User Manual
216 Pages
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About this Manual P/N: 01.54.455711-12 Release Date: June 2013 © Copyright EDAN INSTRUMENTS, INC. 2012-2013. All rights reserved.
Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable.
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Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.
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Table of Contents Chapter 1 Intended Use and Safety Guidance ................................................................................1 1.1 Intended Use...........................................................................................................................1 1.2 Safety Guidance .....................................................................................................................2 1.3 Explanation of Symbols on the Monitor ................................................................................4 Chapter 2 Installation ........................................................................................................................8 2.1 Initial Inspection.....................................................................................................................8 2.2 Mounting the Monitor ............................................................................................................8 2.2.1 Installing Wall Mount for the Monitor........................................................................8 2.3 Connecting the Power Cable..................................................................................................8 2.4 Checking Out the Monitor .....................................................................................................8 2.5 Checking the Recorder...........................................................................................................9 2.6 Setting the Date and Time ......................................................................................................9 2.7 Handing Over the Monitor .....................................................................................................9 Chapter 3 Basic Operation..............................................................................................................10 3.1 Overview ..............................................................................................................................10 3.1.1 Front View.................................................................................................................10 3.1.2 Rear View..................................................................................................................13 3.1.3 Side View ..................................................................................................................17 3.1.4 Configuration ............................................................................................................19 3.2 Operating and Navigating ....................................................................................................19 3.2.1 Using Keys ................................................................................................................21 3.3 Operating Mode ...................................................................................................................22 3.3.1 Demo Mode...............................................................................................................22 3.3.2 Standby Mode ...........................................................................................................23 3.3.3 Night Mode ...............................................................................................................23 3.4 Changing Monitor Settings ..................................................................................................23 3.4.1 Adjusting Screen Brightness .....................................................................................23 3.4.2 Changing Date and Time...........................................................................................24 3.5 Adjusting Volume.................................................................................................................24 III
3.5.1 Adjusting Key Volume ..............................................................................................24 3.5.2 Adjusting Alarm Volume ...........................................................................................24 3.5.3 Adjusting Beat Volume..............................................................................................24 3.6 Checking Your Monitor Version ..........................................................................................24 3.7 Networked Monitoring.........................................................................................................24 3.8 Setting Languages ................................................................................................................25 3.9 Understanding Screens.........................................................................................................25 3.10 Calibrating Screens ............................................................................................................25 3.11 Disabling the Touch Screen................................................................................................25 3.12 Using the Barcode Scanner ................................................................................................26 3.13 Resolving IBP Label Conflicts...........................................................................................26 Chapter 4 Alarms .............................................................................................................................27 4.1 Alarm Category ....................................................................................................................27 4.1.1 Physiological alarms .................................................................................................27 4.1.2 Technical Alarms.......................................................................................................27 4.1.3 Prompts .....................................................................................................................27 4.2 Alarm Levels ........................................................................................................................27 4.3 Controlling Alarm ................................................................................................................28 4.3.1 Setting Parameter Alarm ...........................................................................................28 4.3.2 Temporary Alarm Mute.............................................................................................29 4.3.3 Alarm Mute ...............................................................................................................29 4.3.4 Controlling Alarm Volume ........................................................................................30 4.4 Latching Alarms ...................................................................................................................30 4.5 Disabling Sensor Off Alarms ...............................................................................................30 4.6 Testing Alarms......................................................................................................................30 Chapter 5 Alarm Information.........................................................................................................31 5.1 Physiological Alarm Information.........................................................................................31 5.2 Technical Alarm Information ...............................................................................................36 5.3 Prompts ................................................................................................................................48 5.4 Adjustable Range of Alarm Limits.......................................................................................50 IV
Chapter 6 Managing Patients .........................................................................................................55 6.1 Admitting a Patient...............................................................................................................55 6.1.1 Patient Category and Paced Status ............................................................................55 6.2 Quick Admit .........................................................................................................................56 6.3 Editing Patient Information..................................................................................................56 6.4 Updating a Patient ................................................................................................................56 6.5 Central Monitoring System ..................................................................................................56 Chapter 7 User Interface .................................................................................................................58 7.1 Setting Interface Style ..........................................................................................................58 7.2 Selecting Display Parameters...............................................................................................58 7.3 Changing Waveform Position ..............................................................................................58 7.4 Changing Interface Layout...................................................................................................58 7.5 Viewing Trend Screen ..........................................................................................................58 7.6 Viewing Oxygen Screen.......................................................................................................59 7.7 Viewing Large Font Screen..................................................................................................59 7.8 Viewing the Bed View Window ...........................................................................................60 7.8.1 Opening the Bed View Window................................................................................60 7.8.2 Settings of the Bed View Window ............................................................................60 7.9 Changing Parameter and Waveform Colors.........................................................................60 7.10 User Configuration.............................................................................................................60 7.11 Default Configuration ........................................................................................................61 Chapter 8 Monitoring ECG ............................................................................................................62 8.1 Overview ..............................................................................................................................62 8.2 ECG Safety Information ......................................................................................................62 8.3 ECG Display ........................................................................................................................63 8.3.1 Changing the Size of the ECG Wave ........................................................................63 8.3.2 Changing the ECG Filter Settings.............................................................................64 8.4 Using ECG Alarms...............................................................................................................64 8.5 Selecting Calculation Lead ..................................................................................................64 8.6 Monitoring Procedure ..........................................................................................................65 V
8.6.1 Preparation ................................................................................................................65 8.6.2 Connecting ECG Cables ...........................................................................................65 8.7 Selecting Lead Type .............................................................................................................65 8.8 Installing Electrodes.............................................................................................................65 8.8.1 Electrode Placement for 3-lead .................................................................................66 8.8.2 Electrode Placement for 5-lead .................................................................................67 8.8.3 Electrode Placement for 12-lead ...............................................................................68 8.8.4 Recommended ECG Lead Placement for Surgical Patients......................................69 8.9 ECG Menu Setup .................................................................................................................70 8.9.1 Setting Alarm Source ................................................................................................70 8.9.2 Smart Lead Off..........................................................................................................70 8.9.3 Setting Beat Volume..................................................................................................70 8.9.4 ECG Display .............................................................................................................71 8.9.5 Setting Pace Status ....................................................................................................71 8.9.6 ECG Calibration........................................................................................................71 8.9.7 ECG Waveform Settings ...........................................................................................71 8.9.8 12 Leads ECG ...........................................................................................................72 8.10 ST Segment Monitoring.....................................................................................................72 8.10.1 Setting ST Analysis .................................................................................................72 8.10.2 ST Display...............................................................................................................72 8.10.3 ST Analysis Alarm Setting ......................................................................................72 8.10.4 About ST Measurement Points................................................................................73 8.10.5 Adjusting ST and ISO Measurement Points............................................................73 8.11 Arr. Monitoring...................................................................................................................73 8.11.1 Arrhythmia Analysis................................................................................................73 8.11.2 ARR Analysis Menu................................................................................................75 8.12 12-Lead ECG Monitoring ..................................................................................................76 8.12.1 Diagnosis Function..................................................................................................76 8.12.2 Measurement and Interpretation .............................................................................77 Chapter 9 Monitoring RESP...........................................................................................................78 VI
