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DRE VidaStat DM Defibrillator Monitor User’s Manual

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: Ÿ Installation, transfer installation, maintenance and repairs by any person other than an authorized employee or technician by DRE. Ÿ Damage sustained to the DRE product(s) caused by product(s) from another company excluding products delivered by DRE. Ÿ Damage – caused by mishandling and/or misuse – is the responsibility of the user. Ÿ Maintenance and repairs utilizing maintenance components that are not specified by DRE. Ÿ Device modifications or use of accessories not recommended by DRE . Ÿ Damage caused by accidents or natural disasters (earthquakes, flooding, etc.). Ÿ Damage resulting from usage where caution statements and operating instructions shown in this manual have not been followed. Ÿ Damage due to neglect of specified maintenance checks.  This warranty only covers the hardware of the VidaStat DM. The warranty does not cover the following selections: Ÿ Whatever damage or loss results from the attachment of accessories or their operation. Ÿ In the event of a defect in the product, contact our sales outlet or EU representative as noted on the back cover.  The VidaStat DM conforms to the EMC standard IEC60601 -1- 2. Note that mobile phones should not be used in the vicinity of the VidaStat . DM Note, however, any device not complying to the EMC standard that is used with the VidaStat DM renders the VidaStat DM 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 VidaStat .................................................................................................................. DM 13 Indications for Use ............................................................................................................................... 13 About This Manual............................................................................................................................... 15 Identifying the VidaStat DM 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 ....................................................................................................... 31 BATTERY OPERATION .............................................................................................................................. 33 Operating the defibrillator/monitor on Battery Power .......................................................................... 34 Battery Status Indication ...................................................................................................................... 35 USING THE DEFIBRILLATOR/MONITOR ................................................................................................. 37 Turning on the defibrillator/monitor ...................................................................................................... 38 Setting Date and Time ......................................................................................................................... 39 Continued use ..................................................................................................................................... 39 Setting the Main Screen ...................................................................................................................... 40 ALARMS AND LIMITS................................................................................................................................ 43 General ................................................................................................................................................ 43 Alarm Priority and Messages .............................................................................................................. 44 Visual Alarm Indication ........................................................................................................................ 48 Audible Alarm Indication ...................................................................................................................... 48 Verifying Audible Alarm Indication ....................................................................................................... 48 Changing Alarm Limits......................................................................................................................... 49 Audio Paused and OFF ....................................................................................................................... 52 ECG MONITORING .................................................................................................................................... 53 General ................................................................................................................................................ 53 Setup Connections .............................................................................................................................. 54 12-lead ECG ........................................................................................................................................ 56 Preparing the 12 Lead ......................................................................................................................... 60 Calculation Feature ............................................................................................................................. 61 Description of HR/PR Menu Functions................................................................................................ 64 HR/PR Source ..................................................................................................................................... 65 AED(Automated External Defibrillator) MODE ....................................................................................... 67 2010 AHA Guidelines for CPR and ECC ............................................................................................. 70 Major changes in the 2010 AHA Guidelines for CPR and ECC .......................................................... 70 CPR Guidelines 2010 .......................................................................................................................... 71 AHA 2010 Configuration ...................................................................................................................... 73 Note Performing CPR .......................................................................................................................... 73 Description of AED Mode Menu Functions ......................................................................................... 74 i

MANUAL MODE ......................................................................................................................................... 75 General ................................................................................................................................................ 75 Preparing for Defibrillation ................................................................................................................... 76 Operating the Manual Mode of defibrillator/monitor ............................................................................ 76 Defibrillating (async mode) .................................................................................................................. 77 Synchronized Cardioversion (sync mode) .......................................................................................... 77 Description of Manual Mode Menu Functions ..................................................................................... 79 MONITOR MODE ........................................................................................................................................ 85 General ................................................................................................................................................ 85 Description of Pacing Mode Menu Functions ...................................................................................... 85 PACING MODE ........................................................................................................................................... 91 General ................................................................................................................................................ 91 Demand Mode (Sync Mode) and Async Mode .................................................................................... 91 Operating the Pacing Mode of defibrillator/monitor ............................................................................. 92 Demand Mode (Sync mode) Pacing ................................................................................................... 92 Async Mode Pacing ............................................................................................................................. 93 Description of Pacing Mode Menu Functions ...................................................................................... 93 NIBP MONITORING.................................................................................................................................... 97 General ................................................................................................................................................ 98 Theory of Operation............................................................................................................................. 98 Setup Connections ............................................................................................................................ 101 Description of NIBP Menu Functions ................................................................................................ 102 SpO2 MONITORING.................................................................................................................................. 105 General .............................................................................................................................................. 106 Theory of Operation........................................................................................................................... 106 Setup Connections ............................................................................................................................ 108 RESPIRATION MONITORING .................................................................................................................. 111 General .............................................................................................................................................. 111 Theory of Operation........................................................................................................................... 112 Setup Connections ............................................................................................................................ 112 Description of Respiration Menu Functions ...................................................................................... 113 CAPNOGRAPHY MONITORING .............................................................................................................. 115 General .............................................................................................................................................. 116 Theory of Operation........................................................................................................................... 116 Setup Connections ............................................................................................................................ 117 Calibrating the CO2 Sensor ............................................................................................................... 117 Description of EtCO2 Menu Functions ............................................................................................... 119 TEMPERATURE MONITORING ............................................................................................................... 121 General .............................................................................................................................................. 121 Theory of Operation........................................................................................................................... 121 Setup Connections ............................................................................................................................ 121 Description of Temperature Menu Functions..................................................................................... 122 IBP MONITORING .................................................................................................................................... 123 General .............................................................................................................................................. 124 Theory of Operation........................................................................................................................... 124 Setup Connections ............................................................................................................................ 124 Description of IBP 1 Menu Functions ................................................................................................ 125 Description of IBP 2 Menu Functions ................................................................................................ 126 SELF-TEST FUNCTION ........................................................................................................................... 129 General .............................................................................................................................................. 129 Functions to be tested in Self-test ..................................................................................................... 130 Self-test result transmission (if configured with Wireless module option) ......................................... 130 Self-test result printing ....................................................................................................................... 130 External shock test ............................................................................................................................ 131 Trouble shooting ................................................................................................................................ 131 EVENT ....................................................................................................................................................... 133 ii

General .............................................................................................................................................. 133 Event Data List Display ..................................................................................................................... 133 Event Review Display ........................................................................................................................ 134 12 Lead Record Display .................................................................................................................... 135 ID# ..................................................................................................................................................... 135 MENU STRUCTURE ................................................................................................................................. 137 PRINTING ................................................................................................................................................. 153 General .............................................................................................................................................. 153 Printer Settings .................................................................................................................................. 153 Print-Out ............................................................................................................................................ 154 EXTERNAL INTERFACE .......................................................................................................................... 157 General .............................................................................................................................................. 157 USB Host Type .................................................................................................................................. 157 SD Memory Card ............................................................................................................................... 157 Central System Communication ........................................................................................................ 157 MAINTENANCE ........................................................................................................................................ 159 Recycling and Disposal ..................................................................................................................... 159 Returning the defibrillator/monitor and System Components............................................................ 160 Service ............................................................................................................................................... 160 Periodic Safety Checks ..................................................................................................................... 160 Cleaning ............................................................................................................................................ 160 Battery Maintenance.......................................................................................................................... 161 Loading Printer Paper ....................................................................................................................... 162 TROUBLESHOOTING .............................................................................................................................. 163 General .............................................................................................................................................. 163 Obtaining Technical Assistance ......................................................................................................... 163 EMI (Electromagnetic Interference)................................................................................................... 164 FACTORY DEFAULTS .............................................................................................................................. 167 General .............................................................................................................................................. 167 Parameter Ranges and Default Settings ........................................................................................... 167 SPECIFICATION ....................................................................................................................................... 175 Display ............................................................................................................................................... 175 Controls ............................................................................................................................................. 175 Alarms ............................................................................................................................................... 175 Physical Characteristics and Printer.................................................................................................. 175 Electrical ............................................................................................................................................ 176 Environmental Conditions.................................................................................................................. 177 Tone Definition ................................................................................................................................... 178 Measurement Parameters ................................................................................................................. 179 Event ................................................................................................................................................. 185 Defibrillator (Technical Specification)................................................................................................. 186 Compliance ........................................................................................................................................ 201 Manufacturer’s Declaration ............................................................................................................... 205

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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.................................................................................................................. 30 Figure 9. Battery Placement ........................................................................................................................ 34 Figure 10. Mode Select Knob ...................................................................................................................... 38 Figure 11. Select Date/Time Menu .............................................................................................................. 39 Figure 12. Setup: Display mode Menu ........................................................................................................ 40 Figure 13. Normal Screen (4 waveform, Defibrillation mode, Full option) .................................................. 40 Figure 14. Large Numeric Screen (2 waveform, Monitor mode, Full option) .............................................. 41 Figure 15. Black-yellow Screen (4 waveform, Defibrillation mode, Full option) .......................................... 41 Figure 16. Volume Menu Display ................................................................................................................ 43 Figure 17. Alarm Limit Menu ....................................................................................................................... 49 Figure 18. Standard 3 Electrode Placement ............................................................................................... 54 Figure 19. 5 Electrode Placement ............................................................................................................... 55 Figure 20. Varying choice of baselines. ...................................................................................................... 58 Figure 21. Baseline at the level of QRS onset as used by the Glasgow program. ..................................... 58 Figure 22. Illustration of isoelectric segments I and K. ............................................................................... 58 Figure 23. Definitions for QRS end / ST junction ........................................................................................ 59 Figure 24. 12 lead Placement ..................................................................................................................... 60 Figure 25. Measurement Reference............................................................................................................ 61 Figure 26. 12-Lead ECG Preview Screen ................................................................................................... 63 Figure 27. HR/PR Display ........................................................................................................................... 64 Figure 28. ECG Waveform Display ............................................................................................................. 64 Figure 29. HR/PR Menu .............................................................................................................................. 64 Figure 30. AED Mode Menu ........................................................................................................................ 74 Figure 31. Patient Info: ID Menu ................................................................................................................. 74 Figure 32. Manual Mode Screen ................................................................................................................. 76 Figure 33. Manual Mode Menu ................................................................................................................... 79 Figure 34. Setup Menu ................................................................................................................................ 81 Figure 35. Alarm Limit Menu ....................................................................................................................... 82 Figure 36. Patient Info: ID Menu ................................................................................................................. 83 Figure 37. Monitor Mode Menu ................................................................................................................... 85 Figure 38. Setup Menu ................................................................................................................................ 87 Figure 39. Alarm Limit Menu ....................................................................................................................... 88 Figure 40. Patient Info: ID Menu ................................................................................................................. 89 Figure 41. Pacing mode screen .................................................................................................................. 92 Figure 42. Pacing Mode Menu .................................................................................................................... 93 Figure 43. Setup Menu ................................................................................................................................ 95 Figure 44. Alarm Limit Menu ....................................................................................................................... 96 Figure 45. Patient Info: ID Menu ................................................................................................................. 96 Figure 46. NIBP Display ............................................................................................................................ 102 Figure 47. NIBP Menu Display .................................................................................................................. 102 Figure 48. Oxyhemoglobin Dissociation Curve ......................................................................................... 107 Figure 49. SpO2 Display ........................................................................................................................... 109 Figure 50. SpO2 Waveform Display .......................................................................................................... 109 Figure 51. SpO2 Menu Display .................................................................................................................. 109 Figure 52. Respiration Display .................................................................................................................. 113 Figure 53. Respiration Waveform Display ................................................................................................. 113 Figure 54. Respiration Menu Display ........................................................................................................ 113 Figure 55. Connection for mainstream ...................................................................................................... 117 iv

