iPM-9800 Patient Monitor Operator’s Manual © Copyright 2009-2010 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is 2010-06. I Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. , and are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners. II Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel; the electrical installation of the relevant room complies with the applicable national and local requirements;and the product is used in accordance with the instructions for use. NOTE z This equipment must be operated by skilled/trained clinical professionals. WARNING z It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury. III Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to: Malfunction or damage caused by improper use or man-made failure. Malfunction or damage caused by unstable or out-of-range power input. Malfunction or damage caused by force majeure such as fire and earthquake. Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people. Malfunction of the instrument or part whose serial number is not legible enough. Others not caused by instrument or part itself. IV Company Contact Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. E-mail Address: [email protected] Tel: +86 755 26582479 26582888 Fax: +86 755 26582934 26582500 EC-Representative: Shanghai International Holding Corp. GmbH(Europe) Address: Eiffestraβe 80, Hamburg 20537, Germany Tel: 0049-40-2513175 Fax: 0049-40-255726 V Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed. Intended Audience This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients. Illustrations All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your patient monitor. Conventions Italic text is used in this manual to quote the referenced chapters or sections. [ ] is used to enclose screen texts. → is used to indicate operational procedures. VI Content 1 Safety ................................................................................................................................. 1-1 1.1 Safety Information .......................................................................................................... 1-1 1.1.1 Dangers .............................................................................................................. 1-2 1.1.2 Warnings............................................................................................................. 1-2 1.1.3 Cautions ............................................................................................................. 1-3 1.1.4 Notes .................................................................................................................. 1-3 1.2 Equipment Symbols ........................................................................................................ 1-4 2 The Basics ......................................................................................................................... 2-1 2.1 Monitor Description ........................................................................................................ 2-1 2.1.1 Intended Use....................................................................................................... 2-1 2.1.2 Contraindications ............................................................................................... 2-1 2.1.3 Components ....................................................................................................... 2-1 2.2 Main unit ......................................................................................................................... 2-2 2.2.1 Front View.......................................................................................................... 2-2 2.2.2 Side View ........................................................................................................... 2-4 2.2.3 Rear View........................................................................................................... 2-5 2.3 Display Screen ................................................................................................................ 2-6 2.4 QuickKeys....................................................................................................................... 2-8 3 Basic Operations .............................................................................................................. 3-1 3.1 Installation....................................................................................................................... 3-1 3.1.1 Unpacking and Checking ................................................................................... 3-2 3.1.2 Environmental Requirements............................................................................. 3-2 3.2 Getting Started ................................................................................................................ 3-3 3.2.1 Inspecting the Monitor ....................................................................................... 3-3 3.2.2 Switching On...................................................................................................... 3-3 3.2.3 Starting Monitoring ............................................................................................ 3-3 3.3 Disconnecting from Power.............................................................................................. 3-4 3.4 Operating and Navigating ............................................................................................... 3-4 3.4.1 Using the Knob .................................................................................................. 3-4 3.4.2 Using Keys ......................................................................................................... 3-5 3.4.3 Using the Touchscreen ....................................................................................... 3-5 3.4.4 Using the On-Screen Keyboard.......................................................................... 3-5 3.4.5 Using the Main Menu......................................................................................... 3-6 3.5 Operating Modes............................................................................................................. 3-7 3.6 Using an External Storage Device................................................................................... 3-8 3.7 Using an External Display .............................................................................................. 3-9 3.8 Changing General Measurement Settings ....................................................................... 3-9 1 3.8.1 Switching On/Off Modules ................................................................................ 3-9 3.8.2 Changing Measurement Settings...................................................................... 3-10 3.8.3 Changing Waveform Settings........................................................................... 3-10 3.9 Changing General Settings............................................................................................ 3-10 3.9.1 Setting up a Monitor..........................................................................................3-11 3.9.2 Changing Language ..........................................................................................3-11 3.9.3 Setting DIAP Baud Rate....................................................................................3-11 3.9.4 Adjusting the Screen Brightness .......................................................................3-11 3.9.5 Setting the Date and Time ................................................................................ 3-12 3.9.6 Adjusting Volume ............................................................................................. 3-13 4 Managing Patients............................................................................................................ 4-1 4.1 Admitting a Patient.......................................................................................................... 4-1 4.2 Editing Patient Information............................................................................................. 4-2 4.3 Discharging a Patient ...................................................................................................... 4-2 4.4 Switching between Wire and Wireless Networks............................................................ 4-3 4.5 Transferring Patient Data ................................................................................................ 4-3 4.6 Connecting to a Central Monitoring System................................................................... 4-5 5 Managing Configurations................................................................................................ 5-1 5.1 Introduction..................................................................................................................... 5-1 5.2 Entering and Exiting the Configuration Mode ................................................................ 5-2 5.3 Viewing and Changing Configurations ........................................................................... 5-3 5.4 Adding a Configuration................................................................................................... 5-4 5.5 Deleting a Configuration................................................................................................. 5-4 5.6 Loading a Configuration ................................................................................................. 5-5 5.7 Setting Default Configuration at Startup......................................................................... 5-5 5.8 Loading the Latest Configuration Automatically............................................................ 5-6 5.9 Transferring a Configuration........................................................................................... 5-7 6 User Screens...................................................................................................................... 6-1 6.1 Tailoring Your Screens .................................................................................................... 6-1 6.1.1 Setting the Waveform Sweep Mode ................................................................... 6-1 6.1.2 Changing the Wave Line Size ............................................................................ 6-1 6.1.3 Choosing the Way to Draw Waves ..................................................................... 6-1 6.1.4 Changing Parameter and Waveform Colors ....................................................... 6-2 6.1.5 Selecting Waveforms for Display....................................................................... 6-2 6.1.6 Changing Screen Layout .................................................................................... 6-2 6.2 Viewing Minitrends......................................................................................................... 6-3 6.2.1 Having a Split-Screen View of Minitrends ........................................................ 6-3 6.2.2 Changing Minitrend Length ............................................................................... 6-4 6.2.3 Changing a Parameter for Viewing .................................................................... 6-4 6.3 Viewing oxyCRG ............................................................................................................ 6-5 6.4 Viewing Other Patients.................................................................................................... 6-6 2 6.4.1 Care Group ......................................................................................................... 6-6 6.4.2 Viewing the Care Group Overview Bar ............................................................. 6-6 6.4.3 Understanding the View Other Patient Window ................................................ 6-7 6.5 Understanding the Big Numerics Screen ........................................................................ 6-8 7 Alarms ............................................................................................................................... 7-1 7.1 Alarm Categories............................................................................................................. 7-1 7.2 Alarm Levels ................................................................................................................... 7-2 7.3 Alarm Indicators.............................................................................................................. 7-2 7.3.1 Alarm Lamp ....................................................................................................... 7-3 7.3.2 Alarm Message................................................................................................... 7-3 7.3.3 Flashing Numeric ............................................................................................... 7-3 7.3.4 Audible Alarm Tones.......................................................................................... 7-3 7.3.5 Reminder Tones.................................................................................................. 7-4 7.4 Understanding Alarm Statuses ........................................................................................ 7-4 7.4.1 Pausing Alarms................................................................................................... 7-4 7.4.2 Switching Off Alarms......................................................................................... 7-5 7.4.3 Silencing the Alarm Sound................................................................................. 7-5 7.4.4 Switching off Alarm Sound................................................................................ 7-6 7.5 Alarm Configuration ....................................................................................................... 7-6 7.5.1 Alarm Tone Configuration.................................................................................. 7-6 7.5.2 Displaying Alarm Limits.................................................................................... 7-7 7.5.3 Setting Alarm Delay Time.................................................................................. 7-7 7.5.4 Using Alarms...................................................................................................... 7-7 7.5.5 Mass Alarm Setup .............................................................................................. 7-9 7.5.6 Adjusting Alarm Limits Automatically .............................................................. 7-9 7.6 Latching Alarms .............................................................................................................. 7-9 7.7 Clearing Technical Alarms ............................................................................................ 7-10 7.8 Testing Alarms .............................................................................................................. 7-10 7.9 When an Alarm Occurs ................................................................................................. 7-10 7.10 Using Care Group Alarms ............................................................................................7-11 7.10.1 Care Group Auto Alarms.................................................................................7-11 7.10.2 Viewing Alarm Information ............................................................................7-11 7.10.3 Silencing Care Group Alarms ........................................................................ 7-12 8 Monitoring ECG .............................................................................................................. 8-1 8.1 Introduction..................................................................................................................... 8-1 8.2 Safety .............................................................................................................................. 8-1 8.3 Preparing to Monitor ECG .............................................................................................. 8-2 8.3.1 Preparing the Patient and Placing the Electrodes ............................................... 8-2 8.3.2 Choosing a Lead Set and AHA or IEC Lead Placement .................................... 8-2 8.3.3 ECG Lead Placements........................................................................................ 8-3 8.3.4 Switching ECG Lead Set.................................................................................... 8-5 8.3.5 Checking Paced Status ....................................................................................... 8-6 3 8.4 Understanding the ECG Display ..................................................................................... 8-7 8.5 Changing ECG Settings .................................................................................................. 8-8 8.5.1 Setting Pacemaker Rate (For Mortara Only)...................................................... 8-8 8.5.2 Choosing the Alarm Source................................................................................ 8-8 8.5.3 Choosing a 5-Lead ECG Display Screen ........................................................... 8-8 8.5.4 Changing the ECG Filter Settings...................................................................... 8-9 8.5.5 Switching the Notch Filter On or Off................................................................. 8-9 8.5.6 Switching Defibrillator Synchronization On/Off ............................................. 8-10 8.5.7 Selecting ECG Waves for Display ....................................................................8-11 8.5.8 Changing ECG Wave Settings ..........................................................................8-11 8.5.9 Choosing an ECG Lead for HR Computing and Arrh. Monitoring...................8-11 8.5.10 Adjusting QRS Volume .................................................................................. 8-12 8.6 About ST Monitoring .................................................................................................... 8-12 8.6.1 Switching ST On and Off................................................................................. 8-12 8.6.2 Changing ST Filter Settings ............................................................................. 8-13 8.6.3 Understanding the ST Display ......................................................................... 8-13 8.6.4 Changing the ST Unit....................................................................................... 8-13 8.6.5 Changing the ST Alarm Limits ........................................................................ 8-13 8.6.6 Setting ST Alarm Delay Time .......................................................................... 8-14 8.6.7 Adjusting ST Measurement Points ................................................................... 8-14 8.7 About Arrhythmia Monitoring ...................................................................................... 8-15 8.7.1 Understanding the Arrhythmia Events ............................................................. 8-16 8.7.2 Switching Arrhythmia Analysis On and Off .................................................... 8-18 8.7.3 Changing Arrhythmia Alarm Settings .............................................................. 8-18 8.7.4 Changing Arrhythmia Threshold Settings (For Mortara Only) ........................ 8-18 8.7.5 Initiating Arrhythmia Relearning Manually ..................................................... 8-19 8.7.6 Automatic Arrhythmia Relearn ........................................................................ 8-20 8.7.7 Reviewing Arrhythmia Events ......................................................................... 8-20 8.8 12-Lead ECG Monitoring ............................................................................................. 8-21 8.8.1 Entering the 12-lead ECG Monitoring Screen ................................................. 8-21 8.8.2 Interpretation of resting 12-Lead ECG............................................................. 8-22 8.8.3 Reviewing Interpretation of resting 12-Lead ECG Results.............................. 8-23 9 Monitoring Respiration (Resp) ....................................................................................... 9-1 9.1 Introduction..................................................................................................................... 9-1 9.2 Safety .............................................................................................................................. 9-1 9.3 Placing Resp Electrodes.................................................................................................. 9-1 9.3.1 Optimizing Lead Placement for Resp ................................................................ 9-2 9.3.2 Cardiac Overlay ................................................................................................. 9-2 9.3.3 Abdominal Breathing ......................................................................................... 9-2 9.3.4 Lateral Chest Expansion..................................................................................... 9-3 9.4 Understanding the Resp Display ..................................................................................... 9-3 9.5 Changing Resp Settings .................................................................................................. 9-3 9.5.1 Choosing the Respiration Lead .......................................................................... 9-3 4 9.5.2 Setting the Apnea Alarm Delay .......................................................................... 9-3 9.5.3 Changing Resp Detection Mode ........................................................................ 9-4 9.5.4 Changing the Size of the Resp Wave ................................................................. 9-5 10 Monitoring PR.............................................................................................................. 10-1 10.1 Introduction................................................................................................................. 10-1 10.2 Changing PR Settings ................................................................................................. 10-1 10.2.1 Setting the PR Source..................................................................................... 10-1 10.2.2 Selecting the Active Alarm Source................................................................. 10-2 10.2.3 Adjusting QRS Volume .................................................................................. 10-2 11 Monitoring SpO2 ...........................................................................................................11-1 11.1 Introduction ..................................................................................................................11-1 11.2 Safety............................................................................................................................11-2 11.3 Identifying SpO2 Modules............................................................................................11-2 11.4 Applying the Sensor .....................................................................................................11-2 11.5 Changing SpO2 Settings ...............................................................................................11-3 11.5.1 Adjusting the Desat Alarm Limit.....................................................................11-3 11.5.2 Setting SpO2 Sensitivity ..................................................................................11-3 11.5.3 Changing Averaging Time...............................................................................11-3 11.5.4 Monitoring SpO2 and NIBP Simultaneously...................................................11-4 11.5.5 Sat-Seconds Alarm Management ....................................................................11-4 11.5.6 Pitch Tone........................................................................................................11-5 11.6 Measurement Limitations.............................................................................................11-6 11.7 Masimo Information.....................................................................................................11-6 11.8 Nellcor Information......................................................................................................11-7 12 Monitoring NIBP.......................................................................................................... 12-1 12.1 Introduction................................................................................................................. 12-1 12.2 Safety .......................................................................................................................... 12-2 12.3 Measurement Limitations............................................................................................ 12-2 12.4 Setting Up the NIBP Measurement ............................................................................. 12-3 12.4.1 Preparing to Measure NIBP ........................................................................... 12-3 12.4.2 Starting and Stopping Measurements............................................................. 12-3 12.4.3 Correcting the Measurement if Limb is not at Heart Level............................ 12-3 12.5 Measurement Methods ................................................................................................ 12-4 12.5.1 Enabling NIBP Auto Cycling and Setting the Interval................................... 12-4 12.5.2 Starting a STAT Measurement........................................................................ 12-4 12.6 Understanding the NIBP Numerics ............................................................................. 12-5 12.7 Changing NIBP Settings ............................................................................................. 12-6 12.7.1 Choosing NIBP Alarm Source ....................................................................... 12-6 12.7.2 Displaying NIBP Measurements .................................................................... 12-6 12.7.3 Setting the Pressure Unit ................................................................................ 12-6 12.7.4 Setting the cuff inflation pressure .................................................................. 12-7 5 12.8 Assisting Venous Puncture .......................................................................................... 12-7 12.9 Resetting NIBP ........................................................................................................... 12-7 12.10 NIBP Leakage Test.................................................................................................... 12-7 12.11 NIBP Accuracy Test .................................................................................................. 12-8 12.12 Calibrating NIBP....................................................................................................... 12-9 13 Monitoring Temp.......................................................................................................... 13-1 13.1 Introduction................................................................................................................. 13-1 13.2 Safety .......................................................................................................................... 13-1 13.3 Making a Temp Measurement..................................................................................... 13-1 13.4 Understanding the Temp Display ................................................................................ 13-2 13.5 Setting the Temperature Unit ...................................................................................... 13-2 14 Monitoring IBP ............................................................................................................ 14-1 14.1 Introduction................................................................................................................. 14-1 14.2 Safety .......................................................................................................................... 14-1 14.3 Setting Up the Pressure Measurement ........................................................................ 14-1 14.4 Understanding the IBP Display................................................................................... 14-3 14.5 Changing IBP Settings ................................................................................................ 14-4 14.5.1 Changing a Pressure for Monitoring .............................................................. 14-4 14.5.2 Choosing the Pressure Alarm Source ............................................................. 14-4 14.5.3 Changing Averaging Time.............................................................................. 14-5 14.5.4 Setting the Pressure Unit ................................................................................ 14-5 14.5.5 Setting Wave Overlapping.............................................................................. 14-5 14.5.6 Setting Up the IBP Wave................................................................................ 14-5 14.6 Measuring PAWP ........................................................................................................ 14-6 14.6.1 Preparing to Measure PAWP .......................................................................... 14-6 14.6.2 Setting Up the PAWP Measurement............................................................... 14-8 14.7 Zeroing the Transducer ............................................................................................... 14-9 15 Monitoring Cardiac Output ........................................................................................ 15-1 15.1 Introduction................................................................................................................. 15-1 15.2 Understanding the C.O. Display ................................................................................. 15-1 15.3 Influencing Factors...................................................................................................... 15-2 15.4 Setting Up the C.O. Measurement .............................................................................. 15-2 15.5 Measuring the Blood Temperature .............................................................................. 15-5 15.6 Changing C.O. Settings............................................................................................... 15-6 15.6.1 Setting the Temperature Unit ......................................................................... 15-6 15.6.2 Setting the Interval between Measurements................................................... 15-6 16 Monitoring Carbon Dioxide ........................................................................................ 16-1 16.1 Introduction................................................................................................................. 16-1 16.2 Preparing to Measure CO2 .......................................................................................... 16-2 16.2.1 Using a Sidestream CO2 Module ................................................................... 16-2 6 16.2.2 Using a Microstream CO2 module ................................................................. 16-3 16.2.3 Using a Mainstream CO2 module................................................................... 16-4 16.3 Changing CO2 Settings ............................................................................................... 16-5 16.3.1 Entering the Standby Mode............................................................................ 16-5 16.3.2 Setting the Pressure Unit ................................................................................ 16-5 16.3.3 Setting up Gas Compensations....................................................................... 16-5 16.3.4 Setting up Humidity Compensation ............................................................... 16-6 16.3.5 Setting the Apnea Alarm Delay ...................................................................... 16-7 16.3.6 Choosing a Time Interval for Peak-Picking ................................................... 16-7 16.3.7 Setting the Flow Rate ..................................................................................... 16-7 16.3.8 Setting up the CO2 Wave................................................................................ 16-7 16.4 Setting Barometric Pressure Compensation ................................................................ 16-8 16.5 Measurement Limitations............................................................................................ 16-8 16.6 Troubleshooting the Sidestream CO2 Sampling System ............................................. 16-8 16.7 Removing Exhaust Gases from the System ................................................................ 16-9 16.8 Zeroing the Sensor ...................................................................................................... 16-9 16.8.1 For Sidestream and Microstream CO2 Modules............................................. 16-9 16.8.2 For Mainstream CO2 Modules ....................................................................... 16-9 16.9 Calibrating the Sensor ............................................................................................... 16-10 16.10 Oridion Information ................................................................................................ 16-10 17 Monitoring AG ............................................................................................................. 17-1 17.1 Introduction................................................................................................................. 17-1 17.2 Preparing to Measure AG............................................................................................ 17-2 17.3 Understanding the AG Display ................................................................................... 17-4 17.4 MAC Values ................................................................................................................ 17-5 17.5 Changing AG Settings................................................................................................. 17-6 17.5.1 Selecting an Anesthetic Gas for Monitoring .................................................. 17-6 17.5.2 Setting Gas Unit ............................................................................................. 17-6 17.5.3 Setting the Apnea Alarm Delay ...................................................................... 17-6 17.5.4 Changing the Sample Flow Rate.................................................................... 17-6 17.5.5 Setting up the O2 Compensation .................................................................... 17-6 17.5.6 Entering the Standby Mode............................................................................ 17-7 17.5.7 Setting up the AG Wave ................................................................................. 17-7 17.6 Changing the Anesthetic Agent ................................................................................... 17-7 17.7 Measurement Limitations............................................................................................ 17-8 17.8 Troubleshooting .......................................................................................................... 17-8 17.8.1 When the Gas Inlet is Blocked ....................................................................... 17-8 17.8.2 When an Internal Occlusion Occurs............................................................... 17-8 17.9 Removing Exhaust Gases from the System ................................................................ 17-9 18 Freezing Waveforms .................................................................................................... 18-1 18.1 Freezing Waveforms ................................................................................................... 18-1 18.2 Viewing Frozen Waveforms ........................................................................................ 18-1 7 18.3 Unfreezing Waveforms................................................................................................ 18-2 18.4 Recording Frozen Waveforms..................................................................................... 18-2 19 Review ........................................................................................................................... 19-1 19.1 Accessing Respective Review Windows..................................................................... 19-1 19.2 Reviewing Graphic Trends.......................................................................................... 19-2 19.3 Reviewing Tabular Trends .......................................................................................... 19-4 19.4 Reviewing NIBP Measurements ................................................................................. 19-6 19.5 Reviewing Alarms....................................................................................................... 19-7 19.6 Reviewing Waveforms ................................................................................................ 19-8 20 Calculations .................................................................................................................. 20-1 20.1 Introduction................................................................................................................. 20-1 20.2 Dose Calculations........................................................................................................ 20-2 20.2.1 Performing Calculations................................................................................. 20-2 20.2.2 Selecting the Proper Drug Unit ...................................................................... 20-2 20.2.3 Titration Table ................................................................................................ 20-3 20.3 Oxygenation Calculations ........................................................................................... 20-3 20.3.1 Performing Calculations................................................................................. 20-3 20.3.2 Entered Parameters......................................................................................... 20-4 20.3.3 Calculated Parameters .................................................................................... 20-4 20.4 Ventilation Calculations .............................................................................................. 20-5 20.4.1 Performing Calculations................................................................................. 20-5 20.4.2 Entered Parameters......................................................................................... 20-5 20.4.3 Calculated Parameters .................................................................................... 20-6 20.5 Hemodynamic Calculations ........................................................................................ 20-6 20.5.1 Performing Calculations................................................................................. 20-6 20.5.2 Entered Parameters......................................................................................... 20-7 20.5.3 Calculated Parameters .................................................................................... 20-7 20.6 Renal Calculations ...................................................................................................... 20-8 20.6.1 Performing Calculations................................................................................. 20-8 20.6.2 Entered Parameters......................................................................................... 20-8 20.6.3 Calculated Parameters .................................................................................... 20-9 20.7 Understanding the Review Window............................................................................ 20-9 21 Recording...................................................................................................................... 21-1 21.1 Using a Recorder......................................................................................................... 21-1 21.2 Overview of Recording Types..................................................................................... 21-2 21.3 Starting and Stopping Recordings............................................................................... 21-3 21.4 Setting up the Recorder............................................................................................... 21-3 21.4.1 Accessing the Record Setup Menu................................................................. 21-3 21.4.2 Selecting Waveforms for Recording .............................................................. 21-3 21.4.3 Setting the Realtime Recording Length ......................................................... 21-4 21.4.4 Setting the Interval between Timed Recordings............................................. 21-4 8 21.4.5 Changing the Recording Speed ...................................................................... 21-4 21.4.6 Switching Gridlines On or Off ....................................................................... 21-4 21.4.7 Clearing Recording Tasks .............................................................................. 21-4 21.5 Loading Paper ............................................................................................................. 21-4 21.6 Removing Paper Jam................................................................................................... 21-5 21.7 Cleaning the Recorder Printhead................................................................................. 21-6 22 Printing ......................................................................................................................... 22-1 22.1 Printer.......................................................................................................................... 22-1 22.2 Connecting a Printer.................................................................................................... 22-1 22.3 Setting Up the Printer.................................................................................................. 22-1 22.4 Starting Report Printouts............................................................................................. 22-2 22.5 Stopping Report Printouts ........................................................................................... 22-3 22.6 Setting Up Reports ...................................................................................................... 22-3 22.6.1 Setting Up ECG Reports ................................................................................ 22-3 22.6.2 Setting Up Tabular Trends Reports ................................................................ 22-3 22.6.3 Setting Up Graphic Trends Reports ............................................................... 22-4 22.6.4 Setting Up Realtime Reports.......................................................................... 22-4 22.7 End Case Reports ........................................................................................................ 22-4 22.8 Printer Statuses............................................................................................................ 22-5 22.8.1 Printer Out of Paper ....................................................................................... 22-5 22.8.2 Printer Status Message ................................................................................... 22-5 23 Other Functions............................................................................................................ 