9.1 Overview ..............................................................................................................................78 9.2 RESP Safety Information .....................................................................................................78 9.3 Resp Display ........................................................................................................................79 9.4 Electrode Placement for Monitoring Resp...........................................................................79 9.5 Cardiac Overlay ...................................................................................................................79 9.6 Chest Expansion...................................................................................................................79 9.7 Abdominal Breathing ...........................................................................................................80 9.8 Selecting Resp Lead.............................................................................................................80 9.9 Changing Hold Type ............................................................................................................80 9.10 Changing the Size of the Respiration Wave.......................................................................80 9.11 Using Resp Alarms.............................................................................................................80 9.12 Changing the Apnea Time..................................................................................................80 Chapter 10 Monitoring SpO2 ..........................................................................................................81 10.1 Overview ............................................................................................................................81 10.2 SpO2 Safety Information ....................................................................................................81 10.3 Measuring SpO2 .................................................................................................................82 10.4 Measurement Procedure.....................................................................................................82 10.5 Understanding SpO2 Alarms ..............................................................................................83 10.6 Adjusting Alarm Limits......................................................................................................83 10.7 Setting SpO2 as Pulse Source.............................................................................................83 10.8 Setting Pitch Tone ..............................................................................................................83 10.9 Setting Sensitivity ..............................................................................................................84 Chapter 11 Monitoring PR ..............................................................................................................85 11.1 Overview ............................................................................................................................85 11.2 Setting PR Source...............................................................................................................85 11.3 Setting PR Volume .............................................................................................................85 11.4 Using Pulse Alarms ............................................................................................................85 11.5 Selecting the Active Alarm Source.....................................................................................85 Chapter 12 Monitoring NIBP .........................................................................................................86 12.1 Overview ............................................................................................................................86 VII
12.2 NIBP Safety Information ...................................................................................................86 12.3 Introducing the Oscillometric NIBP Measurement............................................................87 12.4 Measurement Limitations...................................................................................................87 12.5 Measurement Methods .......................................................................................................88 12.6 Measurement Procedures ...................................................................................................88 12.7 Operation Prompts .............................................................................................................89 12.8 Correcting the Measurement if Limb is not at Heart Level ...............................................89 12.9 NIBP Alarm........................................................................................................................90 12.10 Resetting NIBP.................................................................................................................90 12.11 Calibrating NIBP..............................................................................................................90 12.12 Leak Test ..........................................................................................................................90 12.12.1 Procedure of Leak Test..........................................................................................90 Chapter 13 Monitoring TEMP........................................................................................................92 13.1 Overview ............................................................................................................................92 13.2 TEMP Safety Information ..................................................................................................92 13.3 TEMP Monitoring Setup ....................................................................................................92 13.4 Calculating Temp Difference .............................................................................................92 Chapter 14 Monitoring Quick TEMP* ..........................................................................................93 14.1 Overview ............................................................................................................................93 14.2 Quick TEMP Safety Information .......................................................................................93 14.3 Measuring Procedure .........................................................................................................94 14.3.1 Measurement for Oral Temperature ........................................................................94 14.3.2 Measurements for Rectal Temperatures..................................................................95 14.3.3 Measurements for Axillary Temperatures ...............................................................95 14.4 Changing Temp Unit ..........................................................................................................96 Chapter 15 Monitoring IBP ............................................................................................................97 15.1 Overview ............................................................................................................................97 15.2 IBP Safety Information ......................................................................................................97 15.3 Monitoring Procedures.......................................................................................................97 15.4 Selecting a Pressure for Monitoring...................................................................................98 VIII
15.5 Zeroing the Pressure Transducer........................................................................................98 15.6 Zeroing a Pressure Measurement .......................................................................................99 15.7 Troubleshooting the Pressure Zeroing (Taking Art for Example)......................................99 15.8 IBP Pressure Calibration ....................................................................................................99 15.9 Troubleshooting the Pressure Calibration ........................................................................100 15.10 IBP Alarm.......................................................................................................................101 Chapter 16 Monitoring CO2 ..........................................................................................................102 16.1 Overview ..........................................................................................................................102 16.2 CO2 Safety Information....................................................................................................102 16.3 Monitoring Procedures.....................................................................................................103 16.3.1 Zeroing the sensor .................................................................................................103 16.3.2 Sidestream CO2 Module........................................................................................103 16.3.3 Mainstream CO2 Module ......................................................................................105 16.4 Setting CO2 Waveform Setup...........................................................................................107 16.5 Setting CO2 Corrections...................................................................................................107 16.6 Changing CO2 Alarms......................................................................................................108 16.7 Changing the Apnea Alarm Delay....................................................................................108 Chapter 17 Monitoring C.O. .........................................................................................................109 17.1 Overview ..........................................................................................................................109 17.2 C.O. Safety Information...................................................................................................109 17.3 C.O. Monitoring Procedures ............................................................................................109 17.4 C.O. Measurement Window............................................................................................. 110 17.5 Measurement Process.......................................................................................................112 17.6 Editing C.O. ..................................................................................................................... 113 17.7 Blood Temperature Monitoring........................................................................................ 113 17.8 Setting the Computation Constant ................................................................................... 114 17.9 Recording C.O. Measurements ........................................................................................ 114 17.10 Setting INJ. TEMP Source ............................................................................................. 114 Chapter 18 Monitoring AG ........................................................................................................... 115 18.1 Overview .......................................................................................................................... 115 IX
18.2 Safety Information ........................................................................................................... 115 18.2.1 Safety Information for ISA Analyzer ....................................................................115 18.2.2 Safety Information for IRMA Module ..................................................................117 18.3 Monitoring Steps.............................................................................................................. 118 18.3.1 Monitoring Steps for ISA Analyzer.......................................................................118 18.3.2 Monitoring Steps for IRMA Module.....................................................................120 18.4 Setting Work Mode ..........................................................................................................123 18.5 Setting Alarms..................................................................................................................124 18.6 Setting Apnea Alarm Time ...............................................................................................124 18.7 Working Status of ISA analyzer .......................................................................................124 18.8 Working Status of IRMA Module ....................................................................................124 18.9 N2O and O2 Compensations .............................................................................................125 18.10 Effects of humidity.........................................................................................................125 Chapter 19 Freeze ..........................................................................................................................126 19.1 Overview ..........................................................................................................................126 19.2 Entering/Exiting Freeze Status.........................................................................................126 19.2.1 Entering Freeze Status...........................................................................................126 19.2.2 Exiting Freeze Status.............................................................................................126 19.3 Reviewing Frozen Waveform...........................................................................................127 Chapter 20 Review .........................................................................................................................128 20.1 Trend Graph Review ........................................................................................................128 20.1.1 Selecting Trend Graph of Specific Parameter.......................................................128 20.1.2 Adjusting Trend Scale ...........................................................................................128 20.1.3 Setting Resolution .................................................................................................129 20.1.4 Scrolling Left and Right the Screen ......................................................................129 20.1.5 Switching to the Trend Table ................................................................................129 20.1.6 Record ...................................................................................................................129 20.2 Trend Table Review .........................................................................................................129 20.2.1 Setting Resolution .................................................................................................129 20.2.2 Scrolling the Screen ..............................................................................................129 X
