On / Off Print on self-test On / Off 12 lead auto printing On / Off Analyze auto printing On / Off Return Erase data Erase 12 lead records Yes / No Erase event records Yes / No Erase internal memory Yes / No Return Waveform setting 2nd Waveform ECG l, ll, lll, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads SpO2 RESP IBP1 IBP2 EtCO2 Return 3rd Waveform ECG l, ll, lll, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads SpO2 RESP IBP1 IBP2 EtCO2 Return 4th Waveform 155



-



-



-



ECG l, ll, lll, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads SpO2 RESP IBP1 IBP2 EtCO2 Return Return Display Mode Large Numeric Display Black-white Invert Mode Return Clinical action list Manual self-test Button test Service Menu Display 3 digit code Return Alarm Limit “Alarm limits adjustment/Limit Alarm Pause for each parameters” HR/PR SpO2 120 100 50 90



RESP 30 8



EtCO2 80 0



InCO2 20 0



T1 39.0 36.0



T2 39.0 36.0



On



On



On



On



On



On



On



Off



Off



Off



Off



Off



Off



Off



SYS 160 90



NIBP MAP 110 60



DIA 90 50



SYS 120 70



P1 MEAN 90 50



DIA 70 40



SYS 120 70



CVP MEAN 90 50



DIA 70 40



On



On



On



On



On



On



On



On



On



-



-



-



-



-



Off Off Off Off Off Off Off Off Off Return Patient Info ID Confirm / Return Name Confirm / Return Age Confirm / Return Gender Male / Female / Return Event records Data review Print / Return ID#ID / Name / Age / Gender / Return Return Real-time Data Print / Download / Return Return Sync On/Off (Toggle button)



156



AED MODE MENU -



Patient Info ID Confirm / Return Name Confirm / Return Age Confirm / Return Gender Male / Female Event records Data review Print / Return ID# ID / Name / Age / Gender / Return Return Real-time Data Print / Download / Return Return Resume analyzing (Menu activated only during CPR mode)



PACING MODE MENU -



Pause/Resume Pacing Setup Volume



-



-



Alarm / Beep / Button / Charging alarm / Voice prompt / CPR metronome / Pacing alarm / Return



Printer setting Print on alarm On / Off Print on charge On / Off Print on shock On / Off Print on mark On / Off Print on BP On / Off Print on self-test On / Off 12 lead auto printing On / Off Analyze auto printing On / Off Return Erase data Erase 12 lead records Yes / No Erase event records Yes / No Erase internal memory Yes / No Return Waveform setting 2nd Waveform ECG l, ll, lll, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads SpO2 RESP IBP1 IBP2 EtCO2 Return 3rd Waveform ECG l, ll, lll, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads SpO2 RESP IBP1 IBP2 EtCO2 Return 4th Waveform ECG l, ll, lll, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads SpO2 RESP IBP1 IBP2 157



-



-



-



EtCO2 Return Return Display Mode Large Numeric Display Black-white Invert Mode Return Clinical action list Manual self-test Button test Service Menu Display 3 digit code Return Return Alarm Limit “Alarm limits adjustment/Limit Alarm Pause for each parameters” HR/PR SpO2 120 100 50 90



RESP 30 8



EtCO2 80 0



InCO2 20 0



T1 39.0 36.0



T2 39.0 36.0



On



On



On



On



On



On



On



Off



Off



Off



Off



Off



Off



Off



SYS 160 90



NIBP MAP 110 60



DIA 90 50



SYS 120 70



P1 MEAN 90 50



DIA 70 40



SYS 120 70



CVP MEAN 90 50



DIA 70 40



On



On



On



On



On



On



On



On



On



-



-



-



-



-



Off Off Off Off Off Off Off Off Off Return Patient Info ID Confirm / Return Name Confirm / Return Age Confirm / Return Gender Male / Female Event records Data review Print / Return ID# ID / Name / Age / Gender / Confirm / Return Return Real-time Data Print / Download / Return Return Demand / Fixed



MONITOR MODE MENU 158



12 lead -



Acquire Setup Filter Transmission Return 12 lead ON/OFF Patient info ID Name



0.05Hz ~ 40Hz / 0.05Hz ~ 150Hz / Return



Confirm / Return Confirm / Return



-



Setup -



Age Confirm / Return Gender Male / Female / Return 12 lead records Print / Transmission / ID # / Return Return



-



-



Printer setting Print on alarm On / Off Print on charge On / Off Print on shock On / Off Print on mark On / Off Print on BP On / Off Print on self-test On / Off 12 lead auto printing On / Off Analyze auto printing On / Off Return Erase data Erase 12 lead records Yes / No Erase event records Yes / No Erase internal memory Yes / No Return Waveform setting 2nd Waveform ECG l, ll, lll, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads SpO2 RESP IBP1 IBP2 EtCO2 Return 3rd Waveform ECG l, ll, lll, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads SpO2 RESP IBP1 IBP2 EtCO2 Return 4th Waveform ECG l, ll, lll, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6, Pads SpO2 RESP IBP1 IBP2 EtCO2 Return Return Display Mode Large Numeric Display Black-white Invert Mode Clinical action list Manual self-test Button test Service Menu Display 3 digit code Return



Volume



Alarm / Beep / Button / Charging alarm / Voice prompt / CPR metronome / Pacing alarm / Return



159



-



-



-



Alarm Limit



“Alarm limits adjustment/Limit Alarm Pause for each parameters”



HR/PR SpO2 120 100 50 90



RESP 30 8



EtCO2 80 0



InCO2 20 0



T1 39.0 36.0



T2 39.0 36.0



On



On



On



On



On



On



On



Off



Off



Off



Off



Off



Off



Off



SYS 160 90



NIBP MAP 110 60



DIA 90 50



SYS 120 70



P1 MEAN 90 50



DIA 70 40



SYS 120 70



CVP MEAN 90 50



DIA 70 40



On



On



On



On



On



On



On



On



On



-



-



-



-



-



Off Off Off Off Off Off Off Off Off Return Patient Info ID Confirm / Return Name Confirm / Return Age Confirm / Return Gender Male / Female Event records Data review Print / Return ID# ID / Name / Age / Gender / Return Return Real-time Data Print / Download / Return Return Sync On/Off (Toggle button)



MONITORING PARAMETER (It is applied to 4 modes equally) HR/PR MENU -



HR/PR Source Pacer Detect Filter Select Alarm Limit “Alarm limit” HR/PR 120 50 “Limit Alarm Pause”



On Off -



160



Return



Auto / HR / PR / Return Enable / Disable / Return 0.5Hz ~ 21Hz / 0.05Hz ~ 40Hz / 1Hz ~ 21Hz / Return



SpO2 MENU -



Alarm Limit “Alarm limit (%)” %SpO2 100 90 “Limit Alarm Pause”



On Off -



Return



NIBP MENU -



Inflate Pressure “Adult/Pediatric” 120/140/160/180/200/220/240/260/280 mmHg, Return “Neonatal” 80/100/120/140 mmHg, Return Auto Interval Off, Cont, 1/2.5/3/5/10/15/20/30/60/90 min, Return Patient Type Adult / Pedi, Neonatal, Return Alarm Limit “Alarm limit (mmHg)” SYS MAP DIA 160



110



90



90 60 50 “Limit Alarm Pause” On Off -



Return



IBP1 MENU -



Zero Setting Scale Label Alarm Limit “Alarm limit (mmHg)” SYS MEAN DIA 120 90 70 70 50 40 “Limit Alarm Pause”



Enter / Return 0~50 / 0~100 / 0~200 / 0~300mmHg, Auto, Return P1 / ABP / Return



On Off -



Return



161



IBP2 MENU -



Zero Setting Scale Label Alarm Limit “Alarm limit (mmHg)” SYS MEAN DIA 120 90 70 70 50 40 “Limit Alarm Pause”



Enter / Return 0~50 / 0~100 / 0~200 / 0~300mmHg, Auto, Return P2 / CVP / PAP / LAP / Return



On Off -



Return



EtCO2 MENU -



EtCO2 EtCO2 Setting N2O Gas O2 Gas Calibration Scale Alarm Limit “Alarm limit” EtCO2 InCO2 80



On / Off / Return On / Off / Return On / Off / Return Enter / Return 0~40mmHg / 0~60mmHg / 0~80mmHg / Auto / Return



20



0 0 “Limit Alarm Pause” On Off -



Return



RESPIRATION MENU -



Respiration Setting PR Source Size Return Apnea time setting Alarm Limit “Alarm limit” RESP 30 8 “Limit Alarm Pause”



On Off 162



Return



Auto / Impedance / Airway / Return X 0.5 / X 1 / X 1.5 / X 2 Off, 10 / 20 / 30 / 40 / 50 / 60 seconds, Return



TEMPERATURE MENU -



Alarm Limit “Alarm limit (ºC)” T1



T2



39.0



39.0



36.0 36.0 “Limit Alarm Pause” On



On



-



Off Off Return



DATE TIME MENU -



Date Format YY/MM/DD MM/DD/YY DD/MM/YY Return Set Date Year Month Day Return Set Time Hour Minute Second Return Return



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PRINTING General The defibrillator/monitor prints real-time graphical and numeric information after that event in accordance with current mode until Print soft key is pressed. Printing may be set in two ways: 1.



When the print is displayed on the screen, select the Print soft key.



2.



To start printing, press the PRINT button and to stop printing during print out, press the PRINT button again. (Refer to Figure 79.)



Printer Settings 1. 2.



Press the Setup soft key. (Setup is displayed on the initial screen of each mode.) Rotate the Multi function knob to highlight Printer setting via Setup Menu, and then press the Multi function knob to select Printer setting.



Figure 81. Printer setting Menu 3.



Set Printer on alarm, Printer on shock, 12 lead auto printing and Analyze auto printing.



165



Print on alarm If Print on alarm is set to On, the defibrillator/monitor will automatically print out information before and after 10 seconds when a physiological alarm condition is activated. Print on charge If Print on alarm is set to On, the defibrillator/monitor will automatically print out information before and after 10 seconds when the defibrillator/monitor is charging. Print on shock If Print on shock is set to On, the defibrillator/monitor will automatically print out information before and after 10 seconds when a shock is generated. Print on mark If Print on alarm is set to On, the defibrillator/monitor will automatically print out information before and after 10 seconds when a clinical action is activated. Print on BP If Print on alarm is set to On, the defibrillator/monitor will automatically print out information before and after 10 seconds when NIBP measurement is completed. Print on self-test If Print on alarm is set to On, the defibrillator/monitor will automatically print out information before and after 10 seconds when a 12 lead measurement is completed. 12 lead auto printing If 12 lead auto printing is set to On, the defibrillator/monitor will automatically print out after 12 lead ECG is acquired. Analyze auto printing If Analyze auto printing is set to On, the defibrillator/monitor will automatically print out analyzing data for 10 seconds after starting the analyze.