23-1 23.1 Marking Events ........................................................................................................... 23-1 23.2 Analog Output ............................................................................................................. 23-1 23.3 Transferring Data ........................................................................................................ 23-2 23.3.1 Data Export System........................................................................................ 23-2 23.3.2 Transferring Data by Different Means ........................................................... 23-2 23.4 Nurse Call ................................................................................................................... 23-3 23.5 Wireless Network ........................................................................................................ 23-5 24 Batteries ........................................................................................................................ 24-1 24.1 Overview..................................................................................................................... 24-1 24.2 Installing or Replacing a Battery................................................................................. 24-2 24.3 Battery Guidelines....................................................................................................... 24-3 24.4 Battery Maintenance ................................................................................................... 24-4 24.5 Battery Recycling........................................................................................................ 24-5 25 Care and Cleaning........................................................................................................ 25-1 25.1 Introduction................................................................................................................. 25-1 25.2 Cleaning ...................................................................................................................... 25-2 25.3 Disinfecting................................................................................................................. 25-2 9 26 Maintenance ................................................................................................................. 26-1 26.1 Safety Checks.............................................................................................................. 26-1 26.2 Service Tasks............................................................................................................... 26-2 26.3 Checking Monitor and Module Information ............................................................... 26-2 26.4 Calibrating ECG.......................................................................................................... 26-3 26.5 Calibrating the Touchscreen........................................................................................ 26-3 26.6 Calibrating CO2 .......................................................................................................... 26-4 26.7 Calibrating AG ............................................................................................................ 26-5 26.8 Setting up IP Address .................................................................................................. 26-6 26.9 Entering/Exiting Demo Mode ..................................................................................... 26-6 27 Accessories .................................................................................................................... 27-1 27.1 ECG Accessories......................................................................................................... 27-1 27.2 SpO2 Accessories........................................................................................................ 27-3 27.3 NIBP Accessories........................................................................................................ 27-5 27.4 Temp Accessories........................................................................................................ 27-6 27.5 IBP/ICP Accessories ................................................................................................... 27-6 27.6 C.O. Accessories ......................................................................................................... 27-8 27.7 CO2 Accessories .......................................................................................................... 27-8 27.8 AG Accessories ..........................................................................................................27-11 27.9 Others ........................................................................................................................ 27-12 10 1 Safety 1.1 Safety Information DANGER z Indicates an imminent hazard that, if not avoided, will result in death or serious injury. WARNING z Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury. CAUTION z Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage. NOTE z Provides application tips or other useful information to ensure that you get the most from your product. 1-1 1.1.1 Dangers There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective sections of this manual. 1.1.2 Warnings WARNINGS z Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition. z The equipment must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor, disconnect it from the power line and operate it on battery power, if possible. z To avoid explosion hazard, do not use the equipment in the presence of flammable anesthetics, vapors or liquids. z Do not open the equipment housings. All servicing and future upgrades must be carried out by the personnel trained and authorized by Mindray only. z Do not come into contact with patients during defibrillation. Otherwise serious injury or death could result. z Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off may result in a hazard to the patient. Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring. z The physiological data and alarm messages displayed on the equipment are for reference only and cannot be directly used for diagnostic interpretation. z To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement or strangulation by patients or personnel. z Dispose of the package material, observing the applicable waste control regulations and keeping it out of children’s reach. Keep the battery out of children’s reach. 1-2 1.1.3 Cautions CAUTIONS z To ensure patient safety, use only parts and accessories specified in this manual. z At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact us. z Electromagnetic field is capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. z Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or in this manual. z Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force. 1.1.4 Notes NOTES z Put the equipment in a location where you can easily see the screen and access the operating controls. z Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when needed. z The software was developed in compliance with IEC60601-1-4. The possibility of hazards arising from software errors is minimized. z This manual describes all features and options. Your equipment may not have all of them. 1-3 1.2 Equipment Symbols Some symbols may not appear on your equipment. Attention: Consult accompanying documents (this manual). Power ON/OFF (for a part of the equipment) Battery indicator Alternating current (AC) Alarm silenced. Alarms paused Record Freeze/unfreeze waveforms Main menu NIBP start/stop key Video output Equipotential grounding Network Connector USB Connector Auxiliary output connector Signal input/output Gas outlet Serial number Manufacture date European community representative ESD warning symbol for electrostatic sensitive devices. Type CF applied part. Defibrillator-proof protection against electric shock. Type BF applied part. Defibrillator-proof protection against electric shock. The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive. The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased it. * For system products, this label may be attached to the main unit only. 1-4 2 The Basics 2.1 Monitor Description 2.1.1 Intended Use This patient monitor is intended to be used for monitoring, displaying, reviewing, storing and transferring of multiple physiological parameters including ECG, respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), End tidal CO2 value (EtCO2) and anesthetic gas (AG) of single adult, pediatric and neonatal patients. This monitor is to be used in healthcare facilities by clinical professionals or under their direction. It is not intended for helicopter transport or home use. WARNING z This patient monitor is intended for use only by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on it. 2.1.2 Contraindications None 2.1.3 Components This patient monitor consists of a main unit, display, ECG cables, SpO2 sensor, NIBP cuff, Temp sensor, IBP cables, C.O. cables, CO2 components, AG components, etc. 2-1 2.2 Main unit 2.2.1 Front View 1. Alarm lamp When a physiological or technical alarm occurs, this lamp will flash as defined below. High level alarms: the lamp flashes quickly in red. Medium level alarms: the lamp flashes slowly in yellow. Low level alarms: the lamp lights yellow without flashing. 2. Handle 3. Display Screen 2-2 4. Power On/Off Switch Press this switch to turn the patient monitor on. Press it again and hold for 2 seconds to turn the patient monitor off. An indicator is built in this switch. It turns on when the patient monitor is on and turns off when the patient monitor is off. 5. 6. Battery LED On: when the battery is being charged or already fully charged. Off: when no battery is installed or no AC source is connected. Flashes: when the patient monitor operates on battery power. AC power LED It turns on when AC power is connected. 7. Press to silence or restore all alarm sounds or clear alarms. 8. Press to pause or restore alarms. 9. Press to freeze or unfreeze waveforms. 10. Press to start or stop recordings. 11. Press to start or stop NIBP measurements. 12. If no menu is displayed on the screen, pressing it will enter the main menu. If there is a menu displayed on the screen, pressing it will close that menu. 13. Knob Rotate the Knob clockwise or anti-clockwise. With each click, the highlight jumps to the neighboring item. When you reach your desired item, press the Knob to select it. 2-3 2.2.2 Side View 5 6 1 2 7 3 8 4 9 1. SpO2 connector 2. ECG connector 3. IBP connector (four channels) 4. C.O. connector 5. NIBP connector 6. Temp connector (double channels) 7. Exhaust gas outlet of CO2 module or AG module 8. Watertrap connector (sidestream CO2 module or AG module) This connector is also optional for microstream or mainstream CO2 module. 9. 10 3 Battery door 10. CF storage card slot cover 11. Recorder 2-4 11 2.2.3 Rear View 1 2 3 4 5 6 7 1. Network Connector It is a standard RJ45 connector, through which the patient monitor can be networked. 2. Video Connector It connects a standard VGA color monitor, which extends the display capability of your monitor. The contents displayed on the secondary display screen accord with those displayed on the monitor screen. 3. Auxiliary Output It is a standard BNC connector, through which analog signals, alarm signals or synchronization signals can be outputted, depending on how your monitor is configured. 4. RS232 serial port It is a DB9 connector, used to connect a PC for data or a compatible device, and supports DIAP communication protocol. 5. USB Connectors They connect external storage devices. 6. AC Power Input 7. Equipotential Grounding Terminal When the patient monitor and other devices are to be used together, their equipotential grounding terminals should be connected together, eliminating the potential difference between them. 2-5 2.3 Display Screen This patient monitor adopts a high-resolution TFT LCD to display patient parameters and waveforms. A typical display screen is shown below. 1 2 3 4 5 6 7 8 1. 9 Patient Information Area This area shows the patient information such as department, bed number, patient name, patient category and paced status. : indicates that no patient is admitted or the patient information is incomplete. : indicates that the patient has a pacer. If no patient is admitted, selecting this area will enter the [Patient Setup] menu. If a patient has been admitted, selecting this area will enter the [Patient Demographics] menu. 2. Date and Time This area shows the system time of the patient monitor. By selecting this area, you can enter the [System Time] setup menu. 3.Alarm Symbols indicates alarms are paused. indicates alarms are turned off. indicates alarm sounds are silenced. indicates alarm sounds are turned off. 2-6 4. Technical Alarm Area This area shows technical alarm messages and prompt messages. When multiple messages come, they will be displayed circularly. Select this area and the technical alarm list will be displayed. 5. Physiological Alarm Area This area shows physiological alarm messages. When multiple alarms occur, they will be displayed circularly. Select this area and the physiological alarm list will be displayed. 6. Waveform Area This area shows measurement waveforms. The waveform name is displayed at the upper left corner of the waveform. Select this area and the corresponding waveform setup menu will be displayed. 7. Parameter Area This area shows measurement parameters. Each monitored parameter has a parameter window and the parameter name is displayed at the upper left corner. When this area cannot accommodate all parameters, the excess parameters will automatically occupy the waveform area from bottom to top. Select this area and the corresponding measurement setup menu will be displayed. 8. Prompt Message Area This area shows the prompt messages, network status icons, battery status icons, etc. For details about battery status symbols, refer to the chapter Batteries. indicates the patient monitor is connected to a wired network successfully. indicates the wireless function is working. indicates the patient monitor has failed to connect a wired network. indicates the wireless function is not working. indicates a CF storage card is inserted. indicates an USB storage card is inserted. 9. QuickKeys Area This area contains QuickKeys that give you fast access to functions. 2-7 2.4 QuickKeys A QuickKey is a configurable graphical key, located at the bottom of the main screen. They give you fast access to functions. Their availability and the order in which they appear on your screen, depend on how your patient monitor is configured. By default, there are two QuickKeys that remain on the screen all the time to give you fast access to functions. Review tabular trends Return to the main screen Besides, you can have four more QuickKeys as shown below. By selecting or , you can unfold or fold the four QuickKeys. When there is no operation on the four QuickKeys for 15 seconds after they are unfolded, they will be folded automatically. Besides, you can set the four QuickKeys in configuration mode: 1. Enter the configuration mode. Select [Others] in either configuration. 2. In the [Select QuickKeys] area, select your desired QuickKeys 1-4. 3. Save the configuration. The following QuickKeys can be selected: Enter standby mode Alarm Limits Setup Change screen Start Auto NIBP measurement Zero IBP Perform calculations Mark Event Discharge a Patient 2-8 3 Basic Operations 3.1 Installation WARNING z The equipment shall be installed by personnel authorized by Mindray. z The software copyright of the equipment is solely owned by Mindray. No organization or individual shall resort to juggling, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission. z Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. Any personnel who connect devices to the equipment’s signal input/output port is responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1-1.If you have any question, please contact us. z If it is not evident from the equipment specifications whether a particular combination is hazardous, for example, due to summation of leakage currents, consult the manufacturers or else an expert in the field, to ensure the necessary safety of all devices concerned will not be impaired by the proposed combination. z Combinations of medical equipment with non-medical equipment must comply with IEC 60601-1-1. Never use a multiple portable socket-outlet or extension cord when combining equipment unless the socket outlet is supplied specifically for use with that equipment. 3-1 3.1.1 Unpacking and Checking Before unpacking, examine the packing case carefully for signs of damage. If any damage is detected, contact the carrier or us. If the packing case is intact, open the package and remove the equipment and accessories carefully. Check all materials against the packing list and check for any mechanical damage. Contact us in case of any problem. NOTE z Save the packing case and packaging material as they can be used if the equipment must be reshipped. WARNING z When disposing of the packaging material, be sure to observe the applicable waste control regulations and keep it out of children’s reach. z The equipment might be contaminated during storage and transport. Before use, please verify whether the packages are intact, especially the packages of single use accessories. In case of any damage, do not apply it to patients. 3.1.2 Environmental Requirements The operating environment of the equipment must meet the requirements specified in this manual. The environment where the equipment is used shall be reasonably free from noises, vibration, dust, corrosive, flammable and explosive substances. If the equipment is installed in a cabinet, sufficient space in front and behind shall be left for convenient operation, maintenance and repair. Moreover, to maintain good ventilation, the equipment shall be at least 2 inches (5cm) away from around the cabinet. When the equipment is moved from one place to another, condensation may occur as a result of temperature or humidity difference. In this case, never start the system before the condensation disappears. WARNING z Make sure that the operating environment of the equipment meets the specific requirements. Otherwise unexpected consequences, e.g. damage to the equipment, could result. 3-2 3.2 Getting Started 3.2.1 Inspecting the Monitor WARNING z Do not use the patient monitor for any monitoring procedure on a patient if you suspect it is not working properly, or if it is mechanically damaged. Contact your service personnel or us. 1. Before you start to make measurements, check the patient monitor for any mechanical damage and make sure that all external cables, plug-ins and accessories are properly connected. 2. Plug the power cord into the AC power source. If you run the patient monitor on battery power, ensure that the battery is sufficiently charged. 3. Check all functions you need to monitor your patient, and ensure that the monitor is in good working order. 3.2.2 Switching On After the inspection is finished, you can switch on the monitor: 1. Press the power on/off switch on the monitor’s front. The monitor performs a self test. The system gives a beep, and at the same time, the alarm lamp turns yellow and then red. The start-up screen is displayed. 2. The monitor enters the main screen. 3.2.3 Starting Monitoring 1. Check that the patient cables and sensors are correctly connected. 2. Check that the patient settings such as [Patient Cat.], [Paced], etc, are appropriate for your patient. 3. Refer to corresponding measurement sections for details of how to perform the measurements you want to make. 3-3 3.3 Disconnecting from Power To disconnect the patient monitor from the AC power source, follow this procedure: 1. Disconnect the patient cables and sensors from the patient. 2. Press and hold the power on/off switch for above 2 seconds. The patient monitor shuts down and you can unplug the power cable. CAUTION z Although not recommended, you can press and hold the power on/off switch for 4 seconds to forcibly shut down the monitor when it could not be shut down normally or under some special situations. This may cause loss of data of the patient monitor. 3.4 Operating and Navigating 3.4.1 Using the Knob Rotate the Knob clockwise or counter-clockwise. With each click, the highlight jumps to the neighboring item. When you reach your desired item, press the Knob to select it. When you rotate the knob, a cursor moves across the screen, following the direction of the knob. You can position the cursor by rotating the knob so as to perform the desired operation. 3-4 3.4.2 Using Keys The monitor has three types of keys: Softkey: A softkey is a graphic key on the screen, giving you fast access to certain menus or functions. The monitor has three types of softkeys: Waveform keys: Each waveform area can be seen as a softkey. You can enter a waveform setup menu by selecting its corresponding waveform area. Parameter keys: Each parameter area can be seen as a softkey. You can enter a parameter setup menu by selecting its corresponding parameter area. QuickKeys: QuickKeys are configurable graphical keys, located at the bottom of the main screen. For details, refer to the section QuickKeys. Hardkeys: A hardkey is a physical key on a monitoring device, such as the main menu hardkey on the monitor’s front. Pop-Up Keys: Pop-up keys are task-related keys that appear automatically on the monitor screen when required. For example, the confirm pop-up key appears only when you need to confirm a change. 3.4.3 Using the Touchscreen Select screen items by pressing them directly on the patient monitor’s screen. You can enable or disable touchscreen operations by pressing and holding the [Home] QuickKey at the lower right corner of the screen for 3 seconds. A red padlock symbol displayed if touchscreen operations are disabled. 3.4.4 Using the On-Screen Keyboard The on-screen keyboard enables you to enter information. Use the [Back] key to delete the previously entered character. Use the [Caps] to toggle between uppercase and lowercase letters. Select [Enter] to confirm what you have entered and close the on-screen keyboard. 3-5 is 3.4.5 Using the Main Menu To enter the main menu, select the hardkey on the monitor’s front. Most of monitor operations and settings can be performed through the main menu. 1 2 3 4 Other menus are similar to the main menu and contain the following parts: 1. Heading: gives a sum-up for the current menu. 2. Main body: displays options, buttons, prompt messages, etc. The menu button with “>>’’ enlarges a secondary window to reveal more options or information. 3. Online help area: displays help information for the highlighted menu item. 4. Confirm button area: accommodates confirm buttons such as [Previous Menu], [Ok], [Exit], [Cancel], etc., which allows you to confirm menu operations. 3-6 3.5 Operating Modes Your monitor has four operating modes. Some are password protected. Monitoring Mode: This is the normal, every day working mode that you use for monitoring patients. You can change elements such as alarm limits, parameter units and so forth. When you discharge the patient, these elements return to their default values. Configuration Mode: Password protected, this mode is for clinical professionals in configuration tasks. For details, refer to the Managing Configuration section. Maintenance Mode: Password protected, this is for professional service personnel in the tasks of maintenance, repair, basic information setup and calibration. Demonstration Mode: Password protected, this is for demonstration purposes only. Standby Mode: Standby mode can be used when you want to temporarily interrupt monitoring. To enter standby mode, unfold the QuickKeys area to select the [Standby] QuickKey, or select [Standby] when you want to discharge a patient. The monitor enters the standby mode after discharging the current patient. Standby suspends patient monitoring. All waves and numerics disappear from the display but all settings and patient data information are retained. A standby screen is displayed. To exit the standby mode, click anywhere on the screen or press any key. You can select [Yes] or [No] from the popup dialog box. [Yes]: The monitor enters the monitoring mode after discharging the current patient or clearing the current patient’s data. [No]: The monitor enters the monitoring mode and continues monitoring the current patient. 3-7 3.6 Using an External Storage Device An external storage device is used to prevent data loss in case of a sudden power failure. The patient data such as trend data, waveform data, etc., will be automatically saved into the external storage device during patient monitoring. In case of a sudden power failure, the patient data can be retrieved from the external storage device after the patient monitor restarts. So far only CF storage card is supported. CF storage card can also be used to transfer patient data. USB storage card can be used to transfer monitor configuration. Please refer to the corresponding sections for details. To insert a CF storage card, open the compartment and then insert the card until the button flips out. To remove the CF storage card, follow this procedure: 1. In the main menu, select [Unload CF Storage Card]. 2. Select [Ok] from the popup menu to unload the CF storage card. A status message shown in the prompt message area will report completion of the unloading. 3. Press the button until the CF storage card flips out. To browse the data saved in the CF storage card, follow this procedure: 1. In the main menu, select [Archives >>]. If the [Archives Access] is set as [Direct], you can directly enter into the [Patient Data] menu. If the [Archives Access] is set as [Password], you need a password to enter into the [Patient Data] menu. This password is the same as the one for entering the configuration mode. 2. Select [History Data >>]. Select a patient whose data you want to view from the [Patient Data List] and then select [Review]. 3. In the [Review] menu, select the data you want to review. The monitor allows only the history data saved in the CF storage card to be reviewed so far. As reviewing the history patient’s data is just like reviewing the current patient’s data, you can refer to the chapter Review for details. 3-8 NOTE z Data may be unable to be saved into the CF storage card shortly after the card is inserted. z If no CF storage card is used or the card has been removed, all the data saved will get lost in case that the monitor shuts down or a sudden power interrupt occurs. z Admitting too many patients will affect the read-write speed of the CF storage card. Please clear the patients’ data in time. CAUTION z Unload the CF storage card before removing it from the patient monitor. Otherwise it may cause damage to the data in the card. z Use only the CF storage card specified by Mindray. 3.7 Using an External Display An external display, showing the same screen as the host display, can be connected to the monitor through the video output connector, for viewing only. The recommended specification is as below. External display Screen type Medical-grade VGA monitor Resolution 800×600 pixels or above EMC MPR II, CISPR 11B Third certificate UL, C-UL, TUV, CE, FCC 3.8 Changing General Measurement Settings This chapter covers only general measurement settings in monitoring mode. Other specific measurement settings can be referred to in respective sections. 3.8.1 Switching On/Off Modules You can switch on or off measurement modules as required. In the main menu, select [Others>>]→ [Module Switch]. Select parameters for measuring, and then select [Exit] to save the settings. 3-9 3.8.2 Changing Measurement Settings Each measurement has a setup menu in which you can adjust all of its settings. You can enter a setup menu by selecting a certain measurement numeric. For example, by selecting the ECG numeric, you can access the [ECG Setup] menu. This menu displays numeric-related measurement settings, such as alarm limits, alarm switch and so forth. You can set each measurement as required. 3.8.3 Changing Waveform Settings Accessing the Waveform Setup Menu Each wave-related measurement has a waveform setup menu. You can enter a setup menu by selecting a certain measurement waveform. This menu displays wave-related measurement settings, such as gain, wave speed and so forth. You can set each measurement’s waveform as required. For example, by selecting the Art wave, you can adjust its wave speed, scale and so forth in the [Art Waveform] setup menu. Changing a Wave Speed In waveform setup menu for your desired measurement, select [Sweep] and then select the appropriate setting. Lowering the wave speed compresses the wave and lets you view a longer time period. Increasing the speed expands the waveform, giving you a more detailed view. 3.9 Changing General Settings General settings refer to the settings regarding how the monitor works, e.g. alarm volume, brightness and so forth. Most general settings can be carried out in configuration mode. This chapter covers some general settings that can be carried out in monitoring or maintenance mode. 3-10 3.9.1 Setting up a Monitor In situations where you install a patient monitor or change the patient monitor’s application site, you need to setup the patient monitor as follows: 1. In the main menu, select [Maintenance >>] → [User Maintenance >>] → enter the required password. 2. Select [Device Setup>>]. In the pop-up menu, select, in turn, [Monitor Name], [Institution Name], [Department] and [Bed No.], and then change their settings. 3.9.2 Changing Language 1. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password and then select [Device Setup >>]. 2. In the [Device Setup] menu, select [Language] and then select the desired language. 3. Restart the patient monitor. 3.9.3 Setting DIAP Baud Rate 1. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password and then select [Device Setup >>]. 2. Select [DIAP Baud Rate] and then select the desired baud rate. WARNING z When connecting compatible devices to the patient monitor via RS232 serial port, make sure the baud rate of the compatible devices is consistent with that of the patient monitor. Otherwise, the compatible devices can’t communicate with the patient monitor. 3.9.4 Adjusting the Screen Brightness 1. In the main menu, select [Others >>]. 2. Select [Brightness].Select the appropriate setting for the screen brightness. 10 is the brightest, and 1 is the least bright. If the patient monitor operates on battery power, you can set a less bright screen to prolong the operating time of the battery. 3-11 3.9.5 Setting the Date and Time 1. In the main menu, select [Maintenance >>] → [System Time>>]. 2. Set [Year], [Month], [Day], [Hour], [Minute] and [Second]. To set the date format and the time format, 1. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password and then select [Device Setup >>]. 2. Select [Date Format] and toggle between [yyyy-mm-dd], [mm-dd-yyyy] and [dd-mm-yyyy]. 3. Select [Time Format] and toggle between [24h] and [12h]. WARNING z When connecting compatible devices to the patient monitor via RS232 serial port, make sure that the baud rate of the compatible devices is consistent with that of the patient monitor. Otherwise, the compatible devices fail to communicate with the patient monitor properly. 3-12 3.9.6 Adjusting Volume Alarm Volume 1. In the main menu, select [Alarm Setup >>]. 2. Select the appropriate volume from [Alm Volume]: X-10, in which X is the minimum volume, depending on the set minimum alarm volume (refer to the chapter Alarm), and 10 the maximum volume. Key Volume 1. In the main menu, select [Others >>]. 2. Select [Key Volume] and then select the appropriate volume.0 means off, and 10 the maximum volume. QRS Volume The QRS tone is derived from either the HR or PR, depending on which is currently selected as the alarm source in the ECG setup menu.When monitoring SpO2, there is a variable pitch tone which changes as the patient’s saturation level changes. The pitch of the tone rises as the saturation level increases and falls as the saturation level decreases. The volume of this tone is user adjustable. Take PR as an example, to adjust QRS volume, 1. Select the PR parameter window. you can access the [PR Setup] menu. 2. Select [Beat Vol] and then select the appropriate volume. 0 means off, and 10 the maximum volume. 3-13 FOR YOUR NOTES 3-14 4 Managing Patients 4.1 Admitting a Patient The patient monitor displays physiological data and stores them in the trends as soon as a patient is connected. This allows you to monitor a patient that is not admitted yet. However, it is recommended that you fully admit a patient so that you can clearly identify your patient, on recordings, reports and networked devices. If the patient monitor already admits a patient, it is recommended to discharge this patient before admitting a new patient. Otherwise, the new patient’s data will be stored into that patient’s data. To admit a patient: 1. In the main menu, select [Patient Setup >>]. 2. Select [Admit Patient]. If there is a patient currently in your monitor, select [Ok] from the popup menu to discharge the current patient. Otherwise, select either: 3. 4. [Yes] to apply the data in your patient monitor to the new patient, or [No] to clear any previous patient data. In the [Patient Demographics] menu, enter the demographic details, of which: [Patient Cat.] determines the way your patient monitor processes and calculates some measurements, and what safety and alarm limits apply for your patient. [Paced] determines whether to show pace pulse marks on the ECG waveform. When the [Paced] is set to [No], pace pulse marks are not shown in the ECG waveform. Select [Ok]. 4-1 WARNING z [Patient Cat.] and [Paced] will always contain a value, regardless of whether the patient is fully admitted or not. If you do not specify settings for these fields, the patient monitor uses the default settings from the current configuration, which might not be correct for your patient. z For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the patient monitor could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak. z For non-paced patients, you must set [Paced] to [No].If it is incorrectly set to [Yes], the patient monitor may be unable to detect premature ventricular beats (including PVCs) and perform ST segment analysis. 4.2 Editing Patient Information To edit the patient information after a patient has been admitted, or when the patient information is incomplete, or when you want to change the patient information: 1. In the main menu, select [Patient Setup >>]. 2. Select [Patient Demographics] and then make the required changes. 3. Select [Ok]. 4.3 Discharging a Patient To discharge a patient: 1. In the main menu, select [Patient Setup >>]. 2. Select [Discharge Patient] or [Clear Patient Data]. In the popup menu, you can: 3. Directly select [Ok] to discharge the current patient, or Select [Standby] then [Ok]. The patient monitor enters the standby mode after discharging the current patient, or Select [Cancel] to exit without discharging the patient. If a printer is connected to your patient monitor, you can select [Print End Case Report] to print all contents that you are setting up to print as an End Case report before discharging the patient. After printing is completed, the patient monitor will automatically enter the standby mode or return to the main screen, depending on your previous setting. 4-2 NOTE z Discharging a patient clears all history data in the monitor. 4.4 Switching between Wire and Wireless Networks To switch between wire and wireless networks: 1. In the main menu, select [Maintenance >>]→ [User Maintenance >>]. 2. Enter the required password. 3. In the user maintenance menu, select [Network Setup] 4. In the network setup menu, select the [Network Type] drop-down box and then toggle between [Wire] and [Wireless]. NOTE z If the [Network Type] option is grey, it indicates your monitor is not configured with a wireless network card. You cannot switch to the wireless network. 4.5 Transferring Patient Data You can transfer patient data between monitors with a CF storage card without re-entering the patient demographic information. Transferring of patient data enables you to understand the patient’s history condition. The patient data that can be transferred includes: patient demographics, trend data, alarm events and parameters alarm limits. To transfer the current patient data from the source monitor to the CF storage card: 1. In the main menu, select [Patient Setup >>]. 2. Select [Transfer Patient Data]. Then select [Ok] in the popup menu to transfer patient data and unload the CF storage card. 3. Remove the card after the message [CF Storage Card Unloaded Successfully] displays. To transfer the patient data from the CF storage card to the receiving monitor: 1. Insert the card into the receiving monitor. 4-3 2. 3. In the popup [Transfer Patient Data] menu, you can: Select [Transfer Patient] to transfer the patient data to the monitor, or Select [Cancel Transfer] to cancel the operation of transferring patient data. Then the patient data to be transferred becomes archived patient data. The current patient data starts to be saved in the card. Select [Unload CF Storage Card] to not transfer the patient data and to unload the card. The current patient data will not be saved in the card. When you select [Transfer Patient], the monitor compares the patient information stored in both the CF storage card and the monitor and deals with the patient data based on the following. Different Patients: The monitor erases all the current patient data, transfers the patient data from the CF storage card, and loads the configuration according to the patient category. Same Patient: In the popup dialog box, you can: Select [Yes] to merge the patient data in the monitor and CF storage card. Select [No] to erase all the current patient data in the monitor and to transfer the patient data from the CF storage card. Please notice that only the patient data in the past specified number of hours can be transferred from the CF storage card. The number of hours is called [Transferred Data Length] and can be specified in the configuration mode. If the latest patient data stored on the card has a time stamp newer than the time displayed on the receiving monitor, data transfer will be prohibited. WARNING z After a patient is successfully transferred, check if the patient settings (especially patient category, paced status and alarm limits settings, etc.) on the monitor are appropriate for this patient. 4-4 4.6 Connecting to a Central Monitoring System If your patient monitor is connected to a central monitoring system (CMS): 1. All patient information, measurement data and settings on the patient monitor can be transferred to the CMS. 2. All patient information, measurement data and settings can be displayed simultaneously on the patient monitor and CMS. For some functions such as editing patient information, admitting a patient, discharging a patient, starting/stopping NIBP measurements, etc., bi-directional control can be achieved between your patient monitor and the CMS. For details, refer to the CMS’s instructions for use. 4-5 FOR YOUR NOTES 4-6 5 Managing Configurations 5.1 Introduction When performing continuous monitoring on a patient, the clinical professional often needs to adjust the monitor’s settings according to the patient’s condition. The collection of all these settings is called a configuration. Allowing you to configure the monitor more efficiently, the monitor offers different sets of configuration to suit different patient categories and departments. You can change some settings from a certain set of configuration and then save the changed configuration as a user configuration. The default configurations provided for your monitor are department-oriented. You can choose either from: General OR ICU NICU CCU Each department has three different sets of configurations tailored for adult, pediatric and neonatal patients. WARNING z The configuration management function is password protected. The configuration management tasks must be performed by clinical professionals. The system configuration items can be classified as: Global configuration items These items can affect all the monitor settings. Most global configuration items, such as monitor name, system time, etc., can be set in maintenance mode. The global configuration items that need to be set in configuration mode include default patient category, whether to load the selected configuration at startup, etc., which are usually displayed on the system configuration-main screen. Parameter configuration items These items relates to parameters, e.g., waveform gain, alarm switch, alarm limits.. 5-1 Conventional configuration items These items define how the monitor works, e.g., screen layout, record, print and alarm settings. For all the configuration items and their default values, see appendix Configuration Default Information. 5.2 Entering and Exiting the Configuration Mode To enter the configuration mode, 1. Press the 2. Select [Manage Configuration >>] → [Configuration >>]. Enter the required password and then select [Ok]. hardkey on the monitor’s front to enter the main menu. To exit the configuration mode, 1. Select [Exit] in the system configuration-main screen. 2. Then select [Ok] from the popup dialog box. The monitor will restart and the modified configuration will take effect afterwards. 5-2 5.3 Viewing and Changing Configurations In configuration mode, you can view, change and save all the configuration items for each department. 1. After entering the configuration mode, verify that the current department is the one you desire. 2. In the system configuration-main screen, select the desired configuration and then select [View Config.]. 3. As shown below, in the configuration category menu, you can view all the parameters and conventional configuration items. 4. Select to enter a certain configuration category, e.g. ECG, then you can view all the related configuration items by selecting [Prev Page] or [Next Page] and change them if necessary. 5. After the change is done, select [Save Config.] to save the changed configuration. If you have made some changes when viewing the default configuration of a certain department, you can specify a name in the popup name configuration window to save the changed configuration. If the current department configuration is not the one you want to view, you can select [Change Department >>] in the system configuration-main screen and then choose the one you want for viewing as shown below. After returning to the main screen, you can still view and change the configuration following the above steps. 5-3 NOTE z Changing the department will delete all the saved user configurations automatically. Please act with caution. 5.4 Adding a Configuration You can change monitor settings as required and then save the changed settings into a user configuration. You can specify a name for the saved user configuration. The monitor can save up to 3 sets of user configuration for the current department. 1. Select [Add Config.] in the system configuration-main screen. 2. In the load configuration menu, select a configuration as template. [Defaults]: factory default configurations for each department. user customized configuration: already saved user configuration [Latest Settings under Monitor Mode]: If you have changed some settings before entering the configuration mode, you can import these settings to your newly added user configuration by selecting [Latest Settings under Monitor Mode]. 3. Enter a name and then select [Ok]. 4. Change the settings if necessary and make sure that the settings are appropriate for your patient. 5. After the change is done, select [Save Config.] or [Main] and then [Ok]. 5.5 Deleting a Configuration You can delete an already saved user configuration. 1. Select [Delete Config.] in the system configuration-main screen. 