Philips Medical Systems North America MX40SH2B4 INTELLIVUE MX40 2.4GHz PATIENT WORN DEVICE User Manual MX40 IFU Athens
Philips Medical Systems North America Co. INTELLIVUE MX40 2.4GHz PATIENT WORN DEVICE MX40 IFU Athens
Users Manual
op ft ra IntelliVue MX40 Instructions for Use Release B.0 Notice Proprietary Information This document contains proprietary information, which is protected by copyright. First Edition 2012 4535 643 15721 Copyright op Copyright © 2012 Koninklijke Philips Electronics N.V. All rights reserved. Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder. Philips Medical Systems Nederland B.V. reserves the right to make changes in specifications and/or to discontinue any products at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. ft This product contains software licensed under an open source license. For acknowledgments, license texts and source code, please refer to the IntelliVue Information Center iX M3290B Software\References\README.pdf. Windows ® is a registered trademark of Microsoft Corporation in the United States and other countries. EASI is a trademark of Zymed Inc. ra OxiCliq ® and OxiMax ® are registered trademarks of Nellcor Incorporated. Duracell ® is a registered trademark of Procter & Gamble Incorporated. STERRAD ® is a registered trademark of Advanced Sterilization Products. GORE-TEX ® is a registered trademark of W.L. Gore & Assoc. Incorporated. Tone modulation is licensed under US patent 4,653,498 from Nellcor Puritan Bennett Incorporated. Manufacturer Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 (978) 687-1501 Printed in USA Document number ii 4535 643 15721 Warranty The information contained in this document is subject to change without notice. Philips Medical Systems makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Philips Medical Systems shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material. FCC op This device complies with Part 15 and/or Part 95 of the FCC Rules. Operation is subject to the following two conditions: (1) these devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. Changes and modifications not expressly approved by Philips Medical Systems can void your authority to operate this equipment under Federal Communications Commission's rules ft Protecting Personal Information ra It is recommended that customers have policies and procedures for the proper handling of personal or sensitive information, ePHI (electronic protected health information) and PHI (protected health information), which will maintain the confidentiality, integrity, and the availability of these types of data. Any organization using this product should implement the required protective means necessary to safeguard personal information consistent with each applicable country law, code and regulation; and consistent with their developed and maintained internal policies and procedures. While handling personal information is outside the scope of this document; in general, each organization is responsible for identifying: Who has access to personal data and under what conditions an individual has authorization to use that data. What security controls are in place to protect personal and sensitive data. How the data is stored and the conditions by which it is stored. How the data is transmitted and the conditions under which that data is transmitted. iii Protecting personal health information is a primary component of a security strategy. Personal and sensitive information should be protected according to the applicable laws, regulations and directives, such as HIPAA, PIPEDA and/or Council of the European Union security and privacy rules. Compliance Uses of the system for purposes other than those intended and expressly stated by the manufacturer, as well as incorrect use, incorrect operation, or modifications made to the system without explicit approval from Philips, may relieve the manufacturer (or his agent) from all or some responsibilities for resultant noncompliance, damage or injury. Printing History op New editions of this document will incorporate all material updated since the previous edition. Update packages may be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Note that pages which are rearranged due to changes on a previous page are not considered revised. February 2012 ra First Edition ft The documentation printing date and part number indicate its current edition. The printing date changes when a new edition is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document part number changes when extensive technical changes are incorporated. Document Conventions In this guide: Warnings Warning A Warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. iv Cautions Caution A Caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury. Notes ra ft op A Note contains additional information on the product's usage. vi ra op ft Contents 1. Introducing the IntelliVue MX40 1-1 MX40 Features-------------------------------------------------------------------------- 1-2 MX40 Models ---------------------------------------------------------------------------- 1-3 MX40 Release B.0 Compatibility --------------------------------------------------- 1-4 2. What's New? 2-1 New Features and Enhancements------------------------------------------------- 2-2 3. Product Safety 3-1 General Safety -------------------------------------------------------------------------- 3-2 Safety Symbols & Other Marks ----------------------------------------------------- 3-5 ra ft op 4. Basic Operation 4-1 Controls, Indicators and Connectors ---------------------------------------------- 4-2 MX40 Controls and Indicators -------------------------------------------------- 4-2 Multi-Function Button ----------------------------------------------------------- 4-3 Silence Alarm Button ----------------------------------------------------------- 4-3 SmartKeys Button --------------------------------------------------------------- 4-3 Main Screen Button ------------------------------------------------------------- 4-4 SmartKeys ------------------------------------------------------------------------- 4-4 Alarms Area ----------------------------------------------------------------------- 4-5 Patient Information Area ------------------------------------------------------- 4-6 Paced Status --------------------------------------------------------------------- 4-6 Display Lock ---------------------------------------------------------------------- 4-6 Status Area------------------------------------------------------------------------ 4-7 Operating and Navigating ------------------------------------------------------------ 4-8 Power-On Self Test --------------------------------------------------------------- 4-8 Navigating --------------------------------------------------------------------------- 4-8 Selecting Display Elements ----------------------------------------------------- 4-8 Locking the Display---------------------------------------------------------------- 4-9 Measurement Area ---------------------------------------------------------------- 4-9 Measurement Area Display Configurations --------------------------------- 4-9 Connecting/Disconnecting the Patient Cable ----------------------------- 4-10 Understanding Settings -------------------------------------------------------------- 4-12 Changing Measurement Settings --------------------------------------------- 4-12 ECG Settings at the MX40 ----------------------------------------------------- 4-12 Waveform Settings at the MX40 ---------------------------------------------- 4-13 Battery Information -------------------------------------------------------------------- 4-14 Battery Safety Information ------------------------------------------------------ 4-14 Lithium-ion Rechargeable Battery Care ------------------------------------ 4-15 Lithium-ion Rechargeable Battery Handling Precautions ------------ 4-15 Lithium-ion Rechargeable Battery Storage ------------------------------ 4-16 Contents Inserting/Removing Batteries ------------------------------------------------Inserting Batteries---------------------------------------------------------------Removing the Batteries -------------------------------------------------------Battery Charge Status ---------------------------------------------------------Lithium-ion Rechargeable Battery Charge Status -------------------AA Battery Charge Status --------------------------------------------------- 4-16 4-17 4-19 4-20 4-20 4-21 Pouch Use -----------------------------------------------------------------------------Securing the Pouch-------------------------------------------------------------Showering -------------------------------------------------------------------------Telemetry Mode Use ---------------------------------------------------------------Monitoring Mode Use ---------------------------------------------------------------Briefing the Patient ------------------------------------------------------------------- 4-22 4-22 4-24 4-26 4-27 4-28 op 5. Alarms 5-1 Alarms Overview ------------------------------------------------------------------------ 5-2 Visual Alarm Indicators ----------------------------------------------------------- 5-3 Alarm Message------------------------------------------------------------------- 5-3 Alarm Indicator ------------------------------------------------------------------- 5-4 Flashing Numeric ---------------------------------------------------------------- 5-4 ft Audible Alarm Indicators when in Monitoring Mode ---------------------- 5-5 Traditional Audible Alarms (HP/Agilent/Philips/Carenet) -------------- 5-5 ISO/IEC Standard Audible Alarms ------------------------------------------ 5-5 ra Acknowledging Alarms ----------------------------------------------------------- 5-6 Pausing or Switching Off Alarms----------------------------------------------- 5-6 To Pause All Alarms ------------------------------------------------------------ 5-6 While Alarms are Paused ----------------------------------------------------- 5-7 Restarting Paused Alarms ---------------------------------------------------- 5-7 Alarm Limits ------------------------------------------------------------------------- 5-7 Viewing Individual Alarm Limits ---------------------------------------------- 5-8 Reviewing Alarms ------------------------------------------------------------------ 5-8 Review Alarms Window -------------------------------------------------------- 5-8 Alarm Reminders ---------------------------------------------------------------- 5-8 Latching Alarms -------------------------------------------------------------------- 5-9 Alarm Latching Behavior --------------------------------------------------------- 5-9 Alarm Behavior at Power On---------------------------------------------------- 5-9 Physiologic Alarms ------------------------------------------------------------------- 5-10 Technical Alarms (INOPs) --------------------------------------------------------- 5-14 6. ECG and Arrhythmia Monitoring 6-1 ECG Safety Information--------------------------------------------------------------- 6-2 For Paced Patients ---------------------------------------------------------------- 6-3 Measuring ECG ------------------------------------------------------------------------- 6-5 Connecting and Positioning ECG Electrodes ----------------------------------- 6-6 Contents ft op Selecting the Primary and Secondary ECG Leads ---------------------------- 6-8 Checking Paced Status --------------------------------------------------------------- 6-9 Understanding the ECG Display -------------------------------------------------- 6-10 Monitoring Paced Patients ---------------------------------------------------------- 6-11 Optimizing Lead Selection for Paced Patients ---------------------------- 6-11 Changing the Size of the ECG Wave -------------------------------------------- 6-12 Choosing EASI or Standard Lead Placement --------------------------------- 6-13 Derived 12-lead ECG----------------------------------------------------------------- 6-14 Hexad -------------------------------------------------------------------------------- 6-14 EASI ---------------------------------------------------------------------------------- 6-14 ECG Configuration -------------------------------------------------------------------- 6-15 ECG Leads Monitored --------------------------------------------------------------- 6-16 Reconstructed Leads ----------------------------------------------------------------- 6-18 Chest Electrode Placement --------------------------------------------------------- 6-19 3-Wire Placement --------------------------------------------------------------------- 6-20 5-Wire Placement (Standard Mode) ---------------------------------------------- 6-21 5-Wire Placement (EASI Mode) --------------------------------------------------- 6-22 6-Wire Placement --------------------------------------------------------------------- 6-23 Selecting Positions of Va and Vb Chest Leads --------------------------- 6-23 6-Wire Placement (Hexad Mode) ------------------------------------------------- 6-24 Monitoring during Leads Off -------------------------------------------------------- 6-25 ECG Fallback ---------------------------------------------------------------------- 6-25 Relearning -------------------------------------------------------------------------- 6-25 ST/AR Arrhythmia Monitoring ------------------------------------------------------ 6-27 ST/AR Arrhythmia Algorithm --------------------------------------------------- 6-27 Indications for Use ------------------------------------------------------------- 6-27 ra How the ST/AR Algorithm Works --------------------------------------------- 6-27 Aberrantly-Conducted Beats ------------------------------------------------ 6-28 Atrial Fibrillation Alarm -------------------------------------------------------- 6-28 Intermittent Bundle Branch Block ------------------------------------------ 6-29 ECG and Arrhythmia Alarm Overview --------------------------------------- 6-29 Using ECG Alarms --------------------------------------------------------------- 6-30 Extreme Alarm Limits for Heart Rate -------------------------------------- 6-30 Arrhythmia Alarm Settings --------------------------------------------------- 6-30 Yellow Arrhythmia Alarms ---------------------------------------------------- 6-31 Viewing Arrhythmia Waves -------------------------------------------------- 6-31 Arrhythmia Beat Labels ------------------------------------------------------- 6-32 Enhanced Arrhythmia Chain------------------------------------------------- 6-33 Basic Arrhythmia Chain ------------------------------------------------------- 6-34 Learning ----------------------------------------------------------------------------- 6-34 Learning Phase ----------------------------------------------------------------- 6-34 Single Lead Analysis ---------------------------------------------------------- 6-35 Multilead Analysis -------------------------------------------------------------- 6-35 Multilead Analysis With Changes in One Lead ------------------------- 6-35 Contents EASI ECG Monitoring -------------------------------------------------------- 6-36 6-36 6-37 6-37 6-38 6-38 6-38 6-39 6-39 6-40 6-40 6-41 ST Alarms -------------------------------------------------------------------------STE Alarms -----------------------------------------------------------------------QT Interval Monitoring--------------------------------------------------------------Intended Use ---------------------------------------------------------------------How the QT Analysis Algorithm Works ------------------------------------Adjusting QT Settings -------------------------------------------------------Limitations for QT Monitoring ----------------------------------------------- 6-41 6-41 6-42 6-43 6-43 6-44 6-45 op Initiating Arrhythmia Relearning Manually --------------------------------ST/AR ST Analysis Algorithm ----------------------------------------------------Introduction -----------------------------------------------------------------------The Measurements -------------------------------------------------------------Overview --------------------------------------------------------------------------Turning ST or STE On and Off ----------------------------------------------Displayed ST Data --------------------------------------------------------------ST Lead Groups -----------------------------------------------------------------Derived 12 Lead ECG ---------------------------------------------------------EASI ST Analysis -------------------------------------------------------------HEXAD ST Analysis ---------------------------------------------------------- ft 7. Monitoring Pulse Rate 7-1 Pulse Rate Measurement ------------------------------------------------------------ 7-2 Displaying the Pulse Rate Measurement at the MX40 ----------------------- 7-3 ra 8. Monitoring Respiration Rate (Resp) 8-1 Respiration Rate Measurement----------------------------------------------------- 8-2 Resp Safety Information -------------------------------------------------------------- 8-3 Lead Placement for Monitoring Resp --------------------------------------------- 8-4 Optimizing Lead Placement for Resp ----------------------------------------- 8-4 Cardiac Overlay -------------------------------------------------------------------- 8-4 Abdominal Breathing -------------------------------------------------------------- 8-4 Displaying Resp on the MX40 ------------------------------------------------------- 8-5 9. SpO2 Monitoring 9-1 SpO2 Safety Information -------------------------------------------------------------- 9-2 SpO2 Information for the User -------------------------------------------------- 9-3 Pulse Oximetry Measurement ------------------------------------------------------- 9-5 SpO2 Sensors ----------------------------------------------------------------------- 9-6 Selecting an SpO2 Sensor ------------------------------------------------------- 9-6 Sensor Application Safety Information --------------------------------------- 9-7 Applying the Sensor --------------------------------------------------------------- 9-8 Connecting SpO2 Cables -------------------------------------------------------- 9-8 Tone Modulation Indication------------------------------------------------------ 9-8 Signal Quality Indicator ----------------------------------------------------------- 9-8 Measuring SpO2 -------------------------------------------------------------------- 9-9 Contents Understanding SpO2 Alarms --------------------------------------------------- 9-10 10. Monitoring with other Assigned Devices 10-1 Assigning Devices --------------------------------------------------------------------- 10-3 Device Assignment at the Information Center ---------------------------- 10-3 Device Assignment at the MX40 ---------------------------------------------- 10-3 Device Assignment at the Patient Monitor --------------------------------- 10-4 Controls Available when Assigned to IntelliVue Cableless Measurements10-6 Controls Available when Assigned to IntelliVue Patient Monitors -------- 10-7 Networked Device Synchronized Settings -------------------------------------- 10-8 MX40 Display when Wirelessly Connected to a Patient Monitor --------- 10-9 op 11. Monitoring with the MX40 at the Information Center 11-1 MX40 Connection to the Information Center ----------------------------------- 11-2 MX40 Controls in the Patient Window (IIC) ------------------------------------ 11-3 MX40 Controls in the Patient Window (IIC iX) --------------------------------- 11-5 Locating the MX40 (Find Device) ------------------------------------------------- 11-7 Viewing Device Location and Location History (optional) ------------------ 11-8 Using the Device Location Client (optional - IIC only) ----------------------- 11-9 Patient Configurable Settings in Telemetry Setup -------------------------- 11-10 Unit Configurable Settings -------------------------------------------------------- 11-13 ft 12. Operating with Information Center Release L or M 12-1 Display ----------------------------------------------------------------------------------- 12-2 Alarms ------------------------------------------------------------------------------------ 12-3 ra 13. Trends 13-1 Viewing Vital Trend Information --------------------------------------------------- 13-2 14. Maintenance 14-1 Cleaning --------------------------------------------------------------------------------- 14-2 Cleaning Materials for the MX40 --------------------------------------------- 14-3 Disposing of the MX40 --------------------------------------------------------------- 14-5 Label Assignment for Replacement MX40 ------------------------------------- 14-6 Re-assigning an Equipment Label at the IntelliVue Information Center14-6 Re-assigning an Equipment Label at the IntelliVue Information Center iX -------------------------------------------------------------------------------------- 14-7 Charging Lithium-ion Rechargeable Batteries --------------------------------- 14-8 Battery Power Indicators -------------------------------------------------------- 14-8 Charging Station LEDs-------------------------------------------------------- 14-8 Battery Status on the Charging Station Display ------------------------ 14-9 Battery Lifetime Management ------------------------------------------------- 14-9 Battery Disposal ----------------------------------------------------------------- 14-10 15. Safety Standards & Specifications 15-1 Regulatory Information --------------------------------------------------------------- 15-2 Software Hazard Prevention --------------------------------------------------- 15-2 Contents op AC Power Source ---------------------------------------------------------------Industrie Canada Compliance (Canada)----------------------------------Safety Standards ----------------------------------------------------------------Intended Use Statement ------------------------------------------------------Indications for Use --------------------------------------------------------------Intended Uses of MX40 -------------------------------------------------------Authorized EU Representative ----------------------------------------------Patient Population --------------------------------------------------------------Rx -----------------------------------------------------------------------------------Essential Performance --------------------------------------------------------Risk Management Considerations -----------------------------------------Electromagnetic Compatibility----------------------------------------------------Reducing Electromagnetic Interference -----------------------------------Restrictions for Use-------------------------------------------------------------Electromagnetic Compatibility (EMC) Specifications ------------------Accessories Compliant with EMC Standards -------------------------- 15-2 15-2 15-2 15-3 15-3 15-3 15-4 15-4 15-4 15-4 15-5 15-8 15-9 15-9 15-9 15-9 ft Electromagnetic Emissions--------------------------------------------------- 15-10 Electromagnetic Immunity ---------------------------------------------------- 15-10 Recommended Separation Distance -------------------------------------- 15-11 Electrosurgery Interference/Defibrillation/Electrostatic Discharge15-13 Restart Time ------------------------------------------------------------------- 15-13 ra Battery Specifications -------------------------------------------------------------- 15-14 Lithium-ion Battery Charge Time ------------------------------------------------ 15-17 Physical Specifications ------------------------------------------------------------- 15-18 MX40 1.4 GHz Smart-Hopping Radio ------------------------------------------ 15-19 MX40 2.4 GHz Smart-Hopping Radio ------------------------------------------ 15-20 MX40 Short-Range Radio --------------------------------------------------------- 15-22 MX40 2.4GHz WLAN Radio ------------------------------------------------------ 15-23 FCC and Industry Canada Radio Compliance -------------------------- 15-24 Environmental Specifications ----------------------------------------------------- 15-25 Measurement Specifications ----------------------------------------------------- 15-26 ECG -------------------------------------------------------------------------------- 15-26 ECG Performance Disclosure/Specifications ---------------------------- 15-27 Respiration ------------------------------------------------------------------------ 15-29 Respiration Alarm------------------------------------------------------------- 15-29 FAST SpO2 ----------------------------------------------------------------------- 15-30 SpO2 Sensor Accuracy -------------------------------------------------------- 15-31 A. Accessories A-1 MX40 Accessories --------------------------------------------------------------------- A-2 Pouches ------------------------------------------------------------------------------ A-2 Miscellaneous ----------------------------------------------------------------------- A-2 ECG Accessories ----------------------------------------------------------------------- A-3 Electrodes ---------------------------------------------------------------------------- A-3 Contents Leadsets and Patient Cables --------------------------------------------------- A-3 SpO2 Accessories ---------------------------------------------------------------------- A-5 Philips/Nellcor Disposable Sensors ------------------------------------------- A-5 Philips Reusable Sensors ------------------------------------------------------- A-5 Adapter Cables --------------------------------------------------------------------- A-6 B. Default Settings B-1 Alarm Default Settings ---------------------------------------------------------------- B-2 ECG, Arrhythmia, ST and QT Default Settings --------------------------------- B-3 Configuration Default Settings at the MX40 ------------------------------------- B-5 C-1 ra ft op C. Sales and Support Offices Contents op ft ra Contents 1. Introducing the IntelliVue MX40 This section introduces the IntelliVue MX40 wearable patient monitor. MX40 Features ........................................................................................... 1-2 MX40 Models ............................................................................................. 1-3 ra ft op MX40 Release B.0 Compatibility ............................................................. 1-4 Introducing the IntelliVue MX40 1-1 MX40 Features MX40 Features Easy for clinicians to use and comfortable for patients to wear. 2.8" color, touch sensitive display. Smart, multi-measurement cable system available for use with reusable and single-patient use supplies. FAST SpO2 (continuous, automatic or manual measurement). Standard, EASI or Hexad ECG lead system selection. Impedance-based Respiration measurement. op 6-lead with two V-leads for diagnosing multiple cardiac abnormalities, including wide-QRS complex tachycardias and acute myocardial ischemia/infarction. Local measurement trend/alarm history. Local alarming for measurements (requires IntelliVue Information Center Release N or later or IntelliVue Information Center iX). ft Integrated radio for connection to an Information Center iX. Integrated Short-Range Radio (SRR). Communication with IntelliVue Patient Monitors and Cableless Measurements via Short-Range Radio connection (MP5/MP5T/MP5SC, MP2 and X2 monitors only). ra Powered by three AA batteries or rechargeable lithium-ion battery pack. Note — The WLAN MX40 (Model Number 865352) is powered only by the rechargeable lithium ion battery pack. Audio feedback for out-of-range and lost device. Battery gauge on device and at Information Center. Alarm suspend and resume from standby at device and Information Center. Pouch with clear front that closes securely. Note — Unlike a traditional bedside monitor which operates on AC power, the MX40 is powered by battery and provides time-limited screen display and local alarming. 1-2 Introducing the IntelliVue MX40 MX40 Models MX40 Models ra ft op The MX40 is available in three models (ECG only, ECG and FAST SpO2, or ECG and SpO2 Ready (for future upgrade). Introducing the IntelliVue MX40 1-3 MX40 Release B.0 Compatibility MX40 Release B.0 Compatibility The MX40 is compatible for use with IntelliVue Information Center Release N and IntelliVue Information Center iX Release A. Limited compatibility is offered when used with IntelliVue Information Center Release L or M. See the "Operating with Release L or M" chapter for more information. The MX40 is compatible for use with IntelliVue Patient Monitors Release G or later when wirelessly connected. The MX40 is compatible for use with IntelliVue Cableless Measurements Release A.1. op The MX40 is compatible for use with Access Point Controller 862147, Release B.00.19 and Access Point Controller 865346, Release C.00.04. ra ft The MX40 Patient Cable is compatible for use with IntelliVue Patient Monitor platforms MP2/X2, MP5/MP5T/MP5SC, MP20/30 with MMS or X2, MP40/50 with MMS or X2, MP60/70 with MMS or X2, MP80/90 with MMS or X2, and MX800/700/600 with MMS or X2. 1-4 Introducing the IntelliVue MX40 2. What's New? This section lists the most important new features and improvements to the MX40 and its user interface. Further information is provided in other sections of this book. You might not have all of these features, depending on the MX40 configuration purchased by your hospital. ra ft op New Features and Enhancements ........................................................... 2-2 What's New? 2-1 New Features and Enhancements New Features and Enhancements Compatibility The MX40 B.0 offers compatibility with the new IntelliVue Information Center iX Respiration The MX40 now offers a Respiration Rate measurement (available with the IntelliVue Information Center iX only). Rotating Alarm Presentation Numeric Only Display op When multiple alarms are active, the MX40 will rotate the display of the alarm message every three seconds (Only INOPS are displayed with IntelliVue Information Center Release L or M). A new display orientation is available showing six numerics only. No waveforms are shown (available with IntelliVue Information Center iX). ECG Waveform Size Adjustment ft The size of the ECG waveform can now be adjusted by touching the waveform on the display. Wireless LAN Availability ra The MX40 is now available as a Wireless LAN device for 802.11 a/b/g communication (for use with IntelliVue Information Center iX only). ST and QT Measurement Analysis ST and QT values can be displayed on the MX40 (available with IntelliVue Information Center iX only). Hexad A 12-lead ECG derived from a 6-wire electrode leadset is available to increase patient comfort and reduce interference (available with IntelliVue Information Center iX only). 2-2 What's New? 3. Product Safety This section consolidates the general safety warnings associated with the IntelliVue MX40. These warnings are repeated throughout the book in context where relevant. Safety symbols and other markings on the MX40 are also described here. General Safety ............................................................................................ 3-2 ra ft op Safety Symbols & Other Marks ............................................................... 3-5 Product Safety 3-1 General Safety General Safety Warnings The MX40 operates exclusively via a wireless network connection, thereforel, it should not be used for primary monitoring in applications where momentary loss of the ECG is unacceptable at the Information Center. It sends ECG and optionally pulse oximetry data to the Information Center, where the Information Center displays real-time patient data, provides alarm annunciation, data storage and review applications. The ECG waveform data, alarms and optionally SpO2 can always be viewed on the MX40 regardless of the connection to the Information Center. ft op A wireless patient monitoring system will never be as reliable as a patient monitoring system that transmits its signal through a wire, due to the inherent nature of radio frequency and the many variables that affect over-the-air communication. This factor should be considered when electing to monitor patients using wireless technologies. If occasional loss of ECG monitoring at the Information Center is not clinically acceptable for certain patients, alternatives must be sought. As the IntelliVue MX40 does not provide a wired network connection, we would recommend the use of an IntelliVue patient monitor with a wired connection to the Information Center for these patients. ra For continued safe use of this equipment, it is necessary that the listed instructions are followed. Instructions in this manual in no way supersede established medical procedures. Do not touch the patient, or table, or instruments, during defibrillation. The battery door must be closed during defibrillation. These steps protect the clinician from high defibrillator voltage. This device is not to be used in the vicinity of electrosurgical units because such use may interrupt or interfere with the transmission of signals from the MX40. This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, or with oxygen or nitrous oxide. This equipment is not suitable for use in an MRI environment. Do not use patient cables with detachable lead wires that have exposed male pins. Electrocution could result if these pins are plugged into AC power. 