166



Print-Out Print-out The defibrillator/monitor prints numeric data and waveforms by pressing PRINT button. Patient Information. ID : _________________ NAME : _________________ Gender : _________________ AGE : _________________ Time. 2010-01-01



ECG II Filter : 0.5HZ ~ 21HZ



05:30:00



Mode : DEFIB HR/PR : 60/min RESP : 15/min NIBP : 120/ 80 ( 93) mmHg SpO2 : 98% T1 : 36.7°C T2 : 36.7°C EtCO2 : 80mmHg InCO2 : 2mmHg ABP : 120/ 80 ( 94) mmHg CVP : 120/ 80 ( 40) mmHg



RESP



ECG III Filter : 0.5HZ ~ 21HZ



1mV



05:29:50



Figure 82. Print-out Print-out on shock



The defibrillator/monitor prints shock information by pressing SHOCK button. Shock can be delivered when the defibrillator/monitor is turned on in Manual or AED mode. Patient Information. ID : _________________ NAME : _________________ Gender : _________________ AGE : _________________ Time. 2010-01-01



Shock Count : 2 / Select Energy : 150 J / Charge Energy : 50 J / ECG II Filter : 0.5HZ ~ 21HZ



05:30:00



Mode : DEFIB HR/PR : 60/min RESP : 15/min NIBP : 120/ 80 ( 93) mmHg SpO2 : 98% T1 : 36.7°C T2 : 36.7°C EtCO2 : 80mmHg InCO2 : 2mmHg ABP : 120/ 80 ( 94) mmHg CVP : 120/ 80 ( 40) mmHg



1mV



05:29:50



05:29:53



Figure 83. Print-out on shock



167



Print-out on 12 lead ECG data If 12 lead auto printing is set to On, the defibrillator/monitor prints the 12 lead ECG data automatically after 12 lead ECG analysis. When the defibrillator/monitor displays 12 lead records, desired 12 lead ECG analysis can be printed by pressing PRINT soft key. Note: The printer speed option for 12 lead ECG can be selected via the Service Menu. The detailed information is described in the service manual. Patient Information. ID : _________________ NAME : _________________ Gender : _________________ AGE : _________________ Time. 2010-01-01



05:30:00



HR/PR : 60/min RESP : 15/min NIBP : 120/ 80 ( 93) mmHg SpO2 : 98% T1 : 36.7°C T2 : 36.7°C EtCO2 : 80mmHg InCO2 : 2mmHg ABP : 120/ 80 ( 94) mmHg CVP : 120/ 80 ( 40) mmHg



Analyzing Result. SINUS RHYTHM Public Analyze Data. PR Interval : 0ms QT Interval : 0ms QTc Interval : 0ms P-axis : 0deg QRS-axis : 0deg T-axis : 0deg P duration : 0ms QRS duration : 0ms



Analyze Data. P amplitude P’ amplitude q amplitude … … (mV) (mV) (mV) ------------------------------------------ ------------------------------------------ -------ECG I 0 0 0 …… ECG LEAD



ECG II



0



0



0



……



ECG III



0



0



0



……



ECG AVL



0



0



0



ECG AVR



0



0



0



……



ECG AVF



0



0



0



……



ECG V1



0



0



0



……



ECG V2



0



0



0



……



ECG V3



0



0



0



……



ECG V4



0



0



0



……



ECG V5



0



0



0



……



ECG V6



0



0



0



……



……



Filter : 0.05HZ ~ 40 HZ / Recording Speed : 25 mm/s ECG I



ECG aVR



ECG V1



ECG V4



ECG II



ECG aVL



ECG V2



ECG V5



ECG III



ECG aVF



ECG V3



ECG V6



05:29:57



05:29:57



05:29:57



05:29:57



Figure 84. Print-out on 12 lead ECG data Print-out on self-test result If ‘Print On Self-test’ menu is set to On, the defibrillator/monitor prints the self-test result automatically after self-test analysis.



S/N : 150123456789 Self Test Time. 2010-01-01 05:30:00 Self Test Result. HV Module Alive Test : PASS Body Impedance test : PASS ECG Circuit/Algorithm : PASS Internal Shock Test : PASS ( 10J / 11J) Internal Pacing Test : PASS Pads/Paddle connection : Pads connected System ROM Test : PASS System RAM Test : PASS Battery Test : PASS Real Time Clock Test : PASS Installed Module Alive Test : PASS



Figure 85. Print-out on self-test result



168



Print-out on setting information When the defibrillator/monitor is in Service Menu, the defibrillator/monitor will print out all internal settings by pressing the PRINT button. Refer to the service manual for the detailed instructions.



2010-01-01



05:30:00



System Setting------------------------------------System information Serial number : 000000000000 Main software : 0.00.00 Display software : 0.00.00 (ENG) Analog software : 0.00.00 Voice prompt : 0.0 (ENG) Charger : 0.00 Printer : 0.00 H/V : 0.00 ECG : 0.00 SpO2 : 0.0.0.0 NIBP main : 0.0.0 NIBP sub : 0.0.0 TEMP : 00.00 IBP : 0.00 EtCO2 : 0.00 Alarm volume : 5 Beep volume : 4 Button volume : 4 Alarm pause time : 60 sec



Alarm off time : Indefinite Alarm reminder tone : off Alarm active at power up : Disabled Voice recording : On Self-test time : 0 o＇clock Self-test interval : Off Internal shock energy :10J Clinical action list 1 : None Clinical action list 2 : None Clinical action list 3 : None Clinical action list 4 : None Clinical action list 5 : None Clinical action list 6 : None Clinical action list 7 : None Clinical action list 8 : None Clinical action list 9 : None Clinical action list 10 : None Device installation ID : ______________ Device ID : ____________ 12 lead institution name : ________________________ 12 lead location code : ______________ Communication phone numbers



Case ---------------------------------------------------------------------Start time: 2014-12-26 15:18:49 Data duration : 00:01:55 Comments:



Patient Info. ---------------------------------------------------------------------Patient ID: Patient name: Gender: Age: Weight: Height: Total Shocks: 3 Total time paced: 00:00:00 Total 12-Lead ECG: 0



Device Info. ---------------------------------------------------------------------Device type: Operator: Serial number: 000000000000



ECG-Nr. 1 15:18:49



I



25mm/s 10mm/mV



: _________________________ Manual mode protection : Disable Pacing mode protection : Disable Printer Setting------------------------------------Print on alarm : Off Print on charge : Off Print on shock : Off Print on mark : Off Print on BP : Off Print on self-test : On Parameter Default Setting---------------------HR/PR High alarm (BPM) : 120 HR/PR Low alarm (BPM) : 50 RESP High alarm (RR/min) : 30 RESP Low alarm (RR/min) : 8 Power on waveform select 1st waveform : I 2nd waveform : SpO2 3rd waveform : IBP1 4th waveform : EtCO2 SpO2 High alarm (%) : 100



Time Event ECG-Nr. ----------------------------------------------------------------------------------------------------------15:18:49 Power on AED mode Start ECG 1 15:18:50 Adult pads 15:18:52 Analyzing heart rhythm 15:18:54 Low heart rate limits violated 15:19:02 ECG: V-FIB 2 Shock advise 15:19:04 Charging (125J) 15:19:08 Shock ready 15:19:11 Shock delivered (1, 125J, 51ohm) 3 15:19:13 CPR 15:20:14 Manual mode: NO SYNC 15:20:15 Charging (125J) 15:20:19 Shock ready 15:20:20 Shock delivered (2, 125J, 51ohm) 4 15:20:30 Charging (125J) 15:20:33 Shock ready 15:20:37 Shock delivered (3, 125J, 51ohm) 5 15:20:43 Power off



Time Shock# Energy -------------------------------------15:19:11 1 125J 15:20:20 2 125J 15:20:37 3 125J



Time HR/PR RR SpO2 TEMP NIBP -------------------------------------------------------------15:18:54 0↓ --- --- ---.- ---/--(---) 15:19:02 51 --- --- ---.- ---/--(---)



15:18:44 Pads



15:18:44



Figure 86. Print-out on setting information



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EXTERNAL INTERFACE General The defibrillator/monitor provides external connectors on the right panel to support communication with external equipment and functions such as software upgrade or data download. The defibrillator/monitor with its optional wireless network(3G or Wi-Fi) module, functionality performs the same as a defibrillator/monitor connected to the central system. The defibrillator/monitor with a wireless network(3G or Wi-Fi) can send and receive patient data through the central system Any connections between this defibrillator/monitor and other devices must comply with applicable medical systems safety standards such as IEC 60601-1. Failure to do so could result in unsafe leakage current and grounding conditions. Inserting or removing the data card while the defibrillator/monitor is on or reading and writing on the data card can corrupt the Data Card and prevent the defibrillator/monitor from powering on again. If this occurs, see Troubleshooting Tips. Use only a Mediana defibrillator/monitor-compatible SD Card. These cards, or other types of cards (such as memory cards) will not work, and may cause the defibrillator/monitor to malfunction. Note: The defibrillator/monitor is to be used on a wireless network are limited to inside of the building. SD Memory Card The SD Memory Card is used to the new system software and to load voice prompt data and to download the trend data. Trend data downloaded on SD card can be viewed on PC. Wireless Connection The defibrillator/monitor can connect to a network using a wireless network (3G or Wi-Fi). The wireless connection can only be set by authorized personnel via the Service Menu. Table 42. Wireless Status Icon and Bed Number Icon Icon



Description Not connected to Wi-Fi network Active Wi-Fi network connection Not connected to 3G network Active 3G network connection Configured bed number Not configured for bed number



171



Central System Communication The transmitted data by using 3G/Wi-Fi module is divided as follows; - All vital signs are transmitted to the medical person in the hospital. - 12-Lead reports for 20 seconds are transmitted to the medical person in the hospital. - The self-test result and the log file are transmitted to the biomedical engineer in the hospital. The defibrillator condition, service action according to the self-test and the history of the key pressing are transmitted by the wireless network. All vital sign can be transmitted in real-time. Note: The details are provided in the central system manual. Please contact the representative of Mediana for more information.



172



MAINTENANCE The cover should be removed only by qualified service personnel. There are no internal user-serviceable parts except for the battery. Do not use the defibrillator/monitor when the case appears damaged. Do not spray, pour, or spill any liquid on the defibrillator/monitor, its accessories, connectors, switches or openings in the chassis. Unplug the power cord from the defibrillator/monitor before cleaning the defibrillator/monitor. Disposal of the defibrillator/monitor with the battery inserted presents a potential shock hazard. Do not autoclave, ultrasonically clean, or immerse the Mediana defibrillator/monitor. Do not use abrasive cleaners or strong solvents such as acetone or acetone-based cleaners. Do not ultrasonically clean or immerse the paddles and paddles cables. Do not ultrasonically clean, immerse, autoclave or steam sterilize the pads cable. Do not ultrasonically clean, immerse, autoclave or steam sterilize the ECG cable. Do not clean the ECG cable with alcohol. Alcohol can cause the plastic to become brittle and may cause the cable to fail prematurely. Do not clean any part of this defibrillator/monitor or accessories with bleach dilution or phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not attempt to sterilize this defibrillator/monitor or any accessories unless otherwise specified in accessory operation instructions. Do not soak or immerse the sensors or cables in any liquid solution. Do not attempt to sterilize.



Recycling and Disposal When the defibrillator/monitor, battery, or accessories reach the end of useful life, recycle or dispose of the equipment according to appropriate local and regional regulations. Note: The defibrillator/monitor should be disposed of separately from the municipal waste stream via designated collection facilities appointed by the government or the local authorities. Note: The correct disposal of your old appliance will help prevent potential negative consequences for the environment and human health. Note: For more detailed information about disposal of your old appliance, please contact your city office, waste disposal service or the shop where you purchased the defibrillator/monitor.



173



Returning the defibrillator/monitor and System Components Pack the defibrillator/monitor with sensors, cable or other accessory items in its original shipping carton. If the original carton is not available, use a suitable carton with appropriate packing material to protect the defibrillator/monitor during shipping.