5-4 2. In the select user configuration menu, select the user configurations you want to delete and then select [Ok]. 3. Select [Ok] in the popup dialog box. 5.6 Loading a Configuration You may make changes to some settings during operation. However, these changes or the pre-selected configuration may not be appropriate for the newly admitted patient. Therefore, the monitor allows you to load aother user configuration of the current department under monitoring mode so as to ensure that all the settings are appropriate for your patient. To load a configuration, 1. In monitoring mode, select [Manage Configuration >>] from the main menu. 2. Select the default configuration or a certain user configuration according to the patient’s condition. 3. Select [Ok]. NOTE z In monitoring mode, only the default configuration of the current department or the already saved user configuration can be loaded. You can only change the department in configuration mode. 5.7 Setting Default Configuration at Startup When the monitor restarts after quitting for over 120 seconds, it will load the pre-set default configuration to restore the system configuration. The default configuration can be the latest configuration, or a factory default configuration or user configuration. 5-5 To set the default configuration at startup, 1. Enter the configuration mode. 2. In the load configuration area, select a factory default configuration of the current department or a user configuration as the default configuration. 3. Select [Adu] or [Ped] or [Neo] from the [Patient Cat.] as the default patient category. 4. You can change the department by selecting [Change Department >>]. But this will delete all the saved user configurations. 5. Set the [Load Selected Config at Startup] option: Selected: When the monitor restarts after quitting for over 120 seconds, it will load the configuration you have selected in the load configuration area. Deselected: The monitor will load the latest configuration at startup no matter how long it has been quitted. NOTE z To find out which configuration has been loaded when the monitor starts, check the message (lasting for about 10 seconds) displayed at the bottom of the screen after the main screen comes out. 5.8 Loading the Latest Configuration Automatically During operation, you may make changes to some settings. These changes may not be saved as user configuration. To prevent the changes from loss in case of a sudden power failure, the monitor stores the configuration in real time. The stored configuration is the latest configuration. If [Load Selected Config. at Startup] is selected, the monitor will load the latest configuration if restarts within 60 seconds after the power failure. And it will load the default configuration rather than the latest configuration if restarts 120 seconds later after the power failure. The monitor may load either the latest configuration or the default configuration if restarts from 60 to 120 seconds after the power failure. If [Load Selected Config. at Startup] is not selected, the monitor will load the latest configuration at startup. 5-6 5.9 Transferring a Configuration When installing several monitors with identical user configuration it is not necessary to set each unit separately. An USB storage card may be used to transfer the configuration from monitor to monitor. To export the current monitor’s configuration: 1. Insert the USB storage card into the monitor’s USB port. 2. Select [Transfer Config.] in the system configuration-main screen. 3. Select [Export Config.>>] in the transfer config menu and then select [Ok] in the popup dialog box. A status message will report completion of the transfer. To import the configuration in the card to the monitor: 1. Insert the USB storage card into the monitor’s USB port. 2. Select [Transfer Config.] in the system configuration-main screen. 3. Select [Import Config.>>] in the transfer config menu and then select [Ok] in the popup dialog box. A status message will report completion of the transfer. 5-7 FOR YOUR NOTES 5-8 6 User Screens 6.1 Tailoring Your Screens You can tailor your patient monitor’s screens by setting: Waveform sweep mode Wave line size The way to draw waves The color in which each measurement’s numerics and waveform are displayed The waveforms to be displayed and their display order. Some settings can be changed manually in monitoring mode. For details about configuration mode, refer to the Managing Configuration chapter. 6.1.1 Setting the Waveform Sweep Mode 1. In the main menu, select [Others >>] or select [Waveform] in configuration mode. 2. Select [Sweep Mode] and toggle between [Refresh] and [Scroll]. [Refresh]: The waveforms keep stationary, being refreshed from left to right by a moving “erase bar”. [Scroll]: The waveforms move from the right to the left with time passing by. 6.1.2 Changing the Wave Line Size 1. Select [Waveform] in configuration mode. 2. Select [Wave Line] and toggle between [Thick], [Med] and [Thin]. 6.1.3 Choosing the Way to Draw Waves 1. Select [Waveform] in configuration mode. 2. Select [Draw Wave] and then toggle between [Color] and [Mono]: [Color]: The waveform is optimized by the system and appears smooth. [Mono]: The waveform is unsmoothed. 6-1 6.1.4 Changing Parameter and Waveform Colors 1. Select [Waveform] in configuration mode. 2. In the [Parameter/Wave Color] area, you can set color for each parameter and waveform. Selecting [Next Page] allows you to set color for more parameters and waveforms. 6.1.5 Selecting Waveforms for Display Your can select waveforms for display on the screen: 1. In the main menu, select [Others >>]→[Wave Setup >>]→[Select Waves >>]. 2. In the [Select Waves] menu, select the waveforms you want for display on the screen. 3. Select [Exit]. Your selections will take effect automatically. Additionally, you can change the order the waveforms are displayed on the screen if needed. 1. In the main menu, select [Others >>]→[Wave Setup >>]. 2. In the [Wave Sequence] menu, you can sequence the waveforms displayed on the screen. 3. Select [Exit]. Your change will take effect automatically. Select [Screens] in configuration mode, and you can also change the order in which all waveforms are displayed on the all parameters screen. 6.1.6 Changing Screen Layout 1. In the main menu, select [Screen Layout >>]. 2. Select a normal screen, such as all parameters screen, big numerics screen, etc. 3. You can also select a split-screen functional view if necessary, such as minitrends, others, etc. But the functional view is available only with the all parameters screen. You can select [Screens] in configuration mode and select your desired screen. Then, your selected screen will be displayed when the configuration is applied. 6-2 6.2 Viewing Minitrends 6.2.1 Having a Split-Screen View of Minitrends You can split the all parameters screen so that one part of the screen, on the left hand side, continuously shows graphic minitrends beside waveforms as shown in the figure below. To have a split-screen view of minitrends, you can: In the main menu, select [Screen Layout >>]→[Minitrends]→[Ok]. Minitrend view The split-screen view provides minitrends for multiple parameters. In each field, the label, scale and time are respectively displayed at the top, left, and bottom as shown below. 6-3 6.2.2 Changing Minitrend Length The minitrend length cannot be chosen for individual parameters. You can only change the minitrend length for all parameters: 1. Select either parameter’s minitrend field. 2. In the [Minitrend Setup] menu, select [Minitrend Length] and then select your desired setting. 3. Select [Exit]. Your change will take effect automatically. 6.2.3 Changing a Parameter for Viewing You can also select your desired parameters to view their minitrends. 1. Select either parameter’s minitrend field. 2. In the [Minitrend Setup] menu, you can select your desired parameter from the select parameter area. If you want to select other parameter, select [Other Parameters >>] and then select your desired parameters. 3. Select [Ok]. 6-4 6.3 Viewing oxyCRG To have a split screen view of oxyCRG, you can: In the main menu, select [Screen Layout >>]. Select [oxyCRG]→[Ok]. 1 2 3 4 The split-screen view covers the lower part of the waveform area and shows HR trend, SpO2 trend and RR trend (or Resp Wave). At the bottom, there are controls: 1. Trend length list box In the trend length list box, you can select [1 min], [2 min], [4 min], or [8 min]. 2 Resp Wave (or RR Trend) list box From this list box, you can select either [Resp Wave] or [RR Trend] for display. 3. Record Through this button, you can print out the currently displayed oxyCRG trends by the recorder. 4. Exit You can select it to exit the oxyCRG screen and return to the all parameters screen. 6-5 6.4 Viewing Other Patients 6.4.1 Care Group If your patient monitor is connected to a central monitoring system, you can select up to 8 bedside monitors into a Care Group. This lets you: View information on the monitor screen from another bed in the same Care Group. Be notified of physiological and technical alarm conditions at the other beds in the same Care Group. To have a Care Group: 1. Select [Screens] QuickKey or select [Screen Layout >>] in the main menu. Then, select [Others] and [Ok] from the popup menu. 2. In the [View Other Patient] window, select the care group setup button. 3. Select the desired bedside monitors from the [Connected Monitor List], and then select the [Exit] button. 6.4.2 Viewing the Care Group Overview Bar The Care Group overview bar locates at the bottom of the [View Other Patient] window. In the overview bar, the department and bed label for any Care Group beds are displayed. The color in which a Care Group bed appears matches its status: Red: indicates the bed is giving high-level physiological alarms. Yellow: indicates the bed is giving medium- or low-level physiological alarms, or medium-level technical alarms. Blue: indicates the bed is giving low-level technical alarms. Grey: indicates the bed fails to be networked (bright grey) or stays in the standby mode (dark grey). Black: indicates the bed is networked but gives no alarms. When multiple alarms occur to a Care Group bed, the Care Group bed appears in the color that matches the highest level alarm. You can view a Care Group bed’s alarms by selecting it from the care group, and as well you can select the [View This Patient] button to view this bed in the [View Other Patient] window. For more details about Care Group alarms, refer to the Alarms chapter. 6-6 6.4.3 Understanding the View Other Patient Window When you first open the [View Other Patient] window, the patient monitor automatically selects a monitor from the network to display in the [View Other Patient] window. 4 5 6 1 2 3 The view other patient window covers the lower part of the waveform area and consists of: 1. Information Area: shows the patient information (including department, bed number, patient name, etc.) and network status symbols. 2. View Area: shows physiological waveforms and parameters. You can switch a waveform area to a parameter area by selecting your desired waveform area and then selecting [Switch to Parameter Area], or switch a parameter area to a waveform area by selecting your desired parameter area and then selecting [Switch to Waveform Area]. 3. Care Group Overview Bar. 4. Message Area: shows physiological and technical messages from the currently viewed bed. By selecting this area, you can enter the [Alarm Information List] to view all physiological and technical messages coming from the currently viewed bed. 5. Alarm Silence Control Button: allows you to control the currently viewed bed to enter or exit the alarm silence status. For details, refer to the Alarms chapter. 6. Care Group Setup Button: allows you to enter the [Connected Monitor List] and select monitors into your Care Group. 6-7 Additionally, you can change a waveform or parameter for viewing. To change a waveform for viewing, select the waveform segment where you want a new waveform to appear and then select the waveform you want from the popup menu. To change a parameter for viewing, select the parameter window where you want a new parameter to appear and then select the parameter you want from the popup menu. 6.5 Understanding the Big Numerics Screen To enter the big numerics screen: 1. In the main menu, select [Screen Layout >>]. 2. Select [Big Numerics] and then [Ok]. You can select your desired parameters to display in this screen: select the [Para. Setup] QuickKey and then select the parameters you want. For parameters having a waveform, the waveform will also be displayed. 6-8 7 Alarms Alarms, triggered by a vital sign that appears abnormal or by technical problems of the patient monitor, are indicated to the user by visual and audible alarm indications. WARNING z A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area, e.g. an intensive care unit or cardiac operating room. z If your patient monitor is connected to a CMS, remote suspension, inhibition, silence and reset of monitor alarms via the CMS may cause a potential hazard. 7.1 Alarm Categories By nature, the patient monitor’s alarms can be classified into three categories: physiological alarms, technical alarms and prompt messages. 1. Physiological alarms Physiological alarms, also called patient status alarms, are triggered by a monitored parameter value that violates set alarm limits or an abnormal patient condition. Physiological alarm messages are displayed in the physiological alarm area. 2. Technical alarms Technical alarms, also called system status alarms, are triggered by a device malfunction or a patient data distortion due to improper operation or mechanical problems. Technical alarm messages are displayed in the technical alarm area. 3. Prompt messages As a matter of fact, prompt messages are not alarm messages. Apart from the physiological and technical alarm messages, the patient monitor will show some messages telling the system status. Messages of this kind are included into the prompt message category and usually displayed in the prompt information area. But for some measurements, their related prompt messages are displayed in their respective parameter windows. 7-1 7.2 Alarm Levels By severity, the patient monitor’s alarms can be classified into three categories: high level, medium level and low level. Physiological alarms Technical alarms High level Indicate that your patient is in a life threatening situation, such as Asystole, Vfib/Vtac and so forth, and an emergency treatment is demanded. Indicate a severe device malfunction or an improper operation, which could make it possible that the monitor cannot detect critical patient status and thus threaten the patient’s life, such as low battery and so forth. Medium level Indicate that your patient’s vital signs appear abnormal and an immediate treatment is required. Indicate a device malfunction or an improper operation, such as ECG/SpO2 lead off, which may not threaten the patient’s life but may compromise the monitoring of vital physiological parameters. Low level Indicate that you patient’s vital signs appear abnormal and an immediate treatment may be required. Indicate a device malfunction or an improper operation, which may compromise a certain monitoring function but will not threaten the patient’s life. The level for some alarms, such as Asystole, Vfib/Vtac, etc., is predefined before the patient monitor leaves the factory and cannot be changed. However, for most of the other physiological alarms, alarm settings are user adjustable, e.g. alarm limits. For some technical alarms, the alarm level is also user adjustable. 7.3 Alarm Indicators When an alarm occurs, the patient monitor will indicate it to the user through visual or audible alarm indications. Alarm lamp Alarm message Flashing numeric Audible alarm tones Reminder tones 7-2 7.3.1 Alarm Lamp If an alarm occurs, the alarm lamp will flash. The flashing color and frequency match the alarm level as follows: High level alarms: the lamp flashes quickly in red. Medium level alarms: the lamp flashes slowly in yellow. Low level alarms: the lamp turns yellow without flashing. 7.3.2 Alarm Message When an alarm occurs, an alarm message will appear in the technical or physiological alarm area. For physiological alarms, the asterisk symbols (*) before the alarm message match the alarm level as follows: High level alarms: *** Medium level alarms: ** Low level alarms: * Additionally, the alarm message uses different background color to match the alarm level: High level alarms: red Medium level alarms: yellow Low level physiological alarms: yellow Low level technical alarms: light blue You can view the alarm messages by selecting the physiological or technical alarm area. 7.3.3 Flashing Numeric If an alarm triggered by an alarm limit violation occurs, the numeric of the measurement in alarm will flash every second, and the corresponding alarm limit will also flash at the same frequency indicating the high or low alarm limit is violated. 7.3.4 Audible Alarm Tones The patient monitor uses different alarm tone patterns to match the alarm level: High level alarms: triple+double+triple+double beep. Medium level alarms: triple beep. Low level alarms: single beep. 7-3 NOTE z When multiple alarms of different levels occur simultaneously, the patient monitor will select the alarm of the highest level and give visual and audible alarm indications accordingly. 7.3.5 Reminder Tones When alarms are turned off or alarm tones are paused or turned off, the patient monitor will give a single beep as the reminder tone in case of an active alarm condition. You can set the reminder volume as [High], [Med] or [Low] in the [Alarm Setup] menu and set the reminder interval as [1 min], [2 min] or [3 min] in configuration mode. You can only switch on/off the reminder tone in configuration mode. 7.4 Understanding Alarm Statuses You can set your monitor to one of the following four alarm statuses. The alarm symbols match the alarm statuses as follows. Alarms paused Alarms off Alarm sound silenced Alarm sound off 7.4.1 Pausing Alarms If you want to temporarily prevent alarms from sounding, you can pause alarms by pressing the hardkey on the monitor’s front. No physiological alarm lamps flash and no alarms are sounded. No alarm messages are shown. No numeric and alarm limit flash. The remaining pause time is displayed in the physiological alarm area. For technical alarms, no alarms are sounded. The alarm lamps and alarm messages remain active. The alarms paused symbol is displayed in the alarm status symbol area. 7-4 When the alarm pause time expires, the alarm paused status is automatically cancelled and the alarm tone will sound. You can also cancel the alarm paused status by pressing the hardkey. You can set the alarm pause time as desired in configuration mode. The default alarm pause time is 2 minutes. 7.4.2 Switching Off Alarms If you have set the alarm pause time as permanent, the monitor will enter the alarm off status when you press the hardkey. Besides the characteristics of the alarm pause status, the alarm off status has the following characteristics. [Alarm Off] is displayed in the physiological alarm area. The alarm off symbol is displayed in the alarm status symbol area. You can cancel the alarm off status by pressing the hardkey. If a high level technical alarm, such as low battery, occurs, the alarm pause and alarm off statuses are all automatically cancelled. WARNING z Pausing or switching off alarms may result in a hazard to the patient. Please be very careful. 7.4.3 Silencing the Alarm Sound You can silence all alarm sounds temporarily by pressing the hardkey on the monitor’s front. In that case, the alarm lamps and alarm messages remain active and appears in the alarm status symbol area. If the monitor switches to other alarm status or a new alarm occurs, the alarm sound silenced status is automatically cancelled. You can also cancel the alarm sound silenced status by pressing the hardkey. 7-5 7.4.4 Switching off Alarm Sound In configuration mode, you can set the minimum alarm volume. The minimum alarm volume refers to the minimum value you can set for the alarm volume. When the alarm volume is set to 0, the monitor stays in alarm sound off status and a symbol appears on the screen. The alarm sound off status is cancelled and the alarm volume returns to the factory default value automatically when: The monitor shuts down and then restarts. The monitor changes to other alarm status, such as alarms paused status or alarms off status. The alarm volume restores the default value after the monitor reloads the configuration. WARNING z When the alarm sound is switched off, the patient monitor will give no audible alarm tones even if a new alarm occurs. Therefore the user should be very careful about whether to switch off the alarm sound or not. 7.5 Alarm Configuration 7.5.1 Alarm Tone Configuration Changing the Alarm Volume 1. In the main menu, select [Alarm Setup >>]. 2. Select the appropriate volume from [Alm Volume]: X-10, in which X is the minimum volume, depending on the set minimum alarm volume, and 10 the maximum volume. Setting the Alarm Tone Interval You can set the interval between alarm tones for high-level, medium-level and low-level alarms. For details, refer to the chapter Managing Configuration. WARNING z Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient. Always keep the patient under close surveillance. 7-6 7.5.2 Displaying Alarm Limits To have a better view of measurement numerics, you can choose not to display alarm limits in the parameter window by switching off displaying alarm limits in configuration mode. For details, refer to the chapter Managing Configuration. 7.5.3 Setting Alarm Delay Time You can set the alarm delay time for over-limit alarms of continuously measured parameters. If the alarm triggered condition disappears within the delay time, the patient monitor will not issue the alarm. You can select [Alarm Setup>>] from [Main Menu] and then set [Alarm Delay]. In the configuration mode, you can follow these steps to set [Alarm Delay] and [ST Alarm Delay] respectively. hardkey on the monitor’s front to enter the main menu. 1. Press the 2. Select [Manage Configuration >>] → [Configuration >>]. Enter the required password and then select [Ok]. 3. Select [View Config.]→ [Alarm] and set [Alarm Delay] and [ST Alarm Delay]. NOTE z The alarm delay time can not be set in case of the following physiological alarms: Resp Apnea (The apnea time needs to be set independently), ST Alarm (The delay time needs to be set independently), Arrh. Alarm, PVCs Too High, ECG Weak Signal, Resp Artifact, SpO2 Desat, No pulse, Nellcor SpO2 over-limit alarm, FiO2 Too Low, over-limit alarms of discontinuously measured parameters and MAC >3. 7.5.4 Using Alarms Switching Individual Measurement Alarms On/Off 1. Select the parameter window for your desired measurement to enter its setup menu. 2. Select [Alarm] and toggle between [On] and [Off]. [On]: The patient monitor gives alarm indications in accordance with the preset alarm level and stores the related waveforms and parameters. [Off]: The alarm off symbol “ ” is displayed in the measurement parameter window. 7-7 Setting the Alarm Level 1. Select the parameter window for your desired measurement to enter its setup menu. 2. Select [Alm Lev] and toggle between [High], [Med] and [Low]. You can also set alarm levels for all alarms together: 1. In the main menu, select [Alarm Setup >>]→[Alarm Levels Setup >>]. 2. You can view and set alarm levels for all the ongoing measurements in the popup menu. Adjusting Alarm Limits To adjust alarm limits for individual measurements, 1. Select the parameter window for your desired measurement to enter its setup menu. 2. In the setup menu, select the alarm limit you want to change and then select the appropriate setting. WARNING z Make sure that the alarm limits settings are appropriate for your patient before monitoring. z Setting alarm limits to extreme values may cause the alarm system to become ineffective. For example, High 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. Recording Alarms Automatically When a measurement alarm occurs, automatic recording of all the measurement numerics and related waveforms is possible when the measurement’s [Alarm] and [Alm Rec] are set on. To enable or disable automatic start of alarm recordings for individual measurements, you can select [Alm Rec] and toggle between [On] and [Off] in the setup menu for your desired measurement. Additionally, you can change the length of the recorded waveforms. In the [Alarm Setup] menu, select [Recording Length] and toggle between [8 s], [16 s] and [32 s]: [8 s]: 4 seconds respectively before and after the alarm trigger moment. [16 s]: 8 seconds respectively before and after the alarm trigger moment. [32 s]: 16 seconds respectively before and after the alarm trigger moment. 7-8 7.5.5 Mass Alarm Setup In the main menu, select [Alarm Setup >>]→[Mass Alarm Setup>>]. You can review and set alarm limits, alarm switches and alarm recordings for all parameters. 7.5.6 Adjusting Alarm Limits Automatically The monitor can automatically adjust alarm limits according to the measured vital signs, using the auto limits function. When auto limits are selected, the monitor calculates safe auto limits based on the latest measured values. To get accurate auto alarm limits, you need to collect a set of measured vital signs as a baseline. Then, in the main menu, select [Alarm Setup >>]→[Mass Alarm Setup>>]→[Auto Limits]. The monitor will create new alarm limits based on the measured values. Before applying these automatically created alarm limits, confirm if they are appropriate for your patient in the mass alarm setup menu. If not, you can adjust them manually. These alarm limits will remain unchanged until you select auto limits again or adjust them manually. 7.6 Latching Alarms The alarm latching setting for your patient monitor defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their alarm indications end when the alarm condition ends. If you switch alarm latching on, all visual and audible alarm indications last until you acknowledge the alarms, except that the measurement numeric and violated alarm limit stop flashing as soon as the alarm condition goes away. You can switch alarm latching on or off in configuration mode. For details, refer to the chapter Managing Configuration. You can clear the latched alarms by pressing the 7-9 hardkey. 7.7 Clearing Technical Alarms For some technical alarms, their alarm lamp flashing and alarm tones are cleared and the alarm messages change to prompt messages after the hardkey is pressed. After the patient monitor restores the normal alarm status, it can give alarm indications correctly in case these alarms are triggered again. For some technical alarms, all their alarm indications are cleared after the hardkey is pressed. After the patient monitor restores the normal alarm status, it can give alarm indications correctly in case these alarms are triggered again. For others, their alarm tones are cleared but the alarm lamp flashing and alarm messages remain after the hardkey is pressed. After the patient monitor restores the normal alarm status, all the alarm indications will continue if the alarm conditions still present. 7.8 Testing Alarms When the monitor starts up, a self-test will be performed automatically. The system gives a beep indicating that the visible and audible alarm indicators are functioning correctly. In the meantime, the alarm lamp turns yellow then red. The start-up screen is displayed. For further testing of individual measurement alarms, perform the measurement on yourself (for example SpO2 or CO2) or using a simulator. Adjust alarm limits and check if alarms behave correctly. 7.9 When an Alarm Occurs When an alarm occurs, observe the following steps and take proper actions: 1. Check the patient’s condition. 2. Confirm the alarming parameter or alarm category. 3. Identify the source of the alarm. 4. Take proper action to eliminate the alarm condition. 5. Make sure the alarm condition is corrected. For troubleshooting specific alarms, see appendix Alarm Messages. 7-10 7.10 Using Care Group Alarms 7.10.1 Care Group Auto Alarms When auto alarm is set on for viewing other patient and a Care Group is set up on your monitor, a flashing symbol will appear beside the QuickKeys area if any monitor in your Care Group, which is not currently viewed by your monitor, is alarming. The alarm symbol is shown as below. The department and bed label of the alarming monitor appear on the symbol. You can enter the view other patient window by pressing this symbol. To switch auto alarm on or off for viewing other patient: 1. Select [Screen Layout >>] in the main menu. Then, select [Others] and [Ok] from the popup menu. 2. In the view other patient window, select the care group setup button. Then, select [Auto Alarm] and toggle between [On] and [Off]. 7.10.2 Viewing Alarm Information You can view the alarm information from the currently viewed bed by selecting the message area in the view other patient window. The Care Group overview bar locates at the bottom of the View Other Patient window. In the overview bar, the department and bed label for any Care Group beds are displayed. The colour in which a Care Group bed appears matches its status. For details, refer to the Viewing Other Patients chapter. You can view the alarm information from other Care Group bed by selecting the department and bed label key in the Care Group Overview Bar. 7-11 7.10.3 Silencing Care Group Alarms You can silence the alarm sound of the currently viewed bed in the view other patient window. This function can be set in configuration mode only. When the alarm silence function for other patients is active and the currently viewed bed is in normal alarm status or alarm sound off status, press the button in the view other patient window. The currently viewed bed will then enter into the alarm silenced status. Pressing this button again returns to the normal alarm status. Note that this button is disabled when the currently viewed bed is in alarms off or paused status. 7-12 8 Monitoring ECG 8.1 Introduction The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the patient monitor as a waveform and a numeric. ECG monitoring provides two algorithms: 1. Basic algorithm The Basic algorithm enables 3-, 5- or 12-lead ECG monitoring, ST-segment analysis, arrhythmia analysis and interpretation of resting 12-lead ECG. 2. Mortara algorithm The Mortara algorithm enables 3-, 5- or 12-lead ECG monitoring, ST-segment analysis and arrhythmia analysis. You can select either algorithm as required. For the patient monitor incorporating the Mortara algorithm, interpretation of resting 12-lead ECG in the Basic algorithm is optional. For the patient monitor incorporating the Mortara algorithm, there is a Mortara logo at the monitor’s front. 8.2 Safety WARNING z Use only ECG electrodes and cables specified in this manual. z When connecting electrodes and/or patient cables, make sure that the connectors never come into contact with other conductive parts, or with earth. In particular, make sure that all of the ECG electrodes are attached to the patient, to prevent them from contacting conductive parts or earth. z Periodically inspect the electrode application site to ensure skin quality. If the skin quality changes, replace the electrodes or change the application site. z Use defibrillator-proof ECG cables during defibrillation. z Do not touch the patient, or table, or instruments during defibrillation. z After defibrillation, the screen display recovers within 10 seconds if the correct electrodes are used and applied in accordance with the manufacturer’s instructions for use. z Interference from a non-grounded instrument near the patient and electrosurgery interference can cause problems with the waveform. 8-1 8.3 Preparing to Monitor ECG 8.3.1 Preparing the Patient and Placing the Electrodes 1. Prepare the patient’s skin. Proper skin preparation is necessary for good signal quality at the electrode, as the skin is a poor conductor of electricity. To properly prepare the skin, choose flat, non-muscular areas and then follow this procedure: Shave hair from skin at chosen sites. Gently rub skin surface at sites to remove dead skin cells. Thoroughly cleanse the site with a mild soap and water solution. We do not recommend using ether or pure alcohol, because this dries the skin and increases the resistance. Dry the skin completely before applying the electrodes. 2. Attach the clips or snaps to the electrodes before placing them. 3. Place the electrodes on the patient. 4. Attach the electrode cable to the patient cable and then plug the patient cable into the ECG connector. 8.3.2 Choosing a Lead Set and AHA or IEC Lead Placement 1. Select the ECG parameter window to enter the [ECG Setup] menu. 2. Select [Lead Set] and then select [Auto], [3-lead], [5-lead] or [12-lead] according to the applied electrodes. Besides, you need to choose a standard that applies for your ECG lead placement in maintenance mode: 1. In the main menu, Select [Maintenance >>]→[User Maintenance >>]→enter the required password. 2. Select [Device Setup >>]→[ECG Standard] and then select [AHA] or [IEC] according to the standard that is applied for your hospital. 8-2 8.3.3 ECG Lead Placements The electrode placement illustrations in this chapter adopt the AHA standard. 3-Leadwire Electrode Placement Following is an electrode configuration when using 3 leadwires: 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 lower abdomen. 5-Leadwire Electrode Placement Following is an electrode configuration when using 5 leadwires: 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 lower abdomen. LL placement: on the left lower abdomen. V placement: on the chest. 8-3 The chest (V) electrode can be placed on one of the following positions: V1 placement: on the fourth intercostal space at the right sternal border. V2 placement: on the fourth intercostal space at the left sternal border. V3 placement: midway between the V2 and V4 electrode positions. V4 placement: on the fifth intercostal space at the left midclavicular line. V5 placement: on the left anterior axillary line, horizontal with the V4 electrode position. V6 placement: on the left midaxillary line, horizontal with the V4 electrode position. V3R-V6R placement: on the right side of the chest in positions corresponding to those on the left. VE placement: over the xiphoid process. V7 placement: on posterior chest at the left posterior axillary line in the fifth intercostal space. V7R placement: on posterior chest at the right posterior axillary line in the fifth intercostal space. 12-Leadwire Electrode Placement 12-lead ECG uses 10 electrodes, which are placed on the patient’s four limbs and chest. The limb electrodes should be placed on the soft skin and the chest electrodes placed according to the physician’s preference. Lead Placement for Surgical Patients The surgical site should be taken into consideration when placing electrodes on a surgical patient. e.g. for open-chest surgery, the chest electrodes can be placed on the lateral chest or back. To reduce artifacts and interference from electrosurgical units, you can place the limb electrodes close to the shoulders and lower abdomen and the chest electrodes on the left side of the mid-chest. Do not place the electrodes on the upper arm. Otherwise, the ECG waveform will be very small. 8-4 WARNING z When using electrosurgical units (ESU), patient leads should be placed in a position that is equal distance from the Electrosurgery electrotome and the grounding plate to avoid burns to the patient. Never entangle the ESU cable and the ECG cable together. z When using electrosurgical units (ESU), never place ECG electrodes near to the grounding plate of the ESU, as this can cause a lot of interference on the ECG signal. 8.3.4 Switching ECG Lead Set When [Lead Set] is set to [Auto], the patient monitor can switch from 3-lead ECG to 5-lead ECG, or from 5-lead ECG to 12-lead ECG automatically. The following table describes the contions of the lead switch. Switch from 3-lead to 5-lead RL and any two of limb leads (RA, LL, LA) are connected to a patient for 5 seconds. Switch from 5-lead to 3-lead RA, LA, LL, and V are all disconnected or RL is disconnected from a patient and the disconnection lasts for 10 seconds. Switch from 12-lead to 3-lead All the leads are disconnected or RL is disconnected from a patient and the disconnection lasts for 10 seconds. Switch from 5-lead to12-lead RA, LA, RL, and LL are connected to a patient properly, any lead from V2 to V6 is connected properly and the connection lasts for 5 seconds. 8-5 8.3.5 Checking Paced Status It is important to set the paced status correctly when you start monitoring ECG. The paced symbol is displayed when the [Paced] status is set to [Yes]. The pace pulse markers “|” are shown on the ECG wave when the patient has a paced signal. To change the paced status, you can select either: the patient information area, or [Patient Setup >>] in the main menu and then [Patient Demographics], or, the ECG parameter window, and then, select [Paced] from the popup menu and toggle between [Yes] and [No]. WARNING z For paced patients, you must set [Paced] to [Yes]. If it is incorrectly set to [No], the patient monitor could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak. Do not rely entirely on rate meter alarms when monitoring patients with pacemakers. Always keep these patients under close surveillance. z For non-paced patients, you must set [Paced] to [No]. If it is incorrectly set to [Yes], the patient monitor may be unable to detect premature ventricular beats (including PVCs) and perform ST segment analysis. 8-6 8.4 Understanding the ECG Display In the all parameters screen, the patient monitor allows up to three ECG to be displayed simultaneously. Following is an ECG display screen with 5-lead set and for reference only. Your display may be configured to look slightly different. 1 2 3 4 1. Lead label of the displayed wave 2. ECG gain 3. ECG filter label 4. Notch filter status Besides, pace pulse marks “|” are shown above the ECG wave if the [Paced] is set to [Yes] and the patient has a paced signal. 2 1 3 1. Current heart rate alarm limits 2. Heart beat symbol 3. Current heart rate For 12-lead ECG display screen, refer to the section 12-Lead ECG Monitoring. 8-7 8.5 Changing ECG Settings 8.5.1 Setting Pacemaker Rate (For Mortara Only) Some pacemaker pulses cannot be rejected. When this happens, the pulses are counted as a QRS complex and could result in an incorrect HR and a failure in detecting some arrhythmias. Select [ECG Setup]→[Others >>], and you can set [Pacemaker Rate] to the pacemaker’s rate in the popup menu. In this way, the patient monitor can calculate HR and detect arrhythmias more accurately. When [Paced] is set to [No], the pacemaker rate cannot be set. 8.5.2 Choosing the Alarm Source In most cases the HR and PR numerics are identical. In order to avoid simultaneous alarms on HR and PR, the monitor uses either HR or PR as its active alarm source. To change the alarm source, select [Alm Source] in the [ECG Setup] menu and then select either: [HR]: if you want the HR to be the alarm source for HR/PR. [PR]: if you want the PR to be the alarm source for HR/PR. [Auto]: If the [Alm 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 a valid heart rate is available. If the heart rate becomes unavailable, for example if leads becomes disconnected, and a pulse source is switch on and available, the monitor will automatically switch to Pulse as the alarm source. When the Leads Off condition is corrected, the monitor will automatically switch back to the heart rate as the alarm source. 8.5.3 Choosing a 5-Lead ECG Display Screen When monitoring with a 5-lead set, you can, in the [ECG Setup] menu, set the [ECG Display] screen to: [Normal]: The ECG waveform area shows 2 ECG waveforms by default. You can select 3 ECG waveforms for display. [Full-Screen]: The whole waveform area shows 7 ECG waveforms only. [Half-Screen]: The upper half part of the whole waveform area displays 7 ECG waveforms. 8-8 When [ECG Display] is set to [Normal] and [Sweep Mode] is set to [Refresh], cascaded ECG waveforms can be displayed. To cascade ECG waveforms: 1. Select either ECG wave to enter its lead menu. 2. Select [Cascade] and then select [On]. A cascaded waveform is displayed in two waveform positions. 8.5.4 Changing the ECG Filter Settings The ECG filter setting defines how ECG waves are smoothed. The default filter mode is different for different departments. To change the filter mode which will be applied for all ECG waveforms, select either ECG wave to enter its lead menu and then set [Filter] to: [Monitor]: Use under normal measurement conditions. [Diagnostic]: 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 segment are visible. [Surgery]: Use when 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 wandering or rough baseline. In the operating room, the surgery filter reduces artifacts and interference from electrosurgical units. Under normal measurement conditions, selecting [Surgery] may suppress the QRS complexes too much and then interfere with ECG analysis. NOTE z As the [Monitor] or [Surgery] filter may cause ECG waveform distortions, try to use the [Diagnostic] filter for ST analysis as possible as you can. Besides, the [Surgery] filter may also affect arrhythmia analysis results. 8.5.5 Switching the Notch Filter On or Off The notch filter removes the line frequency interference. When [Filter] is not set to [Diagnostic], the notch filter always stays on. When [Filter] is set to [Diagnostic], you can switch the notch filter on or off as required. 1. Select the ECG parameter window to enter its setup menu and then select [Others >>]. 2. Select [Notch Filter] and toggle between [On] and [Off]. Switching the notch filter on is recommended when there is interference (such as spikes) with the waveform. 8-9 Besides, you can set the notch frequency in maintenance mode: 1. In the main menu, Select [Maintenance >>]→[User Maintenance >>]→enter the required password. 2. Select [Device Setup >>] and then set [Notch Filter] to [50Hz] or [60Hz] according to the power line frequency. 8.5.6 Switching Defibrillator Synchronization On/Off As defibrillator synchronization, analog output and nurse call share the same signal output port, you need to set the port for defibrillator synchronization before getting the monitor and defibrillator synchronized. To set the port for defibrillator synchronization: 1. In the main menu, Select [Maintenance >>]→[User Maintenance >>]→enter the required password. 2. Select [Device Setup >>] to access the [Device Setup] menu. 3. Select [Auxiliary Output] and then [Defib. Sync]. To switch defibrillator synchronization on or off: 1. Select the ECG parameter window and then select [Others >>]. 2. Select [Defib. Sync] and toggle between [On] and [Off]. If a defibrillator is connected, a defibrillator synchronization pulse (100 ms, +5V) is outputted through the Defib. Sync connector every time when the patient monitor detects an R-wave. When [Defib. Sync] is set on, the message [Defib Sync On] is displayed in the technical alarm area. WARNING z Improper use of a defibrillator may cause injury to the patient. The user should determine whether to perform defibrillation or not according to the patient’s condition. z Before defibrillation, the user must ensure both defibrillator and monitor has passed the system test and can be safely used jointly. z Before defibrillation, make sure that [Defib. Sync] is set to [On] and the [Filter] is set to [Diagnostic]. z After defibrillation is finished, set [Defib. Sync] to [Off] and select the filter mode as required. 