Figure 56. Connection for sidestream ....................................................................................................... 118 Figure 57. EtCO2 Display .......................................................................................................................... 119 Figure 58. EtCO2 Waveform Display ......................................................................................................... 119 Figure 59. EtCO2 Menu Display ................................................................................................................ 119 Figure 60. Temperature Display ................................................................................................................ 122 Figure 61. Temperature Menu Display ...................................................................................................... 122 Figure 62. IBP connections ....................................................................................................................... 124 Figure 63. IBP 1 Display ............................................................................................................................ 125 Figure 64. IBP 1 Waveform Display .......................................................................................................... 125 Figure 65. IBP 1 Menu Display .................................................................................................................. 125 Figure 66. IBP 2 Display ............................................................................................................................ 126 Figure 67. IBP 2 Waveform Display .......................................................................................................... 126 Figure 68. IBP 2 Menu Display .................................................................................................................. 126 Figure 69. External shock test ................................................................................................................... 131 Figure 71. Event Data List Display ............................................................................................................ 133 Figure 72. Event Review Display .............................................................................................................. 134 Figure 73. 12 Lead Record Display ........................................................................................................... 135 Figure 74. Patient Info Menu ..................................................................................................................... 135 Figure 75. Printer setting Menu ................................................................................................................. 153 Figure 76. Print-out .................................................................................................................................... 154 Figure 77. Print-out on shock .................................................................................................................... 154 Figure 78. Print-out on 12 lead ECG data ................................................................................................. 154 Figure 79. Print-out on setting information ................................................................................................ 155 Figure 80. Printer Paper Replacement ...................................................................................................... 162 Figure 81. Biphasic Waveforms at 300 Joules and 360 Joules ................................................................ 190 Figure 82. Biphasic Waveforms at 200 Joules .......................................................................................... 190 Figure 83. Biphasic Waveforms at 175 Joules .......................................................................................... 191 Figure 84. Biphasic Waveforms at 150 Joules .......................................................................................... 191 Figure 85. Biphasic Waveforms at 125 Joules .......................................................................................... 192 Figure 86. Biphasic Waveforms at 100 Joules .......................................................................................... 192 Figure 87. Biphasic Waveforms at 75 Joules ............................................................................................ 193 Figure 88. Biphasic Waveforms at 50 Joules ............................................................................................ 193 Figure 89. Biphasic Waveforms at 40 Joules ............................................................................................ 194 Figure 90. Biphasic Waveforms at 30 Joules ............................................................................................ 194 Figure 91. Biphasic Waveforms at 20 Joules ............................................................................................ 195 Figure 92. Biphasic Waveforms at 10 Joules ............................................................................................ 195 Figure 93: Biphasic Waveforms at 9 Joules .............................................................................................. 196 Figure 94. Biphasic Waveforms at 8 Joules .............................................................................................. 196 Figure 95. Biphasic Waveforms at 7 Joules .............................................................................................. 197 Figure 96. Biphasic Waveforms at 6 Joules .............................................................................................. 197 Figure 97. Biphasic Waveforms at 5 Joules .............................................................................................. 198 Figure 98. Biphasic Waveforms at 4 Joules .............................................................................................. 198 Figure 99. Biphasic Waveforms at 3 Joules .............................................................................................. 199 Figure 100. Biphasic Waveforms at 2 Joules ............................................................................................ 199 Figure 101. Biphasic Waveforms at 1 Joules ............................................................................................ 200

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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 ..................................................................................... 34 Table 9. The defibrillator/monitor Battery Status Icon ................................................................................. 35 Table 10. Date/Time Menu .......................................................................................................................... 39 Table 11. High Priority Alarm ....................................................................................................................... 44 Table 12. Medium Priority Alarm ................................................................................................................. 44 Table 13. Low Priority Alarm ........................................................................................................................ 45 Table 14. Informative Messages ................................................................................................................. 46 Table 15. Defibrillator Messages ................................................................................................................. 47 Table 16. Visual Alarm Characteristics ........................................................................................................ 48 Table 17. Audible Alarm Characteristics ...................................................................................................... 48 Table 18. Alarm Limits Ranges .................................................................................................................... 50 Table 19. Bell Icon ....................................................................................................................................... 52 Table 20. ECG Lead Colors......................................................................................................................... 55 Table 21. ECG Lead Pairs ........................................................................................................................... 55 Table 22. Measurement Matrix .................................................................................................................... 62 Table 23. HR/PR Menu................................................................................................................................ 64 Table 24. AED Mode Menu ......................................................................................................................... 74 Table 25. Manual Mode Menu ..................................................................................................................... 79 Table 26. Manual Mode Menu ..................................................................................................................... 85 Table 27. Pacing Mode Menu ...................................................................................................................... 93 Table 28. Cuff Size .................................................................................................................................... 101 Table 29. NIBP Menu................................................................................................................................. 102 Table 30. SpO2 Sensors ........................................................................................................................... 108 Table 31. SpO2 Menu................................................................................................................................ 109 Table 32. Respiration Menu....................................................................................................................... 113 Table 33. EtCO2 Menu ............................................................................................................................... 119 Table 34. Temperature Sensors ................................................................................................................ 121 Table 35. Temperature Menu..................................................................................................................... 122 Table 36. IBP 1 Menu ................................................................................................................................ 125 Table 37. IBP 2 Menu ................................................................................................................................ 127 Table 38. Self-test functions ...................................................................................................................... 130 Table 39. Trouble shooting of Self-test ...................................................................................................... 131 Table 40. Parameter Ranges and Factory Defaults .................................................................................. 167 Table 41. Delivered Energy at Every Defibrillator Settings into a Range of Loads ................................... 189 Table 42. Electromagnetic Emissions (IEC60601-1-2) ............................................................................. 205 Table 43. Electromagnetic Immunity (IEC60601-1-2) ............................................................................... 205 Table 44. Electromagnetic Immunity (IEC60601-1-2) ............................................................................... 206 Table 45. Electro-surgical Unit Interference (IEC60601-2-27, IEC-60601-2-30) ...................................... 207 Table 46. Recommended Separation Distances ....................................................................................... 207 Table 47. Cables (IEC60601-1-2) .............................................................................................................. 208

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SAFETY INFORMATION General Safety Information This section contains important safety information related to general use of the VidaStat DM defibrillator/ monitor . Other important safety information appears throughout the manual.The VidaStat DM 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 are identified by the WARNING symbol shown above. Warnings alert you to potential serious outcomes (death, injury, or adverse events) to the patient or user. WARNING: Do not take or use the defibrillator/monitor in locations where highly combustible anesthetics or flammable gases are used or in high-pressure 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. WARNING: When using the defibrillator/monitor with anesthetics, nitrous oxide or high concentrations of oxygen, connect the gas outlet to a scavenger system. WARNING: 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. WARNING: Do not connect grounding wire to gas pipes. This could cause fire. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: Do not take mobile phones or transceivers into a room where this defibrillator/monitor is installed, as such devices may cause accidents. WARNING: In order to avoid accidents, do not use any unauthorized accessories or options.

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WARNING: 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. WARNING: 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. WARNING: Do not use power source other than the specified voltage, (100240V~50/60Hz) as this may cause fire or electric shock. WARNING: Pre-use inspection and preventive maintenance must be performed for safe use. WARNING: The defibrillator/monitor may be used with electrical surgical equipment. 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. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: Do not place heavy objects on the power cord, as doing so may cause fire or electric shock. WARNING: Before conducting maintenance work, turn the power off and unplug the power cord from the wall socket to prevent electric shock. WARNING: 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. l There is smoke or a strange odor leaking out of the defibrillator/monitor. l The defibrillator/monitor has been dropped or impacted by an object. l Liquid or foreign matter gets inside the defibrillator/monitor.

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l 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 wall socket. 2. 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.

WARNING: Do not connect more than one patient to the defibrillator/monitor. Do not connect more than one defibrillator/monitor to a patient. WARNING: The defibrillator/monitor is a prescription device and is to be operated by qualified personnel only. WARNING: As with any medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: 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. WARNING: Do not make any clinical judgments based on this defibrillator/monitor’s measurement only. WARNING: 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). WARNING: 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. WARNING: 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. WARNING: 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 patchers, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating energy away from the heart muscle. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: Conductive gel on the paddle handles can allow the electrical energy to be discharged through the operator during defibrillation. Completely clean the paddle electrode surfaces, handles, and storage area after defibrillation.

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WARNING: 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. WARNING: During defibrillation checks, the discharged energy passes through the cable connectors. Securely attach cable connectors to the simulator. WARNING: 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. WARNING: The defibrillator/monitor should be out of contact with water (puddles or water spray). It may cause electrical shocks and device failure. Electrical safety of the defibrillator/monitor may not work properly when wet. WARNING: Defibrillation may cause implanted devices to malfunction. Place standard paddles or pads away from implanted devices if possible. Check implanted device function after defibrillation. WARNING: 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. WARNING: To ensure patient electrical isolation, connect only to other equipment with circuits that are electrically isolated. WARNING: To avoid risk of electric shock, the device must only be connected to a supply mains with protective earth. WARNING: 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. WARNING: 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. WARNING: Check leakage levels prior to use. Leakage current may be excessive if more than one monitor or other piece of equipment is connected to the patient. WARNING: Do not place or use the device 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 device near the place of a gasoline or other volatile substances spill may cause an explosion. WARNING: Do not disassemble the defibrillator. It contains no operator serviceable components and dangerous high voltages may be present. Contact authorized service personnel for repair. WARNING: 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.

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WARNING: 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. WARNING: Check leakage levels prior to use. Leakage current may be excessive if more than one monitor or other piece of equipment is connected to the patient. WARNING: 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 DRE recommended data transmission cables. For more information, contact DRE Technical Support. WARNING: 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. WARNING: Electric shock hazards exist internally. Do not remove assembly screws. Refer servicing to qualified personnel. WARNING: 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 oxmeter sensors. Consuit the MRI manufacturer for more information. WARNING: Medical electrical equipment which does not incorporate defibrillator protection should be disconnected during defibrillation. WARNING: 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

Cautions are identified by the CAUTION symbol shown above. Caution statements identify conditions or practices that could result in damage to the equipment or other property.

CAUTION: Always check that the defibrillator/monitor functions properly and is in proper condition before use. CAUTION: Federal law restricts this device to sale by or on the order of a physician. CAUTION: 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. CAUTION: 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. CAUTION: 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 DRE Technical Support Representative. CAUTION: Risk of explosion if battery is replaced by an incorrect type. CAUTION: 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.

12

INTRODUCTION WARNING: 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 VidaStat DM 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, 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

Contraindications

Manual Defibrillation

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.

Automated External Defibrillation

AED mode is to be used only on patients of at least 8 years of age in cardiopulmonary arrest. The patient must be unconscious, pulseless, and not breathing normally before using the defibrillator to analyze the patient’s ECG rhythm. External pacing is indicated for symptomatic bradycardia in patients with a pulse. Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.

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. 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 contraindicated for the treatment of ventricular fibrillation and asystole. External pacing in the presence of severe hypothermia may be contraindicated and is 13

Electrocardiography

Noninvasive Blood Pressure

Pulse Oximetry

Invasive Pressure

Blood

End-Tidal CO2

Temperature

14

The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection. 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. Pulse oximetry monitoring is intended to be used to monitor functional arterial oxygen saturation and pulse rate. 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. 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. Temperature monitoring is indicated for use in patients who require continuous monitoring of body temperature.

contraindicated for use on neonates. No known contraindications

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 is not intended for use with severe peripheral vascular disease and severe anemia (decreased Hemoglobin). No known contraindications

No known contraindications

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 VidaStat DM Configurations The following table identi fies VidaStat DMdefibrillator/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 D500O-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, 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 (Mainstream) 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

32

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

17

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.

18

Top Panel Components 1

2

3

4

5

Figure 2. Top panel components 1 2 3

Symbols

Paddle Energy level button REC button

4 SHOCK button 5 CHARGE button

Table 2. The defibrillator/monitor controls on paddle Description CHARGE button charges to the desired energy level automatically. 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

21

Symbols

Table 3. Panel and Label Symbols Description Symbols Description AC indicator

Dust and water resistance

Direct current

CE mark

Battery indicator

charging

Consult Instructions for use

Service indicator

Separate Collection

Type BF- Defibrillator Proof

EU representative

Type CF- Defibrillator Proof

Manufacturer

NIBP connector

Date of manufacture

Temperature 1 connector

Reference number

Temperature 2 connector

Serial number

IBP 1 connector

Environmental shipping/storage altitude limitations

IBP 2 connector

Environmental shipping/storage humidity limitations

EtCO2 connector

Environmental shipping/storage temperature limitations

SpO2 conector

Fragile

ECG connector

Keep dry

AC power input rating

This way up

Equipotential terminal

Single patient use only

Class II equipment

22

status

Displays 1

2

3 4

5

6

11 7 8

9

10

12

13

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 Title of waveform parameter

8 9 10 11 12 13

Waveform area Waveform Alarm/Informative message area Numerical area Date/Time Soft key menu

23

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

Shock count number / icon

NIBP icon : Noninvasive Blood Pressure

Elapsed time (Power on) icon

SpO2 waveform icon

Neonatal icon

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

DC power input icon Battery status icon AC power input icon

IBP1 waveform icon

Time display

IBP1 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

IBP2 waveform icon

ECG gain

Temperature 1 icon Temperature 2 icon

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

Table 5. Display Colors Factory Defaults Function ECG Waveform SpO2 Waveform Respiration Waveform EtCO2 Waveform ECG NIBP SpO2 Respiration Rate EtCO2 Temperature1 Temperature2 IBP 1 IBP 2 General background Alarm/Informative message Defibrillator message Low priority alarm message Medium priority alarm message High priority alarm message Battery status icon (normal) Battery status icon (low battery)

Color Green Cyan Light Blue Light Purple Green White Cyan Light Blue Light Purple Pink Pink Red Yellow Black Black background, Green font Black background, White font Black background, Yellow font Black background, Yellow font Black background, Red font White Yellow or Red (refer to Table 8)

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 WARNING: To ensure accurate performance and prevent device 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. WARNING: 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. WARNING: Make sure that the defibrillator/monitor speaker is not obstructed. Failure to do so could result in an inaudible alarm tone. CAUTION: Recharging the battery is strongly recommended when the battery has not been recharged for 6 or more months. CAUTION: Follow local government ordinances and recycling instructions regarding disposal or recycling of defibrillator/monitor components, including batteries. CAUTION: The use of accessories, cables, transducers and sensors sourced from manufacturers, which DRE has not recommended may cause incorrect analysis. CAUTION: 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 DRE 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

VidaStat DM defibrillator/monitor Operator’s manual AC power cord Printer paper Defibrillation pads for adult Defibrillation pads for pediatric Pads extension cable ECG 3 leads cable (SNAP) SpO2 sensor *Only when SpO2 option is installed.

