EDAN INSTRUMENTS IM60EDAN Patient Monitor User Manual

EDAN INSTRUMENTS, INC. Patient Monitor

User Manual

I About this Manual P/N: 01.54.455711-1201 Release Date: August 2013 © Copyright EDAN INSTRUMENTS, INC. 2012-2013. All rights reserved. StatementThis 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 ManufacturerEDAN 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.
II Terms Used in this ManualThis 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. CAUTIONA 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.
IIITable 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 2.8 FCC Statement* .....................................................................................................................9 2.9 FCC RF Radiation Exposure Statement*.............................................................................10 Chapter 3 Basic Operation.............................................................................................................. 11 3.1 Overview..............................................................................................................................11 3.1.1 Front View.................................................................................................................11 3.1.2 Rear View..................................................................................................................14 3.1.3 Side View ..................................................................................................................18 3.1.4 Configuration ............................................................................................................20 3.2 Operating and Navigating ....................................................................................................20 3.2.1 Using Keys................................................................................................................22 3.3 Operating Mode ...................................................................................................................23 3.3.1 Demo Mode...............................................................................................................23 3.3.2 Standby Mode ...........................................................................................................24 3.3.3 Night Mode ...............................................................................................................24 3.4 Changing Monitor Settings ..................................................................................................24 3.4.1 Adjusting Screen Brightness .....................................................................................24
IV3.4.2 Changing Date and Time...........................................................................................25 3.5 Adjusting Volume.................................................................................................................25 3.5.1 Adjusting Key Volume ..............................................................................................25 3.5.2 Adjusting Alarm Volume...........................................................................................25 3.5.3 Adjusting Beat Volume..............................................................................................25 3.6 Checking Your Monitor Version ..........................................................................................25 3.7 Networked Monitoring.........................................................................................................25 3.8 Setting Languages ................................................................................................................26 3.9 Understanding Screens.........................................................................................................26 3.10 Calibrating Screens ............................................................................................................26 3.11 Disabling the Touch Screen................................................................................................26 3.12 Using the Barcode Scanner ................................................................................................27 3.13 Resolving IBP Label Conflicts...........................................................................................27 Chapter 4 Alarms .............................................................................................................................28 4.1 Alarm Category ....................................................................................................................28 4.1.1 Physiological alarms .................................................................................................28 4.1.2 Technical Alarms.......................................................................................................28 4.1.3 Prompts .....................................................................................................................28 4.2 Alarm Levels ........................................................................................................................28 4.3 Controlling Alarm ................................................................................................................29 4.3.1 Setting Parameter Alarm ...........................................................................................29 4.3.2 Temporary Alarm Mute.............................................................................................30 4.3.3 Alarm Mute ...............................................................................................................30 4.3.4 Controlling Alarm Volume........................................................................................31 4.4 Latching Alarms...................................................................................................................31 4.5 Disabling Sensor Off Alarms ...............................................................................................31 4.6 Testing Alarms......................................................................................................................31 Chapter 5 Alarm Information.........................................................................................................32 5.1 Physiological Alarm Information.........................................................................................32 5.2 Technical Alarm Information ...............................................................................................37
V5.3 Prompts ................................................................................................................................49 5.4 Adjustable Range of Alarm Limits.......................................................................................51 Chapter 6 Managing Patients .........................................................................................................56 6.1 Admitting a Patient...............................................................................................................56 6.1.1 Patient Category and Paced Status............................................................................56 6.2 Quick Admit.........................................................................................................................57 6.3 Editing Patient Information..................................................................................................57 6.4 Updating a Patient................................................................................................................57 6.5 Central Monitoring System..................................................................................................57 Chapter 7 User Interface.................................................................................................................59 7.1 Setting Interface Style ..........................................................................................................59 7.2 Selecting Display Parameters...............................................................................................59 7.3 Changing Waveform Position ..............................................................................................59 7.4 Changing Interface Layout...................................................................................................59 7.5 Viewing Trend Screen ..........................................................................................................59 7.6 Viewing Oxygen Screen.......................................................................................................60 7.7 Viewing Large Font Screen..................................................................................................60 7.8 Viewing the Bed View Window ...........................................................................................61 7.8.1 Opening the Bed View Window................................................................................61 7.8.2 Settings of the Bed View Window ............................................................................61 7.9 Changing Parameter and Waveform Colors.........................................................................61 7.10 User Configuration.............................................................................................................61 7.11 Default Configuration ........................................................................................................62 Chapter 8 Monitoring ECG ............................................................................................................63 8.1 Overview..............................................................................................................................63 8.2 ECG Safety Information ......................................................................................................63 8.3 ECG Display ........................................................................................................................64 8.3.1 Changing the Size of the ECG Wave ........................................................................64 8.3.2 Changing the ECG Filter Settings.............................................................................65 8.4 Using ECG Alarms...............................................................................................................65
VI8.5 Selecting Calculation Lead ..................................................................................................65 8.6 Monitoring Procedure ..........................................................................................................66 8.6.1 Preparation ................................................................................................................66 8.6.2 Connecting ECG Cables ...........................................................................................66 8.7 Selecting Lead Type .............................................................................................................66 8.8 Installing Electrodes.............................................................................................................66 8.8.1 Electrode Placement for 3-lead .................................................................................67 8.8.2 Electrode Placement for 5-lead .................................................................................68 8.8.3 Electrode Placement for 12-lead ...............................................................................69 8.8.4 Recommended ECG Lead Placement for Surgical Patients......................................70 8.9 ECG Menu Setup .................................................................................................................71 8.9.1 Setting Alarm Source ................................................................................................71 8.9.2 Smart Lead Off..........................................................................................................71 8.9.3 Setting Beat Volume..................................................................................................71 8.9.4 ECG Display .............................................................................................................72 8.9.5 Setting Pace Status ....................................................................................................72 8.9.6 ECG Calibration........................................................................................................72 8.9.7 ECG Waveform Settings ...........................................................................................72 8.9.8 12 Leads ECG ...........................................................................................................73 8.10 ST Segment Monitoring.....................................................................................................73 8.10.1 Setting ST Analysis .................................................................................................73 8.10.2 ST Display...............................................................................................................73 8.10.3 ST Analysis Alarm Setting......................................................................................73 8.10.4 About ST Measurement Points................................................................................74 8.10.5 Adjusting ST and ISO Measurement Points............................................................74 8.11 Arr. Monitoring...................................................................................................................74 8.11.1 Arrhythmia Analysis................................................................................................74 8.11.2 ARR Analysis Menu................................................................................................76 8.12 12-Lead ECG Monitoring ..................................................................................................77 8.12.1 Diagnosis Function..................................................................................................77
VII8.12.2 Measurement and Interpretation .............................................................................78 Chapter 9 Monitoring RESP...........................................................................................................79 9.1 Overview..............................................................................................................................79 9.2 RESP Safety Information.....................................................................................................79 9.3 Resp Display ........................................................................................................................80 9.4 Electrode Placement for Monitoring Resp...........................................................................80 9.5 Cardiac Overlay ...................................................................................................................80 9.6 Chest Expansion...................................................................................................................80 9.7 Abdominal Breathing ...........................................................................................................81 9.8 Selecting Resp Lead.............................................................................................................81 9.9 Changing Hold Type ............................................................................................................81 9.10 Changing the Size of the Respiration Wave.......................................................................81 9.11 Using Resp Alarms.............................................................................................................81 9.12 Changing the Apnea Time..................................................................................................81 Chapter 10 Monitoring SpO2..........................................................................................................82 10.1 Overview............................................................................................................................82 10.2 SpO2 Safety Information....................................................................................................82 10.3 Measuring SpO2.................................................................................................................83 10.4 Measurement Procedure.....................................................................................................83 10.5 Understanding SpO2 Alarms ..............................................................................................84 10.6 Adjusting Alarm Limits......................................................................................................84 10.7 Setting SpO2 as Pulse Source.............................................................................................84 10.8 Setting Pitch Tone ..............................................................................................................84 10.9 Setting Sensitivity ..............................................................................................................85 Chapter 11 Monitoring PR..............................................................................................................86 11.1 Overview ............................................................................................................................86 11.2 Setting PR Source...............................................................................................................86 11.3 Setting PR Volume .............................................................................................................86 11.4 Using Pulse Alarms ............................................................................................................86 11.5 Selecting the Active Alarm Source.....................................................................................86
VIIIChapter 12 Monitoring NIBP .........................................................................................................87 12.1 Overview............................................................................................................................87 12.2 NIBP Safety Information ...................................................................................................87 12.3 Introducing the Oscillometric NIBP Measurement............................................................88 12.4 Measurement Limitations...................................................................................................88 12.5 Measurement Methods.......................................................................................................89 12.6 Measurement Procedures ...................................................................................................89 12.7 Operation Prompts .............................................................................................................90 12.8 Correcting the Measurement if Limb is not at Heart Level ...............................................90 12.9 NIBP Alarm........................................................................................................................91 12.10 Resetting NIBP.................................................................................................................91 12.11 Calibrating NIBP..............................................................................................................91 12.12 Leak Test ..........................................................................................................................91 12.12.1 Procedure of Leak Test..........................................................................................91 Chapter 13 Monitoring TEMP........................................................................................................93 13.1 Overview............................................................................................................................93 13.2 TEMP Safety Information..................................................................................................93 13.3 TEMP Monitoring Setup....................................................................................................93 13.4 Calculating Temp Difference .............................................................................................93 Chapter 14 Monitoring Quick TEMP* ..........................................................................................94 14.1 Overview............................................................................................................................94 14.2 Quick TEMP Safety Information .......................................................................................94 14.3 Measuring Procedure .........................................................................................................95 14.3.1 Measurement for Oral Temperature ........................................................................95 14.3.2 Measurements for Rectal Temperatures..................................................................96 14.3.3 Measurements for Axillary Temperatures ...............................................................96 14.4 Changing Temp Unit ..........................................................................................................97 Chapter 15 Monitoring IBP ............................................................................................................98 15.1 Overview............................................................................................................................98 15.2 IBP Safety Information ......................................................................................................98
IX15.3 Monitoring Procedures.......................................................................................................98 15.4 Selecting a Pressure for Monitoring...................................................................................99 15.5 Zeroing the Pressure Transducer........................................................................................99 15.6 Zeroing a Pressure Measurement.....................................................................................100 15.7 Troubleshooting the Pressure Zeroing (Taking Art for Example)....................................100 15.8 IBP Pressure Calibration ..................................................................................................100 15.9 Troubleshooting the Pressure Calibration ........................................................................101 15.10 IBP Alarm.......................................................................................................................102 Chapter 16 Monitoring CO2..........................................................................................................103 16.1 Overview..........................................................................................................................103 16.2 CO2 Safety Information....................................................................................................103 16.3 Monitoring Procedures.....................................................................................................104 16.3.1 Zeroing the sensor.................................................................................................104 16.3.2 Sidestream CO2 Module........................................................................................104 16.3.3 Mainstream CO2 Module ......................................................................................106 16.4 Setting CO2 Waveform Setup...........................................................................................108 16.5 Setting CO2 Corrections...................................................................................................108 16.6 Changing CO2 Alarms......................................................................................................109 16.7 Changing the Apnea Alarm Delay....................................................................................109 Chapter 17 Monitoring C.O..........................................................................................................110 17.1 Overview..........................................................................................................................110 17.2 C.O. Safety Information................................................................................................... 110 17.3 C.O. Monitoring Procedures ............................................................................................110 17.4 C.O. Measurement Window............................................................................................. 111 17.5 Measurement Process.......................................................................................................113 17.6 Editing C.O. .....................................................................................................................114 17.7 Blood Temperature Monitoring........................................................................................ 114 17.8 Setting the Computation Constant ...................................................................................115 17.9 Recording C.O. Measurements ........................................................................................115 17.10 Setting INJ. TEMP Source .............................................................................................115
XChapter 18 Monitoring AG ........................................................................................................... 116 18.1 Overview..........................................................................................................................116 18.2 Safety Information ...........................................................................................................116 18.2.1 Safety Information for ISA Analyzer ....................................................................116 18.2.2 Safety Information for IRMA Module ..................................................................118 18.3 Monitoring Steps.............................................................................................................. 119 18.3.1 Monitoring Steps for ISA Analyzer.......................................................................119 18.3.2 Monitoring Steps for IRMA Module.....................................................................121 18.4 Setting Work Mode ..........................................................................................................124 18.5 Setting Alarms..................................................................................................................125 18.6 Setting Apnea Alarm Time...............................................................................................125 18.7 Working Status of ISA analyzer .......................................................................................125 18.8 Working Status of IRMA Module ....................................................................................125 18.9 N2O and O2 Compensations.............................................................................................126 18.10 Effects of humidity.........................................................................................................126 Chapter 19 Freeze ..........................................................................................................................127 19.1 Overview..........................................................................................................................127 19.2 Entering/Exiting Freeze Status.........................................................................................127 19.2.1 Entering Freeze Status...........................................................................................127 19.2.2 Exiting Freeze Status.............................................................................................127 19.3 Reviewing Frozen Waveform...........................................................................................128 Chapter 20 Review .........................................................................................................................129 20.1 Trend Graph Review ........................................................................................................129 20.1.1 Selecting Trend Graph of Specific Parameter.......................................................129 20.1.2 Adjusting Trend Scale ...........................................................................................129 20.1.3 Setting Resolution .................................................................................................130 20.1.4 Scrolling Left and Right the Screen......................................................................130 20.1.5 Switching to the Trend Table ................................................................................130 20.1.6 Record ...................................................................................................................130 20.2 Trend Table Review .........................................................................................................130
XI20.2.1 Setting Resolution .................................................................................................130 20.2.2 Scrolling the Screen ..............................................................................................130 20.2.3 Switching to Trend Graph .....................................................................................131 20.2.4 Recording ..............................................................................................................131 20.3 NIBP Review....................................................................................................................131 20.3.1 Scrolling the Screen ..............................................................................................131 20.3.2 Recording ..............................................................................................................131 20.4 Alarm Review...................................................................................................................131 20.4.1 Scrolling the Screen ..............................................................................................131 20.4.2 Selecting Alarm Event of Specific Parameter.......................................................132 20.4.3 Setting Time Index ................................................................................................132 20.5 Arr Review .......................................................................................................................132 20.5.1 Scrolling the Screen ..............................................................................................132 20.6 12-lead Diagnosis Review................................................................................................133 20.6.1 Scrolling the Screen ..............................................................................................133 20.6.2 Deleting Diagnosis Results ...................................................................................133 20.6.3 Switching Between Waveforms and Results.........................................................133 20.6.4 Recording ..............................................................................................................133 Chapter 21 Calculation and Titration Table................................................................................134 21.1 Drug Calculation ..............................................................................................................134 21.1.1 Calculation Procedures..........................................................................................134 21.1.2 Calculation Unit ....................................................................................................135 21.2 Titration Table ..................................................................................................................135 21.3 Hemodynamic Calculation...............................................................................................136 21.3.1 Calculation Procedure ...........................................................................................136 21.3.2 Input Parameters....................................................................................................136 21.3.3 Output Parameters.................................................................................................136 Chapter 22 Recording....................................................................................................................138 22.1 General Information.........................................................................................................138 22.2 Performance of the Recorder ...........................................................................................138
XII22.3 Recording Type ................................................................................................................139 22.4 Starting and Stopping Recording .....................................................................................139 22.5 Recorder Operations and Status Messages ......................................................................140 22.5.1 Record Paper Requirement ...................................................................................140 22.5.2 Proper Operation ...................................................................................................140 22.5.3 Paper Out...............................................................................................................141 22.5.4 Replacing Paper ....................................................................................................141 22.5.5 Removing Paper Jam.............................................................................................142 Chapter 23 Other Functions..........................................................................................................143 23.1 Nurse Call.........................................................................................................................143 23.2 Analog Output and Defibrillator Synchronization ...........................................................143 23.3 Storing Data in a Removable Device ...............................................................................143 23.3.1 Data Stored in the Removable Device ..................................................................143 23.3.2 Activating/ Deactivating Data Storing ..................................................................144 23.3.3 Selecting a Removable Device..............................................................................144 23.3.4 Reviewing Data Stored in a Removable Device ...................................................144 23.3.5 Deleting Data Stored in a Removable Device.......................................................144 23.3.6 Ejecting a Removable Device ...............................................................................145 Chapter 24 Using Battery..............................................................................................................146 24.1 Battery Power Indicator ...................................................................................................146 24.2 Battery Status on the Main Screen ...................................................................................146 24.3 Checking Battery Performance ........................................................................................146 24.4 Replacing the Battery.......................................................................................................147 24.5 Recycling the Battery.......................................................................................................148 24.6 Maintaining the Battery....................................................................................................148 Chapter 25 Care and Cleaning .....................................................................................................149 25.1 General Points ..................................................................................................................149 25.2 Cleaning ...........................................................................................................................149 25.2.1 Cleaning the Monitor ............................................................................................149 25.2.2 Cleaning the Accessories.......................................................................................150
XIII25.3 Disinfection......................................................................................................................151 Chapter 26 Maintenance ...............................................................................................................152 26.1 Inspecting .........................................................................................................................152 26.2 Maintenance Task and Test Schedule...............................................................................152 Chapter 27 Warranty and Service................................................................................................154 27.1 Warranty ...........................................................................................................................154 27.2 Contact information .........................................................................................................154 Chapter 28 Accessories ..................................................................................................................155 28.1 ECG Accessories..............................................................................................................155 28.2 SpO2 Accessories .............................................................................................................157 28.3 NIBP Accessories.............................................................................................................158 28.4 Temp Accessories.............................................................................................................160 28.5 Quick Temp Accessories* ................................................................................................160 28.6 IBP Accessories................................................................................................................160 28.7 CO2 Accessories...............................................................................................................161 28.8 C.O. Accessories* ............................................................................................................162 28.9 AG Accessories* ..............................................................................................................162 28.10 Other Accessories...........................................................................................................163 A Product Specification .................................................................................................................165 A.1 Classification.....................................................................................................................165 A.2 Physical Specifications......................................................................................................165 A.2.1 Size and Weight......................................................................................................165 A.2.2 Environment Specification.....................................................................................165 A.2.3 Display ...................................................................................................................166 A.2.4 Battery Specification ..............................................................................................167 A.2.5 Recorder .................................................................................................................167 A.2.6 Data Storage ...........................................................................................................168 A.3 ECG...................................................................................................................................168 A.4 RESP .................................................................................................................................173 A.5 NIBP..................................................................................................................................174
XIVA.6 SpO2..................................................................................................................................176 A.7 TEMP ................................................................................................................................177 A.8 Quick TEMP .....................................................................................................................177 A.9 IBP.....................................................................................................................................177 A.10 CO2..................................................................................................................................178 A.11 C.O. .................................................................................................................................181 A.12 AG ...................................................................................................................................182 A.12.1 Phasein Sidestream...............................................................................................182 A.12.2 Phasein Mainstream .............................................................................................184 B EMC Information.......................................................................................................................188 B.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS.................................188 B.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS .................................188 B.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING................................................................................................................190 B.4 Recommended Separation Distances ................................................................................191 C Default Settings...........................................................................................................................193 C.1 Patient Information Default Settings .................................................................................193 C.2 Alarm Default Settings ......................................................................................................193 C.3 ECG Default Settings ........................................................................................................193 C.4 RESP..................................................................................................................................195 C.5 SpO2...................................................................................................................................195 C.6 PR ......................................................................................................................................195 C.7 NIBP..................................................................................................................................196 C.8 TEMP ................................................................................................................................196 C.9 Quick TEMP......................................................................................................................197 C.10 IBP...................................................................................................................................197 C.11 CO2..................................................................................................................................198 C.12 C.O...................................................................................................................................198 C.13 AG....................................................................................................................................199 D Abbreviations..............................................................................................................................200
Patient Monitor User Manual Intended Use and Safety Guidance - 1 - 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.
Patient Monitor User Manual Intended Use and Safety Guidance - 2 - 1.2 Safety Guidance WARNING1Before 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. 2Medical 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. 3EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur. 4SHOCK 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. 5Extreme 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. 6Magnetic 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. 7Route all cables away from patient’s throat to avoid possible strangulation. 8Devices connecting with monitor should be equipotential. 9Accessory 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.
Patient Monitor User Manual Intended Use and Safety Guidance - 3 - WARNING11 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. CAUTION1Electromagnetic 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. 2Keep the environment clean. Avoid vibration. Keep it far away from corrosive medicine, dust area, high temperature and humid environment. 3Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid pouring fluids directly on the transducer. 4Do not use autoclave or gas to sterilize the monitor, recorder or any accessories. 5The device and reusable accessories could be sent back to the manufacturer for recycling or proper disposal after their useful lives. 6Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.
Patient Monitor User Manual Intended Use and Safety Guidance - 4 - CAUTION7Remove a battery whose life cycle has expired from the monitor immediately. 8Avoid liquid splash on the device. The temperature must be kept between 5qC and 40qC while working. And it should be kept between -20qC and 55qC during transportation and storage. 9To 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:1Position the device in a location where the operator can easily see the screen and access the operating controls. 2The monitor can only be used on one patient at a time. 3If the monitor gets damp or liquid pours on the monitor, please contact the service personnel of EDAN. 4This monitor is not a device for treatment purposes. 5The pictures and interfaces in this manual are for reference only. 6Regular preventive maintenance should be carried out every two years. You are responsible for any requirements specific to your country. 7The monitor may not be compatible with all models of USB flash drives. Use the USB flash drives that are recommended by EDAN. 8It 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”
Patient Monitor User Manual Intended Use and Safety Guidance - 5 - 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
Patient Monitor User Manual Intended Use and Safety Guidance - 6 - 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
Patient Monitor User Manual Intended Use and Safety Guidance - 7 - 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)
Patient Monitor User Manual Installation - 8 - Chapter 2 Installation NOTE:1The monitor settings must be specified by the authorized hospital personnel. 2To 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 MonitorFor 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: 1Make sure the AC power supply complies with the following specifications: 100V-240V~, 50Hz/60Hz. 2Apply 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.
Patient Monitor User Manual Installation - 9 - WARNINGIf 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:1Check all the functions of the monitor and make sure that the monitor is in good status.2If rechargeable batteries are provided, charge them after using the device every time, to ensure the electric power is enough. 3The interval between double pressing of POWER switch should be longer than 1 minute.4After 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: zUser Manual (this book) - for full operating instructions. zQuick Reference Card - for quick reminders during use. 2.8 FCC Statement**The statement is not applicable to iM50 or iM80. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may
Patient Monitor User Manual Installation - 10 - cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: 1. Reorient or relocate the receiving antenna. 2. Increase the separation between the equipment and receiver. 3. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 4. Consult the dealer or an experienced radio/TV technician for help. This device complies with Part 15 of FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. NOTE:The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. Such modifications could void the user’s authority to operate this equipment. 2.9 FCC RF Radiation Exposure Statement**The statement is not applicable to iM50 or iM80. This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with a minimum distance of 20 centimeters between the radiator and your body.
Patient Monitor User Manual Basic Operation - 11 - 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 iM50123 4 5 6 7891000
Patient Monitor User Manual Basic Operation - 12 - iM60iM70123 4 5 6 7 8 9 1012103 4 5 6 7 8 9
Patient Monitor User Manual Basic Operation - 13 - iM801 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. 32145678910
Patient Monitor User Manual Basic Operation - 14 - 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 iM501 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. 12345 6 7 8 9 1011
Patient Monitor User Manual Basic Operation - 15 - 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 iM60/iM701 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 123458910116 7
Patient Monitor User Manual Basic Operation - 16 - 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. iM8012345678910111213
Patient Monitor User Manual Basic Operation - 17 - 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
Patient Monitor User Manual Basic Operation - 18 - 3.1.3 Side View iM501 Sensor interface 2 CO2 module holder 3 Recorder door 4 Battery door iM60/iM7012341234
Patient Monitor User Manual Basic Operation - 19 - 1 Sensor port 2 CO2 module holder 3 Recorder door 4 Battery door iM801 Sensor port 2 AG module holder 3 Recorder door 4 Battery door 1234
Patient Monitor User Manual Basic Operation - 20 - 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 iM70 328mm(L) × 158mm(W) × 285mm(H) ECG, RESP, SpO2, NIBP, TEMP, IBP, C.O., CO2, AG iM80 370 mm (L) × 175 mm (W) × 320 mm (H) ECG, RESP, SpO2, NIBP, TEMP, IBP, C.O., CO2, AG 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.
Patient Monitor User Manual Basic Operation - 21 - 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
Patient Monitor User Manual Basic Operation - 22 - 14 Shortcut key area 15 Scroll left to display more shortcut keys 16 Mute key 17 Parameter waveform 3.2.1 Using KeysThe 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
Patient Monitor User Manual Basic Operation - 23 - 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: zStoring no data of new patient. zPausing to give all types of alarm. zPausing to transmit patient data to CMS and other network devices. zPausing to store the currently recorded data, and clearing the memory used to store recording and printing data.
Patient Monitor User Manual Basic Operation - 24 - zReal data: the parameter measurement value and real waveform displayed on the screen are from the predefined analog data, not the truly monitoring patients’ data. zHistory 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. WARNINGThis 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 on the screen directly. To resume monitoring, select anything on the screen or press any key. 3.3.3 Night Mode To switch to night mode, you may: zSelect the shortcut key on the main screen, or zSelect 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, 1is the least bright. Your monitor may be configured with lower brightness in standby mode and also for transport to conserve battery power.
Patient Monitor User Manual Basic Operation - 25 - 3.4.2 Changing Date and Time To change the date and time, please refer to Section Setting Date and Time. WARNINGChange to date and time will influence the storage of trend data. 3.5 Adjusting Volume3.5.1 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.
Patient Monitor User Manual Basic Operation - 26 - 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.
Patient Monitor User Manual Basic Operation - 27 - 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.
Patient Monitor User Manual Alarms - 28 - Chapter 4 Alarms The alarm information here applies to all measurements. Measurement-specific alarm information is discussed in the sections of individual measurements. WARNINGA 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.
Patient Monitor User Manual Alarms - 29 - 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: Alarmlevel Prompt Physiological alarms Technical alarms High Mode is “DO-DO-DO------DO-DO, DO-DO-DO------DO-DO”, which is triggered once every 10 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 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 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. No definition Low Mode is “DO-”, which is triggered once every 30 seconds. The alarm indicator flashes in yellow. The alarm message flashes with yellow background, 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. 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.
Patient Monitor User Manual Alarms - 30 - WARNING1 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 set Mute to On, then press the key on the front panel for more than three seconds or press the Silence shortcut key on the screen directly. And alarm reminder tone DO is heard every three minutes. Setting value of high alarm limit HighAlarm LimitLow Alarm LimitUpper arrow or lower arrow to increase or decrease the alarm limit Setting value of low alarm limit
Patient Monitor User Manual Alarms - 31 - 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 AlarmsTo 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 AlarmsTo 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 AlarmsWhen 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.
Patient Monitor User Manual Alarm Information - 32 - 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, V4, V5 or V6) User-selectable 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, V4, V5 or V6) User-selectable 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 less than 600 ms. High 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<100ˈR-R interval is less than 1/3 the average interval, followed by a compensating pause of 1.25X the average R-R interval (the next R wave advances onto the previous T wave). User-selectable PVC Single PVC detected in normal heartbeats. User-selectable TACHY 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). User-selectable BRADY 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). User-selectable
Patient Monitor User Manual Alarm Information - 33 - 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 When HR is  120 beats/min, no beat is tested within 1 second. User-selectable 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 limit. User-selectable T1 Low Measuring value of T1 channel is below lower alarm limit. User-selectable T2 High Measuring value of T2 channel is above upper alarm limit. User-selectable T2 Low Measuring value of T2 channel is below lower alarm limit. User-selectable TD High Measuring value of TD channel is above upper alarm limit. User-selectable
Patient Monitor User Manual Alarm Information - 34 - 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
Patient Monitor User Manual Alarm Information - 35 - 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 can be detected using CO2 module. High 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 limit. User-selectable EtCO2 (AG) Low EtCO2 (AG) measuring value is below lower alarm limit. User-selectable FiCO2 (AG) High FiCO2 (AG) measuring value is above alarm limits. User-selectable AwRR (AG) High AwRR (AG) measuring value is above upper alarm limit. User-selectable AwRR (AG) Low AwRR (AG) measuring value is below lower alarm limit. User-selectable 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
Patient Monitor User Manual Alarm Information - 36 - 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 can be detected using AG module. High TB High TB measuring value is above upper alarm. User-selectable TB Low TB measuring value is below lower alarm. User-selectable
Patient Monitor User Manual Alarm Information - 37 - 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 Action Taken 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 Make sure that all electrodes, leads and patient cables are properly connected. 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.