20.2.3 Switching to Trend Graph .....................................................................................130 20.2.4 Recording ..............................................................................................................130 20.3 NIBP Review....................................................................................................................130 20.3.1 Scrolling the Screen ..............................................................................................130 20.3.2 Recording ..............................................................................................................130 20.4 Alarm Review...................................................................................................................130 20.4.1 Scrolling the Screen ..............................................................................................130 20.4.2 Selecting Alarm Event of Specific Parameter.......................................................131 20.4.3 Setting Time Index ................................................................................................131 20.5 Arr Review .......................................................................................................................131 20.5.1 Scrolling the Screen ..............................................................................................131 20.6 12-lead Diagnosis Review................................................................................................132 20.6.1 Scrolling the Screen ..............................................................................................132 20.6.2 Deleting Diagnosis Results ...................................................................................132 20.6.3 Switching Between Waveforms and Results.........................................................132 20.6.4 Recording ..............................................................................................................132 Chapter 21 Calculation and Titration Table................................................................................133 21.1 Drug Calculation ..............................................................................................................133 21.1.1 Calculation Procedures..........................................................................................133 21.1.2 Calculation Unit ....................................................................................................134 21.2 Titration Table ..................................................................................................................134 21.3 Hemodynamic Calculation...............................................................................................135 21.3.1 Calculation Procedure ...........................................................................................135 21.3.2 Input Parameters....................................................................................................135 21.3.3 Output Parameters.................................................................................................135 Chapter 22 Recording....................................................................................................................137 22.1 General Information .........................................................................................................137 22.2 Performance of the Recorder ...........................................................................................137 22.3 Recording Type ................................................................................................................138 22.4 Starting and Stopping Recording .....................................................................................138 XI
22.5 Recorder Operations and Status Messages ......................................................................139 22.5.1 Record Paper Requirement ...................................................................................139 22.5.2 Proper Operation ...................................................................................................139 22.5.3 Paper Out...............................................................................................................140 22.5.4 Replacing Paper ....................................................................................................140 22.5.5 Removing Paper Jam.............................................................................................141 Chapter 23 Other Functions..........................................................................................................142 23.1 Nurse Call.........................................................................................................................142 23.2 Analog Output and Defibrillator Synchronization ...........................................................142 23.3 Storing Data in a Removable Device ...............................................................................142 23.3.1 Data Stored in the Removable Device ..................................................................142 23.3.2 Activating/ Deactivating Data Storing ..................................................................143 23.3.3 Selecting a Removable Device..............................................................................143 23.3.4 Reviewing Data Stored in a Removable Device ...................................................143 23.3.5 Deleting Data Stored in a Removable Device.......................................................143 23.3.6 Ejecting a Removable Device ...............................................................................144 Chapter 24 Using Battery ..............................................................................................................145 24.1 Battery Power Indicator ...................................................................................................145 24.2 Battery Status on the Main Screen ...................................................................................145 24.3 Checking Battery Performance ........................................................................................145 24.4 Replacing the Battery.......................................................................................................146 24.5 Recycling the Battery.......................................................................................................147 24.6 Maintaining the Battery....................................................................................................147 Chapter 25 Care and Cleaning .....................................................................................................148 25.1 General Points ..................................................................................................................148 25.2 Cleaning ...........................................................................................................................148 25.2.1 Cleaning the Monitor ............................................................................................148 25.2.2 Cleaning the Accessories.......................................................................................149 25.3 Disinfection ......................................................................................................................150 Chapter 26 Maintenance ...............................................................................................................151 XII
26.1 Inspecting .........................................................................................................................151 26.2 Maintenance Task and Test Schedule...............................................................................151 Chapter 27 Warranty and Service................................................................................................153 27.1 Warranty ...........................................................................................................................153 27.2 Contact information .........................................................................................................153 Chapter 28 Accessories ..................................................................................................................154 28.1 ECG Accessories..............................................................................................................154 28.2 SpO2 Accessories .............................................................................................................156 28.3 NIBP Accessories.............................................................................................................157 28.4 Temp Accessories.............................................................................................................159 28.5 Quick Temp Accessories* ................................................................................................159 28.6 IBP Accessories................................................................................................................159 28.7 CO2 Accessories ...............................................................................................................160 28.8 C.O. Accessories* ............................................................................................................161 28.9 AG Accessories* ..............................................................................................................161 28.10 Other Accessories...........................................................................................................162 A Product Specification .................................................................................................................164 A.1 Classification.....................................................................................................................164 A.2 Physical Specifications......................................................................................................164 A.2.1 Size and Weight......................................................................................................164 A.2.2 Environment Specification.....................................................................................164 A.2.3 Display ...................................................................................................................165 A.2.4 Battery Specification ..............................................................................................166 A.2.5 Recorder .................................................................................................................166 A.2.6 Data Storage ...........................................................................................................167 A.3 ECG...................................................................................................................................167 A.4 RESP .................................................................................................................................172 A.5 NIBP..................................................................................................................................173 A.6 SpO2 ..................................................................................................................................175 A.7 TEMP ................................................................................................................................176 XIII
A.8 Quick TEMP .....................................................................................................................176 A.9 IBP.....................................................................................................................................176 A.10 CO2 ..................................................................................................................................177 A.11 C.O. .................................................................................................................................180 A.12 AG ...................................................................................................................................181 A.12.1 Phasein Sidestream...............................................................................................181 A.12.2 Phasein Mainstream .............................................................................................183 B EMC Information.......................................................................................................................187 B.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS.................................187 B.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS .................................187 B.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING................................................................................................................189 B.4 Recommended Separation Distances ................................................................................190 C Default Settings...........................................................................................................................192 C.1 Patient Information Default Settings .................................................................................192 C.2 Alarm Default Settings ......................................................................................................192 C.3 ECG Default Settings ........................................................................................................192 C.4 RESP..................................................................................................................................194 C.5 SpO2 ...................................................................................................................................194 C.6 PR ......................................................................................................................................194 C.7 NIBP ..................................................................................................................................195 C.8 TEMP ................................................................................................................................195 C.9 Quick TEMP......................................................................................................................196 C.10 IBP...................................................................................................................................196 C.11 CO2 ..................................................................................................................................197 C.12 C.O...................................................................................................................................197 C.13 AG....................................................................................................................................198 D Abbreviations..............................................................................................................................199
XIV
Patient Monitor User Manual
Intended Use and Safety Guidance
Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use The iM50 patient monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2) and quick temperature (Quick TEMP). This monitor is suitable for use in intra-hospital transport and hospital environments including clinic, emergency department, wards, PACU and NICU. The iM60 patient monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2) and cardiac output (C.O.). This monitor is suitable for use in hospital environments including OR, ICU, NICU, PACU and wards. The iM70 patient monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.) and anesthetic gas (AG). This monitor is suitable for use in hospital environments including OR, ICU, NICU, PACU and wards. The iM80 patient monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.) and anesthetic gas (AG). This monitor is suitable for use in hospital environments including OR, ICU, NICU, PACU and wards. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
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Patient Monitor User Manual
Intended Use and Safety Guidance
1.2 Safety Guidance WARNING 1 Before using the device, the equipment, patient cable and electrodes etc. should be checked. Replacement should be taken if there is any evident defect or signs of aging which may impair the safety or performance. 2 Medical technical equipment such as these monitor/monitoring system must only be used by persons who have received adequate training in the use of such equipment and who are capable of applying it properly. 3 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur. 4 SHOCK HAZARD-The power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet. 5 Extreme care must be exercised when applying medical electrical equipment. Many parts of the human/machine circuit are conductive, such as the patient, connectors, electrodes, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device. Such contact would bridge the patient's isolation and cancel the protection provided by the isolated input. In particular, there must be no contact of the neutral electrode and ground. 6 Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. 7 Route all cables away from patient’s throat to avoid possible strangulation. 8 Devices connecting with monitor should be equipotential. 9 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the standard IEC/EN 60601-1-1. Therefore anybody, who connects additional equipment to the signal input or output connector to configure a medical system, must make sure that it complies with the requirements of the valid version of the system standard IEC/EN60601-1-1. If in doubt, consult our technical service department or your local distributor. 10 Only patient cable and other accessories supplied by EDAN can be used. Or else, the performance and electric shock protection cannot be guaranteed, and the patient may be injured.
