iM50 iM60 iM70 and iM80 Patient Monitor User Manual Ver 1.2

Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.

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Table of Contents Chapter 1 Intended Use and Safety Guidance ...1 1.1 Intended Use...1 1.2 Safety Guidance ...2 1.3 Explanation of Symbols on the Monitor ...4 Chapter 2 Installation ...8 2.1 Initial Inspection...8 2.2 Mounting the Monitor ...8 2.2.1 Installing Wall Mount for the Monitor...8 2.3 Connecting the Power Cable...8 2.4 Checking Out the Monitor ...8 2.5 Checking the Recorder...9 2.6 Setting the Date and Time ...9 2.7 Handing Over the Monitor ...9 Chapter 3 Basic Operation...10 3.1 Overview ...10 3.1.1 Front View...10 3.1.2 Rear View...13 3.1.3 Side View ...17 3.1.4 Configuration ...19 3.2 Operating and Navigating ...19 3.2.1 Using Keys ...21 3.3 Operating Mode ...22 3.3.1 Demo Mode...22 3.3.2 Standby Mode ...23 3.3.3 Night Mode ...23 3.4 Changing Monitor Settings ...23 3.4.1 Adjusting Screen Brightness ...23 3.4.2 Changing Date and Time...24 3.5 Adjusting Volume...24 III

3.5.1 Adjusting Key Volume ...24 3.5.2 Adjusting Alarm Volume ...24 3.5.3 Adjusting Beat Volume...24 3.6 Checking Your Monitor Version ...24 3.7 Networked Monitoring...24 3.8 Setting Languages ...25 3.9 Understanding Screens...25 3.10 Calibrating Screens ...25 3.11 Disabling the Touch Screen...25 3.12 Using the Barcode Scanner ...26 3.13 Resolving IBP Label Conflicts...26 Chapter 4 Alarms ...27 4.1 Alarm Category ...27 4.1.1 Physiological alarms ...27 4.1.2 Technical Alarms...27 4.1.3 Prompts ...27 4.2 Alarm Levels ...27 4.3 Controlling Alarm ...28 4.3.1 Setting Parameter Alarm ...28 4.3.2 Temporary Alarm Mute...29 4.3.3 Alarm Mute ...29 4.3.4 Controlling Alarm Volume ...30 4.4 Latching Alarms ...30 4.5 Disabling Sensor Off Alarms ...30 4.6 Testing Alarms...30 Chapter 5 Alarm Information...31 5.1 Physiological Alarm Information...31 5.2 Technical Alarm Information ...36 5.3 Prompts ...48 5.4 Adjustable Range of Alarm Limits...50 IV

Chapter 6 Managing Patients ...55 6.1 Admitting a Patient...55 6.1.1 Patient Category and Paced Status ...55 6.2 Quick Admit ...56 6.3 Editing Patient Information...56 6.4 Updating a Patient ...56 6.5 Central Monitoring System ...56 Chapter 7 User Interface ...58 7.1 Setting Interface Style ...58 7.2 Selecting Display Parameters...58 7.3 Changing Waveform Position ...58 7.4 Changing Interface Layout...58 7.5 Viewing Trend Screen ...58 7.6 Viewing Oxygen Screen...59 7.7 Viewing Large Font Screen...59 7.8 Viewing the Bed View Window ...60 7.8.1 Opening the Bed View Window...60 7.8.2 Settings of the Bed View Window ...60 7.9 Changing Parameter and Waveform Colors...60 7.10 User Configuration...60 7.11 Default Configuration ...61 Chapter 8 Monitoring ECG ...62 8.1 Overview ...62 8.2 ECG Safety Information ...62 8.3 ECG Display ...63 8.3.1 Changing the Size of the ECG Wave ...63 8.3.2 Changing the ECG Filter Settings...64 8.4 Using ECG Alarms...64 8.5 Selecting Calculation Lead ...64 8.6 Monitoring Procedure ...65 V