Qty 1 1 1 2 1 1 1 1 1

SpO2 extension cable

1

NIBP cuff for adult

1

NIBP cuff for pediatric

1

NIBP cuff hose for adult and pediatric

1

CAPNOSTAT 5 mainstream CO2 sensor

1

*Only when SpO2 option is installed. *Only when NIBP option is installed. *Only when NIBP option is installed. *Only when NIBP option is installed. *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

Single patient use neonatal airway adapter

box/1ea

Cable holding clips

box/5ea

*Only when CO2 option is installed. *Only when CO2 option is installed. *Only when CO2 option is installed.

SMPS Li-ion battery

28

1 1

Optional items may be ordered if needed. Contact your local supplier for pricing and ordering information. Table 7. Optional Accessories Items External paddle for pediatric Paddle plate for adult Defibrillation / external pacing pads for adult Defibrillation / external pacing pads for pediatric 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

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 WARNING: Do not connect to an electrical outlet controlled by a wall switch or dimmer because the defibrillator/monitor may be accidentally turned off. CAUTION: If the integrity of the AC power source is defibrillator/monitor must be operated from its internal battery.

in

doubt,

the

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. Connect the female type connector end of the AC power cord to mains connector on the defibrillator/monitor’s rear panel. 2. Plug the male type connector end of the AC power cord into a properly grounded mains outlet. 3. 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. 4. 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. 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

30

1. Connect an external DC-DC adaptor (input: 12-16 Vdc output: 18Vdc) to defibrillator/monitor rear panel connecter identified with the DC power symbol. 2. 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 an external DC jack. 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.

Measurement Cable Connections WARNING: For best product performance and measurement accuracy, use only accessories supplied or recommended by DRE. 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. WARNING: Connect the sensor, probe, cuff/hose or transducer firmly into socket and do not use a damaged sensor, probe or cuff/hose. WARNING: To avoid damage to the cable, always hold by the connector rather than the cable, when connecting or disconnecting either end. WARNING: 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)

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Defibrillator Paddle and Pads 1. Connect a paddle or pads to paddle / pads connector on the defibrillator/monitor’s front panel. (see Figure 1) 2. Use LEAD button to select pads. (If paddle is connected, the mode is automatically changed to paddle.) 3. Apply conductive material to paddles. 4. Apply paddles or pads to patient’s bare skin. NIBP Hoses and Cuffs (if configured with NIBP option) 1. Select an appropriate size cuff for the patient. (Refer to the NIBP Monitoring section.) 2. Connect the hose to the NIBP connector making sure to tighten the connector in the clockwise direction. (see Figure 1) 3. Attach the cuff to the end of the hose. SpO2 Cables and Sensors (if configured with SpO2 option) 1. Select an appropriate sensor for the patient and desired application. (Refer to the SpO2 Monitoring section.) 2. Connect the extension cable to the SpO2 connector on the defibrillator/monitor’s front panel. (see Figure 1) 3. Attach the sensor to the end of the cable. Temperature Probes (if configured with Temperature option) 1. Select the appropriate probe(s) for the desired application. (Refer to the Temperature Monitoring section.) 2. 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. Select the appropriate CO2 sensor according to the operational mode. (Refer to the Capnography Monitoring section.) 2. Connect Mainstream or Sidestream sensor to the CO2 connector on the defibrillator/monitor’s side option case. (see Figure 1) IBP Transducers (if configured with IBP option) 1. 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) 2. 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 WARNING: 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. WARNING: DRE has no information regarding the performance or effectiveness of its DRE 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 DRE ’s battery or battery charger. WARNING: 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. CAUTION: Recharging the battery is strongly recommended when it has not been fully recharged for 6 or more months. CAUTION: Do not install the battery into the defibrillator/monitor when storage may exceed 90 days. Battery damage may occur. CAUTION: When the voltage of the battery is very low, it is a possibility of not operating. CAUTION: Check for the battery-in-use indication when the defibrillator/monitor is operating on mains and apply corrective action. CAUTION: Do not operate the defibrillator/monitor without a battery. Keep a fully charged spare battery pack with the defibrillator/monitor at all times. CAUTION: Partial charge of battery results in a shortened service life. CAUTION: Storing at temperatures above 40°C (104°F) for extended periods of time will significantly reduce a battery’s life-expectancy. CAUTION: Using an improperly maintained battery to power the defibrillator/monitor may cause power failure without warning. Use the appropriate battery charger to charge batteries. CAUTION: 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. CAUTION: When storing the defibrillator/monitor for an extended period of time, the battery should be removed from the defibrillator/monitor. CAUTION: 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.

33

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.

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

34

Front Panel Indications Battery charge icon is displayed on the screen. AC/DC in LED is lit. Battery charge icon is displayed on the screen. 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: l l l l l

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.

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 White (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 WARNING: Each time the defibrillator/monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. WARNING: 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. WARNING: 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. WARNING: Be aware of patient cables, including ECG monitoring equipment when used with high frequency surgical equipment. WARNING: 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. WARNING: 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. WARNING: Pediatric defibrillation energy levels should be set based on sitespecific clinical protocols. WARNING: 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. WARNING: Place the patient on a firm surface before performing CPR. WARNING: 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. WARNING: Pitted or damaged paddles may cause patient skin burns during defibrillation. WARNING: The ECG rhythm analysis function does not warn the operator of patient asystole, as it is not a shockable rhythm. WARNING: Determination of electrical capture should only be performed by viewing the ECG on the screen with its ECG cable directly attached to the patient. WARNING: 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. 37

CAUTION: The defibrillator does not automatically adjust energy when using pediatric electrodes. Manually select the appropriate energy prior to defibrillating the patient. CAUTION: 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 to disarm itself. CAUTION: Do not discharge the defibrillator except as indicated in the instructions. CAUTION: 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. CAUTION: 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. CAUTION: If using defibrillation pads, make sure that the size of the pad is large enough to cover the entire paddle electrode area. CAUTION: Pads should be replaced after 8 hours of continuous pacing to ensure maximum patient benefit. CAUTION: Be sure to safely discharge external paddles.

Turning on the defibrillator/monitor Before using the defibrillator/monitor, confirm that the defibrillator/monitor is working properly and is safe to use as described below. CAUTION: 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 Ÿ AED mode - to enable AED mode for semi-automated external defibrillation. Ÿ Manual mode - to enable manual mode for asynchronous or synchronous defibrillation. Ÿ 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. Ÿ Pacing mode - to enable pacing mode for demand (sync) or fixed mode pacing. Note: Monitor mode can be used in each mode.

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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. When the soft key is pressed, the relevant Menu will appear. Rotate and press the Multi function knob to change the desired format or number.

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 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. 39

Setting the Main Screen You may select the main screen to be displayed; 4 waveform screen, large numeric screen or Black-yellow invert screen. 1. Press Setup soft key to change main screen (4 waveform screen) to large numeric screen or black-yellow invert screen. 2. Select Display mode menu. Display mode menu will be displayed on screen. 3. Rotate and press the Multi function knob to change the desired display mode. Note: Large numeric screen can only be selected in monitor mode.

Figure 12. Setup: Display mode Menu ü

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

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

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ü

Large Numeric Screen

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

Black-yellow Invert Screen (Mono-color screen)

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

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ALARMS AND LIMITS WARNING: Each time the defibrillator/monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. WARNING: 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. WARNING: Always respond immediately to a system alarm since the patient may not be monitored during certain alarm conditions. CAUTION: 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: l l l

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. Select the Setup soft key and then the Setup menu will be displayed. 2. Rotate the Multi function knob to highlight Volume and then press the Multi function knob to select Volume Menu. 3. Rotate the Multi function knob to highlight desired menu. 4. Selected menu is activated by pressing the Multi function knob. 5. Rotate the Multi function knob to adjust the volume. 6. Press the Multi function knob to save the desired volume and to select the other menu. 7. Press the Return soft key. Then the current menu returns to the previous menu.

Figure 16. Volume Menu Display 43

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

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

NIBP

Resp IBP

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Technical Alarm Message 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 Low Systolic blood pressure limits violated Low Diastolic blood pressure limits violated Low MAP blood pressure limits violated High Respiration Rate limits violated Low Respiration Rate limits violated IBP Over the systolic upper limit

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

Parameter

Technical Alarm Message Condition

IBP Under the systolic lower limit

IBP Over the diastolic upper limit

IBP Under the diastolic lower limit

IBP Over the mean upper limit

IBP Under the mean lower limit

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

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) 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

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

Temp

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

NIBP

IBP

Overpressure Artifact Artifact Time-Out Failed in zero calibration

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 {label}: Unable to zero calibration.

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Technical Alarm Message Condition

Parameter

Messages

(ex. {label}: P1, P2, ABP, CVP, PAP, LAP) Out of range

{label}: Out of range. (ex. {label}: P1, P2, ABP, CVP, PAP, LAP)

Cable/Sensor disconnected.

{label}: Cable/Sensor disconnected. (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 EtCO2 : Adapter Calibration Failed EtCO2 : Check Adapter SYSTEM : Printer out of paper SYSTEM : Low Battery

SpO2 - Technical Error

%SpO2

Resp

EtCO2

System

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 Adapter Calibration Failed Check Adapter Printer out of paper Low Battery

Informative Messages Informative messages indicate a system condition that needs to be corrected.

Condition

Table 14. Informative Messages Messages

SpO2 Pulse search SpO2 Motion interference IBP No zero reading

SpO2 : Pulse search SpO2 : Motion interference

IBP Zero cal in progress

{label}: Zero cal in progress (ex. {label}: P1, P2, ABP, CVP, PAP, LAP) SYSTEM : Abnormally shut down last time SYSTEM : Audio off SYSTEM : Demo Mode SYSTEM : Printer is not available SYSTEM : Not enough memory SYSTEM : Not enough memory(Internal memory)

Abnormally shut down last time Audio Off Demo Mode Printer is not available Not Enough Memory Not Enough Memory(Internal Memory)

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

Note: There may be other informative messages that are not listed above.

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

Press Paddle Shock button Shock Delivered It is Safe to touch the patient Begin CPR Press Charge button Disable Sync 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

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 Analyzing heart rhythm (Voice prompt: Analyzing heart rhythm.) Do not touch the patient (Voice prompt: 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 Delivered (Voice prompt: Shock Delivered.) It is Safe to touch the patient (Voice prompt: It is Safe to touch the patient.) Begin CPR (Voice prompt: Begin CPR.) Press Charge button Disable Sync 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

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Condition

Messages

Pacing Paused

Pacing Paused

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 WARNING: Do not turn off the audible alarm or decrease its volume if patient safety could be compromised. WARNING: 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 as described in Table 14 or temporarily paused.

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. Connect the defibrillator/monitor to an AC power source. 2. Rotate the Mode select knob to turn on the defibrillator/monitor. 3. 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. 48

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 WARNING: Each time the defibrillator/monitor is used, check alarm limits to make sure that they are appropriate for the patient being monitored. WARNING: 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. CAUTION: 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: l l

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. Soft key is displayed on the lower of the normal screen. (Refer to figure 13.) 2. Press the Alarm Limit soft key located lower right corner of the screen. 3. Select the parameter menu to be changed by pressing the Multi function knob.