Service The defibrillator/monitor requires no routine service other than cleaning, battery maintenance, and service activity which is mandated by the user’s institution. For more information, refer to the defibrillator/monitor service manual. Qualified service personnel in the user’s institution should perform periodic inspections of the defibrillator/monitor. If service is necessary, contact qualified service personnel or your local supplier.



Periodic Safety Checks It is recommended that the following checks be performed every year.  Inspect the equipment for mechanical and functional damage.  Inspect the external safety labels for legibility.



Cleaning The defibrillator/monitor may be surface-cleaned by using a soft cloth dampened with either a commercial, nonabrasive cleaner or one of the solutions listed below. Lightly wipe the top, bottom and front surfaces of the defibrillator/monitor.    



Quatemary Ammonium (fungicidal, bactericidal and virucidal against enveloped viruses) 70% Isopropyl alcohol 10% Chlorine bleach solution PDI sani-system



The cleaning method for paddles and paddle plates are same as defibrillator/monitor. For cables, sensors, cuffs, and probes, follow the cleaning instructions in the directions for use shipped with those components. Avoid spilling liquid on the defibrillator/monitor, especially in connector areas. If liquid is accidentally spilled on the defibrillator/monitor, clean and dry thoroughly before reuse. If in doubt about defibrillator/monitor safety, refer the unit to qualified service personnel for checking.



174



Battery Maintenance Recharging the battery is strongly recommended when the battery has not been recharged for 6 or more months. Follow local government ordinances and recycling instructions regarding disposal or recycling of defibrillator/monitor components, including batteries. Do not short-circuit the battery, as it may generate heat. To avoid shortcircuiting, do not let the battery come in contact with metal objects at any time, especially when transporting. Do not solder the battery directly. Heat applied during soldering may damage the safety vent in the battery’s positive cover. Do not deform the battery by applying pressure. Do not throw, hit, drop, fold or impact the battery. Do not connect the battery reversed in positive (+) and negative (-) terminals. Do not charge the battery with polarities reversed, as it may swell or explode. Do not use any chargers not specified by Mediana. Do not use the battery with other maker’s batteries, different types or models of batteries such as dry batteries, nickel-metal hydride batteries, or Li-ion batteries together, as they might leak electrolyte heat or explode. Do not mistreat the battery, or use the battery in applications not recommended by Mediana. Keep the battery out of reach of babies and children to avoid any accidents. If there are any problems with the battery, immediately put the battery in a safe place and contact qualified service personnel. If the defibrillator/monitor has not been used for 6 months, the Li-ion battery will need charging. To charge the battery, connect the defibrillator/monitor to an AC or DC power source as described in the Battery Operation section. Note: Storing the defibrillator/monitor for a long period without charging the battery may degrade the battery capacity. It would take about 8 hours to fully charge the battery from the moment that low battery alarm is activated. Note: The battery should be removed from the defibrillator/monitor if placed in storage or if it will not be used for a long period. It is recommended that the defibrillator/monitor’s Li-ion battery be replaced every 24 months. Refer to the service manual for battery replacement and general service instructions.



175



Loading Printer Paper Using other manufacturers’ printer paper may cause the printer to function improperly or damage the print head. Use only Mediana printer paper. Load printer paper as follows: 1. 2. 3. 4.



Pull the printer door. Pick out the paper by using the ejector. Insert a new printer paper with grid side up. Push the printer door.



Note: To make sure that the paper is aligned in the slot and has not been pinched in the door.



Figure 87. Printer Paper Replacement



176



TROUBLESHOOTING If you are uncertain about the accuracy of any measurement, check the patient’s vital signs by alternate means; then make sure the defibrillator/monitor is functioning correctly. The cover should be removed only by qualified service personnel. There are no user-serviceable parts inside except for the battery. The large current draw required for defibrillator charging may cause the defibrillator to reach a shutdown voltage level with no low battery indication.



General If the defibrillator/monitor detects an error or potential problem during use, it displays a system or momentary message. If service is necessary, contact qualified service personnel. Before calling to qualified service personnel or your local supplier, make sure it meets environmental conditions provided in the manual as temperature, humidity, altitude and so on. Note: For repair instructions or for additional technical information, refer to the defibrillator/monitor Service Manual.



Obtaining Technical Assistance For technical information and assistance, or to order a service manual, call your local supplier. The service manual provides information required by qualified service personnel when servicing the defibrillator/monitor. When calling your local supplier, you may be asked to provide the software version number of your defibrillator/monitor. The software version can confirm in service menu.



177



EMI (Electromagnetic Interference) Keep patients under close surveillance when monitoring. It is possible, although unlikely, that radiated electromagnetic signals from sources external to the patient and defibrillator/monitor can cause inaccurate measurement readings. Do not rely entirely on the defibrillator/monitor readings for patient assessment. It is possible that any radio frequency transmitting equipment and other nearby sources of electrical noise may result in disruption in the defibrillator/monitor operation. Operator’s manual is attached for the minimum recommended separation distance between the RF emitting equipment and the device. It is possible, although unlikely, that large equipment using a switching relay for its power on/off may affect defibrillator/monitor operation. Do not operate the defibrillator/monitor in such environments. Using cables, electrodes or accessories not specified for use with this device may result in increased emissions or decreased resistance to electromagnetic interference which could affect the performance of this defibrillator/monitor or of equipment in close proximity. Use only parts and accessories specified in this manual. Defibrillator/monitor may cause electromagnetic interference (EMI) especially during charge and energy transfers. EMI may affect the performance of equipment operating in close proximity. If possible, verify the effects of defibrillator discharge on other equipment prior to using the defibrillator in an emergency situation. Operating high frequency electrosurgical equipment in the vicinity of the defibrillator/monitor can produce interference in the defibrillator/monitor and cause incorrect measurements. Do not use the defibrillator/monitor with nuclear spin tomography (MRT, NMR, NMT) as the function of the defibrillator/monitor may be disturbed. This device has been tested and found to comply with the limits for medical devices to the IEC60601-1-2, and the Medical Device Directive 93/42/EEC. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in health care environments (such as electrosurgical equipment, defibrillator, cellular phones, mobile two-way radios, electrical appliances, and high-definition television), it is possible that high levels of such interference due to close proximity or strength of a source may affect defibrillator/monitor operation.



178



The defibrillator/monitor is designed for use in environments in which the signal can be obscured by electromagnetic interference. During such interference, measurements may seem inappropriate or the defibrillator/monitor may not seem to operate correctly. The defibrillator/monitor disruption may be indicated by erratic readings, cessation of operation, or other incorrect functioning. If this occurs, survey the site to determine the source of this disruption. Try the following actions to see if they eliminate the disruption:  Turn equipment in the vicinity off and on to isolate the offending equipment.  Reorient or relocate the interfering equipment.  Increase the separation between the interfering equipment and this equipment. The defibrillator/monitor generates, uses, and can radiate radio frequency energy. If the defibrillator/monitor is not installed and used in accordance with these instructions, the defibrillator/monitor may cause harmful interference with other devices in the vicinity. If assistance is required, contact your local supplier.



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FACTORY DEFAULTS General The defibrillator/monitor is shipped with factory default settings. Authorized personnel can use the procedures described in the service manual to change default settings.



Parameter Ranges and Default Settings Table 43. Parameter Ranges and Factory Defaults Parameter ECG MENU HR/PR Source AC line filter* Pacer Detect ECG size* Filter Select HR/PR High Alarm Limits HR/PR Low Alarm Limits Auto transmit* Print on 12 lead measurement** Print on 12 lead interpretation** Setting print lead - 1st waveform* Setting print lead - 2nd waveform* Setting print lead - 3rd waveform* 12 lead frequency response* Print 2 copies 12 lead** 12 lead print second** 12 lead print speed** SpO2 MENU % SpO2 High Alarm Limits % SpO2 Low Alarm Limits NIBP MENU Inflate Pressure



Auto Interval Patient type NIBP Unit* NIBP SYS High Alarm Limits



Ranges / Selections (Adjust step)



Factory Defaults



Auto, HR, PR 50Hz, 60Hz, Off Enable, Disable x0.5, x1, x1.5, x2, x3 0.5 to 21 Hz, 0.05 to 40 Hz, 1 to 21 Hz 25 to 300 BPM (5 BPM steps) 20 to 295 BPM (5 BPM steps) On, Off On, Off



Auto 60 Hz Disable x1 1 to 21 Hz 120 BPM 50 BPM On On



On, Off



On



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6



I



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6



II



I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6



III



0.05 Hz ~ 40 Hz, 0.05 Hz ~ 150 Hz On, Off 2.5 sec, 10 sec 25mm/sec, 50mm/sec



0.05 Hz ~ 40 Hz Off 2.5 sec 25mm/sec



21 to 100 % (1 % steps) 20 to 99 % (1 % steps)



100 % 90 %



120, 140 160, 180, 200, 220, 240, 260, 280 mmHg (Adult/Pediatric) 80, 100, 120, 140 mmHg (Neonatal) 1, 2.5, 3, 5, 10, 15, 30, 60, 90, Off Adult/Pedi, Neonatal mmHg, kPa adult/pediatric 35 to 270 mmHg (4.7 to 36.0 kPa) neonatal 45 to 130 mmHg (6.0 to 17.3 kPa) (5 mmHg, 0.6 or 0.7kPa steps)



180 mmHg (Adult/Pediatric) 120 mmHg (Neonatal) Off Adult/Pedi mmHg adult/pediatric 160 mmHg (21.3 kPa) neonatal 90 mmHg (12.0 kPa)



181



Parameter NIBP SYS Low Alarm Limits



NIBP DIA High Alarm Limits



NIBP DIA Low Alarm Limits



NIBP MAP High Alarm Limits



NIBP MAP Low Alarm Limits



IBP1 MENU IBP1: Scale IBP1: Label IBP 1 SYS High Alarm Limits



IBP 1 SYS Low Alarm Limits



IBP 1 DIA High Alarm Limits



IBP 1 DIA Low Alarm Limits



182



Ranges / Selections (Adjust step) adult/pediatric 30 to 265 mmHg (4.0 to 35.3 kPa) neonatal 40 to 125 mmHg (5.3 to 16.7 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric 15 to 250 mmHg (2.0 to 33.3 kPa) neonatal 25 to 90 mmHg (3.3 to 12.0 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric 10 to 245 mmHg (1.3 to 32.7 kPa) neonatal 20 to 85 mmHg (2.7 to 11.3 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric 25 to 260 mmHg (3.3 to 34.7 kPa) neonatal 35 to 110 mmHg (4.7 to 14.7 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric 20 to 255 mmHg (2.7 to 34.0 kPa) neonatal 30 to 105 mmHg (4.0 to 14.0 kPa) (5 mmHg, 0.6 or 0.7kPa steps)



Factory Defaults adult/pediatric 90 mmHg (12.0 kPa) neonatal 40 mmHg (5.3 kPa)



Auto, 0~50mmHg, 0~100mmHg, 0~200mmHg, 0~300mmHg P1, ABP adult/pediatric -45 to 300 mmHg (-6.0 to 40.0 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric -50 to 295mmHg (-6.7 to 39.3 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric -45 to 300 mmHg (-6.0 to 40.0 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric -50 to 295 mmHg (-6.7 to 39.3 kPa) (5 mmHg, 0.6 or 0.7kPa steps)