8-10 8.5.7 Selecting ECG Waves for Display In the all parameters screen, the patient monitor allows up to three ECG to be displayed simultaneously. When monitoring with a 5-lead set, you can select [Waveforms] in the ECG setup menu and then select either one, or two, or three waves for display. When you select three ECG waves for display, there must be one ECG wave that will be displayed permanently on the screen. For 5-lead ECG monitoring, the permanently displayed ECG wave is lead V, and for 12-lead ECG monitoring, the permanently displayed one is lead V1. 8.5.8 Changing ECG Wave Settings To change a wave’s settings, select the wave you want to change to enter its lead menu. If the wave is too small or clipped, you can change its size by selecting an appropriate [Gain] setting. If you select [Auto] from [Gain], the patient monitor will automatically adjust the size of the ECG waves. In the all parameters screen, only the selected ECG wave’s size is adjusted. In other screens, all ECG waves’ size is adjusted simultaneously. You can adjust a wave’s position by adjusting the Wave] button. You can restore a wave to its original position by selecting [Back to Default]. or button beside [Adjust 8.5.9 Choosing an ECG Lead for HR Computing and Arrh. Monitoring For the Basic algorithm, to compute HR and to analyze and detect arrhythmia more accurately, you can choose a lead of best quality signals as the HR lead. To select a lead as the HR lead, in the all parameters screen, select the wave corresponding to the HR parameter to enter its lead menu. In the lead menu, select [HR Source] and then select the lead you want. The selected lead should have the following characteristics: The QRS should be tall and narrow, with no notch R-wave should be either completely above or below the baseline and it should not be biphasic. The height of pace pulses should not be above R-wave T-wave should be smaller than 1/3 R-wave height. The P-wave should much smaller than the T-wave. 8-11 For the Mortara algorithm, the system will analyze ECG waveforms from multiple channels simultaneously so as to compute HR and to analyze and detect arrhythmia. 8.5.10 Adjusting QRS Volume When HR is selected as the alarm source, QRS sounds are produced based on the HR. To adjust the QRS volume, select [Beat Vol] in the [ECG Setup] menu and select the appropriate setting. When a valid SpO2 measured value is available, the system adjusts the pitch tone of QRS volume based on the SpO2 value. 8.6 About ST Monitoring ST segment analysis is intended for adult patients. The default setting is off. ST segment analysis calculates ST segment elevations and depressions for a specified lead. Measurement unit of the ST segment: mm or mV. A positive value indicates ST segment elevation; a negative value indicates ST segment depression. Measurement range of the ST segment: -2.0 mV to +2.0 mV. WARNING z The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment changes needs to be determined by a clinician. 8.6.1 Switching ST On and Off To switch ST monitoring on or off: 1. Select the ECG parameter window and then select [ST Analysis >>] from the popup menu. 2. Select [ST Analysis] to toggle between [On] and [Off]. Reliable ST monitoring can hardly be ensured if: You are unable to get a lead that is not noisy. Arrhythmias such as atrial fib/flutter cause irregular baseline. The patient is continuously and ventricularly paced. The patient has left bundle branch block. In these cases, you may consider switching ST monitoring off. 8-12 8.6.2 Changing ST Filter Settings When ST-segment analysis is performed, dedicated filters are used to ensure the diagnostic quality. When ST-segment analysis is switched on, [Filter] switches to [Diagnostic] automatically when it is not in the diagnostic mode. 8.6.3 Understanding the ST Display This example shows ST numerics with 5-lead ECG. Your monitor screen may look slightly different from the illustration. By selecting the ST parameter window, you can enter the [ST Analysis] menu. 8.6.4 Changing the ST Unit In the [ST Analysis] menu, you can select [ST Unit] menu to toggle between [mm] and [mV]. You can also change the ST unit in configuration mode. 8.6.5 Changing the ST Alarm Limits For 3-lead ECG monitoring, you can directly change the ST alarm limits in the [ST Analysis] menu. For 5- or 12-lead ECG monitoring, you can select [Adjust ST Limits >>] from [ST Analysis] and then set the ST alarm limits for each lead. 8-13 8.6.6 Setting ST Alarm Delay Time You can set ST alarm delay time by selecting [ST Alarm Delay] from [ST Analysis>>]. The following ST alarm delay time is optional: 30s (default), 45s, 1min, 1.5min, 2 min, and 3min. 8.6.7 Adjusting ST Measurement Points As shown in the figure below, the ST measurement for each beat complex is the vertical difference between two measurement points with the R-wave peak as the baseline for the measurement. R-wave peak T P Isoelectric point ST measurement point Difference=ST value The ISO and ST points need to be adjusted when you start monitoring or if the patient’s heart rate or ECG morphology changes significantly. Exceptional QRS complexes are not considered for ST-segment analysis. WARNING z Always make sure that the positions of ST measurement points are appropriate for your patient. Basic algorithm To adjust ST measurement points: 1. In the [ST Analysis] menu, select [Adjust ST Points >>]. In the [Adjust ST Points] window, two vertical lines represent the ISO and ST point positions respectively. 2. Select the points. and arrow keys beside the [ISO] or [ST] to move the measurement ISO-point (isoelectric): provides baseline for the measurement. ST: marks the end point of the ST segment analysis. 8-14 Mortara algorithm 1. In the [ST Analysis] menu, select [Adjust ST Points >>]. In the [Adjust ST Points] window, three vertical lines represent the ISO, J and ST points’ positions respectively. 2. Select [View Leads] and use the Knob to select an ECG lead with obvious J point and R wave. 3. Select [ISO], [J] or [ST] and then use the Knob to adjust the position of each point. The ISO-point (isoelectric) position is given relative to the R-wave peak. Position the ISO-point in the middle of the flattest part of the baseline (between the P and Q waves or in front of the P wave). The J-point position is given relative to the R-wave peak and helps locating the ST-point. Position the J-point at the end of the QRS complex and the beginning of the ST segment. The ST-point is positioned a fixed distance from the J-point. Move the J-point to position the ST-point at the midpoint of the ST segment. Position the ST-point relative to the J-point at either J+60 or J+80. 8.7 About Arrhythmia Monitoring Arrhythmia analysis provides information about your patient’s condition, including heart rate, PVC rate, rhythm and ectopics. The arrhythmia detection is intended for adult and pediatric patients. WARNING z Arrhythmia analysis program is intended to detect ventricular arrhythmias. It is not designed to detect atrial or supraventricular arrhythmias. It may incorrectly identify the presence or absence of an arrhythmia. Therefore, a physician must analyze the arrhythmia information with other clinical findings. 8-15 8.7.1 Understanding the Arrhythmia Events Basic algorithm Arrhythmia message Description Asystole No QRS complex for 4 consecutive seconds (in absence of ventricular fibrillation or chaotic signals). Vfib/Vtac A fibrillatory wave for 4 consecutive seconds. A dominant rhythm of adjacent Vs and a HR > the V-Tach Heart Rate Limit. PNP No pace pulse detected for 1.75 x average R-to-R intervals following a QRS complex (for paced patients only). PNC No QRS complex detected for 300 milliseconds following a pace pulse (for paced patients only). PVC One PVC detected in normal heartbeats. Couplet Paired PVCs detected in normal heartbeats. VT>2 More than 2 consecutive PVCs within the last minute. Bigeminy A dominant rhythm of N, V, N, V, N, V. Trigeminy A dominant rhythm of N, N, V,N, N, V, N, N, V. R on T R on T detected in normal heartbeats. Missed Beats No beat detected for 1.75 x average R-R interval for HR <120, or No beat for 1 second with HR >120 (for non-paced patients only), or No beat detected for more than the set pause threshold. Brady The average heart rate is less than 60 bpm. Tachy The average heart rate is greater than 100 bpm. 8-16 Mortara algorithm Arrhythmia message Description Asystole No QRS complex for 4 consecutive seconds (in absence of ventricular fibrillation or chaotic signals). Vfib Ventricular fibrillation occurs and persists for 6 seconds. Vtac Ventricular HR is greater or equal to the preset threshold and the number of consecutive PVCs is greater than the preset threshold. PNP No pace pulse detected for (60*1000/pace rate +90) milliseconds following a QRS complex or a pacer pulse (for paced patients only). PNC No QRS complex detected for 300 milliseconds following a pace pulse (for paced patients only). Multif. PVC More than 2 PVCs of different forms occur in the predefined search window (3-31). Couplet Paired PVCs detected in normal heartbeats. VT>2 Ventricular HR is greater than or equal to the preset threshold and the number of PVCs is greater than or equal to 3 but less than the preset threshold. Vent. Rhythm Ventricular HR is less than the preset threshold and the number of PVCs is greater than or equal to 3. Bigeminy A dominant rhythm of N, V, N, V, N, V. Trigeminy A dominant rhythm of N, N, V,N, N, V, N, N, V. R on T R on T is detected. Irr. Rhythm Consistently irregular rhythm Missed Beats No beat detected for 1.75x average R-R interval for HR <120, or No beat for 1 second with HR >120 (for non-paced patients only), or No beat detected for more than the set pause threshold. Brady The HR is less than the set bradycardia low limit. Tachy The HR is greater than the set tachycardia high limit. 8-17 8.7.2 Switching Arrhythmia Analysis On and Off To switch arrhythmia analysis on or off: 1. Select the ECG parameter window and then select [Arrh. Analysis >>] from the popup menu. 2. Select [Arrh. Analysis] to toggle between [On] and [Off]. PVC numeric When arrhythmia analysis is turned off, the PVC numeric will not be displayed. 8.7.3 Changing Arrhythmia Alarm Settings To change arrhythmia alarm settings, select the ECG parameter area and then select [Arrh. Analysis >>]. In the [Arrh. Analysis] menu, you can: switch on or off the alarm for PVCs by selecting [PVCs] and then toggling between [On] and [Off]. set the alarm level, alarm record, and alarm limit for PVCs by selecting [Alm Lev], [Alm Rec] and [PVCs High] respectively and then selecting the appropriate settings. select [Arrh. Alarm Setup >>] to change alarm settings for individual arrhythmia events. For Mortara algorithm, Asystole, Vfib and Vtac are exclusively high-level alarms and their alarm level is unchangeable. Furthermore, these alarms will be triggered only if their alarm conditions are active, regardless of whether arrhythmia analysis is switched on. 8.7.4 Changing Arrhythmia Threshold Settings (For Mortara Only) Select the ECG parameter window→[Arrh. Analysis >>]→[Arrh. Threshold Setup], and you can then change threshold settings for some arrhythmia alarms. In case an arrhythmia violates its threshold, an alarm will be triggered. The asystole delay time relates to arrhythmia relearning. When HR is less than 30 bpm, it is recommended to set the asystole delay time to 10 seconds. 8-18 Mortara algorithm Arrh. event Range Default configurations Interval Unit Asys. Delay 2 to 10 NICU: 3 Other departments: 5 1 s Vtac Rate 100 to 200 NICU: 150 Other departments: 130 5 bpm Vtac PVC 3 to12 6 1 beats Multif. PVC’s Window 3 to 31 15 1 beats Tachy High Adult: 100 to 300 Pediatric: 160 to 300 Neonate: 180 to 350 Adult: 100 Pediatric: 160 Neonate: 180 5 bpm Brady Low Adult: 15 to 60 Pediatric: 15 to 80 Neonate: 15 to 90 Adult: 60 Pediatric: 80 Neonate: 90 5 bpm 8.7.5 Initiating Arrhythmia Relearning Manually During ECG monitoring, you may need to initiate an arrhythmia relearning when the patient’s ECG template changes dramatically. A change in the ECG template could result in: incorrect arrhythmia alarms loss of ST measurement, and/or inaccurate heart rate Arrhythmia relearning allows the monitor to learn the new ECG template so as to correct arrhythmia alarms and HR value, and restore ST measurements. To initiate a relearning manually, select the ECG parameter window→[Arrh. Analysis >>]→[Relearn Arrh.]. When the patient monitor is learning, the message [Arrh. Learning] is displayed in the technical alarm area. CAUTION z Take care to initiate arrhythmia relearning only during periods of predominantly normal rhythm and when the ECG signal is relatively noise-free. If arrhythmia learning takes place during ventricular rhythm, the ectopics may be incorrectly learned as the normal QRS complex. This may result in missed detection of subsequent events of V-Tach and V-Fib. 8-19 8.7.6 Automatic Arrhythmia Relearn Arrhythmia relearning is initiated automatically whenever: The ECG lead or lead label is changed The HR computing lead is changed. The ECG lead is re-connected A new patient is admitted The paced status setting is changed Arrhythmia analysis is switched on. The ECG module becomes active. After the calibration is completed, select [Stop Calibrating ECG] 8.7.7 Reviewing Arrhythmia Events To review previously happened arrhythmia events, in the [ECG Setup] menu, select [Arrh. Analysis >>]→[Arrh. Review >>]. In the [Arrh. Review] window, you can: Select [Index] and then set a time as the index for finding your desired arrhythmia events. Rename an arrhythmia event by selecting the arrhythmia event you want to rename and then selecting [Rename] to enter a new name for it. Delete an arrhythmia event by selecting the one you want to delete and then selecting [Delete Event]. Have more event selections by selecting After an event is selected, select [Waveforms] and then select [Scroll] to navigate through the waveforms. Print out the currently displayed arrhythmia waveforms and numerics through the recorder by selecting [Record]. Print out the currently displayed arrhythmia waveforms and numerics through the printer by selecting [Print]. 8-20 , , or . or beside 8.8 12-Lead ECG Monitoring 8.8.1 Entering the 12-lead ECG Monitoring Screen 1. Refer to the section 8.3.3 ECG Lead Placement for placing the electrodes. 2. Select the ECG parameter window and then set [Lead Set] to [12-Lead], and [ECG Display] to [12-Lead] in the popup menu. There are totally 12 ECG waves and 1 rhythm wave displayed on the screen. The rhythm lead is the HR-derived lead before entering the 12-lead ECG monitoring screen. The ST numerics are displayed in three groups: ST Ant (anterior): V1, V2, V3, V4 ST Inf (inferior): II, III, aVF, (aVR) ST Lat (lateral): I, aVL, V5, V6 Although aVR is displayed in the ST Inf group, it is not an inferior lead. Additionally, the 12-lead ECG monitoring has the following features: The [Filter] mode is fixed to [Diagnostic] and cannot be changed. The hardkey on the monitor’s front is disabled. 8-21 8.8.2 Interpretation of resting 12-Lead ECG Interpretation of resting 12-lead ECG is intended for adult patients. You can only start an interpretation of resting 12-lead ECG 11 seconds after entering the 12-lead ECG monitoring screen. Otherwise, the prompt message [Not enough data. Cannot analyze.] will be displayed. To start an interpretation of resting 12-lead ECG, select [Freeze] and then [Analyze]. Then, the following screen will be displayed. In this screen, you can: Select [Record Result] to print out the interpretation of resting 12-lead ECG results by the recorder. Select [Record Wave] to print out the interpretation of resting 12-lead ECG results and waves by the recorder. Select [Print Report] to print out the interpretation of resting 12-lead ECG report by the printer. Besides, after selecting [Freeze], you can: Browse the frozen ECG waves by selecting [Scroll] and rotating the Knob, or selecting the or button beside [Scroll]. Print out the currently frozen waves by selecting [Record]. 8-22 8.8.3 Reviewing Interpretation of resting 12-Lead ECG Results In the 12-lead ECG monitoring screen, you can review previous interpretation of resting 12-lead ECG results by selecting [Review]. In this review window, you can: Switch between [Results] and [Waveforms] for review. Select or to view more results. Select or beside [Scroll] to navigate through the waveforms. Delete the currently displayed interpretation of resting 12-lead ECG results by selecting [Delete]. Select [Record] to print out the currently displayed interpretation of resting 12-lead ECG results by the recorder. Select [Print] to print out the currently displayed interpretation of resting 12-lead ECG results by the printer. 8-23 FOR YOUR NOTES 8-24 9 Monitoring Respiration (Resp) 9.1 Introduction Impedance respiration is measured across the thorax. When the patient is breathing, the volume of air changes in the lungs, resulting in impedance changes between the electrodes. Respiration rate (RR) is calculated from these impedance changes, and a respiration waveform appears on the patient monitor screen. 9.2 Safety WARNING z When monitoring the patient’s respiration, do not use ESU-proof ECG cables. z If 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. z The respiration measurement does not recognize obstructive and mixed apneas. It only indicates an alarm when a preset time had elapsed since the last detected breath. Therefore, it cannot be used for diagnostic purpose. 9.3 Placing Resp Electrodes As the skin is a poor conductor of electricity, preparing the skin is necessary for a good Respiration signal. You can refer to the ECG section for how to prepare the skin. As the respiration measurement adopts the standard ECG electrode placement, you can use different ECG cables (3-lead, 5-lead or 12-lead). Since the respiration signal is measured between two ECG electrodes, if a standard ECG electrode placement is applied, the two electrodes should be RA and LA of ECG Lead I, or RA and LL of ECG Lead II. NOTE z To optimize the respiration waveform, place the RA and LA electrodes horizontally when monitoring respiration with ECG Lead I; place the RA and LL electrodes diagonally when monitoring respiration with ECG Lead II. 9-1 Lead I Lead II 9.3.1 Optimizing Lead Placement for Resp If you want to measure Resp when you are measuring ECG, you may need to optimize the placement of the two electrodes between which Resp will be measured. Repositioning ECG electrodes from standard positions results in changes in the ECG waveform and may influence ST and arrhythmia interpretation. 9.3.2 Cardiac Overlay Cardiac 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 electrodes 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. 9.3.3 Abdominal Breathing Some patients with restricted 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. 9-2 9.3.4 Lateral Chest Expansion In clinical applications, some patients (especially neonates) expand their chests laterally, causing a negative intrathoracic pressure. In these cases, it is better to place the two respiration electrodes in the right midaxillary and the left lateral chest areas at the patient’s maximum point of the breathing movement to optimize the respiratory waveform. 9.4 Understanding the Resp Display Gain Resp lead label Respiration rate The waveform area and the parameter area are unnecessarily in horizontally parallel. By selecting the waveform area, you can enter the [Resp Waveform] menu. By selecting the Resp parameter window, you can enter the [Resp Setup] menu. NOTE z Respiration monitoring is not for use on the patients who are very active, as this will cause false alarms. 9.5 Changing Resp Settings 9.5.1 Choosing the Respiration Lead In the [Resp Waveform] menu, select [Lead] and toggle between [I] and [II]. 9.5.2 Setting the Apnea Alarm Delay The apnea alarm is a high-level alarm used to detect apneas. You can set the apnea alarm delay time after which the patient monitor alarms if the patient stops breathing. In the [Resp Setup] menu, select [Apnea Time] and then select the appropriate setting. 9-3 9.5.3 Changing Resp Detection Mode In the [Resp Waveform] menu, select [Detection Mode] and toggle between [Auto] and [Manual]. In auto detection mode, the patient monitor adjusts the detection level automatically, depending on the wave height and the presence of cardiac artifact. Note that in auto detection mode, the detection level (a dotted line) is not displayed on the waveform. Use auto detection mode for situations where: The respiration rate is not close to the heart rate. Breathing is spontaneous, with or without continuous positive airway pressure (CPAP). Patients are ventilated, except patients with intermittent mandatory ventilation (IMV). In manual detection mode, you adjust the dotted detection level line to the desired level by selecting [Upper Line] or [Lower Line] and then selecting or beside them. Once set, the detection level will not adapt automatically to different respiration depths. It is important to remember that if the depth of breathing changes, you may need to change the detection level. Use manual detection mode for situations where: The respiration rate and the heart rate are close. Patients have intermittent mandatory ventilation. Respiration is weak. Try repositioning the electrodes to improve the signal. In Auto Detection Mode, if you are monitoring Resp and ECG is switched off, the monitor cannot compare the ECG and Resp rates to detect cardiac overlay. The respiration detection level is automatically set higher to prevent the detection of cardiac overlay as respiration. In Manual Detection Mode, cardiac overlay can in certain situations trigger the respiration counter. This may lead to an false indication of a high respiration or an undetected apnea condition. If you suspect that cardica overlay is being registered as breathing activity, raise the detection level above the zone of cardiac overlay. If the Resp wave is so small that raising the detection level is not possible, you may need to optimize the electrode placement as described in the section "Lateral Chest Expansion". 9-4 9.5.4 Changing the Size of the Resp Wave WARNING z When monitoring in manual detection mode, make sure to check the respiration detection level after you have increased or decreased the size of the respiration wave. Select the Resp wave to enter the [Resp Waveform] menu. Then, you can select [Gain] and then select an appropriate setting. The bigger the gain is, the larger the wave amplitude is. 9-5 FOR YOUR NOTES 9-6 10 Monitoring PR 10.1 Introduction The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart. You can display a pulse from any measured SpO2 or any arterial pressure (see the IBP section). The displayed pulse numeric is color-coded to match its source. 2 1 3 1. Alarm Limits 2. PR Source 3. PR: detected pulsations per minute. 10.2 Changing PR Settings 10.2.1 Setting the PR Source The current pulse source is displayed in the PR parameter area. The pulse rate chosen as pulse source: is monitored as system pulse and generates alarms when you select PR as the active alarm source. is stored in the monitor’s database and reviewed in the graphic/tabular trends. In trend graphs, as the PR curve is in the same color with the PR source, it is unlikely to distinguish the PR source. is sent via the network to the central monitoring system, if available. To set which pulse rate as PR source: 1. Enter the [PR Setup] menu. 2. Select [PR Source] and then select a label or [Auto] from the popup menu. The popup menu displays the currently available PR sources from top to bottom by priority. When you select [Auto], the system will automatically select the first option as the PR source from the popup menu. When the current PR source is switched off, the system will automatically switch [PR Source] to [Auto]. When you select [IBP], the system will automatically select the first pressure label as the PR source from the popup menu. 10-1 10.2.2 Selecting the Active Alarm Source In most cases the HR and PR 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 [Alm Source] in the [ECG Setup] or [PR Setup] menu and then select either: [HR]: if you want the HR to be the alarm source for HR/PR. [PR]: if you want the PR to be the alarm source for HR/PR. [Auto]: If the [Alm 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 a valid heart rate is available. If the heart rate becomes unavailable, for example if leads becomes disconnected, and a pulse source is switch on and available, the monitor will automatically switch to Pulse as the alarm source. When the Leads Off condition is corrected, the monitor will automatically switch back to the heart rate as the alarm source. 10.2.3 Adjusting QRS Volume When PR is used as the alarm source, the PR source will be used as a source for the QRS tone. You can change the QRS volume by adjusting [Beat Vol] in the [PR Setup] menu. When a valid SpO2 value exists, the system will adjust the pitch of QRS tone according to the SpO2 value. 10-2 11 Monitoring SpO 2 11.1 Introduction SpO2 monitoring is a non-invasive technique used to measure the amount of oxygenated haemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the probe passes through the tissue and is converted into electrical signals by the photodetector in the probe. The SpO2 module processes the electrical signal and displays a waveform and digital values for SpO2 and pulse rate. This device is calibrated to display functional oxygen saturation. It provides four measurements: 1 2 3 4 1. Pleth waveform (Pleth): visual indication of patient’s pulse. The waveform is normalized. 2. Oxygen saturation of arterial blood (SpO2): percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin. 3. Perfusion indicator: the pulsatile portion of the measured signal caused by arterial pulsation. 4. Pulse rate (derived from pleth wave): detected pulsations per minute. 11-1 11.2 Safety WARNING z Use only SpO2 sensors specified in this manual. Follow the SpO2 sensor’s instructions for use and adhere to all warnings and cautions. z When a trend toward patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. z Do not use SpO2 sensors during magnetic resonance imaging (MRI). Induced current could potentially cause burns. z Inspect the sensor site every two hours and move the sensor if the skin quality changes. For neonates, or patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently. Prolonged continuous monitoring may increase the risk of undesirable changes in skin characteristics, such as irritation, reddening, blistering or necrosis. 11.3 Identifying SpO2 Modules To identify which SpO2 module is incorporated into your patient monitor, see the company logo located at the lower left corner on your monitor’s front. If it is: Mindray SpO2 module, there is no logo. Masimo SpO2 module, there is the Masimo SET logo. Nellcor SpO2 module, there is the Nellcor logo. The connectors for these three SpO2 sensors are mutually exclusive. 11.4 Applying the Sensor 1. Select an appropriate sensor according to the module type, patient category and weight. 2. Remove colored nail polish from the application site. 3. Apply the sensor to the patient. 4. Select an appropriate adapter cable according to the connector type and plug this cable into the patient monitor. 5. Connect the sensor cable to the adapter cable. 11-2 11.5 Changing SpO2 Settings 11.5.1 Adjusting the Desat Alarm Limit The desat alarm is a high level alarm notifying you of potentially life threatening drops in oxygen saturation. To adjust the desat alarm limit, select [Desat Limit] in the [SpO2 Setup] menu and then adjust the limit. When the SpO2 value is below the desat alarm limit, the message [SpO2 Desat] is displayed. 11.5.2 Setting SpO2 Sensitivity For Masimo SpO2 module, you can set [Sensitivity] to [Normal] or [Maximum] in the [SpO2 Setup] menu. When the [Sensitivity] is set to [Maximum], the patient monitor is more sensitive to minor signals. When monitoring critically ill patients whose pulsations are very weak, it is strongly recommended that the sensitivity is set to [Maximum]. When monitoring neonatal or non-critically ill patients who tends to move a lot, noise or invalid signals may be caused. In this case, it is recommended that the sensitivity is set to [Normal] so that the interference caused by movement can be filtered and therefore the measurement stability can be ensured. 11.5.3 Changing Averaging Time The SpO2 value displayed on the monitor screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the patient monitor responds to changes in the patient’s oxygen saturation level. Contrarily, the longer the averaging time is, the slower the patient monitor responds to changes in the patient’s oxygen saturation level, but the measurement accuracy will be better. When monitoring critically ill patients, selecting shorter averaging time will help understanding the patient’s state. To set the averaging time: For Mindray SpO2 module, select [Sensitivity] in the [SpO2 Setup] menu and then toggle between [High], [Med] and [Low], which respectively correspond to 7 s, 9 s and 11 s. For Masimo SpO2 module, select [Averaging] in the [SpO2 Setup] menu and then toggle between [2-4 s], [4-6 s], [8 s], [10 s], [12 s], [14 s] and [16 s]. For Nellcor SpO2 module, select [Averaging] in the [SpO2 Setup] menu and then toggle between [8 s] and [16 s]. 11-3 11.5.4 Monitoring SpO2 and NIBP Simultaneously When monitoring SpO2 and NIBP on the same limb simultaneously, you can switch [NIBP Simul] on in the [SpO2 Setup] menu to lock the SpO2 alarm status until the NIBP measurement ends. If you switch [NIBP Simul] off, low perfusion caused by NIBP measurement may lead to inaccurate SpO2 readings and therefore cause false physiological alarms. 11.5.5 Sat-Seconds Alarm Management With traditional pulse oximetry alarm management, high and low alarm limits are set for monitoring oxygen saturation. During monitoring, as soon as a limit is violated, an alarm is triggered. When the patient % SpO2 fluctuates near an alarm limit, the alarm sounds each time the limit is violated. Such frequent alarm can be distracting. Nellcor’s Sat-Seconds alarm management technique is used to reduce these nuisance alarms. The Sat-Seconds feature is available with the Nellcor SpO2 module to decrease the likelihood of false alarms caused by motion artifacts. To set the Sat-Seconds limit, select [Sat-Seconds] in the [SpO2 Setup] menu and then select the appropriate setting. With Sat-Seconds alarm management, high and low alarm limits are set in the same way as traditional alarm management. A Sat-Seconds limit is also set. The Sat-Seconds limit controls the amount of time that SpO2 saturation may be outside the set limits before an alarm sounds. The method of calculation is as follows: the number of percentage points that the SpO2 saturation falls outside the alarm limit is multiplied by the number of seconds that it remains outside the limit. This can be stated as the equation: Sat-Seconds= Points × Seconds Only when the Sat-Seconds limit is reached, the monitor gives a Sat-Seconds alarm. For example, the figure below demonstrates the alarm response time with a Sat-Seconds limit set at 50 and a low SpO2 limit set at 90%. In this example, the patient % SpO2 drops to 88% (2 points) and remains there for 2 seconds. Then it drops to 86% (4 points) for 3 seconds, and then to 84% (6 points) for 6 seconds. The resulting Sat-Seconds are: % SpO2 2× 4× 6× Seconds 2= 3= 6= Sat-Seconds 4 12 36 Total Sat-Seconds= 52 11-4 After approximately 10.9 seconds, a Sat-Second alarm would sound, because the limit of 50 Sat-Seconds would have been exceeded. SpO2% Seconds Saturation levels may fluctuate rather than remaining steady for several seconds. Often, the patient % SpO2 may fluctuate above and below an alarm limit, re-entering the non-alarm range several times. During such fluctuation, the monitor integrates the number of %SpO2 points, both positive and negative, until either the Sat-Seconds limit is reached, or the patient%SpO2 re-enters the non-alarm range and remains there. 11.5.6 Pitch Tone The pitch tone function enables the patient monitor to give a variable pitch of the heart beat tone or pulse beat tone as the patient’s saturation level changes. This monitor provides 22 levels of pitch tone. The pitch of the heart rate tone or pulse rate tone rises as the saturation level increases and falls as the saturation level descreases. There are two pitch tone modes: [Mode 1] and [Mode 2], of which you can select either in configuration mode. The pitch tone volume can be changed in certain measurements’ setup menu. If PR is selected as the alarm source in the [ECG Setup] menu, the pitch tone volume is subject to the pulse beat tone. Otherwise, the pitch tone volume is subject to the heart beat tone. When either the pulse beat tone or the heart beat tone is set to 0, the pitch tone volume will be muted. If the SpO2 is disabled, the pitch tone function will be disabled also. 11-5 11.6 Measurement Limitations If you doubt the measured SpO2, check patient vital signs first. Then check the patient monitor and SpO2 sensor. The following factors may influence the accuracy of measurement: Ambient light Physical movement (patient and imposed motion) Diagnostic testing Low perfusion Electromagnetic interference, such as MRI environment Electrosurgical units Dysfunctional haemoglobin, such as carboxyhemoglobin (COHb)and methemoglobin (MetHb) Presence of certain dyes, such as methylene and indigo carmine Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 Drop of arterial blood flow to unmeaurable level caused by shock, anemia, low temperature or vasoconstrictor. 11.7 Masimo Information Masimo Patents This device is covered under one or more of the following U.S.A. patents: 5,758,644, 5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975, 7,469,157 and other applicable patents listed at: www.masimo.com/patents.htm. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device. 11-6 11.8 Nellcor Information Nellcor Patents This device is covered under one or more the following U.S. Patents: 4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136; 5,351,685; 5,485,847; 5,533,507; 5,577,500; 5,803,910; 5,853,364; 5,865,736; 6,083,172; 6,463,310; 6,591,123; 6,708,049; Re.35,122 and international equivalents. U.S.A international patents pending. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device. 11-7 FOR YOUR NOTES 11-8 12 Monitoring NIBP 12.1 Introduction This monitor uses the oscillometric method for measuring the non-invasive blood pressure (NIBP). This measurement can be used for adults, pediatrics and neonates. Automatic non-invasive blood pressure monitoring uses the oscillometric method of measurement. To understand how this method works, we’ll compare it to the auscultative method. With auscultation, the clinician listens to the blood pressure and determines the systolic and diastolic pressures. The mean pressure can then be calculated with reference to these pressures as long as the arterial pressure curve is normal. Since the monitor cannot hear the blood pressure, it measures cuff pressure oscillation amplitudes. Oscillations are caused by blood pressure pulses against the cuff. The oscillation with the greatest amplitude is the mean pressure. This is the most accurate parameter measured by the oscillometric method. Once the mean pressure is determined, the systolic and diastolic pressures are calculated with reference to the mean. Simply stated, auscultation measures systolic and diastolic pressures and the mean pressure is calculated. The oscillometric method measures the mean pressure and determines the systolic and diastolic pressures. As specified by IEC 60601-2-30/EN60601-2-30, NIBP measurement can be performed during electro-surgery and discharge of defibrillator. NIBP diagnostic significance must be decided by the doctor who performs the measurement. NOTE z Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method or an intra-arterial blood pressure measurement device, within the limits prescribed by the American National Standard, Manual, electronic, or automated sphygmomanometers. 12-1 12.2 Safety WARNING z Be sure to select the correct patient category setting for your patient before measurement. Do not apply the higher adult settings for pediatric or neonatal patients. Otherwise it may present a safety hazard. z Do not measure NIBP on patients with sickle-cell disease or any condition where skin damage has occurred or is expected. z Use clinical judgment to determine 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. z Do not use the NIBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation. z If you doubt the NIBP readings, determines the patient’s vital signs by alternative means and then verify that the monitor is working correctly. 12.3 Measurement Limitations Measurements are impossible with heart rate extremes of less than 40bpm or greater than 240bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible: If a regular arterial pressure pulse is hard to detect With excessive and continuous patient movement such as shivering or convulsions With cardiac arrhythmias Rapid blood pressure changes Severe shock or hypothermia that reduces blood flow to the peripheries Obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery 12-2 12.4 Setting Up the NIBP Measurement 12.4.1 Preparing to Measure NIBP 1. Power on the monitor. 2. Verify that the patient category is correct. Change it if necessary. 3. Plug the air tubing into the NIBP connector. 4. Select a correct sized cuff and then apply it as follows: 5. Determine the patient’s limb circumference. Select an appropriate cuff by referring to the limb circumference marked on the cuff. The width of the cuff should be 40% (50% for neonates) of the limb circumference, or 2/3 of the upper arm’s length. The inflatable part of the cuff should be long enough to encircle at least 50% to 80% of the limb. Apply the cuff to an upper arm or leg of the patient and make sure the Φ marking on the cuff matches the artery location. Do not wrap the cuff too tightly around the limb. It may cause discoloration, and ischemia of the extremities. Make sure that the cuff edge falls within the marked range. If it does not, use a larger or smaller cuff that will fit better. Connect the cuff to the air tubing and make sure that the bladder inside the cover is not folded and twisted. NOTE z The use of the equipment is restricted to one patient at a time. 12.4.2 Starting and Stopping Measurements You can start and stop measurements by using the hardkey on the monitor’s front. 12.4.3 Correcting the Measurement if Limb is not at Heart Level The cuff should be applied to a limb at the same level as the patient’s heart. If the limb is not at the heart level, to the displayed value: Add 0.75 mmHg (0.10 kPa) for each centimeter higher, or Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower. 12-3 12.5 Measurement Methods There are three methods of measuring NIBP: Manual: measurement on demand. Auto: continually repeated measurements at set intervals. STAT: continually rapid series of measurements over a five minute period, then return to the previous mode. 12.5.1 Enabling NIBP Auto Cycling and Setting the Interval 1. Select the NIBP parameter window to enter the [NIBP Setup] menu. 2. Select [Interval] and then select a desired time interval. Selecting [Manual] switches to manual mode. 3. Start a measurement manually. The monitor will then automatically repeat NIBP measurements at the set time interval. You can also start a measurement by pressing the [Auto NIBP] QuickKey. Then monitor will then automatically repeat NIBP measurements at the set time interval per current settings. 12.5.2 Starting a STAT Measurement 1. Select the NIBP parameter window to enter the [NIBP Setup] menu. 2. Select [NIBP STAT]. The STAT mode initiates 5 minutes of continuous, sequential, automatic NIBP measurements. WARNING z Continuous non-invasive blood pressure measurements may cause purpura, ischemia and neuropathy in the limb with the cuff. Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If any abnormity occurs, move the cuff to another site or stop the blood pressure measurements immediately. 12-4 12.6 Understanding the NIBP Numerics The NIBP display shows numerics only as below. Your display may be configured to look slightly different. 1 4 3 2 5 6 7 8 9 10 1. Time of last measurement 2. Time remaining to next measurement 3. Measurement mode 4. Unit of pressure: mmHg or kPa 5. Alarm Limits 6. Prompt message area: shows NIBP-related prompt messages 7 Systolic pressure 8. Mean pressure 9. Diastolic pressure 10. If you have chosen to display PR from NIBP in configuration mode, the PR value will be displayed at this position after each measurement ends. During the measurement, the cuff pressure is displayed at this position. 12-5 12.7 Changing NIBP Settings 12.7.1 Choosing NIBP Alarm Source You can monitor for alarm conditions in systolic, diastolic and mean pressure, either singly or in parallel. In the [NIBP Setup], select [Alm Source] and choose from: [Sys]: alarms are given only when the systolic pressure violates the alarm limits. [Dia]: alarms are given only when the diastolic pressure violates the alarm limits. [Mean]: alarms are given only when the mean pressure violates the alarm limits. [Sys&Mean]: alarms are given when the systolic or mean pressure violates the alarm limits. [Mean&Dia]: alarms are given when the mean or diastolic pressure violates the alarm limits. [Sys&Dia]: alarms are given when the systolic or diastolic pressure violates the alarm limits. [All]: alarms are given when the systolic or mean or diastolic pressure violates the alarm limits. 12.7.2 Displaying NIBP Measurements You can display one set or multiple sets of NIBP measurements simultaneously. In the [NIBP Setup] menu, select [Display NIBP] and toggle between [Single-Group] and [Multi-Group]: [Single-Group]: only the latest set of NIBP measurements is displayed in the NIBP parameter window. [Multi-Group]: multiple sets of most recent NIBP measurements are displayed below the waveform area. And PR displayed is derived from NIBP. You can not display multiple sets of NIBP measurements in some screens such as the big numerics screen and the 12-lead ECG analysis screen. 12.7.3 Setting the Pressure Unit In the [NIBP Setup] menu, select [Press. Unit] and toggle between [mmHg] and [kPa]. 12-6 12.7.4 Setting the cuff inflation pressure You can set the initialcuff inflation pressure . In the [NIBP Setup] menu, select [Inflation Pressure] and then select the appropriate setting. 12.8 Assisting Venous Puncture You can use the NIBP cuff to cause sub-diastolic pressure to block the venous blood vessel and therefore help venous puncture. 1. In the [NIBP Setup] menu, verify that the [Cuff Press.] value is appropriate. Change it if necessary. 2. Select [VeniPuncture] 3. Puncture vein and draw blood sample. 4. Reselect either [VeniPuncture] or the hardkey to deflate the cuff. The cuff deflates automatically after a set time if you do not deflate it. During measurement, the NIBP display shows the inflation pressure of the cuff and the remaining time in venous puncture mode. 12.9 Resetting NIBP If the blood pressure pump works incorrectly but the monitor does not alarm for it, you can check the pump by resetting it. To reset the pump, select [Reset] from [NIBP Setup]. 12.10 NIBP Leakage Test The NIBP leakage test checks the integrity of the system and of the valve. It is required at least once every two years or when you doubt the measured NIBP. If the test failed, corresponding prompt messages will be given. If no message is displayed, it means no leakage is detected. Tools required: An adult cuff An air tubing A correct sized cylinder 12-7 Follow this procedure to perform the leakage test: 1. Set the patient category to [Adu]. 2. Connect the cuff to the NIBP connector on the monitor. 3. Wrap the cuff around the cylinder as shown below. Cylinder Monitor Connector for NIBP cuff Air tubing Cuff 4. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password and then select [Maintain NIBP]→[NIBP Leakage Test]. Then, [Leakage Testing…] is displayed in the NIBP parameter area. 5. After about 20 seconds, the monitor will automatically deflate. This means the test is completed. 