Figure 17. Alarm Limit Menu

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4. Change the alarm limit by rotating the Multi function knob. 5. Selected parameter menu is returned to normal screen by pressing the Return soft key. 6. 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 (4.6 ~ 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 ~ 34.6 kPa, 14.6 kPa) 35 ~ 110 mmHg, 70 mmHg Neonatal (4.6 ~ 14.6 kPa, 9.3 kPa) SpO2 (%) 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 (32.2 ~ 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 (0.13 ~ 10.7 kPa, 10.7 kPa) (0 ~ 10.5 %, 10.5%) InCO2 (mmHg, kPa, %) 1 ~ 20 mmHg, 20 mmHg Adult/Pediatric (0.13 ~ 2.7 kPa, 2.7 kPa) (0.13 ~ 2.6 %, 2.6 %) P1 Systolic (mmHg, kPa) -45 ~ 300 mmHg, 120mmHg Adult/Pediatric (16.0 kPa) P1 MEAN (mmHg, kPa) -45 ~ 300 mmHg, 90 mmHg Adult/Pediatric (12.0 kPa) P1 Diastolic (mmHg, kPa)

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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 ~ 16.6 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 ~ 32.6 kPa, 6.6 kPa) 20 ~ 85 mmHg, 20 mmHg (2.6 ~ 11.3 kPa, 2.6 kPa)

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

20 ~ 255 mmHg, 60 mmHg (2.6 ~ 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)

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 (9.3 kPa)

5 mmHg (0.6 or 0.7 kPa)

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

5 mmHg (0.6 or 0.7 kPa)

Parameters

Upper Limit, Default

-45 ~ 300 mmHg, 70 mmHg Adult/Pediatric (9.3 kPa) P2 Systolic (mmHg, kPa) -45 ~ 300 mmHg, 120mmHg Adult/Pediatric (16.0 kPa) P2 MEAN (mmHg, kPa) -45 ~ 300 mmHg, 90 mmHg Adult/Pediatric (12.0 kPa) P2 Diastolic (mmHg, kPa) -45 ~ 300 mmHg, 70 mmHg Adult/Pediatric (9.3 kPa)

Lower Limit, Default

Resolution

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

5 mmHg (0.6 or 0.7 kPa)

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

5 mmHg (0.6 or 0.7 kPa)

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

5 mmHg (0.6 or 0.7 kPa)

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

5 mmHg (0.6 or 0.7 kPa)

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Audio Paused and OFF WARNING: Do not pause the audio or decrease its volume if patient safety could be compromised. WARNING: 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. WARNING: 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. WARNING: 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. 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. To initiate an audible alarm off, press the Alarm button and hold it for at least 2 seconds. 2. 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. 52

ECG MONITORING WARNING: For best product performance and measurement accuracy, use only accessories supplied or recommended by DRE. Use accessories according to the manufacturer’s directions for use and your facility’s standards. It may cause burns to the patients or device failure to use of pacing/defibrillation pads or adapters from sources other than DRE. WARNING: 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. WARNING: 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. WARNING: Do not use ECG electrodes with expired dates. Do not use defective ECG electrodes. These might cause improper performance. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: Correct the electrode placement. Improper electrode placement may cause incorrect result. User must be aware of proper device operation. WARNING: Use only high quality ECG electrodes. ECG electrodes are for rhythm acquisition only. Do not attempt to defibrillate or pace through ECG electrodes. WARNING: 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. WARNING: The defibrillator/monitor may be used in conjunction with and must not be damaged by typical electrosurgical equipment operation.

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: 53

l Heart rate in beats per minute l Detection of a “lead off” condition if an electrode is disconnected or poorly connected l Detection of the presence of pacemaker signals within the ECG waveform complex Note: Occasionally, electromagnetic interference beyond the range guaranteed from the manufacturer’s 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: DRE 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. Connect the ECG lead. 3. Connect the ECG lead to the ECG connector on the defibrillator/monitor’s front panel. 4. 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 WARNING: 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. WARNING: 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 overreading 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 34. 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.

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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. 58

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 mV. 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. 59

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. Attach the electrodes to the patient as above figure 24. 12 lead Placement. 2. Attach the 12 lead cable lead wires to the electrodes on the patient. 3. Attach the 12 lead cable to the defibrillator/monitor’s front panel. 4. Turn on the manual mode of defibrillator/monitor by rotating the Mode select knob to Manual Mode. 5. Enter patient information. 6. Check the patient’s pulse.

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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. l LEAD REVERSAL/DEXTROCARDIA l RESTRICTED ANALYSIS l MISCELLANEOUS PRELIMINARY STATEMENTS Measurement Parameter Measurement parameters are fundamentally obtained after ECG analysis. l HEART RATE l INTERVALS l ATRIAL ABNORMALITIES l QRS AXIS DEVIATION Results on QRS Wave Analysis Results on QRS wave analysis shows diagnosis results of QRS waveform and measurement values. l CONDUCTION DEFECTS WOLFF-PARKINSON-WHITE PATTERN BRUGADA PATTERN

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l 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. l MYOCARDIAL INFARCTION INFERIOR INFARCTION LATERAL INFARCTION ANTEROSEPTAL INFARCTION ANTERIOR INFARCTION SEPTAL INFARCTION POSTERIOR INFARCTION ANTEROLATERAL INFARCTION EXTENSIVE INFARCTION l ST ABNORMALITIES l ST-T ABNORMALITIES (ISCHAEMIA ETC). Rhythm Statements Rhythm statements includes diagnosis results according to occurrence of beats, etc. l DOMINANT RHYTHM l SUPPLEMENTARY RHYTHM 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 62

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.

Measurement STAMP 1/8STT 2/8STT 3/8STT T+AMP T-AMP QRSAR TMORPH RWNCH DWCON STSLOP TON

Meaning 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.

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, SpO2, 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

1 2 3 4

5

HR/PR icon HR/PR source icon Pacer pulse detection icon HR/PR unit

6

5 6 7

7

ECG size 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

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 64

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

HR/PR Source You may select Auto, HR, PR to decide the source of the heart rate or pulse rate. 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. When HR is selected, the heart rate (HR) is measured from ECG. When PR is selected, the pulse rate (PR) is measured from IBP, SpO2 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 “---”. The HR/PR tone volume can be adjusted in the Setup menu. 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 WARNING: 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. WARNING: The defibrillator/monitor should not be used on someone who is responsive when shaken or breathing normally. WARNING: 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. WARNING: Do not use pediatric 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. WARNING: Do not use paddles for AED mode. AED mode is enabled only with pads. WARNING: Disconnect non-defibrillation proof electronic devices or equipment from patient before defibrillation. WARNING: Do not administer a shock using the electrode monitoring cable. WARNING: 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. WARNING: The Adult pads must be used on patients over 8 years old. The Pediatric pads must be used on patients less than 8 years old or less than 25 kg (55lb). Do not use the defibrillator/monitor in AED mode on patient less than 1 years old. WARNING: 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. WARNING: 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: l unresponsive to stimulus, l not breathing, l 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 WARNING: 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. Confirm that the patient is: l unresponsive to stimulus, l not breathing, l exhibiting no signs of life. 2. 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. 3. Make sure the pads packaging is intact and within the expiration date shown. 4. Apply pads to the patient as directed on the pads package. Use the anterioranterior(anterior-lateral) pads placement. 5. 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.

Operating the AED Mode of defibrillator/monitor WARNING: 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. WARNING: 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 dried-out multifunction pads. CAUTION: 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.

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2010 AHA Guidelines for CPR and ECC The 2010 AHA Guidelines for CPR and ECC are based on the most current and comprehensive review of resuscitation literature ever published, the 2010 ILCOR International Consensus on CPR and ECC Science with Treatment Recommendations. Bystanders, first responders and healthcare providers all play key roles in providing CPR for victims of cardiac arrest. In addition, advanced providers can provide excellent periarrest and postarrest care. Note: The software may be upgraded and changed without notice because of the update of AHA guidance for CPR and ECC. Please contact sales/service representative for more information.

Major changes in the 2010 AHA Guidelines for CPR and ECC l The BLS algorithm has been simplified, and “Look, Listen and Feel” has been removed from the algorithm. Performance of these steps in inconsistent and time consuming. l Encourage Hands-only (compression only) CPR for the untrained lay rescuer. HandsOnly CPR is easier to perform by those with no training and can be more readily guided by dispatchers over the telephone. l Initiate chest compressions before giving rescue breaths. (Compression-AirwayBreathing rather than Airway-Breathing-Chest compressions) l There is an increased focus on methods to ensure that high-quality CPR is performed. Adequate chest compressions require that compressions be provided at the appropriate depth and rate, allowing complete recoil of the chest after each compression and an emphasis on minimizing any pauses in compressions and avoiding excessive ventilation.

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CPR Guidelines 2010

Person not responsive? No signs of life? Address person and shake on shoulder! Perform the CPR Call for help, get AED

Engage other people to help you and alternate CPR! Open the airway. Check for breathing!

Look, listen and feel

Note: “Look, listen and feel” is removed from the CPR sequence for assessment of breathing after opening the airway in 2010 guidelines. But 2010 guideline recommends that the healthcare provider briefly checks for breathing when checking responsiveness to detect signs of cardiac arrest.

Perform CPR until an AED is available or arrival of emergency physician 30 Compressions 2 Breaths UNTIL EMC ARRIVE 30/2 If the AED available, turn on and follow instructions ANALYSIS SHOCK DECISION YES Alternate with second person after one cycle or 2 minutes

NO

DELIVER SHOCK

Continue CPR for 2 minutes/ 5 cycles

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Using AED Mode 1. Turn on the AED Mode of defibrillator/monitor by rotating the Mode select knob. 2. Verify the AED Mode of defibrillator/monitor is activated normally and follow audio guidance and STEP icon. 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.

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.

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STEP 6

Press the SHOCK button now. Shock delivered.

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.

AHA 2010 Configuration  

It is safe to touch the patient. Begin CPR.

Use the metronome sound from the defibrillator/monitor in AED mode for compression rate – the defibrillator/monitor emits a tone corresponding at least more than 100 beats per minute (to current AHA guidelines). The defibrillator/monitor will remain in CPR mode for 2 minutes or 5 cycles. After 2 minutes of CPR you will hear the following voice prompt: 

Stop CPR.

The defibrillator/monitor in AED mode will then return to Step 4. Ensure that no-one is in contact with the patient and proceed as before.

Note Performing CPR When performing CPR watch and listen to the defibrillator/monitor, the Begin CPR will flash. The defibrillator/monitor emits 100 beeps per minute and Give two breaths. voice prompt as a guide to CPR. At least more than 100 beats per minutes is the recommended rate to perform compressions under AHA 2010 guidelines. Note: Your DRE 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 AED mode. 73

Description of AED Mode Menu Functions

Figure 30. AED Mode Menu

Level1 Menu Patient Info ID Name Age Gender Event records

Level 2 Menu or Response Confirm Confirm Confirm Male Female Data review ID#

Table 24. AED Mode Menu Level 3 Menu or Response

Level 4 Menu or Response

Print ID Name Age Gender

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 31. Patient Info: ID Menu More details for Data Review and ID# in Event Records menu, please refer to Event Section. 74

MANUAL MODE WARNING: 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). WARNING: Artifact introduced by paddle movement may resemble an R-wave and trigger a defibrillation shock when performing synchronized defibrillation (cardioversion). WARNING: Disconnect non-defibrillation-proof electronic devices or equipment from patient before defibrillation. WARNING: 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. CAUTION: Whenever possible, DRE 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.

Operating the Manual Mode of defibrillator/monitor 1. Select manual mode of defibrillator/monitor by rotating the Mode select knob. 2. 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 32. 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 do not press Select Energy Level button, 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 of pediatric patients. 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.

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. 3.1 Press the SHOCK button which is placed on the front side of defibrillator/ monitor. 3.2 Press the SHOCK button located on the external paddles

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.

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, 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: Clinicians must select an appropriate energy level for defibrillation of pediatric patients.

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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.

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. 5.1 Press the SHOCK button which is placed on the front side of defibrillator/ monitor. 5.2 Press the SHOCK button located on the external paddles The shock will be delivered when the next R-wave is detected.

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; 1. 2.

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.

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Description of Manual Mode Menu Functions

Figure 33. Manual Mode Menu Level 2 Menu or Response

Level1 Menu 12 Lead Acquire Setup

Filter

Table 25. Manual Mode Menu Level 3 Menu or Response

Level 4 Menu or Response

0.05Hz ~ 40Hz 0.05Hz ~ 150Hz

Transmission 12 lead ON Patient info

ID Name Age Gender 12 lead records

Setup Volume

Printer Setting

Alarm Beep Button Print on alarm Print on shock 12 lead auto printing

Erase data

Erase 12 lead records

Confirm Confirm Confirm Male Female Print Transmission ID #

ID Name Age Gender

On Off On Off On Off Yes 79

Level 2 Menu or Response

Level1 Menu

Erase event records Erase internal memory Waveform setting

nd

2 Waveform

rd

3 Waveform

th

4 Waveform

Level 3 Menu or Response No Yes No Yes No ECG SpO2 RESP IBP1 IBP2 EtCO2 ECG SpO2 RESP IBP1 IBP2 EtCO2 ECG SpO2 RESP IBP1 IBP2 EtCO2

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

Sync On Off 80

Large numeric display Black-yellow Invert Mode

(Display 3 digit code)

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

Print ID Name Age Gender

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

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

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 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 34. Setup Menu Volume The Volume options allow you to adjust the volume of Alarm, Beep and Button. Alarm volume can be set at level 1 to 8 and Beep volume and Button volume can be set at level 1 to 7 or Off. 1. Rotate the Multi function knob to highlight Alarm volume, Beep volume or Button volume. 2. Press the Multi function knob. Levels of Alarm volume, Beep volume or Button volume will appear. 3. Rotate the Multi function knob to select a volume level. 4. 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 shock, 12 lead auto printing or Analyze auto printing. 1. Rotate the Multifunction knob to highlight Printer on alarm, Print on shock, 12 lead auto printing or Analyze auto printing. 2. Press the Multifunction knob. Multifunction knob toggles between On and Off.