8.6.1 Preparation ...65 8.6.2 Connecting ECG Cables ...65 8.7 Selecting Lead Type ...65 8.8 Installing Electrodes...65 8.8.1 Electrode Placement for 3-lead ...66 8.8.2 Electrode Placement for 5-lead ...67 8.8.3 Electrode Placement for 12-lead ...68 8.8.4 Recommended ECG Lead Placement for Surgical Patients...69 8.9 ECG Menu Setup ...70 8.9.1 Setting Alarm Source ...70 8.9.2 Smart Lead Off...70 8.9.3 Setting Beat Volume...70 8.9.4 ECG Display ...71 8.9.5 Setting Pace Status ...71 8.9.6 ECG Calibration...71 8.9.7 ECG Waveform Settings ...71 8.9.8 12 Leads ECG ...72 8.10 ST Segment Monitoring...72 8.10.1 Setting ST Analysis ...72 8.10.2 ST Display...72 8.10.3 ST Analysis Alarm Setting ...72 8.10.4 About ST Measurement Points...73 8.10.5 Adjusting ST and ISO Measurement Points...73 8.11 Arr. Monitoring...73 8.11.1 Arrhythmia Analysis...73 8.11.2 ARR Analysis Menu...75 8.12 12-Lead ECG Monitoring ...76 8.12.1 Diagnosis Function...76 8.12.2 Measurement and Interpretation ...77 Chapter 9 Monitoring RESP...78 VI

9.1 Overview ...78 9.2 RESP Safety Information ...78 9.3 Resp Display ...79 9.4 Electrode Placement for Monitoring Resp...79 9.5 Cardiac Overlay ...79 9.6 Chest Expansion...79 9.7 Abdominal Breathing ...80 9.8 Selecting Resp Lead...80 9.9 Changing Hold Type ...80 9.10 Changing the Size of the Respiration Wave...80 9.11 Using Resp Alarms...80 9.12 Changing the Apnea Time...80 Chapter 10 Monitoring SpO2 ...81 10.1 Overview ...81 10.2 SpO2 Safety Information ...81 10.3 Measuring SpO2 ...82 10.4 Measurement Procedure...82 10.5 Understanding SpO2 Alarms ...83 10.6 Adjusting Alarm Limits...83 10.7 Setting SpO2 as Pulse Source...83 10.8 Setting Pitch Tone ...83 10.9 Setting Sensitivity ...84 Chapter 11 Monitoring PR ...85 11.1 Overview ...85 11.2 Setting PR Source...85 11.3 Setting PR Volume ...85 11.4 Using Pulse Alarms ...85 11.5 Selecting the Active Alarm Source...85 Chapter 12 Monitoring NIBP ...86 12.1 Overview ...86 VII

12.2 NIBP Safety Information ...86 12.3 Introducing the Oscillometric NIBP Measurement...87 12.4 Measurement Limitations...87 12.5 Measurement Methods ...88 12.6 Measurement Procedures ...88 12.7 Operation Prompts ...89 12.8 Correcting the Measurement if Limb is not at Heart Level ...89 12.9 NIBP Alarm...90 12.10 Resetting NIBP...90 12.11 Calibrating NIBP...90 12.12 Leak Test ...90 12.12.1 Procedure of Leak Test...90 Chapter 13 Monitoring TEMP...92 13.1 Overview ...92 13.2 TEMP Safety Information ...92 13.3 TEMP Monitoring Setup ...92 13.4 Calculating Temp Difference ...92 Chapter 14 Monitoring Quick TEMP* ...93 14.1 Overview ...93 14.2 Quick TEMP Safety Information ...93 14.3 Measuring Procedure ...94 14.3.1 Measurement for Oral Temperature ...94 14.3.2 Measurements for Rectal Temperatures...95 14.3.3 Measurements for Axillary Temperatures ...95 14.4 Changing Temp Unit ...96 Chapter 15 Monitoring IBP ...97 15.1 Overview ...97 15.2 IBP Safety Information ...97 15.3 Monitoring Procedures...97 15.4 Selecting a Pressure for Monitoring...98 VIII