3-2 Product Safety General Safety Do not use patient cables or accessory cables and sensors if prior visual inspection reveals cable damage or the presence of liquid, lint or dust inside. The system is not completely immune from radio interference although it is designed to minimize interference. Sources of interference that may be a problem include failing fluorescent lights and construction equipment. See "Electromagnetic Compatibility p. 15-8". The product should not be used next to or stacked with other equipment. If you must stack the product, you must check that normal operation is possible in the necessary configuration before the product is used on patients. op Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. ft If the MX40 enters a continuous "boot-up" cycle or the main display does not appear or update, ensure that you are using a freshly charged lithium-ion battery or new disposable batteries. If the batteries are fresh and the device reboots or does not update, remove the device from service and contact your service personnel. Place the MX40 in a pouch or over clothing, or both, during patient use. The device should not touch the patient’s skin during use. ra Patients should be instructed not to open the battery compartment while the MX40 is in use. Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement satisfactory maintenance as needed may cause undue equipment failure and possible health hazards. Because the coverage range of Access Points can sometimes overlap, including different floor levels, the IntelliVue Device Location feature is not intended for use when attempting to locate a patient. Product Safety 3-3 General Safety Short-range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, and DECT phones. Outside the frequency band and 5% above and below, i.e. the exclusion band according to IEC 60601-1-2, the short-range radio connection is immune up to 3V/m in the frequency range from 80MHz to 2.5 GHz. Depending on the strength and duration of the interference, the interruption may occur for an extended period. Any interruption of the signal due to interference, moving out of range, or for other reasons is indicated with a Tele Disconnected INOP message on the IntelliVue Patient Monitor. Caution ra ft op Philips recommends that when using a pouch to attach the MX40 to your patient that you consider your patient's condition and are careful about placement of the straps as the straps could present a strangulation hazard. 3-4 Product Safety Safety Symbols & Other Marks Safety Symbols & Other Marks The table below describes the safety symbols and other markings present on the MX40 and the lithium-ion battery. Label Definition FCC ID: Federal Communications Commission (FCC) ID IC: Industry Canada Number Global Medical Device Nomenclature op GMDN: Federal Communications Commission (FCC) ra ft Declaration of Conformity Rechargeable Battery CE Mark (MX40) Compliance to Council Directive 93/42/EEC (Medical Device Directive) and 1995/5/EC (Radio Equipment and Telecommunications Equipment Directive) Symbol for Class 2 Radio Equipment CE Mark (Rechargeable Lithium-ion Battery) Compliance to Council Directive 2004/108/EC (EMC Directive) Non-Ionizing Radiation Interference to electronic equipment may occur in the vicinity of devices marked with this symbol. Product Safety 3-5 Safety Symbols & Other Marks Label Definition Disposal Dispose of in accordance with the local country’s requirements. 2002/96/EC (Waste Electrical and Electronic Equipment). Follow operating instructions. op Prescription Device CSA Mark for ft Certified by CSA to the applicable Canadian and US standards.. Defibrillation Proof ra Patient connections are protected against defibrillation (DEFIBRILLATION-PROOF) and are a TYPE CF APPLIED PART. Service Identification Number Used to identify the equipment during a call to Philips Healthcare (Service) Serial Number Used to identify the equipment during a call to the Philips Healthcare (Service). Reference Number Indicates Philips Product Number MAC Address Manufacturer and Date of Manufacture Battery Polarity 3-6 Product Safety Safety Symbols & Other Marks Label Definition IPX Waterproof Rating Protected against the effects of temporary immersion in water. 2D Barcode UL Listed Device Listed by Underwriters Laboratories ra ft op Attention! See Instructions for Use. Product Safety 3-7 D ra ft op Safety Symbols & Other Marks 3-8 Product Safety 4. Basic Operation This section gives you an overview of the IntelliVue MX40 and its functions. It tells you how to perform tasks that are common to all measurements, such as turning a measurement on and off, adjusting wave size and information in preparation for use. op Familiarize yourself with all instructions including warnings and cautions before starting to monitor patients. Read and keep the Instructions for Use that come with any accessories as these contain additional important information. Controls, Indicators and Connectors ...................................................... 4-2 Operating and Navigating ....................................................................... 4-8 Understanding Settings .......................................................................... 4-12 ft Battery Information ................................................................................. 4-14 Pouch Use ................................................................................................. 4-22 Telemetry Mode Use ............................................................................... 4-26 Monitoring Mode Use ............................................................................. 4-27 ra Briefing the Patient .................................................................................. 4-28 Basic Operation 4-1 Controls, Indicators and Connectors Controls, Indicators and Connectors This section describes the clinical controls of the IntelliVue MX40. These controls include buttons, display icons, visual and auditory indicators, ports, and safety labeling located on the front and back of the device. MX40 Controls and Indicators 1. Patient Cable 2. Patient Information Area 3. Active Alarms Area op 4. INOP Area 5. Measurement Area 1 6. Measurement Area 2 7. Waveform 1 8. Waveform 2 ra ft 9. Radio/Network/Battery Status Area 4-2 Basic Operation 10. Leads Off Status Area 11. Silence Alarms Button 12. SmartKeys Button 13. Main Screen Button 14. Multi-Function Button Controls, Indicators and Connectors Multi-Function Button Button Function Depending on configuration at the Information Center: generates a Nurse Call; Initiates a Delayed Recording; Both, or; None Note — the Multi-Function Button does not operate when paired with an IntelliVue Patient Monitor via the short-range radio connection. Button op Silence Alarm Button Function Initiates a local silence/acknowledgment of all active alarms when enabled (IIC). ft Initiates a global silence/acknowledgment of all active alarms when enabled (IIC iX). Silences the "Find Device" sound. ra Note — Alarms at the MX40 can be silenced from the Information Center. When silenced from the Information Center, the alarm sound is not silenced at the Information Center until it receives feedback from the MX40. This may take several seconds. SmartKeys Button Button Function Displays the SmartKey Menu on the touch screen. Basic Operation 4-3 Controls, Indicators and Connectors Main Screen Button Button Function Activates the Touch Display if touched for two seconds. Cycles through the display screens if touched repeatedly. Resumes from Standby. When pressed from a sub-menu, returns display to the Main Screen. SmartKeys op The following table lists the SmartKeys available on the display of the MX40. Note—gray text on a SmartKey signifies that the item is unavailable. Function Start SpO2 Starts a manual SpO2 measurement. ft SmartKey Note — This ra SmartKey is unavailable when SpO2 mode is continuous. Delay Record Starts a delayed recording at the Information Center. Alarms Alarm Volume setting. Review of up to 50 previous alarm conditions (entries are stored during power cycle). Pause Alarms for configured time period (if enabled at the Information Center). Mode: Telemetry / Toggles between modes. In Telemetry Mode: Monitor Mode, display and audio are off; in Monitor Mode, display and audio are always on. 4-4 Basic Operation Controls, Indicators and Connectors Function Standby Puts the device into Standby locally and at the Information Center. Displays purchased/enabled product options. To resume from Standby, touch the Main Screen button. Add/Remove Displays available monitors and IntelliVue Cableless Measurements to assign to via the short-range radio. Print Reports Prints the pre-configured report as designated at the Information Center. Vitals Trends View up to 24 hours of tabular trend data. One hour standard. 24 hours optional. Setup Screen Determines time period that the display remains active after user interaction or whether the display is always On or always Off. op SmartKey Locks/Unlocks the display. Op Mode Selects either Monitoring, Demo, Config or Service modes. ft Lock/Unlock Alarms Area ra The Alarm Area of the MX40 displays physiological alarms and technical alarms. A multiple alarm indicator (down arrow) is displayed when multiple alarm conditions are present and the alarm message rotates every 3 seconds. A check mark in front of the alarm text signifies that the alarm has been acknowledged by touching the Silence Alarms button. Alarm Indicators display in the Patient Information Area in place of the time clock when alarm/INOP conditions are present but have not been acknowledged. Touching the Alarms Area displays a list of all active alarms. The alarms paused icon communicates whether the alarm system is on/off. Local Alarm Audio is off when the alarm volume symbol is present next to the time.. Basic Operation 4-5 Controls, Indicators and Connectors Patient Information Area The Patient Information Area displays the following information: Bed Label Patient Name (up to 15 characters will display) Time Touching the Patient Information Area displays the Patient Demogr. menu which lists the following: Patient Name (Last, First, Middle) Lifetime ID Encounter ID Patient Category Height Weight Date of Birth Gender op Paced Mode Note — If you use an alternative ID, it will display at the Information Center and on printed ft reports. It will not display at the MX40. ra Paced Status 1. Pacing algorithm is on. 2. Pacing algorithm is off. 3. Pacing algorithm is on. Patient's paced status is unknown. Display Lock The Lock symbol appears in the lower left of the display when the MX40 is in a locked state after five minutes of non-use. Locking the display provides additional protection against accidental patient access. The display is unlocked using the SmartKeys menu. 4-6 Basic Operation Controls, Indicators and Connectors Status Area ra ft op The status area of the MX40 displays short-range radio connection (optional) and system wireless connection status. You can also view battery strength for the type of battery used in the device, AA or rechargeable Li-on. Basic Operation 4-7 Operating and Navigating Operating and Navigating The principle method of operating your MX40 is via the Touch Display. Almost every element on the display is interactive. Display elements include measurement numerics, information fields, alarm fields, waveforms, SmartKeys and menus. Power-On Self Test op Once battery power is supplied, the MX40 performs a power-on self test to check operational status prior to start-up. Should a failure be detected, an INOP tone will sound and if possible, the appropriate INOP message for the failure will be communicated to the Information Center and displayed locally. A successful power-on self test will then transition the MX40 to the start-up screen. Selectable background colors can be configured and display on the screen for assistance with device identification. This can be helpful when devices are in a pooled use setting. ft If the MX40 enters a continuous "boot-up" cycle or the main display does not appear or update, ensure that you are using a freshly charged lithium-ion battery or new disposable batteries. If the batteries are fresh and the device reboots or does not update, remove the device from service and contact your service personnel. ra You must visually check that a waveform is present on the display. You can access further status information is by touching the status area on the display. Navigating Touching the Navigation Bar on the right of the display will scroll through additional display items. Solid downward arrows indicate there are additional elements that are not currently displayed. The arrows briefly illuminate when touched. Your selection from the menu also illuminates when touched. Selecting Display Elements Touch a display element to get to the actions linked to that element. For example, touch the Patient Information element to call up the Patient Info window, or touch the HR numeric to call up the Setup ECG menu. Touch the ECG waveform to call up the wave selection menu. 4-8 Basic Operation Operating and Navigating Locking the Display To provide additional protection against accidental patient access to the MX40, the display can be locked using the Lock SmartKey. When Lock is selected, the SmartKey menu automatically changes to the Main Screen. When Unlock is selected, you must close the SmartKey menu to return to the Main Screen. Display Locked / Active Display Locked / Inactive Display Unlocked / Active Display Unlocked / Inactive Display Touch No No Yes No Main Screen Button No Yes Yes Yes SmartKeys Button Yes No Yes No Silence Button No No Yes No ft Function op The display automatically locks when there is no interaction for the configured time period (1-30 minutes with a default of 5 minutes). Measurement Area ra The measurement area of the MX40 display is optimized to show available parameter numerics, waveforms, and alarm limits. Each element is a touch object and when you select it, further controls and menus become available. Measurement Area Display Configurations The display of your MX40 is configured/can operate in one of four available orientations: Portrait - No Waveforms and six Numerics (IIC iX only) Portrait - One Waveform and four Numerics Portrait - Two Waveforms and two Numerics (IIC Release N and IIC iX only) Landscape - Two Waveforms and three Numerics (IIC Release N and IIC iX only) Portrait - Viewable Chest Diagram and two Numerics Basic Operation 4-9 Operating and Navigating Connecting/Disconnecting the Patient Cable op The patient cable is connected to the MX40 as shown in the illustration below. ft When connecting to the MX40, there is a slight clicking sound that signifies that the cable is securely connected. ra Typically, the patient cable may be disconnected as shown below. 