Patient Monitor User Manual Alarm Information - 38 - Message Cause Alarm Level Action Taken ECG Comm Fail ECG module failure or communication failure High Stop measuring function of ECG module, and notify biomedical engineer or manufacturer’s service staff. ECG Noise ECG measuring signal is greatly interrupted. Low Check lead connection and patient condition ECG V1 Lead Off ECG electrode V1 falls off the skin or the ECG cable V1 falls off. Low ECG V2 Lead Off ECG electrode V2 falls off the skin or the ECG cable V2 falls off. Low ECG V3 Lead Off ECG electrode V3 falls off the skin or the ECG cable V3 falls off. Low ECG V4 Lead Off ECG electrode V4 falls off the skin or the ECG cable V4 falls off. Low ECG V5 Lead Off ECG electrode V5 falls off the skin or the ECG cable V5 falls off. Low ECG V6 Lead Off ECG electrode V6 falls off the skin or the ECG cable V6 falls off. Low Make sure that all electrodes, leads and patient cables are properly connected. RESP Comm Fail RESP module failure or communication failure High Stop measuring function of RESP module, and notify biomedical engineer or the manufacturer’s service staff.
Patient Monitor User Manual Alarm Information - 39 - Message Cause Alarm Level Action Taken RR Exceed RR measuring value is out of the measure range (less than 6rpm or greater than 150rpm). Medium Check whether interference to the respiratory signal exists. And check whether the patient is breathing normally; breathing too rapidly or too slowly may endanger patient’s life. RESP Cardiac ArtifactNo RESP waveform can be detected due to apnea or shallow breathing of the patient. High Check whether the patient is breathing normally. Take measures to help the patient breathe normally when necessary. If the patient is breathing normally, try to adjust the electrode position on the patient in order to reduce the interference of cardiogenic artifact. RESP Noise RR cannot be measured due to patient movement. Low Check whether the RESP leads are well connected. Keep the patient calm for better monitoring. SpO2 Sensor Off SpO2 sensor may be disconnected from the patient or the monitor. Low Make sure the sensor is well connected to the patient’s finger or other parts. SpO2 Sensor Err Malfunction in the SpO2 sensor or in the extension cable. Low Replace the SpO2 sensor or the extension cable. SpO2 No Sensor SpO2 sensor was not connected well or connected to the monitor, or the connection is loose. Low Make sure the monitor and sensor is well connected, reconnect the sensor.
Patient Monitor User Manual Alarm Information - 40 - Message Cause Alarm Level Action Taken SpO2 Comm Fail SpO2 module failure or communication failure High Stop using measuring function of SpO2 module, and notify biomedical engineer or manufacturer’s service staff. SpO2 Low Perfusion The pulse signal is too weak or the perfusion of the measurement site is too low Low Reconnect the SpO2 sensor and change the measurement site. If problem exists, please notify biomedical engineer or manufacturer’s service staff. SpO2 Noisy Signal There is interference with SpO2 measurement signals and the waveform is abnormal. Low Check the condition of patient and avoid patient movement; make sure the cable is well connected. SpO2 Light Interference Ambient light around the sensor is too strong. Low Reduce interference of the ambient light and avoid sensor’s exposure to strong light. NIBP Comm Fail NIBP module failure or communication failure High Stop using measuring function of NIBP module, and notify biomedical engineer or manufacturer’s service staff.
Patient Monitor User Manual Alarm Information - 41 - Message Cause Alarm Level Action Taken NIBP Leak NIBP pump, valve, cuff or tube has a leakage. Low Properly wrap the cuff and connect the tube. Measure again; if failure persists, stop measuring function of NIBP module and notify biomedical engineer or manufacturer’s service staff. NIBP Excessive Pressure Pressure has exceeded the specified upper safety limit. Low Measure again, if failure persists, stop measuring function of NIBP module and notify biomedical engineer or manufacturer’s service staff. NIBP Init Pressure High The initial pressure is too high during measuring Low Measure again, if failure persists, stop measuring function of NIBP module and notify biomedical engineer or manufacturer’s service staff. NIBP Self Test Error Sensor or other hardware errors. High If failure persists, stop using measuring function of NIBP module and notify biomedical engineer or manufacturer’s service staff. NIBP Cuff Type Error The cuff type used isn’t consistent with the patient type. Low Confirm the patient type and change the cuff.
Patient Monitor User Manual Alarm Information - 42 - Message Cause Alarm Level Action Taken Air Pressure Error Malfunction in pressure sensor or valve Low Check whether the airway is occluded or pressure sensor works properly. If the problem still exists, contact your service personnel. NIBP System Failure Malfunction in hardware High Contact your service personnel. NIBP Weak Signal Cuff is too loose or patient pulse is too weak. Low Check the connection of the cuff and try again. If failure persists, use other methods to measure blood pressure. NIBP Range ExceededMaybe the patient blood pressure value is beyond the measurement range. Low Use other methods to measure blood pressure. NIBP Loose Cuff Cuff is not properly wrapped or no cuff is connected. Low Properly wrap the cuff. NIBP Interference Signal noise is too large or pulse rate is not regular. Low Make sure that the patient under monitoring is motionless. HW Excessive Pressure Hardware excessive pressure protection High Notify biomedical engineer or manufacturer’s service staff. NIBP Time Out Measuring time has exceeded the specified time. Low Measure again or use other measuring methods. TEMP T1 Sensor Off Temperature cable of TEMP channel 1 may be disconnected from the monitor. Low Make sure that the cable is properly connected
Patient Monitor User Manual Alarm Information - 43 - Message Cause Alarm Level Action Taken TEMP T2 Sensor Off Temperature cable of TEMP channel 2 may be disconnected from the monitor. Low Make sure that the cable is properly connected. Excessive T1 TEMP1 measuring value is beyond measuring range. High Check sensor connection and patient condition Excessive T2 TEMP2 measuring value is beyond measuring range. High Check sensor connection and patient condition TEMP Comm Fail TEMP module failure or communication failure. High Stop measuring function of TEMP module, and notify biomedical engineer or Manufacturer’s service staff. YY Sensor Off (YY stands for the IBP label name) IBP sensor falls off. Low Check the sensor connection and reconnect the sensor. YY Comm Fail (YY stands for the label name) IBP module failure or communication failure High Stop measuring function of IBP module, and notify biomedical engineer or Manufacturer’s service staff. C.O. Comm Fail C.O. module failure or communication failure High Stop measuring of C.O. module, or notify biomedical engineer or Manufacturer’s service staff. C.O. TI No Sensor C.O. TI sensor not connected Low Insert injective temperature sensor. C.O. TB No Sensor C.O. TB sensor not connected Low Insert TB sensor. TEMP Out Of Range TB measuring value is above measuring range. High Please check TB sensor.
Patient Monitor User Manual Alarm Information - 44 - Message Cause Alarm Level Action Taken C.O. Lack Param C.O. measuring needs parameters High Please input patient’s height and weight. AA Out Of Range The AA concentration exceeds the accuracy range of AG module. High Reduce AA concentration. O2 Sensor Error The oxygen sensor of the sidestream AG module has a failure. Medium Stop measuring of AG module, and notify biomedical engineer or Manufacturer’s service staff. AG Comm Fail AG module failure or communication failure. High Stop measuring function of AG module, and notify biomedical engineer or Manufacturer’s service staff. AG Zero Required AG module requires zero. Low Please perform zeroing. AG Self-Testing AG module is self testing. Low Please wait the self testing finishing. AG Replace O2 Sensor O2 sensor needs to be replaced. High Please replace the O2 sensor. AG Check Adapter AG module checks adapter. Low Please wait check finishing. O2 Cali Required O2 needs to be calibrated. Low Please calibrate O2. AG Software Error AG module software abnormal High Please replace software revision. AG Hardware Error AG module has hardware failure. High Please check whether the hardware work properly. AG Motor Error AG module motor abnormal High Please check whether the motor works properly. AG Uncalibrated AG module uncalibrated Low Please calibrate the AG module. AG Replace Adapter AG module needs to change adapter. High Please replace the adapter.
Patient Monitor User Manual Alarm Information - 45 - Message Cause Alarm Level Action Taken O2 Out Of Range O2 is out of range. High Please make O2 range resume normal. AG TEMP Out Of Range AG module temperature out of range High Please make the temperature resume normal. AG Baro Press Out Of Range AG module baro pressure out of pressure High Please make the baro pressure value resume normal. AG AA Id Unreliable AG module can’t identify the AG agent. Medium Reduce gas agent type. AG Span Calib In Progress AG module is calibrating. Low Please wait calibration finishing. AG Calibration Fail AG module calibration failure Medium Please check whether the module works properly. Unable To Calibrate AG module can’t be calibrated. Medium Please check whether the module works properly. AG Zero In Progress AG module is zeroing. Low Please wait zeroing. AG Occlusion The sampling line is clogged. Medium Replace the sampling line. AG Init Fail AG module has a failure. High AG module works improperly. AG Data Limit Error AG module has a failure. High AG module works improperly. AG Usa Error AG module has a failure. High AG module works improperly. AG Cal Fail AG module fails to calibrate. High AG module works improperly. AG Zref Fail AG module fails to zero. High AG module works improperly. AG Change Oxygen Sensor Replace oxygen sensor of AG module. Low Please wait changing finishing. AG No Oxygen Sensor The oxygen sensor falls off from the AG module. High Connect the sensor again.
Patient Monitor User Manual Alarm Information - 46 - Message Cause Alarm Level Action Taken AG Mixed Agents AG module detects mixture gas agent. Medium Close the subsidiary gas agent. CO2 Occlude Water trap of SideStream is occluded. High Make sure the gas exhaust works well CO΍ Out Of Range The CO2 concentration exceeds the accuracy range of CO2 module. High Reduce CO2 concentration. CO2 Sensor Faulty CO2 module failure High Stop measuring function of CO2 module, notify biomedical engineer. CO2 Sensor Over Temp CO2 measure value exceeds the measure range of the monitor. High Stop measuring function of CO2 module, notify biomedical engineer. CO2 Comm. Failed CO2 module failure or communication failure High Check if the water tray has been fixed. CO2 Zero Required Zero calibration failure Low Disconnect the sampling cannula or adapter from the airway; initiate the zeroing before making sure that no expired air is inside the sampling cannula and adapter.
Patient Monitor User Manual Alarm Information - 47 - Message Cause Alarm Level Action Taken CO2 Check Adapter 1) For the Respironics CO2 module: The cannula is off or disconnected. 2) For the EDAN CO2 module: The water trap is disconnected or not properly connected. Low 1) For the Respironics CO2 module: Check whether the adapter is properly connected or replace the adapter. 2) For the EDAN CO2 module: Properly connect the water trap. AA Out Range The AA concentration exceeds the accuracy range of AG module. High Reduce AA concentration. O2 Sensor Error The oxygen sensor of the sidestream AG module has a failure. Medium Stop measuring of AG module, and notify biomedical engineer or Manufacturer’s service staff. QuickTemp Comm Fail TEMP module failure or communication failure. High Stop measuring function of TEMP module, and notify biomedical engineer or manufacturer’s service staff. Temp exceed limit The TEMP value is beyond the range of +25qC ~ +45qC. Med Put the sensor into the sensor bracket, take it out and measure again. No Temp Sensor TEMP sensor is not connected to the TEMP module. Low Connect the sensor and the monitor well, and measure again. Ambient temp too high The Sensor temperature is higher than +40qC. Low Put the sensor into the sensor bracket, measure again after the ambient temperature reaches normal value.
Patient Monitor User Manual Alarm Information - 48 - Message Cause Alarm Level Action Taken Ambient temp too low The Sensor temperature is lower than +10qC. Low Put the sensor into the sensor bracket, measure again after the ambient temperature reaches normal value. Probe data error Offline: NTC resistance >R 0 qC; Short: NTC resistance <R+100 qC. Med Put the sensor into the sensor bracket, take it out and measure again. If the problem persists, stop using measuring function of TEMP module, and notify biomedical engineer or manufacturer’s service staff. Probe heater error Single failure Med Put the sensor into the sensor bracket, take it out and measure again. If the problem persists, stop using measuring function of TEMP module, or notify biomedical engineer or manufacturer’s service staff. Probe temp too high The original temperature of sensor >+33 qC & +40 qC. Low Put the sensor into the sensor bracket, measure again after the sensor temperature reaches normal value. Temp Sensor Off After the sensor temperature reaches Predict value, it descends to the value lower than Predict value. Med Reconnect the sensor and make sure that the cable is properly connected.
Patient Monitor User Manual Alarm Information - 49 - Message Cause Alarm Level Action Taken Battery Low Battery Low High Please change the battery or charging. Recorder Out Of Paper Recorder Out Of Paper Low Please install the paper Recorder setup needed The user presses the RECORD button when the monitor is not installed with a recorder. Low Notify the manufacturer’s service staff to install and set the recorder. Removable device is full Less than 10M space is left in the removable device. Low Delete some data in the removable device or use another removable device. Removable dev read-only The removable device is read-only. Low Repair the removable device or replace it with a new one. 5.3 Prompts Message Cause ECG Arr Learning The QRS template building required for Arr. Analysis is in process. SpO2 Search Pulse SpO2 module is analyzing the patient signal and searching for the pulse to compute the saturation, when sensor is connected with patient. Manual Measuring In manual measuring mode Continual Measuring In continuous measuring mode Auto Measuring In automatic measuring mode Measure Abort Measurement over Calibrating During calibrating Calibrate Abort Calibration over Leak Testing During pneumatic test Leak Test Ok NIBP module has passed leak test. Leak Test Abort Pneumatic test over
Patient Monitor User Manual Alarm Information - 50 - Message Cause Resetting NIBP module in resetting Please Start NIBP module is in idle status. Done NIBP measurement successfully done Continual Measuring NIBP module performs continual measuring Stat Measuring NIBP module performs STAT function. Please Switch To Maintain Mode NIBP module is in normal mode, the user can’t start leak test and pressure calibration. Please enter User Maintain > NIBP Maintain and switch to Maintain Mode to perform leak test or pressure calibration. Please Switch To Normal Mode NIBP module is in maintaining mode, the user can’t start blood pressure measurement. Please enter User Maintain > NIBP Maintain and switch to Normal Mode to perform blood pressure measurement. Quick TEMP Is Warming Up Quick TEMP Is Warming Up. Place Probe On Measure Place Probe isn’t placed on the measurement site. CO2 Standby Turn from measuring mode to standby mode, making the module in energy-saving status. CO2 Sensor Warm Up The CO2 module is in warm-up state. Zeroing... The CO2 module is performing the zero calibration. Excessive C.O. Temp TB measuring value is beyond measuring range. Excessive Temp, C.O. Measurement Fail. C.O. measuring needs parameters. C.O. measure need param HEMOD calculation needs parameters. Insufficient factors for Hemod Dynamics HEMO Dynamics calculation needs parameters. No Sensor, C.O. measurement fail No Sensor,C.O. measurement fail Measuring... The C.O. module is performing measuring. Ready for new measurement C.O. module is ready for new measurement. Invalid C.O. result C.O. measurement result is invalid. C.O. Measurement Complete C.O. Measurement is completed. C.O. Measurement Abort C.O. Measurement is aborted. Warm-up over The monitor displays this message after taking the sensor out of the bracket and warm-up is over.
Patient Monitor User Manual Alarm Information - 51 - Message Cause Measure over After the Predict measuring is over, the data and message display on the interface. Measure time out No measuring result after the module entering Predict state for 30s. AG Standby AG module is operating in the standby status. 5.4 Adjustable Range of Alarm Limits ECG alarm limits are listed as follows: unit (bpm) Patient Type ALM HI ALM LO HR ADU 300 15 PED 350 15 NEO 350 15 ST analysis alarm limits are listed as follows: unit (mV) ALM HI ALM LO ST 2.0 -2.0 PVCs alarm upper limits are listed as follows: ALM HI ALM LO PVCs 10
Patient Monitor User Manual Alarm Information - 52 - RESP alarm limits are listed as follows: unit (rpm) Patient Type ALM HI ALM LO ADU 120 6 PED 150 6 NEO 150 6 SpO2 alarm limits are listed as follows (unit %): ALM HI ALM LO SpO2 100 0 PR alarm limits is listed as follows: unit (bpm) ALM HI ALM LO PR 300 30 NIBP alarm limits are listed as follows (EDAN module): unit (mmHg) Patient Type ALM HI ALM LO ADU SYS DIA MAP 270 215 235 40 10 20 PED SYS DIA MAP 200 150 165 40 10 20 NEO SYS DIA MAP 135 100 110 40 10 20 NIBP alarm limits are listed as follows (Omron module): unit (mmHg) Patient Type ALM HI ALM LO ADU(PED) SYS DIA MAP 250 200 235 60 40 45 NEO SYS DIA MAP 120 90 100 40 20 30
Patient Monitor User Manual Alarm Information - 53 - TEMP alarm limits are listed as follows: ALM HI ALM LO T1 50qC (122 º F) 0qC (32 º F) T2 50qC (122 º F) 0qC (32 º F) TD 50qC (90 º F) 0qC (0 º F) IBP alarm limits are listed as follows: unit (mmHg) ALM HI ALM LO Art 300 0 RAP 40 -10 LAP 40 -10 CVP 40 -10 PA 120 -6 ICP 40 -10 P1 300 -50 P2 300 -50 CO2 alarm limits are listed as follows: ALM HI ALM LO EtCO2 150 mmHg 0 FiCO2 50 mmHg 3 AwRR 150 rpm 2 rpm C.O. alarm limits are listed as follows: ALM HI ALM LO TB 43qC (109.4̧) 23qC(73.4̧) Quick Temp alarm limits are listed as follows: Patient Type ALM HI ALM LO ADU 42qC (107.6̧) 35.5qC (95.9̧) PED 42qC (107.6̧) 35.5qC (95.9̧)
Patient Monitor User Manual Alarm Information - 54 - AG alarm limits are listed as follows: Patient Type ALM HI ALM LO ADU FiCO2 EtCO2 FiO2 EtO2 FiN2O EtN2O EtDes FiDes EtIso FiIso EtHal FiHal EtSev FiSev EtEnf FiEnf awRR Apnea Time 25.0% 25.0% 88.0% 90.0% 100.0% 100.0% 18.0% 18.0% 5.0% 5.0% 5.0% 5.0% 8.0% 8.0% 5.0% 5.0% 150 rpm 40s 0.0% 0.0% 18.0% 18.0% 0.0% 0.0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0 rpm 20s PED FiCO2 EtCO2 FiO2 EtO2 FiN2O EtN2O EtDes FiDes EtIso FiIso EtHal FiHal 25.0% 25.0% 88.0% 90.0% 100.0% 100.0% 18.0% 18.0% 5.0% 5.0% 5.0% 5.0% 0.0% 0.0% 18.0% 18.0% 0.0% 0.0% 0% 0% 0% 0% 0% 0%
Patient Monitor User Manual Alarm Information - 55 - EtSev FiSev EtEnf FiEnf awRR Apnea Time 8.0% 8.0% 5.0% 5.0% 150 rpm 40s 0% 0% 0% 0% 0 rpm20s NEO FiCO2 EtCO2 FiO2 EtO2 FiN2O EtN2O EtDes FiDes EtIso FiIso EtHal FiHal EtSev FiSev EtEnf FiEnf awRR Apnea Time 25.0% 25.0% 88.0% 90.0% 100.0% 100.0% 18.0% 18.0% 5.0% 5.0% 5.0% 5.0% 8.0% 8.0% 5.0% 5.0% 150 rpm 40 s 0.0% 0.0% 18.0% 18.0% 0.0% 0.0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0% 0 rpm 20 s
Patient Monitor User Manual Managing Patients - 56 - Chapter 6 Managing Patients 6.1 Admitting a PatientThe monitor displays physiological data and stores it in the trends as soon as a patient is connected. This allows you monitor a patient who is not yet admitted. It is however important to admit patients properly so that you can identify your patient on recordings, reports, and networked devices. During admission you enter data that the monitor needs for safe and accurate operation. For example, the patient category setting determines the algorithm the monitor uses to process and calculate some measurements, the safety limits that are applied for some measurements, and the alarm limit ranges. To admit a patient, please: 1. Select the Admission key on the screen or. 2. Select Menu > Patient Setup > New Patient, then a message is displayed to ask the user to confirm to update patient. 3. Click on No to cancel this operation; click on Yes, the Patient Info window is displayed. 4. Enter the patient information: zSerial No: Enter the patient’s medical record number (MRN), for example 12345678. zLast name: Enter the patient’s last name (family name), for example Smith. zFirst name: Enter the patient’s first name, for example Joseph. zGender: Male, Female and N/A. zType: Choose the patient type, either Adult, Pediat, or Neonat. zBloodType: N/A, A, B, AB and O. zPace: Choose On or Off (You must select On if your patient has a pacemaker). zDate of Birth: Enter the patient’s date of birth. zDate of Admission: Enter the patient’s date of admission. zHeight: Enter the patient’s height. zWeight: Enter the patient’s weight. zDoctor: Enter any extra information about the patient or treatment. 5. Select Exit. 6.1.1 Patient Category and Paced StatusThe patient category setting determines the algorithm the monitor uses to process and calculate some measurements, the safety limits that are applied for some measurements, and the alarm limit ranges. The paced setting determines whether the monitor shows pacemaker pulses or not. When Pace is set to Off, pace pulses are filtered and therefore do not show in the ECG wave.
Patient Monitor User Manual Managing Patients - 57 - WARNING1Changing the patient category may change the arrhythmia and NIBP alarm limits. Always check alarm limits to make sure that they are appropriate for your patient. 2For paced patients, you must set Paced to On. If it is incorrectly set to Off, the monitor could mistake a pace pulse for a QRS and fail to give an alarm during asystole. 6.2 Quick Admit If you do not have the time or information to fully admit a patient. Complete the rest of the patient information later. To quickly admit a patient, please: 1. Select Menu > Patient Setup > Quick Admit, then a message is displayed to ask the user to confirm to update patient. 2. Click on No to cancel this operation; click on Yes to continue and the Patient Info window is displayed, choose Type and Pace and set them to the correct mode. 3. Select Exit. 6.3 Editing Patient Information To edit the patient information after a patient has been admitted, select Menu > Patient Setup >Patient Info., and make the required changes on the popup interface. 6.4 Updating a Patient You should always perform an update before starting monitoring for a new patient. When you select Menu > Patient Setup > Quick Admit, or Menu > Patient Setup > New Patient,a message of Press ‘Yes’ to create new patient profile by clearing all current patient data... is displayed. zIf the user selects Yes, the monitor will update the patient information. zIf the user selects No, the monitor won’t update the patient information and returns to patient setup interface. NOTE:Discharging patient will clear the history data in the monitor associated with the patient. 6.5 Central Monitoring System The monitor can be connected to the central monitoring system. Through the network: 1. The monitor sends patient information, real-time monitoring or measurement data to the central monitoring system. 2. The real-time monitoring information is displayed on the central monitoring system as the
Patient Monitor User Manual Managing Patients - 58 - same to the monitor, and the central monitoring system can perform some bilateral control. For example: changing patient information, alarm limit and so forth. For detailed information, please refer to MFM-CMS Central Monitoring System User Manual andCNS Central Monitoring System User Manual. And the monitor supports HL 7 protocol. NOTE:1 Make sure the network connection between the monitor and the central monitoring system is in good condition when the time synchronization function on the monitor is active. 2 The time synchronization function might not be available to all software versions of MFM-CMS. Consult our technical service department or your local distributor for more information.
Patient Monitor User Manual User Interface - 59 - Chapter 7 User Interface7.1 Setting Interface Style The user can set the interface based on the requirement, and the set options include the following: zSweep of the waveform. zParameters needing to be monitored. Change to some settings may have the risk, so only the authorized person can change them. After changing the settings, please notify the operator. 7.2 Selecting Display Parameters The user can select the display parameters based on the monitoring and measurement requirements. To select the parameter, please: 1. Select Menu > System Setup > Module Switch. 2. Select the required parameters from the popup interface. 3. Press Exit to exit the menu and the screen will adjust the parameters automatically. 7.3 Changing Waveform Position The user can exchange the waveform positions of parameter A and parameter B, please refer to the following steps to do so: 1. Select waveform A and open the setup menu of waveform A. 2. Select Change from the popup menu and select the desired label name of waveform B from the pull-down list. 7.4 Changing Interface Layout To change the interface layout, please refer to the following steps: 1. Select Menu > Display Setting. 2. Select one interface from the popup menu. 3. The user can implement one kind of function screen based on the requirements. If the user selects the Large Font option, there is no function screen to be selected. 7.5 Viewing Trend Screen To view the short trend screen, the user can press the Trend Screen key on the screen directly or select Menu > Display Setting > View Selection > TrendScreen.
Patient Monitor User Manual User Interface - 60 - 7.6 Viewing Oxygen Screen To view the oxygen screen, the user can press the oxyCRG key on the screen or select Menu > Display Setting > View Selection > oxyCRG. This interface is always used in NICU because the SpO2, HR and Resp of the neonate are different from those of adults. 7.7 Viewing Large Font Screen To open the large font screen, please refer to the following steps: 1. Select the Large Font key on the screen directly or. 2. Select Menu > Display Setting > View Selection > Large Font to open this interface. To view the large font interface of specific parameter, please select the parameter pull-down dialog on the interface (the red circle shown in the following figure).
Patient Monitor User Manual User Interface - 61 - 7.8 Viewing the Bed View Window The Bed View window allows you to view one waveform, numeric information of all parameters and alarm information from another bed on the same network. The monitor enables a maximum of eight beds to be viewed. NOTE:1 The IP addresses of the monitors configured with bed view function should share the same network segment. The IP addresses of the monitors on the same LAN should be unique from each other; you cannot use the bed view function in the monitors in which an IP address conflict exits. 2 To use the bed view function smoothly, make sure the network connection is in good condition.3 In the Bed View window, you cannot view the over-limit alarms of physiological parameters occurring on other beds. Besides, arrhythmia alarms and vital alarms will be indicated only by alarm icons. 7.8.1 Opening the Bed View Window Before opening the Bed View window, make sure the bed view function is configured on your monitor. To open the Bed View window, select Menu> Display Setup and choose Bed View in the View Selection list. 7.8.2 Settings of the Bed View Window Click on the Bed View window to open the ViewBed Setup menu on which you can zAssign a bed to be viewed by selecting the bed No. in the Bed No. list. zSelect the waveform to be displayed on the window in the Wave Type list. zUse the buttons and to view more numeric information of parameters in the window. 7.9 Changing Parameter and Waveform Colors The user can set the display colors of parameter and waveform as desire. To change the display color, please select Menu > Maintenance > User Maintain, enter the required password ABC. Then select Color Select to make color changes on parameter and color. 7.10 User Configuration Users can save the current monitor’s configuration, delete the saved user configuration and rename it. Three pieces of user configuration can be saved in the monitor.
Patient Monitor User Manual User Interface - 62 - To save the user configuration: 1. Select Menu > Maintenance > User Maintain, enter the required password ABC and then select User Configure. 2. Click on Save, enter a file name for the configuration and confirm it. A message will display after the operation. To delete the user configuration: 1. Select Menu > Maintenance > User Maintain, enter the required password ABC and then select User Configure. 2. Select the configuration file needed to delete from the list, click on Delete and confirm the operation. A message will display after the operation. To rename the user configuration: 1. Select Menu > Maintenance > User Maintain, enter the required password ABC and then select User Configure. 2. Select a configuration file needed to rename from the list and click on Rename. 3. Enter a name for the configuration file and confirm it. 7.11 Default ConfigurationTo set default configuration, please select Menu > Default and choose a configuration (adult, pediatric or neonate) based on your patient category. This configuration is factory configuration.