15.5 Zeroing the Pressure Transducer...98 15.6 Zeroing a Pressure Measurement ...99 15.7 Troubleshooting the Pressure Zeroing (Taking Art for Example)...99 15.8 IBP Pressure Calibration ...99 15.9 Troubleshooting the Pressure Calibration ...100 15.10 IBP Alarm...101 Chapter 16 Monitoring CO2 ...102 16.1 Overview ...102 16.2 CO2 Safety Information...102 16.3 Monitoring Procedures...103 16.3.1 Zeroing the sensor ...103 16.3.2 Sidestream CO2 Module...103 16.3.3 Mainstream CO2 Module ...105 16.4 Setting CO2 Waveform Setup...107 16.5 Setting CO2 Corrections...107 16.6 Changing CO2 Alarms...108 16.7 Changing the Apnea Alarm Delay...108 Chapter 17 Monitoring C.O. ...109 17.1 Overview ...109 17.2 C.O. Safety Information...109 17.3 C.O. Monitoring Procedures ...109 17.4 C.O. Measurement Window... 110 17.5 Measurement Process...112 17.6 Editing C.O. ... 113 17.7 Blood Temperature Monitoring... 113 17.8 Setting the Computation Constant ... 114 17.9 Recording C.O. Measurements ... 114 17.10 Setting INJ. TEMP Source ... 114 Chapter 18 Monitoring AG ... 115 18.1 Overview ... 115 IX

18.2 Safety Information ... 115 18.2.1 Safety Information for ISA Analyzer ...115 18.2.2 Safety Information for IRMA Module ...117 18.3 Monitoring Steps... 118 18.3.1 Monitoring Steps for ISA Analyzer...118 18.3.2 Monitoring Steps for IRMA Module...120 18.4 Setting Work Mode ...123 18.5 Setting Alarms...124 18.6 Setting Apnea Alarm Time ...124 18.7 Working Status of ISA analyzer ...124 18.8 Working Status of IRMA Module ...124 18.9 N2O and O2 Compensations ...125 18.10 Effects of humidity...125 Chapter 19 Freeze ...126 19.1 Overview ...126 19.2 Entering/Exiting Freeze Status...126 19.2.1 Entering Freeze Status...126 19.2.2 Exiting Freeze Status...126 19.3 Reviewing Frozen Waveform...127 Chapter 20 Review ...128 20.1 Trend Graph Review ...128 20.1.1 Selecting Trend Graph of Specific Parameter...128 20.1.2 Adjusting Trend Scale ...128 20.1.3 Setting Resolution ...129 20.1.4 Scrolling Left and Right the Screen ...129 20.1.5 Switching to the Trend Table ...129 20.1.6 Record ...129 20.2 Trend Table Review ...129 20.2.1 Setting Resolution ...129 20.2.2 Scrolling the Screen ...129 X

20.2.3 Switching to Trend Graph ...130 20.2.4 Recording ...130 20.3 NIBP Review...130 20.3.1 Scrolling the Screen ...130 20.3.2 Recording ...130 20.4 Alarm Review...130 20.4.1 Scrolling the Screen ...130 20.4.2 Selecting Alarm Event of Specific Parameter...131 20.4.3 Setting Time Index ...131 20.5 Arr Review ...131 20.5.1 Scrolling the Screen ...131 20.6 12-lead Diagnosis Review...132 20.6.1 Scrolling the Screen ...132 20.6.2 Deleting Diagnosis Results ...132 20.6.3 Switching Between Waveforms and Results...132 20.6.4 Recording ...132 Chapter 21 Calculation and Titration Table...133 21.1 Drug Calculation ...133 21.1.1 Calculation Procedures...133 21.1.2 Calculation Unit ...134 21.2 Titration Table ...134 21.3 Hemodynamic Calculation...135 21.3.1 Calculation Procedure ...135 21.3.2 Input Parameters...135 21.3.3 Output Parameters...135 Chapter 22 Recording...137 22.1 General Information ...137 22.2 Performance of the Recorder ...137 22.3 Recording Type ...138 22.4 Starting and Stopping Recording ...138 XI