4-10 Basic Operation Operating and Navigating Caution op During initial use of the MX40, the secure connection between the patient cable and the device may be difficult to disconnect. Should this occur, use the alternative procedure shown below. ra ft Never disconnect the patient cable by pulling on the leadwires, as this may damage wires over time. Basic Operation 4-11 Understanding Settings Understanding Settings Each aspect of how the MX40 works and looks is defined by a setting. There are a number of different categories of settings, including: Screen Settings - to define the selection and appearance of elements on each individual display screen. Measurement Settings - to define setting unique to each measurement, e.g. high and low alarm limits. Monitor Settings -including settings that affect more than one measurement or display screen, for example alarm volume and alarm pause time. op You must be aware that, although many settings can be changed during use, permanent changes to settings can only be done in Configuration Mode. All settings are restored to their default setting when the patient is discharged or the MX40 is powered off. ft Changing Measurement Settings Each measurement has a setup menu in which you can adjust its settings. You enter the setup menu by selecting the measurement numeric. ECG Settings at the MX40 ra Setting Description Alarm Limits Heart Rate alarm limits can be viewed locally at the MX40. Limits set at the Information Center (Release N or later or iX) are reflected at the MX40 when connected on the network. Primary (used for arrhythmia analysis only) I, II, III, aVR, aVL, aVF, V1-V9, MCL, V3R, V4R, V5R. Available waveforms are based on lead set type. Lead II is the default. (Set at IIC Release N or IIC iX. View only.) Secondary (used for arrhythmia analysis only) (Set at IIC Release N or IIC iX. View only.) I, II, III, aVR, aVL, aVF, V1-V9, MCL, V3R, V4R, V5R. Available waveforms are based on lead set type. Lead V is the default. Paced Mode On, Off (Set at IIC Release N or IIC iX) 4-12 Adjust Size Set ECG gain to x1/2, x1, x2, x4 Arrhythmia Initiate an Arrhythmia Relearn; View Arrhythmia Alarm Limits; Turn Arrhythmia Annotation On/Off. Lead Placement Set EASI, Standard Basic Operation Understanding Settings Setting Description ECG Set ECG On/Off New Lead Setup When IntelliVue Patient Monitor lead sets are in use, select 3-wire, or 5-wire. Va Lead Shows position of Va, or C1, electrodes. Choices are V1-V9, v3R, V4R, V5R. Vb Lead Shows position of Vb, or C2, electrodes. Choices are V1-V9, v3R, V4R, V5R. Change Numeric Selects parameter numeric to display in place of current HR numeric. op Waveform Settings at the MX40 Setting Description ra Wave 2 Primary, Secondary, I, II, III, aVR, aVL, aVF, V1-V9, MCL, V3R, V4R, V5R. Available waveforms are based on patient cable type. Lead II is the default. If Primary or Secondary are selected, then the waveform displayed is the waveform configured as primary or secondary for arrhythmia analysis. ft Wave 1 Primary, Secondary, I,II, III, aVR, aVL, aVF, V1-V9, MCL, V3R, V4R, V5R, Pleth (if SpO2 is available), Resp (if Resp is available). Available waveforms are based on patient cable type. Lead V is the default. If Primary or Secondary are selected, then the waveform displayed is the waveform configured as primary or secondary for arrhythmia analysis. Primary or secondary waveform configuration changes made at the Information Center change the MX40. Basic Operation 4-13 Battery Information Battery Information Battery Safety Information Warnings The battery compartment door must be closed during defibrillation. Use the Philips Rechargeable Lithium-ion Battery or 3 Duracell Alkaline batteries, size AA, MN 1500, 1.5V, to ensure specified performance and correct battery gauge reporting. Outdated, mismatched, or poor-quality batteries can give unacceptable performance (e.g., insufficient Battery-Low warning time). If you are using disposable batteries, the use of fresh high-quality alkaline batteries is strongly recommended. op Certain failure conditions, such as short circuits, can cause a battery to overheat during use. High temperatures can cause burns to the patient and/or user. If the MX40 becomes hot to the touch, remove it from the patient and place it aside until it cools. Then remove the batteries and discard them. Have the MX40 checked by your service provider to identify the cause of overheating. ft If you receive a TELE BATTERY LOW, TELE BATTERY EMPTY, REPLACE BATTERY T, or TELE BATTERY TEMP alarm, the batteries must be promptly replaced. If these conditions are not corrected, they will result in a device shutdown and cessation of monitoring. ra Disposable batteries should be removed from the MX40 at the end of the battery’s useful life to prevent leakage. If battery leakage should occur, use caution in removing the battery. The leaked substance may cause eye or skin irritation. Avoid contact with skin. Clean the battery compartment according to the instructions in the Maintenance section. Wash hands. To eliminate the risk of electrical shock or burn, do not carry loose batteries on your person, e.g. in clothing pockets. Cautions Use of AA Lithium batteries or batteries with terminal voltage >1.6V may cause damage to the device. When monitoring with the WLAN version of the MX40 (Model 865352), the lithium-ion rechargeable battery is the only approved power source. Use of AA disposable batteries is not supported. 4-14 Basic Operation Battery Information Lithium-ion Rechargeable Battery Care Care of the rechargeable battery begins when you receive a new battery for use and continues throughout the life of the battery. The table below lists battery care activities and when they should be performed. When to Perform Perform a visual inspection. Before inserting a battery in the MX40. Charge the battery. Upon receipt, after use, or if a low battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible. Clean the battery At each patient discharge, or in cases when the battery is exposed to contaminants. op Activity Charge stored batteries to at least 90% of their capacity every six months. When not in use for an extended period of time. Decommission the battery When any of the following INOPs are displayed on the MX40: TELE SERVICE BATTERY ft TELE BATTERY TEMP Rechargeable batteries are charged using the IntelliVue CL Charging Station. For information on charging station use, see Charging Li-ion Rechargeable Batteries p. 14-8 . ra Note — The battery capacity of re-chargeable batteries degrades over time and number of recharge cycles. Toward the end of its useful life, the battery capacity may be reduced by 25-30%. If this reduced battery life is unacceptable based on your use model, Philips recommends replacing the rechargeable battery sooner. Lithium-ion Rechargeable Battery Handling Precautions Lithium-ion batteries store a large amount of energy in a small package. Use caution when handling the batteries; misuse or abuse could cause bodily injury and/or equipment damage. Do not short circuit - take care that the terminals do not contact metal (e.g. coins) or other conductive materials during transport and storage. Do not crush, drop or puncture - mechanical abuse can lead to internal damage and internal short circuits that may not be visible externally. Do not apply reverse polarity. Basic Operation 4-15 Battery Information Do not incinerate batteries or expose them to temperatures above 60oC (140oF). If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not: discontinue use. dispose of the battery in accordance with the disposal instructions. Lithium-ion Rechargeable Battery Storage When storing rechargeable batteries, make sure that the battery terminals do not come into contact with metallic objects or other conductive materials. op If batteries are stored for an extended period of time, they should be stored in a cool, dry place, ideally at 15oC (60oF), with a state of charge of 20% to 90%. Storing batteries in a cool place slows the aging process. ft The batteries should not be stored at a temperature outside the range of -20oC (-4oF) to 50oC (122oF). Stored batteries should be should be charged to at least 90% of their capacity every 6 months. They should be charged to full capacity prior to use. ra Note — Storing batteries at temperatures above 38oC (100oF) for extended periods of time could significantly reduce the batteries' life expectancy. Inserting/Removing Batteries Warning Arrhythmia relearning is initiated whenever the MX40's batteries are removed for one minute or longer. Be sure to check your patient’s arrhythmia annotation for accuracy whenever relearn has occurred. Caution Remove the batteries before storing the MX40 for an extended period of time. 4-16 Basic Operation Battery Information The battery compartment is located on the back of the MX40, accessible by opening the compartment door from the bottom. It accommodates three AA 1.5V Alkaline batteries or the Philips Rechargeable Lithium-ion battery. Only these batteries should be used. Note— Lithium-ion batteries should be fully charged prior to first use. Important— Do not use other rechargeable batteries. Use of this type of battery will adversely affect: Battery gauge performance Battery low warnings Battery life performance op Inserting Batteries Insert the rechargeable lithium-ion battery using the following procedure: ra ft Open the battery compartment by lifting up on both bottom sides of the compartment door. Remove the AA battery tray if present. Insert the battery pack so that the raised tab is aligned with the cutout in the base of the battery compartment. Close the battery compartment door. Basic Operation 4-17 ft op Battery Information Close the battery compartment door. Watch for the start-up screen on the front of the MX40 to illuminate briefly. ra Insert AA batteries into the MX40 using the following procedure: Open the battery compartment by lifting up on both bottom sides of the compartment door. Insert the AA battery tray if not already present. Insert three AA 1.5V Alkaline batteries, matching the polarity with the + indications inside the compartment. Note—all batteries are inserted with the + polarity in the same direction. Use of AA batteries is not supported with the WLAN MX40 (Model Number 865352). Use only the rechargeable lithium-ion battery. 4-18 Basic Operation op Battery Information Close the battery compartment door. Watch for the start-up screen on the front of the MX40 to illuminate briefly. ft Removing the Batteries ra Batteries should be removed when the MX40 is not in use or is being stored. To remove the batteries, open the battery compartment door and push from the opening at the bottom of the compartment to pop the batteries out. Device settings (patient cable type, SpO2 mode, volume, etc.) are retained when the batteries are removed. Do not use AA batteries that have different energy levels remaining. Fresh AA batteries are recommended for each new application. Important— Do not "store" disposable AA batteries by leaving them in the incorrect polarity position in the MX40. Be careful not to short circuit the batteries. Batteries can get hot when shorted. Short circuits are caused when a piece of metal touches both the positive and negative terminals simultaneously. More than a momentary short circuit will generally reduce the battery life. In case of a short circuit, discard the batteries, or just the shorted one if the batteries are new. Basic Operation 4-19 Battery Information Disposal of Batteries When disposing of batteries, follow local laws for proper disposal. Dispose of batteries in approved containers. If local regulations require you to recycle batteries, recycle batteries in accordance with those regulations. Battery Charge Status The battery charge indicator displays in the Status Area and communicates the remaining battery charge time when using both AA batteries or the rechargeablelithium-ion battery. op When the MX40 is initially powered-on, it takes approximately 25 seconds for the indicator to populate. During this time, the indicator displays a ? in the battery icon. In order to guarantee overall device performance, certain functionality is disabled when the battery charge reaches critical levels. See the tables below for additional information about battery status. ft Lithium-ion Rechargeable Battery Charge Status Approximate Time Remaining (ECG only) ra Approximate Battery Life Remaining 4-20 Approximate Functionality Battery Time Disabled Indicator Remaining LCD (ECG & Spo2 Segments Continuous) 100% ~ 25 hours ~ 14 hours None 5 Green 75% < 19 hours < 10.5 hours None 4 Green 50% < 13 hours < 7 hours None 3 Green 25% < 6 hours < 3.5 hours None 2 Green 10% < 3 hours < 1.5 hours None 1 Green Low battery level to replace/charge battery level < 30 minutes < 30 minutes SpO2 and short-range radio are disabled. Display is at half brightness 1 Red Red Battery Icon Audio Replace/charge battery level < 10 minutes < 10 minutes Device shutdown 1 Red Red Battery Icon Basic Operation Battery Information AA Battery Charge Status Approximate Time Remaining (ECG only) Approximate Functionality Battery Time Disabled Indicator Remaining LCD (ECG & Spo2 Segments Continuous) 100% ~ 24 hours ~ 9 hours None 5 Green 75% < 18 hours < 7 hours None 4 Green 50% < 12 hours < 5 hours None 3 Green 25% < 6 hours < 2 hours None 2 Green 10% < 2 hours < 1 hours None 1 Green Low battery level to replace/charge battery level < 30 minutes < 30 minutes SpO2 and short-range radio are disabled. Display is at half brightness. 1 Red Red Battery Icon Audio Replace/charge battery level < 10 minutes op Approximate Battery Life Remaining Device shutdown 1 Red Red Battery Icon ra ft < 10 minutes Basic Operation 4-21 Pouch Use Pouch Use The MX40 is not intended for direct contact with the patient’s skin. During normal use, the MX40 should be worn over clothing, in a pocket or, preferably, in a pouch. The Waterproof Carry Pouch with clear front is an appropriate means for holding the MX40. See Appendix A, "Accessories" for ordering information. Securing the Pouch See the Carry Pouch, Waterproof, Instructions for Use, P/N 453564267571, for more information. Insert the MX40 into the pouch with lead wires and SpO2 sensor cable, if used, exiting from the side opening of the pouch. Pinch the velcro enclosures together to close the pouch around the cables. ra ft op 4-22 Basic Operation Pouch Use Seal the pouch. Secure the pouch on the patient with the ties around the patient’s shoulder and under the arm. ra ft op Check that the patient is comfortable wearing the pouch with the MX40. Cautions The pouch is designed to be used exclusively with the MX40. It is not intended to be used to store patient's personal devices, e.g. cell phones. Philips recommends that when using a pouch to attach the MX40 to your patient, consider your patient's condition and be careful about placement of the straps, as the straps could present a strangulation hazard. Basic Operation 4-23 Pouch Use Showering Warning When the patient is showering, signal quality and leads off detection may be compromised due to significant movement. Appropriate clinical precautions must be taken. Caution Because the touchscreen display is sensitive to water impact, the display should be locked when showering. op The MX40 can be used to monitor a patient in the shower, but only when placed inside a Philips carrying pouch and secured on the patient as described above. The combination of the MX40 and pouch will withstand showering for up to 10 minutes. Drying the MX40 after Showering ft After showering, perform the following steps to continue monitoring: Remove the battery. Pat dry the patient cable connections at the electrodes. Wipe the lead wires with care. ra If wet, dry the outside of the MX40 with a non-lint producing cloth. If wet, wipe dry the inside of the battery compartment. Dry the batteries. If wet, disconnect the patient cable and shake out any water. Dry the connector pin area with a cotton swab. Re-insert the battery. Caution The MX40 should not be used for monitoring if the battery compartment is wet. Remove the batteries and wipe the compartment dry before continued monitoring use. 4-24 Basic Operation Pouch Use Accidental Liquid Exposure ra ft op If the MX40 is accidentally immersed in liquid, no damage to the device and no electrical safety issues for the patient will result. Remove the device, dry it off, and follow the procedure for cleaning/sterilization under "Cleaning and Sterilization" as needed. Basic Operation 4-25 Telemetry Mode Use Telemetry Mode Use ra ft op To minimize patient disruption, the MX40 operates in Telemetry Mode when connected to the Information Center. In Telemetry Mode, the local volume is set to zero and the display is off. You can activate the display at any time by touching the Main Screen button for two seconds. All active alarms can be viewed when the display is on, however audible alarm indicators are not annunciated. Regardless of the display status, all measurement data is being sent to the Information Center. Telemetry Mode is only available when connected to the Information Center. 4-26 Basic Operation Monitoring Mode Use Monitoring Mode Use You may find the use of Monitoring Mode helpful when spending extended time directly with your patient, e.g. during transport, showering, dressing change. The display is always on for easy viewing and should an alarm condition occur, it will be announced locally at the MX40 and at the Information Center if networked connected. If the MX40 is not network connected, the alarm is only announced locally. To use Monitor Mode: Press the SmartKeys Button. Press the Mode: Telemetry / Mode: Monitor SmartKey and choose Mode: Monitor. ra ft op Basic Operation 4-27 Briefing the Patient Briefing the Patient Warning Patients should be instructed not to interact with the display of the device and to not open the battery compartment while the MX40 is in use. Note — Pausing alarms at the Information Center activates the MX40 display. Patients should be notified that this is normal operation and not cause for any concern. op If the Multi-Function button has been configured to generate a Nurse Call alarm, recording at the Information Center, or both, instruct the patient to use the button when needed. ra ft If desired, you can turn off patient use of the Multi-Function button at the Information Center. For more information see Patient Configurable Settings in Telemetry Setup p. 11-10. 4-28 Basic Operation 5. Alarms The section provides alarm information that applies to all measurements. Measurement-specific alarm information is discussed in the sections on individual measurements. Alarms Overview ...................................................................................... 