Auto



adult/pediatric 90 mmHg (12.0 kPa) neonatal 60 mmHg (8.0 kPa) adult/pediatric 50 mmHg (6.7 kPa) neonatal 20 mmHg (2.7 kPa) adult/pediatric 110 mmHg (14.7 kPa) neonatal 70 mmHg (9.3 kPa) adult/pediatric 60 mmHg (8.0 kPa) neonatal 30 mmHg (4.0 kPa)



P1 adult/pediatric 120 mmHg (16.0 kPa) adult/pediatric 70 mmHg (9.3 kPa) adult/pediatric 70 mmHg (9.3 kPa) adult/pediatric 40 mmHg (5.3 kPa)



Parameter IBP 1 MEAN High Alarm Limits



IBP 1 MEAN Low Alarm Limits



IBP2 MENU IBP2: Scale IBP2: Label IBP 2 SYS High Alarm Limits



IBP 2 SYS Low Alarm Limits



IBP 2 DIA High Alarm Limits



IBP 2 DIA Low Alarm Limits



IBP 2 MEAN High Alarm Limits



IBP 2 MEAN Low Alarm Limits



IBP unit* EtCO2 EtCO2 N2O Gas O2 Gas Scale EtCO2 High Alarm Limits



EtCO2 Low Alarm Limits



InCO2 High Alarm Limits



Ranges / Selections (Adjust step) adult/pediatric -45 to 300 mmHg (-6.0 to 40.0 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric -50 to 295 mmHg (-6.7 to 39.3 kPa) (5 mmHg, 0.6 or 0.7kPa steps)



Factory Defaults adult/pediatric 90 mmHg (12.0 kPa)



Auto, 0~50mmHg, 0~100mmHg, 0~200mmHg, 0~300mmHg P2, CVP, PAP,LAP adult/pediatric -45 to 300 mmHg (-6.0 to 40.0 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric -50 to 295mmHg (-6.7 to 39.3 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric -45 to 300 mmHg (-6.0 to 40.0 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatricl -50 to 295mmHg (-6.7 to 39.3 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric -45 to 300 mmHg (-6.0 to 40.0 kPa) (5 mmHg, 0.6 or 0.7kPa steps) adult/pediatric -50 to 295mmHg (-6.7 to 39.3 kPa) (5 mmHg, 0.6 or 0.7kPa steps) mmHg, kPa



Auto



On, Off On, Off On, Off 0~40 mmHg, 0~60 mmHg, 0~80 mmHg, Auto adult/pediatric 1 to 80 mmHg (0.1 to 10.7 kPa), (0.1 to 10.5 %) (1 mmHg, 0.13 kPa, 0.13 % steps) adult/pediatric 0 to 79 mmHg (0 to 10.5 kPa), (0 to 10.4 %) (1 mmHg, 0.13 kPa, 0.13 % steps) adult/pediatric 1 to 20 mmHg (0.1 to 2.7 kPa), (0.1 to 2.6 %) (1 mmHg, 0.13 kPa, 0.13 % steps)



ON OFF OFF Auto adult/pediatric 80 mmHg (10.7 kPa), (10.5 %)



adult/pediatric 50 mmHg (6.7 kPa)



P2 adult/pediatric 120 mmHg (16.0 kPa) adult/pediatric 70 mmHg (9.3 kPa) adult/pediatric 70 mmHg (9.3 kPa) adult/pediatric 40 mmHg (5.3 kPa) adult/pediatric 90 mmHg (12.0 kPa) adult/pediatric 50 mmHg (6.7 kPa) mmHg



adult/pediatric 0 mmHg (0 kPa), (0 %) adult/pediatric 20 mmHg (2.7 kPa), (2.6 %)



183



Parameter InCO2 Low Alarm Limits



EtCO2 unit* Temperature MENU TEMP1 High Alarm Limits



TEMP1 Low Alarm Limits



TEMP2 High Alarm Limits



TEMP2 Low Alarm Limits



TEMP Unit* Respiration MENU Respiration



Ranges / Selections (Adjust step) adult/pediatric 0 to 19 mmHg (0 to 2.5 kPa), (0 to 2.5 %) (1 mmHg, 0.13 kPa steps) mmHg, kPa, %



Factory Defaults adult/pediatric 0 mmHg (0 kPa), (0 %)



0.1 to 50.0 °C (32.1 to 122.0 °F) (0.1°C, 0.1 or 0.2°F steps) 0.0 to 49.9 °C (32.0 to 121.8 °F) (0.1°C, 0.1 or 0.2°F steps) 0.1 to 50.0 °C (32.2 to 122.0 °F) (0.1°C, 0.1 or 0.2°F steps) 0.0 to 49.9 °C (32.0 to 121.8 °F) (0.1°C, 0.1 or 0.2°F steps) °C, °F



39.0 °C (102.2 °F)



ON OFF RR Source Auto Impedance Airway Size x0.5, x1, x1.5, x2 Apnea time setting Off, 10 seconds, 20 seconds, 30 seconds 40 seconds, 50 seconds, 60 seconds RR High Limits 4 to 120 BPM (1 BPM step) RR Low Limits 3 to 119 BPM (1 BPM step) Manual, AED, Pacing, Monitor Mode MENU Alarm 1, 2, 3, 4, 5, 6, 7, 8 Beep OFF, 1, 2, 3, 4, 5, 6, 7 Button OFF, 1, 2, 3, 4, 5, 6, 7 Charging alarm 1, 2, 3, 4, 5, 6, 7, 8 Voice prompt 1, 2, 3, 4, 5, 6, 7, 8 CPR metronome OFF, 1, 2, 3, 4, 5, 6, 7 Pacing mode OFF, 1, 2, 3, 4, 5, 6, 7 nd 2 Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5, ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2 3rd Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5, ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2 4th Waveform ECG I, ECG II, ECG III, ECG aVL, ECG aVF, ECG aVR, ECG V1, ECG V2, ECG V3, ECG V4, ECG V5, ECG V6, Pads, SpO2, RESP, IBP1, IBP2, EtCO2 Print on alarm** On, Off Print on charge** On, Off Print on shock** On, Off Print on mark** On, Off Print on BP** On, Off Print on self-test** On, Off 12 lead auto printing** On, Off



184



mmHg



36.0 °C (96.8 °F) 39.0 °C (102.2 °F) 36.0 °C (96.8 °F) °C ON Auto



x1 10 seconds 30 BPM 8 BPM 5 4 4 4 4 4 2 SpO2 Waveform



IBP1 Waveform – P1



EtCO2 Waveform



Off Off Off Off Off On On



Parameter Analyze auto printing** Message display* Elapsed time display* CPR guide display* Voice prompt* Basic auto energy escalation* Above 200J setting* Manual shock energy – 1st energy*



Ranges / Selections (Adjust step) On, Off On, Off Enable, Disable Enable, Disable Enable, Disable Enable, Disable Enable, Disable 1~200J (Adult/Pediatric External paddle and Adult Pads) 1~100J (Pediatric (Infant-Child) Pads)



Manual shock energy – 2nd energy*



1~200J (Adult/Pediatric External paddle and Adult Pads) 1~100J (Pediatric (Infant-Child) Pads)



Manual shock energy – 3rd energy*



1~200J (Adult/Pediatric External paddle and Adult Pads) 1~100J (Pediatric (Infant-Child) Pads)



Analyze continuous mode* Auto charge* Remain in sync mode after shock* Charging hold time* ECG display with paddle in openair* Setup Menu* Alarm Limit Menu* 12 Lead Menu* AED display setting – Waveform display* AED display setting – Icon display* AED display setting – Value display* AED display setting – AED step 1 display* AED display setting – AED step 2 display* AED display setting – AED step 3 display* AED Mode energy – Above 200J setting* AED shock energy – 1st energy*



Enable, Disable On, Off On, Off



Factory Defaults Off Off Enable Enable Enable Enable Disable 125J (Adult/Pediatric External paddle and Adult Pads) 50J (Pediatric (InfantChild) Pads) 150J (Adult/Pediatric External paddle and Adult Pads) 50J (Pediatric (InfantChild) Pads) 200J (Adult/Pediatric External paddle and Adult Pads) 50J (Pediatric (InfantChild) Pads) Enable On On



15 sec, 60 sec On, Off



60 sec On



Enable, Disable Enable, Disable Enable, Disable Enable, Disable



Disable Disable Disable Enable



Enable, Disable



Enable



Enable, Disable



Enable



Enable, Disable



Disable



Enable, Disable



Disable



Enable, Disable



Disable



Enable, Disable



Disable



1~200J (Adult Pads) 1~100J (Pediatric (Infant-Child) Pads)



AED shock energy – 2nd energy*



1~200J (Adult Pads) 1~100J (Pediatric (Infant-Child) Pads)



AED shock energy – 3rd energy*



1~200J (Adult Pads) 1~100J (Pediatric (Infant-Child) Pads)



125J (Adult Pads) 50J (Pediatric (InfantChild) Pads) 150J (Adult Pads) 50J (Pediatric (InfantChild) Pads) 200J (Adult Pads) 50J (Pediatric (Infant-



185



Parameter



Ranges / Selections (Adjust step)



Fixed Pacing* Pace Pulse Rate* Default Pacing Energy* Others Parameters Color - ECG*



On, Off 30 ~ 180 bpm 0, 30, 70, 100, 140 mA



Parameters Color - NIBP*



Parameters Color - SpO2*



Parameters Color - RESP*



Parameters Color - TEMP*



Parameters Color - IBP 1*



Parameters Color - IBP 2*



Parameters Color - EtCO2*



Brightness* Audio pause time* Audio off time* Alarm reminder tone* Alarm active at power up* Auto block erase* Auto self-test : Self-test time* Auto self-test :



186



Factory Defaults Child) Pads) Off 70 bpm 0 mA



00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 6464FA(Light blue), FA96FA(Pink), FA0000(Red), FAFA00(Yellow), 9696C8(Light purple), FA9600, 0096FA, FA00FA, 96FA32, C8C8C8, 0096C8, C89600, C8C832 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 6464FA(Light blue), FA96FA(Pink), FA0000(Red), FAFA00(Yellow), 9696C8(Light purple), FA9600, 0096FA, FA00FA, 96FA32, C8C8C8, 0096C8, C89600, C8C832 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 6464FA(Light blue), FA96FA(Pink), FA0000(Red), FAFA00(Yellow), 9696C8(Light purple), FA9600, 0096FA, FA00FA, 96FA32, C8C8C8, 0096C8, C89600, C8C832 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 6464FA(Light blue), FA96FA(Pink), FA0000(Red), FAFA00(Yellow), 9696C8(Light purple), FA9600, 0096FA, FA00FA, 96FA32, C8C8C8, 0096C8, C89600, C8C832 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 6464FA(Light blue), FA96FA(Pink), FA0000(Red), FAFA00(Yellow), 9696C8(Light purple), FA9600, 0096FA, FA00FA, 96FA32, C8C8C8, 0096C8, C89600, C8C832 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 6464FA(Light blue), FA96FA(Pink), FA0000(Red), FAFA00(Yellow), 9696C8(Light purple), FA9600, 0096FA, FA00FA, 96FA32, C8C8C8, 0096C8, C89600, C8C832 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 6464FA(Light blue), FA96FA(Pink), FA0000(Red), FAFA00(Yellow), 9696C8(Light purple), FA9600, 0096FA, FA00FA, 96FA32, C8C8C8, 0096C8, C89600, C8C832 00FA00(Green), FAFAFA(White), 64FAFA(Cyan), 6464FA(Light blue), FA96FA(Pink), FA0000(Red), FAFA00(Yellow), 9696C8(Light purple), FA9600, 0096FA, FA00FA, 96FA32, C8C8C8, 0096C8, C89600, C8C832 1, 2, 3, 4 30 sec, 60 sec, 90 sec, 120 sec 3 min, 5 min, 10 min, Indefinite 3 min, 10 min, Off Enable, Disable Enable, Disable 0 ~ 23 o‘clock