Patient Monitor User Manual Monitoring ECG - 63 - Chapter 8 Monitoring ECG 8.1 OverviewThe electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the monitor as a waveform and a numeric. This chapter also tells you about arrhythmia monitoring and ST monitoring. 8.2 ECG Safety Information WARNING1Do not come into contact with the patient, table, or the monitor during defibrillation. 2Only use the ECG leads supplied by the manufacturer when using the monitor for ECG monitoring. 3When connecting the cables and electrodes, make sure no conductive part is in contact with the ground. Verify that all ECG electrodes, including neutral electrodes, are securely attached to the patient but not the conductive part or ground. 4Check every day whether there is skin irritation resulted from the ECG electrodes. If yes, replace electrodes every 24 hours or change their sites. 5Place the electrode carefully and ensure a good contact. 6Check if the lead connection is correct before monitoring. If you unplug the ECG cable from the socket, the screen will display the error message “ECG LEAD OFF” and the audible alarm is activated. 7When using the monitor with the defibrillator or other high-frequency equipment, please use defibrillator-proof ECG lead to avoid burn. 8In order to avoid being burnt, please keep the electrodes far away from the radio knife while using electrosurgical equipment. 9When using Electrosurgery (ES) equipment, do not place an electrode near the grounding plate of the Electrosurgery device: otherwise there will be a great deal of interference with the ECG signal. 10 For patients with pacemakers, the pacing impulse analysis function must be switched ON. Otherwise, the pacing impulse may be counted as normal QRS complex, which results in failure of ECG LOST error detection. 11 The electrodes should be made of the same metal materials. 12 ECG cables can be damaged when connected to a patient during defibrillation. Check cables for functionality before using them again.
Patient Monitor User Manual Monitoring ECG - 64 - NOTE:1Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform. 2IEC/EN60601-1-2 (protection against radiation is 3v/m) specifies that the electrical field density exceeding 1v/m may cause measurement error in various frequencies. It is accordingly suggested that do not use equipment generating electrical radiation near ECG/RESP monitoring devices. 3The simultaneous use of cardiac pacemaker and other patient-connected equipment may cause safety hazard. 4If the pacemaker signals are beyond the claimed range, the heart rate may be calculated incorrectly. 5In the default settings of the monitor, the ECG waveforms are the first two waveforms from top in the waveform area. 6For measurements in or near the heart we recommend connecting the monitor to the potential equalization system. 7For protecting environment, the used electrodes must be recycled or disposed of properly.8.3 ECG Display The figure below is for reference only. The symbol “ķ”indicates lead name of display waveform: there are other leads for selection, such as I, II, III, aVR, aVF, aVL, V. If you want to change the lead, please refer to section Selecting Calculation Lead. The symbol “ĸ” indicates waveform gain: there are several options, such as X0.125, X0.25, X0.5, X1, X2, X4 and Auto. If you want to change it, please refer to section Changing the size of the ECG Wave. The symbol “Ĺ” indicates Filter setting, there are three options: monitoring, surgery, diagnosis. If you want to change it, please refer to section Changing the ECG Filter Setting. 8.3.1 Changing the Size of the ECG Wave If any of the displayed ECG waveform is too small or clipped, you can change the size of it on the screen. First select ECG Wave Setup > ECG Gain, then select an appropriate factor from the pop-up box to adjust the ECG waveform.
Patient Monitor User Manual Monitoring ECG - 65 - X0.125 to make strength of ECG signal waveform of 1mV become 1.25mm; X0.25 to make strength of ECG signal waveform of 1mV become 2.5mm; X0.5 to make strength of ECG signal waveform of 1mV become 5mm; X1 to make strength of ECG signal waveform of 1mV become 10mm; X2 to make strength of ECG signal waveform of 1mV become 20mm; X4 to make strength of ECG signal waveform of 1mV become 40mm; Auto let the monitor choose the optimal adjustment factor for all the ECG waves. 8.3.2 Changing the ECG Filter Settings The ECG filter setting defines how ECG waves are smoothed. An abbreviation indicating the filter type is shown underneath the lead label on the monitor display. Filter settings do not affect ST measurement. To change the filter setting, in the ECG Setup menu, select Filter and then select the appropriate setting. – Monitor: Use this mode under normal measurement conditions. – Surgery: The filter reduces interference to the signal. It should be used if the signal is distorted by high frequency or low frequency interference. High frequency interference usually results in large amplitude spikes making the ECG signal look irregular. Low frequency interference usually leads to a wandering or rough baseline. In the operating room, the Filter reduces artifacts and interference from electro-surgical units. Under normal measurement conditions, selecting Surgery may suppress the QRS complexes too much and thus interfere with the clinical evaluation of the ECG displayed on the monitor. – Diagnos: Use when diagnostic quality is required. The unfiltered ECG wave is displayed so that changes such as R-wave notching or discrete elevation or depression of the ST segments are visible. 8.4 Using ECG Alarms ECG alarms can be switched on and off and the changes to high and low alarm limits are just like other measurement alarms, which are described in the Alarms section. Special alarm features applying only to ECG are described here. 8.5 Selecting Calculation Lead On the Normal interface, the users can select either 3 LEADS or 5 LEADS for this item. Normal QRS complex should be: The normal QRS should be either completely above or below the baseline and it should not be biphasic. For paced patients, the QRS complexes should be at least twice the height of pace pulses.
Patient Monitor User Manual Monitoring ECG - 66 - The QRS should be tall and narrow. The P-waves and the T-waves should be less than 0.2 mV. 8.6 Monitoring Procedure 8.6.1 Preparation The skin is a poor conductor of electricity, therefore preparation of the patient's skin is important to facilitate good electrode contact to skin. Select sites with intact skin, without impairment of any kind. Shave hair from sites, if necessary. Wash sites thoroughly with soap and water. (Never use ether or pure alcohol, because this increases skin impedance). Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease. 8.6.2 Connecting ECG Cables 1. Attach clip or snap to electrodes prior to placement. 2. Put the electrodes on the patient. Before attaching, apply some conductive jelly on the electrodes if the electrodes are not electrolyte self-supplied. 3. Connect the electrode lead to the patient's cable. CAUTIONTo protect the monitor from damage during defibrillation, for accurate ECG information and to protect against noise and other interference, use only ECG electrodes and cables specified by EDAN. 8.7 Selecting Lead Type To change the lead type, please: 1. Select the ECG parameter area, open the ECG Setup menu; 2. Set Lead Type to 3 Leads, 5 Leads or 12 Leads based on the lead used. 8.8 Installing ElectrodesNOTE:The following table gives the corresponding lead names used in Europe and America respectively. (Lead names are represented by R, L, F, N, C, C1-C6 in Europe, whose corresponding lead names in America are RA, LA, LL, RL, V, V1-V6.)
Patient Monitor User Manual Monitoring ECG - 67 - AHA (American Standard) IEC (Europe Standard) Electrode Labels Color Electrode Labels Color RA White R Red LA Black L Yellow LL Red F Green RL Green N Black V Brown C White V1 Brown/ Red C1 White/ Red V2 Brown/ Yellow C2 White/ Yellow V3 Brown/ Green C3 White/ Green V4 Brown/Blue C4 White/ Brown V5 Brown/Orange C5 White/ Black V6 Brown/Purple C6 White/ Purple 8.8.1 Electrode Placement for 3-lead Take the American standard for example, see the following figure:  RA placement - directly below the clavicle and near the right shoulder.  LA placement: directly below the clavicle and near the left shoulder.  LL placement - on the left hypogastrium. Electrode Placement for 3-lead
Patient Monitor User Manual Monitoring ECG - 68 - 8.8.2 Electrode Placement for 5-lead Take the American standard for example, see the following figure:  RA placement: directly below the clavicle and near the right shoulder.  LA placement: directly below the clavicle and near the left shoulder.  RL placement: on the right hypogastrium.  LL placement: on the left hypogastrium.  V placement: on the chest, the position depends on your required lead selection. Electrode Placement for 5-lead NOTE:To ensure the patient safety, all leads must be attached to the patient. For 5-lead, attach the V electrode to one of the indicated positions as below:  V1 On the 4th intercostal space at the right sterna margin.  V2 On the 4th intercostal space at the left sterna margin.  V3 Midway between V2 and V4 electrodes.  V4 On the 5th intercostal space at the left clavicular line.  V5 On the left anterior axillary line, horizontal with V4 electrode.  V6 On the left middle axillary line, horizontal with V4 electrode.  V3R-V6R On the right side of the chest in positions corresponding to those on the left.  VE Over the xiphoid position.  V7 On the 5th intercostal space at the left posterior axillary line of back.  V7R On the 5th intercostal space at the right posterior axillary line of back.
Patient Monitor User Manual Monitoring ECG - 69 - V-Electrode Placement for 5-lead 8.8.3 Electrode Placement for 12-leadTake the American standard for example. The 12-lead electrodes should be placed on extremities and chest. The electrodes for extremities should be placed on the skin of legs or arms, the electrodes placed on chest should follow the doctor’s advice. Please see the following figure.
Patient Monitor User Manual Monitoring ECG - 70 - Electrode Placement for 12-lead 8.8.4 Recommended ECG Lead Placement for Surgical PatientsWARNINGWhen using Electrosurgery (ES) equipment, leads should be placed in a position in equal distance from Electrosurgery electrotome and the ES grounding plate to avoid cautery. Electrosurgery equipment wire and ECG cable must not be tangled up. Monitoring ECG leads are mainly used for monitoring the patient’s vital signs. When using the patient monitor with other electrosurgery equipment, it is advised to use the counteracting defibrillation ECG lead. The placement of the ECG leads will depend on the type of surgery that is being performed. For example, in an open chest surgery the electrodes may be placed laterally on the chest or on the back. In the operating room, artifacts may affect the ECG waveform due to the use of ES (Electrosurgery) equipment. To help reduce this you can place the electrodes on the right and leftshoulders, the right and left sides near the abdomen, and the chest lead on the left side at mid-chest. Avoid placing the electrodes on the upper arms. Otherwise the ECG waveform will be too small.
Patient Monitor User Manual Monitoring ECG - 71 - NOTE:1If an ECG waveform is not accurate, while the electrodes are tightly attached, try to change the lead. 2Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform. 8.9 ECG Menu Setup8.9.1 Setting Alarm Source To change the alarm source, please select ECG Setup > Alarm Source, then a pop-up box is displayed: HR: the monitor considers the HR as HR/PR alarm source; PR: the monitor considers the PR as HR/PR alarm source; AUTO: If the Alarm Source is set to Auto, the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without a technical condition. The monitor will automatically switch to Pulse as the alarm source if: –a valid ECG lead can no longer be measured and –a pulse source is switched on and available. The monitor then uses the pulse rate from the measurement currently active as system pulse. While Pulse is the alarm source, all arrhythmia and ECG HR alarms are switched off. If an ECG lead becomes available again, the monitor automatically uses HR as alarm source. 8.9.2 Smart Lead Off In 5 LEADS, 12 LEADS mode, if CH1 and CH2 cannot be measured because of the lead off or other reasons, it can shift to other modes to collect an ECG waveform. To change smart lead off setting, please select ECG Setup > Smart Leadoff, then a pop-up menu is displayed. 8.9.3 Setting Beat Volume Beat volume is from HR or PR, depending on your HR alarm setting. Five selections are available: 0, 1, 2, 3, 4, 5. 5 indicates the maximum volume. 0 indicates the minimum volume. To change the beat volume, first select ECG Setup > Beat Volume, and then select an appropriate volume from the pop-up list.
Patient Monitor User Manual Monitoring ECG - 72 - 8.9.4 ECG Display It varies with Lead Type. When Lead Type is set to 3 Leads, Display can be set to Normal, and it can display one ECG waveform on the main screen.When Lead Type is set to 5 Leads, Display can be set to Normal, Full-Scr and Half-Scr. Select Normal to display two ECG waveforms on the main screen; select Full-Scr to display seven ECG waveforms which occupy the area of seven waveforms on the main screen; Select Half-Scr to display seven ECG waveforms on the screen, occupying the area of four waveforms. NOTE:If 3 Leads is selected in the ECG Setup menu, only Normal can be selected for Displayin the sub-menu. 8.9.5 Setting Pace Status It is important to set the paced status correctly when you start monitoring ECG. To change the paced status in the ECG Setup menu, select Pace to toggle between On or Off. When Pace is set to On: - Pace Pulse Rejection is switched on. This means that pacemaker pulses are not counted as extra QRS complexes. ̢Paced symbol is displayed as | on the main screen. NOTE:1When monitoring a patient with a pacemaker, set Pace to On. If monitoring a patient without a pacemaker, set Pace to Off.2If Pace is set to On, the system will not perform some types of ARR analysis. WARNINGSome pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Keep pacemaker patients under close observation. 8.9.6 ECG Calibration This item is used to calibrate ECG waveform. When you select this item from ECG Setup menu again, the ECG waveform calibration ends. NOTE:The device can’t be monitored during ECG calibration. 8.9.7 ECG Waveform Settings To change this speed, select ECG Wave Setup > Sweep, then select an appropriate setting from the pop-up list. The bigger the value is, the wider the waveform is.
Patient Monitor User Manual Monitoring ECG - 73 - 8.9.8 12 Leads ECG When the monitor is installed with 12-lead, it can provide 3-lead, 5-lead and 12-lead ECG monitoring functions. 8.10 ST Segment Monitoring The monitor performs ST segment analysis on normal and atrially paced beats and calculates ST segment elevations and depressions. This information can be displayed in the form of ST numeric and snippets on the monitor. ST segment monitoring function is shut off by default. You can switch it to On when necessary. When using the ST analysis function, the ST analysis results will be displayed on the right of the main screen, please refer to the following figure. NOTE: The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment changes need to be determined by a clinician. 8.10.1 Setting ST AnalysisTo change ST analysis, please select ECG Setup > ST Analysis, then select On or Off from the pop-up list. 8.10.2 ST DisplayYour monitor screen may be configured to look slightly different from the illustrations. ST IIIIII0.080.100.02aVRaVLaVF-0.090.030.06V0.04 NOTE:1When setting ST Analysis to on, the monitor should be in Diagnos mode. 2ECG monitoring should be in Diagnos mode. 8.10.3 ST Analysis Alarm Setting The user can select ECG Setup > ST Analysis > Alarm Setup to set the upper alarm limit and lower alarm limit. ALM HI can be set to 0.2 mV ~ 2.0 mV, and ALM LO can be set to –2.0 mV ~ 0.2 mV. ALM HI should be higher than ALM LO.
Patient Monitor User Manual Monitoring ECG - 74 - 8.10.4 About ST Measurement Points The ST value for each beat complex is the vertical difference between the ISO point and the ST point, as shown in the diagram below. The isoelectric (ISO) point provides the baseline, and the ST point is at the midpoint of the ST segment. The J point is where the QRS complex changes its slope; as it is a fixed distance away from the ST point, it can be useful to help you position the ST point correctly. DEF POINT The ST and ISO measurement points need to be adjusted when you start monitoring, and if the patient's heart rate or ECG morphology changes significantly. Always ensure that ST measurement points are appropriate for your patient. Abnormal QRS complex is not considered in ST segment analysis. 8.10.5 Adjusting ST and ISO Measurement PointsDepending on your monitor’s configuration, the ST point can be positioned, too. These two points can be adjusted by turning the knob. When adjusting ST measurement point, the system will show the ST Measurement Point Window. The system displays the QRS complex template in the window. It is adjustable for the highlight bar in the window. You may select ISO or ST, switch the knob left or right to move the cursor line. When the cursor is at the required position, you may select the base point or the measurement point. 8.11 Arr. Monitoring 8.11.1 Arrhythmia AnalysisThe arrhythmia algorithm is used to monitor ECG of patients in clinics, and detect the changes of heart rate and ventricular rhythm, and also save arrhythmia events and generate alarming information. Arrhythmia algorithm can monitor paced and non-paced patients. Qualified personnel can use arrhythmia analysis to evaluate patient’s condition (such as heart rate, PVCs frequency, rhythm and ectopic beat) and decide the treatment. Besides detecting change of ECG, arrhythmia algorithm can also monitor patients and give proper alarm for arrhythmia.
Patient Monitor User Manual Monitoring ECG - 75 - The monitor can support up to 16 different arrhythmia analyses. ARR Types Occurring Condition ASYSTOLE No QRS is detected for 4 consecutive seconds VFIB/VTAC Ventricular tachycardia: The RR interval of 4-second fibrillation wave or 5 consecutive ventricular beats is less than 600 ms. VT>2 3< the number of cluster PVCs < 5 COUPLET 2 consecutive PVCs BIGEMINY Vent Bigeminy TRIGEMINY Vent Trigeminy R ON T A type of single PVC under the condition that HR<100ˈR-R interval is less than 1/3 the average interval, followed by a compensating pause of 1.25X the average R-R interval (the next R wave advances onto the previous T wave). PVC Single PVC detected in normal heartbeats. TACHY 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). BRADY 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). 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 When HR is  120 beats/min, no beat is tested within 1 second. IRR IRREGULAR RHYTHM: The patient has irregular heart rate. PNC PACE NOT CAPTURE: After the pacemaker is paced, QRS complex can not be detected during 300ms. PNP PACER NOT PACED: After the QRS complex, no pace is detected during 1.75 times of RR interval. VBRADY VENTRICULAR BRADYCARDIA: The interval of 5 consecutive ventricular wave is more than 1000 ms. VENT VENTRICULAR RHYTHM: The interval of 5 consecutive ventricular wave ranges from 600 ms to 1000 ms.
Patient Monitor User Manual Monitoring ECG - 76 - 8.11.2 ARR Analysis Menu8.11.2.1 Switching ARR Analysis On and Off To switch ARR Analysis on or off, in the ECG Setup menu, select ARR Analysis to toggle between On and Off from the popup interface. 8.11.2.2 PVCs Alarm Select On in the menu to enable prompt message when an alarm occurs; select Off to disable the alarm function, and there will be a symbol beside PVCs. WARNINGWhen the PVCs 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. 8.11.2.3 ARR Relearning Pick this item to start a learning procedure, and ECG ARR LEARNING is displayed on the screen. The ECG ARR LEARNING will start automatically in the following status: zChanging lead type; zConnection leads; zUpdating the patients; zStarting ARR learning manually; zAfter the ARR analysis is switched on; zThe module is set to on; zCalibration mode is changed to normal measurement mode; zExiting the Demo mode; zExiting the standby mode; 8.11.2.4 ARR Alarm The users can switch on or off all arrhythmia alarms by selecting ECG Setup > ARR Analysis > ARR Alarm. And some arrhythmia alarms can be individually switched on or off. They are: ASYSTOLE, VFIB/VTAC, R-ON-T, VT>2, COUPLET, PVC, BIGEMINY, TRIGEMINY, TACHY, BRADY, MISSED BEATS, IRR, PNC, PNP, VBRADY and VENT. To switch individual alarm on or off, select ECG Setup > ARR Analysis > ARR Alarm. The user can set the individual ARR alarm from the popup interface.
Patient Monitor User Manual Monitoring ECG - 77 - 8.12 12-Lead ECG Monitoring8.12.1 Diagnosis FunctionIf iM80 is equipped with 12 leads monitoring, the device has automatically diagnosis function. To perform this function, please: 1 Set Lead Type in the ECG Setup menu to 12 Leads and set Display in the ECG Setup menu to 12 Leads. 2 Select the ECG Analysis shortcut key on the screen. 3 The Diagnosis Review interface is displayed, shown in figure a. And the diagnosis result is displayed on the interface after approximately 10 seconds, shown in figure b. Figure a Figure b
Patient Monitor User Manual Monitoring ECG - 78 - Figure b shows analysis time, HR (heart rate), P/QRS/T Axis, RR Interval, RVS/SV1 Amp (RVS/SV1 amplitude), QRS Duration, RV5+SV1 Amp (RV5+SV1 amplitude), QT/QTC Interval and Diagnosis code. More information about diagnosis review, please refer to Section 12-lead Diagnosis Review. 8.12.2 Measurement and InterpretationThe measurement function provides the automatic measurement of these common parameters, such as heart rate, PR interval, QRS complex duration, QT interval, P/QRS/T axis, RV5/SV1 amplitude etc. The interpretation function provides the automatic diagnosis of hundreds of abnormal cases, such as Arrhythmia, AV block, ventricular conduction block, myocardial infarction, ventricular hypertrophy and atria enlargement, ST-T abnormality and electrical axes deviation.
Patient Monitor User Manual Monitoring RESP - 79 - Chapter 9 Monitoring RESP 9.1 OverviewThe monitor measures respiration from the amount of thoracic impedance between two ECG electrodes. The change of impedance between the two electrodes, (due to the thoracic movement), produces a respiratory waveform on the screen. 9.2 RESP Safety InformationWARNING1If you do not set the detection level for the respiration correctly in manual detection mode, it may not be possible for the monitor to detect apnea. If you set the detection level too low, the monitor is more likely to detect cardiac activity, and to falsely interpret cardiac activity as respiratory activity in the case of apnea. 2The respiration measurement does not recognize obstructive and mixed apneas - it only indicates an alarm when a pre-adjusted time has elapsed since the last detected breath.3If operating under conditions according to the EMC Standard EN 60601-1-2 (Radiated Immunity 3V/m), field strengths above 1V/m may cause erroneous measurements at various frequencies. Therefore it is recommended to avoid the use of electrically radiating equipment in close proximity to the respiration measurement unit. 4Cardiogenic artifact in impedance respiration monitoring may make it difficult to detect breaths or may otherwise be counted as breaths. In some instances, the breath rate may also correspond to the heart rate making it difficult to determine if the signal is due to breathing or the cardiac cycle. Do not rely on RESP monitoring as the sole method for detecting cessation of breathing. Follow hospital guidelines and best clinical practices for apnea detection including monitoring additional parameters that indicate the patient’s oxygenation status, such as etCO2 and SpO2.NOTE:The RESP monitoring is not recommended to be used on patients who are very active, as this can cause false alarms.
Patient Monitor User Manual Monitoring RESP - 80 - 9.3 Resp Display Resp143089.4 Electrode Placement for Monitoring RespCorrect patient skin preparation techniques for electrode placement are important for Resp measurement: you will find this information in the chapter on Monitoring ECG. The Resp signal is always measured between two of the ECG electrodes. There are two standard ECG leads for selection: I lead (RA and LA) and II lead (RA and LL). Electrodes Placement for 5-lead 9.5 Cardiac OverlayCardiac activity that affects the Resp waveform is called cardiac overlay. It happens when the Resp electrodes pick up impedance changes caused by the rhythmic blood flow. Correct electrode placement can help to reduce cardiac overlay: avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes. This is particularly important for neonates. 9.6 Chest ExpansionSome patients, especially neonates, expand their chests laterally. In these cases it is best to place the two respiratory electrodes in the right mid-axillary and left lateral chest areas at the patient’s maximum point of breathing movement to optimize the respiratory wave.
Patient Monitor User Manual Monitoring RESP - 81 - 9.7 Abdominal BreathingSome patients with restricted chest movement breathe mainly abdominally. In these cases, you may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory wave. NOTE:Place the red and green electrodes diagonally to optimize the respiration waveform. Avoid the liver area and the ventricles of the heart in the line between the RESP electrodes so as to avoid cardiac overlay or artifacts from pulsating blood flow. This is particularly important for neonates. 9.8 Selecting Resp LeadTo change Resp lead, in the Resp Setup menu, select Resp Lead to pick up the appropriate lead from the pop-up list. 9.9 Changing Hold TypeTo change the calculation mode, in the Resp Setup menu, set Hold Type to Manual or Auto. When it is set to the AUTO mode, Hold High and Hold Low are unavailable, and the monitor can calculate the respiration rate automatically. When it is set to the Manual mode, you can adjust the broken lines in RESP area by the Hold High and Hold Low items. 9.10 Changing the Size of the Respiration WaveSelect the Resp waveform area to open the Resp Wave Setup menu: zSelect AMP, then choose an appropriate value. The value is bigger, the waveform amplitude is higher. zSelect Sweep: select an appropriate setting from the pop-up list. 9.11 Using Resp AlarmsResp alarms can be switched on and off and the high and low alarm limits can be changed just like other measurement alarms, as described in the Alarms chapter. 9.12 Changing the Apnea TimeThe apnea alarm is a high priority red alarm used to detect apneas. The apnea alarm delay time defines the time period between the point where the monitor cannot detect any respiration activity and the indication of the apnea alarm. 1. In the Resp Setup menu, select Apnea Alm. 2. Select the appropriate setting from the popup list.
Patient Monitor User Manual Monitoring SpO2 - 82 - Chapter 10 Monitoring SpO210.1 OverviewSpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. SpO2 Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood. If, for example, 97% of the hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has a SpO2 oxygen saturation of 97%. The SpO2 numeric on the monitor will read 97%. The SpO2 numeric shows the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin. The SpO2/PLETH parameter can also provide a pulse rate signal and a plethysmogram wave. 10.2 SpO2 Safety InformationWARNING1If the SpO2 sensor cannot work properly, please reconnect the sensor or change a new one. 2Do not use the sterile supplied SpO2 sensors if the packaging or the sensor is damaged and return them to the vendor. 3Prolonged and continuous monitoring may increase the risk of unexpected change of dermal condition such as abnormal sensitivity, rubescence, vesicle, repressive putrescence, and so on. It is especially important to check the sensor placement of neonate and patient of poor perfusion or immature dermogram by light collimation and proper attaching strictly according to changes of the skin. More frequent examinations may be required for different patients. 4Tissue damage may be caused by incorrect application or prolonged measurement duration using the sensor (more than 4 hours). Inspect the sensor periodically according to the sensor user manual. 5Use only EDAN permitted sensors and extension cables with the monitor. Other sensors or extension cables may cause improper monitor performance and/or minor personal injury. NOTE:1Make sure the nail covers the light window. The wire should be on the backside of the hand. 2SpO2 waveform is not proportional to the pulse volume. 3Avoid placing the sensor on extremities with an arterial catheter, or intravascular venous infusion line.
Patient Monitor User Manual Monitoring SpO2 - 83 - 4Don’t use the functional tester to access the SpO2 accuracy. 5The device is calibrated to display functional oxygen saturation. 6The materials with which the patient or any other person can come into contact conform with the standard of EN ISO 10993-1:2003. 10.3 Measuring SpO21. Select the correct patient category setting (adult/pediatric and neonatal), as this is used to optimize the calculation of the SpO2 and pulse numeric. 2. During measurement, ensure that the application site: – has a pulsatile flow, ideally with a good circulation perfusion. – has not changed in its thickness, causing an improper fit of the sensor. 10.4 Measurement Procedure1. Switch on the monitor. 2. Attach the sensor to the appropriate site of the patient finger. 3. Plug the connector of the sensor extension cable into the SpO2 socket on the SpO2 module. Mounting of the Sensor WARNINGInspect the application site every two to three hours to ensure skin quality and correct optical alignment. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. NOTE:Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements. Interference can be caused by: zHigh levels of ambient light or strobe lights or flashing lights (such as fire alarm lamps). (Hint: cover application site with opaque material.) zHigh-frequency electrical noise, including electro-surgical apparatus and defibrillators
Patient Monitor User Manual Monitoring SpO2 - 84 - zIntravascular dye injections zSignificant concentrations of dysfunctional hemoglobin, such as carboxyhemoglobin and methemoglobin zExcessive patient movement and vibration zImproper sensor application zLow perfusion or high signal attenuation zVenous pulsation zPlacement of the sensor on an extremity that has a blood pressure cuff, arterial catheter, or intravascular line 10.5 Understanding SpO2 AlarmsThis refers to SpO2 specific alarms. See the Alarms section for general alarm information. SpO2 offers high and low limit alarms, and the users can adjust them. 10.6 Adjusting Alarm LimitsIn the SpO2 Setup menu, select Alarm Setup: zSet the SpO2 High Alarm Limit to an appropriate value from the popup interface. zSet the SpO2 Low Alarm Limit to an appropriate value from the popup interface. WARNINGHigh oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration do NOT set the high alarm limit to 100%, which is equivalent to switching the alarm off. 10.7 Setting SpO2 as Pulse Source1. In the PR Setup menu, select PR Source; 2. Select SpO2 from the pop-up list. 10.8 Setting Pitch ToneIf tone modulation is on, the PR sound lowers when the SpO2 level drops. In the SpO2 Setup menu, select pitch tone to toggle between On and Off.