5-2 Physiologic Alarms ................................................................................. 5-10 ra ft op Technical Alarms (INOPs) ..................................................................... 5-14 Alarms 5-1 Alarms Overview Alarms Overview The MX40 has two different types of alarms: physiological alarms and INOPs. For MX40 devices operating with IntelliVue Information Center Release L and M, physiological alarms are not available locally on the MX40. INOPs are displayed as described here. Physiological Alarms op For MX40 devices operating with IntelliVue Information Center Release N or IntelliVue Information Center iX, physiological alarms are available locally on the MX40 regardless of network connection to the Information Center. Alarm settings are as configured by the Information Center. Changes to physiological alarm settings can only be made at the Information Center. Audible alarm indicators are annunciated only when operating in Monitor Mode or when the MX40 is not networked connected. INOPs ft Physiological alarms are red and yellow alarms. A red alarm indicates a high priority patient alarm such as a potentially life threatening situation (for example, asystole). A yellow alarm indicates a lower priority patient alarm (for example, a low SpO2 alarm limit violation). Additionally there are short yellow alarms, most of which are specific to arrhythmia-related patient conditions (for example, ventricular bigeminy). ra INOPs are technical alarms, they indicate that the monitor cannot measure or detect alarm conditions reliably. If an INOP interrupts monitoring and alarm detection (for example, LEADS OFF), the monitor places a question mark in place of the measurement numeric and an audible indicator tone will be sounded. INOPs without this audible indicator indicate that there may be a problem with the reliability of the data, but that monitoring is not interrupted. Most INOPs are light blue, however there are a small number of INOPs which are always yellow or red to indicate a severity corresponding to red and yellow alarms. The following INOPs can also be configured as red or yellow INOPs to provide a severity indication: ECG LEADS OFF REPLACE BATTERY (when using disposable batteries) TELE BATT EMPTY (when using the rechargeable battery pack) All monitors in a unit should have the same severity configured for these INOPs. 5-2 Alarms Alarms Overview The MX40 is designed to achieve visual alarm notification at a distance of up to one meter, which is consistent with its intended use model as a wearable monitor. Alarms are indicated after the alarm delay time. This is made up of the system delay time plus the trigger delay time for the individual measurement. For more information see ECG Performance Disclosure/Specifications p. 15-27 . A downward facing arrow symbol next to the alarm message informs you that more than one message is active and the messages rotate every three seconds. The monitor sounds an audible indicator for the highest priority alarm. Warning op Visual Alarm Indicators ft The MX40 display is inactive for a majority of the time because it is operating in Telemetry Mode. You must activate the screen to view or hear any alarms at the MX40. Upon activating the screen, the alarm volume may be set to zero if desired. ra Alarm Message An alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm. The background color of the alarm message matches the alarm priority: red for red alarms, yellow for yellow alarms, light blue for standard INOPs, red for red INOPs and yellow for yellow INOPs. The asterisk symbols (*) beside the alarm message match the alarm priority: *** for red alarms, ** for yellow alarms, * for short yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have exclamation marks beside the alarm message: !!! for red INOPs and !! for yellow INOPs. If more than one alarm is present, there is a downward facing arrow symbol at the right side and the active alarm/inop messages rotate every three seconds. Alarm limit violation messages are displayed in text form, for example ** SpO2 LOW. Alarms 5-3 Alarms Overview Alarm Indicator An Alarm Indicator on the MX40 main display communicates alarm/INOP conditions that have not been acknowledged. The alarm indicator is divided into two sections and appears in the upper right hand corner normally occupied by the time display. The right section flashes for a physiological alarm, except for short yellow alarms where the indicator will light for approximately six seconds. The color is yellow or red corresponding to the highest priority alarm currently present. op An unacknowledged physiological alarm and INOP appears as (portrait view): ft An acknowledged physiological alarm and INOP with an additional unacknowledged physiological alarm appears as (landscape view): ra The left section lights continuously for a standard INOP and flashes for INOPs configured as red or yellow alarms as follows: INOP Color On Off Yellow 1.0 seconds 1.0 seconds Red 0.25 seconds 0.25 seconds If only physiological alarms are present, and no INOPs, the physiological alarms will use both left and right sections to flash (for red and yellow alarms) or light for approximately six seconds (for short yellow alarms). If only INOPs are present, and no physiological alarms, red and yellow INOPs will use both left and right sections to flash, but standard INOPs will always light continuously in the left section only. Once all alarm/INOP conditions are acknowledged, the time display reappears. Flashing Numeric The numeric of the measurement in alarm flashes. 5-4 Alarms Alarms Overview Audible Alarm Indicators when in Monitoring Mode The audible alarm indicators configured for your monitor depend on which alarm standard applies in your hospital. Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). Warning Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. ft op No audible alarm indicators are available when the MX40's volume setting is zero or when operating in Telemetry Mode. Audible alarm indicators become active as soon as the MX40 is no longer connected to the Information Center. Traditional Audible Alarms (HP/Agilent/Philips/Carenet) Red alarms and red INOPs: A high pitched sound is repeated once a second. ra Two-star yellow alarms and yellow INOPs: A lower pitched sound is repeated every two seconds. One-star yellow alarms (short yellow alarms): The audible indicator is the same as for yellow alarms, but of shorter duration. Standard INOPs: an INOP tone is repeated every two seconds. ISO/IEC Standard Audible Alarms Red alarms and red INOPs: A high pitched tone is repeated five times, followed by a pause. Two-star yellow alarms and yellow INOPs: A lower pitched tone is repeated three times, followed by a pause. One-star yellow alarms (short yellow alarms): The audible indicator is the same as for yellow alarms, but of shorter duration. Standard INOPs: a lower pitched tone is repeated twice, followed by a pause. Alarms 5-5 Alarms Overview Acknowledging Alarms To acknowledge all active physiological alarms and INOPs, touch the Silence Alarm button. This switches off the audible alarm indicators, if present, and alarm messages at the MX40 and at the IntelliVue Information Center iX. A check mark beside the alarm message indicates that the alarm has been acknowledged . op If the condition that triggered the alarm is still present after the alarm has been acknowledged, the alarm message stays on the screen with a check mark symbol beside it, except for NBP alarms and alarms from other intermittent measurements. When such an alarm is acknowledged the alarm message disappears. If the alarm condition is no longer present, all alarm indicators stop and the alarm is reset. ft Switching off the alarms for the measurement in alarm, or switching off the measurement itself, also stops alarm indication. Pausing or Switching Off Alarms ra If you want to temporarily prevent alarms from sounding, for example while you are moving a patient, you can pause alarms, if configured. Depending on your MX40 configuration, alarms are paused for one, two or three minutes. Cautions When operating with Information Center Release L or M, the alarm pause time of the MX40 is not configurable. The alarm pause time for the MX40 is always two minutes. When operating with Information Center Release L or M, if alarms are paused at the Information Center, the "Alarms Paused" message is only displayed at the Information Center. To Pause All Alarms Select the Alarms SmartKey and select Pause Alarms. A timer on the display shows the remaining pause time. 5-6 Alarms Alarms Overview While Alarms are Paused In the alarm field, the MX40 displays the message ALARMS PAUSED 1:28 or ALARMS OFF, together with the alarms paused symbol or the alarms off symbol. No alarms are sounded and no alarm messages are shown. INOP messages are shown but no INOP tones are sounded. The only exceptions are the INOPs CUFF NOT DEFLATED, NBP CUFF OVERPRESS and INOPs relating to empty, missing and malfunctioning batteries. Warning op These INOPs switch the alarms on, and the INOP tones are sounded, even if alarms are paused or off. You need to remove the INOP condition first before you can switch the alarm tones off again. ft If connection to the Information Center is lost during an alarms paused period, upon reconnection, alarms remain paused at the Information Center for the set time. You can resume alarms from the Patient Window at the Information Center at any time. ra Restarting Paused Alarms To manually switch on alarm indication again after a pause, select Pause Alarms. Alarm Limits The alarm limits you set determine the conditions that trigger yellow and red limit alarms. For some measurements (for example, SpO2), where setting the high alarm limit to the maximum of 100 switches the high alarm off, or setting the low alarm limit to the minimum of 0 switches it off. In these cases, the alarms off symbol is not displayed. Warning Be aware that the monitors in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring. Alarms 5-7 Alarms Overview Viewing Individual Alarm Limits You can see the alarm limits set for each measurement next to the measurement numeric on the main screen. Reviewing Alarms op You can see which alarms and INOPs are currently active in the respective alarms and INOPs fields at the top of the screen. To see the currently active alarms and INOPs listed in one place, touch the Alarms area. ft All alarms and INOPs are erased from the Alarm Messages window when you discharge a patient, or if you change to Demonstration Mode. Review Alarms Window ra The Review Alarms window contains a list of the 50 most recent alarms and INOPs with date and time information. The Review Alarms window also shows when alarms are paused or silenced. Note — Alarms that occur during an alarm suspend period will appear in the Review Alarm window, however, they are not communicated to the Information Center. Alarm Reminders The MX40 provides alarm reminders when operating with IIC Release N or IIC iX. The reminder time period is selected at the Information Center. For Information Center Release L/M, reminders are only available for INOPs. 5-8 Alarms Alarms Overview Latching Alarms The alarm latching setting for your MX40 defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the monitor after the alarm condition ends. The indication lasts until you acknowledge the alarm by touching the Alarm Silence button. Alarm Latching Behavior Alarm tone on. Alarm message. Flashing numerics. Alarm tone on. Alarm message. Flashing numerics. Alarm condition no longer present. All audible and visual alarm indicators automatically stop. Alarm tone on. Alarm message . Flashing numerics. Alarm condition still present. Alarm tone off. Alarm message with check mark. Flashing numerics. Audible alarm reminder (if configured) Alarm tone off. Alarm message with check mark. Flashing numerics. Audible alarm reminder (if configured) Alarm condition no longer present. Audible and visual alarm indicators automatically stop. Audible and visual alarm indicators automatically stop. ra Alarm has been acknowledged. Visual and Audible Latching Alarm condition still present. ft Alarm has not been acknowledged. Non-latching Alarms op Red & Yellow Measurement Alarms Alarm Behavior at Power On If the MX40 is powered off for longer than one minute and then powered on again (or after a loss of power lasting longer than one minute, or when a patient is discharged), the device restores the latest alarm settings from the Information Center. If battery power is lost for less than one minute, the alarm on/off condition prior to the power loss is restored. Alarms 5-9 Physiologic Alarms Physiologic Alarms Physiologic alarms indicate a life-threatening situation or a less urgent situation such as heart rate beyond limits. Warning Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. op Arrhythmia alarm chaining and customizing arrhythmia alarm settings are described in the ECG and Arrhythmia Monitoring chapter. There are two levels of arrhythmia analysis available: Basic and Enhanced. Enhanced analysis includes Basic alarms. ft The MX40 provides physiological alarms based on the settings at the Information Center Release N or IntelliVue Information Center iX. Alarming is not active on the MX40 until it is configured via an active association with the Information Center. In the following table, Red (***) alarms are listed alphabetically, followed by the Yellow (**) alarms, and the Yellow (*) alarms. ra Note — The physiological alarm messages displayed on the MX40 use a short text format. Alarm messages displayed at the Information Center use and extended text format, e.g. "*HR yyy5 minutes for 2 consecutive time periods. ECG/QT ** MULTI ST Yellow ** NBP High Yellow ** NBP Low Yellow op Alarm Text ECG/ST High limit has been exceeded for high pressure limit. NBP Low limit has been exceeded for low pressure limit. NBP Yellow QTc value has exceeded the QTc high limit for > 5 minute for2 consecutive time periods. ECG/QT Yellow The respiration rate has exceeded the high alarm limit. RESP Yellow The respiration rate has dropped below the low alarm limit. RESP **SpO2T HIGH Yellow High SpO2. SpO2 value (yyy) greater than high SpO2 limit (xxx) SpO2 ** SpO2T LOW Yellow Low SpO2. SpO2 ** QTc High ra ** RR HIGH ft Two contiguous ST leads have values exceeding elevation or depression alarm limits for > 60 sec. Note — Only available with IIC iX. ** RR LOW Note — Only available with IIC iX. SpO2 value (yyy) less than low SpO2 limit (xxx). ** ST-LEAD HIGH Yellow ST segment is elevated. ECG/ST ** ST-LEAD LOW Yellow ST segment is depressed. ECG/ST ** ST ELEV Yellow Two contiguous leads have ST values exceeding the STEMI limits. ECG/ST */**AFIB Yellow Atrial fibrillation waveform detected. ST/AR Enhanced Arrhythmia Alarms 5-11 Physiologic Alarms Alarm Text Priority Condition Source */** HR High Yellow Heart Rate (yyy) greater than the upper Heart rate limit (xxx). ST/AR Basic & Enhanced Arrhythmia */** HR Low Yellow Heart Rate (yyy) lower than the lower Heart Rate limit (xxx). ST/AR Basic & Enhanced Arrhythmia */** IRREGULAR HR Yellow Consistently irregular rhythm (irregular R-R intervals). ST/AR Enhanced Arrhythmia Yellow No beat detected for 1.75 x average R-R ST/AR interval for Heart Rate greater than 120, or Enhanced no beat for 1 second with Heart Rate Arrhythmia greater than 120 (non-paced patient only). * MULTIFORM PVCs Yellow The occurrence of two differently shaped ST/AR Vs, each occurring at least twice within the Enhanced last 300 beats as well as each occurring at Arrhythmia least once within the last 60 beats. * NON-SUSTAIN VT Yellow A run of Vs having a ventricular Heart Rate greater than V-Tach limit but lasting for less than the V-Tach Run limit. ft Yellow ra *Nurse Call * PACER NOT CAPTURE * PACER NOT PACING * PAIR PVCs op * MISSED BEAT Yellow Yellow Yellow ST/AR Enhanced Arrhythmia The patient has pressed the Multi-Function Button on the MX40. No QRS for 1.75 x the average R-R interval with Pace Pulse (paced patient only). ST/AR Basic & Enhanced No QRS and Pace Pulse for 1.75 x the average R-R interval (paced patient only). ST/AR Basic & Enhanced Arrhythmia Arrhythmia Two consecutive PVCs between non-PVCs. ST/AR Enhanced Arrhythmia * PAUSE Yellow No QRS detected for x seconds. Choices of >1.5 to 2.5 seconds. ST/AR Enhanced Arrhythmia * PVCs /MIN HIGH Yellow PVCs within one minute exceed by the PVCs/min limit (xxx). ST/AR Basic & Enhanced Arrhythmia 5-12 Alarms Physiologic Alarms Alarm Text Priority Condition Source * R-ON-T PVCs Yellow For Heart Rate less than 100, a PVC with ST/AR R-R interval less than 1/3 the average Enhanced interval followed by a compensatory pause Arrhythmia