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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-yellow 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 3 digit code is required for access. Refer to the service manual for instructions. Alarm Limit

Figure 35. 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 36. Patient Info: ID Menu More details for Data Review and ID# in Event Records Menu, please refer to Event Section. Sync Press the Sync soft key to operate the sync mode.

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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 37. Monitor Mode Menu

Level 2 Menu or Response

Level1 Menu 12 Lead Acquire Setup

Filter

Table 26. Manual Mode Menu Level 3 Menu or Response

Level 4 Menu or Response

0.05Hz ~ 40Hz 0.05Hz ~ 150Hz

Transmission 12 lead ON Patient info

ID Name Age Gender 12 lead records

Confirm Confirm Confirm Male Female Print Transmission 85

Level 2 Menu or Response

Level1 Menu

Level 3 Menu or Response ID #

Setup Volume

Printer Setting

Alarm Beep Button Print on alarm Print on shock 12 lead auto printing

Erase data

Erase 12 lead records Erase event records Erase internal memory

Waveform setting

nd

2 Waveform

rd

3 Waveform

th

4 Waveform

On Off On Off On Off Yes No Yes No Yes No ECG SpO2 RESP IBP1 IBP2 EtCO2 ECG SpO2 RESP IBP1 IBP2 EtCO2 ECG SpO2 RESP IBP1 IBP2 EtCO2

Display Mode Clinical action list Manual selftest Button test Service menu Return Alarm Limit ▲ 86

Large numeric display Black-yellow Invert Mode

(Display 3 digit code)

Upper Alarm Limit

Level 4 Menu or Response ID Name Age Gender

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

Level1 Menu ▼ Patient Info ID Name Age Gender Event records

Level 2 Menu or Response Lower Alarm Limit Confirm Confirm Confirm Male Female Data review ID#

Level 3 Menu or Response

Level 4 Menu or Response

Print ID Name Age Gender

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 38. Setup Menu Volume The Volume options allow you to adjust the volume of Alarm, Beep and Button. Alarm volume can be set at level 1 to 8 and Beep volume and Button volume can be set at level 1 to 7 or Off. 1. Rotate the Multi function knob to highlight Alarm volume, Beep volume or Button volume. 2. Press the Multi function knob. Levels of Alarm volume, Beep volume or Button volume will appear. 87

3. Rotate the Multi function knob to select a volume level. 4. 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 shock, 12 lead auto printing or Analyze auto printing. 1. Rotate the Multifunction knob to highlight Printer on alarm, Print on shock, 12 lead auto printing or Analyze auto printing. 2. 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 Blackyellow 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 39. 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. 88

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 40. Patient Info: ID Menu More details for Data Review and ID# in Event Records Menu, please refer to Event Section.

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PACING MODE WARNING: Use demand mode (sync mode) pacing whenever possible. Use async mode pacing when motion artifact or other ECG noise makes R-wave detection unreliable. WARNING: Observe the patient continuously while the pacemaker is in use. Patient response to pacing therapy (for example, capture threshold) may change over time. WARNING: 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. WARNING: 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. WARNING: 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 re-activate the pacing function. WARNING: 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. WARNING: Use of other ECG monitoring devices may provide misleading information due to the presence of pace artifacts. WARNING: Under certain conditions it may not be possible to properly defibrillator/monitor or pace while electrosurgical apparatus is operating.

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.

Demand Mode (Sync Mode) and Async Mode The defibrillator/monitor can deliver pace pulses in either demand mode (sync mode) or Async mode. 1. In demand mode (sync mode), the defibrillator/monitor only delivers pace pulses when the patient’s heart rate is lower than the selected pacing rate. 2. In Async mode, the defibrillator/monitor delivers pace pulses at the selected rate. Note: Use demand mode (sync mode) pacing whenever possible. Use async 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. 91

Operating the Pacing Mode of defibrillator/monitor 1. Select the pacing mode of defibrillator/monitor by rotating the Mode select knob. 2. 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 41. Pacing mode screen

Demand Mode (Sync mode) Pacing When the pacing mode is turned on by rotating the Mode select knob, the demand mode (sync mode) operates automatically. 1. 2. 3. 4. 5. 6. 7.

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. Press and rotate 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. Press and rotate 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 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 (sync 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.

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Async Mode Pacing After the pacing mode is turned on by rotating the Mode select knob, press the Async soft key to operate the Async mode pacing. 1. 2. 3. 4. 5. 6. 7.

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. Press and rotate the Multi function knob to select the desired number 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. Press and rotate the Multi function knob to select the desired output. The value is changed by 2 mA. 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.

Description of Pacing Mode Menu Functions

Figure 42. Pacing Mode Menu

Level1 Menu Pause Pacing Setup Volume

Printer Setting Erase data

Level 2 Menu or Response

Alarm Beep Button Print on alarm

Table 27. Pacing Mode Menu Level 3 Menu or Response

Level 4 Menu or Response

On Off 93

Level1 Menu

Level 2 Menu or Response Print on shock 12 lead auto printing Erase 12 lead records

Erase data

Erase event records Erase internal memory Erase internal memory

Waveform setting

nd

2 Waveform

rd

3 Waveform

th

4 Waveform

Level 3 Menu or Response On Off On Off Yes No Yes No Yes No Yes No ECG waveform SpO2 waveform Respiration waveform IBP1 waveform IBP2 waveform EtCO2 waveform ECG waveform SpO2 waveform Respiration waveform IBP1 waveform IBP2 waveform EtCO2 waveform ECG waveform SpO2 waveform Respiration waveform IBP1 waveform IBP2 waveform EtCO2 waveform

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

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Black-yellow Invert Mode

(Display 3 digit code)

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

Print ID Name

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

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

Level1 Menu

Level 2 Menu or Response

Level 3 Menu or Response

Level 4 Menu or Response

Age Gender Async On Off 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 43. Setup Menu Volume The Volume options allow you to adjust the volume of Alarm, Beep and Button. Alarm volume can be set at level 1 to 8 and Beep volume and Button volume can be set at level 1 to 7 or OFF. 1. Rotate the Multifunction knob to highlight Alarm volume, Beep volume or Button volume. 2. Press the Multifunction knob. Levels of Alarm volume, Beep volume or Button volume will appear. 3. Rotate the Multi function knob to select a volume level. 4. 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 shock, 12 lead auto printing or Analyze auto printing. 1. Rotate the Multi function knob to highlight Printer on alarm, Print on shock, 12 lead auto printing or Analyze auto printing. 2. 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-yellow invert mode. Large numeric screen can only be selected in monitor mode.

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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. Alarm Limit

Figure 44. 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 45. Patient Info: ID Menu More details for Data Review and ID# in Event Records Menu, please refer to Event Section. Async Press the Async soft key to operate the Async mode pacing. 96

NIBP MONITORING WARNING: For best product performance and measurement accuracy, use only accessories supplied or recommended by DRE. Use accessories a ccording to the manufacturer’s directions for use and your facility’s standards. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: Ensure the patient is quiet with minimal movement during NIBP readings; minimize the patient’s shivering. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: Do not place the cuff over a wound as this could cause further injury when pressurized. WARNING: 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. WARNING: The application of the cuff to the arm on the same side as a mastectomy should be avoided. CAUTION: 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. CAUTION: Any excessive patient motion may cause inaccurate measurements of non-invasive blood pressure. Minimize motion to improve blood pressure measurements.

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CAUTION: 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. CAUTION: Make sure that heavy objects are not placed on the cuff hose. Avoid crimping or undue bending, twisting, or entanglement of the hose. CAUTION: 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. 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.

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.

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● Oscillometric Response (Pressure Pulses)

MAP Distole Systole

Systole

Distole

MAP

Systole

TIME

● Cuff Pressure

MAP Distole

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. DRE’s measurement technology utilizes a unique deflation technique, Dynamic Linear Deflation. This cuff deflation technique allows the DRE 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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Setup Connections 1. 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. 2. Connect the cuff hose to the connector on the defibrillator/monitor’s side option case and turn to right to lock (see Figure 2). 3. Connect a cuff to the cuff hose and turn the connector to right to lock the hoses together. Firm connection must be made. 4. Patient should be seated with back comfortably and arms supported. 5. Patient should have their legs uncrossed, feet flat on the floor with their back and arms supported. 6. 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. 7. 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. CAUTION: 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. CAUTION: Refrain from talking during the measurement procedure, and at least 5 minutes should elapse before the first reading is taken. 8. Maintain the height of the cuff-wrapped upper arm artery to that of the heart’s right ventricle during measurement. 9. 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.12 Cuff No.13 HEM-CS23 HXA-GCUFF-SSLA HXA-GCUFF-SLA HEM-CR23

Arm circumference (cm) 3.5 to 6 5.0 to 7.5 7.5 to 10.5 8.5 to 13 13 to 22 12 to 18 17 to 22 22 to 32

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Model Number HEM-CL23 HEM-CX23 HXA-GCUFF-MLA HXA-GCUFF-LLA HXA-GCUFF-XLLA

Arm circumference (cm) 32 to 42 42 to 50 22 to 32 32 to 43 42 to 50

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 46. NIBP Display

Figure 47. 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) OFF, Cont, 1, 2.5, 3, 5, 10, 15, 30, 60, 90 (min) Adult/Pedi Neonatal 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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SpO2 MONITORING WARNING: For best product performance and measurement accuracy, use only ® accessories manufactured by Nellcor or supplied by DRE. Use accessories according to the manufacturer’s directions for use and your facility’s standards. WARNING: 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. WARNING: 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. WARNING: 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 WARNING: Do not attach any cable to the sensor port connector that is intended for computer use. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: Do not rely solely on SpO2 reading: assess the patient at all times. SpO2 readings may be inaccurate in the presence of significant levels of carboxyhemoglobin or methemoglobin, in patients with restricted blood flow to the extremities (such as those in severe shock or hypothermia), or in the presence of excessive motion. WARNING: Failure to apply the sensor properly may reduce the accuracy of the SpO2 measurement. 105

WARNING: 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. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: 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. CAUTION: 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. CAUTION: 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 SpO2 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.

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

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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)

Measured versus Calculated Saturation When calculating saturation from a blood gas partial pressure of oxygen (PO2), 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 (PCO2), and 2,3-DPG, that shift the relationship between PO2 and SpO2.

Figure 48. Oxyhemoglobin Dissociation Curve 1 % Saturation Axis 2 PO2 (mmHg) Axis

6 Increased pH; Decreased temperature, PCO2, and 2,3-DPG 7 Decreased pH; Increased temperature, PCO2, and 2,3-DPG 107

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 DRE sales department for ordering information. 1. Select the proper sensor for the patient. 2. Connect the extension cable to the SpO2 connector on the defibrillator/monitor’s front panel and lock it. 3. Connect the sensor to the extension cable and lock it. 4. 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 TM Pedi-Check pediatric Spot Check clip (Reusable, non-sterile) D-YSPD ® OXIMAX MAX-FAST adhesive reflectance MAXoxygen transducer FAST

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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

Description of SpO2 Menu Functions 1 3 4

2

1 2

SpO2 icon Pulse amplitude indicator

3 4

SpO2 value Bell icon

Figure 49. SpO2 Display

1

2

1

SpO2 waveform icon

2

SpO2 waveform

Figure 50. SpO2 Waveform Display Pulse Amplitude Indicator The pulse amplitude indicator is the segmented display within the SpO2 numerical area that shows the relative strength of the detected pulse. A stronger pulse causes a larger amplitude indicator.

Figure 51. 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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RESPIRATION MONITORING WARNING: For best product performance and measurement accuracy, use only accessories supplied or recommended by DRE. Use accessories according to the manufacturer’s directions for use and your facility’s standards. WARNINGS: The defibrillator/monitor does not detect apnea when the respiration signal is measured by trans-thoracic impedance. WARNING: 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. CAUTION: 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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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.

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.