Patient Monitor User Manual Monitoring SpO2 - 85 - 10.9 Setting Sensitivity The different sensitivity indicates different refresh frequency. High indicates the refresh frequency of SpO2 value is the most frequent. To change the sensitivity, please follow the steps: 1Select the SpO2 Setup menu; 2Select Sensitivity on the interface and select the desired sensitivity from the popup list.
Patient Monitor User Manual Monitoring PR - 86 - Chapter 11 Monitoring PR 11.1 Overview The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart in beats per minute (bpm). You can display a pulse from any measured SpO2 signal or any arterial pressure. 11.2 Setting PR Source The monitor provides PR source options. You can select SpO2 or arterial pressure labels as the PR source in the PR Source list on the PR Setup menu. NOTE:In the PR Source list, an arterial pressure label accompanied with a label with brackets indicates this label is in conflict. Do not select a conflicting label as the PR source. 11.3 Setting PR Volume Six selections are available: 0, 1, 2, 3, 4, and 5. 5 indicates the maximum volume. 0 indicates no sound. You can change PR Volume in the PR Setup menu.11.4 Using Pulse Alarms You can change pulse rate alarm limits in the PR Setup menu by selecting Alarm Setup. Pulse alarms are only generated when the active alarm source is set to PR, a pulse source is set as system pulse and pulse alarms are switched on. 11.5 Selecting the Active Alarm Source In most cases, the HR and Pulse numerics are identical. In order to avoid simultaneous alarms on HR and Pulse, the monitor uses either HR or Pulse as its active alarm source. To change the alarm source, select Alarm Source in the HR/Pulse Alarms menu, then select zHR: if you want HR to be the alarm source for HR/Pulse. zPR: if you select Pulse as the active alarm source, the monitor will prompt you to confirm your choice. Be aware that if you select Pulse as the alarm source, all arrhythmia and ECG HR alarms are switched off. zAUTO: if the Alarm Source is set to Auto, the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without a technical alarm condition. The monitor will automatically switch to Pulse as the alarm source.
Patient Monitor User Manual Monitoring NIBP - 87 - Chapter 12 Monitoring NIBP12.1 Overview This monitor uses the oscillometric method for measuring NIBP. It can be used for adult, pediatric and neonatal patients. Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. In adult and pediatric mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10-1992) in relation to mean error and standard deviation, when compared to auscultatory measurements in a representative patient population. For the auscultatory reference, the fifth Korotkoff sound was used to determine the diastolic pressure. In neonatal mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10-1992) in relation to mean error and standard deviation, when compared to intra-arterial measurements in a representative patient population. 12.2 NIBP Safety Information WARNING 1Do not measure NIBP on patients with sickle-cell disease or any condition where skin damage has occurred or is expected. 2Use clinical judgement to decide whether to perform frequent unattended blood pressure measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff. 3Ensure that the correct setting is selected when performing measurements. It may be dangerous for the children to use an over pressure level. 4The equipment is suitable for use in the presence of electrosurgery. 5The equipment can provide protective means to prevent the patient from being burned when used with HF SURGICAL EQUIPMENT. The equipment can protect against the effects of the discharge of a defibrillator. 6Before starting a measurement, verify that you have selected a setting appropriate for your patient (adult, pediatric or neonatal.) 7Do not apply the cuff to a limb that has an intravenous infusion or catheter in place. This could cause tissue damage around the catheter when infusion is slowed or blocked during cuff inflation.
Patient Monitor User Manual Monitoring NIBP - 88 - WARNING 8Make sure that the air conduit connecting the blood pressure cuff and the monitor is neither blocked nor tangled. 9Do not attach the cuff to a limb being used for IV infusions as the cuff inflation can block the infusion, potentially causing harm to patient. NOTE:1It is suggested that the user should not start NIBP measuring when the low battery displays, or the monitor may be turned off automatically. 2If you spill liquid onto the equipment or accessories, particularly if there is a chance that it can get inside the tubing or the measurement device, contact your service personnel. 3Continuous use of the automatic measuring mode for short intervals may lead to the discomfort of patient. 12.3 Introducing the Oscillometric NIBP Measurement Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. 12.4 Measurement Limitations Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 240 bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible in the following situations: zA regular arterial pressure pulse is hard to detect. zPatients with cardiac arrhythmias. zPatients with excessive and continuous movement such as shivering or convulsions. zPatients with rapid blood pressure changes. zPatients with severe shock or hypothermia that reduces blood flow to the peripheries. zPatients with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery. zPatients on an edematous extremity.
Patient Monitor User Manual Monitoring NIBP - 89 - 12.5 Measurement Methods There are three methods of measuring NIBP: zManual - measurement on demand. zAuto - continually repeated measurements (between 1 and 480 minute adjustable interval). zSequence - the measurement will run consecutively in five minutes, then the monitor enters manual mode. WARNING Prolonged non-invasive blood pressure measurements in Auto mode may be associated with purport, ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the extremities of the limb frequently for normal color, warmth and sensitivity. If any abnormality is observed, stop the blood pressure measurements. 12.6 Measurement Procedures 1. Connect the air hose and switch on the monitor. 2. Apply the blood pressure cuff to the patient's arm or leg and follow the instructions below. Ensure that the cuff is completely deflated. Apply the appropriate size cuff to the patient (About the cuff size selection, please refer to Section NIBP accessories), and make sure that the symbol "" is over the artery. Ensure that the cuff is not wrapped too tightly around the limb. Excessive tightness may cause discoloration and eventual ischemia of the extremity. NOTE:The width of the cuff should be either approximately 40% of the limb circumference (50% for neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 50-80% of the limb. The wrong size of cuff can cause erroneous readings. If the cuff size is in question, use a larger cuff. Cuff Usage
Patient Monitor User Manual Monitoring NIBP - 90 - 3. Connect the cuff to the air tubing. 4. Check whether the patient mode is appropriately selected. Access the Patient Setup menu from Menu. Turn the knob to select the required patient Type in the Patient Info. menu. 5. Select a measurement mode in the NIBP Setup menu. Refer to section Operation Promptsfor details. 6. Press the button on the front panel to start a measurement. 12.7 Operation Prompts 1. Manual Measuring Access the NIBP Setup menu and set the Measure Mode item to Manual. Then press the button on the front panel to start a manual measurement.During the idle period of measurement process, press the button on the front panel at any time to start a manual measurement. Then press the button on the front panel to stop manual measurement and the system continues to execute auto measurement program according to the selected time interval. 2. Automatical Measurement Access the NIBP Setup menu and set the Measure Mode item to Auto, then press the button on the front panel to start the automatical measurement according to the selected time interval. 3. Continuous measurement Access the NIBP Setup menu and pick the Continual item to start a continuous measurement. The continuous measurement will last 5 minutes. 4. Stopping continuous measurementDuring continuous measurement, press the button on the front panel at any time to stop continuous measurement. 12.8 Correcting the Measurement if Limb is not at Heart Level To correct the measurement if the limb is not at heart level to the displayed value:Add 0.75mmHg (0.10kPa) for each centimeter higher or Deduct 0.75mmHg (0.10kPa) for each centimeter lower or Add 1.9mmHg (0.25kPa) for each inch higher Deduct 1.9mmHg (0.25kPa) for each inch lower
Patient Monitor User Manual Monitoring NIBP - 91 - 12.9 NIBP Alarm When NIBP Alarm is set to On, the physiology alarm occurs if any measurement value of Systolic pressure, Mean pressure, Diastolic pressure exceeds alarm limit. The users can adjust the alarm limit by accessing NIBP Setup > Alarm Setup > Sys Alarm/Map Alarm/Dia Alarm. 12.10 Resetting NIBP When the pressure does not work properly and the system fails to give a message for the problem, pick Reset in the User Maintain > NIBP Maintain menu to activate self-test procedure, and thus restore the system from abnormal performance.12.11 Calibrating NIBP NIBP is not user-calibrated. Cuff-pressure transducers must be verified and calibrated on a yearly interval by a qualified service professional. See the Service Manual for details. 12.12 Leak Test This item is used for leak test. Turn the knob to pick the Leak Test item in the User Maintain > NIBP Maintain menu to start the air leakage test. When the item is selected, it will change into Stop. If this item is selected again, the system will stop air leakage test. And the item returns to Leak Test. WARNING This pneumatic test other than being specified in the EN 1060-1 standard is to be used by the user to simply determine whether there are air leaks in the NIBP airway. If at the end of the test the system gives the prompt that the NIBP airway has air leaks, please contact the manufacturer for repair. 12.12.1 Procedure of Leak TestzConnect the cuff securely with the socket for NIBP air hole. zWrap the cuff around the cylinder of an appropriate size. zAccess User Maintain > NIBP Maintain. zTurn the knob to the Leak Test item and press the item. Then the prompt of LeakTesting will appear indicating that the system has started performing leak test. For iM70/iM80 with the Omron module: The system will automatically inflate the pneumatic system to about 180 mmHg (285mmHg for Omron Module). After 20 seconds (4 minutes for Omron Module), the system will automatically open the deflating valve, which marks the completion of a pneumatic measurement.
Patient Monitor User Manual Monitoring NIBP - 92 - For iM50/iM60/iM70 with the EDAN module: The system will automatically inflate the pneumatic system to about 180 mmHg. After 20 seconds, the system will automatically open the deflating valve, which marks the completion of a pneumatic measurement. For iM80 with the EDAN module: The system will automatically inflate the pneumatic system to about 180mmHg. After 20 to 40 seconds, if system leakage has detected, the system will automatically open the deflating valve to stop the leak test and indicates NIBP Leak. If no system leakage is detected when the pneumatic system is inflated to 180mmHg, the system will perform a deflation to an approximate value of 40mmHg and subsequently perform the second phase leak test. After 20 to 40 seconds, the system will automatically open the deflating valve and provide corresponding indication based on the test result. zIf the alarm information of NIBP Leak appears, it indicates that the airway may have air leaks. In this case, the user should check for loose connection. After confirming secure connections, the user should re-perform the pneumatic test. If the failure prompt still appears, please contact the manufacturer for repair. Diagram of NIBP Air Leakage Test
Patient Monitor User Manual Monitoring TEMP - 93 - Chapter 13 Monitoring TEMP 13.1 Overview Body temperature is measured by means of a thermistor probe (a semiconductor whose resistance changes with temperature) that is inserted in the rectum. Two TEMP probes can be used simultaneously to measure two TEMP values, and get the temperature difference. The standard configuration is axilla sensor for adult. 13.2 TEMP Safety InformationWARNING1Verify probe cables fault detection before the beginning of monitoring phase. Unplug the temperature probe cable of the channe1 from the socket, and then the screen will display the error message TEMP T1 Sensor Off and the audible alarm is activated. It is the same to the other channel. 2Take the TEMP probe and cable carefully. When they are not in use, you should coil up the probe and cable into a loose circle. If the wire inside the cable is tensely pulled, it may cause mechanical damage to the probe and the cable. 13.3 TEMP Monitoring Setup With a reusable TEMP probe you can plug the probe directly into the monitor. Apply the TEMP probes securely to the patient. Switch on the monitor. It takes 2 min ~ 3 min for the body temperature to stabilize. 13.4 Calculating Temp DifferenceThe monitor can calculate and display the difference between two temperature values by subtracting T2 from T1. The difference is labeled TD.
Patient Monitor User Manual Monitoring Quick TEMP - 94 - Chapter 14 Monitoring Quick TEMP* *not available in the U.S.A., Canada, UK and Germany 14.1 OverviewQuick temperature measurement is to establish thermal balance between probe and human body. When the probe is placed on the measurement site until a steady reading is available - after approximately three minutes for oral and rectal measurements and five minutes for axillary measurements. And the measurement temperature is the monitoring temperature. The temperature curve in this process has a certain discipline. The approximatively actual temperature curve can be simulated by temperature data sampled earlier. The temperature at thermal balance is calculated through the specific algorithm based on the curve. The monitor can only measure temperature of adult and pediatric patients. If the user measures temperature of neonatal patient, the monitor will not display data. The oral/axillary sensor and rectal sensor are of standard configuration. 14.2 Quick TEMP Safety Information WARNING1To ensure optimal accuracy, always confirm that the correct mode and alarm limit are selected. Changing the measure position may lead to the change of alarm limit. 2Verify probe cables fault detection before the beginning of monitoring phase. Unplug the temperature probe cable from the socket, and then the screen will display the error message TEMP SENSOR OFF and the audible alarm is activated. 3Take the TEMP probe and cable carefully. When they are not in use, you should coil up the probe and cable into a loose circle. If the wire inside the cable is tensely pulled, it may cause mechanical damage to the probe and the cable. 4The calibration of the temperature module is necessary every two years (or as frequently as dictated by your Hospital Procedures Policy). When you need to calibrate the temperature measurement, please contact the manufacturer. 5Patient actions may interfere with accurate oral temperature readings. Ingesting hot or cold liquids, eating food, chewing gum or mints, brushing teeth, smoking or performing strenuous activity may affect temperature readings for up to 20min after activity has ended. 6Do not take an axillary temperature through patient’s clothing. Direct probe cover to skin contact is required. 7Biting the sensor tip while taking a temperature may result in damage to the sensor.
Patient Monitor User Manual Monitoring Quick TEMP - 95 - WARNING8Make sure disposable TEMP sensor covers are used to limit patient cross-contamination. The use of any other probe cover may produce temperature measurement errors or result in inaccurate readings. 9Quick Temp measurement isn’t suitable for use during defibrillation. 14.3 Measuring Procedure 14.3.1 Measurement for Oral Temperature1. Ensure the oral probe (white probe) and probe well are installed. 2. Remove the probe from the probe well. 3. Observe the oral mode indicator on the screen (flashing head icon). If this icon is not flashing, press the Measure Pos button and set it to Oral until the head icon appears. 4. Load the probe cover. 5. Place the probe tip deep into the patient’s sublingual pocket as shown in the following figure. Measuring Position in Mouth 6. Do not hand the probe to the patient to place in his or her own mouth. 7. Always hold the probe in place, maintaining tissue contact until temperature is complete. If necessary, repeat the measurement procedure shown above. Sublingual Pocket
Patient Monitor User Manual Monitoring Quick TEMP - 96 - NOTE:1After one measurement, the user should put the sensor well to the sensor bracket and then take it out for starting a new measurement. 2To ensure optimal accuracy, always confirm that the correct measurement position is selected.14.3.2 Measurements for Rectal Temperatures1. Ensure that the rectal probe (red probe) and probe well are installed. 2. Remove the red probe from the probe well. 3. Observe the Rectal Mode indicator on the display (flashing lower body icon). 4. Load a probe cover. Apply lubricant if desired. 5. Separate the buttocks and gently insert the probe only 1.5cm (5/8 inch), less for infants and children. Measuring Position in Rectal WARNINGIncorrect insertion can cause bowel perforation. 14.3.3 Measurements for Axillary Temperatures1. Ensure that the white probe and probe well are installed. 2. Remove the probe from the probe well. 3. Press Quick TEMP Setup > Measure Pos and select the Axillary mode. 4.Observe the axillary mode indicator on the display (flashing axillary icon). 5. Load a probe cover. 6. Adjust clothing to visualize the axilla. 7. Avoid folds in the axilla and place the probe tip vertically as high as you can as shown. 8. Place the arm at the patient’s side. Hold in this position without movement of the arm or probe during the measurement cycle.
Patient Monitor User Manual Monitoring Quick TEMP - 97 - Measuring Position in Axillary NOTE:Do not take an axilliary temperature through the patient’s clothing. Direct contact between the patient’s skin and the probe is required. To obtain accurate rectal temperature, use the white temperature probe. 14.4 Changing Temp UnitTo change Temp Unit, please: 1 Select the Quick Temp Setup menu to open it and select Unit on the interface. 2 Select the appropriate unit from the popup list.
Patient Monitor User Manual Monitoring IBP - 98 - Chapter 15 Monitoring IBP15.1 OverviewIBP is measured by means of a catheter inserted directly into the circulatory system. A pressure transducer connected to the catheter converts the mechanical force exerted by the blood into an electrical signal, which is displayed graphically as pressure versus time on a monitor screen or numerically on digital display. The monitor measures direct blood pressure of one selected blood vessel through two channels or four channels, and displays waveforms and pressure of measured direct blood pressure (SYS, DIA and MAP). 15.2 IBP Safety InformationWARNING1The operator should avoid contact with the conductive parts of the appurtenance when it is connected or applied. 2When the monitor is used with HF surgical equipment, the transducer and the cables must be avoided from conductive connection to the HF equipment. This is to protect against burns to the patient.3Disposable IBP transducer or domes should not be reused. 4If any kind of liquid, other than solution to be infused in pressure line or transducer, is splashed on the equipment or its accessories, or enters the transducer or the monitor, contact the Hospital Service Center immediately. NOTE:1Use only the pressure transducer listed in the IBP Accessories 2Calibrate the instrument either whenever a new transducer is used, or as frequently as dictated by your Hospital Procedures Policy.15.3 Monitoring ProceduresPreparatory steps for IBP measurement: 1. Plug the pressure cable into the corresponding socket and switch on the monitor. 2. Flushing through the system with normal saline solution. Ensure that the system is free of air bubbles. 3. Connect the patient catheter to the pressure line, making sure that there is no air present in the catheter or pressure line.
Patient Monitor User Manual Monitoring IBP - 99 - 4. Position the transducer so that it is at the same level with the patient’s heart, approximately mid-axillary line. 5. For the label name selection, please refer to Selecting a Pressure for Monitoring. 6. To zero the transducer, please refer to Zeroing the Pressure Transducer. WARNINGIf there are air bubbles in the pressure line or the transducer, you should flush the system with the solution to be infused. 15.4 Selecting a Pressure for Monitoring Tell the monitor which pressure you want to monitor by selecting its pressure label. The label is a unique identifier for each type of pressure. When you choose a label, the monitor uses that label’s stored settings, for example color, wave scale and alarm settings. The label also determines which algorithm is used to process the pressure signal, so an incorrect label can lead to incorrect pressure values. To select the label, please refer to the following table: Label Description ART Arterial blood pressure PA Pulmonary artery pressure CVP Central venous pressure ICP Intracranial pressure LAP Left atrial pressure RAP Right atrial pressure P1-P2 Alternative non-specific pressure labels 15.5 Zeroing the Pressure TransducerTo avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in accordance with your hospital policy (at least once per day). You must perform a zero: zWhen you use a new transducer or tubing zEvery time you reconnect the transducer cable to the monitor; zIf you think the monitor’s pressure readings are not correct. When using a pressure module, the zero information is stored in the module.
Patient Monitor User Manual Monitoring IBP - 100 - 15.6 Zeroing a Pressure MeasurementThe zeroing procedure is listed as below: 1. Turn off the stopcock to the patient. 2. Vent the transducer to atmospheric pressure, to compensate for the static and atmospheric pressure exerted on the transducer. 3. In the setup menu for the pressure, select Zero. 4. When you see the message Zero Ok, please close the stopcock to atmospheric pressure, and open the stopcock to the patient.15.7 Troubleshooting the Pressure Zeroing (Taking Art for Example)The status message lists the probable cause of an unsuccessful calibration. Message Corrective Action Art ZERO FAIL Make sure that the transducer is not attached to the patient Art SENSOR OFF, FAIL Make sure that transducer is not off, and then proceed zeroing IN DEMO, FAIL Make sure that the monitor is not in DEMO mode. Contact service technician if necessary PRESSURE OVER RANGE, FAIL Make sure that the stopcock is vented to atmosphere. If the problem persists, please contact service technician PULSATILE PRESSURE ZERO FAIL Make sure that the transducer is vented to air, not connected to a patient, and try again. 15.8 IBP Pressure Calibration 1. Mercury calibration should be performed by the biomedical engineering department either whenever a new transducer is used, or as frequently as dictated by your Hospital Procedures Policy. 2. The purpose of the calibration is to ensure that the system gives you accurate measurements. 3. Before starting a mercury calibration, a zero procedure must be performed. If you need to perform this procedure yourself, you will need the following equipment: Standard sphygmomanometer, 3-way stopcock and Tubing (approximately 25 cm long). The calibration procedure is listed below: 1. Close the stopcock that was open to atmospheric pressure for the zero calibration. 2. Attach the tubing to the sphygmomanometer.
Patient Monitor User Manual Monitoring IBP - 101 - 3. Ensure that connection to patient is off. 4. Connect the 3-way connector to the 3-way stopcock that is not connected to the patient catheter. 5. Open the port of the 3-way stopcock to the sphygmomanometer. 6. Select the channel to be calibrated in the menu and select the pressure value to which the IBP is to be adjusted. 7. Inflate to make the mercury bar rise to the setup pressure value. 8. Adjust repeatedly until the value in the menu is equal to the pressure value shown by the mercury calibration. 9. Press the Start button, the device will begin calibrating. 10. Wait for the calibrated result. You should take corresponding measures based on the prompt information. 11. After calibration, disassemble the blood pressure tubing and the attached 3-way valve. 1: Hydrargyrum pressure meter; 2: 3-way connector; 3: 3-way stopcock; 4: Pressure transducer; 5: Pressure transducer interface cable; 6: Monitor IBP Calibration 15.9 Troubleshooting the Pressure CalibrationThe status line lists the probable reasons of an unsuccessful calibration. Causes Corrective Action Sensor Off, Fail! Make sure that sensor is not off, and then start the calibration. Contact service technician if necessary. Unable to calibrate in Demo Mode. Make sure that the monitor is not in DEMO mode. Contact service technician if necessary. 6 5 4 3 2 1
Patient Monitor User Manual Monitoring IBP - 102 - Pressure out of normal range, fail. Make sure that you have selected transducer value in IBP CAL, and then start the calibration. Contact service technician if necessary. Pulsate Pressure Calibration Fail Make sure that pressure value shown by hydrargyrum pressure meter is changeless. Contact service technician if necessary. 15.10 IBP Alarm When Alarm Switch is set to On, the physiology alarm occurs if any measurement value of Systolic pressure, Mean pressure, or Diastolic pressure exceeds alarm limit. Users can adjust the alarm limit by accessing XX Options (XX stands for the label name) > Setup > SYS Alarm / MAP Alarm / DIA Alarm.
Patient Monitor User Manual Monitoring CO2 - 103 - Chapter 16 Monitoring CO216.1 Overview The monitor provides the sidestream and mainstream methods for CO2 monitoring. EDAN module and Respironics Sidestream CO2 module are used for sidestream measuring, and Respironics Mainstream CO2 module is used for mainstream measuring. The principle of CO2 measurement is primarily based on the fact that CO2 molecule can absorb 4.3m infrared ray. Absorption intensity is proportional to CO2 concentration of patient sample, the CO2 concentration will compute according to the detecting CO2 absorption intensity of patient sample. zSidestream measurement takes a sample of the respiratory gas with a constant sample flow from the patient’s airway and analyzes it with a remote CO2 sensor. You can measure Sidestream CO2 using the monitor’s built-in CO2 measurement. zMainstream measurement uses a CO2 sensor attached to an airway adapter directly inserted into the patient’s breathing system. 16.2 CO2 Safety InformationWARNING1Do not use the device in the environment with flammable anesthetic gas. 2The device should be used by trained and qualified medical personnel authorized by EDAN.3Nitrous oxide, elevated levels of oxygen, helium, xenon, halogenated hydrocarbons, and barometric pressure can influence the CO2 measurement. 4The monitor will be damaged if any pipeline from the CO2 module is disconnected, or the air tube /the air inlet /the air outlet are plugged by water or other materials. 5The accuracy of the CO2 measurement will be affected by the following reasons: the airway was highly obstructed; the leakage of air way connection or quick variation of environment temperature. 6Follow precautions for electrostatic discharge (ESD) and electromagnetic interference (EMI) to and from other equipment. 7In the presence of electromagnetic devices (i.e., electrocautery), patient monitoring may be interrupted due to electromagnetic interference. Electromagnetic fields up to 20V/m will not adversely affect module performance. 8Do not place the sensor cables or tubing in any manner that may cause entanglement or strangulation. 9Do not store the CO2 Module at temperatures less than -40º F (-40º C) or greater than 158º F (70º C). Do not operate the CO2 Module at temperatures less than 32ºF (0º C) or greater than 104º F (40º C).
Patient Monitor User Manual Monitoring CO2 - 104 - NOTE:After the low battery alarm appears, please do not start the CO2 measurement, or the monitor may turn off for the low battery.16.3 Monitoring Procedures16.3.1 Zeroing the sensor You must perform zeroing following the steps when using the new airway adapter. 1. Expose the sensor to room air and keep it away from all sources of CO2 including the ventilator, the patient’s breath and the operator’s. 2. In the CO2 Setup menu, please set the Work Mode to Measure. 3. For EDAN module, select User Maintain > CO2 Maintain, and click Zero. For Respironics modules, click Zero in the CO2 Setup menu. 4. If the system briefly displays Zero In Progress, the process is successful. After the zeroing calibration is finished, you can start CO2 Monitoring. If the system displays Breath detected or Zero required, zeroing has failed. Zero calibration must be performed again. 16.3.2 Sidestream CO2 Module 16.3.2.1 Measurement Steps EDAN Module 1 Appropriately connect the cannula, airway adapter or sample line to the sensor. 2 Set Work Mode to Measure. 3 For intubated patients, an airway adapter is required. For non-intubated patients, place the nasal cannula onto the patient. NOTE:Disconnect the water trap from the holder or set Work Mode to Standby when the module is not in use. Respironics Sidestream Module 1 Plug the sensor cable into the monitor’s CO2 input connector. Allow the sensor two minutes for warm-up. 2 Appropriately connect the cannula, airway adapter or sample line to the sensor. It will click into place when seated correctly.
Patient Monitor User Manual Monitoring CO2 - 105 - Connecting Respironics Sidestream Module 3 To zero the sensor, please refer to zeroing the sensor. 4 For intubated patients, an airway adapter is required; Air adapter For non-intubated patients: Place the nasal cannula onto the patient. Place the nasal cannula NOTE:1You must perform a zero calibration as described in this procedure each time the ambient temperature changes more than 10°C (for example during transport).
Patient Monitor User Manual Monitoring CO2 - 106 - 2Always connect the airway adapter to the sensor before inserting the airway adapter into the breathing circuit. In reverse, always remove the airway adapter from the breathing circuit before removing the sensor. 3Always disconnect the cannula, airway adapter or sample line from the sensor when the sensor is not in use. 16.3.2.2 Removing Exhaust Gases from the System WARNINGAnesthetics: When using the sidestream CO2 measurement on patients who are receiving or have recently received anesthetics, connect the outlet to a scavenging system, to avoid exposing medical staff to anesthetics. Use an exhaust tube to remove the sample gas to a scavenging system. Attach it to the sidestream sensor at the outlet connector. 16.3.3 Mainstream CO2 ModuleNOTE:You must perform a zero calibration as described in this procedure each time you use a new airway adapter. Respironics Mainstream CO2Module 16.3.3.1 Measurement Steps1 Attach the sensor connector to the CO2 connector on the monitor. 2 Wait two minutes, allowing the sensor to reach its operating temperature and a stable thermal condition. 3 Choose the appropriate airway adapter and connect it to the sensor head. The airway adapter clicks into place when seated correctly.
Patient Monitor User Manual Monitoring CO2 - 107 - Connecting Sensor 4 To zero the sensor, please refer to zeroing the sensor. 5 Install the airway adapter at the proximal end of the circuit between the elbow and the ventilator Y-section. Connecting Airway Adapter WARNING1No routine user calibration required. 2Accuracy is affected by temperature and barometric pressure. 3It is forbidden to insert or draw out the module when the monitor is working, for it can cause instability of the system. If you do it inadvertently, please turn off the module in menu immediately. The module enters STANDBY mode if you reconnect it to monitor which it is powered on. If the readings are inaccurate, you should do calibration.