6. If the message [NIBP Pneumatic Leak] is displayed, it indicates that the NIBP airway may have leakages. Check the tubing and connections for leakages. If you ensure that the tubing and connections are all correct, perform a leakage test again. If the problem persists, contact your service personnel. NOTE z The leakage test is intended for use to simply determine whether there are leakages in the NIBP airway. It is not the same as that specified in the EN 1060-3 standard. 12.11 NIBP Accuracy Test The NIBP accuracy test is required at least once every two years or when you doubt the measured NIBP. Tools required: T-shape connector Appropriate tubing Balloon pump Metal Vessel (volume 500±25 ml) Reference manometer (calibrated with accuracy higher than 1 mmHg) 12-8 Follow this procedure to perform the accuracy test: 1. Connect the equipment as shown. Manometer Monitor Connector for NIBP cuff Tubing Balloon pump Metal vessel 2. Before inflation, the reading of the manometer should be 0.If not, disconnect the airway and reconnect it until the readings is 0. 3. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password and then select [Maintain NIBP]→[NIBP Accuracy Test]. 4. Compare the manometer values with the displayed values. The difference between the manometer and displayed values should not be greater than 3 mmHg. 5. Raise the pressure in the metal vessel to 50 mmHg with the balloon pump. Repeat step 3 and 4. 6. Raise the pressure in the metal vessel to 200 mmHg with the balloon pump. Repeat step 3 and 4. If the difference between the manometer and displayed values is greater than 3 mmHg, contact your service personnel. 12.12 Calibrating NIBP NIBP is not user-calibrated. Cuff-pressure transducers must be verified and calibrated once every two years by a qualified service professional. Contact your service personnel when a calibration is necessary. 12-9 FOR YOUR NOTES 12-10 13 Monitoring Temp 13.1 Introduction This patient monitor allows you to monitor two temperature sites simultaneously and calculate the temperature difference between them. 13.2 Safety WARNING z Verify that the probe detection program works correctly before monitoring. Besides, make sure that if you plug out the temperature probe cable from the T1 or T2 connector, the monitor will trigger a technical alarm and give the alarm message [T1 Sensor Off] or [T2 Sensor Off] correctly. z The temperature measurement functioning should be calibrated every two years, or as indicated by your standard hospital procedure. 13.3 Making a Temp Measurement 1. Select an appropriate probe for your patient. 2. If you are using a disposable probe, connect the probe to the temperature cable. 3 Plug the probe or temperature cable to the temperature connector. 4. Attach the probe to the patient correctly. 5. Check that the alarm settings are appropriate for your patient. 13-1 13.4 Understanding the Temp Display The temperature monitoring is displayed on the monitor as three numerics: T1, T2 and TD. By selecting this area, you can enter the [Temp Setup] menu. 13.5 Setting the Temperature Unit In the [Temp Setup] menu, select [Unit] and toggle between [ºC] and [ºF]. 13-2 14 Monitoring IBP 14.1 Introduction The monitor can monitor up to 4 invasive blood pressures and displays the systolic, diastolic and mean pressures and a waveform for each pressure. 14.2 Safety WARNING z Use only pressure transducers specified in this manual. Never reuse disposable pressure transducers. z Make sure that the applied parts never come into contact with other electric devices. z To reduce the hazard of burns during high-frequency surgical procedure, ensure that the monitor’s cables and transducers never come into contact with the high-frequency surgical units. z When using accessories, their operating temperature should be taken into consideration. For details, refer to instructions for use of accessories. 14.3 Setting Up the Pressure Measurement 1. Plug the pressure cable into the IBP connector. 2. Prepare the flush solution. 3. Flush the system to exhaust all air from the tubing. Ensure that the transducer and stopcocks are free of air bubbles. WARNING z If air bubbles appear in the tubing system, flush the system with the infusion solution again. Air bubble may lead to wrong pressure reading. 14-1 4. Connect the pressure line to the patient catheter. 5. Position the transducer so that it is level with the heart, approximately at the level of the midaxillary line. 6. Select the appropriate label. 7. Zero the transducer. After a successful zeroing, turn off the stopcock to the atmosphere and turn on the stopcock to the patient. Heparinised fluid bag Pressure transduce Valve Stopcock Flushing set Adapter cable for using disposable transducers Pressure line Monitor WARNING z If measuring intracranial pressure (ICP) with a sitting patient, level the transducer with the top of the patient’s ear. Incorrect leveling may give incorrect values. 14-2 14.4 Understanding the IBP Display The IBP measurement is displayed on the monitor as a waveform and numeric pressures. The figure below shows the waveform and numerics for the Art pressure. For different pressures, this display may be slightly different. 1 1. 2 Waveform 4. Mean pressure 2. 4 5 Systolic pressure 5. Pressure unit 3 3. Diastolic pressure For venous pressures, the parameter window shows the mean pressure only. For different pressures, their default units may be different. When multiple IBP signals are measured, IBP waveforms can be displayed overlappingly in a two-channel waveform area. All the overlapped waveforms use the same upper, middle, lower gridline and the same pressure unit. The labels and scale of arterial pressures (except for PA) are displayed at the left side of the waveform area, and the labels and scale of venous pressures at the right side of the waveform area. If ICP and one or more of Art, Ao, BAP, FAP pressures are measured simultaneously, the ICP parameter area will display numeric cerebral perfusion pressure (CPP), which is obtained by subtracting ICP from the mean pressure of one of the above-mentioned arterial pressures. 14-3 14.5 Changing IBP Settings 14.5.1 Changing a Pressure for Monitoring 1. Select the pressure you want to change to enter its setup menu. 2. Select [Label] and then select your desired label from the list. The already displayed labels cannot be selected. Label Description Label Description PA Pulmonary artery pressure CVP Central venous pressure Ao Aortic pressure LAP Left atrial pressure UAP Umbilical arterial pressure RAP Right atrial pressure BAP Brachial arterial pressure ICP Intracranial pressure FAP Femoral arterial pressure UVP Umbilical venous pressure Art Arterial blood pressure P1 to P4 Non-specific pressure label 14.5.2 Choosing the Pressure Alarm Source You can monitor for alarm conditions in systolic, diastolic and mean pressure, either singly or in parallel. In the setup menu for the pressure, select [Alm Source] and choose from: [Sys]: alarms are given only when the systolic pressure violates the alarm limits. [Dia]: alarms are given only when the diastolic pressure violates the alarm limits. [Mean]: alarms are given only when the mean pressure violates the alarm limits. [Sys&Mean]: alarms are given when the systolic or mean pressure violates the alarm limits. [Mean&Dia]: alarms are given when the mean or diastolic pressure violates the alarm limits. [Sys&Dia]: alarms are given when the systolic or diastolic pressure violates the alarm limits. [All]: alarms are given when the systolic or mean or diastolic pressure violates the alarm limits. 14-4 14.5.3 Changing Averaging Time The IBP value displayed on the monitor screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the patient monitor responds to changes in the patient’s blood pressure. Contrarily, the longer the averaging time is, the slower the patient monitor responds to changes in the patient’s blood pressure, but the measurement accuracy will be improved. For critically ill patients, selecting shorter averaging time will help understanding the patient’s state. To set the averaging time, in the setup menu for the pressure, select [Response] and toggle between [High], [Med] and [Low]. The corresponding averaging time is about 1 s, 8 s and 12 s respectively. 14.5.4 Setting the Pressure Unit In the setup menu for the pressure, select [Unit] and toggle between [mmHg], [cmH2O] and [kPa]. 14.5.5 Setting Wave Overlapping When two or more IBP channels are used, you can have IBP waves overlapped in the same area for a better view. In the waveform menu for the pressure, set [Wave Overlapping] as [On]. 14.5.6 Setting Up the IBP Wave In the waveform menu for the pressure, you can: Change the size of the pressure’s waveform by adjusting [Upper Scale], [Middle Scale] or [Lower Scale]. When [Auto Scaling] is set on, the size of the pressure’s waveform will be adjusted automatically. When IBP waveforms are overlapped, you can select the overlapped waveforms to enter the [Overlap IBP Waves] menu. In the [Overlap IBP Waves] menu, you can: In the [Arterial Pressure] and [Venous Pressure] area, adjust [Upper Scale], [Middle Scale] or [Lower Scale]. In the [Select Wave] area, select the IBP waveforms you want to overlap. 14-5 14.6 Measuring PAWP Pulmonary Artery Wedge Pressure (PAWP) values, used to assess cardiac function, are affected by fluid status, myocardial contractility, and valve and pulmonary circulation integrity. Obtain the measurement by introducing a balloon-tipped pulmonary artery flotation catheter into the pulmonary artery. When the catheter is in one of the smaller pulmonary arteries, the inflated balloon occludes the artery allowing the monitor to record changes in the intrathoracic pressures that occur throughout the respiration cycle. The pulmonary wedge pressure is the left ventricular end diastolic pressure when the airway pressure and valve function are normal. The most accurate PAWP values are obtained at the end of the respiration cycle when the intrathoracic pressure is fairly constant and the artifact caused by respiration is minimal. 14.6.1 Preparing to Measure PAWP 1. Prepare the same accessories as in the C.O. measurement. Connect the parts such as catheter, syringe, etc. following the C.O. measurement steps and use the balloon inflation port. 2. Connect the PAWP cable into the IBP connector on the monitor. Since PAWP is measured on PA, selecting [PA] as the IBP label is recommended. 3. Select the PA parameter window to enter its setup menu. Then, select [PAWP] to enter the PAWP measurement window. You can also enter the PAWP measurement window from the P1-P4 parameter window. 14-6 NOTE z After entering the PAWP measurement window, the monitor will turn off the PA alarm automatically. 14-7 14.6.2 Setting Up the PAWP Measurement 1. Wedge the flotation catheter into the pulmonary artery. Then inflate the balloon and pay attention to PA waveform changes on the screen. 2. After obtaining a stable PAWP waveform, press the [Freeze] key to freeze the waveform and deflate the balloon. 3. or You can adjust the PAWP scale to an appropriate position by adjusting beside the [Adjust] button. Press the [Confirm] key to save one PAWP measurement. 4. If you need to start a new measurement, select [Next Measure]. WARNING z Prolonged inflation can cause pulmonary hemorrhage, infarction or both. Inflate the balloon for the minimum time necessary to get an accurate measurement. z If the PAWP is greater than the PA (systolic), deflate the balloon and report the incident in accordance with hospital policy. Because the pulmonary artery could be accidentally ruptured, and the PAWP value derived will not reflect the patient’s hemodynamic state, but will merely reflect the pressure in the catheter or balloon. 14-8 14.7 Zeroing the 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).Zero whenever: A new transducer or adapter cable is used. You reconnect the transducer cable to the monitor. The monitor restarts. You doubt the readings. 1. Turn off the stopcock to the patient. Pressure transducer 3-way stopcock Pressure adapter cable Monitor 2. Vent the transducer to the atmospheric pressure by turning on the stopcock to the air. 3. In the setup menu for the pressure (e.g. Art), select [Zero Art >>]→[Zero]. During zero calibration, the [Zero] button appears dimmed. It recovers after the zero calibration is completed. 4. After the zero calibration is completed, close the stopcock to the air and open the stopcock to the patient. NOTE z Your hospital policy may recommend that the ICP transducer is zeroed less frequently than other transducers. 14-9 FOR YOUR NOTES 14-10 15 Monitoring Cardiac Output 15.1 Introduction The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using the right heart (atria) thermodilution method. A cold solution of known volume and temperature is injected into the right atrium through the proximal port of a pulmonary artery (PA) catheter. The cold solution mixes with the blood in the right ventricle and the change in blood temperature is measured with a thermistor at the distal end of the catheter in the pulmonary artery. The temperature change is displayed as a curve in the C.O. split screen, and the monitor calculates the C.O. value from this curve. The C.O. value is inversely proportional to the area under the curve. As cardiac output varies continuously, a series of measurements must be carried out to achieve a reliable C.O. average value. Always use the average of multiple thermodilution measurements for therapy decisions. The monitor is capable of storing 6 measurements. C.O. monitoring is restricted to adult patients only. 15.2 Understanding the C.O. Display The C.O. measurement is displayed on the monitor as numeric C.O. and TB in the C.O. parameter window as shown below. To enter the [C.O. Setup] menu, select the C.O. parameter window. Cardiac output Temperature unit Blood temperature 15-1 15.3 Influencing Factors The factors that affect cardiac output are: temperature of injectate solution, volume of injectate solution, patient’s baseline blood temperature, patient’s inspiratory/expiratory cycle, The degree of the catheter’s distal end in close proximity to the lung, the catheter itself, the patient rhythm and hemodynamic status, and any other rapid IV solutions which are infused while the C.O. measurement is being performed. Followings are some technique suggestions to obtain accurate C.O.: Injectate solution must be cooler than the patient’s blood. Inject solution rapidly and smoothly. Inject at end expiration. Wait 1 minute between injections to allow baseline to become stabilized. 15.4 Setting Up the C.O. Measurement WARNING z Use only accessories specified in this manual. Make sure that the accessories never come into contact with conductive parts. 1. Connect the C.O. cable to the C.O. connector on the monitor. 2. Interconnect the patient monitor, catheter and syringe as shown below. 15-2 Injectate C.O. cable Patient monitor PA catheter Syringe Stopcock Hole In-line probe Balloon inflation port Ice water 3. Check if the height and weight are appropriate for your patient in the [Patient Demographics] menu. Change if necessary. 4. Select the C.O. parameter window to enter the [C.O. Setup] menu. In the [C.O. Setup] menu: 5. Check that the correct computation constant is entered. To change the computation constant, select [Comp. Const] and then enter the correct value. When a new catheter is used, the computation constant should be adjusted in accordance with the manufacturer’s instructions for use. Switch [Auto Ti] on and the injectate temperature is automatically obtained. When [Auto Ti] is switched off, you can enter the injectate temperature in the [Manual Ti] field. Select [C.O. Measure] to enter the C.O. measurements window. 15-3 E A F B C D A. Currently measured numeric B. Currently measured C.O. curve C. Prompt message area D. Buttons E. Averaged values F. Measurement windows 6. When you see the message [Ready for New Measurement], select the [Start] button and then inject the solution within 4 seconds. As shown in the figure above, during the measurement, the currently measured thermodilution curve is displayed. At the end of the measurement, the thermodilution curve is transferred to one of the 6 measurement windows and the monitor prompts you to wait for a certain period of time before starting a new measurement. 7. Repeat step 6 until you have completed the measurements you want to perform. A maximum of 6 measurements can be stored. If you perform more than six measurements without rejecting any, the oldest will be automatically deleted when a seventh curve is stored. After the measurements are completed, you can select from the 6 measurement curves. Then, the system will automatically calculate and display the averaged C.O. and C.I. values. When injecting, the stopcock to the PA catheter is open and the stopcock to the injectate solution is closed. After the measurement is completed, turn off the stopcock to the PA catheter and turn on the stopcock to the injectate solution, and then draw the injectate solution into the injectate syringe. 15-4 In the buttons area, you can: Select [Start] to start a C.O. measurement. Select [Stop] to stop the current measurement. Select [Cancel] during a measurement to cancel the measurement. Selecting it after a measurement deletes the measured results. Select [X-Scale] to adjust the scale of the X-axis. Options for scale range are 30 s and 60 s. Select [Y-Scale] to adjust the scale of the Y-axis. Options for scale range are 0.5ºC, 1ºC and 2.0ºC. Select [Record] to print out the most recently-measured curve and numerics by the recorder. Select [Setup >>] to access the [C.O. Setup] menu. Select [Calc >>] to access the [Hemodynamic Calculation] menu. NOTE z During the cardiac output measurement, blood temperature alarms are inactive. 15.5 Measuring the Blood Temperature As shown below, the blood temperature is measured with a thermistor at the distal end of the catheter in the pulmonary artery. During C.O. measurements, blood temperature alarms are suppressed to avoid false alarms. They will automatically recover as soon as the C.O. measurements are completed. Pulmonary artery PA catheter Balloon Right atrium Thermistor Right ventricle 15-5 15.6 Changing C.O. Settings 15.6.1 Setting the Temperature Unit In the [C.O. Setup] menu, select [Temp Unit] to toggle between [ºC] and [ºF]. 15.6.2 Setting the Interval between Measurements To avoid inaccurate measurements, a certain period of time should be allowed for the blood temperature to become stable before starting a new measurement. To set the interval between two measurements, in the [C.O. Setup] menu, select [Interval (s)] and enter an appropriate value. Every time when a measurement is completed, the monitor will count down the remaining time and give corresponding prompt messages. A new measurement will not start until the time is elapsed. 15-6 16 Monitoring Carbon Dioxide 16.1 Introduction CO2 monitoring is a continuous, non-invasive technique for determining the concentration of CO2 in the patient’ airway by measuring the absorption of infrared (IR) light of specific wavelengths. The CO2 has its own absorption characteristic and the amount of light passing the gas probe depends on the concentration of the measured CO2. When a specific band of IR light is passed through respiratory gas samples, some of IR light will be absorbed by the CO2 molecules. The amount of IR light transmitted after it has been passed through the respiratory gas sample is measured with a photodetector. From the amount of IR light measured, the concentration of CO2 is calculated There are two methods for measuring CO2 in the patient’s airway: 1. Mainstream measurement uses a CO2 sensor attached to an airway adapter directly inserted into the patient’s breathing system. 2. Sidestream/Microstream measurement samples expired patient gas at a constant sample flow from the patient’s airway and analyzes it with a CO2 sensor built into the CO2 module. The measurement provides: 1. A CO2 waveform. 2. End tidal CO2 value (EtCO2): the CO2 value measured at the end of the expiration phase. 3. Fraction of inspired CO2 (FiCO2): the smallest CO2 value measured during inspiration. 4. Airway respiration rate (awRR): the number of breaths per minute, calculated from the CO2 waveform. 16-1 16.2 Preparing to Measure CO2 16.2.1 Using a Sidestream CO2 Module 1. Attach the watertrap to the module and then connect the CO2 components as shown below. Watertrap fixer Sampling line Watertrap 2. By default, the sidestream CO2 module is in standby mode. Access the [CO2 Setup] menu to set [Operating Mode] to [Measure]. The [CO2 Startup] message appears on the screen. 3. After start-up is finished, the CO2 module needs time to warm up to reach the operating temperature. The message [CO2 Sensor Warmup] is displayed. If you perform CO2 measurements during warm-up, the measurement accuracy may be compromised. 4. After warm-up is finished, you can perform CO2 measurements. NOTE z To extend the lifetime of the watertrap and module, disconnect the watertrap and set the operating mode to standby mode when CO2 monitoring is not required. 16-2 CAUTION z The watertrap collects water drops condensed in the sampling line and therefore prevents them from entering the module. If the collected water reaches a certain amount, you should drain it to avoid blocking the airway. z The watertrap has a filter preventing bacterium, water and secretions from entering the module. After a long-term use, dust or other substances may compromise the performance of the filter or even block the airway. In this case, replace the watertrap. It is recommended to replace the watertrap once every two months, or when the watertrap is found leaky, damaged or contaminated. 16.2.2 Using a Microstream CO2 module 1. Connect the sampling line to the module and then connect the CO2 components as shown below. Connector for sampling line Sampling line 2. By default, the microstream CO2 module is in measure mode. The message [CO2 Sensor Warmup] appears on the screen when the CO2 module is plugged. 3. After warm-up, you can perform CO2 measurements. 16-3 16.2.3 Using a Mainstream CO2 module 1. Connect the sensor to the module. 2. By default, the microstream CO2 module is in measure mode. The message [CO2 Sensor Warmup] appears on the screen when the CO2 module is plugged. 3. After warm-up is finished, connect the transducer to the airway adapter. 4. Perform a zero calibration per the Zeroing the Sensor section. 5. After the zero calibration is finished, connect the airway as shown below. Connect to the monitor Sensor Airway adapter Connect to the patient 6. Make sure there are no leakages in the airway and then start a measurement. NOTE z Always position the sensor with the adapter in an upright position to avoid collection of fluids on the windows of the adapter. Large concentrations of fluids at this point will obstruct gas analysis. 16-4 16.3 Changing CO2 Settings 16.3.1 Entering the Standby Mode The standby mode of the CO2 module relates to the standby mode of the monitor as follows: If the monitor enters the standby mode, the CO2 module will also enter the standby mode. If the monitor exits the standby mode, the CO2 module will also exit the standby mode. If the CO2 module enters or exits the standby mode, it will not affect the monitor. To enter or exit the standby mode manually, select [Operating Mode] in the [CO2 Setup] menu and toggle between [Standby] and [Measure]. For the microstream CO2 module, you can set a period of time after which the CO2 module enters the standby mode if no breath is detected since the CO2 module is powered on or the CO2 module switches to the measure mode or the automatic standby time is re-set. To set the standby time, in the [CO2 Setup] menu, select [Auto Standby (min)] and then select the appropriate setting. 16.3.2 Setting the Pressure Unit In the [CO2 Setup] menu, select [Press. Unit] and toggle between [mmHg], [%] and [kPa]. 16.3.3 Setting up Gas Compensations WARNING z Make sure that the appropriate compensations are used. Inappropriate compensations may cause inaccurate measurement values and result in misdiagnosis. For the sidestream CO2 module: 1. Select [CO2 Setup]. 2. According to the actual condition, set the concentration required for the following compensations: [O2 Compen] [N2O Compen] [Des Compen] 16-5 For the microstream CO2 module, gas compensations are not required. For the maintream CO2 module, in the [CO2 Setup] menu, respectively select: [Balance Gas] and toggle between [Room Air], [N2O] and [He]. Select [Room Air] when air predominates in the ventilation gas mixture, [N2O] when N2O predominates in the ventilation gas mixture, and [He] when He predominates in the ventilation gas mixture. [O2 Compen] and then select [Off] or an appropriate setting according to the amount of O2 in the ventilation gas mixture. When the amount of O2 is less than 30%, you’d better switch this compensation off. [AG Compen] and enter the concentration of anesthetic gas present in the ventilation gas mixture. This could compensate for the effect of AG on the readings. 16.3.4 Setting up Humidity Compensation Sidestream and microstream CO2 modules are configured to compensate CO2 readings for either Body Temperature and Pressure, Saturated Gas (BTPS), to account for humidity in the patient’s breath, or Ambient Temperature and Pressure, Dry Gas (ATPD). 1. ATPD: Pco 2 (mmHg) = CO2 (vol%) × Pamb / 100 2. BTPS: PCO 2 ( mmHg ) = CO2 (vol %) × ( Pamb − 47 ) / 100 Where, PCO 2 = partial pressure, vol % = CO2 concentration, Pamb = ambient pressure, and unit is mmHg. As the mainstream CO2 module has a built-in heating component to prevent water vapor from condensing, setting humidity compensation is not needed. For the sidestream and microstream CO2 module, you can set the humidity compensation on or off according to the actual condition. To set the humidity compensation:: 1. In the [CO2 Setup] menu, select [Humidity Compen]. 2. Select either [On] for BTPS or [Off] for ATPD, depending on which compensation applies. 16-6 16.3.5 Setting the Apnea Alarm Delay In the [CO2 Setup] menu, select [Adjust CO2 Limits >>] → [Apnea Time] and then select the appropriate setting. The monitor will alarm if the patient has stopped breathing for longer than the preset apnea time. 16.3.6 Choosing a Time Interval for Peak-Picking For microstream and mainstream CO2 modules, you can select a time interval for picking the highest CO2 as the EtCO2 and the lowest one as the FiCO2. In the [CO2 Setup] menu, select [Max Hold] and toggle between [Single Breath], [10 s], [20 s] and [30 s]. [Single Breath]: EtCO2 and FiCO2 are calculated for every breath. [10 s], [20 s] or [30 s]: EtCO2 and FiCO2 are calculated using 10, 20 or 30 seconds of data. 16.3.7 Setting the Flow Rate For the sidestream CO2 module, you can change the sampling rate of respiratory gas in the patient’s airway by setting the flow rate. To set the flow rate, enter the [CO2 Setup] menu and select an appropriate setting from [Flow Rate]. WARNING z Consider the patient’s actual bearing capability and select the appropriate flow rate when setting the flow rate. 16.3.8 Setting up the CO2 Wave In the [CO2 Waveform] menu, you can: Select [Wave Type] and toggle between [Draw] and [Fill]. [Draw]: The CO2 wave is displayed as a curved line. [Fill]: The CO2 wave is displayed as a filled area. Change the size of the CO2 waveform by adjusting the wave [Scale]. 16-7 16.4 Setting Barometric Pressure Compensation The mainstream CO2 module does not have the function of automatic barometric pressure compensation. For the mainstream CO2 module, the default barometric pressure is 760 mmHg. You must modify the barometric pressure based on the actual situation as follows: 1. In the main menu, select [Maintenance >>] → [User Maintenance >>] → enter the required password and then select [Maintain CO2] from the popup menu. 2. Select [Barometric Pressure] and then enter the value of barometric pressure to which the patient monitor is exposed to. WARNING z Be sure to set the altitude properly before using the mainstream CO2 module. Improper settings will result in erroneous CO2 reading. NOTE z Both sidestream and microstream CO2 modules are configured with automatic barometric pressure compensation function. 16.5 Measurement Limitations The following factors may influence the accuracy of measurement: Leaks or internal venting of sampled gas Mechanical shock Cyclic pressure up to 10 kPa (100 cmH2O) Other sources of interference, if any 16.6 Troubleshooting the Sidestream CO2 Sampling System When the sampling system of the sidestream CO2 module works incorrectly, check if the sampling line is kinked. If not, remove it from the watertrap. If the monitor gives a message indicating the airway still works incorrectly, it indicates that the watertrap must have been blocked, and you should replace with a new one. Otherwise, you can determine that the sampling line must have been blocked. Replace with a new sampling line. 16-8 16.7 Removing Exhaust Gases from the System WARNING z Anesthetics: When using the Sidestream or Microstream CO2 measurement on patients who are receiving or have recently received anesthetics, connect the outlet to a scavenging system, or to the anesthesia machine/ventilator, to avoid exposing medical staff to anesthetics. To remove the sample gas to a scavenging system, connect an exhaust tube to the gas outlet connector of the module. 16.8 Zeroing the Sensor The zero calibration eliminates the effect of baseline drift during CO2 measurement exerted on the readings and therefore maintains the accuracy of the CO2 measurements. 16.8.1 For Sidestream and Microstream CO2 Modules For sidestream and microstream CO2 modules, a zero calibration is carried out automatically when necessary. You can also start a manual zero calibration if necessary. To manually start a zero calibration, select [Start Zero Cal.] in the [CO2 Setup] menu. Disconnecting the patient airway is not required when performing a zero calibration. 16.8.2 For Mainstream CO2 Modules For mainstream CO2 modules, zero the sensor whenever: 1. A new adapter is used; 2. You reconnect the sensor to the module; 3. You see the message [CO2 Zero Required].In this case, check the airway adapter for any blockage, e.g. mucus, etc. If a blockage is detected, clear or replace the adapter. To zero the sensor, follow this procedure: 1. Connect the sensor to the module. 2. In the [CO2 Setup] menu, set the [Operating Mode] to [Measure]. The message [CO2 Sensor Warmup] is displayed. 16-9 3. After warm-up is finished, connect the sensor to a clean, dry airway adapter. The adapter should be vented to the air and isolated from CO2 sources, such as ventilator, the patient’s breathing, your own breathing, etc. 4. Select [Start Zero Cal.] in the [CO2 Setup] menu. The message [CO2 Zero Running] is displayed. 5. It takes about 15 to 20 seconds. The message disappears when the zero calibration is completed. WARNING z When perform a zero calibration during the measurement, disconnect the transducer from the patient’s airway first. 16.9 Calibrating the Sensor For sidestream or microstream CO2 modules, a calibration should be performed once every year or when the readings go far beyond the range. For maintream CO2 module, no calibration is needed. For details, refer to the chapter Maintenance. 16.10 Oridion Information This trademark is registered in Israel, Japan, German and America. Oridion Patents This device and the CO2 sampling consumables designed for use herewith is covered by one or more of the following USA patents: 4,755,675; 5,300,859; 5,657,750; 5,857,461 and international equivalents. USA and international patents pending. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized CO2 sampling consumables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device and/or CO2 sampling consumable. 16-10 17 Monitoring AG 17.1 Introduction The anesthetic gas (AG) module measures the patient’s anesthetic and respiratory gases, and can be integrated into the optional O2 module. The AG module determines the concentration of certain gases using the infrared (IR) light absorption measurement. The gases that can be measured by the AG module absorb IR light. Each gas has its own absorption characteristic. The gas is transported into a sample cell, and an optical IR filter selects a specific band of IR light to pass through the gas. For multiple gas measurement, there are multiple IR filters. The higher the concentration of gas in a given volume the more IR light is absorbed. This means that higher concentration of IR absorbing gas cause a lower transmission of IR light. The amount of IR light transmitted after it has been passed though an IR absorbing gas is measured. From the amount of IR light measured, the concentration of gas present can be calculated. Oxygen does not absorb IR light as other breathing gases and is therefore measured relying on its paramagnetic properties.Inside the O2 sensor are two nitrogen-filled glass spheres mounted on a strong rare metal taut-band suspension. This assembly is suspended in a symmetrical non-uniform magnetic field. In the presence of paramagnetic oxygen, the glass spheres are pushed further away from the strongest part of the magnetic field. The strength of the torque acting on the suspension is proportional to the oxygen concentration. From the strength of the torque, the concentration of oxygen is calculated. There are two types of AG modules: AION 02 type, which cannot identify anesthetic gases automatically. AION 03 type, which can identify two anesthetic gases in a mixture automatically and distinguish between them according to their proportion for display as the primary and secondary anesthetis agent. The AG module provides end tidal (Et) and inspired (Fi) values for the following gases: End tidal CO2 value (EtCO2): the CO2 value measured at the end of the expiration phase. N2O. O2 : optional. AA: represents Des (desflurane), Iso (isoflurane), Enf (enflurane), Sev (sevoflurane), or Hal (halothane). Airway respiration rate (AwRR): the number of breaths per minute (rpm). 17-1 WARNING z To avoid explosion hazard, do not use flammable anesthetic agent such as ether and cyclopropane for this equipment. NOTE z The AG module is configured with automatic barometric pressure compensation function. 17.2 Preparing to Measure AG 1. Select an appropriate watertrap according to patient category and attach it to the module. 2. Connect the gas sample line to the connector of the watertrap. 3. Connect the other end of the gas sampling line to the patient via the airway adapter. 4. Connect the exhaust tube to the gas outlet on the module to scavenge the sample gas to the waste gas disposal system. AG module Patient monitor Airway adapter Exhaust tube Gas sampling line Vent to the patient 5. The patient monitor prompts [AG Startup].After startup is finished, [AG Warmup] is prompted. Then the AG module enters the warm up status. After warm-up is finished, you can perform AG measurements. 17-2 CAUTION z Position the airway adapter so that the part connecting to the gas sample line is pointing upwards. This prevents condensed water from passing into the gas sample line and causing an occlusion. z The watertrap collects water drops condensed in the sampling line and therefore prevents them from entering the module. If the collected water reaches the time to empty the watertrap , you should drain it to avoid blocking the airway. z The watertrap has a filter preventing bacterium, water and secretions from entering the module. After a long-term use, dust or other substances may compromise the performance of the filter or even block the airway. In this case, replace the watertrap. Replacing the watertrap once a month is recommended. WARNING z Do not apply adult watertrap to the neonate patient. Otherwise, patient injury could result. z Make sure that the connections are tight. Any leak in the system can result in erroneous readings due to ambient air mixing with patient gases. z Using high frequency electrosurgical equipment may increase the risk of skin burns. In this case, be careful to use antistatic or conductive masks or breathing tubes. 17-3 17.3 Understanding the AG Display The AG module can send waves and numerics for all measured anesthetic gases for display on the monitor, including: CO2, O2, N2O and AA waves awRR: airway respiratory rate MAC: minimal alveolar concentration End tidal (Et) and fraction of inspired (Fi) numerics for CO2, O2, N2O and AA The patient monitor can display up to four anesthetic gas waveforms simultaneously, which are CO2, AA, O2 and N2O. When the AG module is AION 03, the AA waveform area displays the primary anesthetic gas’s waveform, and the parameter area displays end tidal (Et) and inspired (Fi) values for two anesthetic gases. When O2 module does not exist, no O2 waveform will be displayed. When O2 module exists, the O2 waveform will be displayed only when the O2 waveform is currently switched on. When too many other waveforms are displayed, O2 waveform will not be displayed even if the O2 waveform is switched on. In this case, you may need to switch off some other waveforms. 17-4 17.4 MAC Values Minimum alveolar concentration (MAC) is the minimum concentration of the agent in the alveoli. It is a basic index to indicate the depth of anesthesia. The standard ISO 21647 defines MAC as this: alveolar concentration of an inhaled anesthetic agent that, in the absence of other anesthetic agents and at equilibrium, prevents 50% of patients from moving in response to a standard surgical stimulus. Minimum alveolar concentration (MAC) values are listed below: Agent DES ISO ENF SEV HAL N2O 1 MAC 7.3%* 1.15% 1.7% 2.1% 0.77% 105%** * The data is taken from a patient of 25 years old. ** indicates 1 MAC nitrous oxide can only be reached in hyperbaric chamber. NOTE z The MAC values shown in the table above are those published by the U.S. Food and Drug Administration for a healthy 40-year-old adult male patient. z In actual applications, the MAC value may be affected by age, weight and other factors. The formula to calculate the MAC value is as follows: N −1 MAC = ∑ i =0 EtAgent i AgentVoli Where N is the number of all agents (including N2O) that the AG module can measure, EtAgenti is the concentration of each agent and AgentVoli is the concentration of each agent at 1 MAC. For example, the AG module measures there are 4% of Des, 0.5% of Hal and 50% of N2O in the patient’s end-tidal gas: MAC = 4.0% 0.5% 50% + + = 1.67 7.3% 0.77% 105% NOTE z The formula mentioned above is intended for adult patients only. 17-5 17.5 Changing AG Settings 17.5.1 Selecting an Anesthetic Gas for Monitoring As the AION 02-type module cannot automatically identify 5 anesthetic gases, you need to select an anesthetic gas before use. To select the anesthetic gas, in the [Gas Setup] menu, select [Agent] and then select the appropriate setting. 17.5.2 Setting Gas Unit For N2O and AA, the unit of the measured gas is fixed to “%”. For EtCO2, select [CO2 Unit] from the [CO2 Setup] menu and toggle between [mmHg], [%] and [kPa]. For AG module integrating O2 module, you can set [O2 unit] in the [Gas Setup] menu to [mmHg], [%] or [kPa]. 17.5.3 Setting the Apnea Alarm Delay In the setup menu for any gas, select [Apnea Time] and select the appropriate setting. The monitor will alarm if the patient has stopped breathing for longer than the preset apnea time. 17.5.4 Changing the Sample Flow Rate In the setup menu for any gas, select [Flow Rate] and then choose: [200 ml/min], [150 ml/min] or [120 ml/min] for adult and pediatric patients; [120 ml/min], [90 ml/min] or [70 ml/min] for neonatal patients. 17.5.5 Setting up the O2 Compensation If the AG module does not incorporate the O2 module, you need to manually select [O2 Compen] and then select [Off] or an appropriate setting according to the amount of O2 in the ventilation gas mixture. When the amount of O2 is less than 30%, you’d better switch this compensation off. If the AG module incorporates the O2 module, the system will directly use the O2 concentration detected by the O2 module to make compensation. At this time, the [O2 Compen] in the setup menu for any gas is fixed to [Off]. 17-6 17.5.6 Entering the Standby Mode For the AG module, the default operating mode is measure. When you set the AG module to the standby mode, the AG gas sample intake pump automatically sets the sample flow rate to zero. When exiting the standby mode, the AG module continues to work at preset sample flow rate with no need to warm up again. After nearly 1 minute, the module enters the full accuracy mode. The standby mode of the CO2 module relates to the standby mode of the monitor as follows: If the monitor enters the standby mode, the AG module will also enter the standby mode. If the monitor exits the standby mode, the AG module will also exit the standby mode. If the CO2 module enters or exits the standby mode, it will not affect the monitor. To enter or exit the standby mode manually, in the agent’s setup menu, select [Operating Mode] and then toggle between [Standby] and [Measure].You can also set a period of time after which the AG module enters the standby mode automatically if no breath is detected since the last detected breath. .To set the standby time, in the agent’s setup menu, select [Auto Standby] and then select the appropriate setting. 17.5.7 Setting up the AG Wave Select a gas’ waveform area to enter its waveform menu. In this menu, you can: Select [Wave Type] and toggle between [Draw] and [Fill]. [Draw]: The CO2 wave is displayed as a curved line. [Fill]: The CO2 wave is displayed as a filled area. Change the size of the waveform by adjusting the [Scale]. 17.6 Changing the Anesthetic Agent If the anesthetic agent administered to the patient changes, a mixture of both gases is detected by the AG module during the transition. The time needed to complete the exchange depends on the type of anesthesia (low flow or high flow), and the characteristics of the agents administered (pharmacokinetics). During the exchange, no prompt message will be given and MAC value may be inaccurate. The AION 02-type AG module cannot identify anesthetic agents automatically. Accordingly, you must change the setting of [Agent] in the corresponding menu to achieve the consistency between the preset anesthetic agent and the actually used one. 17-7 The AION 03-type AG module can identify two anesthetic agents automatically. When the proportion of the primary and secondary anesthetic agents in the mixture changes and the secondary anesthetic agent becomes dominant, the primary and seconday anesthetic agents will be exchanged for display and a physiological alarm may be triggered. 17.7 Measurement Limitations The following factors may influence the accuracy of measurement: Leaks or internal venting of sampled gas Mechanical shock Cyclic pressure up to 10 kPa (100 cmH2O) Other sources of interference, if any 17.8 Troubleshooting 17.8.1 When the Gas Inlet is Blocked If the gas inlet (including watertrap, sampling line and airway adapter) is occluded by condensed water, the message [AG Airway Occluded] will appear. To remove the occlusion: Check the airway adapter for an occlusion and replace if necessary. Check the sampling line for an occlusion or kinking and replace if necessary. Check the watertrap for a build up of water. Empty the watertrap. If the problem persists, replace the watertrap. 17.8.2 When an Internal Occlusion Occurs Condensed water may enter the module and cause contamination and/or internal occlusions. In this case, the message [AG Airway Occluded] will be displayed. To remove the occlusion: Check for any occlusion in the gas inlet and/or outlet system. If the problem persists, internal occlusions may exist. Contact your service personnel. 17-8 17.9 Removing Exhaust Gases from the System WARNING z Anesthetics: When using the AG measurement on patients who are receiving or have recently received anesthetics, connect the outlet to a scavenging system, or to the anesthesia machine/ventilator, to avoid exposing medical staff to anesthetics. To remove the sample gas to a scavenging system, connect an exhaust tube to the gas outlet connector of the module. 