of 1.25 x average R-R interval, or 2 such Vs without a compensatory pause occurring within 5 minutes of each other. (When Heart Rate is greater than 100, 1/3 R-R interval is too short for detection.) * RUN PVCs Yellow Run of PVCs greater than or equal to 2. ST/AR Enhanced Arrhythmia Yellow Run of SVPBs greater than or equal to SVT Run limit and with SVT Heart Rate greater than the SVT Heart Rate limit. ST/AR Enhanced Arrhythmia * VENT BIGEMINY Yellow A dominant rhythm of N, V, N, V (where N= supraventricular beat, V=ventricular beat). ST/AR Enhanced A dominant rhythm of adjacent Vs greater than Vent Rhythm limit and ventricular Heart Rate less than V-Tach limit. ST/AR Enhanced Yellow ft * VENT RHYTHM op * SVT Yellow A dominant rhythm of N, N, V, N, N, V (where N=supraventricular beat, V=ventricular beat). Arrhythmia ST/AR Enhanced Arrhythmia ra * VENT TRIGEMINY Arrhythmia Alarms 5-13 Technical Alarms (INOPs) Technical Alarms (INOPs) Technical Alarms, or INOPs (inoperative conditions), are sourced at the MX40, the ST/AR algorithm running at the Information Center, or the IntelliVue Patient Monitor. They identify inoperative conditions (that is conditions where the system is not operating properly and therefore cannot measure or detect alarm conditions reliably). There are four levels of Technical Alarms: Severe - Monitoring and alarm generation are disabled. Visual alarm indicator on the MX40. Audible tone at the Information Center. Must be acknowledged by a clinician. op Hard - Monitoring and alarm generation are disabled. Visual alarm indicator on the MX40. Audible tone at the Information Center. If the hard INOP is "latched", the sound will be silenced, but the message will remain on the display until resolution of the offending condition. ft Soft - Monitoring and alarms remain active. Visual alarm indicator on the MX40 and at the Information Center. No audible tones are generated at the Information Center Red/Yellow - Replace Battery and ECG Leads Off INOPs may be configured to display as either Red or Yellow Technical Alarms. Note - The ECG Leads Off INOP will initially display as a cyan technical alarm until a valid ECG signal is obtained. ra In the following table, technical alarms are listed alphabetically. Alarm Text Priority BATTERY LOW T Soft Source - MX40 CANNOT ANALYZE ECG Source - MX40 (IIC iX only) and Information Center 5-14 Alarms Hard Condition What to do There is less than 15 minutes of monitoring time remaining (AA batteries). Replace batteries promptly to avoid shutdown and cessation of monitoring. Lithium-ion battery level is < 10% or has <30 minutes remaining time. Insert a charged lithium-ion battery pack. Arrhythmia algorithm cannot reliably analyze the ECG data on any monitored leads. Assess the lead selections, initiate relearn, and validate analyzed rhythm. Check other INOPs for possible source of problem. Technical Alarms (INOPs) Alarm Text Priority CHECK PAIRING Yellow Technical Alarm Source - MX40 cl NBP Batt Low Condition There is a problem with device pairing. When the MX40 is wirelessly paired with an X2 patient monitor (no label) docked with a larger networked MP series monitor, and the network connection is lost. What to do Check that the bedside monitor or cableless measurement device is correctly paired. Select the correct device to be paired. Hard CL NBP Pod weak battery condition. Charge CL NBP Pod. Severe CL NBP Pod empty battery condition. Monitoring is not possible. Replace CL NBP Pod. CL NBP Pod is not connected with the MX40. Resolve interference condition. cl NBP Batt Empty Source - Cableless Measurement Device cl NBP DISCONNECT Hard cl SpO2 Batt Low ft Source - Cableless Measurement Device op Source - Cableless Measurement Device Recharge depleted CL NBP Pod. Reduce range between CL NBP Pod and MX40. Hard CL SpO2 Pod weak battery condition. Charge CL SpO2 Pod. Severe CL SpO2 Pod empty battery condition. Monitoring is not possible. Replace CL SpO2 Pod. CL SpO2 Pod is not connected with the MX40. Resolve interference condition. Source - Cableless Measurement Device ra cl SpO2 Batt Empty Source - Cableless Measurement Device cl SpO2 DISCONNECT Hard Reduce range between CL SpO2 Pod and MX40. Source - Cableless Measurement Device !!!/!! CUFF NOT DEFLATED Recharge depleted SpO2 Pod. Severe Cuff pressure has exceeded the specified safety limit. Remove cuff and tubing and expel air. Severe Cuff pressure has increased above overpressure safety limits. Remove cuff and tubing and expel air. Source - Cableless Measurement Device !!!/!! CUFF OVERPRESS Source - Cableless Measurement Device Alarms 5-15 Technical Alarms (INOPs) Alarm Text Priority Condition What to do ECG/ARRH ALARM(S) OFF Soft ECG is turned off. Turn on ECG. Source - MX40 ECG LEADS OFF Note This INOP may also be configured to display as a Red or Yellow Technical Alarm. Red or Yellow or Hard Technical Alarm Multiple leads are off. Re-attach ECG leads to patient.. Source - MX40 Hard Hard Source - MX40 Patient cable has been unplugged from the MX40. LOCAL AUDIO OFF Re-attach the patient cable. Replace the leadset. Incompatible leadset attached to patient cable. The single-patient use leadset has exceeded its limit of 25 cycles. ft Soft ra LEADSET LIFE Re-attach ECG leads to patient. If primary lead is MCL, lead will be identified as V/C in INOP text. Source - MX40 LEADSET UNPLUGGED Single lead is off. op LEAD OFF Replace with new leadset. Soft There is no alarm audio notification when operating in Telemetry Mode. Change to Monitor Mode. Hard The preset maximum time for the total measurement has been exceeded. Reduce patient movement and avoid interaction with the cuff and tubing. Hard Measurement values cannot be derived. Source - MX40 Note — This is normal operation in Telemetry Mode. NBP INTERRUPTED Source - Cableless Measurement Device NBP MEASURE FAILED Source - Cableless Measurement Device 5-16 Alarms Attach cuff to new location on patient. Replace cuff. Technical Alarms (INOPs) Alarm Text Priority NBP EQUIP MALF Hard Return the MX40 to the coverage area. Patient Sector at the Information Center is in Standby. Select Resume at the Information Center. The paired MX40/bedside monitor is out of short-range radio range or there is excessive radio interference. The MX40 is outside the coverage area, or ft Hard, Latched No batteries in the MX40, or Note — When operating with IIC iX, the INOP will display as NO DATA PWM. The MX40 has failed. ra REPLACE BATTERY T Source - MX40 Note — This INOP may also be configured to display as a Red or Yellow Technical Alarm. RESP EQUIP MALF Red or Yellow or Hard Technical Alarm, Latched Hard Dead battery. No monitoring is occurring. Malfunction in the Resp equipment. Reduce the distance between the devices. Identify and remove interference source. Make sure that the MX40 is within the coverage area and has good batteries. Replace the MX40 if Power On Self Test fails. Put bed in Standby. Contact Service Replace batteries. Contact Service. MX40 requires calibration. Source - MX40 RESP LEAD OFF Condition is not present when operating with Information Center Release N or later (unless specifically configured to operate in this way). op The MX40 is out of range of the network. Source - MX40 Source - Information Center If condition persists, contact Service. Hard Hard NO SIGNAL (appears at the Information Center only) Check tubing. When operating with Information Center Release L Or M, there is no local alarming at the MX40, networked or non-networked. Source - MX40 NO HOST MONITOR What to do Soft Source - MX40 NO CENTRAL MONITOR (appears at MX40 only) Tubing may be obstructed or kinked. Hardware malfunction. Source - Cableless Measurement Device NO ALARM DISPLAY Condition Hard Resp lead off. Re-attach lead to patient. Note — OR leadsets cannot be used to monitor Resp with the MX40. Source - MX40 Alarms 5-17 Technical Alarms (INOPs) Alarm Text Priority Condition What to do SOME ECG ALARMS OFF Soft Some ECG alarms have been turned off at the Information Center. For information only. SpO2T EQUIP MALF Hard Malfunction in the SpO2 equipment Contact Service. Hard Erratic SpO2 measurements, often due to a faulty sensor or invalid SpO2 measurements, or incorrect transducer position Repeat measurement, reposition sensor on patient, or finally, replace sensor. Soft The update period of displayed values is extended due to an NBP measurement on the same limb or an excessively noisy signal. If NBP is not active, check the sensor placement. Reposition the sensor on patient, or replace sensor. Soft Accuracy may be reduced due to low perfusion. Data displayed with ?. Increase perfusion. Change sensor site. Avoid site distal to BP cuff or intra-arterial line. Warm the site. SpO2T ERRATIC Source - MX40 SpO2T EXTD UPDATE Numeric is replaced by a -?-. Source - MX40 SpO2T LOW PERF SpO2T INTERFERENCE Hard Level of ambient light or level of electrical interference are so high that the SpO2 sensor cannot measure SpO2 and pulse rate. ra Source - MX40 ft Source - Monitor op Source - MX40 SpO2T NO SENSOR Reduce ambient light to sensor or electrical noise sources. Hard No sensor attached to SpO2 device. Attach SpO2 sensor. Hard Excessive patient movements or electrical interference are causing irregular pulse patterns Reduce movement or electrical noise sources. Note — Silencing this technical alarm turns off the SpO2 measurement on the MX40 and at the Information Center. Source - MX40 %SpO2T NOISY SIGN Source - MX40 SpO2T NO PULSE Source - MX40 Note — When paired directly with an IntelliVue MP5 Patient Monitor, the INOP will display as SpO2T SENSOR OFF. 5-18 Alarms Hard Pulse is too weak or not detectable Sensor has fallen off at patient. Check connection to patient. Change sensor site. Avoid site distal to BP cuff or intra-arterial line. Technical Alarms (INOPs) Alarm Text Priority Condition SpO2 POOR SIGNAL Soft Although a measurement may be possible, its accuracy may be reduced due to poor signal quality. Source - MX40 Soft The patient signal is analyzed, but a valid numeric is not available yet. Hard The algorithm has determined that a sensor is connected, but not properly applied to the patient. Source - MX40 SpO2T SENSOR OFF Note — The ability of the algorithm to detect this condition depends on the sensor type in use. SpO2T SENSOR MALF Hard TELE BATT EMPTY Note — This INOP may Apply the sensor according to the manufacturer's instructions. If the condition persists, relocate the sensor to a different site on the patient. The connected SpO2 sensor and/or adapter cable is not supported by the hardware version. Use specified sensor and/or adapter cable. Soft SpO2 hardware is in upgrade process. Monitoring is not possible. Wait for the upgrade process to complete. Hard, Latched Lithium-ion battery level is critically low. A 10-minute countdown begins. The MX40 will shut down if the condition is not cleared. Insert a charged lithium-ion battery pack. Hard The temperature of the lithium-ion battery is above 55 C or below -5 C. Replace the lithium-ion battery. Soft Lithium-ion battery has < 25 charge cycles remaining before reaching the charge cycle maximum limit. Be aware that the Lithium-ion battery pack will soon need replacement. Hard ft Source - MX40 Wait for the measurement to complete. Replace sensor. Source - MX40 SpO2T UPGRADE Relocate the sensor to a different site on the patient. Malfunction of the SpO2 sensor/adapter cable Source - MX40 SpO2 UNKN SENSOR Apply the sensor according to the manufacturer's instructions. op SpO2T SEARCHING What to do ra also be configured to display as a Red or Yellow Technical Alarm. Source - MX40 Note — For Information Center Release L or M, this INOP will appear as "REPLACE BATTERY T". TELE BATTERY TEMP Source - MX40 Note — For Information Center Release L or M, this INOP will appear as "REPLACE BATTERY T" TELE CHECK BATT Source - MX40 Alarms 5-19 Technical Alarms (INOPs) Alarm Text Priority Condition What to do TELE MALFUNCTION Hard MX40 malfunction or self-test failure. Contact Service to replace the MX40. Hard, Latched The temperature of the lithium-ion battery is >60 C and the battery must be removed. Replace the lithium-ion battery. The lithium-ion battery has exceeded the maximum charge cycle limit and reached the end of its useful life. Replace the lithium-ion battery. Source - MX40 Source - MX40 Note — For Information Center Release L or M, this INOP will appear as "REPLACE BATTERY T". TELE SERVICE BATT Hard Source - MX40 TELE WEAK SIGNAL Soft Source - MX40 Patient is at outer range of the radio coverage area. The MX40 is receiving a weak signal with high data loss from the AP. Source - MX40 Hard RF Auto Shutoff after 10 minutes of all leads off and no SpO2 sensor connected. Source - MX40 5-20 Alarms Return patient to the coverage area. If patient is in close proximity to AP, replace the MX40. Contact service. The AP covering the specific area is suspect. Contact Service Reattach ECG leads to patient. Reattach SpO2 sensor. The MX40 (WLAN) is connected to the Access Point, but cannot obtain an IP address. Correct the IP address issue. Hard The MX40 (WLAN) is out of range of an access point. Correct the RF coverage issue. Source - MX40 WIFI OUT OF RANGE Dispose of old battery properly. Hard ra UNSUPPORTED LAN ft Condition exists for multiple devices in a specific area TRANSMITTER OFF Dispose of old battery properly. op TELE REMOVE BATT 6. ECG and Arrhythmia Monitoring This section covers the specifics of ECG measurement and the ST/AR Arrhythmia, ST, and QT algorithms used for arrhythmia monitoring. ECG Safety Information ........................................................................... 6-2 Measuring ECG ......................................................................................... 6-5 op Connecting and Positioning ECG Electrodes ........................................ 6-6 Selecting the Primary and Secondary ECG Leads ................................ 6-8 Checking Paced Status .............................................................................. 6-9 Understanding the ECG Display........................................................... 6-10 ft Monitoring Paced Patients ..................................................................... 6-11 Changing the Size of the ECG Wave .................................................... 6-12 Choosing EASI or Standard Lead Placement ...................................... 6-13 Derived 12-lead ECG .............................................................................. 6-14 ECG Configuration.................................................................................. 6-15 ra ECG Leads Monitored ............................................................................ 6-16 Reconstructed Leads ............................................................................... 6-18 Chest Electrode Placement ..................................................................... 6-19 3-Wire Placement..................................................................................... 6-20 5-Wire Placement (Standard Mode)...................................................... 6-21 5-Wire Placement (EASI Mode) ............................................................. 6-22 6-Wire Placement..................................................................................... 6-23 6-Wire Placement (Hexad Mode) .......................................................... 6-24 Monitoring during Leads Off ................................................................ 6-25 ST/AR Arrhythmia Monitoring ............................................................. 6-27 ST/AR ST Analysis Algorithm ............................................................... 6-37 QT Interval Monitoring .......................................................................... 