Patient Monitor User Manual Monitoring CO2 - 108 - NOTE:1Replace the airway adapter, if excessive moisture or secretions are observed in the tubing or if the CO2 waveform changes unexpectedly without a change in patient status.2To avoid infection, use only sterilized, disinfected or disposable airway adapters. 3Inspect the airway adapters prior to use. Do not use it if airway adapter appears damaged or broken. Observe airway adapter color coding for patient population. 4Periodically check the flow sensor and tubing for excessive moisture or secretion buildup.16.3.3.2 Removing Exhaust Gases from the SystemWARNINGAnesthetics: when using the mainstream CO2 measurement on patients who are receiving or have recently received anesthetics, connect the outlet to a scavenging system, to avoid exposing medical staff to anesthetics. Use an exhaust tube to remove the sample gas to a scavenging system. Attach it to the mainstream sensor at the outlet connector.16.4 Setting CO2 Waveform SetupSelect the CO2 waveform area to open the CO2 waveform menu: zSet Mode to Curve or Filled as your desire. zSet Sweep to an appropriate value from the pop-up list. The bigger the value is, the quicker the speed is. 16.5 Setting CO2 CorrectionsTemperature, water vapor in the patient’s breath, barometric pressure, and the proportions of O2, N2O and Helium in the mixture all influence CO2 absorption. If values seem inaccurately high or low, check that the monitor is using the appropriate corrections. For EDAN module, the following items are available in the CO2GOther Setup menu: N2OCompen., O2 Compens., Anest. Agent, Vapor Compen. and Pump Rate. For Respironics module, there are Baro Press, O2 Compens, Anes Agent and Balance Gas in the CO2GOther Setup menu.
Patient Monitor User Manual Monitoring CO2 - 109 - 16.6 Changing CO2 Alarms This refers to CO2 specific alarms. See the Alarms section for general alarm information. To change the alarm, please refer to the following steps: 1. Select the CO2 Setup menu; 2. Select EtCO2 Alarm Setup, FiCO2 Alarm Setup or AwRR Alarm Setup to adjust the alarm limit. About how to adjust the alarm limit, please refer to section Setting alarm limits. 16.7 Changing the Apnea Alarm DelayThis determines the time limit after which the monitor gives an alarm if the patient stops breathing. 1. Select the CO2 Setup menu to open it; 2. Select Apnea Alm from the menu; 3. Choose the apnea alarm time from the pop-up list. WARNINGSafety and effectiveness of the respiration measurement method in the detection of apnea, particularly the apnea of prematurity and apnea of infancy, has not been established.
Patient Monitor User Manual Monitoring C.O. - 110 - Chapter 17 Monitoring C.O.17.1 OverviewThe Cardiac Output (C.O.) measurement is performed by using thermodilution method. The monitor can determine blood temperature, measure cardiac output. You can have iced injecta using either the flow through system or individual syringes of injecta. You can perform up to 6 measurements before editing the average Cardiac Output. The prompt message on the screen will tell you when to inject. 17.2 C.O. Safety InformationWARNING1Make sure that appurtenance applied is in conformity with relevant Medical Device Safety Requirements. 2Appurtenance should be avoided from contact with conductive metal body when being connected or applied.NOTE:To replace the catheter thermistor, please enter the catheter computation coefficient into the Constant item according to the instruction. 17.3 C.O. Monitoring Procedures 1. Plug the C.O. interface cable into the C.O. socket and turn on the monitor. 2. Attach the injective probe connector and catheter thermistor connector to the appropriate parts of the cardiac output interface cable. And open the patient information window to confirm the patients’ height and weight. 3. Pick the C.O. Measure item in the C.O. Option menu. 4. You can perform more than one measurement as required. 5. After the completion of the measurement, access the C.O. Measure window for Review to edit the measured data.
Patient Monitor User Manual Monitoring C.O. - 111 - 1: Monitor; 2: Thermodilution Catheter; 3: Cardiac Output Cable; 4: Injectate Sensor Housing; 5: Injectate; 6: Delivery System; 7: In-line injectate Temperature probe. C.O. Sensor Connection WARNINGMake sure that the computational constant for the measurement is appropriate to the catheter used. NOTE:The blood temperature alarm will not function during C.O. measurement. It will resume automatically when the measurement is over. 17.4 C.O. Measurement WindowSelect the C.O. Option menu to enter the C.O. Measure window and start C.O. measurement. If C.O. transducer is not connected, the monitor will display No Sensor on the screen.
Patient Monitor User Manual Monitoring C.O. - 112 - C.O. Measure Window ķ Measurement curve ĸ Prompt message area Ĺ Cardiac Output ĺ Cardiac Index Ļ Body Surface Area ļ Blood Temperature Ľ Injectate Temperature ľ Start time of the measurement Ŀ Function keys The functional keys on the C.O. measure window are explained in the following table: Start Start a measurement Stop If the blood temperature cannot resume in a considerably long time, the measurement could not stop automatically. Use this button to stop the measurement and display the C.O., CI calculation result. Cancel Cancel the processing measurement or cancel the result after measurement. Record Print out the curve. ķ Ĺĺ Ļ ļ Ľ ľ Ŀ ĸ
Patient Monitor User Manual Monitoring C.O. - 113 - Y axis Change the scale Y (temperature) value. Three models are available: 0~0.5qC, 0~1qC, 0~2.0qC. Adjust the scale by the temperature differences. A smaller scale results in a larger curve. X axis Change the Scale X (time) value. Two modes are available: 0~30s, 0~60s. If you start measurement in the 0~30s mode, it will be switched to 0~60s mode automatically if the measurement cannot finish within 30 seconds. After the switch, no further adjustment can be made to the Scale X. Review Enter the Review window Exit Press the item to exit C.O. Measure. 17.5 Measurement ProcessMeasurement should be taken when the message “Ready for new measurement” appears on the screen. Press the Start button, and then start injection. The thermodilution curve, current blood temperature and the injective temperature are displayed during the measurement. Curve drawing will stop automatically when the measurement finishes, and the C.O. and CI (Ĺand ĺ in the above figure) will be calculated and displayed on the screen. The monitor will display C.O. in the parameter area and the start measurement time (ľ in the above figure). To ensure the accuracy of the measurement, it is suggested that a reasonable interval should take place between two consecutive measurements. The length of the interval can be set in the C.O. Setup menu (Time unit: second). The interval time counter is displayed on the screen. The next measurement cannot be performed until the time reduces to zero and a message Ready for new measurement appears. NOTE:1It is strongly recommended that the user must push the injector within four seconds after pressing the Start button. 2It is strongly recommended that you wait at least 1 minute (or longer depending on the patient’s clinical condition) before starting the next measurement. Repeat this procedure until you have completed the measurements you want. You can perform a maximum of six measurement editing. If you perform additional measurements the earliest measurement each time will be deleted. If any of the curves in the editing window is not selected for calculation (excluded from the averaging calculations), the place will be taken by the new measurement.
Patient Monitor User Manual Monitoring C.O. - 114 - 17.6 Editing C.O. Pick the Review button on the C.O. Measure menu to access the Review as shown below: Window For C.O. Edit Contents displayed in the window: ķ Six curves of the six measurements and C.O. valueĸ Average value of C.O.Ĺ Average value of CIValues of selected measurements can be averaged and stored in the C.O. item in the HEMOD menu as the basis for Hemodynamic calculations. 17.7 Blood Temperature MonitoringBlood temperature monitoring can function when C.O. measurement is not taken. The blood temperature is measured by the thermistor situated in the distal end of the flotation catheter in the pulmonary artery. The blood temperature alarm function will not work during the C.O. measurement. When the measurement ends, the function will automatically resume. The current blood temperature is displayed in the C.O. parameter area. ķ ĸ Ĺ
Patient Monitor User Manual Monitoring C.O. - 115 - Thermodilution Catheter Site 17.8 Setting the Computation ConstantThe computation constant is associated with catheter and injective volume. When the catheter is changed, please adjust Constant in the C.O. Settings menu based on product description provided by the manufacturer. 17.9 Recording C.O. MeasurementsC.O. measurement can be recorded by the recorder. To record the C.O. measurement, please select Record in the C.O. Measure menu. 17.10 Setting INJ. TEMP SourceTo change the INJ Temp Source, please: 1Select Inj Temp Source in the C.O. Settings menu; 2Select Auto or Manual from the list; zManual: directly displaying the injective temperature from INJ. TEMP. zAuto: indicating the system obtains the injective temperature through sampling.Right ventricle
Patient Monitor User Manual Monitoring AG - 116 - Chapter 18 Monitoring AG18.1 Overview The monitor uses ISA sidestreasm gas analyzer (hereinafter called ISA analyzer) and IRMA mainstream module (hereinafter called IRMA module) to monitor the anesthetic gas which can be used to measure the gases of adult, pediatric and neonatal patients during anesthesia, recovery and respiratory care. And the anesthetic gas includes Halothane (HAL), Isoflurane (ISO), Enflurane (ENF), Sevoflurane (SEV), Desflurane (DES), CO2 and N2O. 18.2 Safety Information 18.2.1 Safety Information for ISA Analyzer WARNING1The ISA analyzer is intended for use by authorized and trained medical personnel only. 2Use only Nomoline sampling lines manufactured by PHASEIN. 3The ISA analyzer must not be used with flammable anesthetic agents. 4Carefully route the sampling line to reduce the risk of patient entanglement or strangulation.5Do not re-use disposable sampling line. 6Do not lift the monitor by the sampling line as it could disconnect from the monitor, causing the monitor to fall on the patient. 7Used disposable sampling lines shall be disposed of in accordance with local regulations for medical waste. 8Do not use adult/pediatric type sampling line configurations with infants, as this may add dead space to the patient circuit. 9Do not use infant type sampling line configurations with adults, as this may cause excessive flow resistance. 10 Do not use the ISA analyzer with metered-dose inhalers or nebulized medications as this may clog the bacteria filter. 11 Check that the gas sample flow is not too high for the present patient category. 12 Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2)in the gas analyzer, ensure that the ISA is placed in a well ventilated place. Avoid breathing near the ISA side stream gas analyzer before or during the zeroing procedure.
Patient Monitor User Manual Monitoring AG - 117 - WARNING13 The Nomoline sampling line and its interfaces are non-sterile devices. To avoid damage, do not autoclave any part of the sampling line. 14 Never sterilize or immerse the ISA analyzer in liquid. 15 Measurements can be affected by mobile and RF communications equipment. Make sure that the ISA analyzer is used in the electromagnetic environment specified in this manual. 16 ISA analyzer is intended only as an adjunct in patient assessment. It must be used in conjunction with other assessments of clinical signs and symptoms. 17 Replace the sampling line if the sampling line input connector starts flashing red, or a Nomoline occlusion message is displayed on the host. 18 No modification of this equipment is allowed without authorization of the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe operation. 19 ISA analyzers are not designed for MRI environments. 20 During MRI scanning, the monitor must be placed outside the MRI suite. 21 Use of high frequency electrosurgical equipment in the vicinity of the monitor may produce interference and cause incorrect measurements. 22 Do not use external ambient cooling of the ISA device. 23 Do not apply negative pressure to the Nomoline to remove condensed water. 24 Too strong positive or negative pressure in the patient circuit might affect the sample flow.25 Exhaust gases should be returned to the patient circuit or a scavenging system. 26 Always use a bacteria filter on the evac side if sampled gas is intended to be re-breathed. 27 Do not place the ISA analyzer in any position that might cause it to fall on the patient. CAUTION1The ISA analyzers should be securely mounted in order to avoid the risk of damage to the ISA. 2Do not apply tension to the ISA analyzer cable. 3Do not operate the ISA analyzer outside the specified operating temperature environment.
Patient Monitor User Manual Monitoring AG - 118 - 18.2.2 Safety Information for IRMA ModuleWARNING1The IRMA probe is intended for use by authorized and trained medical personnel only.2The IRMA probe must not be used with flammable anesthetic agents. 3Disposable IRMA airway adapters shall not be reused. Used disposable airway adapters shall be disposed of in accordance with local regulations for medical wastes. 4Use only PHASEIN manufactured oxygen sensor cells. Depleted oxygen sensors shall be disposed of in accordance with local regulations for batteries. 5Do not use the IRMA Adult/Pediatric adapter with infants as the adapter adds 6 ml dead space to the patient circuit. 6Do not use the IRMA airway adapter with adults as this may cause excessive flow resistance.7Measurements can be affected by mobile and RF communications equipment. It should be assured that the IRMA probe is used in the electromagnetic environment specified in this manual. 8Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this may allow patient secretions to block the adapter windows and result in incorrect operation. 9To keep secretions and moisture from pooling on the windows or oxygen sensor port, always position the IRMA probe in a vertical position with the LED pointing upwards.
Patient Monitor User Manual Monitoring AG - 119 - WARNING10 Do not use the IRMA airway adapter with metered dose inhalsers or nebulized medications as this may affect the light transmission of the airway adapter windows. 11 Do not try to open the oxygen sensor assembly. The oxygen sensor is a disposable product and contains a caustic electrolyte and lead. 12 The IRMA probe is intended only as an adjunct in patient assessment. It must be used in conjunction with other assessment of clinical signs and symptoms. 13 Incorrect probe zeroing will result in false gas readings. 14 Incorrect agent selection by the user for IRMA AX (no automatic agent identification) will result in false agent readings. 15 Using IRMA AX (no automatic identification) with gas mixtures containing more than one agent will result in false agent readings. 16 Replace the adapter if rainout/condensation occurs inside the airway adapter. 17 Use only PHASEIN manufactured IRMA airway adapters. CAUTION1Do not apply tension to the probe cable. 2Do not operate the IRMA probe outside the specified operating temperature environment.3Do not leave depleted oxygen sensors mounted in the IRMA probe, even if the probe is not in use. 18.3 Monitoring Steps 18.3.1 Monitoring Steps for ISA Analyzer18.3.1.1 Performing a Pre-use Check Before connecting the Nomoline sampling line to the breathing circuit, do the following: 1. Connect the sampling line to the ISA gas inlet connector (LEGI). 2. Check that the LEGI shows a steady green light (indicating that the system is OK). 3. For ISA OR+ and ISA AX+ module with O2 option fitted: Check that the O2 reading on the monitor is correct (21%). 4. Breathe into the sampling line and check that valid CO2 waveforms and values are displayed on the monitor. 5. Occlude the sampling line with a fingertip and wait for 10 seconds. 6. Check that an occlusion alarm is displayed and that the LEGI shows a flashing red light.
Patient Monitor User Manual Monitoring AG - 120 - 7. If applicable: Perform a tightness check of the patient circuit with the sampling line attached. 18.3.1.2 System Setup for Analyzer If your system is using the plug-in and measure ISA analyzer, please follow the setup instructions below: 1. Connect the ISA analyzer interface cable to the monitor. 2. Connect a Nomoline sampling line to the ISA analyzer input connector. 3. Connect the gas sample exhaust port to a scavenging system or return the gas to the patient circuit. 4. Power up the monitor. 5. A green LED indicates that the ISA analyzer is ready for use. 6. Perform a pre-use check as described in section Perform a pre-use Check. 18.3.1.3 Zeroing The infrared module needs to establish a zero reference level for the CO2, N2O and anesthetic agent gas measurement. This zero calibration is here referred to as "zeroing". ISA analyzer performs zeroing automatically by switching the gas sampling from the respiratory circuit to ambient air. The automatic zeroing is performed every 24 hours, and takes less than 3 seconds for ISA CO2 module and less than 10 seconds for ISA analyzer. If the ISA analyzer is fitted with an oxygen sensor, the automatic zeroing will also include room air calibration of the oxygen sensor. WARNING1Since a successful zeroing requires the presence of ambient air (21% O2 and 0% CO2)in the ISA analyzer, ensure that the ISA analyzer is placed in a well ventilated place. Avoid breathing near the ISA analyzer before or during the zeroing procedure. 2The sampling line should be replaced every two weeks, otherwise it is clogged. 18.3.1.4 Maintenance GAS readings should be verified by conducting the recommended maintenance checks. For details, please refer to Chapter Maintenance. WARNING1. The Nomoline sampling lines are non-sterile devices. To avoid damage, do not autoclave any parts of the sampling line. 2. Never sterilize or immerse the ISA analyzer in liquid.
Patient Monitor User Manual Monitoring AG - 121 - 18.3.1.5 MAC Calculation The MAC value may be calculated and displayed by using end-tidal (Et) gas concentrations according to the following formula:)1()1(%AAXAAEtMAC +)2()2(%AAXAAEt +100)2(% ONEtX (AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=2.05%, DES=6.0%NOTE:Altitude, patient age and other individual factors are not considered in the formula above. 18.3.2 Monitoring Steps for IRMA Module 1Plug the IRMA connector into the IRMA input and switch the power on. 2Snap the IRMA sensor head on the top of the IRMA airway adapter. It will click into place when properly seated. 3A green LED indicates that the IRMA probe is ready for use. 4Connect IRMA/airway adapter 15mm male connector to the breathing circuit Y-piece.
Patient Monitor User Manual Monitoring AG - 122 - 5Connect the IRMA/airway adapter 15mm female connector to the patient’s endotracheal tube. Alternatively, connect an HME (Heat Moisture Exchanger) between the patient’s endotracheal tube and the IPMA probe. Placing an HME in front of the IRMA probe protects the airway adapter from secretions and effects of water vapor and eliminates the need of changing the adapter. It allows free positioning of the IRMA probe as well. 6Unless the IRMA probe is protected with an HME always position the IRMA probe with the status LED pointing upwards.
Patient Monitor User Manual Monitoring AG - 123 - 18.3.2.1 Placement of IRMA Probe When connecting IRMA probe to an infant patient circuit, it is important to avoid a direct contact between the IRMA probe and the infant’s body. If, for whatever the reason, the IRMA probe is in direct contact with any parts of the infant’s body, an insulation material shall be placed between the IRMA probe and the body. WARNINGThe IRMA probe is not intended to be in long term skin contact. 18.3.2.2 Performing a Pre-use Check Prior to connecting the IRMA airway adapter to the breathing circuit, verify the O2 calibration by checking that the O2 reading on the monitor is correct (21%). See the following section on how to perform air calibration. Always verify gas readings and waveforms on the monitor before connecting the airway adapter to the patient circuit. Perform the tightness check of the patient circuit with the IRMA probe snapped on the IRMA airway adapter. 18.3.2.3 Zeroing WARNINGIncorrect probe zeroing will result in false gas readings. In order to secure high precision of the IRMA probe measurements the following zeroing recommendations should be followed. Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe, without connecting the airway adapter to the patient circuit, and then using the host instrument to transmit a zero reference command to the IRMA probe. Special care should be taken to avoid breathing near the airway adapter before or during the zeroing procedure. The presence of ambient air (21% O2 and 0% CO2) in the IRMA airway adapter is of crucial importance for a successful zeroing. If a “ZERO-REQ” alarm should appear
Patient Monitor User Manual Monitoring AG - 124 - directly after a zeroing procedure, the procedure has to be repeated. Always perform a pre-use check after zeroing the probe. Zeroing for IRMA CO2 probes: Zeroing needs to be performed ONLY when an offset in gas values is observed, or when an unspecified accuracy message is displayed. Allow 10 seconds for warm up of the IRMA CO2 probe after power on and after changing the IRMA airway adapter before proceeding with the Zeroing Procedure. The green LED on the probe will be blinking for approximately 5 seconds while zeroing is in progress. Zeroing for IRMA AX+ probes: Zeroing should be performed every time the IRMA airway adapter is replaced, or whenever an offset in gas values or an unspecified gas accuracy message is displayed. Allow 30 seconds for warm up of the IRMA AX+ probes after power on and after changing the IRMA airway adapter before proceeding with the Zeroing Procedure. The green LED on the probe will be blinking for approximately 5 seconds while zeroing is in progress. 18.3.2.4 Cleaning The IRMA probe can be cleaned using a cloth moistened with maximum 70% ethanol or maximum 70% isopropyl alcohol. Remove the disposable IRMA airway adapter prior to cleaning the IRMA probe. CAUTION1The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile devices. Do not autoclave the devices as this will damage them. 2Never sterilize or immerse the IRMA probe in liquid. 18.3.2.5 MAC Calculation The MAC value may be calculated and displayed by using end-tidal (ET) gas concentrations according to the following formula: MAC=%ET(AA1)/X(AA1)+%ET(AA2)/X(AA2)+%ET(N2O)/100 X(AA): HAL=0.75%, ENF=1.7%, ISO=1.15%, SEV=2.05%, DES=6.0% 18.4 Setting Work Mode There are two woke modes: Measure and Standby. To change the work mode, please refer to the following steps: 1Select the AG Setup menu; 2Select Work Mode on the interface and select Measure or Standby from the popup list.
Patient Monitor User Manual Monitoring AG - 125 - 18.5 Setting Alarms Here we take CO2 alarm for example. This refers to CO2 specific alarms. See the Alarms Chapter for general alarm information. To change the alarm, please refer to the following steps: 1Select the CO2 Setup menu; 2Select EtCO2 Alarm High Limit or EtCO2 Alarm Low Limit to adjust the alarm limit. 18.6 Setting Apnea Alarm TimeThis determines the time limit after which the monitor gives an alarm if the patient stops breathing. 1Select the AG Setup menu to open it; 2Select Apnea Alarm from the menu; 3Choose the apnea alarm time from the pop-up list. 18.7 Working Status of ISA analyzerWorking status of the ISA analyzer can be indicated by the indicator. For the detailed information, please refer to the following table. Indication Status Steady green light System OK Blinking green light Zeroing in progress Steady blue light Anesthetic agent present Steady red light Sensor error Blinking red light Check sampling line 18.8 Working Status of IRMA Module The working status of the IRMA module can be transmitted by the IRMA probe. For the detailed information, please refer to the following table. Indication Status Steady green light System OK Blinking green light Zeroing in progress Steady blue light Anesthetic agent present Steady red light Sensor error Blinking red light Check adapter
Patient Monitor User Manual Monitoring AG - 126 - 18.9 N2O and O2 CompensationsThe following models need O2 compensation: IRMA AX+, IRMA CO2, ISA AX+, ISA CO2. The following models need N2O compensation: IRMA CO2 and ISA CO2. For the compensation details, please refer to the following table. O2 Range SetO2 Range 0~30 vol% 21 30~70 vol% 50 70~100 vol% 85 N2O Range Set N2O Range 0~30 vol% 0 30~70 vol% 50 18.10 Effects of humidityThe partial pressure and the volume percentage of CO2, N2O, O2 and anesthetic agents depend on the amount of water vapor in the measured gas. The O2 measurement will be calibrated to show 20.8 vol% at actual ambient temperature and humidity level, instead of showing actual partial pressure. 20.8 vol% O2 corresponds to the actual O2 concentration in room air with 0.7 vol% H2O concentration (at 1013 hPa this equals for example 25°C and 23% RH). The measurement of CO2, N2O, and anesthetic agents (e.g. all gases measured by the IR-bench) will always show the actual partial pressure at the current humidity level. In the alveoli of the patient, the breathing gas is saturated with water vapor at body temperature (BTPS). When the breathing gas flows through the sampling line, the gas temperature will adapt to ambient before reaching the gas analyzer. As the NOMO section removes all condensed water, no water will reach the ISA gas analyzer. The relative humidity of the sampled gas will be about 95%. If CO2 values at BTPS are required, the following equation can be used: where: EtCO2 = EtCO2 value sent from ISA [vol %] Pamb = Ambient pressure sent from ISA [kPa] 3.8 = Typical partial pressure of water vapor condensed between patient circuit and ISA [kPa] EtCO2(BTPS) = EtCO2 gas concentration at BTPS [vol%] O2 is assumed to be room air calibrated at a humidity level of 0.7 vol% H2O.
Patient Monitor User Manual Freeze - 127 - Chapter 19 Freeze19.1 Overview When monitoring a patient, the user may freeze the waveforms and examine them. Generally, the user can review a frozen waveform of a maximum of 120 seconds. The freeze function of this monitor has the following features: Freeze status can be activated on any operating screen. Once entering the Freeze status, the system exits all other operating menus. Besides, the system freezes all waveforms in the Waveform area of the Basic Screen, and also freezes Full Lead ECG waveforms and extra waveforms on the Full Lead ECG interface (if any). Nevertheless the Parameter area refreshes normally. The frozen waveforms can be reviewed and recorded. 19.2 Entering/Exiting Freeze Status 19.2.1 Entering Freeze StatusIn the Non-Freeze status, press the button on the control panel of the monitor to exit the current menu. Freeze status is entered and the popup Freeze menu is displayed. In Freeze status, all waveforms are frozen and will no longer be refreshed. 19.2.2 Exiting Freeze StatusIn the Freeze status, executing any of the following operations will command the system to exit the Freeze status: zSelect the Exit option in/from the Freeze menu; zPress the button on the control panel again; zExecute any operation that may trigger the adjustment of the screen or the display of a new menu. After exiting Freeze status, the system will clear screen waveforms and resume displaying real-time waveforms. In the Screen Refresh mode, the system will sweep the waveforms from left to right in the Waveform Area. Press the button on the control panel, and the Freeze menu will appear on the bottom part of the screen. At the same time, the system freezes the waveforms. REC WAVE: it can be set to any waveform of 8s, such as IBP1, CO2, and PLETH etc. It can also be set to OFF. Review: Used to review frozen waveforms. Exit: The system closes the Freeze menu and exits the Freeze status.
Patient Monitor User Manual Freeze - 128 - NOTE:Pressing the button repeatedly over a short period of time may result in discontinuous waveforms on the screen. 19.3 Reviewing Frozen Waveform By moving the waveform, you may review a waveform of 120 seconds before it is frozen. For a waveform of less than 60 seconds, the remaining part is displayed as a straight line. Use the rotary snob on the control panel to move the cursor to the Review option in the Freeze menu. Press the knob. By turning the knob left or right, frozen waveforms on the screen will move left or right correspondingly. There is an arrow indicating upward on the right side of the last waveform.
Patient Monitor User Manual Review - 129 - Chapter 20 ReviewThe monitor provides 120-hour trend data of all parameters, storage of 1200 NIBP measurement results and 60 alarm events. This chapter gives detailed instruction for review of all data. 20.1 Trend Graph Review  The latest 1-hour trend is displayed every 1 or 5 seconds.  The latest 120-hour trend is displayed every 1, 5 or 10 minutes. To review Trend Graph, please press the Trend Graph key on the screen or select Menu > Review > Trend Graph, then the trend graph interface is displayed. In the trend graph, the y-axis stands for the measurement value and x-axis stands for the time. 20.1.1 Selecting Trend Graph of Specific ParameterThe monitor can review trend graph of different parameters. To change the existing trend graph, please select Menu > Review > Trend Graph and select a required parameter name from the popup list (as shown in red text in the above figure). 20.1.2 Adjusting Trend Scale You can use Zoom on the trend graph review interface to adjust the trend scale. Once you adjust the trend scale on the trend graph review interface, you also change the trend scale of the related parameters for the screen trend displayed on the main screen.