17-9 FOR YOUR NOTES 17-10 18 Freezing Waveforms During patient monitoring, the freeze feature allows you to freeze the currently displayed waveforms on the screen so that you can have a close examination of the patient’s status. Besides, you can select any frozen waveform for recording. 18.1 Freezing Waveforms 1. To freeze waveforms, select the hardkey on the monitor’s front, 2. The system closes the displayed menu (if any), and opens the [Freeze] menu. 3. All displayed waveforms are frozen, i.e. the waveforms stop being refreshed or scrolling. Data in the parameter area update as usual. The freeze feature exerts no effect on the split-screen view of minitrends, oxyCRG and other patients. 18.2 Viewing Frozen Waveforms To view the frozen waveforms, you can either: Select the [Scroll] button and then rotate the Knob clockwise or counter-clockwise, or Directly select the touchscreen. or beside the [Scroll] button using a mouse or through the The frozen waveforms will scroll left or right accordingly. And meanwhile, at the lower right corner of the bottommost waveform, there is an upward arrow. The freeze time is displayed below the arrow and the initial frozen time is [0 s]. With the waveforms scrolling, the freeze time changes at intervals of 1 second. This change will be applied for all waveforms on the screen. 18-1 18.3 Unfreezing Waveforms To unfreeze the frozen waveforms, you can either: Select [Exit] in the [Freeze] menu, Select the Perform any operation through which the screen will re-arrange or a menu will pop up, hardkey on the monitor’s front, or such as plugging in or out a module, pressing the hardkey, etc. 18.4 Recording Frozen Waveforms 1. In the [Freeze] menu, select, in turn, [Wave 1], [Wave 2] and [Wave 3] and then select your desired waveforms. 2. Select the [Record] button. The selected waveforms and all numerics at the freeze time are printed out by the recorder. 18-2 19 Review 19.1 Accessing Respective Review Windows 1. In the main menu, select [Review >>]. 2. Select [Graphic Trends], [Tabular Trends], [NIBP], [Arrh. Events], [Alarms], [Full Disclosure] or [12-Lead Analysis] to access their respective review windows. For details about reviewing arrhythmia events and interpretation of resting 12-lead ECG results, refer to the chapter Monitoring ECG. 19-1 19.2 Reviewing Graphic Trends In the [Review] menu, select [Graphic Trends] to access the following window. B A C D E F A. Parameter combo box B. Slider C. Parameter value D. Parameter scale E. Graphic trends F. Time axis In this review window: To select parameters for viewing, you can either: Select respective parameter combo boxes and then select your desired parameters, or Select [Trend Group] and then select a group from the popup list, or Select [Select Parameter>>] and then select your desired parameters from the popup menu. You can set the start time of the trends you want to view by selecting [Start Time]. 19-2 You can change the resolution of the trend data by selecting [Interval] and then selecting the appropriate setting: [1 s]: select to view up to 1 hours of graphic trends at 1-second resolution. [5 s]: select to view up to 8 hours of graphic trends at 5-second resolution. [1 min], [5 min] or [10 min]: select to view up to 96 hours of graphic trends at 1-, 5-, or 10-minute resolution. To browse the graphic trends, you can either: Select or to move the cursor one step to the left or right to navigate through the graphic trends, or Select or to move the cursor one page to the left or right to navigate through the graphic trends. A time indicating your current position is displayed above the cursor. Measurement numerics corresponding to the cursor location appear at the left side of the [Graphic Trends] window, and change as the cursor moves. By selecting the [Record] button, you can print out the currently displayed graphic trends by the recorder. By selecting the [Print] button, you can print out the currently displayed graphic trends by the printer. 19-3 19.3 Reviewing Tabular Trends In the [Review] menu, select [Tabular Trends] to access the following window. In this review window: To select parameters for viewing, you can either: Select [Trend Group] and then select a group from the popup list, or Select the [Define Group>>] button and then select the parameters you want to view from the popup menu. You can set the start time of the trends you want to view by selecting [Start Time]. 19-4 You can change the resolution of the trend data by selecting [Interval] and then selecting the appropriate setting: [5 s] or [30 s]: select to view up to 8 hours of tabular trends at 5- or 30-second resolution. [1 min], [5 min], [10 min], [30 min] or [1 h]: select to view up to 96 hours of tabular trends at your selected resolution. To browse the tabular trends, you can either: Select or beside the horizontal scrollbar to drag the scrollbar left or right to navigate through the trend database, or Select Select or beside the vertical scrollbar to drag the scrollbar up or down to view more measurement values, or Select or or to scroll left or right to navigate through the trend database. to scroll up or down to view more measurement values. By selecting the [Record] button, you can print out the currently displayed tabular trends by the recorder. By selecting beside the [Record] button, you can access the [Record Setup] menu and set the start and end time of the tabular trends you want to record. This feature is not available when reviewing a history patient. By selecting the [Print] button, you can print out the currently displayed tabular trends by the printer. 19-5 19.4 Reviewing NIBP Measurements In the [Review] menu, select [NIBP] to access the following window. This window displays systolic pressure, diastolic pressure, mean pressure, pulse rate and time for each measurement. Among them, pulse rate comes from NIBP measurements. Besides, the total number of measurements is displayed at the lower left corner. In this review window: Up to 6 measurements can be displayed at a time. You can select the [Scroll] button to view more measurements. By selecting the [Record] button, you can print out the currently displayed NIBP measurements by the recorder. beside the [Record] button, you can access the [Record Setup] By selecting menu and set the start and end time of the tabular trends you want to record. This feature is not available when reviewing a history patient. 19-6 or beside 19.5 Reviewing Alarms When a measurement alarm occurs, all relative measurement numerics at the alarm time and related waveforms 2, 4 or 8 seconds respectively before and after the alarm trigger time are stored. To review the stored alarms, select [Review]→[Alarms] to access the following window. In this window: You can set a time as the index for finding your desired alarm event. If you set a time that is too early, the earliest alarm event will be recalled. If you set a time that is too late, the last alarm event will be recalled. You can view the desired measurement alarms by selecting [Event] and then selecting the measurement whose alarms you want to view. [All] includes all measurements. To select an alarm event for viewing, you can either: Select the or button, or Directly select your desired alarm event on the screen. Select an alarm event then [Waveforms], and you can enter the following window. The waveforms related to this alarm event are displayed in the waveform area, and the parameter values happened at the event moment are displayed in the parameter area. 1 2 1. Waveform area 2. Parameter area 19-7 You can select By selecting the [Record] button, you can print out the currently displayed alarm events by the recorder. By selecting the [Print] button, you can print out the currently displayed alarm events by the printer. You can select [Full Disclosure] to access the waveform review window. However, if you do not save waveforms beforehand, the message [Searching Data Failed!] will be displayed. or beside [Scroll] to navigate through the waveforms. 19.6 Reviewing Waveforms In the [Review] menu, select [Full Disclosure] to access the following window. A B D C E A. Parameter combo box B. Slider D. Full-disclosure waveforms E. Time axis 19-8 C. Parameter value In this review window: Before reviewing full-disclosure waveforms, your monitor must be equipped with an external storage card (only the CF storage card is supported so far) and you need to save waveforms first. To review full-disclosure waveforms, select [Save Waves >>] and then select the parameters whose waveforms you want to view. You can set the start time of the trends you want to view by selecting [Start Time]. You can select a waveform you want to view from either parameter combo box. To view the waveforms, you can either: Select or beside the [Scroll] button to move the cursor one step left or right to navigate through the waveforms, or Select or the waveforms. to move the cursor one page left or right to navigate through A time indicating your current position is displayed above the cursor. Measurement numerics corresponding to the cursor location are displayed at the left side of the [Waveforms] window, and change as the cursor is moved. You can change the wave gain by selecting [Gain] and then selecting the appropriate setting. The number of waveforms displayed in this window is subject to the wave gain. You can change the waveform sweep speed by selecting [Sweep] and then selecting the appropriate setting. By selecting the [Record] button, you can print out the first three waveforms and measurement numerics by the recorder. By selecting the [Print] button, you can print out the waveforms and measurement numerics by the printer. 19-9 FOR YOUR NOTES 19-10 20 Calculations 20.1 Introduction The calculation feature is available with your patient monitor. The calculated values, which are not directly measured, are computed based on the values you provide. Your can perform the following calculations: Dose Calculations Oxygenation Calculations Ventilation Calculations Hemodynamic Calculations Renal Calculations To perform a calculation, select [Calc >>] in the main menu or the [Calc] QuickKey and then select the calculation you want to perform. NOTE z The calculation feature is independent of other monitoring functions and can be therefore used for patients being monitored by other monitors. Any operation in a calculation window does not affect the patient monitoring by the local patient monitor. WARNING z After the calculation is finished, verify the entered values are correct and the calculated values are appropriate. We assume no responsibility for any consequences caused by wrong entries and improper operations. 20-1 20.2 Dose Calculations 20.2.1 Performing Calculations 1. In the main menu, select [Calc >>]→[Dose >>]. 2. Select, in turn, [Patient Cat.] and [Drug Name] and then select the appropriate settings. The dose calculation program has a library of commonly used drugs, of which Drug A through Drug E are for those not specified in this library. Drug A, B, C, D, E Isuprel Aminophylline Lidocaine Dobutamine Nipride Dopamine NItroglycerin Epinephrine Pitocin Heparin 3. The system gives a set of default values when the above steps are finished. However, these values cannot be used as the calculated values. The user must enter values following the doctor’s instructions, and then the calculated values can only be used 4. Enter the patient’s weight. 5. Enter other values. 6. Verify if the calculated values are correct. 20.2.2 Selecting the Proper Drug Unit Each drug has its fixed unit or unit series. Among a unit series, one unit may change to another automatically depending on the entered value. The units for each drug are as follows: Drug A, B, C, Aminophylline, Dobutamine, Dopamine, Epinephrine, Isuprel, Lidocaine, Nipride and NItroglycerin use the unit series: g, mg and mcg. Drug D, Heparin and Pitocin use the unit series: Unit, KU (kilo units) and MU (million units). Drug E uses the unit: mEq (milli-equivalents). You must select the proper drug name (A, B, C, D or E) according to the units when you define a drug not listed in this library. 20-2 20.2.3 Titration Table To open the titration table, select [Titration Table >>] in the dose calculation window after the dose calculation is finished. In the titration table, when you change: [Reference] [Interval] [Dose Type] The titrated values change accordingly. You can also: Select Select [Record] to print out the currently displayed titrated values by the recorder. or , or or beside the vertical scrollbar to view more values. 20.3 Oxygenation Calculations 20.3.1 Performing Calculations 1. In the main menu, select [Calc >>]→[Oxygenation >>]. 2. Enter values for calculation. 3. Select the [Calculate] button. The system performs a calculation per the current settings and displays the calculated values. The values that exceed the range are displayed in yellow background. You can select [Range] to view its normal range in the unit field. For those who are within the range, their unit fields appear blank. Invalid values are displayed as [---]. In the [Oxygenation Calculation] window, you can: Change the pressure unit, Hb unit and oxygen content unit by selecting [Press. Unit], [Hb Unit] and [OxyCont Unit] and then selecting the appropriate settings. The changes take effect automatically. Trigger a recording by selecting the [Record] button. The currently displayed renal calculations are printed out by the recorder. Review the previously performed calculations by selecting [Review]. 20-3 20.3.2 Entered Parameters Abbreviation Unit Full spelling C.O. L/min cardiac output FiO2 % percentage fraction of inspired oxygen PaO2 mmHg partial pressure of oxygen in the arteries PaCO2 mmHg partial pressure of carbon dioxide in the arteries SaO2 % arterial oxygen saturation PvO2 mmHg partial pressure of oxygen in venous blood SvO2 % venous oxygen saturation Hb g/L hemoglobin CaO2 ml/L arterial oxygen content CvO2 ml/L venous oxygen content VO2 ml/min oxygen consumption RQ None respiratory quotient ATMP mmHg atmospheric pressure Height cm height Weight kg weight 20.3.3 Calculated Parameters Abbreviation Unit Full spelling BSA m2 body surface area VO2 calc ml/min oxygen consumption C(a-v)O2 ml/L arteriovenous oxygen content difference O2ER % oxygen extraction ratio DO2 ml/min oxygen transport PAO2 mmHg partial pressure of oxygen in the alveoli AaDO2 mmHg alveolar-arterial oxygen difference CcO2 ml/L capillary oxygen content Qs/Qt % venous admixture C.O. calc L/min calculated cardiac output 20-4 20.4 Ventilation Calculations 20.4.1 Performing Calculations 1. In the main menu, select [Calc >>]→[Ventilation >>]. 2. Enter values for calculation. 3. Select the [Calculate] button. The system performs a calculation per the current settings and displays the calculated values. The values that exceed the range are displayed in yellow background. You can select [Range] to view its normal range in the unit field. For those who are within the range, their unit fields appear blank. Invalid values are displayed as [---]. In the [Ventilation Calculation] window, you can: Change the pressure unit by selecting [Press. Unit] and then selecting the appropriate setting. Corresponding pressure values shall convert and update automatically. Trigger a recording by selecting the [Record] button. The currently displayed renal calculations are printed out by the recorder. Review the previously performed calculations by selecting [Review]. 20.4.2 Entered Parameters Abbreviation Unit Full spelling FiO2 % percentage fraction of inspired oxygen RR rpm respiration rate PeCO2 mmHg partial pressure of mixed expiratory CO2 PaCO2 mmHg partial pressure of carbon dioxide in the arteries PaO2 mmHg partial pressure of oxygen in the arteries TV ml tidal volume RQ None respiratory quotient ATMP mmHg atmospheric pressure 20-5 20.4.3 Calculated Parameters Abbreviation Unit Full spelling PAO2 mmHg partial pressure of oxygen in the alveoli AaDO2 mmHg alveolar-arterial oxygen difference Pa/FiO2 mmHg oxygenation ratio a/AO2 % arterial to alveolar oxygen ratio MV L/min minute volume Vd ml volume of physiological dead space Vd/Vt % physiologic dead space in percent of tidal volume VA L/min alveolar volume 20.5 Hemodynamic Calculations 20.5.1 Performing Calculations 1. In the main menu, select [Calc >>]→[Hemodynamic >>]. 2. Enter values for calculation. 3. For a patient who is being monitored, [HR], [Art mean], [PA mean] and [CVP] are automatically taken from the currently measured values. If you just have performed C.O. measurements, [C.O.] is the average of multiple thermodilution measurements. [Height] and [Weight] are the patient’s height and weight you have entered. If the monitor does not provide these values, their fields appear blank. For a patient who is not being monitored, confirm the values you have entered. Select the [Calculate] button. The system performs a calculation per the current settings and displays the calculated values. The values that exceed the range are displayed in yellow background. You can select [Range] to view its normal range in the unit field. For those who are within the range, their unit fields appear blank. Invalid values are displayed as [---]. In the [Hemodynamic Calculation] window, you can: Trigger a recording by selecting the [Record] button. The currently displayed renal calculations are printed out by the recorder. Review the previously performed calculations by selecting [Review]. 20-6 20.5.2 Entered Parameters Abbreviation Unit Full spelling C.O. L/min cardiac output HR bpm heart rate PAWP mmHg pulmonary artery wedge pressure Art Mean mmHg artery mean pressure PA Mean mmHg pulmonary artery mean pressure CVP mmHg central venous pressure EDV ml end-diastolic volume Height cm height Weight kg weight 20.5.3 Calculated Parameters Abbreviation C.I. Unit Full spelling 2 L/min/m cardiac index 2 BSA m body surface area SV ml stroke volume SI ml/m2 stroke index SVR DS/cm5 SVRI 2 systemic vascular resistance 5 DS·m /cm 5 systemic vascular resistance index PVR DS/cm pulmonary vascular resistance PVRI DS·m2/cm5 pulmonary vascular resistance index LCW kg·m left cardiac work LCWI kg·m/m2 left cardiac work index LVSW g·m left ventricular stroke work 2 LVSWI g·m/m left ventricular stroke work index RCW kg·m right cardiac work RCWI kg·m/m2 right cardiac work index RVSW g·m right ventricular stroke work 2 RVSWI g·m/m right ventricular stroke work index EF % ejection fraction 20-7 20.6 Renal Calculations 20.6.1 Performing Calculations 1. In the main menu, select [Calc >>]→[Renal >>]. 2. Enter values for calculation. 3. Select the [Calculate] button. The system performs a calculation per the current settings and displays the calculated values. The values that exceed the range are displayed in yellow background. You can select [Range] to view its normal range in the unit field. For those who are within the range, their unit fields appear blank. Invalid values are displayed as [---]. In the [Renal Calculation] window, you can: Trigger a recording by selecting the [Record] button. The currently displayed renal calculations are printed out by the recorder. Review the previously performed calculations by selecting [Review]. 20.6.2 Entered Parameters Abbreviation Unit Full spelling URK mmol/L urine pstassium URNa mmol/L urinary sodium Urine ml/24h urine Posm mOsm/ kgH2O plasm osmolality Uosm mOsm/ kgH2O urine osmolality SerNa mmol/L serum sodium Cr μmol/L creatinine UCr μmol/L urine creatinine BUN mmol/L blood urea nitrogen Height cm height Weight kg weight 20-8 20.6.3 Calculated Parameters Abbreviation Unit Full spelling URNaEx mmol/24h urine sodium excretion URKEx mmol/24h urine potassium excretion Na/K % sodium potassium ratio CNa ml/24h clearance of sodium Clcr ml/min creatinine clearance rate FENa % fractional excretion of sodium Cosm ml/min osmolar clearance CH2O ml/h free water clearance U/P osm None urine to plasma osmolality ratio BUN/Cr None blood urea nitrogen creatinine ratio U/Cr None urine-serum creatinine ratio *:BUN/Cr is a ratio under the unit of mol. 20.7 Understanding the Review Window With the review feature, you can review oxygenation, ventilation, hemodynamic and renal calculations. The review window for each calculation is similar. Take the hemodynamic calculations review window for example, you can access it by selecting [Review] in the [Hemodynamic Calculation] window. In this review window: You can select The values that exceed the range are displayed in yellow background. The [Unit] field displays parameter units. If some parameter values are outside of their normal ranges, you can view their normal range in the [Unit] field by selecting [Range]. You can review an individual calculation by selecting its corresponding column and then selecting [Original Calc]. You can record the currently displayed calculations or perform another calculation is this window. , or to view more values. 20-9 FOR YOUR NOTES 20-10 21 Recording 21.1 Using a Recorder The thermal recorder records patient information, measurement numerics, up to three waveforms, etc. 2 1 5 3 4 1. Start/Stop key: press to start a recording or stop the current recording. 2. Indicator On: when the recorder works correctly. Off: when the monitor is switched off. Flashes: if an error occurred to the recorder, e.g., the recorder runs out of paper. 3. Paper outlet 4. Recorder door 5. Latch 21-1 21.2 Overview of Recording Types By the way recordings are triggered, the recordings can be classified into the following categories: 1. Manually-triggered realtime recordings. 2. Timed recordings. 3. Alarm recordings triggered by an alarm limit violation or an arrhythmia event. 4. Manually-triggered, task-related recordings. The task-related recordings include: Frozen wave recording Graphic trends recording Tabular trends recording NIBP measurements Parameter alarms Arrh. alarm recording Full-disclosure waveforms 12-lead ECG waveforms and analysis results Titration Table Hemodynamic calculations recording Oxygenation calculations recording Ventilation calculations recording Renal calculations recording oxyCRG recording C.O. curve recording PAWP measurements Monitor information recording NOTE z For details about alarm recording, refer to the Alarms chapter. z For details about task-related recordings, refer to respective sections of this manual. 21-2 21.3 Starting and Stopping Recordings To manually start a recording, you can either: Select the or Select the [Record] button from the current menu or window. hardkey on the front of either the patient monitor or the recorder module, Automatic recordings will be triggered in the following conditions: Timed recordings will start automatically at preset intervals. If both [Alarm] and [Alm Rec] for a measurement are set on, an alarm recording will be triggered automatically as alarms occur. To manually stop a recording, you can either: Select the Select [Clear All Tasks] in the [Record Setup] menu. hardkey again, or Recordings stop automatically when: The runtime is over. The recorder runs out of paper. When the recorder has an alarm condition. 21.4 Setting up the Recorder 21.4.1 Accessing the Record Setup Menu Select [Record Setup >>] in the main menu, and you can access the [Record Setup] menu. 21.4.2 Selecting Waveforms for Recording The recorder can record up to 3 waveforms at a time. You can select, in turn, [Waveform 1], [Waveform 2] and [Waveform 3] in the record setup menu, and then select the waveforms you want. You can also turn off a waveform recording by selecting [Off]. These settings are intended for realtime and scheduled recordings. 21-3 21.4.3 Setting the Realtime Recording Length The recording time depends on your monitor’s settings when a realtime recording is started. In the [Record Setup] menu, select [Realtime Rec. Length] and toggle between [8 s] and [Continuous]. 1. [8 s]: record 8-second waveforms from the current moment. 2. [Continuous]: record the waveforms from the current moment until stopped manually. 21.4.4 Setting the Interval between Timed Recordings Timed recordings start automatically at preset intervals. Each recording lasts 8 seconds. To set the interval between timed recordings, in the [Record Setup] menu, select [Interval] and then select the appropriate setting. 21.4.5 Changing the Recording Speed In the [Record Setup] menu, select [Paper Speed] and toggle between [25 mm/s] and [50 mm/s].This setting is for all recordings containing waveforms. 21.4.6 Switching Gridlines On or Off In the [Record Setup] menu, select [Gridlines] and toggle between [On] and [Off]. 1. [On]: show gridlines when recording waveforms. 2. [Off]: hide gridlines when recording waveforms. This setting is for all recordings containing waveforms. 21.4.7 Clearing Recording Tasks In the [Record Setup] menu, select [Clear All Tasks]. All queued recording tasks are cleared and the current recording is stopped. 21.5 Loading Paper 1. Use the latch at the upper right corner of the recorder door to pull the door open. 2. Insert a new roll into the compartment as shown below. 3. Close the recorder door. 4. Check if paper is loaded correctly and the paper end is feeding from the top. 21-4 Paper roll CAUTION z Use only specified thermal paper. Otherwise, it may cause damage to the recorder’s printhead, the recorder may be unable to print, or poor print quality may result. z Never pull the recorder paper with force when a recording is in process. Otherwise, it may cause damage to the recorder. z Do not leave the recorder door open unless you reload paper or remove troubles. 21.6 Removing Paper Jam If the recorder works incorrectly or produces unusual sounds, check if there is a paper jam first. If a paper jam is detected, follow this procedure to remove it: 1. Open the recorder door. 2. Take out the paper and tear off the draped part. 3. Reload the paper and close the recorder door. 21-5 21.7 Cleaning the Recorder Printhead If the recorder has been used for a long time, deposits of paper debris may collect on the printhead compromising the print quality and shortening the lifetime of the roller. Follow this procedure to clean the printhead: 1. Take measures against the static electricity such as Disposable Wrist Strap for the work. 2. Open the recorder door and take out the paper. 3. Gently wipe around the printhead using cotton swabs dampened with alcohol. 4. After the alcohol has completely been dried, reload the paper and close the recorder door. CAUTION z Do not use anything that may destroy the thermal element. z Do not add unnecessary force to the thermal head. 21-6 22 Printing 22.1 Printer The monitor can output patient reports via a connected printer. So far, the monitor supports the following printer: HP LaserJet 1606N HP LaserJet 2035N HP LaserJet 4015N HP LaserJet 1505N The specifications of the reports the monitor prints are: Paper: A4, Letter Resolution: 300 dpi Print on One/Both Sides: printing on one and both sides are supported if the printer supports For more details about the printer, see the document accompanying the printer. With the upgrading of products, the monitor will support more printers and no prior notice will be given. If you have any doubt about the printer you have purchased, contact our company. 22.2 Connecting a Printer To print the reports or the trend data of a patient, you can choose either: the local printer Connect the printer and the patient monitor using a network cable, and then start printing what you want, or the Central Monitoring System If your monitor is connected to a central monitoring system, it is recommended to use the central monitoring system for printing. 22.3 Setting Up the Printer To set the printer’s properties, select[Print Setup >>]→[Printer Setup >>] in the main menu. In the [Printer Setup] menu, you can: 22-1 Select a connected printer Select [Printer] and then select a connected printer as the monitor’s printer. Search for a printer If your selected printer is not in the list or a new printer is added into the network, you can select the [Search Printer] to re-search for all printers in the network. Set up the paper Select [Paper Size] and toggle between [A4] and [Letter]. Print on both sides By default, the monitor prints out patient reports on one side. If you set [Print On Both Sides] to [On], the monitor will print out patient reports on both sides. 22.4 Starting Report Printouts Reports Contents Procedures ECG reports ECG waveforms and relevant parameter values Select [Print Setup >>]→[ECG Reports >>]→[Print] in the main menu. Tabular trends Depend on the selected parameter group, resolution and time period Select [Print Setup >>]→[Tabular Trends Reports >>]→[Print] in the main menu, or select[Review >>]→[Tabular Trends]→[Print]→[Print] also in the main menu. Graphic trends Depend on the selected parameter group, resolution and time period Select[Print Setup >>]→[Graphic Trends Reports >>]→[Print] in the main menu, or select[Review >>]→[Graphic Trends]→[Print]→[Print] also in the main menu. Arrhythmia events review ECG waveforms and relevant parameter values Select [Print] in [Arrh. Events] Parameter alarms review Depend on the selected alarms Select [Review >>]→[Alarms]→[Print] in the main menu. Interpretation of resting 12-lead ECG 12-lead ECG waveforms and analysis results Select [12-Lead Analysis]→[Print Report] when an interpretation of resting 12-lead ECG is completed, or select [Review >>]→[12-Lead Analysis]→[Print] in the main menu. Realtime waves Depend on the selected waveforms Select [Print Setup >>]→[ECG Reports >>]→[Print] in the main menu. 22-2 22.5 Stopping Report Printouts To stop report printouts, select[Print Setup >>]→[Stop All Reports] in the main menu. 22.6 Setting Up Reports 22.6.1 Setting Up ECG Reports You can print out ECG reports only under full-screen, half-screen or 12-lead monitoring screen. To set up ECG reports, select [Print Setup >>]→[ECG Reports >>] in the main menu. [Amplitude]: set the amplitude of the ECG waveforms. [Sweep]: set the wave print speed. [Auto Interval]: If [Auto Interval] is set to [On], the system will automatically adjust the space between waveforms to avoid overlapping. [Gridlines]: choose whether to show gridlines. [12-Lead Format]: If you select [12X1], 12 waveforms will be printed on a paper from top to bottom. If you select [6X2], 12 waveforms will be printed from left to right with 6 waveforms on each side and a rhythm waveform will be printed at the bottommost. 22.6.2 Setting Up Tabular Trends Reports To set up tabular trends reports, select [Print Setup >>]→[Tabular Trends Reports >>] in the main menu. Start time: You can set a time period whose trend data will be printed out by setting [From] and [Back]. For example, if you set [From] as 2007-4-2 10:00:00 and [Back] as [2 h], the outputted data will be from 2007-4-2 08:00:00 to 2007-4-2 10:00:00. In addition, the [Back] can be set to either: [Auto]: If [Report Layout] is set to [Time Oriented], the report will be printed by time. If [Report Layout] is set to [Parameter Oriented], the report will be printed by parameters. [All]: If you select [All], all trend data will be printed out. In this case, it is no need to set [From]. [Resolution]: choose the resolution of the tabular trends printed on the report. [Report Layout]: If you select [Time Oriented], the report will be printed by time. If you select [Parameter Oriented], the report will be printed by parameters. 22-3 [Select Parameter >>]: from the popup menu, you can: [Currently Displayed Trended Parameters]: print the parameter trend data selected from the [Tabular Trends]. [Standard Parameter Group]: select the standard parameter group for printing. [Custom]: You can define a parameter group for printing from the parameters displayed in the low part of the menu. 22.6.3 Setting Up Graphic Trends Reports To set up graphic trends reports, select [Print Setup >>]→[Graphic Trends Reports >>] in the main menu. As setting up graphic trends reports is similar with tabular trends reports, you can refer to the Setting Up Tabular Trend Reports section for details. 22.6.4 Setting Up Realtime Reports To set up realtime reports, select [Print Setup >>]→[Realtime Reports >>] in the main menu. [Sweep]: set the wave print speed. [Select Wave >>]: from the popup menu, you can: [Current]: select the currently displayed waves for printing. [Select Wave]: select the desired waves for printing. 22.7 End Case Reports ECG reports, tabular trends reports, graphic trends reports, NIBP review reports and realtime reports can be set as end case reports. When you discharge a patient, the system will automatically print out all contents that are set as end case reports. For example, to set ECG report as end case report: 1. select [Print Setup >>]→[ECG Report >>] in the main menu. 2. select [End Case Report]→[Set as End Case Report] and then select [Ok] from the popup dialog box. 3. set as described in the Setting Up ECG Reports section. 22-4 22.8 Printer Statuses 22.8.1 Printer Out of Paper When the printer runs out of paper, the print request will not be responded. If there are too many print jobs that are not responded, a printer error may occur. In these cases, you need to install paper and then re-send the print request. Restart the printer if necessary. Therefore, you’d better ensure that there is enough paper in the printer before sending a print request. 22.8.2 Printer Status Message Printer Status Message Possible causes and suggested action Printer unavailable The selected printer is not available. Check if the printer is switched on or correctly connected or installed with paper. 22-5 FOR YOUR NOTES 22-6 23 Other Functions 23.1 Marking Events During patient monitoring, some events may exert effects on the patient and as a result change the waveforms or numerics displayed on the monitor. To help analyzing the waveforms or numerics at that time, you can mark these events. To mark an event, 1. Select [Mark Event] QuickKey, or select [Mark Event >>] in the main menu. 2. Select [Event A] and the symbol [@] is displayed on the option. When you are reviewing graphic trends, tabular trends or full-disclosure waveforms, the event symbols such as A, B, C and D are displayed at the time the event is triggered. 23.2 Analog Output The patient monitor provides analog output signals to accessory equipment via the Auxiliary Output connector on the rear of the monitor. To obtain analog output signals, connect the accessory equipment such as an oscillograph, etc. to the monitor and then follow this procedure: 1. In the main menu, Select [Maintenance >>]→[User Maintenance >>]→enter the required password. 2. Select [Device Setup >>] to enter the [Device Setup] menu. 3. Select [Auxiliary Output] and then select [Analog Out.]. 4. In the main menu, select [Others >>]→[Analog Output Setup >>]. 5. Select [Analog Out.] and then select [On]. 6. Select [Waveform] and then select a waveform you want to output. NOTE z The analog output feature is seldom applied in clinical applications. You can contact your service personnel for more details. 23-1 23.3 Transferring Data You can transfer the patient data saved in the monitor to a PC via a crossover network cable or an external storage card, or within a LAN for data management, review or print. 23.3.1 Data Export System You must install the data export system on the intended PC before performing the data transfer operation. Refer to the document accompanying the installation CD-ROM for installation instructions. The data transfer feature also supports patient management, data review, data format conversion, print, etc. Refer to the help file of the system software for more details. 23.3.2 Transferring Data by Different Means NOTE z Never enter the data transfer mode when the patient monitor is in normal operation or performs monitoring. You must re-start the patient monitor to exit the data transfer mode. Transfer data via a crossover network cable Before transferring data using a crossover network cable, do as follows: 1. Connect one end of the crossover network cable to the patient monitor and the other end to the PC. 2. Set the IP address of the PC. This IP address must be in the same network segment with that of the patient monitor. 3. Make sure that the data export system is active on the PC. Then, follow this procedure to transfer data: 1. In the main menu, select [Archives>>]. You may need a password to enter the [Archives] menu, depending on the [Archives Access] setting in configuration mode. Then select [Export Data] from the [Archives] menu. 2. Select [Yes] from the popup message box and enter the [Data Export] window. 3. Input the IP address already set on the PC. 4. Select [Start] to start transferring data. 23-2 Transfer data within a LAN Before transferring data within a LAN, do as follows: 1. Connect the patient monitor and the intended PC into the same LAN and acquire the PC’s IP address. 2. Make sure that the data export system is active on the PC. Follow the same procedure as via a crossover network cable to transfer data. Transfer data via an external storage card So far data can be transferred via CF storage card only. 1. Remove the external storage card from the patient monitor. For details, refer to the Basic Operations section. 2. Run the data export system on the PC. 3. Insert the external storage card into the card reader that connects the PC. 4. Perform the data transfer operation following the help file of the system software. 23.4 Nurse Call The patient monitor also provides nurse call signals to a nurse call system connected to the monitor via the Auxiliary Output connector. To obtain nurse call signals, connect a nurse call system to the monitor and then follow this procedure: 1. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password. 2. Select [Device Setup >>] to access the [Device Setup] menu. 3. Select [Auxiliary Output] and then [Nurse Call]. Then, you can change the following settings: Select [Signal Type] and toggle between [Pulse] and [Continuous]. [Pulse]: the nurse call signals are pulse signals and each pulse lasts 1 second. When multiple alarms occur simultaneously, only one pulse signal is outputted. If an alarm occurs but the previous one is not cleared yet, a new pulse signal will also be outputted. [Continuous]: the nurse call signal lasts until the alarm ends, i.e. the duration of a nurse call signal equals to that of the alarm condition. 23-3 Select [Contact Type] and toggle between [Normally Open] and [Normally Closed]. [Normally Open]: select if your hospital’s nurse call relay contact is normally open. [Normally Closed]: select if your hospital’s nurse call relay contact is normally closed. Another two options, [Alm Lev] and [Alarm Cat.], must be set in configuration mode. [Alm Lev] defines the alarm level for nurse call-triggering alarms, and [Alarm Cat.] defines the category within which the nurse call-triggering alarms fall. Alarm conditions are indicated to nurses only when: The nurse call system is enabled, An alarm that meets your preset requirements occurs, and The monitor is not in the alarm paused or silence status. NOTE z If no setting is selected from [Alm Lev] or [Alarm Cat.], no nurse call signal will be triggered whatever alarms occur. WARNING z Do not rely exclusively on the nurse call system for alarm notification. Remember that the most reliable alarm notification combines audible and visual alarm indications with the patient’s clinical condition. 23-4 23.5 Wireless Network The patient monitors, each equipped with a wireless network card, constitute a wireless network via AP (access point).The designated service engineer or personnel shall be responsible for installing and configuring the wireless network for you and perform relative performance tests as well. The radio device used in the monitor is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC (Radio Equipment and Telecommunications Terminal Equipment Directive). NOTE z The design, installation, reconstruction and maintenance of the wireless network’s distribution shall be performed by authorized service personnel of our company. z The existence of obstacles (such as wall) will exert impact on data transferring or even cause network interruption. z The Central Monitoring System is capable of connecting up to 16 bedside monitors via the wireless network. 23-5 FOR YOUR NOTES 23-6 24 Batteries 24.1 Overview This monitor is designed to operate on battery (sealed lead-acid or Lithium Ion battery) power during intra-hospital patient transfer or whenever the power supply is interrupted. The battery is charged automatically when the monitor is connected to AC power, no matter the monitor is powered on or not. Whenever the AC power is interrupted during patient monitoring, the patient monitor will automatically run power from the internal batteries. Sealed acid batteries and Lithium Ion batteries are differentiated by their contacts, as shown below. Sealed lead-acid battery Lithium Ion battery Lithium Ion battery On-screen battery symbols indicate the battery status as follows: Indicates that batteries work correctly. The solid portion represents the current charge level of the batteries in proportion to its maximum charge level. Indicates that the batteries have low charge level and need to be charged. In this case, the patient monitor provides an alarm message. Indicates that the batteries are almost depleted and need to be charged immediately. Otherwise, the patient monitor will shut down automatically. Indicates that no batteries are installed. The capacity of the internal battery is limited. If the battery capacity is too low, a technical alarm will be triggered and the [Battery Depleted] message displayed. At this moment, apply AC power to the patient monitor. Otherwise, the patient monitor will power off automatically before the battery is completely depleted. 24-1 24.2 Installing or Replacing a Battery The patient monitor uses two battery packs. One battery pack can be easily exchanged while the monitor operates from the other. If the patient monitor uses one battery pack, you should insert a new battery pack before the old one depletes. To install or replace a battery, follow this procedure: 1. Open the battery door. 2. Push aside the latch fixing the battery to be replaced and remove the battery. 3. Insert a battery into the slot with its face up and its contact point inward. Then restore the latch to the original position. 4. If necessary, repeat the steps above to replace the other battery. 5. Close the battery door. 24-2 24.3 Battery Guidelines Life expectancy of a battery depends on how frequent and how long it is used. For a properly maintained and stored lead-acid or lithium ion battery, its life expectancy is about 2 or 3 years respectively. For more aggressive use models, life expectancy can be less. We recommend replacing lead acid batteries every 2 years and lithium ion batteries every 3 years. To get the most out of the battery, observe the following guidelines: The battery performance test must be performed every two years, before monitor repairs, or whenever the battery is suspected as being the source of the problems. Condition a battery once when it is used or stored for 3 months, or when its operating time becomes noticeably shorter. Take out the battery before the monitor is transported or will not be used for more than 3 months. Remove the battery from the monitor if it is not being used regularly. (Leaving the battery in a monitor that is not in regular use will shorten the life of the battery). The shelf-life of a fully charged sealed lead acid battery is about 6 months and in 6 months the battery must be fully charged for storage. The shelf life of a Lithium Ion battery is about 6 months when the battery is stored with the battery power being 50% of the total power. In 6 months the battery power must be depleted before the Lithium Ion battery is fully charged. Then run the monitor on this fully charged battery .When its battery power becomes 50% of the total power, take out the battery from the monitor and store it. WARNING z Keep the battery out of the reach of children. z Use only the battery specified by the manufacturer. z If the battery shows signs of damage or signs of leakage, replace it immediately. Do not use a faulty battery in the monitor. 