6-42 ECG and Arrhythmia Monitoring 6-1 ECG Safety Information ECG Safety Information Warnings The MX40 operates exclusively via a wireless network connection, therefore, it should not be used for primary monitoring in applications where momentary loss of the ECG is unacceptable at the Information Center. It sends ECG and optionally pulse oximetry data to the Information Center, where the Information Center displays real-time patient data, provides alarm annunciation, data storage and review applications. The ECG waveform data, alarms and optionally SpO2 can always be viewed on the MX40 regardless of the connection to the Information Center. op Always confirm MX40 and Information Center observations with clinical observation of the patient before administering interventions. To avoid patient injury, assure that the patient cable is not positioned where leads could become entangled around the patient, or cause choking, strangulation, or inhibit circulation in extremities. ft Every lead must be secured to an electrode on the patient. Conductive parts of electrodes must not contact earth or other conductive parts. ra EASI derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs. As the 12-lead ECG derived with EASI is not exactly identical to the 12-lead conventional ECG obtained from an electrocardiograph, it should not be used for diagnostic interpretations. EASI lead placement is supported for adult patients only. Ensure that the patient cable is properly connected to the MX40. Do not mix and match electrodes of different types. In particular, do not use electrodes of dissimilar metals. This helps ensure optimal signal quality. Non-manufacturer supplied accessories and supplies can corrupt the performance of the equipment. Use only AAMI EC-12 compliant electrodes with this device. Use of electrodes that are non-compliant may provide erroneous results. During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest. 6-2 ECG and Arrhythmia Monitoring ECG Safety Information Caution To protect the MX40 from damage during defibrillation, to ensure accurate ECG information, and to provide protection against signal noise and other interference, use only ECG electrodes and cables specified by Philips. Philips recommends that you change the lead label only to reflect the physical placement of electrodes. This will ensure a match between the monitored lead and the label, and prevent any possible confusion. For Paced Patients Warnings op Note— When switching from EASI to standard monitoring, there is a momentary loss of data. ft The output power of the MX40 and other sources of radio frequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker performance. Due to the shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring any paced patient. ra In order to minimize the possibility of interference, position electrodes, electrode wires, and the MX40 as far away from the pacemaker as possible. Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the MX40. See the IntelliVue Information Center Instructions for Use for additional information on monitoring paced patients. When an external pacemaker is being used on a patient, arrhythmia monitoring is severely compromised due to the high energy level in the pacer pulse. This may result in the arrhythmia algorithm's failure to detect pacemaker non-capture or asystole. Pacemakers that create fusion beats (pace pulse on top of the QRS complex) cannot be detected by the monitor's QRS detector. ECG and Arrhythmia Monitoring 6-3 ECG Safety Information For paced patients who exhibit only intrinsic rhythm, the monitor can erroneously count pace pulses as QRS complexes when the algorithm first encounters them, resulting in missed detection of cardiac arrest. The risk of missing cardiac arrest can be reduced by monitoring these patients with the low heart rate limit at or slightly above the basic/demand pacemaker rate. A low heart rate alarm notifies you when the patient begins pacing. Proper detection and classification of the paced rhythm can then be determined. ra ft op Note— During defibrillation, monitoring may be temporarily interrupted or distorted. It may take several seconds for the ECG trace to reappear on the screen. After defibrillation, the device will continue to monitor as before; the device settings will not be affected. 6-4 ECG and Arrhythmia Monitoring Measuring ECG Measuring ECG The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the MX40 and the Information Center as a waveform and a numeric. In order to compare measured ECG signals, the electrodes (or patient cables) are placed in standardized positions, forming "leads". To obtain ECG signals optimized for use in diagnosis and patient management in different care environments, different leadsets in varying lead placements are used. Standard lead, Hexad and EASI lead placements can be used with the MX40. ra ft op The Heart Rate calculation resides in the arrhythmia algorithm on the MX40. Arrhythmia analysis is always turned on for telemetry patients. Arrhythmia analysis is either Basic or Enhanced, depending on the product configuration. ECG and Arrhythmia Monitoring 6-5 Connecting and Positioning ECG Electrodes Connecting and Positioning ECG Electrodes Correct lead placement is always important for accurate diagnosis. Especially in the precordial leads, which are close the heart, QRS morphology can be greatly altered if an electrode is moved away from its correct location. Each electrode is color-coded. Use the placement diagrams available on the display of the MX40 and in this section for guidance. Additional lead placement information is available in the Online Help at the IntelliVue Information Center. When placing electrodes on the patient, choose a flat, non-muscular site where the signal will not be impacted by either movement or bones. Philips recommends that electrodes be changed every 24 hours. op Clinicians will tend to see more motion related artifact on the ECG of ambulatory patients than on patients that are restricted to a bed. Proper skin preparation and electrode application are very important in reducing this problem. ft Problems with the ECG signal stem from two main sources: Patient-related sources with noise on the waveform caused by clinical considerations such as poor skin prep, dry electrodes, and poor electrode adhesion, as well as by patient motion and muscle artifact Frequency-related sources resulting in dropouts from signal disturbances and loss of signal. See Risk Management Considerations p. 15-5. ra Even in complex situations where problems overlap, most of the time you’ll be able to greatly enhance performance by taking corrective action. In addition to correct positioning of the electrodes, optimal skin preparation prior to electrode placement will help ensure a clear signal for diagnosis. Prepare the patient’s skin. Good electrode-to-skin contact is important for a good ECG signal, as the skin is a poor conductor of electricity. Select sites with intact skin, without impairment of any kind. Clip or shave hair from the site as necessary. Wash site with soap and water, leaving no soap residue. Note— Philips does not recommend using ether or pure alcohol, because they dry the skin and increase the resistance. Dry thoroughly. 6-6 ECG and Arrhythmia Monitoring Connecting and Positioning ECG Electrodes Use ECG skin preparation paper (abrasive) to remove dead skin cells and to improve the conductivity of the electrode site. Check electrodes for moist gel, and attach to the clips. If you are not using pre-gelled electrodes, apply electrode gel to the electrodes before placement. Note— Gel must be moist to provide a good signal. Place the electrodes on the patient according to the lead placement you have chosen (see the electrode placement diagrams following). Place the edge down, then "roll down" the rest of the pad. Press firmly around the adhesive edge toward the center. Attach the patient cable to the MX40. An ECG waveform and numeric appear on the monitor display. ra ft op ECG and Arrhythmia Monitoring 6-7 Selecting the Primary and Secondary ECG Leads Selecting the Primary and Secondary ECG Leads When multilead analysis is used, the MX40 uses the primary and secondary lead selected at the Information Center to compute HR and to analyze and detect cardiac arrhythmias. They are also available for recordings and for display on the Information Center. Only the primary lead is used if your device is configured for single lead arrhythmia analysis. You should choose a lead as primary or secondary lead at the Information Center that has the following characteristics: the QRS complex should be either completely above or below the baseline and it should not be biphasic op the QRS complex should be tall and narrow ra ft the P-waves and T-waves should be less than 0.2 mV 6-8 ECG and Arrhythmia Monitoring Checking Paced Status Checking Paced Status It is important to set the paced status correctly when you start monitoring ECG. Note — Paced status is set at the Information Center and can only be changed at the Information Center. When Paced is set to On: Pacer Algorithm is switched on. This means that pacemaker pulses are not counted as extra QRS complexes. The pacer spikes are shown in white. The paced symbol is displayed. op When Paced is set to Unconfirmed (IIC iX only): Pacer Algorithm is switched on. This means that pacemaker pulses are not counted as extra QRS complexes. The pacer spikes are shown in white. ft The paced symbol with ? is displayed. When Paced is set to Off and your patient has a pacemaker, pace pulses may be counted as regular QRS complexes, which could prevent an asystole event from being detected. ra Warning Pace pulse rejection must be switched on for paced patients by setting Paced to On. Switching pace pulse rejection off for paced patients may result in pace pulses being counted as regular QRS complexes, which could prevent an asystole event from being detected. At admission/discharge, always check that paced status is correct for the patient. Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Make sure that pace pulses are detected correctly by checking the pace pulse markers on the display. Keep pacemaker patients under close observation. ECG and Arrhythmia Monitoring 6-9 Understanding the ECG Display Understanding the ECG Display Your display may be configured to look slightly different. 4. Current heart rate 2. 1 mV calibration bar 5. Current heart rate alarm limits 3. Pacer spikes 6. EASI lead placement label (located here when active) op 1. Lead label of the displayed wave 7. Paced status ft ECG HR numeric: This is the heart rate derived from the monitored ECG. ra Pacer Spikes: The pacer spikes are shown in white. 6-10 ECG and Arrhythmia Monitoring Monitoring Paced Patients Monitoring Paced Patients An ECG optimized for monitoring a paced patient should look like this: 1. Normal Beats 2. Pace Pulses/Beats Choose a lead as primary or secondary lead that has these characteristics: op the normal QRS complex should be either completely above or below the baseline and it should not be biphasic. For paced patients, the QRS complexes should be at least twice the height of pace pulses. the QRS complex should be tall and narrow the P-waves and the T-waves should be less than 0.2 mV. ft Optimizing Lead Selection for Paced Patients Some unipolar pacemakers display pace pulses with repolarization tails. These tails may be counted as QRSs in the event of cardiac arrest or other arrhythmias. ra If you note a visible repolarization tail, choose a lead that decreases the size of the repolarization tail. 1. Repolarization tail (note width) Avoid fusion and pseudofusion beats. 1. Fusion 2. Paced 3. Pseudofusion ECG and Arrhythmia Monitoring 6-11 Changing the Size of the ECG Wave Changing the Size of the ECG Wave If any of the displayed ECG waves is too small or clipped, you can change the size of the ECG waves on the screen. Changing the adjustment factor only changes the visual appearance of the ECG wave on the MX40. It does not affect the ECG signal analyzed by the algorithm. Comparing the wave size to the 1 mV calibration bar on the ECG wave segment can help you get an idea of the true ECG signal strength. To change the size of the ECG waves on the screen by a fixed adjustment factor: Touch the HR parameter. In the Setup ECG menu, scroll to the second page and select Adjust Size. Select the required adjustment factor from the list. op ft Size X1/2 to halve the wave size Size X1 to display the wave without zoom Size X2 to double the wave size ra Size X4 to multiply the wave size by four or 6-12 Touch the ECG wave and enter the size from the Change Wave menu. Select the required adjustment factor from the list. ECG and Arrhythmia Monitoring Choosing EASI or Standard Lead Placement Choosing EASI or Standard Lead Placement Choose either standard lead placement or EASI lead placement: In the Setup ECG menu, select Lead Placement to toggle between Standard or EASI. Select Standard or EASI. Note — When changing lead placement, the patient cable must be attached to the MX40. EASI is shown beside the 1 mV calibration bar on the ECG wave on the display, and EASI is marked on any recorder strips and printouts. ra ft op See the sections on Lead Placement for electrode placement diagrams. ECG and Arrhythmia Monitoring 6-13 Derived 12-lead ECG Derived 12-lead ECG Hexad When operating with the IntelliVue Information Center iX, the optional Hexad algorithm generates a Mason-Likar 12-lead ECG from a 6-wire leadset (including four limb electrodes and two chest electrodes) placed according to the Mason-Likar 6-electrode placement. op To generate a derived 12-lead ECG using this configuration, 8 out of the 12 leads are directly acquired (I, II, III, aVR, aVL, aVF and the two directly-recorded V leads) and only 4 precordial leads need to be derived. This means that 8 of 12 are identical to the 12 leads acquired using a full set of 10-wire standard ECG lead set. For more information refer to the 12 Lead ECG Monitoring Using a Reduced Lead Set Application Note, Part Number 452296278591. Caution EASI ft Hexad derived ECG and their measurements are approximations to the standard ECG, and should not be used for diagnostic interpretation. ra The EASI system, a method of deriving 12ECG leads using a five-electrode configuration (4 monitoring electrodes and a ground electrode), has been developed to better address the goals and challenges of continuous ECG monitoring. EASI monitoring makes it possible to obtain 12-lead ECG information under continuous monitoring conditions across the continuum of care. The EASI method of obtaining a 12-lead ECG requires only five electrodes. The electrodes are placed on the upper sternum (S), the lower sternum (E) at the level of the fifth intercostal space, and on the right and left midaxillary lines (I and A) at the same level as the lower sternum electrode. A fifth ground electrode can be placed anywhere. 6-14 ECG and Arrhythmia Monitoring ECG Configuration ECG Configuration The MX40 supports 3-, 5-, and 6-wire patient cables. The 5-wire patient cable can be used for either standard or EASI electrode configurations. The 6-wire patient cable can be used for either standard or Hexad electrode configurations. The MX40 detects the patient cable type attached and automatically determines the ECG measurement and transmitted leads. Note—The labels and colors of the ECG electrodes differ according to the standards that apply for your hospital. The electrode placement references and illustrations in this chapter use the AAMI labels and colors. See the table below for additional label and color information. Electrode Labels Electrode Colors AAMI EASI AAMI RA LA LL RL White Red Black Yellow Red Green Green Black ft V/Va Vb IEC op IEC C/Ca Brown White Cb Brown/White White/Blue ra Arrhythmia analysis resides in the arrhythmia algorithm on the MX40. Arrhythmia analysis is always turned on for telemetry patients unless operating with the IntelliVue Information Center iX, where it can be turned off. Arrhythmia analysis is either Basic or Enhanced (optional). ECG and Arrhythmia Monitoring 6-15 ECG Leads Monitored ECG Leads Monitored Depending on the patient cable connected to the MX40, a different set of viewable leads are available at the MX40 and the Information Center. The MX40 can source up to four raw ECG waves to the Information Center. If you are using ... these leads can be selected at the MX40 and the Information Center 3-wire I, II, III Sourced (raw) waves are received as: Channel 1 = I, II, or III Factory Default is II. 5-wire (Standard mode) I, II, III, aVR, aVL, aVF, MCL and V op Sourced (raw) waves are received as: Channel 1 = II Channel 2 = III Channel 3 = MCL Factory Defaults are II, V, III. I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 ft 5-wire (EASI mode) In EASI mode, the sourced (raw) waves are received as: Channel 1 = Vector 1 (A-I) Channel 2 = Vector 2 (A-S) ra Channel 3 = Vector 3 (E-S) 6-16 ECG and Arrhythmia Monitoring Factory Defaults are II, V2, III, V5. Arrhythmia monitoring is performed only on the primary and secondary leads selected at the Information Center, although you can view and perform ST analysis on all 12 EASI derived leads. ECG Leads Monitored If you are using ... 6-wire these leads can be selected at the MX40 and the Information Center I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R. Sourced (raw) waves are received as: Channel 1 = II Channel 2 = III Channel 3 = Va Channel 4 = Vb Factory Defaults are II, Va = V2, III, Vb = V5. The two chest leads, Va and Vb, can be placed on the patient in any of the V lead positions (V1 through V9, V3R, V4R, V5R). Lead assignment is available at the Information Center. When unassigned, the chest leads use the defaults. Note— The lead label assigned to Vb cannot op be selected for Va even though Vb does not appear to be used. ft When display of the pleth wave is enabled at the Information Center, the second chest lead (Vb) is not available for monitoring. 