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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 52. Respiration Display

1

2

1

Respiration waveform icon

2

Respiration waveform

Figure 53. Respiration Waveform Display

Figure 54. Respiration Menu Display Table 32. Respiration Menu Level 1 Menu RESPIRATION MENU Respiration (Respiration Setting) RR Source Size Apnea time setting (Alarm Limit) ▲ ▼ (Limit Alarm Pause) Return

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

Respiration When respiration is set to On, The measurement value for respiration rate and respiration waveform are displayed on the screen. And when the respiration is set to Off, respiration rate is not measured and respiration value is displayed with “---”. Respiration rate icon is only displayed when the respiration is set to On. 113

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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CAPNOGRAPHY MONITORING WARNING: For best product performance and measurement accuracy, use only accessories supplied or recommended by DRE . 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. WARNING: The EtCO2 readings do not always correlate closely with blood gas values, especially in patients with pulmonary disease, pulmonary embolism or inappropriate ventilation. WARNING: 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. WARNING: The defibrillator/monitor should not be used as an apnea monitor. WARNING: To ensure patient safety, do not place the defibrillator/monitor in any position that might cause it to fall on the patient. WARNING: To ensure accurate performance and prevent device failure, do not expose the defibrillator/monitor to extreme moisture, such as rain. WARNING: 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. WARNING: CO2 readings and respiratory rate can be affected by sensor application errors, certain ambient environmental conditions, and certain patient conditions. WARNING: The defibrillator/monitor is a prescription device and is to be operated by qualified healthcare personnel only. WARNING: 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. WARNING: Ensure that selection of a volatile anesthetic is done carefully. If an improper selection is made, the measurement values may be incorrect. WARNING: Do not use accessories other than which are specified. Different sampling tube lengths or inside diameters may have an effect on the measurement. WARNING: 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. WARNING: Do not use device without rectifying a gas calibration failure, as correct measurement readings will not be obtained. WARNING: Do not use device on patients that cannot tolerate the withdrawal of 50 cc/min ±10cc /min from airway. WARNING: CO2 should not be measured in the presence of aerosolized pharmaceuticals. WARNING: Do not use a damaged airway adapter. CAUTION: In high-altitude environments, EtCO2 values may be lower than values observed at sea level, as described by Dalton's law of partial pressures. When using the defibrillator/monitor in high-altitude environments, it is advisable to consider adjusting EtCO2 alarm settings accordingly.

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CAUTION: Do not operate the Capnostat sensor when it is wet. Do not immerse the device in water. CAUTION: Do not operate the Capnostat sensor if it appears to have been damage or if it fails to operate properly. CAUTION: 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. CAUTION: 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. CAUTION: Do not insert any object other than the sidestream sample cell into the inlet port of the CO2 module. CAUTION: Inspect the mainstream CO2 sensor and airway adapter connection to ensure correct positioning. CAUTION: Position sidestream airway adapter with the tubing in an upright position. This help keep patient secretions from pooling into the tubing. CAUTION: 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. CAUTION: 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.

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 CO2 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 CO2 concentration in the sample. The CO2 sensor’s response to a known concentration of CO2 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. 116

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 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 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 CO2 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.

1 2 3

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

4 5

Elbow Mainstream CO2 sensor

Figure 55. Connection for mainstream 117

Sidestream Operation Sidestream monitoring uses an external, sidestream sensor that plug into the capnography port on the monitor. Adult, pediatric, or infant sampling lines are then plugged into the sensor receptacle. Respiration can be monitored for intubated or nonintubated 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 monitor. The other end of sampling line is connected to the patient either via a cannula or a sample-T, as shown in Figure 56.

1 2

Cannula Sampling cell

3 4

Sampling-T Sidestream CO2 sensor

Figure 56. Connection for sidestream

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Description of EtCO2 Menu Functions 5

1

6

2

7

3 4

1 2 3 4

EtCO2 icon EtCO2 value InCO2 icon InCO2 value

5 6 7

EtCO2 unit Bell icon InCO2 unit

Figure 57. EtCO2 Display

1

2

1

EtCO2 waveform icon

2

EtCO2 waveform

Figure 58. EtCO2 Waveform Display

Figure 59. EtCO2 Menu Display

Menu EtCO2 MENU EtCO2 EtCO2 Setting

Table 33. EtCO2 Menu Level 2 Menu or Response Level 3 Menu or Response On Off N2O Gas O2 Gas

Scale

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

Calibration 0 ~ 40 mmHg 0 ~ 60 mmHg 0 ~ 80 mmHg Auto

On Off On Off Enter

EtCO2 Upper Limit Adjust EtCO2 Lower Limit Adjust 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. 119

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 O2 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 N2O is administered to the patient, then the remaining balance of the administered mixture is O2. 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 CO2 molecule is free to absorb even more energy which leads to an increase in absorption. Since the increased absorption effect due to N2O 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 CO2 measurement is similar to the effect of N2O. It is recommended N2O Gas is set to On when N2O 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 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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TEMPERATURE MONITORING WARNING: For best product performance and measurement accuracy, use only YSI 400 and 700 series temperature probes recommended by DRE . 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 10 seconds.

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.

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. Insert a body temperature probe into the temperature connector defibrillator/monitor’s side option case. (see Figure 1). 2. Follow the directions for use accompanying the temperature probe.

on

the

Table 34. 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

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Description of Temperature Menu Functions 1

5

2

6

3

7

4

1 2 3 4

Temperature1 icon Temperature1 value Temperature2 icon Temperature2 value

5 6 7

Temperature1 unit Bell icon Temperature2 unit

Figure 60. Temperature Display

Figure 61. Temperature Menu Display Menu TEMPERATURE MENU (Alarm Limit) ▲ ▼ ▲ ▼ (Limit Alarm Pause) Return

Table 35. 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.

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IBP MONITORING WARNING: Proper measurements may not be possible, l If improper zero calibration was performed. l 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. WARNING: If the pressure transducer has been dropped or subjected to strong physical shock, check for faults before use. WARNING: 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. WARNING: 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. WARNING: Do not reuse disposable (single use) transducers. WARNING: Check the time limit on the package not to use transducers with expired dates. WARNING: Ensure that reusable transducers are sufficiently sterilized. WARNING: To ensure patient safety, do not contact any conductive parts to the applied part. WARNING: 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. WARNING: Do not perform the pressure zero setting while measuring the patient. WARNING: If air bubbles appear in the pressure line or transducer, flush the system with the solution to be infused again. WARNING: 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. WARNING: 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. CAUTION: 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. CAUTION: Zeroing is necessary before IBP monitoring can begin. CAUTION: 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. CAUTION: 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.

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.

Setup Connections 1. 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. 2. 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 62. IBP connections 1 2

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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 IBP 1 unit 5 Diastolic value 6 Bell icon

Figure 63. IBP 1 Display

1

2

1 IBP 1 label icon

2 IBP 1 waveform

Figure 64. IBP 1 Waveform Display

Figure 65. IBP 1 Menu Display Table 36. IBP 1 Menu Menu IBP 1 MENU Zero Setting Scale Label (Alarm Limit) ▲ ▼ ▲ ▼ ▲ ▼ (Limit Alarm Pause) Return

Level 2 Menu or Response Enter 0 ~ 50mmHg, 0 ~ 100mmHg, 0 ~ 200mmHg, 0 ~ 300mmHg, Auto P1 ABP 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

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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 IBP 2 unit 5 Diastolic value 6 Bell icon

Figure 66. IBP 2 Display

1

2

1 P2 (CVP, PAP, LAP) icon

2 P2 waveform

Figure 67. IBP 2 Waveform Display

Figure 68. IBP 2 Menu Display

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Table 37. IBP 2 Menu Level 1 Menu IBP 2 MENU Zero Setting Scale

Level 2 Menu or Response

Label

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

(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

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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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 Self-test manually, High-voltage module operational 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, battery test, real time clock test and installed module alive 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.

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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.

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

Figure 69. Auto Self-test display Table 38. Self-test functions Test Description High-Voltage module To check if the High-Voltage module is operational operational test and available to communicate. Body Impedance test 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. Battery test To check the status of the battery. 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.

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.

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

Figure 70. External shock test 1. 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. 2. Place the paddles on the paddle tray. (see Figure 70). 3. Turn on the defibrillator/monitor. 4. Select the defibrillation energy by pressing the Energy level button on paddle. 5. Charge the selected energy to pressing the CHARGE button on paddle. 6. Press the SHOCK button on paddle. 7. Confirm the energy level on the display.

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. Table 39. Trouble shooting of Self-test LED condition Situation To do LED OFF Possibility 1: The self-test has Turn on the defibrillator/monitor not been performed. (Connect the AC or DC power if it is Possibility 2: The self-test has not connected) and perform the been performed but the manual self-test via setup menu. residual of battery was dropped less than 60%, it turned off the LED and buzzer itself. LED Blink The self-test was finished, and Turn on the defibrillator/monitor and no failure was detected. use it safely. LED Fixed The self-test was finished and If AC or DC power is connected, any failure was detected. If AC check the failed item of self-test or DC power is connected, and contact qualified service self-test result will be personnel or your local supplier. displayed, and buzzer sound If the device is using battery power will be generated. If the only, turn on the defibrillator/monitor defibrillator/monitor is using and can check the failed item. After battery power only, the buzzer then, contact qualified service sound will be generated personnel or your local supplier. without display screen.

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EVENT General rd

th

Event data in either graphical or tabular format may be displayed on 3 and 4 waveform display area. 1. Press the Patient Info soft key. 2. 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 71. Event Data List Display

133

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 72. Event Review Display

134

12 Lead Record Display The 12 lead data is displayed in tabular format as shown in Figure 73. 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 73. 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 74.

Figure 74. Patient Info Menu

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MENU STRUCTURE MANUAL MODE MENU -

12 lead Setup -

Acquire Setup Filter 0.05Hz ~ 40Hz 0.05Hz ~ 150Hz Return Transmission Return 12 lead ON 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 Return Printer setting Print on alarm On Off Print on shock On Off 12 lead auto printing On Off Analyze auto printing On Off 137

138

-

Return Erase data Erase 12 lead records Yes No Erase event records Yes No Erase internal memory Yes No Return Waveform setting nd 2 Waveform ECG l ll lll aVL aVF aVR V1 V2 V3 V4 V5 V6 Pads SpO2 RESP IBP1 IBP2 EtCO2 rd 3 Waveform ECG l ll lll aVL aVF aVR V1 V2 V3 V4 V5 V6 Pads SpO2 RESP IBP1 IBP2 EtCO2 th 4 Waveform ECG l ll

-

-

-

lll aVL aVF aVR V1 V2 V3 V4 V5 V6 Pads SpO2 RESP IBP1 IBP2 EtCO2 Return Display Mode Large Numeric Display Black-yellow 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 Name Age Gender

Confirm Return Confirm Return Confirm Return

139

-

Sync -

Male Female Event records Data review Print Return ID# ID Name Age Gender Return Return Return On Off Return

AED MODE MENU -

140

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 Return

PACING MODE MENU -

Pause Pacing Setup Volume Alarm Beep Button Return Printer setting Print on alarm On Off Print on shock 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 nd 2 Waveform ECG l ll lll aVL aVF aVR V1 V2 V3 V4 V5 V6 Pads SpO2 RESP IBP1 IBP2 EtCO2 rd 3 Waveform ECG 141

-

-

142

l ll lll aVL aVF aVR V1 V2 V3 V4 V5 V6 Pads SpO2 RESP IBP1 IBP2 EtCO2 th 4 Waveform ECG l ll lll aVL aVF aVR V1 V2 V3 V4 V5 V6 Pads SpO2 RESP IBP1 IBP2 EtCO2 Return Clinical action list Display Mode Large Numeric Display Black-yellow Invert Mode Return 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 Return Patient Info ID Confirm Return Name Confirm Return Age Confirm Return Gender F M Event records Data review Print Return ID# ID Name Age Gender Confirm Return Return Return ASync On Off Return

Off

Off

Off

Off

Off

-

-

-

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MANUAL MODE MENU 144

12 lead Setup -

Acquire Setup Filter 0.05Hz ~ 40Hz 0.05Hz ~ 150Hz Return Transmission Return 12 lead ON 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 Return Printer setting Print on alarm On Off Print on shock 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 nd 2 Waveform ECG l ll lll aVL aVF aVR V1 V2 V3 V4 V5 V6 Pads SpO2 RESP IBP1 IBP2 EtCO2 rd 3 Waveform ECG l ll lll aVL aVF aVR V1 V2 V3 V4 V5 V6 Pads SpO2 RESP IBP1 IBP2 EtCO2 th 4 Waveform ECG l ll lll aVL aVF aVR 145

-

V1 V2 V3 V4 V5 V6 Pads SpO2 RESP IBP1 IBP2 EtCO2 Return Display Mode Large Numeric Display Black-yellow 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 Return Patient Info ID Confirm Return Name Confirm Return Age Confirm Return Gender Male Female Event records Data review

Off

Off

Off

Off

Off

Off

-

-

-

146

-

-

-

-

Return

ID# Return

Print Return ID Name Age Gender Return

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

HR/PR Source Auto HR PR Return Pacer Detect Enable Disable Return Filter Select 0.5Hz ~ 21Hz 0.05Hz ~ 40Hz 1Hz ~ 21Hz Return Alarm Limit “Alarm limit” HR/PR 120 50 “Limit Alarm Pause”

On Off -

Return

SpO2 MENU -

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

On Off -

Return 147

NIBP MENU -

Inflate Pressure “Adult/Pediatric” 120 mmHg 140 mmHg 160 mmHg 180 mmHg 200 mmHg 220 mmHg 240 mmHg 260 mmHg 280 mmHg Return “Neonatal” 80 mmHg 100 mmHg 120 mmHg 140 mmHg Return Auto Interval Off Cont 1 min 2.5 min 3 min 5 min 10 min 15 min 20 min 30 min 60 min 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 -

148

Return

IBP1 MENU -

Zero Setting Enter Return Scale 0~50mmHg 0~100mmHg 0~200mmHg 0~300mmHg Auto Return Label P1 ABP Return Alarm Limit “Alarm limit (mmHg)” SYS MEAN DIA 120 90 70 70 50 40 “Limit Alarm Pause”

On Off -

Return

IBP2 MENU -

Zero Setting Enter Return Scale 0~50mmHg 0~100mmHg 0~200mmHg 0~300mmHg Auto Return Label P2 CVP PAP LAP Return Alarm Limit “Alarm limit (mmHg)” SYS MEAN DIA 120 90 70 70 50 40 “Limit Alarm Pause”

On Off -

Return 149

EtCO2 MENU -

EtCO2 On Off Return Average 1 breaths 10 seconds 20 seconds 30 seconds Return Alarm Limit “Alarm limit” EtCO2 InCO2 80

20

0 0 “Limit Alarm Pause” On Off -

150

Return

RESPIRATION MENU -

Respiration On Off Return Respiration Setting PR Source Auto Impedance Airway Return Size X 0.5 X1 X 1.5 X2 Return Return Apnea time setting Off 10 seconds 20 seconds 30 seconds 40 seconds 50 seconds 60 seconds Alarm Limit “Alarm limit” RESP 30 8 “Limit Alarm Pause”

On Off -

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

151

DATE TIME MENU -

152

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

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 76.)