Patient Monitor User Manual Review - 130 - 20.1.3 Setting ResolutionThe monitor can support five kinds of resolutions. To set an appropriate resolution, please select Menu > Review > Trend Graph and an interface is displayed. Choose Resolution on the interface to open the list and select an appropriate resolution among 1 sec, 5 sec, 1 min, 5 min and 10 min. 20.1.4 Scrolling Left and Right the Screen All trend graphs can’t be displayed on the current screen due to the screen limitation. The user can scroll left and right the screen manually to see measurement trends that do not fit in the current view by selecting and pressing the symbol and displayed on the trend graph. 20.1.5 Switching to the Trend Table The user can switch to the trend table interface on the Trend Graph interface. To do so, please select Menu > Review > Trend Graph and select the Trend Table option from the popup interface. 20.1.6 Record The monitor can make a tabular trend recording of the data in the current trend graph window. The report will use the current trend interval settings. For the detailed information about recording the trend graph, please refer to Chapter Recording. 20.2 Trend Table Review To review the trend table, please press the Trend Table key on the screen or select Menu > Review > Trend Table, then the trend table is displayed. NOTE:The CO2 module and AG module cannot be measured at the same time, so their trend graph cannot be displayed at the same time. 20.2.1 Setting ResolutionThe monitor can support seven kinds of interval. To set an appropriate resolution, please select Menu > Review > Trend Table and an interface is displayed. Choose Resolution on the interface to open the list and select an appropriate interval among 1 sec, 5 sec, 1 min, 5 min, 10min, 30 min and 60 min. 20.2.2 Scrolling the Screen All trend tables can’t be displayed on the current screen due to the screen limitation. The user can scroll left, right, up and down the screen manually to see measurement trend tables that do not fit
Patient Monitor User Manual Review - 131 - in the current view by selecting and pressing the symbol , , and displayed on the trend graph. 20.2.3 Switching to Trend Graph The user can switch to the trend graph on the Trend Table interface. To do so, please select Menu > Review > Trend Table and select the Trend Graph option from the popup interface. 20.2.4 Recording The monitor can make a tabular trend recording of the data in the current trend graph window. The report will use the current trend interval settings. For the detailed information about recording the trend table, please refer to Chapter Recording. 20.3 NIBP Review To review the NIBP measurement data, select the NIBP Review key on the screen or select Menu > Review > NIBP Review, then the NIBP Review window is displayed. 20.3.1 Scrolling the Screen All measurement data can’t be displayed on the current screen due to the screen limitation. The user can scroll up and down the screen manually to see measurement data that doesn’t fit in the current view by selecting and pressing the symbol and displayed on the NIBP Review interface. 20.3.2 Recording The monitor can record the measurement data in the NIBP review window. For the detailed information about recording the NIBP review, please refer to Chapter Recording. 20.4 Alarm Review The monitor can display up to 10 technical alarm events in the current screen. To review the alarm event, select the Alarm Review key on the screen or select Menu > Review > Alarm Review, then the Alarm Review Window is displayed. 20.4.1 Scrolling the Screen All alarm events can’t be displayed on the current screen due to the screen limitation. The user can scroll up and down the screen manually to see alarm events that don’t fit in the current view by selecting and pressing the symbol and displayed on the Alarm Review interface.
Patient Monitor User Manual Review - 132 - 20.4.2 Selecting Alarm Event of Specific ParameterThe monitor can review alarm event of the specific parameters. To view the alarm event of the specific parameter, please select Menu > Review > Alarm Event and choose Event Type to select the required parameter name from the popup list. 20.4.3 Setting Time Index The user can set end time of alarm review by selecting the Time Index option displayed on the alarm review interface. If the user selects Current Time on the popup interface, the alarm events occurring before the current time are displayed on the alarm event review interface. If the user selects User Define, he can define the review time by setting time box displayed on the interface.The alarm events occurring before the User Define option are displayed on the alarm event review interface. 20.5 Arr Review Select ECG Setup > Arr Analysis> Arr Review or Menu > Review > Arr Review to open the Arr review interface.The interface displays the latest arrhythmia events. 20.5.1 Scrolling the Screen All arrhythmia events can’t be displayed on the current screen due to the screen limitation. The user can scroll up and down the screen manually to see the other arrhythmia events that do not fit in the current view by selecting and pressing the symbol and displayed on the Arrhythmia Review interface.
Patient Monitor User Manual Review - 133 - 20.6 12-lead Diagnosis Review Select Menu > Review > Analysis Review to open the 12-lead analysis review interface. 20.6.1 Scrolling the Screen All analysis results or waveforms can’t be displayed on the current screen due to the screen limitation. The user can scroll up and down the screen manually to see the analysis results or waveforms that do not fit in the current view by selecting and pressing the symbol and displayed on the 12-lead analysis review interface. 20.6.2 Deleting Diagnosis Results The user can delete the analysis results displayed on the current screen by selecting Delete on the interface. 20.6.3 Switching Between Waveforms and ResultsThe user can review the analysis waveforms on the analysis result interface by selecting the Wave option and review the analysis results on the analysis waveform interface by selecting the Results option. 20.6.4 RecordingThe monitor can record the 12-lead diagnosis waveforms or results displayed on the current screen. To do so, press Record on the interface. For the detailed information about recording the diagnosis waveforms or results, please refer to Chapter Recording.
Patient Monitor User Manual Calculation and Titration Table - 134 - Chapter 21 Calculation and Titration Table The monitor provides calculation function and titration table. Calculations are patient data that are not directly measured but calculated by the monitor. The monitor can perform drug calculation and hemodynamic calculation. NOTE:The drug calculation function acts only as a calculator. The patient weights in Drug Calculation menu and in Patient Information menu are independent of each other. Therefore changing the Weight in Drug Calculation menu will not change the weight in the Patient Information menu. 21.1 Drug Calculation 21.1.1 Calculation Procedures The drug calculation window is displayed by selecting Menu > Common Function > Drug Dose. Select the right pull-down box of the Drug option and select the required drug name among the 15 drugs which are listed as follows. And the drug name of Drug A, Drug B, Drug C, Drug D and Drug E can be defined by the user.zDrug A, Drug B, Drug C, Drug D and Drug E zAMINOPHYLLINE zDOBUTAMINE zDOPAMINE zEPINEPHRINE zHEPARIN zISUPREL zLIDOCAINE zNIPRIDE zNITROGLYCERIN zPITOCIN The system generates values that can’t be treated the calculation results. The user must enter the correct parameter value based on the doctor’s instruction. zEnter the patient’s weight. zEnter the correct parameter value. zConfirm whether the calculation result is correct. The following formulas are applied to dose calculation: Concentrate= Amount / Volume
Patient Monitor User Manual Calculation and Titration Table - 135 - INF Rate= DOSE / Concentrate Duration= Amount / Dose Dose= Rate × Concentrate DRIP Rate= INF Rate / 60 × DROP Size 21.1.2 Calculation Unit Each drug has the fixed unit or unit series to calculate. Among the same unit series, the unit binary varies with the entered parameter value. The calculation units of the drugs are listed as follows: Drug Unit DRUG A, DRUG B, DRUG C, AMINOPHYLLINE, DOBUTAMINE, DOPAMINE, EPINEPHRINE, ISUPREL, LIDOCAINE, NIPRIDE, NITROGLYCERIN g, mg, mcg DRUG D, PITOCIN, HEPARIN Ku, mu, Unit DRUG E mEq When defining a drug, select Drug A, Drug B, Drug C, Drug D, and Drug E based on the unit series. NOTE:1The drug calculation is displayed as invalid value before the user edits the drug name and patient weight, and the user can’t enter any value. 2Drip Rate and Drop Size are invalid in the neonatal mode. 21.2 Titration Table After completing the drug calculation, the user can open the Titration on the Drug Dose interface. The user can change the following items in the titration table: zBasic zStep zDose Type The data in the trend table will vary with the changes above. And the user can perform the following: zScroll up and down the screen by selecting and pressing the symbol and displayed on the trend graph. zRecord the data displayed in the current window by selecting Record.
Patient Monitor User Manual Calculation and Titration Table - 136 - 21.3 Hemodynamic Calculation 21.3.1 Calculation Procedure 1. The hemodynamic calculation interface is displayed by selecting Menu > CommonFunction > Hemodynamic. 2. The user must input parameter value manually on this interface. 3. Select Calculate to output parameter value. 4. Select Confirm or Cancel to exit this menu. 21.3.2 Input Parameters Abbreviation English Full Name/Description PAWP Pulmonary artery wedge pressure CVP Central venous pressure HR Heart rate AP MAP Mean Artery Pressure LV_D Left Ventricular Diameter PA MAP Pulmonary artery mean pressure HT Height WT Weight 21.3.3 Output Parameters Abbreviation English Full Name/Description BSA Body surface area SV Stroke volume SVI Stroke volume index SVR Systemic vascular resistance SVRI Systemic vascular resistance index PVR Pulmonary vascular resistance PVRI Pulmonary vascular resistance index LCW Left cardiac work LCWI Left cardiac work index RCW Right cardiac work RCWI Right cardiac work index LVSW Left ventricular stroke work
Patient Monitor User Manual Calculation and Titration Table - 137 - LVSWI Left ventricular stroke work index RVSW Right ventricular stroke work RVSWI Right ventricular stroke work index EF Ejection fraction
Patient Monitor User Manual Recording - 138 - Chapter 22 Recording 22.1 General Information A thermal dot matrix recorder is used for the monitor and can support many recording types and output patient information, measurement data, review data waveform and so forth. 1 Recording indicator 2 Paper feeding key: press this key to start or stop feeding recording paper without outputting anything on the paper 3 Paper outlet 4 Recorder door 22.2 Performance of the Recorder Waveform record is printed at the rate of 25 mm/s or 50 mm/s. 48mm wide printout paper. It can record up to three waveforms. User-selectable real-time recording time and waveform. Auto recording interval is set by the user, and the waveform is in accordance with the real time recording. NOTE:It is suggested that the user should not use the recorder when the low battery displays, or the monitor may be turned off automatically. 1342
Patient Monitor User Manual Recording - 139 - 22.3 Recording Type The monitor provides several types of stripe recording: Continuous real-time recording 8 seconds real-time recording Time recording Alarm recording Trend graph recording Trend table recording NIBP review recording Arrhythmia review recording Alarm review recording Titration recording Hemodynamic Calculation result recording 12-lead analysis recording C.O. measurement recording 22.4 Starting and Stopping Recording You can start and stop the recording in the following ways: Continuous real-time recording Press the Record button on the front panel to start the recording, and repress it to stop the recording. 8 seconds real-time recording Record three waveforms selected in Recorder Setup menu according to the setup time interval in Recorder Setup menu. It will automatically stop in 8 seconds. Trend graph recording Enter the Menu > Review > Trend Graph menu, and press the Record button to start recording. Press the Record button on the front panel to stop recording. Trend table recording Enter the Menu > Review > Trend Table menu, and press the Record button to start recording. Press the Record button on the front panel to stop recording. NIBP review recording Enter the Menu > Review > NIBP Review menu, then press the Record button to start recording. Press the Record button on the front panel to stop recording. Arrhythmia review recording Enter the Menu > Review > ARR Review menu, and select one arrhythmia alarm, then press the Record button to start recording. Press the Record button on the front panel to stop recording.
Patient Monitor User Manual Recording - 140 - Alarm review recording Enter the Menu > Review > Alarm Review menu, and select one alarm, then press the Record button to start recording. Press the Record button on the front panel to stop recording. Drug calculation titration recording Enter the Menu > Common Function > Drug Dose > Titration menu, then press the Record button to start recording. Press the Record button on the front panel to stop recording. Hemodynamic Calculation result recording Enter the Menu > Common Function > Hemod Dynamics menu, then press the Record button to start recording. Press the Record button on the front panel to stop recording. 12-lead diagnosis recording Enter the ECG Setup > 12-L Review menu, then press the Record button to start recording. Press the Record button on the front panel to stop recording. C.O. measurement recording Enter the C.O. Option > C.O. Measure menu, then press the Record button to start recording. Press the Record button on the front panel to stop recording. The recorder will stop recording in the following situations: zThe recording task is finished. zNo paper in the recorder. zMalfunction stops the recorder from running properly. NOTE:You can press the button on the front panel to stop the currently recording process. 22.5 Recorder Operations and Status Messages 22.5.1 Record Paper RequirementOnly standard thermosensitive record paper can be used: otherwise the recorder may not function, the recording quality may be poor, and the thermosensitive printhead may be damaged. 22.5.2 Proper Operation When the recorder is working, the record paper goes out steadily. Do not pull the paper outward with force: otherwise the recorder may be damaged.  Do not operate the recorder without record paper.
Patient Monitor User Manual Recording - 141 - 22.5.3 Paper Out When the Recorder Out OF Paper alarm is displayed, the recorder cannot start. Please insert record paper properly. 22.5.4 Replacing Paper 1. Pull outwards the upper arc part of the recorder casing to release the casing, shown in the following figure. 2. Insert a new roll of paper into the paper cassette, printing side facing upwards. 3. Ensure proper position and tidy margin.
Patient Monitor User Manual Recording - 142 - 4. Pull about 2cm of the paper out, and close the recorder casing. NOTE:Be careful when inserting papers. Avoid damaging the thermo-sensitive print head. Unless when inserting papers or shooting troubles, do not leave the recorder catch open. 22.5.5 Removing Paper JamWhen the recorder functions or sounds improperly, you should open the recorder casing to check for a paper jam. Remove the paper jam in the following way:  Cut the record paper from the feeding edge.  Open the recorder casing.  Re-insert the paper. NOTE:If the monitor is not installed with a recorder, it will indicate RECORDER SETUP NEEDED after pressing the Record button.
Patient Monitor User Manual Other Functions - 143 - Chapter 23 Other Functions 23.1 Nurse Call The monitor provides dedicated nurse call port which is connected to nurse call system through the nurse call cable to perform the nurse call function. You should activate the function following the steps below: 1. Select Maintenance > User Maintain, input the password ABC; 2. Select Other Setups> Aux Output;3. Choose On in the Nurse Call list. 23.2 Analog Output and Defibrillator SynchronizationThe monitor provides analog output signals to accessory equipment. Also, if a defibrillator is connected to the monitor, a defibrillator synchronization pulse can be output. You should activate the function following the steps below: 4. Select Maintenance > User Maintain, input the password ABC; 5. Select Other Setups> Aux Output;6. Choose Analog Output or Defibrillation in the Aux Output list. 23.3 Storing Data in a Removable Device 23.3.1 Data Stored in the Removable Device A single piece of patient data maximally contains the following information: Patient information MRN, name, date of birth, date of admission, gender, type, height, weight, blood type, pace, doctor, bed No., department Trend graph and trend table a maximum of 10 days NIBP measurement review 1200 sets Alarm review 60 sets Arrhythmia event 60 sets 12-lead diagnosis review 50 sets Waveforms 48 hours
Patient Monitor User Manual Other Functions - 144 - 23.3.2 Activating/ Deactivating Data Storing To activate/ deactivate the data storing function, select Menu> Maintenance> User Maintain > Other Setups, and set Data Store to On/ Off. The monitor will stop storing data in the removable device under the following circumstances: zThe removable device is unplugged. zThere is no enough space in the removable device for storing data. zThe removable device is read-only. zThe data storing function is deactivated. zThe monitor is switched off. zThe power supply is off. 23.3.3 Selecting a Removable Device You may plug several removable devices into the monitor at the same time, but only one is operative. You can select a removable device as a working one among the plugging devices by selecting Menu> Removable Device and choosing the device name from the list. By default, the first plugged removable device is the working one. CAUTION1 Not all the removable devices are compatible with the monitor, Use the removable devices recommended by EDAN. 2 Do not set the read-only switch on the removable device to on when the removable device is inserted in the monitor. 23.3.4 Reviewing Data Stored in a Removable Device To review data stored in a removable device, select Menu> Review> External Data, and choose a patient from the list to review the data including patient information, trend graph, trend table, NIBP measurements, arrhythmia event, alarm event, 12-lead diagnosis and waveform. NOTE:12-lead diagnosis review is only applicable to iM80. 23.3.5 Deleting Data Stored in a Removable Device To delete data of one patient, choose the patient from the list after selecting Menu> Review> External Data, and then click Delete Data on the Review menu. Further confirmation of deletion is required. To delete data of all patients, select Menu> Review> External Data and click Delete all data on the External Data Review menu. Further confirmation is required.
Patient Monitor User Manual Other Functions - 145 - 23.3.6 Ejecting a Removable Device Before unplugging a removable device from the monitor, you need to select Menu> Removable Device and click Eject to uninstall the removable device.CAUTIONDo not remove the removable device without ejecting it during data storing, or the removable device might be damaged.
Patient Monitor User Manual Using Battery - 146 - Chapter 24 Using Battery 24.1 Battery Power IndicatorThe indicator labeled Battery on the front panel of the monitor illuminates in green when the monitor is battery powered and illuminates in yellow when battery is being charged. The indicator is not illuminated when the monitor is not powered or when AC power is applied. 24.2 Battery Status on the Main Screen Battery status shows the status of each battery detected and the combined battery power remaining, with an estimate of the monitoring time this represents. There is a sign in the lower left corner of screen to show the charging status, and the yellow part is the electric energy of battery. When the monitor is not equipped with battery, the battery status will be shown as the sign , which means no battery. When the monitor is powered by the battery, the monitor will switch off automatically if there is no electric energy in the battery. When there isn’t enough electric energy, a sign is displayed on the screen. When the monitor is battery powered, the monitor switches off automatically if there is no power. 24.3 Checking Battery Performance The performance of rechargeable batteries may deteriorate over time. Battery maintenance as recommended here can help to slow down this process. 1. Disconnect the patient from the monitor and stop all monitoring and measurement. 2. Switch the monitor power on and charge the battery for more than 6 hours continuously. 3. Disconnect monitor from mains power and let the monitor run until there is no battery power left and the monitor shuts off. 4. The running time of the battery reflects the battery performance. If the running time is obviously less than the specified time in the specification, please change the battery or contact the service personnel. WARNING1Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to read the user manual and safety precautions thoroughly. 2Do not connect the positive (+) and negative (-) terminals with metal objects, and do not put the battery together with metal object, which can result in short circuit.
Patient Monitor User Manual Using Battery - 147 - WARNING3Do not unplug the battery when monitoring. 4Do not heat or throw battery into a fire. 5Do not use, leave battery close to fire or other places where temperature may be above 60qC.6Do not immerse, throw, or wet battery in water/seawater. 7Do not destroy the battery: do not pierce battery with a sharp object such as a needle; Do not hit with a hammer, step on or throw or drop to cause strong shock; Do not disassemble or modify the battery. 8Use the battery only in the monitor. Do not connect battery directly to an electric outlet or cigarette lighter charger. 9Do not solder the leading wire and the battery terminal directly. 10 If liquid leaking from the battery gets into your eyes, do not rub your eyes. Wash them well with clean water and go to see a doctor immediately. If liquid leaks of the battery splash onto your skin or clothes, wash well with fresh water immediately. 11 Keep away from fire immediately when leakage or foul odor is detected. 12 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal condition is detected during use, charge, or storage. Keep it away from the monitor. 13 Do not use a battery with serious scar or deformation. 24.4 Replacing the Battery To install or replace the battery, please follow the procedure: 1. Pull the battery door according to indication on it to open it. 2. Pull the plastic retainer until the battery can be removed. Battery Door
Patient Monitor User Manual Using Battery - 148 - 3. Insert the new battery into the battery compartment. 4. Pull the metal retainer downward to fix the battery and close the battery door. 24.5 Recycling the Battery When the battery no longer holds a charge, it should be replaced. Remove the old battery from the monitor and recycle it properly. NOTE:To prolong the life of rechargeable battery, it is recommended to charge it at least once every month, and it must be done after the electric energy runs out. 24.6 Maintaining the Battery Batteries should be conditioned regularly to maintain their useful life. Remove the batteries from the monitor if they are not used for a longer period of time. And recharge the batteries at a minimum of every 6 months when they are stored. Discharge the battery completely once every month.
Patient Monitor User Manual Care and Cleaning - 149 - Chapter 25 Care and Cleaning Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. EDAN makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Consult your hospital’s Infection Control Officer or Epidemiologist for control infection. 25.1 General Points Keep your monitor, cables and accessories free of dust and dirt. To prevent the device from damage, please follow the procedure: zAlways dilute according to the manufacturer’s instructions or use lowest possible concentration. zDo not immerse any part of the equipment or any accessories in liquid. zDo not pour liquid onto the system. zDo not allow liquid to enter the case. zNever use abrasive material (such as steel wool or silver polish). CAUTIONIf you spill liquid on the equipment, battery, or accessories, or they are accidentally immersed in liquid, contact your service personnel or EDAN service engineer. 25.2 Cleaning WARNINGBefore cleaning the monitor or the sensor, make sure that the equipment is switched off and disconnected from the power line. 25.2.1 Cleaning the Monitor To surface-clean the monitor: Recommended cleaning agents are: Diluted Ammonia Water < 3%; Ethanol 75%, isopropanol 70%
Patient Monitor User Manual Care and Cleaning - 150 - 25.2.2 Cleaning the Accessories 25.2.2.1 Cleaning the ECG Cables and Lead Wires NOTE:1. Use only recommended cleaning substances and disinfectants listed in this document. Others may cause damage (not covered by warranty), reduce product lifetime or cause safety hazards. 2. Keep the cable and lead wires free of dust and dirt. 3. Never immerse or soak the ECG cable. 4. Inspect the cables after cleaning. Recommended cleaning agents are: Ethanol 75%  Isopropanol 70% 25.2.2.2 Cleaning the Blood Pressure Cuff If the cover requires more rigorous cleaning, remove the air bladder first. Allow the cover to thoroughly air dry before use. Cuffs have been tested to withstand the following recommended cleaning agents: isopropyl 70%, ethanol 75%. 25.2.2.3 Cleaning the SpO2 Sensor These reusable sensors should be cleaned and disinfected. The validated cleaning agents are listed below: Recommended cleaning agents are:  Ethanol 75%  Isopropanol 70% 25.2.2.4 Cleaning the IBP/C.O. Cables NOTE:1. Keep the cable free of dust and dirt. 2. Never immerse or soak the cable. 3. Inspect the cables after cleaning. Recommended cleaning agents are:  Ethanol 75%  Isopropanol 70%
Patient Monitor User Manual Care and Cleaning - 151 - 25.2.2.5 Cleaning TEMP/Quick TEMP Sensor Recommended cleaning agents are:  Ethanol 75%  Isopropanol 70% 25.2.2.6 Other Accessories For cleaning, disinfecting other accessories, please contact the manufactures for details. 25.3 Disinfection To avoid extended damage to the equipment, disinfection is only recommended when stipulated as necessary in the Hospital Maintenance Schedule. Disinfection facilities should be cleaned first. Recommended types of disinfecting agents are:  Ethanol 75%, isopropanol 70%  Acetaldehyde up to 3.6% WARNINGDisinfect the monitor and reusable accessories regularly to avoid patient cross infection.
Patient Monitor User Manual Maintenance - 152 - Chapter 26 Maintenance WARNING1Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. 2If you discover a problem with any of the equipment, contact your service personnel, or your authorized supplier. 26.1 Inspecting The overall check of the monitor, including the safety check, should be performed only by qualified personnel every 24 months, and each time after fix up. The following items should be checked: zIf the environment condition and power supply meet requirement. zIf the power supply cord has damage and insulativity meets requirement. zIf the device and accessories have damage. zSpecified accessories. zIf the alarm system can work properly. zIf the recorder can work properly and the paper meets the requirement. zBattery performance zIf all monitoring functions are in good conditions. zIf the grounding resistance and leakage current meet requirement. If any damage or abnormality is found, please don’t use the monitor and contact local Customer Service Center.26.2 Maintenance Task and Test ScheduleThe following tasks are for EDAN-qualified service professionals only. Contact an EDAN-qualified service provider if your monitor needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it.Maintenance and Test Schedule Frequency Safety checks. Selected tests on the basis of IEC60601-1 At least once every two years, or as needed, after any repairs where the power supply is removed or replaced, or if the monitor has been dropped. Check ECG synchronization of the monitor and defibrillator At least once every two years, or as needed.
Patient Monitor User Manual Maintenance - 153 - NIBP Leakage Inspection At least once every two years, or as specified by local laws. NIBP Pressure Calibration At least once every two years, or as specified by local laws. NIBP Calibration At least once every two years, or as specified by local laws. CO2 Calibration and Performance Test At least once every two years, or if you suspect the measurement values are incorrect. AG Calibration If you suspect the measurement values are incorrect and need to calibrate, please contact the manufacturer.
Patient Monitor User Manual Warranty and Service - 154 - Chapter 27 Warranty and Service 27.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: a) damage caused by mishandling during shipping. b) subsequent damage caused by improper use or maintenance. c) damage caused by alteration or repair by anyone not authorized by EDAN. d) damage caused by accidents. e) replacement or removal of serial number label and manufacture label. If a product covered by this warranty is determined to be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period, EDAN will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being repaired. 27.2 Contact information If you have any question about maintenance, technical specifications or malfunctions of devices, contact your local distributor. Alternatively, you can send an email to EDAN service department at: support@edan.com.cn.