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Patient Monitor User Manual
Intended Use and Safety Guidance
WARNING 11 Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. 12 When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients. 13 During monitoring, if the power supply is off and there is no battery for standby, the monitor will be off, and only the patient information and alarm settings can be saved. After reconnecting the power supply, the user should turn on the monitor for monitoring. 14 Keep away from fire immediately when leakage or foul odor is detected. 15 The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product. 16 Dispose of the package material, observing the waste control regulations and keeping it out of children’s reach. 17 After defibrillation, the screen display recovers within 10 seconds if the correct electrodes are used and applied based on the manufacturers’ instructions. 18 This equipment is not intended for family usage.
CAUTION 1 Electromagnetic Interference - Ensure that the environment in which the patient monitor is installed is not subject to any sources of strong electromagnetic interference, such as radio transmitters, mobile telephones, etc. 2 Keep the environment clean. Avoid vibration. Keep it far away from corrosive medicine, dust area, high temperature and humid environment. 3 Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid pouring fluids directly on the transducer. 4 Do not use autoclave or gas to sterilize the monitor, recorder or any accessories. 5 The device and reusable accessories could be sent back to the manufacturer for recycling or proper disposal after their useful lives. 6 Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.
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Patient Monitor User Manual
Intended Use and Safety Guidance
CAUTION 7 Remove a battery whose life cycle has expired from the monitor immediately. 8 Avoid liquid splash on the device. The temperature must be kept between 5°C and 40°C while working. And it should be kept between -20°C and 55°C during transportation and storage. 9 To ensure patient safety, use only parts and accessories manufactured or recommended by EDAN. 10 Federal (U.S.) law restricts this device to sale by or on the order of a physician.
NOTE: 1 Position the device in a location where the operator can easily see the screen and access the operating controls. 2 The monitor can only be used on one patient at a time. 3 If the monitor gets damp or liquid pours on the monitor, please contact the service personnel of EDAN. 4 This monitor is not a device for treatment purposes. 5 The pictures and interfaces in this manual are for reference only. 6 Regular preventive maintenance should be carried out every two years. You are responsible for any requirements specific to your country. 7 The monitor may not be compatible with all models of USB flash drives. Use the USB flash drives that are recommended by EDAN. 8 It is recommended to format the USB flash drive to the FAT file type via PC prior to use.
1.3 Explanation of Symbols on the Monitor This symbol indicates that the equipment is IEC/EN60601-1 Type CF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation. This symbol indicates that the instrument is IEC/EN 60601-1 Type BF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation. Symbol for “Caution”
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Patient Monitor User Manual
Intended Use and Safety Guidance
Equipotential grounding terminal
Alternating Current Power Supply switch
Serial number
Network port
USB (Universal Serial Bus) Connection
Audio alarm is off
NIBP measurement
Trend graph
Freeze
Record
Menu
VGA output, External Monitor
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Patient Monitor User Manual
Intended Use and Safety Guidance
RS-232 port
Nurse call port
SD Card port
Signal output port
Signal output
The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices.
Authorized representative in the European community
Date of manufacture
Manufacturer P/N
Part Number
Recycle The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Consult Instructions For Use
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Patient Monitor User Manual
Intended Use and Safety Guidance
Locked position
Gas inlet
Gas outlet (evac)
ISA equipped to measure CO2 only.
ISA equipped to measure multiple gases.
Federal (U.S.) Law restricts this device to sale by or on the order of a physician. (Only applicable to iM50 and iM80) With respect to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1and CAN/CSA C22.2 No. 601.1, IEC 60601-2-25*, IEC 60601-2-27, IEC 60601-2-30,IEC 60601-2-34, IEC 60601-2-49, IEC 60601-2-51* (Symbol * means this standard only applicable to iM80)
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Patient Monitor User Manual
Installation
Chapter 2 Installation NOTE: 1 The monitor settings must be specified by the authorized hospital personnel. 2 To ensure that the monitor works properly, please read the user manual and follow the steps before using the monitor.
2.1 Initial Inspection Before unpacking, check the packaging and ensure that there are no signs of mishandling or damage. If the shipping cartons are damaged, contact the carrier for compensation and package them again. Open the package carefully and remove the monitor and accessories. Check that the contents are complete and that the correct options and accessories have been delivered. If you have any question, please contact your local supplier.
2.2 Mounting the Monitor If all situations are normal, please place the monitor on a flat, level surface, hung on the bed rail, or mounted on a wall. About how to install the wall mount for the monitor, please refer to the following content.
2.2.1 Installing Wall Mount for the Monitor For how to install wall mount for the monitor, please refer to Wall Mounting Bracket Assembly Instruction.
2.3 Connecting the Power Cable Connection procedure of the AC power line is listed below: 1
Make sure the AC power supply complies with the following specifications: 100V-240V~, 50Hz/60Hz.
2
Apply the power line provided with the monitor. Plug the power line to inlet interface of the monitor. Connect the other end of the power line to a grounded 3-phase power output.
NOTE: Connect the power line to the jack special for hospital usage.
2.4 Checking Out the Monitor Make sure there is no damage on the measurement accessories and cables. Then turn on the monitor, check whether the monitor can start normally. Make sure all alarm lamps light up and the alarm sound is heard when turning on the monitor.
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WARNING If any sign of damage is detected, or the monitor displays some error messages, do not use it on any patient. Contact Customer Service Center immediately.
NOTE: 1 Check all the functions of the monitor and make sure that the monitor is in good status. 2 If rechargeable batteries are provided, charge them after using the device every time, to ensure the electric power is enough. 3 The interval between double pressing of POWER switch should be longer than 1 minute. 4 After continuous 360-hour runtime, please restart the monitor to ensure the monitor’s steady performance and long lifespan.
2.5 Checking the Recorder If your monitor is equipped with a recorder, open the recorder’s door to check if paper is properly installed in the slot. If no paper exists, refer to Chapter Recording for details.
2.6 Setting the Date and Time To set the date and time: 1. Select Menu > Maintenance > User Maintain > Date/Time Setup. 2. Adjust the date display format based on the user’s habit. 3. Set the correct time of year, month, day, hour, min and sec.
2.7 Handing Over the Monitor If you are handing over the monitor to the end-users directly after configuration, make sure that it is in the monitoring mode. The users must be adequately trained to use the monitor before monitoring a patient. To achieve this, they should have access to, and read, the following documentation delivered with the monitor: User Manual (this book) - for full operating instructions. Quick Reference Card - for quick reminders during use.
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Patient Monitor User Manual
Basic Operation
Chapter 3 Basic Operation This manual is for clinical professionals using the iM50/iM60/iM70/iM80 patient monitors. Unless otherwise specified, the information here is valid for all the above products. This user manual describes all features and options. Your monitor may not have all of them; they are not all available in all geographies. Your monitor is highly configurable. What you see on the screen, how the menus appear and so forth, depend on the way it has been tailored for your hospital and may not be exactly as shown here.
3.1 Overview 3.1.1 Front View
1
2 10 00 3
4
5
6
7
8
iM50
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2
10
3
4
5
6
7
8
9
iM60
1
2
10
3
4
5
6 iM70 - 11 -
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Patient Monitor User Manual
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1
2
10
3
4
5
6
7 8
9
iM80
1
Alarm indicator — when an alarm occurs, the alarm indicator will light or flash. The color of light represents the alarm level.
2
Power supply switch — when the monitor is connected to the AC power supply, press the key to turn the monitor on. When the monitor is turned on, press the key to turn the monitor off.
3
Battery indicator, refer to Section Battery Indicator for details.
4
Mute — Press this button to pause the alarm. All the audio alarm will be closed. At the same time, the message of Temporary Alarm Mute **s and the symbol will be displayed in the information area. When you repress it or the pause time is over, the system will resume the normal monitoring status and the message of Temporary Alarm Mute **s and icon will vanish. Symbol is shown in the information area. Pressing or holding the button again can resume the alarm. Further Alarm Mute information can be found in the chapter Alarm Mute.