22.5 Recorder Operations and Status Messages ...139 22.5.1 Record Paper Requirement ...139 22.5.2 Proper Operation ...139 22.5.3 Paper Out...140 22.5.4 Replacing Paper ...140 22.5.5 Removing Paper Jam...141 Chapter 23 Other Functions...142 23.1 Nurse Call...142 23.2 Analog Output and Defibrillator Synchronization ...142 23.3 Storing Data in a Removable Device ...142 23.3.1 Data Stored in the Removable Device ...142 23.3.2 Activating/ Deactivating Data Storing ...143 23.3.3 Selecting a Removable Device...143 23.3.4 Reviewing Data Stored in a Removable Device ...143 23.3.5 Deleting Data Stored in a Removable Device...143 23.3.6 Ejecting a Removable Device ...144 Chapter 24 Using Battery ...145 24.1 Battery Power Indicator ...145 24.2 Battery Status on the Main Screen ...145 24.3 Checking Battery Performance ...145 24.4 Replacing the Battery...146 24.5 Recycling the Battery...147 24.6 Maintaining the Battery...147 Chapter 25 Care and Cleaning ...148 25.1 General Points ...148 25.2 Cleaning ...148 25.2.1 Cleaning the Monitor ...148 25.2.2 Cleaning the Accessories...149 25.3 Disinfection ...150 Chapter 26 Maintenance ...151 XII

26.1 Inspecting ...151 26.2 Maintenance Task and Test Schedule...151 Chapter 27 Warranty and Service...153 27.1 Warranty ...153 27.2 Contact information ...153 Chapter 28 Accessories ...154 28.1 ECG Accessories...154 28.2 SpO2 Accessories ...156 28.3 NIBP Accessories...157 28.4 Temp Accessories...159 28.5 Quick Temp Accessories* ...159 28.6 IBP Accessories...159 28.7 CO2 Accessories ...160 28.8 C.O. Accessories* ...161 28.9 AG Accessories* ...161 28.10 Other Accessories...162 A Product Specification ...164 A.1 Classification...164 A.2 Physical Specifications...164 A.2.1 Size and Weight...164 A.2.2 Environment Specification...164 A.2.3 Display ...165 A.2.4 Battery Specification ...166 A.2.5 Recorder ...166 A.2.6 Data Storage ...167 A.3 ECG...167 A.4 RESP ...172 A.5 NIBP...173 A.6 SpO2 ...175 A.7 TEMP ...176 XIII

A.8 Quick TEMP ...176 A.9 IBP...176 A.10 CO2 ...177 A.11 C.O. ...180 A.12 AG ...181 A.12.1 Phasein Sidestream...181 A.12.2 Phasein Mainstream ...183 B EMC Information...187 B.1 Electromagnetic Emissions - for all EQUIPMENT and SYSTEMS...187 B.2 Electromagnetic Immunity - for all EQUIPMENT and SYSTEMS ...187 B.3 Electromagnetic Immunity - for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING...189 B.4 Recommended Separation Distances ...190 C Default Settings...192 C.1 Patient Information Default Settings ...192 C.2 Alarm Default Settings ...192 C.3 ECG Default Settings ...192 C.4 RESP...194 C.5 SpO2 ...194 C.6 PR ...194 C.7 NIBP ...195 C.8 TEMP ...195 C.9 Quick TEMP...196 C.10 IBP...196 C.11 CO2 ...197 C.12 C.O...197 C.13 AG...198 D Abbreviations...199

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Patient Monitor User Manual

Intended Use and Safety Guidance

Chapter 1 Intended Use and Safety Guidance 1.1 Intended Use The iM50 patient monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2) and quick temperature (Quick TEMP). This monitor is suitable for use in intra-hospital transport and hospital environments including clinic, emergency department, wards, PACU and NICU. The iM60 patient monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2) and cardiac output (C.O.). This monitor is suitable for use in hospital environments including OR, ICU, NICU, PACU and wards. The iM70 patient monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.) and anesthetic gas (AG). This monitor is suitable for use in hospital environments including OR, ICU, NICU, PACU and wards. The iM80 patient monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.) and anesthetic gas (AG). This monitor is suitable for use in hospital environments including OR, ICU, NICU, PACU and wards. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.