24-3 24.4 Battery Maintenance Conditioning a Battery A battery should be conditioned before it is used for the first time. A battery conditioning cycle is one uninterrupted charge of the battery, followed by an uninterrupted battery discharge and charge. . Batteries should be conditioned regularly to maintain their useful life. NOTE z Condition a battery once when it is used or stored for 3 months, or when its operating time becomes noticeably shorter. z The actual battery capacity will decrease over time with use of batteries. When a monitor operates on batteries that have been used before, the full capacity battery symbol does not indicate the capacity and operating time of this battery can still fulfill battery specifications in the operator’s manual. When conditioning a battery, please replace the battery if its operating time is significantly lower than the specified time. To condition a battery, follow this procedure: 1. Disconnect the monitor from the patient and stop all monitoring or measuring. 2. Insert the battery in need of conditioning in the battery slot of the monitor, and leave the other slot empty if your monitor has two slots. 3. Apply AC power to the monitor and allow the battery to charge uninterrupted for 10 hours. 4. Remove AC power and allow the monitor to run from the battery until it shuts off. 5. Apply AC power again to the monitor and allow the battery to charge uninterrupted for 10 hours. 6. This battery is now conditioned and the monitor can be returned to service. 24-4 Checking a Battery The battery performance test must be performed every two years, before monitor repairs, or whenever the battery is suspected as being the source of the problems.The performance of a rechargeable battery may deteriorate over time. To check the performance of a battery, follow this procedure: 1. Disconnect the monitor from the patient and stop all monitoring or measuring. 2. Apply AC power to the monitor and allow the battery to charge uninterrupted for 10 hours. 3. Remove AC power and allow the monitor to run from the battery until it shuts off. 4. The operating time of battery reflects its performance directly. If your monitor has two battery slots, you can check two batteries at the same time. Please replace the battery or contact with the maintenance personnel if its operating time is significantly lower than the specified time. NOTE z The battery might be damaged or malfunctioned if its operating time is too short after being fully charged. The operating time depends on the configuration and operation. For example, measuring NIBP more frequently will also shorten the operating time. z When a battery has visual signs of damage, or no longer holds a charge, it should be replaced. Remove the old battery from the monitor and recycle it properly. 24.5 Battery Recycling When a battery has visual signs of damage, or no longer holds a charge, it should be replaced. Remove the old battery from the monitor and recycle it properly. To dispose of the batteries, follow local laws for proper disposal. WARNING z Do not disassemble batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, leak or heat up, causing personal injury. 24-5 FOR YOUR NOTES 24-6 25 Care and Cleaning Use only the substances approved by us and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by unapproved substances or methods. We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. For the method to control infection, consult your hospital’s Infection Control Officer or Epidemiologist. 25.1 Introduction Keep you equipment and accessories free of dust and dirt. To avoid damage to the equipment, follow these rules: Always dilute according the manufacturer’s instructions or use lowest possible concentration. Do not immerse part of the equipment into liquid. Do not pour liquid onto the equipment or accessories. Do not allow liquid to enter the case. Never use abrasive materials (such as steel wool or silver polish), or erosive cleaners (such as acetone or acetone-based cleaners). WARNING z Be sure to shut down the system and disconnect all power cables from the outlets before cleaning the equipment. CAUTION z If you spill liquid on the equipment or accessories, contact us or your service personnel. NOTE z To clean or disinfect reusable accessories, refer to the instructions accompanying the accessories. 25-1 25.2 Cleaning Your equipment should be cleaned on a regular basis. If there is heavy pollution or lots of dust and sand in your place, the equipment should be cleaned more frequently. Before cleaning the equipment, consult your hospital’s regulations for cleaning the equipment. Recommended cleaning agents are: mild soap (diluted) ammonia (diluted) sodium hypochlorite bleach (diluted) Hydrogen peroxide (3%) Ethanol (70%) Isopropanol (70%) To clean your equipment, follow these rules: 1. Shut down the patient monitor and disconnect it from the power line. 2. Clean the display screen using a soft, clean cloth dampened with a glass cleaner. 3. Clean the exterior surface of the equipment using a soft cloth dampened with the cleaner. 4. Wipe off all the cleaning solution with a dry cloth after cleaning if necessary. 5. Dry your equipment in a ventilated, cool place. If you want to clean the touchscreen during patient monitoring, lock the touchscreen first. 25.3 Disinfecting Disinfection may cause damage to the equipment and is therefore not recommended for this patient monitor unless otherwise indicated in your hospital’s servicing schedule. Cleaning equipment before disinfecting is recommended. The recommended disinfectants include: ethanol 70%, isopropanol 70%, glutaraldehyde-type 2% liquid disinfectants CAUTION z Never use EtO or formaldehyde for disinfection. 25-2 26 Maintenance WARNING z Failure 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. z The safety checks or maintenance involving any disassembly of the equipment should be performed by professional servicing personnel. Otherwise, undue equipment failure and possible health hazards could result. z If you discover a problem with any of the equipment, contact your service personnel or us. 26.1 Safety Checks Before every use, after your patient monitor has been used for 6 to 12 months, or whenever your patient monitor is repaired or upgraded, a thorough inspection should be performed by qualified service personnel to ensure the reliability. Follow these guidelines when inspecting the equipment: Make sure that the environment and power supply meet the requirements. Inspect the equipment and its accessories for mechanical damage. Inspect all power cords for damage, and make sure that their insulation is in good condition. Make sure that only specified accessories are applied. Inspect if the alarm system functions correctly. Make sure that the recorder functions correctly and the recorder paper meets the requirements. Make sure that the batteries meet the performance requirements. Make sure that the patient monitor is in good working condition. Make sure that the grounding resistance and leakage current meet the requirement. In case of any damage or abnormity, do not use the patient monitor. Contact the hospital’s biomedical engineers or your service personnel immediately. 26-1 26.2 Service Tasks The following tasks are for our qualified service professionals only. Contact a qualified service provider if your patient monitor needs the following services. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Maintenance schedule Frequency Safety checks according to IEC60601-1 At least once every two years, after any repairs where the power supply is replaced, or if the patient monitor has been dropped. Performance assurance for all measurements not listed below At least once every two years, or if you doubt the measured values. Defibrillator synchronization At least once every two years, or as needed. NIBP leakage test At least once every two years, or by your hospital policy. NIBP accuracy test At least once every two years, or by your hospital policy. NIBP calibration At least once every two years, or by your hospital policy. CO2 calibration and performance test At least once a year, or if you doubt the measured values. AG calibration At least once a year, or if you doubt the measured values. AG preventative maintenance (pump check, internal fan check, ambient pressure check and so forth as described in the service manual) At least once a year, or if you doubt the measured values. 26.3 Checking Monitor and Module Information In the main menu, select [Maintenance >>]→[System Status >>]. You can view the information about system start time, selftest, etc. from the popup menu. You can print out the information for the convenience of troubleshooting. The information will not be saved during shut down. You can also view the information about the monitor configuration and system software version by selecting [Maintenance >>]→[Software Version >>] in the main menu. 26-2 26.4 Calibrating ECG The ECG signal may be inaccurate due to hardware or software problems. As a result, the ECG wave amplitude becomes greater or smaller. In that case, you need to calibrate the ECG module. 1. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password and then select [Calibrate ECG] from the popup menu. A square wave appears on the screen and the message [ECG Calibrating] is displayed in the ECG waveform area. 2. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%. 3. After the calibration is completed, select [Stop Calibrating ECG]. You can print out the square wave and wave scale and then measure the difference between them if necessary. If the difference exceeds 5%, contact your service personnel. 26.5 Calibrating the Touchscreen 1. 2. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password and then select [Cal. Touchscreen] from the popup menu. will, in turn, appear at different positions of the screen. 3. Select each 4. After the calibration is completed, the message [Screen Calibration Completed!] is displayed. Select [Ok] to confirm the completion of the calibration. as it appears on the screen. 26-3 26.6 Calibrating CO2 For sidestream and microstream CO2 modules, a calibration is needed every year or when the measured values have a great deviation. For maintream CO2 module, no calibration is needed. Tools required: Gas bottle, with 4%, 5% or 6% of CO2. T-shape connector Tubing Follow this procedure to perform a calibration: 1. Make sure that the CO2 module has been warmed up or started up. 2. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password and then select [Maintain CO2 >>] from the popup menu. 3. In the [Maintain CO2] menu, select [Zero]. 4. Connect the gas bottle with the tubing using a T-shape connector as shown below. Check the airway and make sure there are no leaks. Open to the air Tubing Gas valve Monitor Gas bottle 5. Open the gas valve and vent CO2 into the tubing. 6. In the [Calibrate CO2] menu, enter the vented CO2 concentration in the [CO2] field. 7. In the [Maintain CO2] menu, the measured CO2 concentration, barometric pressure, sensor temperature and current flowrate are displayed. After the measured CO2 concentration becomes stable, select [Calibrate CO2] to calibrate the CO2 module. 8. If the calibration is finished successfully, the message [Calibration Completed!] is displayed. If the calibration failed, the message [Calibration Failed!] is displayed. Perform another calibration. 9. Select [Exit] to exit the current menu. 26-4 26.7 Calibrating AG Calibrate the AG module every year or when the measured value has a great deviation. Tools required: Gas bottle, with a certain standard gas or mixture gas. Gas concentration should meet the following requirements: AA>1.5%, CO2>1.5%, N2O>40%, O2>40%, of which AA represents an anesthetic agent. T-shape connector Tubing Reservoir bag Follow this procedure to perform a calibration: 1. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password and then select [Calibrate AG >>] from the popup menu. 2. Check the airway and make sure that there are no occlusions or leaks. Vent the tubing to the air and check if the [Current FlowRate] and [Set FlowRate] are approximately the same. If the deviation is great, it indicates that there is an occlusion in the tubing. Check the tubing for an occlusion. Block the gas inlet of the tubing. The [Current FlowRate] shall fall rapidly and the system prompts that the tubing is blocked. Otherwise, it indicates that there are leakages in the tubing. Check the tubing for leakages. 3. Connect the gas bottle, reservoir bag and the tubing using a T-shape connector as shown in the figure below. Check the airway and make sure there are no leaks. 4. Open the gas valve and vent a certain standard gas or mixture gas into the tubing. Gas valve Tubing AG module Reservoir bag Gas bottle 5. In the [Calibrate AG] menu, the concentration and flowrate of each measured gas are displayed If the difference between the measured gas concentration and the actual one is very small, a calibration is not needed. If the difference is great, you should perform a calibration. Select [Calibrate >>] to enter the calibrate menu. 26-5 6. Enter the vented gas concentration. If you use only one gas for calibration, set other gases’ concentration to 0. 7. Select [Start] to start calibration. 8. If the calibration is finished successfully, the message [Calibration Completed!] is displayed. If the calibration failed, the message [AG Cal. Failed] is displayed. Perform another calibration. 9. Select [Exit] to exit the current menu. 26.8 Setting up IP Address 1. In the main menu, select [Maintenance >>]→[User Maintenance >>]→enter the required password and then select [Network Setup >>] from the popup menu. 2. If your monitor is equipped with a wireless AP, you can set [Network Type] to [WLAN] in the network setup menu. Otherwise, the default setting is [LAN]. 3. Set the IP Address and subnet mask through [IP Address] and [Subnet Mask]. If the patient monitor is connected to a CMS, its IP address should be set up. The user should not change the patient monitor’s IP address randomly. If you want to know details about IP address setup, contact the technical personnel in charge of the CMS. 26.9 Entering/Exiting Demo Mode To enter the Demo mode: 1. In the main menu, select [Maintenance >>]. 2. Select [Demo >>]. Enter the required password and then select [Ok]. To exit the Demo mode: 1. In the main menu, select [Maintenance >>]. 2. Select [Exit Demo] and then select [Ok]. 3. The patient monitor exits the Demo mode. WARNING z The Demo mode is for demonstration purpose only. To avoid that the simulated data are mistaken for the monitored patient’s data, you must not change into Demo mode during monitoring. Otherwise, improper patient monitoring and delayed treatment could result. 26-6 27 Accessories WARNING z Use accessories specified in this chapter. Using other accessories may cause damage to the patient monitor or not meet the claimed specifications. z Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy. z Check the accessories and their packages for any sign of damage. Do not use them if any damage is detected. 27.1 ECG Accessories ECG Electrodes Model Quantity Patient Category Part No. 210 10 pieces Adult 0010-10-12304 2245 50 pieces Pediatric 9000-10-07469 2258-3 3 pieces Neonate 900E-10-04880 12-Pin Separable Trunk Cables Leadwire supported Compatible with Type Patient Category 3-leadwire AHA, IEC Defibrillator-proof 3-leadwire AHA, IEC ESU-proof 3/5-leadwire AHA, IEC Defibrillator-proof 3/5-leadwire AHA, IEC ESU-proof 10-leadwire AHA Defibrillator-proof 10-leadwire IEC Defibrillator-proof 27-1 Length 0010-30-42720 Pediatric, neonate Adult, pediatric Part No. 0010-30-42724 2.9 m 0010-30-42719 0010-30-42723 0010-30-42721 0010-30-42722 Cable Sets 3-Electrode Cable Sets Type Compatible with Model EL6302A IEC Clip EL6304A IEC Snap AHA Adult, pediatric Length Part No. Remark 0.6 m 0010-30-42725 / 1m 0010-30-42732 Long EL6306A Neonate 0.6 m 0010-30-42897 / EL6308A Pediatric 0.6 m 0010-30-42899 / 0.6 m 0010-30-42726 / 1m 0010-30-42731 Long EL6301A AHA Patient Category EL6303A Adult, pediatric EL6305A Neonate 0.6 m 0010-30-42896 / EL6307A Pediatric 0.6 m 0010-30-42898 / EL6302B Adult, pediatric 0010-30-42733 / EL6308B Pediatric 0010-30-42901 / EL6301B Adult, pediatric 0010-30-42734 / EL6307B Pediatric 0010-30-42900 / Model Patient Category Length Part No. Remark EL6502A 0.6 m 0010-30-42728 / EL6504A 1 to 1.4 m 0010-30-42730 Long 0.6 m 0010-30-42727 / 1 to 1.4 m 0010-30-42729 Long 0.6 m 5-Electrode Cable Sets Type Compatible with IEC Clip AHA Snap EL6501A EL6503A Adult, pediatric, neonate IEC EL6502B 0.6 m 0010-30-42736 / AHA EL6501B 0.6 m 0010-30-42735 / Length Part No. Remark EL6802A 0.8 m 0010-30-42903 Limb EL6804A 0.6 m 0010-30-42905 Chest EL6801A 0.8 m 0010-30-42902 Limb 0.6 m 0010-30-42904 Chest 0.8 m 0010-30-42907 Limb EL6804B 0.6 m 0010-30-42909 Chest EL6801B 0.8 m 0010-30-42906 Limb EL6803B 0.6 m 0010-30-42908 Chest 10-Electrode Cable Sets Type Compatible with IEC Clip AHA IEC Snap AHA Model EL6803A EL6802B Patient Category Adult, pediatric 27-2 27.2 SpO2 Accessories Extension Cable Module type Patient Category Mindray Masimo Adult, pediatric, neonate Nellcor Length Remark Part No. 3m / 0010-20-42710 8 pins, purple connector 040-000332-00 7 pins, white connector 0010-30-42738 / 0010-20-42712 2.9m 2.5 m SpO2 Sensors The SpO2 sensor materials that patients or other staff will come into contact with have undertaken the bio-compatibility test and are verified to be in compliance with ISO 10993-1. Mindray SpO2 Module Type Disposable Single patient use Reusable Model Patient Category MAX-A Adult (>30Kg) MAX-P Pediatric (10 to 50Kg) MAX-I Infant (3 to 20Kg) MAX-N Neonate (<3Kg), Adult (>40Kg) 0010-10-12205 520A Adult 520A-30-64101 520P Pediatric 520I Infant 520N Neonate 520N-30-64401 DS-100A Adult 9000-10-05161 OXI-P/I Pediatric, infant OXI-A/N Adult, neonate 518B Adult, pediatric, neonate (Multi-sites) 512E 512F 512G 512H Length Part No. 0010-10-12202 / 1m / Adult (Finger type) Pediatric (Finger type) 27-3 0010-10-12203 0010-10-12204 520P-30-64201 520I-30-64301 9000-10-07308 9000-10-07336 518B-30-72107 1.2 m 512E-30-90390 / 512F-30-28263 1.2 m 512G-30-90607 / 512H-30-79061 Masimo SpO2 Module Type Disposable Reusable Model Patient Category Remark Part No. FPS-1901 Pediatric, neonate (banding type) LNCS-NeoPt-L 0010-10-42626 FPS-1862 Neonate (banding type) LNCS-Neo-L 0010-10-42627 FPS-1861 Infant (banding type) LNCS-Inf-L 0010-10-42628 FPS-1860 Pediatric (banding type) LNCS-Pdt 0010-10-42629 FPS-1859 Adult (banding type) LNCS-Adt 0010-10-42630 FPS-1863 Adult (finger type) LNCS DC-I 0010-10-42600 FPS-1864 Pediatric (finger type) LNCS-DCIP 0010-10-42634 2258 Adult, pediatric, neonate LNCS YI 0010-10-43016 Nellcor SpO2 Module Type Disposable Reusable Model Patient Category Part No. MAX-A Adult (>30Kg) (banding type) 0010-10-12202 MAX-P Pediatric (10 to 50Kg) (banding type) 0010-10-12203 MAX-I Infant (3 to 20Kg) (banding type) 0010-10-12204 MAX-N Neonate (<3Kg), Adult (>40Kg) (banding type) 0010-10-12205 DS-100A Adult 9000-10-05161 OXI-P/I Pediatric, infant (finger type) 9000-10-07308 OXI-A/N Adult, neonate (finger type) 9000-10-07336 Wavelength emiited by the sensors intended for Mindray SpO2 module: red right: 660 nm, infrared light: 905 nm. Wavelength emitted by the sensors intended for Masimo SpO2 module: red light: 660 nm, infrared light: 940 nm. Wavelength emitted by the sensors intended for Nellcor SpO2 module: red light: 660 nm, infrared light: 890 nm. The maximum photic output consumption of the sensor is less than 18 mW. The information about the wavelength range and maximum photic output consumption can be especially useful to clinicians, for example, clinicians performing photodynamic therapy. 27-4 27.3 NIBP Accessories Tubing Type Reusable Patient Category Length Part No. Adult, pediatric 3m 6200-30-09688 Neonate 1.5 m 6200-30-11560 Reusable Cuff Model Patient Category CM1201 Infant CM1202 Pediatric CM1203 Adult CM1204 Large adult CM1205 Thigh Measurement Site Arm Thigh Limb Circumference (cm) Bladder Width (cm) Part No. 10 to 19 9.2 0010-30-12157 18 to 26 12.2 0010-30-12158 24 to 35 15.1 0010-30-12159 33 to 47 18.3 0010-30-12160 46 to 66 22.5 0010-30-12161 Single-Patient Cuff Model Patient Category Measurement Site CM1500A CM1500B CM1500C Neonate CM1500D Arm Limb Circumference (cm) Bladder Width (cm) Part No. 3.1 to 5.7 2.2 001B-30-70692 4.3 to 8.0 2.9 001B-30-70693 5.8 to 10.9 3.8 001B-30-70694 7.1 to 13.1 4.8 001B-30-70695 10 to 19 7.2 001B-30-70697 CM1501 Infant CM1502 Pediatric 18 to 26 9.8 001B-30-70698 CM1503 Adult 25 to 35 13.1 001B-30-70699 CM1504 Large adult 33 to 47 16.5 001B-30-70700 CM1505 Adult 46 to 66 20.5 001B-30-70701 Thigh Disposable Cuff Model Patient Category Measurement Site M1872A M1870A M1868A M1866A Neonate Arm Limb Circumference (cm) Bladder Width (cm) Part No. 7.1 to 13.1 5.1 900E-10-04873 5.8 to 10.9 4.3 900E-10-04874 4.3 to 8.0 3.2 900E-10-04875 3.1 to 5.7 2.5 900E-10-04876 27-5 27.4 Temp Accessories Extension Cable Type Model Temp probe Length Part No. Reusable MR420B MR411, MR412 3m 0011-30-37391 Temp Probes Type Model MR401B Reusable MR403B MR402B MR404B Disposable MR411 MR412 Patient Category Adult Pediatric, neonate Adult, pediatric, neonate Measurement Site Length Part No. Esophageal/Rectal 3m 0011-30-37392 Skin 3.8 m 0011-30-37393 Esophageal/Rectal 3m 0011-30-37394 Skin 3.8 m 0011-30-37395 Esophageal/Rectal / 0011-30-37398 Skin / 0011-30-37397 27.5 IBP/ICP Accessories Accessories Kit No. 6800-30-50616 (Hospira) 6800-30-50877 (BD) Components Length Part No. IM2201 12Pin IBP Cable Kit (Hospira) 4.6 ± 1.0 m 001C-30-70759 Disposable Pressure Transducer 0010-10-42638 Steady Rest for IBP Transducer and Clamp M90-000133--- Steady Rest for IBP Transducer and Clamp M90-000134--- IBP accessories instructions for use (ABBOTT) 0010-20-42913 Bar code printing paper (100×150 mm) A30-000010--- Packaging box 0850-20-30715 IM2202 12Pin IBP Cable Kit (BD) 3.8 m 001C-30-70757 Disposable Transducer 6000-10-02107 Transducer/Manifold Mount 0010-10-12156 IBP accessories instructions for use (BD) 0010-20-42914 Bar code printing paper (100×150 mm) A30-000010--- Module packaging box 6000-20-02055 27-6 ICP Model Material Part No. Gaeltec TYPE.S13 12Pin ICP cable 0010-30-42742 Gaeltec ICT/B Intracranial Pressure Transducer 6800-30-50759 Intracranial Pressure Transducer (global) 0010-10-12151 It is proved through tests that the following accessories are compatible with the patient monitor. Only the accessories proceeded by “*” are available from our company. If you want to purchase other accessories, contact respective manufacturers and make sure if these accessories are approved for sale in local. Manufacturer Accessories Smith Medical (Medex) MX961Z14 Logical Cable, to be used in connection with the Adapter Cable (0010-20-42795) MX960 Reusable Transducer Kit MX9605A Logical 84in(213cm) Single Monitoring Kit MX960 Logical Transducer Mounting Plate MX261 Logical Clamp For Transducer Bracket MX262 Logical Clamp For 2 Transducer Mount Plates (More Logical Clamps are available from Medex. For detailed information, contact Medex.) Braun IBP Reusable Cable (REF: 5203511), to be used in connection with the Adapter Cable (0010-20-42795) Combitrans Monitoring Set (contact Braun for detailed information) Combitrans Attachment Plate Holder (REF: 5215800) Combitrans Attachment Plate (contact Braun for detailed information) Memscap *Truck cable (0010-21-43082) SP844 Physiological Pressure Transducer 844-26 Monitoring Line Set 84X-49 Mounting Bracket Utah Reusable Blood Pressure Monitor Interface Cable (REF: 650-206) Deltran Disposable Pressure Transducer System (More Deltran sensors are available from Utah. For detailed information, contact Utah.) Pole Mount Unit (ERF: 650-150) Deltran Three Slot Organizer, Attaches to I.V. Pole Mount (REF: 650-100) Deltran Four Slot Organizer, Attaches to I.V. Pole Mount (REF: 650-105) Edwards * IBP Truwave Reusable Cable (0010-21-12179) Pressure Monitoring Kit With Truwave Disposable Pressure Transducer. (More Truwave sensors are available from Edwards. For detailed information, contact Edwards.) DTSC IV Pole Clamp for Model DTH4 BackPlate Holder DTH4 Disposable Holder for DPT 27-7 27.6 C.O. Accessories Model Material PN COC-001-SL 12Pin C.O. cable. 0010-30-42743 SP4042 IT Sensor 6000-10-02079 SP5045 IT Sensor Housing 6000-10-02080 12CC 12CC Control Syringe W/1CC Stop W/Rotator 6000-10-02081 131HF7 Dilution Hose 6000-10-02183 CO accessories package 12Pin cable:1 IT Sensor:1 IT Sensor Housing:2 12CC Control Syringe W/1CC Stop W/Rotator:2 6800-30-50617 27.7 CO2 Accessories Sidestream CO2 module Material Patient Category DRYLINE Watertrap Adult, pediatric DRYLINE Watertrap Neonate Sampling Line Adult, pediatric 9200-10-10533 Sampling Line, 2.5m Neonate 9200-10-10555 Nasal CO2 Sample Cannula Adult Nasal CO2 Sample Cannula Pediatric DRYLINE Airway Adapter Adult, pediatric, neonate Straight 9000-10-07486 Adult, pediatric Airway adapter: 2 Adult/pediatric watertrap: 2 Adult/pediatric Sampling line: 2 Adult Nasal CO2 Sample Cannula: 2 Pediatric Nasal CO2 Sample Cannula: 2 6800-30-50618 Neonate Airway adapter: 2 Neonate watertrap: 2 Neonate sampling line: 2 Neonate Nasal CO2 Sample Cannula: 2 Sidestream CO2 accessories instructions for use 6800-30-50467 Mindray CO2 accessories package (M02A) Mindray CO2 accessories package (neonate) Remark Reusable Disposable Part No. 9200-10-10530 9200-10-10574 M02A-10-25937 M02A-10-25938 27-8 Microstream CO2 Module Disposable Airway Sampling Line Model Patient Category Remark Part No. / 0010-10-42560 Humidified 0010-10-42561 Long 0010-10-42563 Long, humidified 0010-10-42564 Humidified 0010-10-42562 Long, humidified 0010-10-42565 Remark Part No. / 0010-10-42566 Plus O2 0010-10-42568 Long, plus O2 0010-10-42570 / 0010-10-42577 Humidified 0010-10-42572 8180 Humidified, plus O2 0010-10-42575 7266 / 0010-10-42567 8175 / 0010-10-42578 Humidified 0010-10-42573 Humidified, plus O2 0010-10-42576 7269 Plus O2 0010-10-42569 7743 Long, plus O2 0010-10-42571 Infant, Neonate Humidified 0010-10-42574 Name Patient Category Remark PN Microstream CO2 accessories package Adult, pediatric Adult/pediatric Sampling line:1 Adult Nasal CO2 Sample Cannula:1 6800-30-50619 XS04620 XS04624 7768 Adult, pediatric 7737 6324 7738 Infant, Neonate Disposable Nasal Sampling Line Model 9818 9822 9826 Patient Category Adult, intermediate 8174 8177 8178 8181 8179 Adult Pediatric Accessories package 27-9 Mainstream CO2 Module Material Model Airway adapter 6421 9960STD Mask 9960LGE Patient Category Remark Part No. Adult Disposable, with mouthpiece 0010-10-42663 / 0010-10-42670 Large 0010-10-42671 Adult 9960PED Pediatric / 0010-10-42669 Cable management straps / / / 0010-10-42667 Sensor holding clips / / / 0010-10-42668 Sensor Capnostat5 Adult, pediatric, neonate Reusable 6800-30-50760 Adult, pediatric, neonate Disposable adult/pediatric airway adapter:1 Disposable pediatric/neonate airway adapter:1 Mainstream CO2 sensor:1 Mainstream CO2 accessories instructions for use 6800-30-50613 Mainstream CO2 accessories package / 27-10 27.8 AG Accessories Material Watertrap Sampling line Airway adapter AG module accessories package (domestic) AG module accessories package (abroad) Patient Category Adult, pediatric Neonate Adult, pediatric Neonate Remark Reusable Disposable Part No. 9200-10-10530 9200-10-10574 9200-10-10533 9200-10-10555 Adult, pediatric, neonate Disposable, straight 9000-10-07486 Adult, pediatric, neonate Disposable, elbow 9000-10-07487 Adult, pediatric Straight airway adapter:2 Elbow airway adapter:2 Adult/pediatric watertrap: 5 Adult sampling line:4 AG accessories instructions for use 6800-30-50620 Adult, pediatric, neonate Straight airway adapter:2 Elbow airway adapter:2 Adult/pediatric watertrap: 5 Adult sampling line:4 Adult/pediatric watertrap: 5 Neonate sampling line:4 Neonate watertrap:4 AG accessories instructions for use 6800-30-50621 27-11 27.9 Others Material Part No. Lead-acid battery M05-302R3R--- Lithium battery M05-010001-06 (black) 0146-00-0099 3-core power cord 509B-10-05996 3-core power cord (V3203C-V1625) 0000-10-10903 Grounding cable 1000-21-00122 Defibrillator synchronization cable 6800-20-50781 Nurse call cable 8000-21-10361 CF storage card 023-000067-00 Recorder TR6F-30-67306 Recorder paper (48 mm) A30-000001--- Recorder for update (installed on the device) TR6F-30-67317 Wireless network card 6802-30-66686 Main unit wall mount bracket Trolly bracket 0010-30-43034 0010-30-42860 0010-30-43033 0010-30-42843 27-12 (gray) A Product Specifications A.1 Monitor Safety Specifications A.1.1 Classifications The patient monitor is classified, according to IEC60601-1: Classification Name Specifications Class I equipment, with both internal and external power supply Type of protection against electric shock When you doubt the integrity of the external protective earth (ground) or the protective earth conductor, switch the equipment to the internal power supply (batteries). Degree of protection against electric shock CO2/AG: BF (defibrillation proof) ECG/RESP/SpO2/NIBP/TEMP/IBP/CO: CF (defibrillation proof) Degree of protection against hazards of explosion Degree of protection against harmful ingress of water Not protected (ordinary) In accordance with IPX1 Tested safety from vertically dripping water (DRIP-PROOF) Mode of operation Continuous Equipment type Portable A-1 A.1.2 Environmental Specifications Operating conditions 0 to 40 Temperature (ºC) 5 to 40 (with Sidestream CO2 module) 0 to 40 (with Microstream CO2 module) 10 to 40 (with Mainstream CO2 module or AG module) Relative humidity (noncondensing) 15% to 95% 428.6-808.3 mmHg(57.0-107.5 kPa) 428 to 790mmHg (with Sidestream CO2 module) Altitude 430 to 795mmHg (with Microstream CO2 module) 400 to 850 mmHg (with Mainstream CO2 module) 525 to 900 mmHg (with AG module) Storage conditions Temperature (ºC) -20 to 60 Relative humidity (noncondensing) 10% to 95% 122.6-808.3 mmHg(16.3-107.5 kPa) 428 to 790mmHg (with Sidestream CO2 module) Altitude 430 to 795mmHg (with Microstream CO2 module) 400 to 850 mmHg (with Mainstream CO2 module) 525 to 900 mmHg (with AG module) A-2 A.1.3 Power requirements Parameter Specifications AC Power Supply Specifications Line Voltage 100 to 240 ~ Current 1.3 to 0.5 A Frequency 50/60 Hz Fuse T3.15 A H, 250 V Internal battery Number of batteries 2 Type Sealed lead-acid battery or lithium-ion battery Time to shutdown >5 min (after the first low-power alarm) Sealed lead-acid battery Rated voltage 12 VDC Capacity 2.3 Ah Minimum operating time 90 minutes or 210 minutes when powered by one or two new fully-charged batteries respectively (25℃, ECG, SpO2, Auto NIBP measurements at intervals of 15 minutes, Screen brightness is 1) Charge time Shut-down: nearly 4 h to 90%, 6 h to 100% Operating: nearly 6 h to 90%, 8 h to 100% Lithium battery Rated voltage 11.1 VDC Capacity 4.4 Ah Minimum operating time 210 minutes or 450 minutes when powered by one or two new fully-charged batteries respectively (25℃, ECG, SpO2, Auto NIBP measurements at intervals of 15 minutes, Screen brightness is 1) Charge time Shut-down: nearly 3 h to 90%, 4 h to 100% Operating: nearly 8 h to 90%, 12 h to 100% A-3 A.2 Hardware specifications A.2.1 Physical Specifications Size 320×270×180mm (width×height×depth) Weight Standard configuration: <5.0kg (without batteries and recorder) A.2.2 Display Host display Screen type Colour TFT LCD Screen Size (diagonal) 12.1" Resolution 800×600 pixels A.2.3 Recorder Method Thermal dot array Horizontal resolution 16 dots/mm (25 mm/s paper speed) Vertical resolution 8 dots/mm Paper width 48 mm Paper length 20 m Paper speed 25 mm/s, 50 mm/s Number of waveform channels 1, 2, or 3 (optional) A.2.4 LEDs Alarm lamp 1 (two colour coded: yellow and red) Operating status indicator 1 (green) AC power LED 1 (yellow green) Battery LED 1 (yellow green) A-4 A.2.5 Audio Indicator Speaker Give alarm tones (45 to 85 dB), key tones, QRS tones; support PITCH TONE and multi-level tone modulation; alarm tones comply with IEC60601-1-8. A.2.6 Alarm Signal Alarm output delay Less than 1 second Pause duration 1, 2, 3, 5, 10, 15 minutes or infinite, depending on configuration A.2.7 Monitor Interface Specifications Power 1 AC power input connector Measurements ECG, RESP, TEMP, SpO2, NIBP, IBP, CO, CO2, AG Wire network 1 RJ45 connector, 100 Base-TX, IEEE 802.3 USB (optional) 2 connectors, USB 1.1 CF 50-pin CF revision 2.0 connector Video interface 1 standard colour VGA monitor connector Auxiliary output 1 connector, standard BNC, the common connector of nurse call signals, analog output signals and defibrillator synchronization signals Equipotential Grounding Terminal 1 RS232 connector 1 connector, supports DIAP communication protocol A-5 A.2.8 Signal Output Auxiliary Output Standard Meets the requirements of EC60601-1 for short-circuit protection and leakage current ECG Analog Output Bandwidth (-3dB; reference frequency:10Hz) Diagnostic mode: 0.05 to 150 Hz Monitor mode: 0.5 to 40 Hz Surgical mode: 1 to 20 Hz Max transmission delay 25 ms (in diagnostic mode, and with Notch off) Sensitivity 1 V/mV ±5% PACE rejection/enhancement No pace rejection or enhancement IBP Analog Output Bandwidth (-3dB; reference frequency:1Hz) 8 Hz, 12.5 Hz and 20 Hz are optional. Max transmission delay 60 ms (with Notch off) Sensitivity 1 V/100 mmHg ±5% Nurse Call Signal Output mode Relay Electrical requirements ≤60W, ≤2A, ≤36VDC, ≤25VAC Conducting impedance <1 Ω Isolation voltage 1500 VAC Contact type Normally open or normally contact (optional) Defib Sync Pulse Max time delay 35 ms (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: < 0.5 V, receiving a maximum of 5 mA input current. Pulse width 100 ms ±10% Output impedance 50Ω Rising and falling time <3 ms VGA Video signals RGB: 0.7 Vp-p/75Ω; Horizontal/vertical synchronization: TTL level A-6 A.3 Data Storage Trends Trends: 96 hours, at 1 min resolution Minitrends: 1 hour, at 1 s resolution Parameter alarms 100 alarms and related parameter waveforms. The waveform recording length can be 8s, 16s or 32s. Arrh. events 80 arrhythmia events and relate waveforms. The waveform recording length can be 8s, 16s or 32s. NIBP measurements 1000 sets 12-lead ECG analysis results 10 sets Full-disclosure waveforms 48 hours at maximum. The specific storage time depends on the waveforms stored and the number of stored waveforms. A.4 Wireless Network Standards IEEE 802.11b/g Frequency range 2.412 to 2.462 GHz A.5 Measurement Specifications The adjustable range of alarm limits is the same with the measurement range of signals unless otherwise specified. A-7 A.5.1 ECG ECG Standards Meet standards of EC11, EC13, EN60601-2-27/IEC60601-2-27, IEC60601-2-25, YY91079, GB9706.25 3-lead: I, II, III Lead set 5-lead: I, II, III, aVR, aVL, aVF, V 12-lead: I, II, III, aVR, aVL, aVF, V1 to V6 ECG standard AHA, IEC Display sensitivity 1.25 mm/mV (X0.125), 2.5 mm/mV (X0.25), 5 mm/mV (X0.5), 10 mm/mV (X1), 20 mm/mV (X2), 40mm/mV (X4), Auto Sweep speed 12.5 mm/s, 25 mm/s, 50 mm/s Bandwidth (-3dB) Common mode rejection ratio (with Notch off) Diagnostic mode: 0.05 to 150 Hz Monitor mode: 0.5 to 40 Hz Surgical mode: 1 to 20 Hz Diagnostic mode: >90 dB Monitor mode: >105 dB Surgical mode: >105 dB 50/60 Hz Notch Monitor and surgical mode: Notch turns on automatically. Diagnostic mode: Notch is turned on/off manually Differential input impedance >5 MΩ Input signal range ±8 mV (peak-to-peak value) Electrode offset potential tolerance ±500 mV Input offset current ≤0.1 μA (except for the driving lead) Baseline recovery time <5 s (after defibrillation) Calibration signal 1mV (peak-to-peak value) Cut mode: 300 W Coagulate mode: 100 W ESU protection Recovery time: ≤10 s In compliance with the requirements in clause 4.2.9.14 of ANSI/AAMI EC 13 ESU noise suppression Based on the test method in clause 5.2.9.14 of EC 13, use ECG lead wires which are in compliance with AAMI. Compared with ECG baseline, the noise of peak to peak value ≤2 mV. A-8 Pace Pulse Pace pulses meeting the following conditions are labelled with a PACE marker: Pace pulse markers Amplitude: ±2 to ±700 mV Width: 0.1 to 2 ms Rise time: 10 to 100 µs When tested in accordance with the ANSI/AAMI EC13: Sections 4.1.4.1 and 4.1.4.3, the heart rate meter rejects all pulses meeting the following conditions. Pace pulse rejection Alarm limit Amplitude: ±2 to ±700 mV Width: 0.1 to 2 ms Rise time: 10 to 100 µs Minimum input slew rate: 50 V/s RTI Range (bpm) HR High HR Low Step (bpm) Adult: (low limit+2) to 300 Pediatric, Neonate: (low limit+2) to 350 15 to 1 (high limit-2) Basic algorithm HR 3-, 5-, and 12-lead ECG Measurement range Interpretation of resting 12-lead ECG Resolution Accuracy Sensitivity Neonate: 15 to 350 bpm Pediatric: 15 to 350 bpm Adult: 15 to 300 bpm Adult: 30 to 120 bpm 1 bpm 3-, 5-, and 12-lead ECG: ±1 bpm or ±1%, whichever is greater. Interpretation of resting 12-lead ECG: ±2 bpm 200μV (lead II) A-9 In compliance with the requirements in Clause 4.1.2.1 d) of ANSI/AAMI EC13, the following method is used: HR averaging method If the last 3 consecutive RR intervals are greater than 1200 ms, the 4 most recent RR intervals are averaged to compute the HR. Otherwise, heart rate is computed by subtracting the maximum and minimum ones from the most recent 12 RR intervals and then averaging them. The HR value displayed on the monitor screen is updated every second. Response to irregular rhythm In compliance with the requirements in Clause 4.1.2.1 e) of ANSI/AAMI EC13, the heart rate after 20 seconds of stabilization is displayed as follows: Ventricular bigeminy (3a): -80±1 bpm Slow alternating ventricular bigeminy (3b): -60±1 bpm Rapid alternating ventricular bigeminy (3c): -120±1 bpm Bidirectional systoles (3d): -90±2 bpm Response time to heart rate change Meets the requirements of ANSI/AAMI EC13: Section 4.1.2.1 f). From 80 to 120 bpm: less than 12 s From 80 to 40 bpm: less than 12 s Meets the requirements of ANSI/AAMI EC13: section 4.1.2.1 g). Waveform Time to alarm for tachycardia 4ah - range: 11 s 4a - range: 11 s 4ad - range: 11 s Waveform 4bh - range: 11 s 4b - range: 11 s 4bd - range: 11 s Tall T-wave rejection capability Meets the requirements of part 4.1.2.1 c) of ANSI/AAMI EC 13 The heart rate meter rejects all 100 ms QRS complexes with less than 1.2 mV of amplitude, and T waves with T-wave interval of 180 ms and those with Q-T interval of 350 ms. Arrhythmia Analysis Classifications Asystole, VFib/VTac, Couplet, Bigeminy, Trigeminy, R on T, VT>2, PVC, Tachy, Brady, Missed Beats, PNP, PNC ST Segment Analysis Measurement range Accuracy Refreshing rate -2.0 to 2.0 mV -0.8 to 0.8 mV: ±0.02 mV or ±10%, whichever is greater. Beyond this range: Not specified. 10 s A-10 Mortara algorithm Only the differences from the Basic algorithm are listed. HR In compliance with the requirements in Clause 4.1.2.1 d) of ANSI/AAMI EC13, the following method is used: HR averaging method Heart rate is computed by averaging the most recent 16 RR intervals, unless the HR by averaging the most recent 4 heart beats is less than or equals to 48 bpm. The HR value displayed on the monitor screen is updated every second. Arrhythmia Analysis Classifications Asystole, Vfib, Vtac, Vent. Rhythm, Couplet, VT>2, Bigeminy, Trigeminy, R on T, Multif. PVC, Irr. Rhythm, Tachy, Brady, Missed Beats, PNP, PNC ST Segment Analysis Refreshing rate per 16 heartbeats A.5.2 Resp Technique Trans-thoracic impedance Lead Options are lead I and II. The default is lead II. Waveform gain X 0.25, X 0.5, X 1, X 2, X 3, X 4, X 5 Excitation current <620 μA RMS Respiration impedance range 0.3 to 5Ω Baseline impedance range 200 to 2500Ω (without the 1kΩ resistance of the ECG cable) Linear signal range At least 3 Ω p-p Minimum detection height It changes according to the settings of display ratio. It is 0.3 Ω when the display ratio is ×5. Differential input impedance >5 MΩ Bandwidth 0.2 to 2 Hz (-3 dB) Noise <0.1 Ω (peak value) (using standard ECG cable, patient impedance 500Ω) Sweep speed 6.25 mm/s, 12.5 mm/s or 25 mm/s A-11 Respiration Rate Measurement range Resolution Adult: 0 to 120 rpm Pediatric, neonate: 0 to 150 rpm 1 rpm Accuracy 7 to 150 rpm: ±2 rpm or ±2%, whichever is greater 0 to 6 rpm: Not specified. Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s Alarm limit Range (rpm) RR High (low limit + 2) to 100 RR Low 0 to (high limit – 2) Step (rpm) 1 A.5.3 SpO2 Alarm limit Range (%) SpO2 High (low limit + 1) to 100 SpO2 Low Desat to (high limit – 1) Desat 50 to (high limit – 1) Step (%) Delay (s) 1 10 Mindray SpO2 Module Standards Meet standards of ISO9919 *Measurement accuracy verification: The SpO2 accuracy has been verified in human experiments by comparing with arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-oximeter measurements. Measurement range 0 to 100% Resolution 1% 70 to 100%: ±2% (measured in adult/pediatric mode) Accuracy 70 to 100%: ±3% (measured in neonate mode) 0% to 69%: Not specified. *Studies were performed to validate the accuracy of Pulse Oximeter with neonatal SpO2 sensors by contrast with a CO-Oximeter. Some neonates aged from 1 day to 30 days with a gestation age of 22 weeks to full term were involved in this study. The statistical analysis of data of this study shows the accuracy (Arms) is within the stated accuracy specification. Please see the following table. A-12 Sensor type Totally neonates Data Arms 518B 97 (51 male & 46 female) 200 pairs 2.38% 520N 122 (65 male & 57 female) 200 pairs 2.88% The Pulse Oximeter with neonatal SpO2 sensors was also validated on adult subjects. Refreshing rate 2s 7 s (When the sensitivity is set to High) SpO2 averaging time 9 s (When the sensitivity is set to Medium) 11 s (When the sensitivity is set to Low) Masimo SpO2 Module SpO2 Standards Meet standards of ISO9919 Measurement range 1 to 100% Resolution 1% 70 to 100%: ±2% (measured without motion in adult/pediatric mode) Accuracy 70 to 100%: ±3% (measured without motion in neonate mode) 70 to 100%: ±3% (measured with motion) 1% to 69%: Not specified. Refreshing rate 1s SpO2 averaging time 2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s Low perfusion conditions Low perfusion SpO2 accuracy Pulse amplitude: >0.02% Light penetration: >5% ±2% A-13 Nellcor SpO2 Module Parameter Specifications Standards Meet standards of ISO9919 Measurement range 1 to 100% 70 to 100%: ±2% (measured in adult/pediatric mode) Accuracy 70 to 100%: ±3% (measured in neonate mode) 0% to 69%: Not specified. Refreshing rate 1s SPO2 averaging time 8 s, 16 s *: When the SpO2 sensor is applied for neonatal patients as indicated, the specified accuracy range is increased by ±1%, to compensate for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood. A.5.4 PR Alarm limit Range (bpm) PR High (low limit +2) to 240 PR Low 25 to (high limit-2) Step (bpm) 1 PR from Mindray SpO2 Module Measurement range 20 to 254 bpm Resolution 1 bpm Accuracy ±3 bpm Refreshing rate 2s 7 s (when sensitivity is set to High) SPO2 averaging time 9 s (when sensitivity is set to Medium) 11 s (when sensitivity is set to Low) PR from Masimo SpO2 Module Measurement range 25 to 240 bpm Resolution 1 bpm Accuracy ±3 bpm (measured without motion) ±5 bpm (measured with motion) Refreshing rate 1s SPO2 averaging time 2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s A-14 PR from Nellcor SpO2 Module Measurement range 20 to 300 bpm Resolution 1 bpm Accuracy 20 to 250 bpm: ±3 bpm 251 to 300 bpm, not specified Refreshing rate 1s SPO2 averaging time 8 s, 16 s PR from IBP Module Measurement range 25 to 350 bpm Resolution 1 bpm Accuracy ±1 bpm or ±1%, whichever is greater Refreshing rate 1s A-15 A.5.5 NIBP Standards Meet standards of EN60601-2-30/IEC60601-2-30, EN1060-1, EN1060-3, EN1060-4 and SP10 Technique Oscillometry Mode of operation Manual, Auto and STAT Auto mode repetition intervals 1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 180, 240 or 480 min Typical measurement time 20 to 40 s (depending on the heart rate and motion artifact) STAT mode cycle time 5 min Measurement time protection Adult, pediatric: 180 s Neonate: 90 s Adult Pediatric Neonate Measurement ranges Systolic: 40 to 270 40 to 200 40 to 135 (mmHg) Diastolic: 10 to 210 10 to 150 10 to 100 Mean: 20 to 230 20 to 165 20 to 110 Accuracy Resolution Cuff inflation pressure Software overpressure protection Max mean error: ±5 mmHg Max standard deviation: 8 mmHg 1mmHg Defaults Range Adult 160 mmHg 80 to 280 Pediatric 140 mmHg 80 to 210 Neonate 90 mmHg 60 to 140 Adult: 297±3 mmHg Pediatric: 240±3 mmHg Neonate: 147±3 mmHg PR Measurement range 40 to 240 bpm Resolution 1 bpm Accuracy ±2bpm or ±2%, whichever is greater Assisting Venous Puncture Pressure range Duration Adult: 20 to 120 mmHg Pediatric: 20 to 80 mmHg Neonate: 20 to 50 mmHg Adult/Pediatric: 170 s Neonate: 85 s A-16 Step 10 mmHg Alarm limit Range (mmHg) Step (mmHg) Adult: (low limit+5) to 270 Sys High Pediatric: (low limit+5) to 200 Neonate: (low limit+5) to 135 Sys Low 40 to (high limit-5) Adult: (low limit+5) to 230 Mean High Pediatric: (low limit+5) to 165 Neonate: (low limit+5) to 110 Mean Low 5 20 to (high limit-5) Adult: (low limit+5) to 210 Dia High Pediatric: (low limit+5) to 150 Neonate: (low limit+5) to 100 Dia Low 10 to (high limit-5) *Measurement accuracy verification: In adult and pediatric modes, the blood pressure measurements measured with this device are in compliance with the American National Standard for Electronic or Automated Sphymomanometers (ANSI/AAMI SP10-1992) in terms of mean error and stardard deviation by comparing with intra-arterial or auscultatory measurements (depending on the configuration) in a typical patient population. For auscultatory reference, the 5th Korotkoff sound was used to determine the diastolic pressure. In neonatal mode, the blood pressure measurements measured with this device are in compliance with the American National Standard for Electronic or Automated Sphymomanometers (ANSI/AAMI SP10-1992 and AAMI/ANSI SP10A-1996) in terms of mean error and stardard deviation by comparing with intra-arterial measurements (depending on the configuration) in a typical patient population. A-17 A.5.6 Temp Standards Meet standard of EN12470-4 Technique Thermal resistance Measurement range 0 to 50 °C (32 to 122 °F) Resolution 0.1 °C Accuracy ±0.1 °C or ±0.2 °F (without probe) Refreshing rate 1s Time for accurate measurement Body surface: <100 s Alarm limit Range T1/T2 High T1/T2 Low TD High Body cavity: <80 s Step (low limit +1) to 50 °C (low limit +1.8) to 122 °F 0 to (high limit -1) °C 0.1 °C 32 to (high limit -1.8) °F 0.1 °F 0 to 50 °C 0 to 90 °F A.5.7 IBP Standards Meet standard of EN60601-2-34/IEC60601-2-34. Technique Direct invasive measurement IBP Measurement range -50 to 300 mmHg Resolution 1 mmHg Accuracy ±2% or ±1 mmHg, whichever is greater (without sensor) Refreshing rate 1s Zero adjustment Range: ±200 mmHg Accuracy: ±1 mmHg Drift: <0.15 mmHg/°C; Less than ±1 mmHg within 24 hours Pressure transducer Excitement voltage 5 VDC, ±2% Sensitivity 5 µV/V/mmHg Impedance range 300 to 3000Ω A-18 Alarm limit Range (mmHg) ART Sys High Ao Mean High FAP Dia High BAP UAP Step (mmHg) (low limit + 2) to 300 1 Sys Low 0 to (high limit – 2) Mean Low Dia Low PA Sys High (low limit + 2) to 120 Mean High Dia High 1 Sys Low -6 to (high limit – 2) Mean Low Dia Low CVP, LAP Mean High (low limit + 2) to 40 RAP, ICP, UVP Mean Low -10 to (high limit – 2) P1 to P4 Sys High 1 (low limit + 2) to 300 Mean High Dia High 1 Sys Low -50 to (high limit – 2) Mean Low Dia Low A.5.8 C.O. Measurement method Measurement range Resolution Accuracy Alarm range Thermodilution method C.O.: 0.1 to 20 L/min TB: 23 to 43°C TI: 0 to 27°C C.O.: 0.1 L/min TB, TI: 0.1°C C.O.: ±5% or ±0.1 L /min, whichever is greater TB, TI: ±0.1°C (without sensor) BT: 23 to 43°C A-19 Alarm limit TB High TB Low Range Step (low limit + 1) to 43 °C (low limit + 1.8) to 109.4 °F 0.1 °C 23 to (high limit - 1) °C 0.1 °F 73.4 to (high limit - 1.8) °F A.5.9 CO2 Standard Meet standard of ISO 21647 Measurement mode Sidestream, microstream, mainstream Technique Infrared absorption Sidestream CO2 Module CO2 Measurement range Accuracy* 0 to 99 mmHg 0 to 40 mmHg: ±2 mmHg 41 to 76 mmHg: ±5% of the reading 77 to 99 mmHg: ±10% of the reading Accuracy drift Meet the requirement for measurement accuracy within 6 hours Resolution 1 mmHg Sample flowrate 70 ml/min, 100 ml/min 120 ml/min, 150 ml/min Sample flowrate tolerance ±15% or ±15 ml/min, whichever is greater. Warm-up time 1 min Response time Measured with a neonatal watertrap and a 2.5-meter neonatal sampling line: <3 s @ 150 ml/min <3 s @ 120 ml/min <3.5 s @ 100 ml/min <4 s @ 70 ml/min Measured with a neonatal watertrap and a 2.5-meter adult sampling line: <4.5 s @ 150 ml/min <5.5 s @ 120 ml/min <5.5 s @ 100 ml/min <7 s @ 70 ml/min Gas sampling delay time Measured with a neonatal watertrap and a 2.5-meter neonatal sampling line: <2.5 s @ 150 ml/min <3 s @ 120 ml/min <3 s @ 100 ml/min <3.5 s @ 70 ml/min A-20 Measured with a neonatal watertrap and a 2.5-meter adult sampling line: <4 s @ 150 ml/min <5 s @ 120 ml/min <5 s @ 100 ml/min <6.5 s @ 70 ml/min awRR measurement range 0 to 120 rpm awRR measurement precision ±2 rpm Apnea time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s Effect of interference gases on CO2 measurements Gas Concentration (% ) N2O ≤60 Hal ≤4 Sev ≤5 Iso ≤5 Enf ≤5 Des ≤15 Quantitive effect* ±1 mmHg ±2 mmHg *: means an extra error should be added in case of gas interference when CO2 measurements are performed under 0-40mmHg. Alarm limit Range Step EtCO2 High (low limit + 2) to 99 mmHg EtCO2 Low 0 to (high limit - 2)mmHg FiCO2 High 0 to 99 mmHg awRR High (low limit + 2) to 100 rpm awRR Low 6 to (high limit - 2) rpm 1 mmHg 1 rpm * Accuracy applies for the following conditions: 1. Measurements begin after the CO2 module warms up; 2. Ambient pressure is from 750 to 760 mmHg, and ambient temperature from 22 to 28ºC; 3. The measured gas is a dry gas and the balance gas N2; 4. Gas sample flow rate is 100 ml/min, respiration rate is 50 rpm with a fluctuation between ±3 rpm, and I:E is 1:2. When the operating temperature (near the module detector) is 5-25°C or 50-55°C, or the respiration rate is greater than 50 rpm, the measurement accuracy is: ±4 mmHg (0 to 40 mmHg) or 12% of the reading (41 to 99 mmHg). A-21 Microstream CO2 Module CO2 Measurement range Accuracy* Accuracy drift 0 to 99 mmHg 0 to 38 mmHg: ±2 mmHg 39 to 99 mmHg: ±5% of the reading+0.08% of (the reading-38) Meet the requirement for measurement accuracy within 6 hours * Accuracy applies for respiration rate up to 80 rpm. For respiration rate above 80 rpm, the accuracy is 4 mmHg or ±12% of the reading, whichever is greater. for EtCO2 exceeding 18 mmHg. For respiration rate above 60 rpm, the above accuracy can be achieved by using the CapnoLine H Set for Infant/Neonatal. In the presence of interfering gases, the above accuracy is maintained to within 4%. Resolution 1 mmHg Sample flow rate 50−+7.5 15 ml/min Initialization time 30 s (typical) 4.5 s (typical) Response time (The response time is the sum of the rise time and the delay time when using a FilterLine of standard length) Rise time: <190 ms (10% to 90%) Delay time: 2.7 s (typical) awRR measurement range awRR measurement accuracy 0 to 150 rpm 0 to 70 rpm: ±1 rpm 71 to 120 rpm: ±2 rpm 121 to 150 rpm: ±3 rpm Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s Alarm limit Range EtCO2 High (low limit + 2) to 99 mmHg EtCO2 Low 0 to (high limit - 2)mmHg FiCO2 High 0 to 99 mmHg awRR High (low limit + 2) to 100 rpm awRR Low 6 to (high limit - 2) rpm Step A-22 1 mmHg 1 rpm Mainstream CO2 Module CO2 Measurement range 0 to 150 mmHg Accuracy Accuracy drift 0 to 40 mmHg: ±2 mmHg 41 to 70 mmHg: ±5% of the reading 71 to 100 mmHg: ±8% of the reading 101 to 150 mmHg: ±10% of the reading Meet the requirement for measurement accuracy within 6 hours Resolution 0 to 69 mmHg: 1 mmHg 70 to 150 mmHg: 0.25 mmHg Rise time <60 ms awRR measurement range 0 to 150 rpm awRR measurement accuracy ±1 rpm Alarm limit Range EtCO2 High (low limit + 2) to 150 mmHg EtCO2 Low 0 to (high limit - 2)mmHg FiCO2 High 0 to 150 mmHg awRR High (low limit + 2) to 100 rpm awRR Low 6 to (high limit - 2) rpm Step 1 mmHg 1 rpm A.5.10 AG Standards Meet standard of ISO 21647 and YY0601 Technique Infrared absorption Warm-up time Sample flow rate Measurement range Resolution Iso accuracy mode: 45 s Full accuracy mode: 10 min Adult, pediatric: 120, 150, 200 ml/min Neonate: 70, 90, 120 ml/min Accuracy: ±10 ml/min or ±10%, whichever is greater CO2: 0 to 10% O2, N2O: 0 to 100% Des: 0 to 18% Sev: 0 to 8% Enf, Iso, Hal: 0 to 5% awRR: 2 to 100 rpm CO2: 1 mmHg awRR: 1 rpm A-23 Iso accuracy CO2: ±0.3%ABS N2O: ±(8%REL+2%ABS) Other anesthetic gases: 8%REL Gases Range (%REL) Accuracy (%ABS) 0 to 1 ±0.1 1 to 5 ±0.2 5 to 7 ±0.3 7 to 10 ±0.5 >10 Not specified 0 to 20 ±2 20 to 100 ±3 0 to 25 ±1 25 to 80 ±2 80 to 100 ±3 0 to 1 ±0.15 1 to 5 ±0.2 5 to 10 ±0.4 10 to 15 ±0.6 15 to 18 ±1 >18 Not specified 0 to 1 ±0.15 1 to 5 ±0.2 5 to 8 ±0.4 >8 Not specified 0 to 1 ±0.15 1 to 5 ±0.2 >5 Not specified 2 to 60 rpm ±1 rpm >60 rpm Not specified CO2 N2O O2 Full accuracy Des Sev Enf, Iso, Hal awRR Accuracy drift Meet the requirement for measurement accuracy within 6 hours Apnea alarm time 20 s, 25 s, 30 s, 35 s, 40 s Refreshing rate 1s A-24 gas sample flow rate 120ml/min, using the DRYLINE™ watertrap and neonatal DRYLINE™ sampling line (2.5m): CO2 ≤250 ms (fall time: 200ms) N2O ≤250 ms O2 ≤600 ms Hal, Iso, Sev, Des ≤300 ms Rise time Enf ≤350 ms (10 % to 90%) gas sample flow rate 200ml/min, using the DRYLINE™ water trap and adult DRYLINE™ sampling line (2.5m): Delay time CO2 ≤250 ms (fall time: 200 ms) N2O ≤250 ms O2 ≤500 ms Hal, Iso, Sev, Des ≤300 ms Enf ≤350 ms <4 s Primary anesthetic agent In full accuracy mode: 0.15%, Anesthetic agent limit (type AION 03) In ISO accuracy mode: 0.4% Second anesthetic agent: In full accuracy mode: 0.3% or 5% REL (10% in ISO accuracy mode) of primary agent if primary agent is greater than 10% In ISO accuracy mode: 0.5% * Accuracy applies for the following conditions: 1. Measurements begin after the module warms up; 2. Ambient pressure is from 750 to 760 mmHg, and ambient temperature from 22 to 28ºC; 3. The measured gas is a dry gas and the balance gas N2; 4.Gas sample flow rate is 120 ml/min, respiration rate is 20 rpm with a fluctuation between ±3 rpm, and I:E is 1:2. A-25 Effect of interference gases on AG measurements Gas Concentration (% ) Quantitive effect (%ABS)3) CO2 N2O Agent 1) O2 CO2 / / 0.1 0 0.2 N2O / 0.1 / 0.1 0.2 Agent 1) 2) / 0.15) 0.15) 0.14) 1 Nitrogen ≤78% 0 0 0 0 Xenon <100% 0.1 0 0 0.5 Helium <50% 0.1 0 0 0.5 Ethanol <0.1% 0 0 0 0.5 Acetone <1% 0.1 0.1 0 0.5 Methane <1% 0.1 0.1 0 0.5 Saturated Isopropanol vapour / 0.1 0 0 0.5 Metered dose inhaler propellants, / Unspecified Unspecified Unspecified 0.5 Methoxyflurane / Unspecified Unspecified Unspecified Unspecified 1) Agent represents one of Des, Iso, Enf, Sev, and Hal. 2) Multiple agent interference on CO2, N2O and O2 is typically the same as single agent interference. 3) For CO2, N2O and Agents, maximum interference from each gas at concentrations within specified accuracy ranges for each gas. The total interference of all gases is never larger than 5%REL. 4) Only applicable for AION 03-type module, meaning the secondary agent interference on the primary one. 5) For AION 02-type module, it is the interference provided that input of used anesthetic agent has been done. A-26 Alarm limit Range Step EtCO2 High (low limit + 2) to 76 mmHg EtCO2 Low 0 to (high limit - 2)mmHg FiCO2 High (low limit + 2) to 76 mmHg FiCO2 Low 0 to (high limit - 2)mmHg awRR High (low limit + 2) to 100 rpm awRR Low 0 to (high limit - 2)rpm EtO2 High (low limit + 0.3) to 100 % EtO2 Low 18 to (high limit - 0.3)% FiO2 High (low limit + 0.3) to 100 % FiO2 Low 18 to (high limit - 0.3)% EtN2O High (low limit + 2) to 100 % EtN2O Low 0 to (high limit - 2)% FiN2O High (low limit + 2) to 100 % FiN2O Low 0 to (high limit - 2)% EtHal/Enf/Iso High (low limit + 0.2) to 5.0 % EtHal/Enf/Iso Low 0 to (high limit - 0.2)% FiHal/Enf/Iso High (low limit + 0.2) to 5.0 % FiHal/Enf/Iso Low 0 to (high limit - 0.2)% EtSev High (low limit + 0.2) to 8.0 % EtSev Low 0 to (high limit - 0.2)% FiSev High (low limit + 0.2) to 8.0 % FiSev Low 0 to (high limit - 0.2)% EtDes High (low limit + 0.2) to 18.0 % EtDes Low 0 to (high limit - 0.2)% FiDes High (low limit + 0.2) to 18.0 % FiDes Low 0 to (high limit - 0.2)% A-27 1 mmHg 1 rpm 0.1% 1% 0.1% 0.1% 0.1% FOR YOUR NOTES A-28 B EMC The equipment meets the requirements of EN 60601-1-2. NOTE z Use of accessories, transducers, and cables other than those specified may result in increased emission and/or decreased immunity of the equipment. z The equipment should not be used adjacent to or stacked with other equipment, and if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used. z The equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below. z The equipment may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements. z Operation of the device, in the case that the patient physiological signal is lower than the minimum amplitude and/or value specified in the product specifications, may cause inaccurate results. B-1 TABLE 1 Guidance and declaration — electromagnetic emissions The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment — guidance RF emissions CISPR 11 Group1 The equipment 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 emissions CISPR 11 Class A Harmonic Emissions IEC61000-3-2 Class A The equipment is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Voltage Fluctuations/Flicker Emissions IEC 61000-3-3 Compliance Pst ,Tdt (ms) Dmax(%) Dc (%) B-2 TABLE 2 Guidance and declaration — electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment — guidance Electrostatic Discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast Transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV for input/output lines (>3m). ±2 kV for power supply lines ±1 kV for input/output lines (>3m) Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ±1 kV differential mode ±2 kV common mode ±1 kV different mode ±2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, Short interruptions and voltage variation on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycle 70% UT (30% dip in UT) for 25 cycle <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 cycle 70% UT (30% dip in UT) for 25 cycle <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 our product requires continued operation during power mains interruptions, it is recommended that our product be powered from an uninterruptible power supply or a battery. Power frequency (50/60 HZ) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. UT is the A.C. mains voltage prior to application of the test level. B-3 TABLE 3 Guidance and declaration — electromagnetic immunity The equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment should assure that it is used in such an environment Immunity test Conduced RF IEC 61000-4-6 IEC 60601 Test level 3 Vrms 150kHz to 80MHz Compliance level 3 Vrms Electromagnetic environment — guidance Portable and mobile RF communications equipment should be used no closer to any part of the equipment, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 x P d = 1.2 x P 80 MHz to 800 MHz d = 2.3 x P 800 MHz to 2.5GHz Radiated RF IEC 61000-4-3 3 V/m 80MHz to 2.5GHz 3V/m 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: Note — At 80 MHz and 800 MHz, the higher frequency range applies. Note — These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile 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 equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the equipment. b Over the frequency ranges 150kHz to 80MHz, field strengths should be less than 3V/m. B-4 TABLE 4 Recommended separation distances between portable and mobile RF communication and the equipment The equipment is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The customer or the user of the equipment can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and the equipment as recommended below, according to the maximum output power of the communication equipment. Rated Maximum Output power of Transmitter W (Watts) Separation Distance According to Frequency of Transmitter M (Meters) 150kHz -80MHz 80MHz -800MHz 800MHz -2.5GHz d = 1 .2 P d = 1 .2 P d = 2 .3 P 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.17 1.17 2.34 10 3.69 3.69 7.38 100 11.67 11.67 23.34 For transmitters at a maximum output power not listed above, the recommended separation distanced in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note — At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note — These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. B-5 FOR YOUR NOTES B-6 C Default Configurations This chapter lists some of the most important factory default settings for each department in configuration mode. You cannot change the factory default configuration itself. However, you can make changes to the settings from the factory default configuration and then save the changed configuration as a user configuration. The last column of the following tables is for your notes and review. Note: In this chapter, O.M means the monitor’s operating mode. Column C refers to the settings that can be changed in configuration Mode. Column M refers to the settings that can be changed in monitoring mode. C.1 Global Configuration Item Name General OR ICU NICU CCU Patient Cat. Adu Adu Adu Neo Adu Load Selected Config at Startup Selected C-1 User Defaults C.2 Parameters Configuration C.2.1 ECG ECG Setup Item Name O.M General OR ICU NICU CCU C M Lead Set * * 5-Lead 3-Lead 5-Lead ECG Waveforms * * 2 1 3 Alm Source * * HR Alarm * * On Alm Lev * * Med * * 120 140 120 Ped 160 180 160 Neo 200 200 200 50 40 50 Ped 75 60 75 Neo 100 90 100 HR High HR Low Adu Adu * * Sweep * * 25 mm/s Beat Vol * * 2 Paced * No * * Off Notch Filter * On HR Source * II Cascade Gain * * X1 Filter * * Monitor * Normal ECG Display Smart Lead Off * * Off Defib. Sync * Off Pacemaker Rate * 60 1 Surgery Monitor C-2 Diagnostic User Defaults ST Analysis Item Name Algorithm O.M General OR ICU NICU CCU C M ST Unit / * * mV ST Analysis / * * Off On Alarm / * * Off On Alm Lev / * * Med ST-X High / * * when ST Unit is mV: 0.20 when ST Unit is mm: 2.0 when ST Unit is mV: -0.20 when ST Unit is mm: -2.0 ST-X Low ISO / Basic * * * * ST ISO 78 ms 109 ms Mortara * * -80 ms J 48 ms ST J + 60 ms *: X represents I, II, III, aVR, aVL, aVF, V, V1, V2, V3, V4, V5 or V6. C-3 User Defaults Arrh. Analysis Item Name Algorithm O.M Genral OR ICU NICU CCU User Defaults C M Arrh. Analysis / * * Off On PVCs Alarm / * * Off On Alm Lev / * * Med PVCs High / * * 10 5 10 * * 5 3 5 Vtac Rate * * 130 150 130 Vtac PVCs * * 6 Multif. PVC’s Window * * 15 Tachy * * Adu: 100 Ped: 160 Neo: 180 Adu: 60 Ped: 80 Neo: 90 Arrhythmia Threshold Settings Asystole Mortara * Brady * Arrhythmia Alarm Settings X Alarm * * On Asystole Alm Lev * * High VFib/VTac Alm Lev * * High X Alm Lev * * Med X Alm Rec * * Off * * On Asystole Alm Lev * * High VFib Alm Lev * * High VTac Alm Lev * * High X Alm Lev * * Med X Alm Rec * * Off * * Med X Alarm All Alm Lev Basic Mortara / *X represents a certain arrhythmia event. Refer to the Specifications chapter for details. The X in “X Alm Lev” refers to all arrhythmia events except for those specially marked ones. C-4 C.2.2 RESP Item Name O.M General OR ICU NICU CCU 15 s 20 s User Defaults C M Alarm * * On Alm Lev * * Med Sweep * * 6.25 mm/s Lead * * II Gain * * X2 Resp High * * Adu, Ped: 30 Neo: Resp Low * * Adu, Ped: 8 Neo: Apnea Time Detection Mode * 100 * 20 s * Auto 30 C.2.3 PR Item Name O.M General OR ICU C M Alarm * * On Alm Lev * * Med HR High Adu * * 120 150 120 Ped 160 180 160 Neo 200 200 200 50 40 50 Ped 75 60 75 Neo 100 90 100 HR Low Adu PR Source Beat Vol * * * * * SpO2 2 1 C-5 NICU CCU User Defaults C.2.4 SpO2 Item Name O.M General OR ICU NICU CCU User Defaults C M Alarm * * On Alm Lev * * Med SpO2 High * * Adu, Ped: 100 Neo: 95 SpO2 Low * * Adu, Ped, Neo: 90 Desat Limit * * Adu, Ped, Neo: 80 Sweep * * 25 mm/s NIBP Simul * Off Pitch Tone * Mode 1 Sensivity * * Med Sensivity (Masimo) * * Normal Averaging (Masimo, Nellcor) * * 8s Sat-Seconds (Nellcor) * * 0s C.2.5 Temp Item Name O.M General OR ICU C M Alarm * * On Alm Lev * * Med Temp Unit * * ºC T1/T2 High (ºC) Adu * * 39.0 Ped 39.0 Neo 39.0 T1/T2 Low (ºC) Adu TD High (ºC) 36.0 35.0 36.0 Ped 36.0 35.0 36.0 Neo 36.0 35.0 36.0 Adu * * * * 2.0 Ped 2.0 Neo 2.0 C-6 NICU CCU User Defaults C.2.6 NIBP Item Name O.M General OR ICU NICU CCU C M Alarm * * On Alm Lev * * Med Alm Source * * All Measure Mode * * Manual Auto Interval * * 15 min 5 min Press. Unit * * mmHg Display NIBP * * Single-group Multi-group Single-group PR Display * Cuff Press (mmHg) Inflation Pressure (mmHg) Manual Auto 15 min Off Adu * * 80 Ped 60 Neo 40 Adu * * 160 Ped 140 Neo 90 Alarm Limits Setup Sys High (mmHg) Sys Low (mmHg) Mean High (mmHg) Mean Low (mmHg) Dia High (mmHg) Dia Low (mmHg) Adu * * 160 180 160 Ped 120 140 120 Neo 90 Adu * * 90 70 90 Ped 70 60 70 Neo 40 120 110 Adu * * 110 Ped 90 Neo 70 Adu * * 60 Ped 50 Neo 25 Adu * * 90 Ped 70 Neo 60 Adu * * 50 Ped 40 Neo 20 C-7 30 min 15 min User Defaults C.2.7 IBP Item Name O.M General OR ICU C M Alarm * * On Alm Lev * * Med P1 Measure * * All P2 Measure * * Mean P3 Measure * * All P4 Measure * * Mean Alarm Source * * All Press. Unit * * mmHg Response * * Med Sweep * * 25 mm/s Auto Scaling * * Off Filter * 12.5 Hz Wave Overlapping * * Off Art, Ao, UAP, BAP, FAP Setup Upper Scale * * 150 Middle Scale * * 75 Lower Scale * * 0 * * 160 180 160 Ped 120 140 120 Neo 90 90 70 90 Ped 70 60 70 Neo 55 120 110 60 70 Sys High (mmHg) Sys Low (mmHg) Mean High (mmHg) Mean Low (mmHg) Dia High (mmHg) Dia Low (mmHg) Adu Adu Adu * * * * 110 Ped 90 Neo 70 Adu * * 70 Ped 50 Neo 35 Adu * * 90 Ped 70 Neo 60 Adu * * 50 Ped 40 Neo 20 C-8 NICU CCU User Defaults PA Setup Upper Scale * * 30 Middle Scale * * 15 Lower Scale * * 0 * * 35 Sys High (mmHg) Sys Low (mmHg) Mean High (mmHg) Mean Low (mmHg) Dia High (mmHg) Dia Low (mmHg) Adu Ped 60 Neo 60 Adu * * 10 Ped 24 Neo 24 Adu * * 20 Ped 26 Neo 26 Adu * * 0 Ped 12 Neo 12 Adu * * 16 Ped 4 Neo 4 Adu * * 0 Ped -4 Neo -4 CVP, LAP, RAP, ICP, UVP Setup Upper Scale * * 30 Middle Scale * * 15 Lower Scale * * 0 * * 10 Mean High (mmHg) Mean Low (mmHg) Adu Ped 4 Neo 4 Adu * * 0 Ped 0 Neo 0 C-9 C.2.8 C.O. Item Name O.M General OR C M Alarm * * On Alm Lev * * Med TB High (ºC) * * 39.0 TB Low (ºC) * * 36.0 Comp. Const * * 0.542 Auto Ti (ºC) * * On Manual Ti (ºC) * * 2.0 Temp Unit * * ºC Interval (s) * * 30 ICU NICU CCU User Defaults C.2.9 CO2 Item Name O.M General OR ICU NICU CCU C M Alarm * * On Alm Lev * * Med Press.Unit * * mmHg Operating Mode * * Sidestream: Standby Microstream/Mainstream: Sweep * * 6.25 mm/s Scale (mmHg) * * 50 Measure Sidestream CO2 Setup Flow Rate * * 100 ml/min Humidity Compen * Off N2O Compen * 0 O2 Compen * 0 Des Compen * 0 70 ml/min 100 ml/min C-10 User Defaults Item Name O.M General OR ICU NICU CCU C M Microstream CO2 Setup Humidity Compen * Off Max Hold * * 20 s Auto Standby (min) * * 0 * * 10 s O2 Compen * Off Balance Gas * Room Air AG Compen * 0 * Adu, Ped: 50 Neo: 45 Adu: 15 Ped: 20 Neo: 30 Mainstream CO2 Setup Max Hold Alarm Limits Setup EtCO2 High (mmHg) EtCO2 Low (mmHg) * * * FiCO2 High (mmHg) * * Adu, Ped, Neo: 4 awRR High * * Adu, Ped: 30 Neo: 100 Adu, Ped: 8 Neo: 30 awRR Low Apnea Time * * * * 20 s 15 s C-11 20 s User Defaults C.2.10 AG Item Name O.M General OR ICU NICU C M Alarm * * On Alm Lev * * Med Sweep * * 6.25 mm/s O2 Compen * Off Operating Mode * * Measure Flow Rate * * Adu, Ped: 120 ml/min Neo: 70 ml/min Auto Standby * * Off Apnea Time * * 20 s CO2 Unit * * mmHg Wave Type * * Draw Scale * * when unit is mmHg: 50 when unit is % 7.0 CO2 Setup EtCO2 High EtCO2 Low * * * * Adu, Ped: 50 Neo: 45 Adu: 15 Ped: 20 Neo: 30 or KPa: FiCO2 High * * 4 FiCO2 Low * * 0 awRR High * * Adu, Ped: 30 Neo: 100 Adu, Ped: 8 Neo: 30 awRR Low * * C-12 CCU User Defaults Gas Setup Agent * --- O2 Unit * * % N2O Scale * * 50 O2 Scale * * when unit is mmHg: 400 when unit is % 50 AA Scale * * 9 Hal/Enf/Iso Scale * * 2.5 Des Scale * * 9 Sev Scale * * 4 EtO2 High * * 90 EtO2 Low * * 18 FiO2 High * * 88 FiO2 Low * * 18 EtN2O High * * 55 EtN2O Low * * 0 FiN2O High * * 53 FiN2O Low * * 0 EtHal/Enf/Iso High * * 3 EtHal/Enf/Iso Low * * 0 FiHal/Enf/Iso High * * 2 FiHal/Enf/Iso Low * * 0 EtSev High * * 6 EtSev Low * * 0 FiSev High * * 5 FiSev Low * * 0 EtDes High * * 8 EtDes Low * * 0 FiDes High * * 6 FiDes Low * * 0 C-13 or KPa: C.3 Routine Configuration C.3.1 Alarm Item Name O.M General OR ICU NICU C M Alarm Pause Time * 2 min Minimum Alarm Volume * 2 1 2 Alm Volume * * 2 1 2 Reminder Tone * Off Reminder Vol * * Low Reminder Interval * 1 min Latching Alarms * Off Display Alarm Limits * On Alm Lev of ECG Lead Off * Low Alm Lev of SpO2 Sensor Off * Low Alarm Tone Interval * High Level Alarm: 10 s Med/Low Level Alarm: 20 s Alarm Delay * * 6s ST Alarm Delay * * 30s C-14 CCU User Defaults C.3.2 Screens Item Name O.M General OR ICU NICU CCU User Defaults C M Select Screen * * All parameters Select Wave 1 Sequence for All 2 Parameters 3 Screen 4 * * ECG Select Parameters for Big Numerics Screen Pleth IBP1 IBP2 5 IBP3 6 IBP4 7 CO2 8 AA Parameter 1 * * ECG Parameter 2 SpO2 Parameter 3 Resp Parameter 4 NIBP C.3.3 Waveform Item Name O.M General OR ICU NICU C M Sweep Mode * * Refresh Wave Line * Medium Draw Wave * Colour CO2 Wave Type * * Draw Waveforms X * * On Parameter/ ECG Wave NIBP Colour SpO2 * Green White Cyan TEMP White Art/Ao/UAP/FAP Red /BAP/P1 to P4 PA Yellow CVP/ICP Blue C-15 CCU User Defaults LAP Purple RAP Orange UVP Cyan CO2 Yellow RESP Yellow AA Yellow N2O Blue O2 Green Hal Red Enf Orange Iso Purple Des Cyan Sev Yellow C.O. White * X represents a waveform label, such as ECG, RESP, CO2 and so forth. The ECG waveform cannot be set off. C.3.4 Archives Item Name O.M General OR ICU NICU CCU C M Archives Access * Tabular Trends Interval * * 5 min Trend Group * * Standard ECG Graphic Trends Interval * * 1s 5s Trend Group * * Standard Event Wave Length * * 16 s Event Modification Right * Minitrend Length * Full Disclosure Direct 32 s On * 2h Gain * X1 Sweep * 12.5 mm/s Save Waves * * All the waveforms that the monitor has C-16 User Defaults C.3.5 Record Item Name O.M C General OR * ECG1 Waveform 2 * ECG2 Waveform 3 * Off Length * * 8s Interval * * Off Paper Speed * * 25 mm/s Gridlines * * On * * Off X NICU CCU M Waveform 1 Alm Rec ICU User Defaults * X represents a parameter label. C.3.6 Print Item Name O.M General OR C M Printer * None Paper Size * A4 Print On Both Sides * Off ECG Reports Tabular Trends Reports ICU NICU CCU User Defaults Set as End Case Report * * Unselected Amplitude * * 10 mm/mV Sweep * * 25 mm/s Auto Interval * * Off Gridlines * * Off 12-Lead Format * * 12X1 Set as End Case Report * * Unselected Back * * Auto Interval * * Auto Report Layout * * Time Oriented Select Parameters * * Currently Displayed Trended Parameters Graphic Set as End Case Report * * Unselected Trends Back * * Auto C-17 Reports Interval * * Auto Select Parameters * * Currently Displayed Trended Parameters Realtime Set as End Case Report * * Unselected Report Sweep * * Auto Select Wave * * Current C.3.7 Others Item Name O.M General OR C M Brightness * * 5 Key Volume * * 2 ICU NICU CCU User Defaults Modules X * * On Analog Out. Analog Out. * Off Waveform * The first ECG waveform on the screen Nurse Call Signal Type * Continuous Contact Type View Other Patient * Normally Closed Alm Lev * High, Med, Low Alarm Cat. * Phys., Tech. Auto Alarm * * On Audio Pause * On Select QuickKey 1 QuickKeys * Standby QuickKey 2 * Limits QuickKey 3 * Screens QuickKey 4 * Auto NIBP Discharge Patient * X represents a module label. C-18 Standby D Alarm Messages This chapter lists only the most important physiological and technical alarm messages. Some messages appearing on your monitor may not be included. In this chapter: The “I” field indicates how alarm indications are cleared: “A” means all alarm indications can be cleared, “B” indicates all alarm indications except the alarm message can be cleared, and “C” indicates only alarm tones can be cleared. The “L” field indicates the alarm level: H means high, M means medium and L means low. “*” means the alarm level is user-adjustable. XX represents a measurement or parameter label, such as ECG, NIBP, HR, ST-I, PVCs, RR, SpO2, PR, etc. In the “Cause and Solution” column, corresponding solutions are given instructing you to troubleshoot problems. If the problem persists, contact your service personnel. D-1 D.1 Physiological Alarm Messages Measurement Alarm messages L Cause and solution XX XX Too High M* XX Too Low M* XX value has risen above the high alarm limit or fallen below the low alarm limit. Check the patient’s condition and check if the patient category and alarm limit settings are correct. ECG Weak Signal H The ECG signal is so weak that the monitor can’t perform ECG analysis. Check the patient’s condition and the ECG connections. Asystole H VFib/VTac H Arrhythmia has occurred to the patient. Check the patient’s condition and the ECG connections. R on T M* VT>2 M* Couplet M* PVC M* Bigeminy M* Trigeminy M* Tachy M* Brady M* Missed Beats M* Irr. Rhythm M* Vent. Rhythm M* Multif. PVC M* PNP M* PNC M* Resp Apnea H The respiration signal was so weak that the monitor cannot perform respiration analysis. Check the patient’s condition and the Resp connections. Resp Artifact H The patient’s heartbeat has interfered with his respiration. Check the patient’s condition and the Resp connections. SpO2 SpO2 Desat H The SpO2 value has fallen below the desaturation alarm limit. Check the patient’s condition and check if the alarm limit settings are correct. PR No pulse H The pulse signal was so weak that the monitor cannot perform pulse analysis. Check the patient’s condition, SpO2 sensor and measurement site. ECG Resp The pacer appears abnormal. Check the pacer. D-2 Measurement Alarm messages L Cause and solution CO2 CO2 Apnea H AG AG Apnea H The patient stops breathing, or the respiration signal was so weak that the monitor cannot perform respiration analysis. Check the patient’s condition and the RM connections. FiO2 Too Low H Check the patient’s condition, the ventilated O2 content and the AG connections. Anesthetic Mixture’s MAC>3 M The system has detected more than one anesthesia gas and the mixture’s MAC was too high. Check the ventilated anesthesia gases’ type and concentration. D.2 Technical Alarm Messages Measurement Alarm message L I Cause and solution XX XX SelfTest Err H C XX Init Err H C XX Comm Err L C An error occurred to the XX module, or there is a problem with the communications between the module and the monitor. Restart the monitor. XX Comm Stop H C XX Comm Abnormal L C XX Limit Err L C XX parameter limit is accidentally changed. Contact your service personnel. XX Overrange L C The measured XX value is not within the specified range for XX measurement. Contact your service personnel. ECG Lead Off M B * ECG YY Lead Off M B * ECG (YY represents a leadwire.) ECG Noisy L C The electrode has become detached from the patient or the lead wire has become disconnected from the adapter cable. Check the connections of the electrodes and leadwires. The ECG signal is noisy. Check for any possible sources of signal noise around the cable and electrode, and check the patient for great motion. D-3 Measurement Alarm message L I Cause and solution ECG Artifact L C Artifacts are detected on the ECG analysis lead and as a result heart rate cannot be calculated and Asystole, Vfib and Vtac cannot be analyzed. Check the connections of the electrodes and leadwires and check for any possible source of interference around the cable and electrode. Check the patient’s condition and check the patient for great motion. ECG High Freq. Noise L C High frequency signals are detected on the ECG analysis lead. Check for any possible source of interference around the cable and electrode. ECG Low Freq. Noise L C Low frequency signals are detected on the ECG analysis lead. Check for any possible source of interference around the cable and electrode. ECG Amplitude Too Small L C The ECG amplitude didn’t reach the detected threshold. Check for any possible source of interference around the cable and electrode. ECG Config. Err L C ECG configuration is wrongly downloaded. Check the downloaded configuration and re-download the correct configuration. Resp Resp Disturbed L C The respiration circuit is disturbed. Restart the monitor. Temp Temp Cal. Err L C A calibration failed. Restart the monitor. T1 Sensor Off L A T2 Sensor Off L A The Temp sensor has become detached from the patient or the module. Check the sensor connections. SpO2 Sensor Off M B * SpO2 Sensor Fault L C SpO2 No Sensor L B SpO2 Unknown Sensor L C SpO2 Sensor Incompatible L C SpO2 Too Much Light L C There is too much light on the SpO2 sensor. Move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light. SpO2 Low Signal L C The SpO2 signal is too low or too weak. Check SpO2 The SpO2 sensor has become detached from the patient or the monitor, or there is a fault with the SpO2 sensor, or an unspecified SpO2 sensor has been used. Check the sensor application site and the sensor type, and make sure if the sensor is damaged. Reconnect the sensor or use a new sensor. D-4 Measurement NIBP Alarm message L I Cause and solution SpO2 Weak Signal L C SpO2 Weak Pulse L C SpO2 Low Perf L B the patient’s condition and change the sensor application site. If the error persists, replace the sensor. SpO2 Interference L C The SpO2 signal has been interfered. Check for any possible sources of signal noise around the sensor and check the patient for great motion. SpO2 Board Fault L C There is a problem with the SpO2 measurement board. Do not use the module and contact your service personnel. SpO2 Non-Pulsatile L C The pulse signal was so weak that the monitor cannot perform pulse analysis. Check the patient’s condition. NIBP Loose Cuff L C NIBP Air Leak L C The NIBP cuff is not properly connected, or there is a leak in the airway. NIBP Pneumatic Leak L C Check the NIBP cuff and pump for leakages. NIBP Cuff Type Wrong L C The cuff type applied mismatches the patient category. Verify the patient category and replace the cuff. NIBP Air Pressure Err L C An error occurred to the air pressure. Verify that the monitor application site meets the environmental requirements and check if there is any source that affects the air pressure. NIBP Weak Signal L C The patient’s pulse is weak or the cuff is loose. Check the patient’s condition and change the cuff application site. If the error persists, replace the cuff. NIBP Signal Saturated L C The NIBP signal is saturated due to excess motion or other sources. NIBP Overrange L C The measured NIBP value is not within the specified range. NIBP Excessive Motion L C Check the patient’s condition and reduce the patient motion. NIBP Cuff Overpress. L C The NIBP airway may be occluded. Check the airway and measure again. NIBP Equip Err H C NIBP Timeout L C NIBP Measure Failed L C An error occurred during NIBP measurement and therefore the monitor cannot perform analysis correctly. Check the patient’s condition and NIBP connections, or replace the cuff. D-5 Measurement IBP Alarm message L I Cause and solution NIBP Illegally Reset L C An illegal reset occurred during NIBP measurement. Check if the airway is occluded. YYSensor Off L A Check the sensor connection and reconnect the sensor. (YY represents an IBP label.) C.O. TB Sensor Off L A CO2 CO2 Sensor High Temp L C Check, stop using or replace the sensor. CO2 Sensor Low Temp L C Check, stop using or replace the sensor. CO2 Airway High Press. L C CO2 Airway Low Press. L C An error occurred in the airway pressure. Check the patient connection and patient circuit, and then restart the monitor. CO2 High Barometric L C CO2 Low Barometric L C CO2 FilterLine Occluded L C The airway or watertrap was occluded. Check the airway and remove the occlusion. CO2 No Watertrap L B Check the watertrap connections. CO2 Check Adapter L C There is a problem with the airway adapter. Check, clean or replace the adapter. CO2 FilterLine Err L C Check if there is a leak in the CO2 sample line or the CO2 sample line has been occluded. CO2 Zero Failed L C Check the CO2 connections. After the sensor’s temperature becomes stabilized, perform a zero calibration again. CO2 Check Cal. L C Perform a calibration. CO2 Check Airway L C An error occurred to the airway. CO2 No Filterline L A Make sure that the filterline is connected. CO2 Main Board Err H C There is a problem with the CO2 module. Restart the monitor. CO2 Replace Scrubber&Pump L C CO2 15V Overrange H C CO2 Hardware Err H C CO2 User Cal Fail L C Check the CO2 connections, make sure that the monitor application site meets the requirements, and check for special sources that affect the ambient pressure. Restart the monitor. Re-calibrate the AG module. D-6 Measurement AG Alarm message L I Cause and solution CO2 Check Sensor L C The CO2 sensor appears abnormal. Check or replace the sensor. CO2 No Sensor L A Make sure that the CO2 sensor is connected. CO2 Temp Overrange L C The module detects that the temperature has exceeded the specified range. Please move away the source of heat or wait for the module to recover. AG No Watertrap L B Check the connections of the watertrap and re-connect it. AG Change Watertrap L C Wait until the change is completed. AG Watertrap Type Wrong L C Make sure that a correct watertrap has been used. YY Accuracy Unspecified L C The measured value has exceeded the specified accuracy range. AG Hardware Mulfunction H C Stop using the AG module and contact your service personnel. AG Airway Occluded L C Check the airway and remove the occlusion. AG Zero Failed L C Restart the monitor, and then perform a zero calibration again. AG Cal. Failed L C Re-calibrate the AG module. Anesthetic Mixture L C The system has detected more than one anesthesia gas. Check the ventilated anesthesia gas. O2 Sensor Err L C The O2 sensor appears abnormal. Contact your service personnel. AG Limit Error L C AG violated set alarm limits seriously and measurements cannot be performed. Contact your service personnel. 12V Too High H C 12V Too Low H C There is a problem with the system power supply. Restart the monitor. 3.3V Too High H C 3.3V Too Low H C Low Battery M C (YY represents O2, N2O, CO2, Enf, Iso, Sev, Hal, Des, or awRR (AG) Power Connect the monitor to an AC power source and D-7 Measurement Recorder System Alarm message L I Cause and solution Battery Depleted H C allow the batteries to charge. Battery Mismatched M C The two batteries have different charge capacity, or the batteries unspecified have been used, or there is a problem with the batteries. Make sure that correct batteries are used and the batteries are not damaged, or replace the batteries. RT Clock Need Reset L C Re-set the system time and restart the monitor. RT Clock Not Exist H C Contact your service personnel. Power Board Comm. Stop H C Contact your service personnel. Recorder SelfTest Err L C Stop the recording and restart the monitor. Recorder Comm Err L C Recorder Head Hot L C The recorder has been working for too long time. Stop the recording and resume the recording till the recorder’s printhead cools down. IP Address Conflict L C Check the monitor’s IP address and re-set it. Loading User Config. Failed. L C Loading Factory Config. Failed. L C The system re-loads configuration automatically. If the re-leading always failed, contact your service personnel. CF Storage Card Err! M C An error occurred when the CF storage card reads and writes. Contact your service personnel. CF Card Space Low L CF card space is lower than 40 M. B D-8 E Symbols and Abbreviations E.1 Symbols µA microampere µV microvolt A ampere Ah ampere hour bpm beat per minute bps bit per second ºC centigrade cc cubic centimeter cm centimeter dB decibel DS dyne second ºF fahrenheit g gram GHz gigahertz GTT gutta h hour Hz hertz in inch kg kilogram kPa kilopascal L litre lb pound m meter mAh milliampere hour Mb mega byte mcg microgram mEq milli-equivalents mg milligram min minute ml milliliter E-1 mm millimeter mmHg millimeters of mercury cmH2O centimeters of water ms millisecond mV millivolt mW milliwatt MΩ megaohm nm nanometer rpm breaths per minute s second V volt VA volt ampere Ω ohm W watt – minus, negative % percent / per; divide; or + plus = equal to < less than > greater than ≤ less than or equal to ≥ greater than or equal to ± plus or minus × multiply E-2 E.2 Abbreviations AaDO2 alveolar-arterial oxygen gradient AAMI Association for Advancement of Medical Instrumentation AC alternating current Adu adult AG anaesthesia gas AHA American Heart Association ANSI American National Standard Institute Ao aortic pressure Art arterial aVF left foot augmented lead aVL left arm augmented lead aVR right arm augmented lead awRR airway respiratory rate BAP brachial aterial pressure BP blood pressure BPSK binary phase shift keying BSA body surface area BTPS body temperature and pressure, saturated C.I. cardiac index C.O. cardiac output CaO2 arterial oxygen content CCO continuous cardiac output CCU cardiac (coronary) care unit CE Conformité Européenne CIS clinical information system CISPR International Special Committee on Radio Interference CMOS complementary metal oxide semiconductor CMS central monitoring system C.O. cardiac output CO2 carbon dioxide COHb carboxyhemoglobin CP cardiopulmonary CVP central venous pressure E-3 DC direct current Des desflurane Dia diastolic DPI dot per inch ECG electrocardiograph EDV end-diastolic volume 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 EtO ethylene oxide EtO2 end-tidal oxygen FAP femoral arterial pressure FCC Federal Communication Commission FDA Food and Drug Administration Fi fraction of inspired FiCO2 fraction of inspired carbon oxygen FiN2O fraction of inspired nitrous oxide FiO2 fraction of inspired oxygen FPGA field programmable gate array Hal halothane Hb hemoglobin Hb-CO carbon mono-xide hemoglobin HbO2 oxyhemoglobin HIS hospital information system HR heart rate IBP invasive brood pressure ICP intracranial pressure ICT/B intracranial catheter tip pressure transducer ICU intensive care unit ID identification IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronic Engineers E-4 IP internet protocol Iso isoflurane LA left arm LAP left atrial pressure Lat lateral LCD liquid crystal display LCW left cardiac work LCWI left cardiac work index LED light emitting diode LL left leg LVDS low voltage differential signal LVSW left ventricular stroke work LVSWI left ventricular stroke work index MAC minimum alveolar concentration 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 noninvasive blood pressure O2 oxygen O2CI oxygen consumption index O2R oxygen extraction ratio OR operating room oxyCRG oxygen cardio-respirogram PA pulmonary artery PAWP pulmonary artery wedge pressure PD photodetector Ped pediatric Pleth plethysmogram PR pulse rate PVC premature ventricular contraction PVR pulmonary vascular resistance PVRI pulmonary vascular resistance index E-5 R right RA right arm RAM random access memory RAP right atrial pressure Rec record, recording Resp respiration RHb reduced hemoglobin RL right leg RR respiration rate SaO2 arterial oxygen saturation Sev sevoflurane SFM self-maintenance SI stroke index SpO2 arterial oxygen saturation from pulse oximetry STR systolic time ratio SV stroke volume SVR systemic vascular resistance SVRI systemic vascular resistance index Sync synchronization Sys systolic pressure Taxil axillary temperature TB blood temperature TD temperature difference Temp temperature TFT thin-film technology TI injectate temperature Toral oral temperature Trect rectal temperature UAP umbilical arterial pressure UPS uninterruptible power supply USB universal serial bus UVP umbilical venous pressure VAC volts alternating current E-6 PN: 9211-20-87439(7.0)
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