5
Start / Stop NIBP measurement — Press this button to inflate the cuff and start blood pressure measurement. During the measurement, press the button to stop the measurement.
6
Trend Key — Press this button to enter trend table review interface.
7
Freeze /Unfreeze — In normal mode, press this button to freeze all the waveforms on the screen. In Freeze mode, press this button to restore the waveform refreshing.
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8
Start / Stop Recording — Press this button to start a real-time recording. During the recording, press this button again to stop recording.
9
Menu — Press this button to return to the main interface when there is no menu open.
10
Rotary Knob (hereinafter called knob) — The user can rotate the knob clockwise or anticlockwise. This operation can make the highlighted item shift up, down, left or right to choose the desired item. Remember, when using the knob, rotate this button to highlight, and press it to select the item.
3.1.2 Rear View
1
2
10
3 4 11
5
6
7
8
9
iM50
1
Equipotential grounding terminal, if the monitor or other processing unit are used in internal examinations on the heart, ensure that the room incorporates an equipotential grounding system to which the monitor and other processing unit have separate connection.
2
Fan
3
Anti-theft lock interface
4
Security lock, used to prevent the power supply cord from falling.
5
Power Supply Inlet
6
USB interface, this port is used to connect the USB device. - 13 -
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7
VGA Interface
8
Network interface, this port is used to connect to the central monitoring system through the standard network wire.
9
Defibrillator synchronization / analog output. When the user selects Analog Output, the monitor outputs the waveform through the auxiliary output port. When the user selects Defibrillation the monitor outputs the defibrillator synchronization signal through the auxiliary output port.
10
Speaker
11
SD Card
1 8
2 3 4
9
5
10 11
6
7
iM60/iM70
1
SD Card
2
USB interface, this port is used to connect the USB device.
3
Network interface, this port is used to connect to the central monitoring system through the standard network wire.
4
VGA output
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Patient Monitor User Manual
Basic Operation
5
Defibrillator synchronization/ analog output/ nurse call port: When the user selects Analog Output, the monitor outputs the waveform through the auxiliary output port. When the user selects Defibrillation, the monitor outputs the defibrillator synchronization signal through the auxiliary output port. When the port is used as nurse call port, it is connected to the call system. When there is an alarm, the monitor outputs nurse call signal to notify the nurse.
6
Anti-theft lock interface
7
Heat sink
8
Speaker
9
Equipotential grounding terminal, if the monitor or other processing unit are used in internal examinations on the heart, ensure that the room incorporates an equipotential grounding system to which the monitor and other processing unit have separate connection.
10
Power Supply Inlet
11
Security lock, used to prevent the power supply cord from falling.
1
13
2 3 12
4
5
11
6
7
8 iM80
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1
SD Card
2
Nurse call port, this port is connected to the call system. When there is an alarm, the monitor outputs nurse call signal to notify the nurse.
3
Defibrillator synchronization / analog output. When the user selects Analog Output, the monitor outputs the waveform through the auxiliary output port. When the user selects Defibrillation, the monitor outputs the defibrillator synchronization signal through the auxiliary output port.
4
VGA output
5
USB interface, this port is used to connect the USB device.
6
RS232 interface
7
Network interface, this port is used to connect to the central monitoring system through the standard network wire.
8
Anti-theft lock interface
9
Heat emission hole
10
Security lock, used to prevent the power supply cord from falling.
11
Equipotential grounding terminal, if the monitor or other processing unit are used in internal examinations on the heart, ensure that the room incorporates an equipotential grounding system to which the monitor and other processing unit have separate connection.
12
Speaker
13
Fan
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Basic Operation
3.1.3 Side View
1 3
2
4
iM50
1
Sensor interface
2
CO2 module holder
3
Recorder door
4
Battery door
1 3
4
2
iM60/iM70
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Basic Operation
1
Sensor port
2
CO2 module holder
3
Recorder door
4
Battery door
3
1
2
4
iM80
1
Sensor port
2
AG module holder
3
Recorder door
4
Battery door
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Patient Monitor User Manual
Basic Operation
3.1.4 Configuration Model
Size (L×W×H)
Function Configuration
iM50
261 mm (L) × 198 mm (W) × 215 mm (H)
ECG, RESP, SpO2, NIBP, IBP ,TEMP, Quick TEMP, CO2
iM60
303mm(L) × 161mm(W) × 254mm(H)
ECG, RESP, SpO2, NIBP, TEMP, IBP, C.O., CO2
328mm(L) × 158mm(W) × 285mm(H)
ECG, RESP, SpO2, NIBP, TEMP, IBP, C.O., CO2, AG
370 mm (L) × 175 mm (W) × 320 mm (H)
ECG, RESP, SpO2, NIBP, TEMP, IBP, C.O., CO2, AG
iM70
iM80
3.2 Operating and Navigating Everything you need to operate the monitor is contained on its screen. Almost every element on the screen is interactive. Screen elements include measurement data, waveforms, screen keys, information fields, alarms fields and menus. The configurability of the monitor means that often you can access the same element in different ways. For example, you might be able to access an item through its on-screen setup menu, via a hard key, or via a shortcut key. The User Manual always describes how to access items via an on-screen menu. You may use whichever way you find most convenient.
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Basic Operation
1
Department
2
Bed number
3
Patient name
4
Patient type
5
Alarm status area
6
Alarm off
7
Measurement value
8
Menu
9
Date and time
10
Scroll right to display more shortcut keys
11
Networking symbol
12
Battery status symbol
13
AC power supply symbol
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Patient Monitor User Manual
Basic Operation
14
Shortcut key area
15
Scroll left to display more shortcut keys
16
Mute key
17
Parameter waveform
3.2.1 Using Keys The monitor has four different types of keys:
3.2.1.1 Permanent Keys A permanent key is a graphical key that remains on the screen all the time to give you fast access to functions. Menu – enter the main setup menu. Mute key – close the audio alarm to switch off the alarm.
3.2.1.2 Shortcut Keys A shortcut key is a configurable graphical key, located at the bottom of the main screen. It gives you fast access to functions. The selection of shortcut keys available on your monitor depends on your monitor configuration and on the options purchased. Perform a 12-lead analysis
Switch to the standard screen
Exit from 12-lead analysis
Switch to the OxyCRG screen
Access the 12-lead review
Switch to the large font screen
Perform 12-lead record
Set the module switch
Admit a patient
Change the key volume
Review the trend graph
Adjust the screen brightness
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Review the trend table
Zero the IBP sensor
Review the alarm event
Alarm setup
Access the NIBP review
Change the beat volume
Access the ARR review
Enter standby mode
Switch to the trend screen
Enter night mode
Select this item by the trim knob to enable the touch screen operation
3.2.1.3 Hardkeys A hardkey is a physical key on a monitoring device, such as the recording key on the front panel.
3.2.1.4 Pop-up keys Pop-up keys are task-related graphical keys that appear automatically on the screen when required. For example, the confirmation pop-up key appears only when you need to confirm a change.
3.3 Operating Mode 3.3.1 Demo Mode To change the operating mode into the demo mode, please refer to the following procedure: Select Menu > Common Function, then choose Demo Mode from the popup interface and input password 3045. After entering Demo Mode, the monitor will perform the followings: Storing no data of new patient. Pausing to give all types of alarm. Pausing to transmit patient data to CMS and other network devices. Pausing to store the currently recorded data, and clearing the memory used to store recording and printing data. - 22 -
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Basic Operation
Real data: the parameter measurement value and real waveform displayed on the screen are from the predefined analog data, not the truly monitoring patients’ data. History data: the monitor will store the analog real-time data in Demo mode, including trend data, patient information, alarm event, waveform and setting. To exit Demo Mode, select Menu > Common Function > Demo Mode to exit. WARNING This is for demonstration purposes only. You must not change into Demo Mode during monitoring. In Demo Mode, all stored trend information is deleted from the monitor’s memory.