00FA00(Green)



24 hours, 48 hours, 72 hours, Off



Off



FAFAFA(White)



64FAFA(Cyan)



9696C8(Light blue)



FA96FA(Pink)



FA0000(Red)



FAFA00(Yellow)



9696C8(Light purple)



4 60 sec Indefinite Off Disable Disable 0 o‘clock



Parameter Self-test time interval* Auto self-test : Internal shock energy* Clinical action list*



Ranges / Selections (Adjust step)



Factory Defaults



1 ~ 10 J



10 J



None, CPR, EPI, Atrop, DOPA, PHEN, Bicarb, Aspirin, Oxygen, IV, Morphine, Valium, β-block, LIDO, Mag Sulf, Thrombo, Sedation, Heparin, Procain, Cordar, Thiamine, Dilantin, Intubate, Narcan, Atrovent, Adenosin, Fentanyl, Digoxin, Vasopr, Dextrose, Paralytic, Nitro, Albuterol, Amrinon, Benadryl, Demerol, Oral Glu, Lasix, Calcium Disable, Confirm, Passcode 000~999



None



Manual mode protection* Disable Manual mode locking (Passcode) passcode* Pacing mode protection* Disable, Confirm, Passcode Disable Pacing mode locking 000~999 (Passcode) passcode* Service menu passcode* 000~999 (Passcode) Power on waveform select – ECG I, ECG II, ECG III, Pads ECG I 1st waveform* Power on waveform select – ECG I, ECG II, ECG III, Pads, SpO2, RESP, IBP1, SpO2 2nd waveform* IBP2, EtCO2 Power on waveform select – ECG I, ECG II, ECG III, Pads, SpO2, RESP, IBP1, IBP1 3rd waveform* IBP2, EtCO2 Power on waveform select – ECG I, ECG II, ECG III, Pads, SpO2, RESP, IBP1, EtCO2 4th waveform* IBP2, EtCO2 Wi-Fi* On, Off On Wireless Channel* Channel 1 ~ 13, Auto Channel 1 Wireless security mode* None, WEP, WPA, WPA2, EAP None WEP key length* 64 bit (10 hex digits), 128 bit (24 hex digits) 64 bit (10 hex digits) Outer Authentication* EAP-FAST, EAP-TLS, EAP-TTLS, EAP-PEAP EAP-FAST Inner Authentication* EAP-MSCHAP, EAP-GTC EAP-MSCHAP 3G* On, Off On USIM1* Enable, Disable Enable Authentication protocol* None, PAP, CHAP PAP USIM2* Enable, Disable Enable Note: An asterisk (*) by a parameter in the above table indicates that the parameter can only be changed by authorized personnel as described in the service manual Note: Asterisks (**) by a parameter in the above table indicates the settings only when an optional printer is installed in the defibrillator/monitor.



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SPECIFICATION Display Screen Size Screen Type Size Number of Traces



Language



8.4” measured diagonally across the TFT-LCD screen Liquid Crystal Display (LCD) Color 170 x 128 mm 4 waveforms Korean, English, Spanish, Italian, German, French, Portuguese, Czech, Polish, Russian Note: The language installed in the device is set only at the factory per the country of sales. If you would like to change the language, please consult with our service center or local distributor as the language is subject not to be changed by the customer. The software update should be required to change the language.



Controls



Standard



Multi function knob; Mode select knob (Off, AED, Manual, Pacing and Monitor); 11 buttons (Shock, Energy Level, Charge, Analyze, NIBP, LEAD, Alarm, Size, Print, RATE, mA); 5 soft key



Alarms Categories Priorities Notification Setting Alarm Volume Level Distributed Alarm System Delay



Patient Status and System Status Low, Medium and High Priorities Audible and Visual Default and Individual 45 to 85 dB Less than 3 sec.



189



Physical Characteristics and Printer



Dimensions Weight Degree of Protection against Electric Shock



Mode of Operation Classification Type Weight Number of Channels Paper Type Paper Width Printer Speed



Instrument 340 × 308 × 216 (mm) (W×H×D) including battery and excluding paddles, options and accessories Approx. 6.16 (kg) including battery and excluding paddles, options and accessories. ECG: Type CF with defibrillator protection SpO2: Type CF with defibrillator protection Temperature: Type CF with defibrillator protection EtCO2: Type CF with defibrillator protection NIBP: Type CF with defibrillator protection IBP: Type CF with defibrillator protection Paddle: Type BF with defibrillator protection Pads: Type BF with defibrillator protection Continuous Class IIb (MDD Annex IX Rule9:MEDDEV 2.4/1 Rev.9) Printer Thermal 190 g 1 to 3 channels Thermal 80 mm 25 mm/sec, 50 mm/sec



Electrical Instrument Power Requirements



AC Mains 100 - 240V, 50/60Hz, 120 - 130VA DC Mains 18Vdc, 7.0A with DC/DC adapter, Model:MDD150-1218 (MDD150-1218: Input: 12-16Vdc, 160 - 160VA, Output: 18Vdc, 7.0A) Note: For 120 Volt applications, use only UL Listed detachable power cord with NEMA configuration 5-15P type (parallel blades) plug cap. For 240 Volt applications use only UL Listed Detachable power supply cord with NEMA configuration 6-15P type (tandem blades) plug cap. Battery (option) Type Li-ion battery Dimension 156 × 104 × 28 (mm) (W×H×D) Voltage/Capacity 4S2P 14.52V/5200mAh Discharge A minimum of 200 shocks at 200 Joules (per battery) Operating time 5 hours (per battery), 10 hours (with two batteries) At the following condition: no printing no external communication no audible alarm sound



190



Recharge



Life Cycle



room temperature : 25°C Over 8 hours with defibrillator/monitor turned on/off (It would take about 8 hours to fully charge the battery from the moment that low battery alarm is activated.) 6 months, new battery fully-charged (- The battery life cycle may vary with the number of recharging, operating temperature, and storage condition. Typically, about 80% capacity of battery may remain after 300 cycles of recharge. If one cycle of recharging would be about 2 or 3 days, the battery may have 80% capacity after about 24 months. - The battery is designed not to be charged for safety reason when it reaches 40°C.) After 2 months storage the defibrillator/monitor would run for 50% of stated battery life.



Environmental Conditions Operation Temperature 0 to 50°C (32 to 122°F) Humidity 15 to 95% RH, non-condensing Altitude -170 to 4,877m (-557 to 16,000 ft) Note: The system may not meet its performance specifications if stored or used outside the specified temperature and humidity range. Note: The battery will not be charged for safety if the operating temperature exceeds 40°C. Shipping and Storage (in shipping container) Temperature −20°C ~ 70°C (−4°F ~ 158°F) Humidity 15 to 95% RH, non-condensing Altitude -304 ~ 6,096m (-1,000 ~ 20,000ft) Note: The system may not meet its performance specifications if stored or used outside the specified temperature and humidity range.



191



Tone Definition



Volume level Pitch (± 48.8Hz) Pulse width (± 10msec) Number of pulses Repetitions Volume level Pitch (± 34.85Hz) Pulse width (± 10msec) Number of pulses Repetitions Volume level Pitch (± 9.4Hz) Pulse width (± 10msec) Number of pulses Volume level Pitch (± 40Hz) Pulse width (± 10msec) Number of pulses Repetitions Volume level Pitch (± 32.5Hz) Pulse width (± 5msec) Number of pulses Repetitions Volume level Pitch Pulse width (± 5msec) Number of pulses Repetitions



192



High Priority Alarm Tone Adjustable (level 1~8) 976 Hz 210 msec 10 pulses per 4 sec, 10 sec inter burst Continually Medium Priority Alarm Tone Adjustable (level 1~8) 697 Hz 210 msec 3 pulses per 1 sec, 15 sec inter burst Continually Low Priority Alarm Tone Adjustable (level 1~8) 488 Hz 210 msec 1 pulse per 0.25 sec, 30 sec inter burst Alarm Reminder Tone Not changeable 800 Hz 200 msec 1 pulse per 1 second, 3 min, 10 min inter burst Continually HR/PR Tone Not changeable 650 Hz (ECG) (162 + 5*SpO2) Hz 100 msec N/A No repeat Key Beep Adjustable (Off, level 1~7) 440 (± 22) Hz (valid) 168 (± 8.4)Hz (invalid) 100 msec N/A No repeat



Measurement Parameters Pacing Mode Pacing rate Resolution Accuracy Output current Resolution Accuracy Pulse Type Pulse Amplitude



Pacing Mode Variable from 30 bpm(ppm) to 180 bpm(ppm) ± 1.5% (increments or decrements by a value of 2 bpm(ppm)) 2 bpm(ppm) ± 1.5 % 0 mA to 140 mA 2 mA ± 5% or 5 mA, whichever is greater. 40 ms constant current pulse Variable 0 mA to 140 mA ± 5% or 5 mA, whichever is greater. Digitally displayed on the defibrillator/monitor (increments or decrements by a value of 2 mA)



Defibrillator AED mode Lead Patient Impedance Heart Rate Accuracy Detection



Lead ll 25 to 175 Ohm 20 to 300 BPM 1 per min Ventricular Fibrillation at a amplitude greater than or equal to 0.2mV Ventricular Tachycardia at a heart rate greater than or equal to 160 bpm Shock Analysis Time < 10 seconds typical Note: Shock analysis would take about 20 seconds at maximum from the start to the completion of analysis if ECG signal is interfered by motion or others. Charging Time to Within 6 seconds with rated main voltage/DC main voltage 200J* Within 7 seconds with fully charged battery *Charging time for other cases, refer to defibrillator (technical specification) Manual Mode Shock Energy Level External paddles for Adult and Pediatric 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 75, 100, 125, 150, 175, 200, 300, 360 J External Pads Adult: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 75, 100, 125, 150, 175, 200, 300, 360 J Pediatric (Infant-Child): 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 75, 100 J 60 seconds



Automatic Discharge Time Charging Time to Within 6 seconds with rated main voltage/DC main voltage 200J* Within 7 seconds with fully charged battery Charging Time to Within 8 seconds with rated main voltage/DC main voltage 360J Within 9 seconds with fully charged battery *Charging time for other cases, refer to defibrillator (technical specification)



193



ECG



Measurement Range Resolution Accuracy Average Response Time Tall T-wave Rejection Leads



Lead Off Detection Pacer Detection



Input Input Impedance Input Dynamic Range Voltage Range Signal Width Output Filter mode



Heart Rate 0, 20 to 300 BPM 1 BPM ± 10% or ±5 bpm, whichever is greater 5 seconds (from 80 to120 BPM) 9 seconds (from 80 to 40 BPM) maximum T-wave amplitude 1.8 mV ECG (Electrocardiograph) 3 / 5 / 12 Lead Lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, Paddle, Pads Detected and displayed Detect pacer pulses of ±2mV to ±700mV with pulse widths of 0.1 to 2msec and rise times 10% of width not to exceed 100msec 5 M ohm or more ±5 mV AC, ±300 mV DC ±0.5 mV ~ ±5 mV 40 to 120 ms (Q to S) 0.5 to 21 Hz 0.05 to 40 Hz 1 to 21 Hz Auto, 5.0, 10.0, 15.0, 20.0, 30.0 mm/mV 25.0 mm/sec