Printer Settings 1. Press the Setup soft key. (Setup is displayed on the initial screen of each mode.) 2. Rotate the Multi function knob to highlight Printer setting via Setup Menu, and then press the Multi function knob to select Printer setting.

Figure 75. Printer setting Menu 3. Set Printer on alarm, Printer on shock, 12 lead auto printing and Analyze auto printing. 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 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. 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.

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Print-Out Print-out The defibrillator/monitor prints numeric data and waveforms by pressing PRINT button.

Figure 76. 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.

Figure 77. Print-out on shock 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 button.

Figure 78. Print-out on 12 lead ECG data

154

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.

Figure 79. 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. WARNING: 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. WARNING: 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. WARNING: Use only a DRE 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: This equipment is to be used on a network and the wireless communication (3G or Wi-Fi) are limited to inside of the building. USB Host Type The USB Host is used to download data. Only memory stick can be used for the USB Host. SD Memory Card The SD Memory Card is used to extend the save space, to install the new system software and to load voice prompt data. 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. - 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 3G/Wi-Fi module network. All vital sign can be transmitted in real-time. Note: The details are provided in the central system. Please contact the representative of DRE for more information.

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MAINTENANCE WARNING: The cover should be removed only by qualified service personnel. There are no internal user-serviceable parts except for the battery. WARNING: Do not use the defibrillator/monitor when the case appears damaged. WARNING: Do not spray, pour, or spill any liquid on the defibrillator/monitor, its accessories, connectors, switches or openings in the chassis. WARNING: Unplug the power cord from the defibrillator/monitor before cleaning the defibrillator/monitor. CAUTION: Disposal of the defibrillator/monitor with the battery inserted presents a potential shock hazard. CAUTION: Do not autoclave, ultrasonically clean, or immerse the DRE defibrillator/monitor. Do not use abrasive cleaners or strong solvents such as acetone or acetone-based cleaners. CAUTION: Do not ultrasonically clean or immerse the paddles and paddles cables. CAUTION: Do not ultrasonically clean, immerse, autoclave or steam sterilize the pads cable. CAUTION: 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. CAUTION: 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. CAUTION: 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.

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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. l Inspect the equipment for mechanical and functional damage. l 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. l l l l

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.

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Battery Maintenance CAUTION: Recharging the battery is strongly recommended when the battery has not been recharged for 6 or more months. CAUTION: Follow local government ordinances and recycling instructions regarding disposal or recycling of defibrillator/monitor components, including batteries. CAUTION: 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. CAUTION: Do not solder the battery directly. Heat applied during soldering may damage the safety vent in the battery’s positive cover. CAUTION: Do not deform the battery by applying pressure. Do not throw, hit, drop, fold or impact the battery. CAUTION: 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. CAUTION: Do not use any chargers not specified by DRE. CAUTION: 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. CAUTION: Do not mistreat the battery, or use the battery in applications not recommended by DRE. CAUTION: Keep the battery out of reach of babies and children to avoid any accidents. CAUTION: 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 strongly 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.

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Loading Printer Paper CAUTION: Using other manufacturers’ printer paper may cause the printer to function improperly or damage the print head. Use only DRE printer paper. Load printer paper as follows: 1. Pull the printer door. 2. Pick out the paper by using the ejector. 3. Insert a new printer paper with grid side up. 4. 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 80. Printer Paper Replacement

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TROUBLESHOOTING WARNING: 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. WARNING: The cover should be removed only by qualified service personnel. There are no user-serviceable parts inside except for the battery. WARNING: 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.

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EMI (Electromagnetic Interference) WARNING: 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. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: 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. WARNING: Operating high frequency electrosurgical equipment in the vicinity of the defibrillator/monitor can produce interference in the defibrillator/monitor and cause incorrect measurements. WARNING: 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. WARNING: 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: l Turn equipment in the vicinity off and on to isolate the offending equipment. l Reorient or relocate the interfering equipment. l Increase the separation between the interfering equipment and this equipment. 164

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 40. 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

NIBP SYS Low 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 0.5 to 21 Hz 120 BPM 50 BPM Off Off

On, Off

Off

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 %

80, 100, 120, 120, 140 160, 180, 200, 220, 240, 260, 280 mmHg 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) adult/pediatric 30 to 265 mmHg

180 mmHg Off Adult/Pedi mmHg adult/pediatric 160 mmHg (21.3 kPa) neonatal 90 mmHg (12 kPa) adult/pediatric 90 mmHg

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Parameter

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

IBP 1 MEAN High Alarm Limits

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Ranges / Selections (Adjust step) (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 (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 to 40 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 to 40 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) adult/pediatric -45 to 300 mmHg

Auto

adult/pediatric 90 mmHg (12.0 kPa) neonatal 60 mmHg (8.0 kPa) adult/pediatric 50 mmHg (6.7 kPa) neonatal 20 mmHg (2.6 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) adult/pediatric 90 mmHg

Parameter

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 Average EtCO2 High Alarm Limits

EtCO2 Low Alarm Limits

InCO2 High Alarm Limits

InCO2 Low Alarm Limits

Ranges / Selections (Adjust step) (-6 to 40 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 (12.0 kPa)

Auto, 0~50mmHg, 0~100mmHg, 0~200mmHg, 0~300mmHg P2, CVP, PAP,LAP adult/pediatric -45 to 300 mmHg (-6 to 40 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 to 40 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 to 40 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 1 breath, 10 seconds, 20 seconds, 30 seconds adult/pediatric 1 to 80 mmHg (0.13 to 10.7 kPa), (0.13 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 (0.13 to 2.7 kPa), (0.13 to 2.6 %) (1 mmHg, 0.13 kPa, 0.13 % steps) adult/pediatric

ON OFF OFF Auto 1 breath 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 %) adult/pediatric

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Parameter

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) 0 to 19 mmHg (0 to 2.5 kPa), (0 to 2.5 %) (1 mmHg, 0.13 kPa steps) mmHg, kPa, %

Factory Defaults 0 mmHg (0 kPa), (0 %)

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) 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 Volume 1, 2, 3, 4, 5, 6, 7, 8 Beep Volume OFF, 1, 2, 3, 4, 5, 6, 7 Button Volume 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 rd 3 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 th 4 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 shock** On, Off 12 lead auto printing** On, Off Analyze auto printing** On, Off Elapsed time display* Enable, Disable CPR guide display* Enable, Disable Message display* Enable, Disable Voice prompt* Enable, Disable Basic auto energy escalation* Enable, Disable Above 200J setting* Enable, Disable Manual mode shock energy – 1~200J 1st energy*

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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 SpO2 Waveform

IBP1 Waveform – P1

EtCO2 Waveform

Off Off On Off Enable Disable Enable Enable Enable Disable 125J

Parameter Manual mode shock energy – 2nd energy* Manual mode shock energy – 3rd energy* Analyze continuous mode* Auto charge* Remain in sync mode after shock* Charging hold time* ECG display under paddle open* 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 shock energy – Above 200J setting* AED shock energy – 1st energy*

Ranges / Selections (Adjust step) 1~200J

Factory Defaults 150J

1~200J

200J

On, Off On, Off On, Off

On 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

Disable

Enable, Disable

Disable

Enable, Disable

Disable

Enable, Disable

Disable

Enable, Disable

Disable

1~200J

125J

AED shock energy – 2nd energy* AED shock energy – 3rd energy* Async Pacing* Pace Pulse Rate* Default Pacing Energy* Others Parameters Color - ECG*

1~200J

150J

1~200J

200J

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

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)

Parameters Color - NIBP*

Parameters Color - SpO2*

FAFAFA(White)

64FAFA(Cyan)

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Parameter Parameters Color - RESP*

Parameters Color - TEMP*

Parameters Color - IBP 1*

Parameters Color - IBP 2*

Parameters Color - EtCO2*

Audio pause time* Audio off time* Alarm reminder tone* Alarm activate at power up* Voice recording* Auto self-test : Self-test time* Auto self-test : Self-test time interval* Auto self-test : Internal shock energy* Clinical action list*

Manual mode protection* Manual mode locking passcode* Pacing mode protection* Pacing mode locking passcode* Service menu passcode* Print on charge** Print on mark** Print on BP** Print on self-test**

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Ranges / Selections (Adjust step) 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 30 sec, 60 sec, 90 sec, 120 sec 3 min, 5 min, 10 min, Indefinite 3 min, 10 min, Off Enable, Disable On, Off 0 ~ 23 o‘clock

Factory Defaults 9696C8(Light blue)

24 hours, 48 hours, 72 hours, Off

Off

5J, 10J, 20J, 30J, 40J, 50J, 100J, 200J

50 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

Disable, Confirm, Passcode 000~999

Disable (Passcode)

000~999 On, Off On, Off On, Off On, Off

(Passcode) Off Off Off Off

FA96FA(Pink)

FA0000(Red)

FAFA00(Yellow)

9696C8(Light purple)

60 sec Indefinite 3 min Enable Off 0 o‘clock

Disable (Passcode)

Parameter Power on waveform select – 1st waveform* Power on waveform select – 2nd waveform* Power on waveform select – 3rd waveform* Power on waveform select – 4th waveform* Wi-Fi* Wireless Channel* Wireless security mode* Wireless WEP key* WEP key length*

Ranges / Selections (Adjust step) ECG I, ECG II, ECG III, Pads

Factory Defaults ECG I

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 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 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 On, Off Channel 1 ~ 13 None, WEP, WPA, WPA2, Return WEP key 1, WEP key 2, WEP key 3, WEP key 4 64 bit (10 hex digits), 128 bit (24 hex digits)

SpO2

IBP1

EtCO2

Off Channel 1 None WEP key 1 64 bit (10 hex digits)

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 indicate 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

8.4” measured diagonally across the TFT-LCD screen Liquid Crystal Display (LCD) Color 170 x 128 mm 4 waveforms

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

Categories Priorities Notification Setting Alarm Volume Level

Patient Status and System Status Low, Medium and High Priorities Audible and Visual Default and Individual 45 to 85 dB

Controls

Alarms

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 × 305 × 210 (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 Rule10:MEDDEV 2.4/1 Rev.8) Printer Thermal 190 g 1 to 3 channels Thermal 80 mm 25 mm/sec, 50 mm/sec

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Electrical Instrument Power Requirements

AC Mains 100 to 240 V, 50/60 Hz, 160 VA

DC Mains 18Vdc, 7.0A with DC/DC adapter, Model:MDD150-1218 (MDD150-1218: Input: 12-16Vdc, 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 150 × 90 × 20 (mm) (W×H×D) Voltage/Capacity 4S2P 14.4V/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 room temperature : 25°C Recharge 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 Life Cycle 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.

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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 to 70°C (−4°F to 158°F) Humidity 15 to 95% RH, non-condensing Altitude -304 to 6,096m (-1,000 to 20,000ft) Note: The system may not meet its performance specifications if stored or used outside the specified temperature and humidity range.