3.3.2 Standby Mode Standby mode can be used when you want to temporarily interrupt monitoring. To enter standby mode, please press the shortcut key anything on the screen or press any key.
on the screen directly. To resume monitoring, select
3.3.3 Night Mode To switch to night mode, you may: Select the shortcut key
on the main screen, or
Select Menu> Common Function> Night Mode. NOTE: In night mode, the sound of key, heart beat and pulse is muted; the alarm volume and screen brightness are down to their minimum; the settings including key volume, beat volume, PR volume, alarm volume and screen brightness are unavailable.
3.4 Changing Monitor Settings 3.4.1 Adjusting Screen Brightness To change the screen brightness, please: 1. Press the Brightness key on the screen directly or. 2. Select Menu > Common Function > Brightness, and select the appropriate setting for the screen brightness. 10 is the brightest, 1 is the least bright. Your monitor may be configured with lower brightness in standby mode and also for transport to conserve battery power.
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3.4.2 Changing Date and Time To change the date and time, please refer to Section Setting Date and Time. WARNING Change to date and time will influence the storage of trend data.
3.5 Adjusting Volume 3.5.1 Adjusting Key Volume The key volume is the volume you hear when you select any field on the monitor screen or when you turn the knob. To adjust the key volume, please: 1. Select the Key Volume key on the screen directly or. 2. Select Menu > System Setup > Key Volume, then select the appropriate setting for the key volume: Five is the loudest and Zero is the quietest.
3.5.2 Adjusting Alarm Volume To change the alarm volume, please 1. Press the Alarm Volume key on the screen directly or. 2. Select Menu > Alarm Setup > Alarm Volume, and select the desired setting from the popup interface. For detailed information, please refer to Section Controlling Alarm Volume.
3.5.3 Adjusting Beat Volume To change the beat volume, please press the Beat Volume key on the screen directly or refer to Section Setting Beat Volume.
3.6 Checking Your Monitor Version To check the monitor version, please select Menu > Common Function > About to check the monitor software revision.
3.7 Networked Monitoring Your monitor can be connected to the wired network. If the monitor is networked, a network symbol is displayed on the screen.
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3.8 Setting Languages To change the language, please: 1. Select Menu > Maintenance > User Maintain, then type the correct password ABC into the displayed interface. 2. Select the Language option on the popup interface to open the language list. 3. Select the desired language from the list. To make the change validate, please restart the monitor.
3.9 Understanding Screens Your monitor comes with a set of preconfigured screens, optimized for common monitoring scenarios such as OR adult, or ICU neonatal. A screen defines the overall selection, size and position of waves, numeric and shortcut keys on the monitor screen when you switch on the monitor. You can easily switch between different screens during monitoring. Screens do NOT affect alarm settings, patient category and so forth. When you switch from a complex to a less complex screen layout, some measurements may not be visible but are still monitored in the background. For detailed information, please refer to Chapter User Interface.
3.10 Calibrating Screens To calibrate the screen, please refer to the following steps: 1. Select Menu > Maintenance > User Maintain, then input maintenance password ABC, then select TouchScr Calibration from the popup interface. 2. The symbol
appears on the screen. .
3. Click on the central point of the symbol
4. After successful calibration, the message of Screen Calibration Completed appears on the screen. Then select Exit to finish the calibration.
3.11 Disabling the Touch Screen The user can disable touch screen operation by pressing and holding the Menu shortcut key for 3 seconds. A message of Screen Locked and the symbol are displayed at the bottom of screen if the touch screen is disabled. To enable the touch screen operation, turn the knob to select the symbol
and press it.
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3.12 Using the Barcode Scanner To enter the barcode setup menu, please select Menu > Maintenance > User Maintain, after entering the required password ABC, select Other Setup > BarCode Setup. Then the user can set serial No, last Name, first Name and so on. If Auto Update is set to On, the patient information is updated automatically by using a bar code scanner. If Auto Update is set to Off, the user needs to update the patient information manually.
3.13 Resolving IBP Label Conflicts Each label must be unique and can only be assigned once. The measurement labels are stored in the measurement modules. If you try to use two IBP channels that have identical labels, this causes a label conflict in the monitor. For example, an IBP channel (channel A) has already been loaded and the label Art is used for channel A. Then another IBP channel (channel B) is loaded and the label Art is also used for channel B. In this case, a label conflict will be triggered. A prompt indicating IBP label conflict will appear on the left of the screen. Additionally, at the corresponding measurements area, a label flickers to indicate a label conflict. The flickering label is the default one assigned by the system. The IBP channel with a label conflict will not provide any measurement data; besides, the functions of setup, zeroing and calibrating are unavailable. To resolve the label conflict, you have to change the conflicting label into a non-conflicting one via the following method: 1
Select the IBP channel with a label conflict on the screen and open the Options menu.
2
Choose another label among the options from the Alias pull-down list to resolve the label conflict.
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Alarms
Chapter 4 Alarms The alarm information here applies to all measurements. Measurement-specific alarm information is discussed in the sections of individual measurements. WARNING A potential hazard can exist 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.
4.1 Alarm Category The monitor provides two types of alarms: physiological alarms and technical alarms.
4.1.1 Physiological alarms If one or several physiological parameters of the currently monitored patient exceed the predefined alarm limit, for example: SpO2 values exceed the alarm limit, the monitor will give an alarm, and this type of alarm is called physiological alarms. About the detailed alarm information, please refer to the Section physiological alarm information.
4.1.2 Technical Alarms If one or several technical status of the device is in abnormal status, such as: lead off or low battery and so on, the monitor will give an alarm. And this type of alarm is called technical alarms. About the detailed alarm information, please refer to Section technical alarm information.
4.1.3 Prompts The monitor can give the character indication of monitoring process or other functions, such as: ARR Relearning and so on. And this character is called prompts. About the detailed alarm information, please refer to Section Prompts.
4.2 Alarm Levels In terms of severity, the device’s alarm levels can be classified into three categories: high level alarms, medium level alarms and low level alarms. 1. High level alarms Indicating that the patient is in a life threatening situation and an emergency treatment is demanded. 2. Medium level alarms The patient’s vital signs appear abnormally or the device system status is abnormal, indicating that prompt operator response is required.
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Alarms
3. Low level alarms The patient’s vital signs appear abnormal or the device system status appears abnormally, indicating that operator awareness is required. The high/medium/low-level alarms are indicated by the system in following different ways: Alarm level
Physiological alarms
Technical alarms The alarm indicator flashes in red. The alarm message flashes with red background, and the symbol *** is displayed at the alarm area.
Medium
Mode is “DO-DO-DO”, which is triggered once every 25 seconds.
The alarm indicator flashes in red, with a frequency of 1.4Hz ～ 2.8Hz.The alarm message flashes with red background, and the symbol *** is displayed at the alarm area. The alarm indicator flashes in yellow, with a frequency of 0.4Hz ～ 0.8Hz. The alarm message flashes with yellow background, and the symbol ** is displayed at the alarm area.
Low
The alarm indicator flashes in yellow. The Mode is “DO-”, which alarm message flashes is triggered once every with yellow background, 30 seconds. and the symbol * is displayed at the alarm area.
The alarm indicator flashes in blue. The alarm message flashes with yellow background, and the symbol * is displayed at the alarm area.
High
Prompt
Mode is “DO-DO-DO------DODO, DO-DO-DO------DO-D O”, which is triggered once every 10 seconds.