ECG Size Display Sweep Speeds Wave Size x0.5, x1, x1.5, x2, x3 Display Sensitivity 10 mm/mV (×1) Pacing Pulse On, Off Detection Electrode Disconnect Display and/or sound Alarm CMRR 90 dB or more Defibrillator Discharge < 5 sec per IEC60601-2-27 Recovery Defibrillator Protection Protected ECG (Arrhythmia Supplemental Information as required by AAMI EC13) Respiration, leads-off amp 0.03 µA sensing, and active common 0.25 µA noise suppression Tall T-wave rejection Maximum T-Wave amplitude 1.8 mV capability Accuracy of input Displacement: 0.1 mV signal reproduction Slope: 0.1 mV/s



194



Heart rate meter accuracy and response to irregular rhythm Response time of heart rate meter to change in heart rate Time to alarm for tachycardia



Provides correct heart rates, as follows: Ventricular bigeminy: 79 to 83 bpm Slow alternating ventricular bigeminy: 51 to 63 bpm Rapid alternating ventricular bigeminy: 119 to 121 bpm Bidirectional systoles: 82 to 94 bpm HR change from 80 to 120 bpm: 3.16 sec HR change from 80 to 40 bpm: 3.05 sec Vent Tachycardia 1 mVpp, 206 bpm: Amplitude 0.5mV, Alarm activated time 6.79 sec Amplitude 1mV, Alarm activated time 9.80 sec Amplitude 2mV, Alarm activated time 8.19 Vent Tachycardia 2 mVpp, 195 bpm: Amplitude 1mV, Alarm activated time 3.43 sec Amplitude 2mV, Alarm activated time 2.97 sec Amplitude 4mV, Alarm activated time 1.47 sec



Time to alarm for cardiac standstill Time to alarm for heart rate Time base selection and accuracy Pacemaker pulse rejection capability



Pacer pulse detector rejection of fast ECG signals



Average: 3.28 sec Low heart rate: average: 5.48 sec High heart rate: average: 5.30 sec 10 successive peaks: 10 mm 20 successive peaks: 20 mm 40 successive peaks: 40 mm Rejection of pacemaker pulses with amplitudes from ±2mV to ±700mV with pulse widths of 0.1 to 2msec Overshoot time constant 4 ms, Test method B (with overshoot) Slew rate: 595mV/s



Respiration



Technique Range Resolution Leads Base impedance Delta impedance Lead Off Condition Defibrillator Protection Display Sweep Speeds Wave Size Technique Range Accuracy



IM Respiration Impedance Pneumography 0, 3 to 120 breaths/min ±3 breaths/min RA to LA 500 to 2000 ohm 0.5 to 3 ohm Detected and displayed Protected 25 mm/sec x0.5, x1, x1.5, x2 AW Respiration Nondispresive Infrared Spectroscopy 0 to 150 breaths/min ±1 breaths/min



195



NIBP



Pulse Rate Range Resolution Pulse Rate Accuracy Technique Measurement Modes Measurement Range



NIBP Accuracy



Pressure Display Range Pressure Display Accuracy Initial Cuff Inflate Pressure



Automatic Cuff Deflation Overpressure Protector Defibrillator Protection Measurement Speed



196



Pulse Rate Adult/Pediatric 40 to 200 BPM Neonatal 40 to 240 BPM 5 BPM ±2 BPM or ±2%, whichever is greater NIBP (Non-Invasive Blood Pressure) Oscillometric Measurement Off, Cont, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 minutes Adult/Pediatric SYS 60 to 250 mmHg MAP 45 to 235 mmHg DIA 40 to 200 mmHg Neonatal SYS 40 to 120 mmHg MAP 30 to 100 mmHg DIA 20 to 90 mmHg Mean error and standard deviation per ANSI/AAMI SP10:2002+A1:2003+A2:2006, IEC 60601-2-30:2009, EN 1060-4:2004 Adult/Pediatric 0 to 300 mmHg Neonatal 0 to 150 mmHg Within ±3 mmHg or 2% Adult/Pediatric 120, 140, 160, 180, 200, 220, 240, 260, 280 mmHg (16.0, 18.7, 21.3, 24.0, 26.7, 29.3, 32.0, 34.7, 37.3 kPa) Neonatal 80, 90, 100, 110, 120, 130, 140 mmHg (10.7, 12.0, 13.3, 14.7, 16.0, 17.3, 18.7 kPa) Measurement time exceeding 180s in adult/pediatric (90s in neonatal) or maximum pressure value exceeding 300 mmHg in adult (150 mmHg in neonatal). Adult/Pediatric: 300 mmHg Neonatal: 150 mmHg Protected About 20 seconds At the following condition: Adult Cuff size 12 cm SYS 120 mmHg MAP 90 mmHg DIA 80 mmHg/ PR 80 BPM Manual Measurements (180 mmHg)



IBP



Pulse Rate Range Accuracy Pulse Rate Resolution Parameter Displayed Measurement Range Resolution Accuracy Input sensitivity Transducer Volume Displacement Zero calibration range Frequency response Wave Size Display Sweep Speeds Defibrillator Protection



Pulse Rate 20 to 250 BPM ± 1 % or ± 1 bpm 1 BPM IBP (Invasive Blood Pressure) P1, ABP P2, CVP, PAP, LAP -50 mmHg to 300 mmHg 20 bpm to 250 bpm 1 mmHg ± 3 mmHg 5µV/V/mmHg 0.1mm3/100mmHg ± 100mmHg DC - 10 Hz ± 1 Hz, -3db 0 to 50, 0 to 100, 0 to 200, 0 to 300, Auto Size 25.0 mm/sec Protected



SpO2



SpO2 saturation range Pulse rate range Perfusion range Display sweep speed



Measurement Ranges 1% to 100% 20 to 300 beats per minute (bpm) 0.03% to 20% 25.0 mm/sec Measurement Accuracy 20 to 250 beats per minute (bpm) ±3 digits 70% to 100% ±2 digits, neonates: ±3 digits



Pulse rate accuracy SpO2 saturation accuracy Note: SpO2 saturation accuracy – The defibrillator/monitor measurements are statistically distributed; about two-thirds of the defibrillator/monitor measurements can be expected to fall in this accuracy (ARMS) range. Reference the Clinical Studies section for test results. For a complete listing of SpO2 accuracy across the full line of available Nellcor™ sensors, contact Covidien, a local Covidien representative, or locate it online at www.covidien.com. Operating Range and Dissipation Red Light Wavelength Approximately 660 nm Infrared Light Approximately 900 nm Wavelength Optical Output Power Less than 15 mW Power Dissipation 52.5 mW



197



Capnography



Parameter Displayed Range Accuracy



Display Accuracy Response Time Baromatric Pressure Correction Gas Compensation Stability and drift



Accuracy Change for interfering Gases and Vapors Anesthetic and interfering agents



Capnography EtCO2, InCO2 0 mmHg ~ 150 mmHg (0kPa ~ 20kPa, 0% ~ 20%) 0-40mmHg ±2mmHg of reading 41-70mmHg ±5% of reading 71-100mmHg ±8% of reading 101-150mmHg ±10% of reading (No degradation due to respiration rate or Inspiration/Expiration ratio (I/E ratio)) ±2mmHg Mainstream: Less than 60ms Sidestream: Less than 3sec. -152.4 to 4572 meters (-500 to 15,000 feet), 775 to 429 mmHg, Automatic User selective at O2 >60% and N2O >50% Short term drift: Less than 0.8 mmHg over 4 hours. Long term drift: Accuracy specification will be maintained over a 120 hour period. 0-40 mmHg ±1 mmHg additional error 41-70 mmHg ±2.5% additional error 71-100 mmHg ±4% additional error 101-150 mmHg ±5% additional error



Additional worst case error when compensation for O 2 and N2O is correctly selected for actual fractional gas constituents present. Warm Up Time 2 minutes maximum Sweep Speeds 25.0 mm/sec Sampling rate 100Hz Sound Noise Level Less than 41dB when ambient sound pressure level is 22dB Note: Respiration rate accuracy was verified by using a solenoid test setup to deliver a square wave of known CO2 concentration to the device. 5% and 10% CO2 concentrations were used and respiration rate was varied over the range of the device. Pass/Fail criteria was comparison of the respiratory rate output from the sensor to the frequency of the square wave. EtCO2 measurements at those rates were compared to the CO2 readings under static flow conditions.



198



Temperature



Probe Type Measurement Method Operating Mode Range Display Accuracy Probe Accuracy



Transient Response Time Defibrillator Protection



Thermistor Temp Thermistor probe YSI 400 series and 700 series Thermistor Direct 0.0 to 50°C (32.0 to 122°F) ±0.1 YSI 400 series and YSI 700 series Probes: ±0.1°C from 25 to 45°C, ±0.2°C from 0 to 25°C and from 45 to 50°C About 17 sec Protected



Event Type Data storage Memory



12 lead, Event Internal memory, SD card 12 lead saves total 100 data saves ECG waveform saves ECG analysis result data saves ECG analysis date and time saves HR/PR, NIBP, SpO2, Respiration, Temperature, IBP 1, IBP 2, EtCO2 numeric data saves alarm condition Event saves total 250 data saves defibrillation shock information (number of shock, energy level, actual passed energy, impedance) saves pacing information (pace rate, pace current, async mode) saves clinical action list saves 1 channel ECG waveform saves Event date and time saves HR/PR, NIBP, SpO2, Respiration, Temperature, IBP 1, IBP 2, EtCO2 numeric data saves alarm condition



199



Defibrillator (Technical Specification) AED Mode



AED Mode Charging Time - 200J



Charging Time - 200J (including time from the initiation of rhythm analysis with a clear ECG signal to readiness for discharge.)