Patient Monitor User Manual Accessories - 155 - Chapter 28 Accessories You can order accessories from EDAN supplies at www.edan.com.cn or consult your local EDAN representative for details. WARNING1Never reuse disposable transducers, sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard. 2Use only EDAN-approved accessories. Using non-EDAN-approved accessories may compromise device functionality and system performance and cause a potential hazard. 3Do not use a sterilized accessory if its packaging is damaged. NOTE:Transducers and sensors have a limited shelf life. Refer to the package labeling. The following cables may not all be available in all countries. Please check availability with your local EDAN supplier. 28.1 ECG Accessories The following table lists the optional configuration for the monitor: Part Number Accessories 01.57.471230 ECG trunk cable, 5-lead, 6pin, ESU, AHA/IEC, 2.7m, reusable 01.57.471231 ECG trunk cable, 5-lead, 6pin, ESU, AHA/IEC, 5.0m, reusable 01.57.471232 ECG trunk cable, 5-lead, 6pin, defibrillator-proof, AHA/IEC, 2.7m, reusable 01.57.471233 ECG trunk cable, 5-lead, 6pin, defibrillator-proof, AHA/IEC, 5.0m, reusable 01.13.036620 ECG limb wires, 5-lead, clip, AHA, 1.0m&1.6m, reusable 01.13.036621 ECG limb wires, 5-lead, clip, AHA, 1.0m, reusable 01.13.036622 ECG limb wires, 5-lead, snap, AHA, 1.0&1.6m, reusable 01.13.036623 ECG limb wires, 5-lead, snap, AHA, 1.0m, reusable 01.13.036624 ECG limb wires, 5-lead, clip, IEC, 1.0m&1.6m, reusable 01.13.036625 ECG limb wires, 5-lead, clip, IEC, 1.0m, reusable 01.13.036626 ECG limb wires, 5-lead, snap, IEC, 1.0&1.6m, reusable
Patient Monitor User Manual Accessories - 156 - Part Number Accessories 01.13.036627 ECG limb wires, 5-lead, snap, IEC, 1.0m, reusable 01.57.471024 3-lead ECG trunk cable, Defibrillator-proof, AHA/IEC 01.57.471025 3-lead clip ECG limb wires, IEC 01.57.471165 3-lead ,clip, ECG limb cable, AHA 01.57.040202 ECG trunk cable, 10-lead, defibrillator-proof, IEC, 2.6m, reusable (Only applicable to iM80) 01.57.040203 ECG limb wires, 10-lead, snap, IEC, 0.9m, reusable (Only applicable to iM80)01.57.109100 ECG trunk cable, 10-lead, defibrillator-proof, AHA, 2.6m, reusable (Only applicable to iM80) 01.57.109101 ECG limb wires, 10-lead, snap, AHA, 0.9m, reusable (Only applicable to iM80) 01.57.471095 ECG Cable, 3 lead, snap, defibrillator-proof, AHA, 3.5m, reusable 01.57.471087 ECG Cable, 3 lead, clip, defibrillator-proof, AHA, 3.5m, reusable 01.57.471096 ECG Cable, 5 lead, snap, defibrillator-proof, AHA, 3.5m, reusable 01.57.471097 ECG Cable, 5 lead, clip, defibrillator-proof, AHA, 3.5m, reusable 01.57.471098 ECG Cable, 3 lead, snap, defibrillator-proof, IEC, 3.5m, reusable 01.57.471099 ECG Cable, 3 lead, clip, defibrillator-proof, IEC, 3.5m, reusable 01.57.471089 ECG Cable, 5 lead, snap, defibrillator-proof, IEC, 3.5m, reusable 01.57.471088 ECG Cable, 5 lead, clip, defibrillator-proof, IEC, 3.5m,reusable 01.57.471196 ECG limb cable, 3-lead, snap, AHA, 0.63m, DIN, reusable 01.57.471198 ECG limb cable, 3-lead, clip, AHA, 0.63m, DIN, reusable 01.57.471195 ECG limb cable, 3-lead, snap, IEC, 0.63m, DIN, reusable 01.57.471197 ECG limb cable, 3-lead, clip, IEC, 0.63m, DIN, reusable 01.57.471193 ECG trunk cable, 3-lead, 6pin, defibrillator-proof, AHA/IEC, 2.9m, DIN, reusable 01.57.471276 ECG conductive adhesive electrodes, TYCO KENKALL MEDI TRACE 210, 10PCS/package 11.57.471056 Adult disposable adhesive electrodes, TYCO H99SG, 30PCS/package, CE
Patient Monitor User Manual Accessories - 157 - Part Number Accessories 11.57.471060 Adult disposable adhesive electrodes, TYCO Medi-Trace 200, 100PCS/package, FDA 11.57.471057 Children/Neonatal disposable adhesive electrodes, TYCO H124SG, 50PCS/package, CE 28.2 SpO2 AccessoriesPart Number Accessories For EDAN Module 02.01.210119 EDAN SH1 Adult Reusable SpO2 Sensor (Lemo) (Only compatible with EDAN SpO2 module), 2.5 m (finger type, for patients more than 40kg) 02.01.210120 EDAN SH1 Adult Reusable SpO2 Sensor (DB9) (Only compatible with EDAN SpO2 module and EDAN SpO2 Extension cable ), 1m (finger type, for patients more than 40kg) 12.01.110492 EDAN SH3 Neonate Warp SpO2 Sensor (DB9) (Only compatible with EDAN SpO2 module and EDAN SpO2 Extension cable),1m (hand or foot, for patients less than 3kg) 02.01.210122 EDAN SH4 Adult Silicone Soft-tip SpO2 Sensor (DB9) (Immersion Disinfection) (Only compatible with EDAN SpO2 module and EDAN SpO2 Extension cable), 1m (finger type, for patients more than 50kg) 02.01.210121 EDAN SH5 pediatric Silicone Soft-tip SpO2 Sensor ( DB9) (Only compatible with EDAN SpO2 module and EDAN SpO2 Extension cable), 1m (finger type, for patients between 10kg to 50kg) 01.13.210001 EDAN SpO2 Extension cable(DB9 to Lemo, 2m, TPU) 01.57.471235 EDAN Adult Single-Patient SpO2 sensor SHD-A (forefinger, for patients over 30kg) 01.57.471236 EDAN Pediatrics Single-Patient SpO2 sensor SHD-P (forefinger, for patients between 10kg to 50kg) 01.57.471237 EDAN Infant Single-Patient SpO2 sensor SHD-I (big toe, for patients between 3kg to 20kg) 01.57.471238 EDAN Neonate Single-Patient SpO2 sensor SHD-N (foot, for patients less than 3kg)
Patient Monitor User Manual Accessories - 158 - Part Number Accessories For Nellcor Module 11.15.30043 Nellcor Reusable Adult SpO2 Sensor (DS-100A OxiMax) (forefinger, for patient over 30kg) 11.15.40096 Nellcor Reusable Adult/Neonate SpO2 Sensor (OXI-A/N OxiMax) (forefinger or foot) 11.13.30131 Nellcor SpO2 Extension cable (Compatible with Nellcor OXI-Max SpO2 module and Nellcor sensor) 28.3 NIBP AccessoriesPartNumber Accessories For EDAN Module 01.57.471326 EDAN Reusable Blood Pressure Cuff Infant E5 01.57.471327 EDAN Reusable Blood Pressure Cuff Small Child E6 01.57.471328 EDAN Reusable Blood Pressure Cuff Child E7 01.57.471329 EDAN Reusable Blood Pressure Cuff Small Adult E8 01.57.471330 EDAN Reusable Blood Pressure Cuff Adult E9 01.57.471331 EDAN Reusable Blood Pressure Cuff Large Adult E10 01.57.471005 NIBP Tube (3m) with connector 01.57.40020 Infant blood pressure cuff (10-19cm)ˈCM1201 01.57.40018 Pediatrics blood pressure cuff (18-26cm)ˈCM1202 01.57.40029 Adult blood pressure cuff (25-35cm)ˈCM1203 01.57.40074 Lager adult blood pressure cuff (33-47cm)ˈCM1204 01.57.471323 NIBP Cuff, Neonate, 10cm-15cm, reusable 01.57.471324 NIBP Cuff, Neonate, 6cm-11cm, reusable 11.57.40097 Neonatal Cuff 5102 (About 6-9cm), for single patient use 11.57.40098 Neonatal Cuff 5104 (About 9-14cm), for single patient use 01.57.471157 NIBP Cuff, neonatal #1, 3-6cm, for single patient use
Patient Monitor User Manual Accessories - 159 - PartNumber Accessories 01.57.471158 NIBP Cuff, neonatal #2, 4-8cm, for single patient use 01.57.471159 NIBP Cuff, neonatal #3, 6-11cm, for single patient use 01.57.471160 NIBP Cuff, neonatal #4, 7-13cm, for single patient use 01.57.471161 NIBP Cuff, neonatal #5, 8-15cm, for single patient use 01.57.471021 Connecting Tube for Neonatal Cuff (Only compatible with Neonatal Disposable and NIBP Tube) 01.57.471303 NIBP spiral Tube with connector 01.57.471291 NIBP Tube (3m) with RECTUS quick connector For Omron Module 01.59.102099 OMRON NIBP Tube (3.5m) /CUFF HOSE (NO.1) length3.5m, CE (Only applicable to iM80 and iM70) 01.57.471078 OMRON CUFF/CUFF (NO.1) arm12—18cmˈwidth7cmˈLATEX, CE (Only applicable to iM80 and iM70) 01.57.471079 OMRON CUFF/CUFF (NO.2) arm17—23cmˈwidth9cmˈLATEX, CE (Only applicable to iM80 and iM70) 01.57.102100 OMRON CUFF/CUFF (NO.3) arm23—33cmˈwidth12cmˈLATEX, CE (Only applicable to iM80 and iM70) 01.57.471080 OMRON CUFF/CUFF (NO.4) arm30—40cmˈwidth14cmˈLATEX, CE (Only applicable to iM80 and iM70) 01.57.471081 OMRON Neonatal disposable cuff/CUFF (NO.10) arm3.5—6cm, width2.5cm, CE (Only applicable to iM80 and iM70) 01.57.471082 OMRON Neonatal disposable cuff/CUFF (NO.11) arm5—7.5cmˈwidth3cm, CE (Only applicable to iM80 and iM70) 01.57.471083 OMRON Neonatal disposable cuff/CUFF (NO.12) arm7.5—10.5cm, width4cm, CE (Only applicable to iM80 and iM70) 01.57.471084 OMRON Neonatal disposable cuff/CUFF (NO.13) arm8.5—13cm, width5cm, CE (Only applicable to iM80 and iM70) 01.59.473003 Connecting Tube for Neonatal Cuff (Only compatible with Neonatal Disposable and NIBP Tube)/CUFF HOSE (NO.3) length3.5mˈCE (Only applicable to iM80 and iM70)
Patient Monitor User Manual Accessories - 160 - 28.4 Temp Accessories Part Number Accessories 01.15.040257 Neonatal/pediatric Skin Temperature Probe (2.252K) 01.15.040258 Neonatal/pediatric Intracavitary Temperature Probe (2.252K) 01.15.040259 Neonatal/pediatric Skin Temperature Probe (10K) 01.15.040260 Neonatal/pediatric Intracavitary Temperature Probe (10K) 01.15.040265 Skin Temperature Probe (2.252K) 01.15.040266 Intracavitary Temperature Probe (2.252K) 01.15.040267 Skin Temperature Probe (10K) 01.15.040268 Intracavitary Temperature Probe (10K) 28.5 Quick Temp Accessories* Part Number Accessories 02.04.110140 Oral/Auxiliary Probe 02.04.110139 Rectal Probe 11.57.110159 Probe Covers * Only applicable to iM50 * Not available in the U.S.A., Canada, UK and Germany 28.6 IBP AccessoriesPart Number Accessories 01.57.471280 6Pin ICP Transducer Interface cable (compatible with Gaeltec ICT/B Intracranial Pressure Transducer) 01.57.471014 Pressure transducer interface cable, BD 01.57.471013 Pressure transducer interface cable, EDWARD 01.57.471027 Pressure transducer interface cable, HOSPIRA 01.57.471028 Pressure transducer interface cable, UTAH 11.57.40121 Disposable pressure transducer kit (BD DTX TM Plus DT-4812 682000)
Patient Monitor User Manual Accessories - 161 - 28.7 CO2 AccessoriesPart Number Accessories For EDAN Module 02.01.210520 Dewatering Cup(Single Patient Use, Adult/Pediatric 10ml) (Only applicable to iM80 and iM70) 01.57.471275 CO2 Sampling Line with Male Luer Lock, 2.0m (Only applicable to iM80 and iM70) 01.57.471282 All Purpose Sampling Cannula without filter (Non Sterile). Size: Adult (Only applicable to iM80 and iM70) 01.57.471283 All Purpose Sampling Cannula without filter (Non Sterile). Size: Infant (Only applicable to iM80 and iM70) 01.57.471284 All Purpose Sampling Cannula without filter (Non Sterile). Size: Neonate (Only applicable to iM80 and iM70) 01.57.471285 Duo Flow O2+CO2 Sampling Cannula (Non Sterile). Size: Adult (Only applicable to iM80 and iM70) 01.57.471286 Duo Flow O2+CO2 Sampling Cannula (Non Sterile). Size: Child (Only applicable to iM80 and iM70) 01.57.471287 Capnomask O2+CO2 Sampling Cannula (Non Sterile). Size: Adult (Only applicable to iM80 and iM70) 01.57.471288 Capnomask O2+CO2 Sampling Cannula (Non Sterile). Size: Child (Only applicable to iM80 and iM70) For Respironics Module 12.08.078137 Respironics EtCO2 module/(Side-stream) 1022054 11.15.040143 Respironics CAPNOSTAT 5 EtCO2 (Main-stream) Module 1015928 12.08.078166 LoFloTM Module Mounting Bracket(Respironics 1027730) 11.57.078139 Disposable CO2 Nasal Cannula - Adult (Respironics 3468ADU-00) 11.57.078151 Adult/Pediatric Airway adapter kit with dehumidification tubing 11.57.078154 Disposable Sampling Line Kit with Dehumidification Tubing (Respironics 3475-00) 11.57.471019 Reuseable Adult/Pediatric Airway Adapter (7007-01) 11.57.471020 Reuseable Neonate/Infant Airway Adapter (7053-01) 11.59.078155 Disposable Adult Airway Adapter (6063-00) 11.59.078156 Disposable Neonatal( infant/pediatric) Airway Adapter (6312-00) 11.57.078142 Adult Nasal CO2 with O2 delivery sampling cannula
Patient Monitor User Manual Accessories - 162 - Part Number Accessories 11.57.078143 Pediatric Nasal CO2 with O2 delivery sampling cannula 11.57.078144 Infant Nasal CO2 with O2 delivery sampling cannula 11.57.101019 Adult Nasal/Oral CO2 sampling cannula 11.57.101020 Pediatric Nasal/Oral CO2 sampling cannula 11.57.101021 Adult Nasal/Oral CO2 with O2 delivery sampling cannula 01.12.031598 Adult/Pediatric Airway adapter kit 11.57.078140 Disposable CO2 Nasal Cannula - Pediatric (Respironics 3468PED-00) 11.57.078141 Disposable CO2 Nasal Cannula - Infant (Respironics 3468INF-00) 11.57.078152 Pediatric/Infant Airway adapter kit with dehumidification tubing 11.57.078158 Pediatric mask/mainstream 9960PED-00 11.57.078159 Adult standard mask /mainstream 9960STD-00 11.57.078160 Adult large mask /mainstream 9960STD-00 11.57.078161 Band/mainstream 8751-00 11.12.078162 bayonet socket 28.8 C.O. Accessories* Part Number Accessories 01.57.471012 Cardiac output cable 11.13.40119 In-line Injection temperature probe (BD 684056-SP4042) 11.57.40120 In-line Injection temperature probe housing (BD 680006-SP5045) 11.57.100175 Control Syringe (Medex MA387) *Not applicable to iM50 28.9 AG Accessories*Part Number Accessories 11.57.471043 Nomoline with Luer Lock connector, Box of 25CAT.NO. 108210 11.57.471042 IRMA Airway AdapterAdult/Pediatric, Box of 25CAT.NO. 106220 01.57.471189 Nomoline Adapter, Cat no: 108220, Sampling line with female luer lock connector.Adult/Pediatric/Infant, 0.15 m
Patient Monitor User Manual Accessories - 163 - Part Number Accessories 01.57.471190 Nomoline Airway Adapter Set, Cat no: 108230, Sampling line with straight airway adapter, single-patient use, Adult/Pediatric, 2.0 m 01.57.471191 Nomo Extension, Cat no: 108240, Sampling line with male luer lock connector, 2.0 m 01.57.471192 T-adapter, Cat no: 108250, Airway adapter with female luer lock connector, Adult/Pediatric * Only applicable to iM70 and iM80 28.10 Other AccessoriesPart Number Accessories 11.57.471048 Assembly board for iM80 gas module 11.21.064143 Rechargeable Lithium-Ion Battery, 14.8V, 4.2Ah 02.01.210217 EPRT-48mm recorder, Serial/parallel port 12.01.19084 Thermal printer 02.01.109592 Pole clamp, 1 set /package 02.01.109636 Pole clamp, 4 sets/package 01.57.78035 Recorder paper 11.21.64056 Vehicle-carried Inverter 01.18.052268 Netac USB Flash Drive (U208, 8G) 11.23.068003 USB barcode scanner 02.01.210080 Wall mounting assembly 02.01.210173 Wall mounting assembly, no basket 02.01.101043 Basket (Only compatible with Wall Mount MS3R-30164) 11.18.078205 Security lock 02.01.101985 MT206 trolley assembly for iM50, no plug board 02.01.101986 MT207 trolley assembly for iM80, no plug board 02.04.101978 Trolley plug board assembly kit 11.13.01950 Three flat power cable, length 3 m
Patient Monitor User Manual Accessories - 164 - Part Number Accessories 01.13.36014 Power cable, length 1.8 m, VDE 11.13.36015 Power cable, length 1.8 m, American standard 01.13.036106 Power cable, length 1.8 m, American standard, medical grade 11.13.114214 Ground Cable 02.01.210633 Recorder 01.18.052307 Sandisk SD Card (CLASS 4, 8G)
Patient Monitor User Manual Product Specification - 165 - A Product Specification A.1 Classification Anti-electroshock type Class I equipment and internal powered equipment Anti-electroshock degree ECG (RESP), TEMP, IBP, C.O., Quick Temp CF SpO2, NIBP, CO2, AG BF Ingress Protection IPX1 (No protection against ingress of water if configured with Quick TEMP module) Disinfection/sterilization method Refer to Chapter Care and Cleaning for details. Working system Continuous operation equipment Compliant with Standards IEC 60601-1: 1988+A1: 1991+A2: 1995; EN 60601-1: 1990+A1: 1993+A2: 1995; IEC 60601-1-2: 2001+A1: 2004; EN 60601-1-2: 2001+A1: 2006; ISO 9919, ISO 21647, IEC/EN 60601-2-27, IEC/EN 60601-2-30, IEC/EN 60601-2-34, IEC/EN 60601-2-49, ANSI/AAMI SP10, AAMI/ANSI EC13, EN12470-4 EN1060-1 EN1060-3, EN1060-4, IEC/EN 60601-2-25*, IEC/EN 60601-2-51* (Symbol * means this standard only applicable to iM80) A.2 Physical Specifications A.2.1 Size and WeightProduct Size Weight (standard configuration, without battery) iM50 261 mm (L) × 198 mm (W) × 215 mm (H) <3.6 kg iM60 303mm(L) × 161mm(W) × 254mm(H) <4.5 kg iM70 328mm(L) × 158mm(W) × 285mm(H) <5.5 kg iM80 370 mm (L) × 175 mm (W)× 320 mm (H) <7 kg A.2.2 Environment Specification The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges. When the monitor and related products have differing environmental specifications, the effective range for the combined products is that range which is common to the specifications for all products.
Patient Monitor User Manual Product Specification - 166 - Temperature Working +5qC ~ +40qC Transport and Storage -20qC ~ +55qC Humidity Working 25% ~ 80% (non-condensing) Transport and Storage 25% ~ 93% (non-condensing) Altitude Working 860hPa ~ 1060hPa Transport and Storage 700hPa ~ 1060hPa 100V-240V~, 50Hz/60Hz iM50 Current=1.0A-0.5A; Fuse: T 1.6AL, 250V iM80 Current=1.4A-0.7A; Fuse: T 1.6AL, 250V Power Supply iM60/iM70 Current=1.4A-0.7A; Fuse: T3.15AH, 250V A.2.3 Display Product Display Messages iM50 Display screen: 8.4 inch color TFT, supporting touch screen Resolution: 800×600 A maximum of 11 waveforms One power LED Two alarm LED One charge LED iM60 Display screen: 10.4 inch color TFT, supporting touch screen Resolution: 800×600 A maximum of 11 waveforms One power LED Two alarm LED One charge LED iM70 Display screen: 12.1 inch color TFT, supporting touch screen Resolution: 800×600 A maximum of 11 waveforms One power LED Two alarm LED One charge LED
Patient Monitor User Manual Product Specification - 167 - iM80 Display screen: 15 inch color TFT, supporting touch screen Resolution: 1024 × 768 A maximum of 13 waveforms One power LED Two alarm LED One charge LED A.2.4 Battery Specification 2.1Ah 180 min or longer iM50 4.2Ah 420 min or longer One battery (4.2Ah) 120 min or longer iM80 Two batteries (2*4.2Ah) 240 min or longer 2.1Ah 150 min or longer Operating Time iM60/iM70 4.2Ah 300 min or longer Condition At 25qC, with (a) new fully charged battery/batteries, continuous SpO2 measurement and NIBP automatic measurement mode at interval of 15 minutes, ECG/TEMP module connected, recording at interval of 10 minutes, brightness set to “1” 2.1Ah 200 min or shorter iM50 4.2Ah 380 min or shorter One battery (4.2Ah) 320 min or shorter iM80 Two batteries (2*4.2Ah) 560 min or shorter 2.1Ah 200 min or shorter Charge Time iM60/iM70 4.2Ah 360 min or shorter Condition Monitor is on or in standby mode. A.2.5 Recorder Record Width 48 mm Paper Speed 25 mm/s, 50 mm/s Trace 3 Recording types Continuous real-time recording 8 seconds real-time recording Time recording
Patient Monitor User Manual Product Specification - 168 - Alarm recording Trend graph recording Trend table recording NIBP review recording Arrhythmia review recording Alarm review recording Drug calculation titration recording Hemodynamic Calculation result recording 12-lead analysis recording C.O. measurement recording A.2.6 Data Storage Trend graph/trend table review 1 hour, at 1 Second Resolution by default 120 hrs, at 1 min. Resolution by default Alarm/Monitoring Event data Up to 60 sets NIBP Measurement Review 1200 sets Arrhythmia events Up to 60 sets 12-lead Diagnosis Review Up to 50 sets A.3 ECGLead Mode 3-Lead: I, II, III 5-Lead: I, II, III, aVR, aVL, aVF, V 12-Lead: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6Waveform 3-Lead: 1-channel waveform; 5-Lead: 2-channel waveform, max. seven waveforms; 12-Lead: 2-channel waveform, a maximum of 13 waveforms; Lead naming style AHA, IEC Display Sensitivity 1.25mm/mV (×0.125), 2.5mm/mV (×0.25), 5mm/mV (×0.5), 10mm/mV (×1), 20mm/mV (×2), 40mm/mV (×4), AUTO gain Waveform Speed 6.25mm/s, 12.5mm/s, 25mm/s, 50mm/s
Patient Monitor User Manual Product Specification - 169 - Bandwidth (-3dB) Diagnosis: 0.05Hz to 150Hz Monitor: 0.5Hz to 40Hz Surgery: 1Hz to 20Hz CMRR (Common Mode Rejection Ratio) Diagnosis: >95dB (the Notch filter is off) Monitor: >105dB (the Notch filter is on) Surgery: >105dB (the Notch filter is on) Notch In diagnosis, monitoring, surgery mode: 50Hz/60Hz (Notch filter can be turned on or off manually) Differential Input Impendance >5M Input Signal Range ±10mV (peak-to-peak value) Accuracy of Input Signal Reconstruction The total error and frequency response comply with ANSI/AAMI EC13:2002, Sect. 4.2.9.8. Electrode Offset Potential Tolerance ±500mV Auxiliary Current (Leads off detection) Active electrode: <100nA Reference electrode: <900nA Recovery time after Defibrillation <5s Leakage current of patient <10A Scale signal 1mV(peak-to-peak value), accuracy is ±5ˁ System noise <30VPP ESU Protection Recovery time: 10s Pace Pulse Pulse indicator Pulse is marked if the requirements of ANSI/AAMI EC13:2002, Sect. 4.1.4.1 are met: Amplitude: ±2 mV ~ ±700 mV Width: 0.1 ms ~2 ms Ascending time: 10 s ~ 100 s Pulse Rejection Pulse is rejected if the requirements of ANSI/AAMI EC13: 2002, Sect. 4.1.4.1 are met: Amplitude: ±2 mV ~ ±700 mV Width: 0.1 ms ~2 ms Ascending time: 10 s ~100 s
Patient Monitor User Manual Product Specification - 170 - Minimum input slew rate >2.5V/S Heart rate Measurement Range ADU: 15 bpm ~ 300 bpm PED/NEO: 15 bpm ~ 350 bpm Accuracy ±1% or ±1 bpm, whichever is greater Resolution 1 bpm PVC Measurement Range ADU: 0~300 PVCs/ min PED/NEO: 0~350 PVCs/ min Resolution 1 PVCs/min ST value(only applicable to adult˅ Measurement Range -2.0 mV ~ +2.0 mV Accuracy -0.8 mV ~ +0.8 mV: ±0.02 mV or 10% (), whichever is greater. Beyond this range: undefined Resolution 0.01 mV HR averaging method Method 1 Heart rate is computed by excluding the minimum and maximum values from the 12 most recent RR intervals and averaging the residual 10 RR intervals. Method 2 If each of three consecutive RR intervals is greater than 1200ms, then the four most recent RR intervals are averaged to compute the HR. Range of Sinus and SV Rhythm Tachy ADU: 120 bpm ~ 300 bpm PED/NEO: 160 bpm ~ 350 bpm Normal ADU: 41 bpm ~ 119 bpm PED/NEO: 61 bpm ~159 bpm Brady ADU: 15 bpm ~ 40 bpm PED/NEO: 15 bpm ~ 60 bpm Range of Ventricular Rhythm Ventricular Tachycardia The interval of 5 consecutive ventricular beats is less than 600 ms
Patient Monitor User Manual Product Specification - 171 - Ventricular Rhythm The interval of 5 consecutive ventricular beats ranges from 600 ms to 1000 ms Ventricular Bradycardia The interval of 5 consecutive ventricular beats is more than 1000 ms Maximum Start-up alarm time for Tachycardia Ventricular Tachycardia 1 mV 206bpm Gain 1.0: 10 s Gain 0.5: 10 s Gain 2.0: 10 s Ventricular Tachycardia 2 mV 195bpm Gain 1.0: 10 s Gain 0.5: 10 s Gain 2.0: 10 s Response time of Heart Rate Meter to Change in HR HR range: 80 bpm ~ 120 bpm Range : 7s ~ 8s, average is 7.5s HR range: 80bpm ~ 40bpm Range : 7s ~ 8s, average is 7.5s Tall T-wave Rejection Complies with ANSI/AAMI EC13: 2002 Sect. 4.1.2.1 C) minimum recommended 1.2mV T-Wave amplitude Accuracy of Heart Rate Meter and Response to Irregular Rhythm Complies with ANSI/AAMI EC13: 2002 Sect.4.1.2.1 e) The HR value displays after a stable period of 20s: Ventricular bigeminy: 80bpm±1bpm Slow alternating ventricular bigeminy: 60bpm±1bpm Rapid alternating ventricular bigeminy: 120bpm±1bpm Bidirectional systoles: 91bpm±1bpm ASYSTOLE VFIB/VTAC COUPLET VT>2 BIGEMINY TRIGEMINY VENT R on T PVC TACHY BRADY MISSED BEATS IRR VBRADY PNC 16 different arrhythmia analysis classification (applicable to adult and pediatric) PNP
Patient Monitor User Manual Product Specification - 172 - Average parameters of heart beat Heart rate (bpm) Time limit of P wave (ms) PR interval (ms) QRS interval (ms) QT/QTC (ms) 12-lead ECG Synchronization Analysis P-QRS-T AXIS ECG Analog Output Bandwidth (-3dB; reference frequency: 10Hz) Diagnosis: 0.05Hz ~ 100Hz Monitor: 0.5Hz ~ 40Hz Surgery: 1Hz ~ 20Hz Maximum transmission delay 500ms (in diagnostic mode, and with notch off) Sensitivity 1V/mV ±10% PACE rejection/enhancement Without Pace enhancement or pace rejection Waveform Display Consistent with the calculation leads. Compliant with Standard and Directive Complies with the requirements in terms of short circuit protection and leakage current in EN60601-1. Defib Sync Pulse Output wave Square pulse Output impedance <500  Maximum Time Delay 35mS (R-wave peak to leading edge of pulse) Amplitude High level: 3.5 to 5 V, providing a maximum of 1 mA output current; Low level: < 0.5V, receiving a maximum of 5 mA input current. Minimum required R wave amplitude 0.3mV Pulse width 100ms ± 10% Limited current 15 mA rating Rising and falling time < 1 ms
Patient Monitor User Manual Product Specification - 173 - A.4 RESP Measurement method Trans-thoracic impedance Measurement lead Lead Options are lead I and II. The default lead is lead II. Waveform amplitude h0.25, ×0.5, ×1, ×2, ×3, ×4, ×5 Waveform speed 6.25mm/s, 12.5mm/s, 25.0mm/s, , 50mm/s Respiration excitation waveform < 300 A, sinusoid, 62.8 kHz (r 10%) Measuring sensitivity 0.3  (base impedance 200 to 4500 ) 200 to 2500  (cable resistance = 0 K) Base impedance range 2200 to 4500  (leads cables 1K resistance) Maximum dynamic range 500  base impedance, 3  variable impedance Waveform bandwidth 0.2 to 2.5 Hz (-3 dB) Differential input impedance >5 M RR measuring range Adult 0 to 120 rpm Neo/Ped 0 to 150 rpm Resolution 1 rpm Accuracy Adult 6 to 120 rpm: r2 rpm 0 to 5 rpm: not specified Neo/Ped 6 to 150 rpm: r2 rpm 0 to 5 rpm: not specified Apnea Alarm delay 10s, 15s, 20s, 25s, 30s, 35s, 40s. The default value is 20s.