No definition
The sound pressure range for audible alarm signals is from 45 dB to 84 dB.
4.3 Controlling Alarm 4.3.1 Setting Parameter Alarm Parameter alarm settings including alarm switch, alarm record, alarm level and alarm limit are available on the respective alarm setup menu for each parameter. To access the menu for parameter alarm settings, use the shortcut key or select Menu> Alarm Setup, and then click Alarm Options to open the menu shown below for alarm settings of each parameter. Also, you can access this menu via the respective parameter setup menu. - 28 -
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Alarms
Upper arrow or lower arrow to increase or decrease the alarm limit
High Alarm Limit
Setting value of high alarm limit
Setting value of low alarm limit
Low Alarm Limit
WARNING 1
When the alarm is set to OFF, the monitor won’t give an alarm prompt even if an alarm occurs. In order to avoid endangering the patient’s life, the user should use this function cautiously.
2
Prior to monitoring, make sure that the alarm limit settings are appropriate for your patient.
3
Setting alarm limits to extreme values may cause the alarm system to become ineffective.
4.3.2 Temporary Alarm Mute The monitor will give an audible alarm when there is an alarm during the audio alarm pause and the alarm indicator and screen flash indicating there is an alarm. The top of monitor displays the following: 1. Alarm pause symbol
.
2. The remaining pause time is displayed in text and the word background is red. The user can set the audio alarm pause to 60 s, 120 s, or 180 s based on the requirement.
4.3.3 Alarm Mute To mute the alarm, please select Menu > Maintenance > User Maintain > Alarm Setup, and key on the front panel for more than three seconds or set Mute to On, then press the press the Silence shortcut key on the screen directly. And alarm reminder tone DO is heard every three minutes.
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4.3.4 Controlling Alarm Volume The monitor provides five levels of alarm volume: 1, 2, 3, 4 and 5. For adjusting the alarm volume, please refer to Section Adjusting Alarm Volume.
4.4 Latching Alarms To set the alarm latch function, please select Menu > Maintenance > User Maintain > Alarm Setup and set Alarm Latch from the pull-down list. If it is set to On, when an alarm occurs, the monitor will display the alarm message of the parameter in the alarm status area. If the parameter resumes to normal, the alarm information of this parameter still displays in the alarm display area and the alarm time is also displayed. If many parameters appear to be latching alarms, the alarm messages are displayed in the physiological alarm message area in turn. To deselect the alarm latch, please set Alarm Latch to Off. When Alarm Latch is set to Off, the latch function is invalid.
4.5 Disabling Sensor Off Alarms To set sensor off alarm, please select Menu > Maintenance > User Maintain and enter the required password ABC. Then select Alarm Setup and set Sensor Off Alm from the pull-down list. If it is set to On, and a sensor off alarm occurs, the user can press the Mute key on the front panel to disable the alarm signal. Then the alarm indicator stops flashing, and the monitor is in temporary mute alarm status. If the user presses the Mute key again or the temporary mute time ends, no audible alarm for sensor-off status will be resumed. Instead, sensor-off status will be announced with a prompt message.
4.6 Testing Alarms When you switch the monitor on, a self test is started. You must check that the alarm indicator lights and that you hear a single tone. This indicates that the visible and audible alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on yourself or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed.
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Patient Monitor User Manual
Alarm Information
Chapter 5 Alarm Information 5.1 Physiological Alarm Information Message
Cause
Alarm level
HR High
HR measuring value is above the upper alarm limit.
User-selectable
HR Low
HR measuring value is below the lower alarm limit.
User-selectable
ST-X High
ST measuring value is above the upper alarm limit. (X stands for I, II, III, aVR, aVL, aVF, V, V1, V2, V3, User-selectable V4, V5 or V6)
ST-X Low
ST measuring value is below the lower alarm limit.(X stands for I, II, III, aVR, aVL, aVF, V, V1, V2, V3, User-selectable V4, V5 or V6)
PVCs High
PVCs measuring value is above the upper alarm limit.
User-selectable
ASYSTOLE
No QRS is detected for 4 consecutive seconds
High
VFIB/VTAC
Ventricular tachycardia: The RR interval of 4-second fibrillation wave or 5 consecutive ventricular beats is High less than 600 ms.
VT>2
3< the number of cluster PVCs < 5
User-selectable
COUPLET
2 consecutive PVCs
User-selectable
BIGEMINY
Vent Bigeminy
User-selectable
TRIGEMINY
Vent Trigeminy
User-selectable
R ON T
A type of single PVC under the condition that HR<100，R-R interval is less than 1/3 the average interval, followed by a compensating pause of 1.25X User-selectable the average R-R interval (the next R wave advances onto the previous T wave).
PVC
Single PVC detected in normal heartbeats.
TACHY
BRADY
Adult: 5 consecutive QRS complex, RR interval < 0.5s (HR range: 120~300bpm). Pediatric/neonatal: 5 consecutive QRS complex, RR interval < 0.375s (HR range: 160~350bpm). Adult: 5 consecutive QRS complex, RR interval ≥ 1.5s (HR range: 15~40bpm). Pediatric/neonatal: 5 consecutive QRS complex, RR interval ≥ 1s (HR range: 15~60bpm).
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User-selectable
User-selectable
User-selectable
Patient Monitor User Manual
Alarm Information
Message
Cause
Alarm level
MISSED BEATS
When HR is less than 120 beats/min., no heart beat is tested during the period 1.75 times of the average RR interval; or
User-selectable
When HR is ≥ 120 beats/min, no beat is tested within 1 second. IRR
IRREGULAR RHYTHM: The patient has irregular heart rate.
User-selectable
PNC
PACE NOT CAPTURE: After the pacemaker is paced, QRS complex can not be detected during 300ms.
User-selectable
PNP
PACER NOT PACED: After the QRS complex, no pace is detected during 1.75 times of RR interval.
User-selectable
VBRADY
VENTRICULAR BRADYCARDIA: The interval of 5 consecutive ventricular wave is more than 1000 ms.
User-selectable
VENT
VENTRICULAR RHYTHM: The interval of 5 consecutive ventricular wave ranges from 600 ms to 1000 ms.
User-selectable
RESP APNEA
RESP can not be measured within the set apnea alarm delay time.
High
RR High
RR measuring value is above upper alarm limit.
User-selectable
RR Low
RR measuring value is below lower alarm limit.
User-selectable
SpO2 High
SpO2 measuring value is above upper alarm limit.
User-selectable
SpO2 Low
SpO2 measuring value is below lower alarm limit.
User-selectable
SpO2 No Pulse
The signal of the measurement site is too weak, so the monitor can’t detect the pulse signal.
High
PR High
PR measuring value is above upper alarm limit.
User-selectable
PR Low
PR measuring value is below lower alarm limit.
User-selectable
T1 High
Measuring value of T1 channel is above upper alarm User-selectable limit.
T1 Low
Measuring value of T1 channel is below lower alarm User-selectable limit.
T2 High
Measuring value of T2 channel is above upper alarm User-selectable limit.
T2 Low
Measuring value of T2 channel is below lower alarm User-selectable limit.
TD High
Measuring value of TD channel is above upper alarm User-selectable limit. - 32 -
Patient Monitor User Manual
Alarm Information
Message
Cause
Alarm level
SYS High
SYS measuring value is above upper alarm limit.
User-selectable
SYS Low
SYS measuring value is below lower alarm limit.
User-selectable
DIA High
DIA measuring value is above upper alarm limit.
User-selectable
DIA Low
DIA measuring value is below lower alarm limit.
User-selectable
MAP High
MAP measuring value is above upper alarm limit.
User-selectable
MAP Low
MAP measuring value is below lower alarm limit.