Waveform parameters



200



Charging condition With Rated Mains Voltage With DC Mains Voltage With fully charged battery



Time (sec) 5.8 5.9 6.4



Charging condition Time (sec) With Rated Mains Voltage 18.1 With DC Mains Voltage 18.4 With fully charged battery 19.3 With Mains Voltage of 90% of the Rated 18.1 value With DC Mains Voltage of 90% of the 18.8 Rated value After 15 maximum energy discharges 19.6 taken from a new fully charged battery With Mains Voltage of 90% of the Rated value, but measured from initially 26.4 switching power on to ready for discharge at maximum energy With DC Mains Voltage of 90% of the Rated value, but measured from initially 26.3 switching power on to ready for discharge at maximum energy After 15 maximum energy discharges taken from a new fully charged battery, but measured from initially switching 26.7 power on to ready for discharge at maximum energy Note: A used battery normally takes more time than the charging time specified in above. The defibrillator/monitor delivers shocks to load impedances from 25 to 175 ohms. The duration of each pulse of the waveform is dynamically adjusted based on delivered charge, in order to compensate for patient impedance variations, as shown below: (When 200J is selected) Load resistance (Ω) Delivered energy(J) 25 195 50 200 75 196 100 199 125 199 150 200 175 200



Manual Mode



Manual Mode Charging Time – 200J



Charging Time – 360J



Charging condition Time (sec) With Rated Mains Voltage 5.8 With DC Mains Voltage 5.9 With fully charged battery 6.4 With Mains Voltage of 90% of the 5.8 Rated value With DC Mains Voltage of 90% of the 6.4 Rated value After 15 maximum energy discharges 6.6 taken from a new fully charged battery With Mains Voltage of 90% of the Rated value, but measured from 11.7 initially switching power on to ready for discharge at maximum energy With DC Mains Voltage of 90% of the Rated value, but measured from 11.9 initially switching power on to ready for discharge at maximum energy After 15 maximum energy discharges taken from a new fully charged battery, but measured from initially switching 12.5 power on to ready for discharge at maximum energy Note: A used battery normally takes more time than the charging time specified in above. Charging condition With Rated Mains Voltage With DC Mains Voltage With fully charged battery With Mains Voltage of 90% of the Rated value With DC Mains Voltage of 90% of the Rated value After 15 maximum energy discharges taken from a new fully charged battery With Mains Voltage of 90% of the Rated value, but measured from initially switching power on to ready for discharge at maximum energy With DC Mains Voltage of 90% of the Rated value, but measured from initially switching power on to ready for discharge at maximum energy After 15 maximum energy discharges taken from a new fully charged battery, but measured from initially switching power on to ready for discharge at maximum energy



Time (sec) 7.4 7.5 8.0 7.4 8.0 8.5



13.0



14.0



14.3



201



Number of discharges



Note: A used battery normally takes more time than the charging time specified in above. The number of maximum energy discharges which are available from a new and fully charged battery at 20°C ambient temperature is above 200 times for 360J and 250 times for 200J



ECG Analysis Performance Rhythm class



AHA-DB



MIT-DB



CU-DB



VF-DB



VF-shockable: TP VF-shockable: FN VF-shockable: sensitivity(%) VT-shockable: TP VT-shockable: FN VT-shockable: sensitivity(%) Non-shockable: TN Non-shockable: FP Specificity(%)



1905 65 96.70



47 1 97.92



549 11 98.04



1052 8 99.25



Total number of sample size 3553 85 97.66



9 0 100.00



-



-



1304 30 97.75



1313 30 97.72



64798 8 99.99



33297 10 99.97



2565 29 98.88



14543 73 99.50



115203 120 99.90



Database for ECG Analysis  From AHA (American Heart Association) official database  From MIT (Massachusetts institute Technology) official database (CU-DB: The Creighton University Sustained Ventricular Arrhythmia Database, VF-DB: MIT-BIH Malignant Ventricular Arrhythmia Database) ECG rhythm to determine if a shock is appropriate  Ventricular Fibrillation at a amplitude greater than or equal to 0.2mV  Ventricular Tachycardia at a heart rate greater than or equal to 160 bpm



202



Biphasic Waveform Characteristics The efficiency of Mediana’s Biphasic waveform has been clinically verified during a ventricular fibrillation (VF) and ventricular tachycardia (VT) defibrillation study. This study (which was conducted using D500 defibrillator/monitors) and the findings are described below. Table 44. Delivered Energy at Every Defibrillator Settings into a Range of Loads Selected Load Accuracy Energy 25 50 75 100 125 150 175 1J 1.0 1.0 1.0 1.0 1.0 1.0 1.0 15% 2J 2.0 2.0 2.0 2.0 2.0 2.0 2.0 15% 3J 3.0 3.0 3.0 3.0 3.0 3.0 3.0 15% 4J 4.0 4.0 4.0 4.0 4.0 4.0 4.0 15% 5J 5.0 5.0 5.0 5.0 5.0 5.0 5.0 15% 6J 6.0 6.0 6.0 6.0 6.0 6.0 6.0 15% 7J 7.0 7.0 7.0 7.0 7.0 7.0 7.0 15% 8J 8.0 8.0 8.0 8.0 8.0 8.0 8.0 15% 9J 9.0 9.0 9.0 9.0 9.0 9.0 9.0 15% 10J 10.0 10.0 10.0 10.0 10.0 10.0 10.0 15% 15J 14.0 15.0 15.0 15.0 15.0 15.0 15.0 15% 20J 19.0 20.0 20.0 20.0 20.0 20.0 20.0 15% 30J 29.0 30.0 30.0 30.0 30.0 30.0 30.0 15% 40J 38.0 40.0 40.0 40.0 40.0 39.0 40.0 15% 50J 48.0 50.0 49.0 50.0 50.0 50.0 50.0 15% 75J 71.0 74.0 74.0 75.0 74.0 74.0 74.0 15% 100J 96.0 100.0 101.0 101.0 100.0 100.0 100.0 15% 125J 120.0 125.0 125.0 126.0 124.0 124.0 124.0 15% 150J 141.0 148.0 150.0 150.0 149.0 149.0 149.0 15% 175J 164.0 173.0 175.0 175.0 174.0 174.0 173.0 15% 200J 187.0 197.0 200.0 198.0 198.0 199.0 198.0 15% 300J 292.0 299.0 302.0 300.0 300.0 299.0 282.0 15% 360J 373.0 370.0 364.0 345.0 323.0 302.0 282.0 15% Note: When the energy is set to 360J and the impedance on the patient chest through the paddle is more than 150ohm or 175ohm, the energy delivered to the paddle, is supposed to be automatically reduced from 360J to approximately 300J, in order to avoid re-fibrillation caused by the increase of duration of energy waveform. Some of study reported that energy delivery with more than 24ms could cause re-fibrillation. HeartOn Biphasic waveformTM adjusts the energy level only with duration. It does not deliver energy more than 24ms.



203



Figure through show the biphasic waveforms that are produced when the defibrillator/monitor is discharged into loads of 25, 50, 75, 100, 125, 150 and 175 ohms at each energy setting (360, 300, 200, 175, 150, 125, 100, 75, 50, 40, 30, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 and 1 joule[s]). The vertical axis shows the voltage in volts (V); the horizontal axis shows the duration in milliseconds (ms).



Figure 88. Biphasic Waveforms at 300 Joules and 360 Joules



Figure 89. Biphasic Waveforms at 200 Joules



204



Figure 90. Biphasic Waveforms at 175 Joules



Figure 91. Biphasic Waveforms at 150 Joules



205



Figure 92. Biphasic Waveforms at 125 Joules



Figure 93. Biphasic Waveforms at 100 Joules



206



Figure 94. Biphasic Waveforms at 75 Joules



Figure 95. Biphasic Waveforms at 50 Joules



207



Figure 96: Biphasic Waveforms at 40 Joules



Figure 97. Biphasic Waveforms at 30 Joules



208



Figure 98. Biphasic Waveforms at 20 Joules



Figure 99. Biphasic Waveforms at 10 Joules



209



Figure 100. Biphasic Waveforms at 9 Joules



Figure 101. Biphasic Waveforms at 8 Joules



210



Figure 102. Biphasic Waveforms at 7 Joules



Figure 103. Biphasic Waveforms at 6 Joules



211



Figure 104. Biphasic Waveforms at 5 Joules



Figure 105. Biphasic Waveforms at 4 Joules



212



Figure 106. Biphasic Waveforms at 3 Joules



Figure 107. Biphasic Waveforms at 2 Joules



213



Figure 108. Biphasic Waveforms at 1 Joules



214



Compliance Item Classification



Standard



Description



IEC 60601-1:2005 +A1:2012,



Class I (on AC power) Internally powered (on battery power)



EN 60601-1:2006 +A1:2013 Type of protection



IEC 60601-1:2005 +A1:2012,



Type BF and Type CF – Applied part



EN 60601-1:2006 +A1:2013 Mode of operation



IEC 60601-1:2005 +A1:2012,



Continuous



EN 60601-1:2006 +A1:2013 Degree of protection



IEC 60529:1989 +A1:1999+A2:2013,



IP34 (provided by enclosures)



EN 60529:1991 +A1:2000+A2:2013 General



93/42/EEC as amended by



Directives for medical devices



2007/47/EC 21CFR820



Code of federal regulations



2012/19/EU



Waste electrical and electronic equipment directive (WEEE)



2011/65/EU



Restriction of the use of Hazardous Substances in electrical and electronic equipment II



93/86/EEC



Battery disposal directive



2006/66/EC as amended



Battery directive



by 2008/103/EC ISO 13485:2003 /Cor1:2009



Quality systems - Medical Devices - Requirements for regulating purposes



EN ISO 13485:2012 /AC:2012 ISO 14971:2007,



Risk analysis managements – medical devices



EN ISO 14971:2012 IEC 60601-1:2005 +A1:2012,



General requirements for safety of medical electrical equipment



EN 60601-1:2006 +A1:2013 IEC 60529:1989 +A1:1999+A2:2013, EN 60529:1991 +A1:2000+A2:2013 ISO 14155:2011 /Cor1:2011 EN ISO 14155:2011 IEC 60601-1-6:2010,



Degree of protection provided by enclosures (IP34)



Clinical investigation of medical devices for human subjects – part 1: General requirements Collateral standard for usability



215



Item



Standard



Description



EN 60601-1-6:2010 ISO 10993-1:2009 /Cor1:2010,



Biological evaluation of medical devices – Part 1: Evaluation and testing



EN ISO 10993-1:2009 /AC:2010



Ambulance



ISO 10993-5:2009,



Biological evaluation of medical devices – Part 5:



EN ISO 10993-5:2009



Tests for in vitro cytotoxicity



ISO 10993-10:2010,



Biological evaluation of medical devices – Part 10:



EN ISO 10993-10:2010



Tests for irritation and delayed-type hypersensitivity



IEC 60601-2-49:2011,



Particular requirements for multifunction patient



EN 60601-2-49:2015



monitoring equipment



IEC 62366:2007



Medical devices – Application of usability



EN 62366:2008



engineering to medical devices



IEC 62304:2006+A1:2015



Medical device software – Software life-cycle



EN 62304:2006+A1:2015



processes



EN 1789:2007+A1:2010



Medical vehicles and their equipment – road ambulance



EN 13718-1:2008



Medical vehicles and their equipment – Air ambulances – Part1:Requirements for medical devices used in air ambulances.