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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

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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 V/F ≤ 200 µV V/T ≤ 160 per min Shock Analysis Time < 13 seconds typical Charging Time to 200J* Within 6 seconds with rated main voltage/DC main voltage Within 7 seconds with fully charged battery *Charging time for other cases, refer to defibrillator (technical specification) Manual Mode Shock Energy Level External paddles: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 40, 50, 75, 100, 125, 150, 175, 200, 300, 360 J Automatic Discharge Time 60 seconds Charging Time to 200J* Within 6 seconds with rated main voltage/DC main voltage Within 7 seconds with fully charged battery Charging Time to 360J Within 8 seconds with rated main voltage/DC main voltage Within 9 seconds with fully charged battery *Charging time for other cases, refer to defibrillator (technical specification)

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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, V, 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 Mohm 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 x0.5, x1, x1.5, x2, x3 10 mm/mV (×1) On, Off Display and/or sound 90 dB or more 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 O2 and N2O is correctly selected for actual fractional gas constituents present. 2 minutes maximum 25.0 mm/sec Less than 41dB when ambient sound pressure level is 22dB

Temperature Probe Type Measurement Method Range Accuracy Resolution Defibrillator Protection

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Thermistor Temp Thermistor probe YSI compatible type Thermistor 0 to 50°C (32.0 to 122°F) 25 to 45 °C (77 to 113°F): ±0.2°C 25 to 45 °C (77 to 113°F): ±0.1°C 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

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Defibrillator (Technical Specification) AED Mode AED Mode Charging Time - 200J Charging condition Time (sec) With Rated Mains Voltage 5.8 With DC Mains Voltage 5.9 With fully charged battery 6.4 Charging Time - 200J Charging condition Time (sec) (including time from the With Rated Mains Voltage 18.1 initiation of rhythm With DC Mains Voltage 18.4 analysis with a clear ECG With fully charged battery 19.3 signal to readiness for With Mains Voltage of 90% of the Rated 18.1 discharge.) 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. Waveform parameters 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

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Manual Mode Charging Time – 200J

Charging Time – 360J

Manual Mode 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 Note: A used battery normally takes more 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 Note: A used battery normally takes more charging time specified in above.

Time (sec) 5.8 5.9 6.4 5.8 6.4 6.6

11.7

11.9

12.5

time than the Time (sec) 7.4 7.5 8.0 7.4 8.0 8.5

13.0

14.0

14.3

time than the

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Number of discharges

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 Shockable rhythm, Ventricular Fibrillation Shockable rhythm, Ventricular Tachycardia Non-Shockable rhythm

ECG analysis performance Complies with IEC60601-2-4:2002 (sensitivity > 90%) Complies with IEC60601-2-4:2002 (sensitivity > 75%) Complies with IEC60601-2-4:2002 (specificity > 95%)

Database for ECG Analysis l From AHA (American Heart Association) official database l From MIT (Massachusetts institute Technology) official database (MIT-BIH Arrhythmia Database and Creighton University Ventricular Tachyarrhythmia Database) ECG rhythm to determine if a shock is appropriate l Ventricular Fibrillation at a amplitude greater than or equal to 0.2mV l Ventricular Tachycardia at a heart rate greater than or equal to 160 bpm

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Biphasic Waveform Characteristics The efficiency of DRE’s Biphasic waveform has been clinically verified during a ventricular fibrillation (VF) and ventricular tachycardia (VT) defibrillation study. This study (which was conducted using VidaStat DM defibrillator/monitors) and the findings are described below. Table 41. 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 11.0 10.0 10.0 10.0 10.0 10.0 10.0 15% 15J 16.0 15.0 15.0 15.0 15.0 15.0 15.0 15% 20J 21.0 20.0 20.0 20.0 20.0 20.0 20.0 15% 30J 31.0 30.0 30.0 30.0 30.0 30.0 30.0 15% 40J 41.0 40.0 40.0 40.0 39.0 39.0 39.0 15% 50J 51.0 50.0 50.0 50.0 49.0 49.0 49.0 15% 75J 77.0 76.0 75.0 75.0 74.0 74.0 74.0 15% 100J 102 101 101 100 99.0 99.0 99.0 15% 125J 127 126 126 124 124 122 123 15% 150J 152 151 150 150 148 147 148 15% 175J 177 174 173 173 173 172 172 15% 200J 203 198 200 199 198 197 197 15% 300J 304 302 300 298 296 297 296 15% 360J 370 371 365 363 363 356 356 15%

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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 81. Biphasic Waveforms at 300 Joules and 360 Joules

Figure 82. Biphasic Waveforms at 200 Joules

190

Figure 83. Biphasic Waveforms at 175 Joules

Figure 84. Biphasic Waveforms at 150 Joules

191

Figure 85. Biphasic Waveforms at 125 Joules

Figure 86. Biphasic Waveforms at 100 Joules

192

Figure 87. Biphasic Waveforms at 75 Joules

Figure 88. Biphasic Waveforms at 50 Joules

193

Figure 89. Biphasic Waveforms at 40 Joules

Figure 90. Biphasic Waveforms at 30 Joules

194

Figure 91. Biphasic Waveforms at 20 Joules

Figure 92. Biphasic Waveforms at 10 Joules

195

Figure 93: Biphasic Waveforms at 9 Joules

Figure 94. Biphasic Waveforms at 8 Joules

196

Figure 95. Biphasic Waveforms at 7 Joules

Figure 96. Biphasic Waveforms at 6 Joules

197

Figure 97. Biphasic Waveforms at 5 Joules

Figure 98. Biphasic Waveforms at 4 Joules

198

Figure 99. Biphasic Waveforms at 3 Joules

Figure 100. Biphasic Waveforms at 2 Joules

199

Figure 101. Biphasic Waveforms at 1 Joules

200

Compliance Item Classification

Type of protection

Mode of operation

Degree of protection

General

Standard

Description

IEC60601-1:1988 +A1:1991+A2:1995, EN60601-1:1996 IEC60601-1:1988 +A1:1991+A2:1995, EN60601-1:1996 IEC60601-1:1988 +A1:1991+A2:1995, EN60601-1:1996 IEC60529:2001, EN60529:1991 +A1:2000

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

93/42/EEC as amended by 2007/47/EC

Directives for medical devices

21CFR820 2012/19/EU

Code of federal regulations Waste electrical and electronic equipment directive (WEEE) Battery disposal directive

93/86/EEC

Type BF and Type CF – Applied part

Continuous

IP34 (provided by enclosures)

2006/66/EC as amended by 2008/103/EC

Battery directive

ISO13485:2003, EN ISO13485:2003

Quality systems - Medical Devices - Requirements for regulating purposes

ISO14971:2007, EN ISO14971:2012 IEC60601-1:1988 +A1:1991+A2:1995, EN60601-1:1996

Risk analysis managements – medical devices

IEC60529:2001, EN60529:1991 +A1:2000

Degree of protection provided by enclosures (IP34)

ISO14155:2011, EN ISO14155:2011

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

AAMI HE75:2009

Human factors engineering guidelines and preferred practices for the design of medical devices

IEC60601-1-1:2000, EN60601-1-1:2001

Collateral standard for medical electrical systems

IEC60601-1-4:2000, EN60601-1-4:1996 +A1:1999

Collateral standard for programmable medical systems

IEC60601-1-6:2006, EN60601-1-6:2007

Collateral standard for usability

ISO 10993-1:2009/ Cor1:2010, EN ISO10993-1:2009

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

General requirements for safety of medical electrical equipment

201

Item

Ambulance

Standard

Description

ISO10993-5:2009, EN ISO10993-5:2009

Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

ISO10993-10:2010, EN ISO10993-10:2010 IEC60601-2-49:2001, EN60601-2-49:2001 IEC62366:2007 EN62366:2008 IEC60601-1-9:2007 EN60601-1-9:2008

Biological evaluation of medical devices – Part 10: Tests for irritation and delayed-type hypersensitivity Particular requirements for multifunction patient monitoring equipment Medical devices – Application of usability engineering to medical devices Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

IEC62304:2006 EN62304:2006 EN1789:2007+A1:2010

Medical device software – Software life-cycle processes Medical vehicles and their equipment – road ambulance Medical vehicles and their equipment – Air ambulances – Part1:Requirements for medical devices used in air ambulances. Environmental Conditions and Test Procedures for Airborne Equipment Alarm systems requirements, tests and guidance in medical electrical equipments systems Particular requirements for the safety of Electrocardiographic monitoring equipment Particular requirements for the basic safety and essential performance of electrocardiographs Cardiac monitors, heart rate meters and alarms ECG cable and leads

EN13718-1:2008

RTCA/ DO-160G Alarms Electrocardiograph

Non-invasive blood pressure

IEC60601-1-8:2006, EN60601-1-8:2007 IEC60601-2-27:2005, EN60601-2-27:2006 IEC60601-2-25:2011 EN60601-2-25:1995 AAMI EC13:2002 ANSI/AAMI EC53A:1998/(R)2008

AAMI EC57:1998(R)2008

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

AAMI SP10:2002 +A1:2003+A2:2006 EN1060-1:1995 +A2:2009 EN1060-3:1997 +A2:2009 EN1060-4:2004

Electronic or automated sphygmomanometers

IEC60601-2-30:1999, EN60601-2-30:2000 Oxygen saturation

202

ISO9919:2005, EN ISO 9919:2009

Non-invasive sphygmomanometers Supplementary requirements for electricalmechanical blood pressure measuring systems Non-invasive sphygmomanometers - Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers Particular requirements for the safety, including essential performance, of automatic cycling indirect blood pressure monitoring equipment Basic safety & essential performance of pulse oximeter for medical use

Standard

Description

Temperature monitoring

Item

EN12470-4:2000 +A1:2009

Performance of electrical thermometers for continuous Measurement

Invasive blood pressure

IEC60601-2-34:2000 EN 60601-2-34:2000

Capnography

ISO21647:2004, EN ISO 21647:2009 IEC 60601-2-4:2002 EN 60601-2-4:2003

Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors Safety of cardiac defibrillators

Defibrillator

AAMI DF80:2003 Electromagnetic compatibility

Package

IEC60601-1, sub clause 36, and IEC60601-1-2:2007, EN60601-1-2:2001 +A1:2006

Safety of cardiac defibrillators (including automated external defibrillators) Electromagnetic compatibility-requirements & test

IEC61000-3-2:2005 +A1:2008 +A2:2009, EN61000-3-2:2006 +A1:2009 +A2:2009 IEC61000-3-3:2008, EN61000-3-3:2008 IEC61000-4-2:2008, EN61000-4-2:2009 IEC61000-4-3:2008 EN61000-4-3:2006 +A1:2008 IEC61000-4-4:2004 +A1:2010, EN61000-4-4:2004 +A1:2010

Harmonic emission Ed 3.2

IEC61000-4-5:2005, EN61000-4-5:2006

Surge current Ed 2.0

IEC61000-4-6:2008, EN61000-4-6:2009 IEC61000-4-8:2009, EN61000-4-8:2010 IEC61000-4-11:2004, EN61000-4-11:2004 CISPR11:2009 +A1:2010 EN55011: 2009 +A1:2010

Conducted disturbances, induced by RF field Ed 3.0 Power frequency (50/60Hz) magnetic field Ed 2.0

CISPR22:2008 EN55022:2010

Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement Pre-Shipment test procedures (Package)

ISTA (Procedure 1A, 2001)

Voltage fluctuations/Flicker emission Ed 2.0 Electrostatic discharge Ed 2.0 Radiated RF electromagnetic field Ed 3.1

Electrical fast transient/burst Ed 2.1

Voltage dips, short interruption and voltage variation on power supply input lines Ed 2.0 Limits and methods of measurement of radio disturbance characteristics of industrial scientific and medical (ISM) radio-frequency equipment RF Emissions Group 1, Class B

203

Item

Standard

Description

ASTM D4169:2009

Standard practice for performance testing of shipping containers and system

IEC60068-1:1998 +A1:1992 EN 60068-1:1994

Environmental testing, Part1: General guidelines

IEC60068-2-1:2007 EN60068-2-1:2007

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

IEC60068-2-2:2007 EN60068-2-2:2007 IEC60068-2-30:2005 EN60068-2-30:2005 IEC60068-2-27:2008, EN60068-2-27:2009 IEC60068-2-6:2007, EN60068-2-6:2008

Environmental testing - Part 2-2: Tests - Test B: Dry heat Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle) Environmental testing – Shock

Labeling

IEC60068-2-64:2008, EN60068-2-64:2008 EN1041:2008

Environmental testing: vibration, broad-band random (digital control) and guidance Information supplied by the manufacturer with medical devices

Marking

IEC /TR60878:2003

Graphical symbols for electrical equipment in

Reliability

Environmental testing – Vibration

medical practice EN980:2008

Graphical symbols for use in the labeling of medical devices

ISO15223-1:2011

ISO15223-2:2010

Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements Symbols to be used with medical device labels, labelling, and information to be supplied -- Part 2: Symbol development, selection and validation

ISO7000:2012

Graphical symbols for use on equipment-index and synopsis

EN50419:2006

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

204

Manufacturer’s Declaration WARNING: For best product performance and measurement accuracy, use only accessories supplied or recommended by DRE . 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. 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 42. 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 43. Electromagnetic Immunity (IEC60601-1-2) Immunity Test

IEC 60601-1-2 Test Level

Compliance Level

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 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

±1 kV differential mode ±2 kV common mode 95 % dip in UT ) for 0.5 cycle

±2 kV for power supply lines ±1 kV for input/output lines ±1 kV differential mode ±2 kV common mode 95 % dip in U T) for 0.5 cycle

40 % U T (60 % dip in UT ) for 5 cycles 70 % U T (30 % dip in UT ) for 25 cycles