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Patient Monitor User Manual

Intended Use and Safety Guidance

1.2 Safety Guidance WARNING 1 Before using the device, the equipment, patient cable and electrodes etc. should be checked. Replacement should be taken if there is any evident defect or signs of aging which may impair the safety or performance. 2 Medical technical equipment such as these monitor/monitoring system must only be used by persons who have received adequate training in the use of such equipment and who are capable of applying it properly. 3 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur. 4 SHOCK HAZARD-The power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet. 5 Extreme care must be exercised when applying medical electrical equipment. Many parts of the human/machine circuit are conductive, such as the patient, connectors, electrodes, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device. Such contact would bridge the patient's isolation and cancel the protection provided by the isolated input. In particular, there must be no contact of the neutral electrode and ground. 6 Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. 7 Route all cables away from patient’s throat to avoid possible strangulation. 8 Devices connecting with monitor should be equipotential. 9 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the standard IEC/EN 60601-1-1. Therefore anybody, who connects additional equipment to the signal input or output connector to configure a medical system, must make sure that it complies with the requirements of the valid version of the system standard IEC/EN60601-1-1. If in doubt, consult our technical service department or your local distributor. 10 Only patient cable and other accessories supplied by EDAN can be used. Or else, the performance and electric shock protection cannot be guaranteed, and the patient may be injured.

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Patient Monitor User Manual

Intended Use and Safety Guidance

WARNING 11 Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. 12 When interfacing with other equipment, a test for leakage current must be performed by qualified biomedical engineering personnel before using with patients. 13 During monitoring, if the power supply is off and there is no battery for standby, the monitor will be off, and only the patient information and alarm settings can be saved. After reconnecting the power supply, the user should turn on the monitor for monitoring. 14 Keep away from fire immediately when leakage or foul odor is detected. 15 The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product. 16 Dispose of the package material, observing the waste control regulations and keeping it out of children’s reach. 17 After defibrillation, the screen display recovers within 10 seconds if the correct electrodes are used and applied based on the manufacturers’ instructions. 18 This equipment is not intended for family usage.

CAUTION 1 Electromagnetic Interference - Ensure that the environment in which the patient monitor is installed is not subject to any sources of strong electromagnetic interference, such as radio transmitters, mobile telephones, etc. 2 Keep the environment clean. Avoid vibration. Keep it far away from corrosive medicine, dust area, high temperature and humid environment. 3 Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid pouring fluids directly on the transducer. 4 Do not use autoclave or gas to sterilize the monitor, recorder or any accessories. 5 The device and reusable accessories could be sent back to the manufacturer for recycling or proper disposal after their useful lives. 6 Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.

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Patient Monitor User Manual

Intended Use and Safety Guidance

CAUTION 7 Remove a battery whose life cycle has expired from the monitor immediately. 8 Avoid liquid splash on the device. The temperature must be kept between 5°C and 40°C while working. And it should be kept between -20°C and 55°C during transportation and storage. 9 To ensure patient safety, use only parts and accessories manufactured or recommended by EDAN. 10 Federal (U.S.) law restricts this device to sale by or on the order of a physician.

NOTE: 1 Position the device in a location where the operator can easily see the screen and access the operating controls. 2 The monitor can only be used on one patient at a time. 3 If the monitor gets damp or liquid pours on the monitor, please contact the service personnel of EDAN. 4 This monitor is not a device for treatment purposes. 5 The pictures and interfaces in this manual are for reference only. 6 Regular preventive maintenance should be carried out every two years. You are responsible for any requirements specific to your country. 7 The monitor may not be compatible with all models of USB flash drives. Use the USB flash drives that are recommended by EDAN. 8 It is recommended to format the USB flash drive to the FAT file type via PC prior to use.

1.3 Explanation of Symbols on the Monitor This symbol indicates that the equipment is IEC/EN60601-1 Type CF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation. This symbol indicates that the instrument is IEC/EN 60601-1 Type BF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation. Symbol for “Caution”

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Patient Monitor User Manual

Intended Use and Safety Guidance

Equipotential grounding terminal

Alternating Current Power Supply switch

Serial number

Network port

USB (Universal Serial Bus) Connection

Audio alarm is off

NIBP measurement

Trend graph

Freeze

Record

Menu

VGA output, External Monitor

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Patient Monitor User Manual

Intended Use and Safety Guidance

RS-232 port

Nurse call port

SD Card port

Signal output port

Signal output

The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices.

Authorized representative in the European community

Date of manufacture

Manufacturer P/N

Part Number

Recycle The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Consult Instructions For Use

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