Alarms



RTCA/ DO-160 section 20,



Environmental Conditions and Test Procedures for



21



Airborne Equipment



IEC 60601-1-8:2006



Alarm systems requirements, tests and guidance in



+A1:2012,



medical electrical equipments systems



EN 60601-1Electrocardiograph



8:2007/AC:2010 IEC 60601-2-27:2011,



Particular requirements for the safety of



EN 60601-2-27:2014



Electrocardiographic monitoring equipment



IEC 60601-2-25:2011,



Particular requirements for the basic safety and



EN 60601-2-25:2015



essential performance of electrocardiographs



AAMI EC53:2013



ECG cable and leads



AAMI EC57:2012



Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms



Non-invasive blood



ISO 81060-2:2009/Cor



pressure



1:2011 EN 1060-3:1997+A2:2009



Electronic or automated sphygmomanometers Supplementary requirements for electricalmechanical blood pressure measuring systems



EN 1060-4:2004



Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers



IEC 80601-2-30:2009 +A1:2013,



216



Particular requirements for the safety, including essential performance, of automatic cycling indirect



Item



Standard



Description



EN 80601-2-



blood pressure monitoring equipment



30:2010/A1:2015 ISO 80601-2-61:2011,



Basic safety & essential performance of pulse



EN ISO 80601-2-61:2011



oximeter for medical use



Temperature



ISO 80601-2-56:2009,



Performance of electrical thermometers for



monitoring



EN ISO 80601-2-56:2012



continuous Measurement



Invasive blood



IEC 60601-2-34:2011



Particular requirements for the safety, including



pressure



EN 60601-2-34:2014



essential performance, of invasive blood pressure



Capnography



ISO 80601-2-55:2011,



Particular requirements for the basic safety and



EN ISO 80601-2-55:2011



essential performance of respiratory gas monitors



IEC 60601-2-4:2010



Safety of cardiac defibrillators



Oxygen saturation



monitoring equipment



Defibrillator



EN 60601-2-4:2011 Electromagnetic compatibility



IEC 60601-1, sub clause 36, and IEC 60601-1-2:2014



Electromagnetic compatibility-requirements & test



EN 60601-1-2:2015 IEC 61000-3-2:2014



Harmonic emission Ed 3.2



EN 61000-3-2:2014 IEC 61000-3-3:2013,



Voltage fluctuations/Flicker emission Ed 2.0



EN 61000-3-3:2013 IEC 61000-4-2:2008,



Electrostatic discharge Ed 2.0



EN 61000-4-2:2009 IEC 61000-43:2006+A1:2007+A2:2010



Radiated RF electromagnetic field Ed 3.1



EN 61000-4-3:2006 +A1:2008+A2:2010 IEC 61000-4-4:2012



Electrical fast transient/burst Ed 2.1



EN 61000-4-4:2012 IEC 61000-4-5:2014,



Surge current Ed 2.0



EN 61000-4-5:2014 IEC 61000-4-6:2013,



Conducted disturbances, induced by RF field Ed



EN 61000-4-6:2014



3.0



IEC 61000-4-8:2009,



Power frequency (50/60Hz) magnetic field Ed 2.0



EN 61000-4-8:2010 IEC 61000-4-11:2004,



Voltage dips, short interruption and voltage



EN 61000-4-11:2004



variation on power supply input lines Ed 2.0



CISPR11:2009 +A1:2010



Limits and methods of measurement of radio



EN 55011: 2009 +A1:2010



disturbance characteristics of industrial scientific and medical (ISM) radio-frequency equipment RF Emissions Group 1, Class B



CISPR22:2008



Information technology equipment - Radio



EN 55022:2010/AC:2011



disturbance characteristics - Limits and methods of measurement



Package



ISTA (Procedure 1A,



Pre-Shipment test procedures (Package)



2014)



217



Item



Standard



Description



IEC 60068-1:2013



Environmental testing, Part1: General guidelines



EN 60068-1:2014



Reliability



IEC 60068-2-1:2007



Environmental testing - Part 2-1: Tests - Test A:



EN 60068-2-1:2007



Cold



IEC 60068-2-2:2007



Environmental testing - Part 2-2: Tests - Test B:



EN 60068-2-2:2007



Dry heat



IEC 60068-2-30:2005



Environmental testing - Part 2-30: Tests - Test Db:



EN 60068-2-30:2005



Damp heat, cyclic (12 h + 12 h cycle)



IEC 60068-2-27:2008,



Environmental testing – Shock



EN 60068-2-27:2009 IEC 60068-2-6:2007,



Environmental testing – Vibration



EN 60068-2-6:2008



Labeling



IEC 60068-2-31:2008 EN 60068-2-31:2008



Environmental testing: Rough handling shocks,



IEC 60068-2-64:2008,



Environmental testing: vibration, broad-band



EN 60068-2-64:2008



random (digital control) and guidance



EN 1041:2008



Information supplied by the manufacturer with



primarily for equipment-type specimens



medical devices Marking



IEC TR 60878:2015



Graphical symbols for electrical equipment in medical practice



ISO 15223-1:2012



Symbols to be used with medical device labels,



EN ISO 15223-1:2012



labelling and information to be supplied -- Part 1: General requirements



ISO 15223-2:2010



Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation



ISO 7000:2014



Graphical symbols for use on equipment-index and synopsis



EN 50419:2006



Marking of electrical and electronic equipment in accordance with article II (2) of directive 2002/96/EC (WEEE)



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Manufacturer’s EMC Declaration For best product performance and measurement accuracy, use only accessories supplied or recommended by Mediana. Use accessories according to the manufacturer’s directions for use and your facility’s standards. The use of accessories, transducers, and cables other than those specified may result in increased emission and/or decreased immunity of the defibrillator/monitor. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the monitor, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. The defibrillator/monitor is suitable for use in the specified electromagnetic environment. The customer and/or user of the defibrillator/monitor should assure that it is used in an electromagnetic environment as described below; Table 45. Electromagnetic Emissions (IEC60601-1-2) Emission Test RF emission CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emission IEC 61000-3-3



Compliance Group 1, Class B Class A Complies



Electromagnetic Environment The defibrillator/monitor is suitable for use in all establishments The defibrillator/monitor is suitable for use in all establishments. The defibrillator/monitor is suitable for use in all establishments.



Table 46. Electromagnetic Immunity (IEC60601-1-2) Immunity Test



IEC 60601-1-2 Test Level ±8 kV contact ±2, 4, 8, 15 kV air



Compliance Level ±8 kV contact ±2, 4, 8, 15 kV air



Electric fast transient/burst IEC 61000-4-4



±2 kV for power supply lines ±1 kV for input/output lines



Surge IEC 61000-4-5



(Input Power Ports) ± 0.5, 1 kV differential mode ±0.5, 1, 2 kV common mode (Signal input/output) 2 kV common mode



±2 kV for power supply lines ±1 kV for input/output lines (Input Power Ports) ± 0.5, 1 kV differential mode ±0.5, 1, 2 kV common mode (Signal input/output) 2 kV common mode



Electrostatic discharge (ESD) IEC 61000-4-2



Electromagnetic Environment Guidance Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial and/or hospital environment Mains power quality should be that of a typical commercial and/or hospital environment



219



Immunity Test



IEC 60601-1-2 Test Level Voltage dips >95 % U T for 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°



Compliance Level Voltage dips >95 % U T for 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°



IEC 61000-4-11



Voltage dips >95 % U T for 1 cycle At 0° Voltage dips 30 % U T for 25/30 cycle At 0° Voltage interruption >95 % U T for 250/300 cycle At 0°



Voltage dips >95 % U T for 1 cycle At 0° Voltage dips 30 % U T for 25/30 cycle At 0° Voltage interruption >95 % U T for 250/300 cycle At 0°



Power frequency (50/ 60 Hz) magnetic field



30 A/m



30 A/m



Voltage dips, short interruptions and voltage variations on power supply



Electromagnetic Environment Guidance Mains power quality should be that of a typical commercial and/or hospital environment. If the user of the defibrillator/monitor requires continued operation during power mains interruption, it is recommended that the defibrillator/monitor be powered from an uninterruptible power supply or battery.



It may be necessary to position the defibrillator/monitor further from the sources of power frequency magnetic fields or to install magnetic shielding. The IEC 61000-4-8 power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low. Note: UT is the AC mains voltage prior to application of the test level.



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Table 47. Electromagnetic Immunity (IEC60601-2-4) Immunity Test



IEC 60601 Compliance Electromagnetic environment test level level guidance The defibrillator/monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the defibrillator/monitor should assure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of the defibrillator/monitor including cables, than the recommended separation distance calculated from the equation appropriate to the frequency of the transmitter. Recommend separation distance Conducted RF IEC 61000-4-6



3 V RMS outside the ISM band



3 Vrms



d = 1.2 p



6 V RMS in the ISM and amateur radio bands



6 Vrms



d = 0.6 p



3 V/m 80 MHz to 2.5 GHz (80 % AM at 2 Hz) According to IEC60601-1-2:2007



3 V/m



d = 1.2 p



80 MHz to 800 MHz



d = 2.3 p



800 MHz to 2.5 GHz



10 V/m 80 MHz to 2.7 GHz (80 % AM at 1 kHz) According to IEC60601-1-2:2014



10 V/m



d = 0.4 p



80 MHz to 800 MHz



d = 2.3 p



800 MHz to 2.7 GHz



20 V/m 80 MHz to 2.5 GHz (80 % AM at 1 kHz) According to particular standards



20 V/m



d = 0.2 p



80 MHz to 800 MHz



d = 0.4 p



800 MHz to 2.5 GHz



150 kHz to 80 MHz Radiated RF IEC 61000-4-3



where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters as deter-mined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:



221



Immunity Test



IEC 60601 test level



Compliance level



Electromagnetic environment guidance



Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the defibrillator/monitor is used exceeds the applicable RF compliance level above, the defibrillator/monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the defibrillator/monitor. b



Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m



Table 48. Electro-surgical Unit Interference (IEC 60601-2-27, IEC 60601-2-30) Interference Test



IEC 60601 test level



Test in cut mode



Output power 300W, 5 times



Complies with IEC 60601-2-2



Test in coagulation mode



Output power of 100W, Working frequency of 400 kHz ± 10 % 5 times



Table 49. Recommended Separation Distances Recommended separation distance between portable and mobile RF communications equipment and the defibrillator/monitor The defibrillator/monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the defibrillator/monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the defibrillator/monitor as recommended below, according to the maximum output power of the communications equipment. Rated Separation distance according to frequency of transmitter in meter Maximum 150 kHz to 150 kHz to 80 MHz to 800 MHz to Output Power 80MHz 80MHz 800MHz 2.5GHz of Transmitter d = 1.2 p (ISM and (Test level (Test level in watt amateur 20 V/m) 20 V/m)



0.01



0.12



radio bands) d = 0.6 p 0.06



d = 0.2 p



d = 0.4 p



0.02



0.04



0.1



0.38



0.19



0.06



0.13



1



1.2



0.6



0.2



0.4



10



3.8



1.9



0.63



1.3



100 12 6 2 4 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note: At 80MHz and 800MHz, the separation distance for the higher frequency range applies Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.



222



Table 50. Immunity to proximity fields from RF wireless communications equipment (IEC 60601-1-2) Test frequency (MHz)



Modulation



Compliance Level (V/m)



Immunity test level (V/m)



385



Pulse modulation b 18 Hz



27



27



450



FM a ± 5 kHz deviation 1 kHz sine



28



28



Pulse modulation b 217 Hz



9



9



Pulse modulation b 18 Hz



28



28



Pulse modulation b 217 Hz



28



28



Pulse modulation b 217 Hz



28



28



710 745 780 810 870 930 1720 1845 1970 2450



5240 Pulse modulation b 5500 9 9 217 Hz 5785 a As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. b The carrier shall be modulated using a 50 % duty cycle square wave signal.



Table 51. Cables (IEC60601-1-2) Cables and Sensors AC Power Cable DC In Cable NIBP Hose Cuff Hose IBP Cable ECG Lead Cable Defibrillator/AED Cable Temperature Cable EtCO2 Cable SpO2 Cable SpO2 Sensor



Maximum Length



Complies with



2.5m 1.8 m 3.5 m 0.5 m 3.0 m 3.0 m 3.0 m 3.0 m 2.0 m 4.0 m 1.0 m



-RF emissions, CISPR 11, Class B/ Group 1 -Harmonic emissions, IEC 61000-3-2 -Voltage fluctuations/flicker emission, IEC 61000-3-3 -Electrostatic discharge (ESD), IEC 61000-4-2 -Electric fast transient/burst, IEC 61000-4-4 -Surge, IEC 61000-4-5 -Conducted RF IEC 61000-4-6 -Radiated RF, IEC 61000-4-3



223