Patient Monitor User Manual Product Specification - 174 - A.5 NIBP EDAN Module Measurement Method Oscillometric Mode Manual, Auto, Continuous Measuring interval in AUTO Mode 1/2/3/4/5/10/15/30/60/90/120/240/480 min Continuous 5min, interval is 5s Measuring type SYS, DIA, MAP, PR Measurement Range Adult mode SYS: 40 mmHg ~ 270 mmHg DIA: 10 mmHg ~ 215 mmHg MAP: 20 mmHg ~ 235 mmHg Pediatric mode SYS: 40 mmHg ~ 200 mmHg DIA: 10 mmHg ~ 150 mmHg MAP: 20 mmHg ~ 165 mmHg Neonatal mode SYS: 40 mmHg ~ 135 mmHg DIA: 10 mmHg ~ 100 mmHg MAP: 20 mmHg ~ 110 mmHg Cuff pressure measuring range 0 mmHg ~ 300 mmHg Accuracy Maximum mean error ±5mmHg Maximum standard deviation 8mmHg Pressure resolution 1mmHg Maximum measuring period Adult/Pediatric 120s Neonate 90s Typical measuring period 30s ~ 45s (depend on HR/motion disturbance) Overpressure protection Adult 297±3mmHg Pediatric 240±3mmHg Neonatal 147±3mmHg
Patient Monitor User Manual Product Specification - 175 - PR Measurement range 40 bpm ~240bpm Accuracy ±3bpm or 3.5%, whichever is greater Omron Module Method Oscillometric Mode Manual, Auto, Continuous Measuring Interval in AUTO Mode 1/2/3/4/5/10/15/30/60/90 min, 2/4/8h Continuous 5min, interval is 5s Maximum measurement period Adult/ Pediatric: 160s Neonatal: 80s Adult/ Pediatric mode: 40bpm ~ 200bpm PR Measurement Range Neonatal mode: 40 bpm ~ 240bpm PR Accuracy r 2 bpm or 2% of the readings Measurement Range Adult/ Pediatric Mode SYS: 60 mmHg ~ 250 mmHg DIA: 40 mmHg ~ 200 mmHg MAP: 45 mmHg ~ 235 mmHg Neonatal Mode SYS: 40 mmHg ~ 120 mmHg DIA: 20 mmHg ~ 90 mmHg MAP: 30 mmHg ~ 100 mmHg Cuff pressure measuring range 0 mmHg ~ 300 mmHg Pressure Resolution 1mmHg Accuracy Maximum Mean Error ±5mmHg Maximum Standard Deviation 8mmHg
Patient Monitor User Manual Product Specification - 176 - A.6 SpO2EDAN Module Measurement Range 0 ~ 100 % Resolution 1 % Accuracy r2 % (70%~100% SpO2) Adult (including Pediatric) Undefined (0~69% SpO2) r3 % (70%~100% SpO2) Neonate Undefined (0~69% SpO2) Pulse Rate Measuring Range 25bpm ~ 300bpm Resolution 1bpm Accuracy r2bpm Data update period 1s Wave length: Red light: 660r3 nm; Infrared light: 905r5 nm Sensor Emitted light energy: <15mW Nellcor Module Measuring Range 1% ~ 100% Resolution 1% Data update period 1s Sensor Type Accuracy Accuracy DS-100A, OXI-A/N r 3%(70% ~ 100% SpO2) * When the sensor is used to neotate as recommendation, the specified accuracy range of the neotate is always higher ±1 than adult. Pulse Rate Measuring Range 20bpm ~ 300bpm Resolution 1bpm Accuracy r 3bpm (20bpm ~ 250bpm) Wave length: approximately 660 and 900nm Sensor Emitted light energy: <15mW
Patient Monitor User Manual Product Specification - 177 - A.7 TEMPMeasurement method Thermal resistance Channel 2 Sensor type YSI-10K and YSI-2.252K Measuring Range 0 qC ~ 50 qC Resolution 0.1qC Accuracy (Without sensor) r0.1qC Unit ć, ̧ Refresh Time 1s ~ 2s A.8 Quick TEMP Measuring Range 25qC ~ 45qC(monitoring mode) 35.5ć̚42ć(prediction mode) Operating Temp 10qC ~ 40qC Sensor Type Oral/Axillary sensor, Rectal sensor Resolution 0.1qC Accuracy(without sensor) r0.1qC (25qC ~ 45qC) (monitoring mode) Response time < 60s Update time 1s ~ 2s Warm-up time Less than 10 seconds Prediction time Less than 30 seconds A.9 IBPMeasurement method Direct invasive measurement Channel iM80: 4 channels iM50/iM60/iM70: 2 channels Pressure sensor Sensitivity 5 (V/V/mmHg) Impedance range 300 to 3000  Frequency response d.c. to 12.5 or 40 Hz Zero Range: r200 mmHg
Patient Monitor User Manual Product Specification - 178 - Unit kPa, mmHg Measuring range Art 0 to 300 mmHg PA -6 to +120mmHg CVP/RAP/LAP/ICP -10 to +40 mmHg P1/P2 -50 to +300 mmHg Resolution 1 mmHg Accuracy (without sensor) r 2 % or 1 mmHg, whichever is greater A.10 CO2EDAN Module Intended patient Adult, pediatric, neonatal Measurement method Non-dispersive infrared gas analysis (NDIR) Unit mmHg, %, kPa CO2 0 mmHg ~ 150 mmHg (0 % ~ 20%) Measuring Range AwRR 2 rpm ~ 150 rpm EtCO2 0.2mmHg (0 mmHg~ 70mmHg), 0.5mmHg (70 ~ 100mmHg) FiCO2 0.2mmHg Resolution AwRR 1rpm r 2 mmHg, 0mmHg ~ 40 mmHg r 5% of reading, 41 mmHg ~ 70 mmHg r 8% of reading, 71 mmHg ~ 100 mmHg r 10% of reading, 101 mmHg ~ 150 mmHg Typical conditions: Ambient temperature: 25r 3ć Barometric pressure: 760r 10 mmHg Balance gas: N2 Respiratory rate: not exceed 60rpm Sample gas flowrate: 100ml/min EtCO2 r12% or r 4 mmHg of reading, whichever is greater All conditions Accuracy AwRR r 1 rpm Sample gas Flowrate 70ml/min or 100ml/min, optional (r15ml/min)
Patient Monitor User Manual Product Specification - 179 - Stability Short term drift: drift over 4 hours < 0.8 mmHg Long term drift: 120 hours Warm-up time Display reading within 20s; reach to the designed accuracy within 2 minutes. Rise time 400ms (typical value, using water trap, sample gas flowrate:100ml/min Response time <4s (water trap) with 2m gas sampling tube, sample gas flowrate: 100ml/min Work mode Standby, measure; default: measure Respiratory inspection The value of concentration change is greater than 1 vol%. O2 compensation Range: 0%~100% Resolution: 1% Default: 16% N2O compensation Range: 0%~100% Resolution: 1% Default: 0% AG compensation Range: 0%~20% Resolution: 0.1% Default: 0% Humidity compensation method ATPD, BTPS (default) Calibration Support Alarm EtCO2, FiCO2, AwRR Apnea alarm delay 10s, 15s, 20s, 25s, 30s, 35s, 40s; default value is 20s. Respironics Module Intended patient Adult, pediatric, neonatal Measurement method Infra-red Absorption Technique Unit mmHg, %, Kpa Measuring Range EtCO2 0 mmHg ~ 150 mmHg FiCO2 3 mmHg ~50 mmHg AwRR 2 rpm ~ 150 rpm(sidestream) 0 rpm ~ 150 rpm(mainstream) Resolution EtCO2 1mmHg
Patient Monitor User Manual Product Specification - 180 - FiCO2 1mmHg AwRR 1 rpm r 2 mmHg, 0 to 40 mmHg r 5 % of reading, 41 to 70 mmHg r 8 % of reading, 71 to 100 mmHg r 10 % of reading, 101 to 150 mmHg EtCO2 Accuracy r 12 % of reading, RESP measurement value exceeds 80rpm (sidestream) AwRR Accuracy r 1 rpm Sample Gas Flowrate (sidestream) 50fml/min Stability Short Term Drift Less than 0.8 mmHg over four hours Long Term Drift Accuracy specification will be maintained over a 120 hour period O2 Compensation Range 0 ~ 100% Resolution 1% Default 16% GAS Compensation Range 0 ~ 20% Resolution 0.1% Default 0.0% Zero Support Work Mode Standby, Measurement Barometric pressure compensation User setup Balance gas compensation Including Helium, N2O and room air Apnea Alarm Delay 10s, 15s, 20s, 25s, 30s, 35s, 40s; default value is 20s. Interfering Gas Effect on EtCO2 Measurement Values: Gas or vapor Gas level (%) Quantitative effect/Comments Nitrous oxide 60 Dry and Saturated Gas
Patient Monitor User Manual Product Specification - 181 - Halothane Enflurane Isoflurane Sevoflurane Xenon Helium Desflurane 4 5 5 5 80 50 15 0 – 40 mmHg: ± 1 mmHg additional error 41 – 70 mmHg: ± 2.5% additional error 71 – 100 mmHg: ± 4% additional error 101 – 150 mmHg: ± 5% additional error *Additional worst case error when compensation for PB, O2, N2O, anesthetic agents, or helium is correctly selected for the actual fractional gas constituents present. Desflurane: The presence of desflurane in the exhaled breath at concentrations greater than 5% will positively bias Carbon Dioxide values by up to an additional 3 mmHg at 38mmHg. Xenon: The presence of Xenon in the exhaled breath will negatively bias Carbon Dioxide values by up to an additional 5 mmHg at 38mmHg. Barometric Pressure on EtCO2 Measurement Values: Quantitative effect Ambient Barometric, Operational 0 – 40 mmHg: ± 1 mmHg additional error 41 – 70 mmHg: ± 2.5% additional error 71 – 100 mmHg: ± 4% additional error 101 – 150 mmHg: ± 5% additional error *Additional worst case error when compensation for PB, O2, N2O, anesthetic agents, or helium is correctly selected for the actual fractional gas constituents present. A.11 C.O.Intended patient Adult Measurement method Thermodilution Technique Measuring range C.O. 0.1 L/min ~ 20L/min TB 23qC ~ 43qC TI -1qC ~ 27qC Resolution C.O. 0.1L/min
Patient Monitor User Manual Product Specification - 182 - TB, TI +0.1qC Accuracy C.O. ±5% or 0.2 L/min, whichever is greater TB r0.1qC(without sensor) TI r0.1qC(without sensor) A.12 AGA.12.1 Phasein Sidestream Temperature Working +5qC ~ +40qC Transport and Storage -20qC ~ +55qC Humidity Working 25% ~ 80% (non-condensing) Transport and Storage 25% ~ 93% (non-condensing) Altitude Working 860hPa ~ 1060hPa Transport and Storage 700hPa ~ 1060hPa ISA AX+ Analyzer Displaying the concentration of CO2, N2O, and two anaesthesia agent and identifying the anaesthesia agent automatically (portable module) Module Type ISA OR+ Analyzer Displaying the concentration of CO2, O2, N2O, and two anaesthesia agent and identifying the anaesthesia agent automatically (portable module) Measurement Parameters CO2 , N2O , O2, Halothane (HAL), Isoflurane(ISO), Enflurane(ENF), Sevoflurane(SEV) , Desflurane(DES), awRR, MAC Measurement Principle CO2, N2O, Anaesthesia Agent: infra-red absorption characteristic; O2: Paramagnetic method Sampling Flow Rate 50±10ml/min Work Mode Measurement Warm-up Time < 20s
Patient Monitor User Manual Product Specification - 183 - Typical Rise Time CO2  200ms HAL, ISO, ENF, SEV, DES  350ms N2O  350ms O2  450ms Primary Anaesthesia Agent Threshold  0.15 vol% Second Anaesthesia Agent Threshold 0.2 vol% + 10% Agent Identificaiton Time < 20 seconds (typically < 10 seconds) Total System Response Time < 3 seconds Data Update Time 1 second Accuracy(Standard Conditions) GAS Measurement Range Accuracy CO2 0 to 15 vol% 15 to 25 vol% ±(0.2 vol% + 2% of reading) Unspecified N2O 0 to 100 vol% ±(2 vol% + 2% of reading) HAL, ENF, ISO 0 to 8 vol % 8 to 25 vol % ±(0.15 vol% + 5% of reading) Unspecified SEV 0 to 10 vol % 10 to 25 vol % ±(0.15 vol% + 5% of reading) Unspecified DES 0 to 22 vol % 22 to 25 vol % ±(0.15 vol% + 5% of reading) Unspecified O2 0 to 100 vol % ±(1 vol% + 2% of reading) Apnea Alarm Delay 10s, 15s, 20s, 25s, 30s, 35s, 40s; default value is 20s. Zero Support O2 Compensation Support N2O Compensation Support Interfering gas and vapor effects CO2 Gas or vapour Gas level ISA CO2 ISA AX+ Agents N2O
Patient Monitor User Manual Product Specification - 184 - N2O4) 60 vol% _ 2) _ 1) _ 1) _ 1) HAL4) 4 vol% _ 1) _ 1) _ 1) _ 1) ENF, ISO, SEV4) 5 vol% +8% of reading 3) _ 1) _ 1) _ 1) DES4) 15 vol% +12% of reading 3) _ 1) _ 1) _ 1) Xe(Xenon)4) 80 vol% -10% of reading 3) _ 1) _ 1) He(Helium) 4) 50 vol% -6% of reading 3) _ 1) _ 1) Metered dose inhaler propellants4) Not for use with metered dose inhaler propellants C2H5OH(Ethanol) 4) 0.3 vol% _ 1) _ 1) _ 1) _ 1) C3H7OH (Isopropanol) 4) 0.5 vol% _ 1) _ 1) _ 1) _ 1) CH3COCH3 (Acetone) 4) 1 vol% _ 1) _ 1) _ 1) _ 1) CH4(Methane) 4) 3 vol% _ 1) _ 1) _ 1) _ 1) CO(Carbon monoxide) 5) 1 vol% _ 1) _ 1) _ 1) _ 1) NO(Nitrogen monoxide) 0.02 vol% _ 1) _ 1) _ 1) _ 1) O25) 100 vol% _ 2) _ 2) _ 1) _ 1) Note 1: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2 readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50 vol% Helium, the actual measured CO2 concentration will typically be (1-0.06)*5.0 vol% =4.7 vol% CO2. Note 2: In addition to the EN ISO 21647 standard. A.12.2 Phasein Mainstream Temperature Working +10qC ~ +40qC Transport and Storage -20qC ~ +55qC
Patient Monitor User Manual Product Specification - 185 - Humidity Working 25% ~ 80% (non-condensing) Transport and Storage 25% ~ 93% (non-condensing) Altitude Working 860hPa ~ 1060hPa Transport and Storage 700hPa ~ 1060hPa Module Type IRMA AX+ Displaying the concentration of CO2, N2O and two anaesthesia agent and indentifying two anaesthesia agent Measurement Parameters CO2, N2O, HAL, Isoflurane(ISO), Enflurane(ENF), Sevoflurane(SEV), Desflurane(DES), awRR, MAC Measurement Principle CO2, N2O, anaesthesia agent: infra-red absorption characteristic Warm-up Time Concentrations are reported and the automatic agent indentification is running within 10 seconds. 20 seconds for IRMA AX+. Rise Time CO2  90ms N2O  300ms HAL, ISO, ENF, SEV, DES  300ms Primary Agent Threshold 0.15 vol% Secondary Agent Threshold 0.2 vol% + 10% of total agent concentration Agent Identificaiton Time < 20 seconds (typically less than 10 seconds) Response Time < 1 second Data Update Time 1 second Accuracy(Standard Conditions) Gas Range Accuracy CO2 0 ~ 10 vol% 10 ~ 15 vol% 15 ~ 25 vol% ±(0.2 vol% + 2% of reading) ±(0.3 vol% + 2% of reading) Unspecified
Patient Monitor User Manual Product Specification - 186 - N2O 0 to 100 vol% ±(2 vol% + 2% of reading) HAL ISO ENF 0 to 8 vol% 8 to 25 vol% ±(0.15 vol% + 5% of reading) Unspecified SEV 0 to 10 vol% 10 to 25 vol% ±(0.15 vol% + 5% of reading) Unspecified DES 0 to 22 vol% 22 to 25 vol% ±(0.15 vol% + 5% of reading) Unspecified AwRR accuracy ±1rpm Real-time gas concentration monitoring Support Zero Support Work Mode Measurement Apnea Alarm Delay 10s, 15s, 20s, 25s, 30s, 35s, 40s; default value is 20s. Interfering gas and vapour effects CO2 Gas or vapour Gas level IRMA CO2 IRMA AX+Agents N2O N2O4) 60 vol% _ 1&2) _ 1&2) _ 1) _ 1) HAL4) 4 vol% _ 1) _ 1) _ 1) _ 1) ENF, ISO, SEV4) 5 vol% +8% of reading 3) _ 1) _ 1) _ 1) DES4) 15 vol% +12% of reading 3) _ 1) _ 1) _ 1) Xe(Xenon)4) 80 vol% -10% of reading 3) _ 1) _ 1) He(Helium) 4) 50 vol% -6% of reading 3) _ 1) _ 1) Metered dose inhaler propellants4) Not for use with metered dose inhaler propellants C2H5OH(Ethanol) 4) 0.3 vol% _ 1) _ 1) _ 1) _ 1) C3H7OH (Isopropanol) 4) 0.5 vol% _ 1) _ 1) _ 1) _ 1)
Patient Monitor User Manual Product Specification - 187 - CH3COCH3 (Acetone) 4) 1 vol% _ 1) _ 1) _ 1) _ 1) CH4(Methane) 4) 3 vol% _ 1) _ 1) _ 1) _ 1) CO(Carbon monoxide) 5) 1 vol% _ 1) _ 1) _ 1) _ 1) NO 0.02 vol% _ 1) _ 1) _ 1) _ 1) O25) 100 vol% _ 1&2) _ 1&2) _ 1) _ 1) Note 1: For probes not measuring N2O and/or O2 the concentrations shall be set from monitor. (IRMA CO2 measures neither N2O, nor O2. IRMA AX+ does not measure O2.) Note 2: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2 readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50 vol% Helium, the measured CO2 concentration will typically be (1-0.06)*5.0 vol% =4.7 vol% CO2. Note 3: In addition to the EN ISO 21647 standard.
Patient Monitor User Manual EMC Information - 188 - B EMC Information - Guidance and Manufacture’s Declaration B.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMSGuidance and manufacture’s declaration – electromagnetic emission The monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the monitor should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emission CISPR 11 Class A Harmonic emissions IEC/EN 61000-3-2 Class A Voltage fluctuations/ flicker emissions IEC/EN 61000-3-3 Complies The monitor is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. B.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMSGuidance and manufacture’s declaration – electromagnetic immunity The monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the monitor should assure that it is used in such an environment. Immunity test IEC/EN 60601 test level Compliance levelElectromagnetic environment - guidanceElectrostatic discharge (ESD) IEC/EN 61000-4-2 r6 kV contact r8 kV air r6 kV contact r8 kV air Floors should be wood, concrete or ceramic tile. If floor are covered with synthetic material, the relative humidity should be at least 30%.
Patient Monitor User Manual EMC Information - 189 - Electrical fast transient/burst IEC/EN 61000-4-4 r2 kV for power supply lines r1 kV for input /output signal r2kV for power supply lines r1 kV for input /output signal Mains power quality should be that of a typical commercial or hospital environment. Surge IEC/EN 61000-4-5 r1 kV for line to line r2 kV for line to ground r1 kV for line to line r2 kV for line to ground Mains power quality should be that of a typical commercial or hospital environment. Power frequency (50/60Hz) magnetic field IEC/EN 61000-4-8 3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC/EN 61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the Patient Monitor requires continued operation during power mains interruptions, it is recommended that the Patient Monitor be powered from an uninterruptible power supply or a battery. NOTE UT is the a.c. mains voltage prior to application of the test level.
Patient Monitor User Manual EMC Information - 190 - B.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunity The Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Patient Monitor should assure that it is used in such an environment.Immunity test IEC/EN 60601 test levelCompliance levelElectromagnetic environment - guidance Conducted RF IEC/EN 61000-4-6 Radiated RF IEC/EN 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 3 V/m Portable and mobile RF communications equipment should be used no closer to any part of the Patient Monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance PVd»¼º«¬ª 15.3 PEd»¼º«¬ª 15.3 80 MHz to 800 MHz PEd»¼º«¬ª 17 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
Patient Monitor User Manual EMC Information - 191 - NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Patient Monitor is used exceeds the applicable RF compliance level above, the Patient Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Patient Monitor. b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m. B.4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the monitor The monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the monitor as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter(m) Rated maximum output power of transmitter (W)150 kHz to 80 MHz PVd»¼º«¬ª 15.380 MHz to 800 MHzPEd»¼º«¬ª 15.3800 MHz to 2.5 GHzPEd»¼º«¬ª 170.01 0.12 0.12 0.23 0.1 0.36 0.37 0.74 1 1.16 1.17 2.33 10 3.69 3.69 7.38 100 11.67 11.67 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Patient Monitor User Manual EMC Information - 192 - NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Patient Monitor User Manual Default Settings - 193 - C Default Settings This appendix documents the most important default settings of your monitor as it is delivered from the factory. Note: If your monitor has been ordered preconfigured to your requirements, the settings at delivery will be different from those listed here. C.1 Patient Information Default Settings Patient Information Settings Patient Type Adult Pace Off C.2 Alarm Default SettingsAlarm Settings Pause Time 120s Mute On Sensor Off Alarm On Alarm Latch Unlatch C.3 ECG Default Settings ECG Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 120 160 200 Alarm Low Limit 50 75 100 Pace Off Lead Type 5 Leads Display Normal Filter Monitor Smart Lead Off Off Heart Volume 2 ST Analysis ADU PED NEO
Patient Monitor User Manual Default Settings - 194 - ST Analysis Off Alarm Switch Off Alarm Level Medium Alarm Record Off Alarm High Limit (ST-X) 0.2 Alarm Low Limit (ST-X) -0.2 X stands for I, II, III, aVR, aVL, aVF, V, V1, V2, V3, V4, V5 or V6. ARR Analysis ARR Analysis On PVCs Alarm Level Medium PVCs Alarm Switch Off PVCs Alarm Record Off ARR Alarm Settings Alarm Switch Alarm Level Alarm Record ASYSTOLE On High Off VFIB/VTAC On High Off R ON T On Medium Off VT > 2 On Medium Off COUPLET On Medium Off PVC On Medium Off BIGEMINY On Medium Off TRIGEMINY On Medium Off TACHY On Medium Off BRADY On Medium Off MISSEDBEATS On Medium Off IRR On Medium Off PNC On Medium Off PNP On Medium Off VBRADY On Medium Off VENT On Medium Off
Patient Monitor User Manual Default Settings - 195 - C.4 RESPRESP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 30 30 100 Alarm Low Limit 8 8 30 Apnea Time 20s Calculation Type Auto Resp Type II Sweep 12.5mm/s Amplitude 1 C.5 SpO2SpO2 Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 100 100 95 Alarm Low Limit 90 90 88 Pitch Tone On Sweep 12.5mm/s C.6 PR PR Settings ADU PED NEO PR Source SpO2 Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit 120 160 200 Alarm Low Limit 50 75 100
Patient Monitor User Manual Default Settings - 196 - Pulse Volume 3 Alarm Source Auto C.7 NIBP NIBP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit (SYS) 160 120 90 Alarm Low Limit (SYS) 90 70 40 Alarm High Limit (Map) 110 90 70 Alarm Low Limit (Map) 60 50 30 Alarm High Limit (Dia) 90 70 60 Alarm Low Limit (Dia) 50 40 20 EDAN Module Inflation value 160 140 100 Omron Module Inflation value 180 180 120 Unit mmHg Interval Manual C.8 TEMPTEMP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit (T1) 39.0 39.0 39.0 Alarm Low Limit (T1) 36.0 36.0 36.0 Alarm High Limit (T2) 39.0 39.0 39.0 Alarm Low Limit (T2) 36.0 36.0 36.0 Alarm High Limit (TD) 2.0 2.0 2.0
Patient Monitor User Manual Default Settings - 197 - Unit qC C.9 Quick TEMPQuick TEMP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit (T1) 39.0 39.0 / Alarm Low Limit (T1) 36.0 36.0 / Unit qC C.10 IBP IBP Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Unit mmHg Filter 12.5Hz SYS, DIA, MAP SYS, DIA, MAP SYS, DIA, MAP Alarm High Limit (ART, P1, P2) 160, 90, 110 160, 90, 110 160, 90, 110 Alarm Low Limit (ART, P1, P2) 90, 50, 70 90, 50, 70 90, 50, 70 Alarm High Limit (PA) 35, 16, 20 35, 16, 20 35, 16, 20 Alarm Low Limit (PA) 10, 0, 0 10, 0, 0 10, 0, 0 MAP MAP MAP Alarm High Limit (CVP, RAP, LAP, ICP) 10 10 10 Alarm Low Limit (CVP, RAP, LAP, ICP) 0 0 0
Patient Monitor User Manual Default Settings - 198 - C.11 CO2CO2 Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Work Mode Standby Unit mmHg Apnea Time 20s O2 Compensate 16% Anes Agent 0% Alarm High Limit (EtCO2) 50 50 45 Alarm Low Limit (EtCO2) 15 20 30 Alarm High Limit (FiCO2) 4 4 4 Alarm High Limit (AWRR) 30 30 100 Alarm Low Limit (AWRR) 8 8 30 Sweep 12.5mm/s Amplitude Low C.12 C.O. C.O. Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Alarm High Limit (TB) 43.0 43.0 43.0 Alarm Low Limit (TB) 23.0 23.0 23.0 Injective Temperature Source Auto Temperature Unit qC Interval 30 Constant 0.542
Patient Monitor User Manual Default Settings - 199 - C.13 AGAG Settings ADU PED NEO Alarm Switch On Alarm Record Off Alarm Level Medium Work Mode Measure Apnea Time 20s Unit % O2 Compensate OFF Anes Agent HAL Alarm High Limit (EtAA) 8.0 8.0 8.0 Alarm Low Limit (EtAA) 0.0 0.0 0.0 Alarm High Limit (FiAA) 6.0 6.0 6.0 Alarm Low Limit (FiAA) 0.0 0.0 0.0 Alarm High Limit (EtN2O) 55 55 55 Alarm Low Limit (EtN2O) 0 0 0 Alarm High Limit (FiN2O) 53 53 53 Alarm Low Limit (FiN2O) 0 0 0 Alarm High Limit (EtO2) 90.0 90.0 90.0 Alarm Low Limit (EtO2) 18.0 18.0 18.0 Alarm High Limit (FiO2) 88.0 88.0 88.0 Alarm Low Limit (FiO2) 18.0 18.0 18.0 Sweep 12.5mm/s Amplitude 2
Patient Monitor User Manual Abbreviation - 200 - D Abbreviations Abbr English Full Name/Description AC Alternating current Adu Adult AG Anaesthesia gas Art Arterial aVF Left foot augmented lead aVL Left arm augmented lead aVR Right arm augmented lead awRR Airway respiration rate BP Blood pressure BTPS Body temperature and pressure, saturated CI Cardiac index C.O. Cardiac output CISPR International Special Committee on Radio Interference CMS Central monitoring system CO2 Carbon dioxide COHb Carboxyhemoglobin CVP Central venous pressure DC Direct current Des Desflurane Dia Diastolic ECG Electrocardiogram EEC European Economic Community EMC Electromagnetic compatibility EMI Electromagnetic interference Enf Enflurane ESU Electrosurgical unit Et End-tidal EtCO2 End-tidal carbon dioxide EtN2O End-tidal nitrous oxide
Patient Monitor User Manual Abbreviation - 201 - Eto Ethylene oxide EtO2 End-tidal oxygen FDA Food and Drug Administration Fi Fraction of inspired FiCO2 Fraction of inspired carbon dioxide FiN2O Fraction of inspired nitrous oxide FiO2 Fraction of inspired oxygen Hal Halothane Hb Hemoglobin Hb-CO Carbon mono-xide hemoglobin HR Heart rate IBP Invasive blood pressure ICP Intracranial pressure ICU Intensive care unit ID Identification IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronic Engineers Iso Isoflurane LA Left arm LAP Left atrial pressure LCD Liquid crystal display LED Light emitting diode LL Left leg MAP Mean arterial pressure MDD Medical Device Directive MetHb Methemoglobin MRI Magnetic resonance imaging N/A Not applied N2 Nitrogen N2O Nitrous oxide Neo Neonate NIBP Non-invasive blood pressure
Patient Monitor User Manual Abbreviation - 202 - O2 Oxygen oxyCRG Oxygen cardio-respirogram PA Pulmonary artery PAWP Pulmonary artery wedge pressure Ped Pediatric Pleth Plethysmogram PR Pulse rate PVC Premature ventricular complex R Right RA Right arm RAP Right atrial pressure Resp Respiration RHb Reduced hemoglobin RL Right leg RR Respiration Rate Sev Sevoflurane SYS Systolic pressure TB Blood Temperature TD Temperature difference TEMP Temperature USB Universal serial bus

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