User-selectable
Art SYS High
Art SYS measuring value is above upper alarm limit.
User-selectable
Art SYS Low
Art SYS measuring value is below lower alarm limit.
User-selectable
Art DIA High
Art DIA measuring value is above upper alarm limit.
User-selectable
Art DIA Low
Art DIA measuring value is below lower alarm limit.
User-selectable
Art MAP High
Art MAP measuring value is above upper alarm limit.
User-selectable
Art MAP Low
Art MAP measuring value is below lower alarm limit.
User-selectable
PA SYS High
PA SYS measuring value is above upper alarm limit.
User-selectable
PA SYS Low
PA SYS measuring value is below lower alarm limit.
User-selectable
PA DIA High
PA DIA measuring value is above upper alarm limit.
User-selectable
PA DIA Low
PA DIA measuring value is below lower alarm limit.
User-selectable
PA MAP High
PA MAP measuring value is above upper alarm limit.
User-selectable
PA MAP Low
PA MAP measuring value is below lower alarm limit.
User-selectable
CVP MAP High
CVP MAP measuring value is above upper alarm limit. User-selectable
CVP MAP Low
CVP MAP measuring value is below lower alarm limit. User-selectable
ICP MAP High
ICP MAP measuring value is above upper alarm limit.
User-selectable
ICP MAP Low
ICP MAP measuring value is below lower alarm limit.
User-selectable
LAP MAP High
LAP MAP measuring value is above upper alarm limit.
User-selectable
LAP MAP Low
LAP MAP measuring value is below lower alarm limit. User-selectable
RAP MAP High
RAP MAP measuring value is above upper alarm limit. User-selectable
RAP MAP Low
RAP MAP measuring value is below lower alarm limit. User-selectable
P1 SYS High
P1 SYS measuring value is above upper alarm limit.
User-selectable
P1 SYS Low
P1 SYS measuring value is below lower alarm limit.
User-selectable
P1 DIA High
P1 DIA measuring value is above upper alarm limit.
User-selectable
P1 DIA Low
P1 DIA measuring value is below lower alarm limit.
User-selectable
P1 MAP High
P1 MAP measuring value is above upper alarm limit.
User-selectable
P1 MAP Low
P1 MAP measuring value is below lower alarm limit.
User-selectable
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Patient Monitor User Manual
Alarm Information
Message
Cause
Alarm level
P2 SYS High
P2 SYS measuring value is above upper alarm limit.
User-selectable
P2 SYS Low
P2 SYS measuring value is below lower alarm limit.
User-selectable
P2 DIA High
P2 DIA measuring value is above upper alarm limit.
User-selectable
P2 DIA Low
P2 DIA measuring value is below lower alarm limit.
User-selectable
P2 MAP High
P2 MAP measuring value is above upper alarm limit.
User-selectable
P2 MAP Low
P2 MAP measuring value is below lower alarm limit.
User-selectable
EtCO2 High
EtCO2 measuring value is above upper alarm limit.
User-selectable
EtCO2 Low
EtCO2 measuring value is below lower alarm limit.
User-selectable
FiCO2 High
FiCO2 measuring value is above alarm limits.
User-selectable
CO2 APNEA
In the set apnea alarm delay time interval, no RESP High can be detected using CO2 module.
AwRR High
AwRR measuring value is above upper alarm limit.
User-selectable
AwRR Low
AwRR measuring value is below lower alarm limit.
User-selectable
EtCO2 (AG) High
EtCO2 (AG) measuring value is above upper alarm User-selectable limit.
EtCO2 (AG) Low
EtCO2 (AG) measuring value is below lower alarm User-selectable limit.
FiCO2 (AG) High
FiCO2 (AG) measuring value is above alarm limits.
AwRR (AG) High
AwRR (AG) measuring value is above upper alarm User-selectable limit.
AwRR (AG) Low
AwRR (AG) measuring value is below lower alarm User-selectable limit.
EtO2 High
EtO2 measuring value is above upper alarm limit.
User-selectable
EtO2 Low
EtO2 measuring value is below lower alarm limit.
User-selectable
FiO2 High
FiO2 measuring value is above upper alarm limit.
User-selectable
FiO2 Low
FiO2 measuring value is below lower alarm limit.
User-selectable
EtN2O High
EtN2O measuring value is above upper alarm limit.
User-selectable
EtN2O Low
EtN2O measuring value is below lower alarm limit.
User-selectable
FiN2O High
FiN2O measuring value is above upper alarm limit.
User-selectable
FiN2O Low
FiN2O measuring value is below lower alarm limit.
User-selectable
EtHAL High
EtHAL measuring value is above upper alarm limit.
User-selectable
EtHAL Low
EtHAL measuring value is below lower alarm limit.
User-selectable
FiHAL High
FiHAL measuring value is above upper alarm limit.
User-selectable
FiHAL Low
FiHAL measuring value is below lower alarm limit.
User-selectable
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User-selectable
Patient Monitor User Manual
Alarm Information
Message
Cause
Alarm level
EtENF High
EtENF measuring value is above upper alarm limit.
User-selectable
EtENF Low
EtENF measuring value is below lower alarm limit.
User-selectable
FiENF High
FiENF measuring value is above upper alarm limit.
User-selectable
FiENF Low
FiENF measuring value is below lower alarm limit.
User-selectable
EtISO High
EtISO measuring value is above upper alarm limit.
User-selectable
EtISO Low
EtISO measuring value is below lower alarm limit.
User-selectable
FiISO High
FiISO measuring value is above upper alarm limit.
User-selectable
FiISO Low
FiISO measuring value is below lower alarm limit.
User-selectable
EtSEV High
EtSEV measuring value is above upper alarm limit.
User-selectable
EtSEV Low
EtSEV measuring value is below lower alarm limit.
User-selectable
FiSEV High
FiSEV measuring value is above upper alarm limit.
User-selectable
FiSEV Low
FiSEV measuring value is below lower alarm limit.
User-selectable
EtDES High
EtDES measuring value is above upper alarm limit.
User-selectable
EtDES Low
EtDES measuring value is below lower alarm limit.
User-selectable
FiDES High
FiDES measuring value is above upper alarm limit.
User-selectable
FiDES Low
FiDES measuring value is below lower alarm limit.
User-selectable
AG FiO2 Low
FiO2 measure value is extremely low.
High
AG APNEA
In the set apnea alarm delay time interval, no RESP High can be detected using AG module.
TB High
TB measuring value is above upper alarm.
User-selectable
TB Low
TB measuring value is below lower alarm.
User-selectable
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Patient Monitor User Manual
Alarm Information
5.2 Technical Alarm Information NOTE: The ECG alarm information listed in the below table describes the lead names in America. For the corresponding lead names in Europe, please refer to Section Installing Electrodes. Message
Cause
Alarm Level
ECG Lead Off
1) The drive lead or more than one ECG limb electrode falls off the skin; 2) ECG cables fall off the monitor.
Low
ECG V Lead Off
ECG electrode V falls off the skin or the ECG cable V falls off the monitor.
Low
ECG LL Lead Off
ECG electrode LL falls off the skin or the ECG cable LL falls off the monitor.
Low
ECG LA Lead Off
ECG electrode LA falls off the skin or the ECG cable LA falls off the monitor.
Low
ECG RA Lead Off
ECG electrode RA falls off the skin or the ECG cable RA falls off the monitor.
Low
ECG Signal Exceed
ECG measuring value is beyond measuring range.
High
Check lead connection and patient condition
ECG Signal Overflow
The amplitude of ECG signal is too wide.
Low
Please modify the ECG gain.
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Action Taken
Make sure that all electrodes, leads and patient cables are properly connected.