6-wire (Hexad Mode) I, II, III, MCL, aVR, aVL, aVF, V1-V6. Factory Defaults = Off, V1/V3, V1/V4, V1/V5, V2/V4, V2/V5, V3/V5, V3/V6 ra Derived leads are labeled, e.g. dV3. ECG and Arrhythmia Monitoring 6-17 Reconstructed Leads Reconstructed Leads Reconstruction of leads from the sourced wave is defined by the calculations in the following table. EASI reconstructed leads are a linear combination of all three raw EASI leads ECG Lead 3-wire 5-wire 6-wire Standard II (default) II (default) II (default) LL-RA III III (default) III (default) MCL V-LA, where V=C aVR RA-(LA+LL)/2 aVL aVL LA-(RA+LL)/2 aVF LL-(LA+RA)/2 aVF V (default) ra ECG and Arrhythmia Monitoring LL-LA aVR ft LA-RA op 6-18 Clinical Calculations in terms of electrodes V-(RA+LA+LL)/3, where V=C Va Va-(RA+LA+LL)/3, where Va=V2 (default) position Vb Vb-(RA+LA+LL)/3, where Vb =V5 (default) position Chest Electrode Placement Chest Electrode Placement V1 on the fourth intercostal space at the right sternal border V2 on the fourth intercostal space at the left sternal border V3 midway between the V2 and V4 electrode positions V4 on the fifth intercostal space at the left midclavicular line V5 on the left anterior axillary line, horizontal with the V4 electrode position V6 on the left midaxillary line, horizontal with the V4 electrode position V3R-V6R on the right side of the chest in positions corresponding to those on the left op VE over the xiphoid process V7 on posterior chest at the left posterior axillary line in the fifth intercostal space V7R on posterior chest at the right posterior axillary line in the fifth intercostal space ft For accurate chest electrode placement and measurement, it is important to locate the fourth intercostal space. To locate the fourth intercostal space: Locate the second intercostal space by first palpating the Angle of Lewis (the little bony protuberance where the body of the sternum joins the manubrium). This rise in the sternum is where the second rib is attached, and the space below this is the second intercostal space. ra Palpate and count down the chest until you locate the fourth intercostal space. ECG and Arrhythmia Monitoring 6-19 3-Wire Placement 3-Wire Placement 1. RA - directly below the clavicle and near the right shoulder 2. LA -directly below the clavicle and near the left shoulder ra ft op 3. LL - on the left lower abdomen 6-20 ECG and Arrhythmia Monitoring 5-Wire Placement (Standard Mode) 5-Wire Placement (Standard Mode) 1. RA directly below the clavicle and near the right shoulder 2. LA directly below the clavicle and near the left shoulder 3. RL on the left lower abdomen 4. LL on the right lower abdomen 5. V on the chest, the position depends on your required lead selection. V1 on the fourth intercostal space at the right sternal border V2 on the fourth intercostal space at the left sternal border op V3 midway between the V2 and V4 electrode positions V4 on the fifth intercostal space at the left midclavicular line V6 on the left midaxillary line, horizontal with the V4 electrode position ra ft V5 on the left anterior axillary line, horizontal with the V4 electrode position ECG and Arrhythmia Monitoring 6-21 5-Wire Placement (EASI Mode) 5-Wire Placement (EASI Mode) 1. E (V) on the lower sternum at the level of the fifth intercostal space 2. A (LL) on the left midaxillary line at the same level as the E electrode 3. S (LA) on the upper sternum 4. I (RA) on the right midaxillary line at the same level as the E electrode ft op 5. N (Reference) can be anywhere, usually below the sixth rib on the right hip ra Make sure that the S and E electrodes line up vertically on the sternum, and that the I, E and A electrodes align horizontally. 6-22 ECG and Arrhythmia Monitoring 6-Wire Placement 6-Wire Placement For a 6-lead placement use the positions from the 5-lead diagram above but with two chest leads. The two chest leads, Va and Vb, can be positioned at any two of the V1 to V6 positions shown in the chest electrode diagram below. The default position of Va - the brown lead - is at the V2 position. The default position for Vb - the brown/white lead - is at the V5 position. op The lead placement for the Va and Vb lead labels must be appropriate. If your unit uses other precordial leads for Va and Vb, they may be assigned in Unit Settings at the Information Center as defaults for your whole unit, or you may need to assign the new positions on a per-patient basis in the Patient Window at the Information Center. Selecting Positions of Va and Vb Chest Leads ra ft The two chest leads for the 6-lead placement can be positioned at any two of the V1 to V9 and V3R, V4R and V5R positions. Select the positions you have used in the Patient Window at the Information Center, so that the chest leads will be correctly labeled. ECG and Arrhythmia Monitoring 6-23 6-Wire Placement (Hexad Mode) 6-Wire Placement (Hexad Mode) The diagram below shows the Mason-Likar Placement for 12-Lead ECG using 6 electrodes. 1. RA directly below the clavicle and near the right shoulder 2. LA directly below the clavicle and near the left shoulder 3. RL on the left lower abdomen 4. LL on the right lower abdomen 5. V on the chest, the position depends on your required lead selection. The typical position is V1, although this may vary according based on your hospital’s protocol. op V1 on the fourth intercostal space at the right sternal border V2 on the fourth intercostal space at the left sternal border V3 midway between the V2 and V4 electrode positions ft Note — In Hexad mode, V leads are chosen in pairs at V4 on the fifth intercostal space at the left midclavicular line the IntelliVue Information Center iX. V5 on the left anterior axillary line, horizontal with the V4 electrode position ra V6 on the left midaxillary line, horizontal with the V4 electrode position 6-24 ECG and Arrhythmia Monitoring Monitoring during Leads Off Monitoring during Leads Off ECG Fallback and Extended monitoring states are supported for the MX40 when the primary and/or secondary leads are in a "Leads Off" INOP condition. Both of these states are entered into after 10 seconds of "Leads Off" in an attempt to maintain monitoring and arrhythmia analysis. ECG Fallback ECG Fallback occurs when the primary lead is in "Leads Off" for 10 seconds and a secondary lead is available. Multilead Analysis op If there is a "Leads Off" technical alarm in the primary lead for > 10 seconds, the active secondary lead becomes the primary lead. The arrhythmia algorithm switches the leads on the display, but relearn does not occur. When the "Leads Off" condition is corrected, the leads are switched back to their original state. ft Single Lead Analysis For single lead analysis, if there are two leads available, the secondary lead is made the primary lead until the "Leads Off" condition is corrected. The arrhythmia algorithm performs a relearn using the available lead. Extended Monitoring ra If both the primary and secondary leads are in a "Leads Off" condition, the ECG source on the MX40 will switch to any available lead. Relearning will occur in this condition. Fallback for EASI If one of the derived EASI leads is in a technical alarm condition, a flat line is displayed. After 10 seconds, the directly acquired EASI AS, EA, or AI lead, depending on which is available, is displayed. Arrhythmia relearn is performed with transition to or from EASI Fallback monitoring using the available lead(s). Relearning Whenever there is a "Leads Off" condition for more than 60 seconds, the arrhythmia algorithm performs a Relearn using the available leads. ECG and Arrhythmia Monitoring 6-25 Monitoring during Leads Off Warning Since Relearn happens automatically, if learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib. For this reason, you should: Respond promptly to any technical alarm. Ensure that the arrhythmia algorithm is labeling beats correctly. ra ft op 6-26 ECG and Arrhythmia Monitoring ST/AR Arrhythmia Monitoring ST/AR Arrhythmia Monitoring ST/AR Arrhythmia Algorithm Indications for Use The ST/AR Arrhythmia Algorithm is indicated for use in instances where the clinician decides to monitor cardiac arrhythmias of adult and pediatric patients and/or the ST segment of adult patients to gain information for treatment, monitor the adequacy of treatment, or to exclude causes of symptoms. op How the ST/AR Algorithm Works ST/AR multi-lead analysis is performed on the user-selected primary and secondary leads. If only one lead is available for multilead, ST/AR analysis is performed on the single available lead. Arrhythmia analysis consists of several steps: The ECG signal is pre-processed to filter out baseline wander, muscle artifact, and signal irregularities. In addition, if the Paced status = On, pace pulses are detected then rejected from the processing to avoid seeing them as QRS beats. Beat detection to locate the QRS complexes for further analysis. ra ft Feature measurement such as R-wave height, width, and timing. Beat classification. Templates are created and are matched to incoming beats, and the appropriate beat label is determined. Atrial Fibrillation Detection. Analyzes the RR intervals and P waves. Ventricular Fibrillation Detection. Looks for a flutter or sinusoidal wave pattern in both ECG channels Rhythm and alarm detection. Beat labels are used to produce the values and events needed to generate rhythms and alarms. Working in parallel with beat detection and classification, a separate detector examines continuously for ventricular fibrillation, asystole, and noise. The quality of the ECG signal is important for accurate arrhythmia analysis. The section below provides guidelines for optimizing signals for arrhythmia analysis. ECG and Arrhythmia Monitoring 6-27 ST/AR Arrhythmia Monitoring For additional information on the ST/AR Algorithm, refer to the Arrhythmia Monitoring ST/AR Algorithm Application Note. Aberrantly-Conducted Beats Atrial Fibrillation Alarm op As P-waves are not analyzed, it is difficult and sometimes impossible for the monitor to distinguish between an aberrantly-conducted supraventricular beat and a ventricular beat. If the aberrant beat resembles a ventricular beat, it is classified as ventricular. You should always select a lead where the aberrantly-conducted beats have an R-wave that is as narrow as possible to minimize incorrect calls. Ventricular beats should look different from these 'normal beats'. Instead of trying to select two leads with a narrow R-wave, it may be easier to just select one lead and use single lead arrhythmia monitoring. Extra vigilance is required by the clinician for this type of patient. ft The MX40 performs atrial fibrillation analysis using information about the RR irregularity, PR interval variability, and P-wave variability. In order to generate an Afib alarm the following criteria must be detected for 1 minute: normal beat RR intervals must be irregular ra PR interval deviation must be large P-wave region must not match well Atrial fibrillation analysis is only available for adult patients and atrial fibrillation detection cannot be performed on PVCs or Paced beats. An *End AFIB alarm will occur when no atrial fibrillation waveform is detected for a configured delay time. Since most atrial flutters have regular RR intervals, they cannot be detected by the atrial fibrillation algorithm. An *AFIB alarm can be falsely detected in the presence of: sinus arrhythmia muscle noise, or electrode motion artifact 6-28 ECG and Arrhythmia Monitoring ST/AR Arrhythmia Monitoring Intermittent Bundle Branch Block Bundle branch and the other fascicular blocks create a challenge for the arrhythmia algorithm. If the QRS during the block changes considerably from the learned normal, the blocked beat may be incorrectly classified as ventricular, causing false PVC alarms. You should always select a lead where the bundle branch block beats have an R-wave that is as narrow as possible to minimize incorrect calls. Ventricular beats should look different from these 'normal beats'. Instead of trying to select two leads with a narrow R-wave, it may be easier to just select one lead and use single lead arrhythmia monitoring. Extra vigilance is required by the clinician for this type of patient. op ECG and Arrhythmia Alarm Overview The ECG and arrhythmia alarms available depend on which measurements are switched on, and the arrhythmia option enabled for your MX40. Cardiotach alarms are available when HR is on and the active alarm source is ECG, but arrhythmia s switched off. ft Basic arrhythmia alarms are available when Arrhythmia is switched on. Enhanced arrhythmia alarms are available when Arrhythmia is switched on and the Enhanced Arrhythmia option has been enabled for your MX40. ra To check your enabled settings, view the Standby screen. Cardiotach Alarms Additional Alarms with Basic Arrhythmia Option Additional Alarms with Enhanced Arrhythmia Option ***Asystole ***Ventricular Tachycardia *Pacer Not Capture *Afib *Pacer Not Pacing *Supraventricular Tach ***Ventricualr Fibrillation/ Tachycardia ***Extreme Bradycardia ***Extreme Tachycardia */**High heart rate */**Low heart rate *PVCs/min HIGH (PVC > limit/min) *End Afib *Missed Beat *Pause *Irregular HR *End Irregular HR *Ventricular Rhythm *Run PVCs High *Pair PVCs *R-on-T PVCs *Ventricular bigeminy *Ventricular trigeminy *Non-sustain VT *Multiform PVCs ECG and Arrhythmia Monitoring 6-29 ST/AR Arrhythmia Monitoring Note — When operating with the IntelliVue Information Center Release N or earlier, the ST/AR Arrhythmia Algorithm operates and generates alarms independently at both the MX40 and the Information Center. Therefore, you may see slight differences between the two, even though the alarm settings and limits are the same. Using ECG Alarms At the Information Center, ECG alarms can be switched on and off and the high and low alarm limits changed just like other measurement alarms, as described in the Alarms chapter. Special alarm features which apply only to ECG are described here. op Extreme Alarm Limits for Heart Rate The extreme rate alarms, Extreme Tachy and Extreme Brady, are set at the Information Center by adding a set value (the D value) to the high and low alarm limits. 2. Low Limit 3. High Limit 4. Extreme Tachy Limit 5. Extreme Brady (D value) 6. Extreme Tachy (D value) ra ft 1. Extreme Brady Limit You need to know which value has been configured for your monitor. Changing the high and low alarm limits automatically changes the extreme alarm limits within the allowed range. Arrhythmia Alarm Settings Some arrhythmia alarms can be turned off at the Information Center depending its configuration. They are: Non-Sustain VT, Vent Rhythm, Run PVCs, Pair PVCs, R-On-T PVC, V.Bigeminy, V.Trigeminy, Multif.PVCs, Pause, SVT, HR High, HR Low Irregular HR (IHR), Missed Beat, PVCs/min, Pacer Not Capture, Pacer Not Pacing,and Afib. Alarms that have been turned off at the Information Center will appear as off in the Arrhythmia menu of the MX40, but they are not accessible, nor can you change limits locally. 6-30 ECG and Arrhythmia Monitoring ST/AR Arrhythmia Monitoring Yellow Arrhythmia Alarms Yellow arrhythmia alarms are short yellow alarms specific to arrhythmia-related patient conditions. Depending on your Information Center configuration, they may be shown with one or two stars. The heart rate alarms (High HR and Low HR) can be configured as short yellow or standard yellow alarms. When they are standard yellow alarms they exist independently of the other arrhythmia alarms and no timeout periods apply. Warning op When arrhythmia analysis is on, all yellow ECG and arrhythmia alarms are short yellow alarms (one-star). This means that the alarm tones (if volume is on) are active for six seconds only, after which the blinking numeric and the alarm message remain for up to three minutes. The only exception to this are the HR High and Low alarms which can be configured as standard yellow alarms. Red alarms behave as usual. ft Viewing Arrhythmia Waves To view arrhythmia beat labels: Go to the Setup ECG menu. Select Arrhythmia. ra Change Annotate Arrhy from Off to On. Beat labels will be annotated above the ECG wave and Delayed will appear beside it. To return to the normal ECG primary lead display: Select Annotate Arrhy. Change to Off. Exit from the Setup ECG menu. ECG and Arrhythmia Monitoring 6-31 ST/AR Arrhythmia Monitoring Arrhythmia Beat Labels Arrhythmia beat labels tell you how the monitor is classifying beats. N = Normal V = Ventricular Ectopic S = Supra-ventricular Premature P = Paced ' = Pacer spike " = Biventricular Pacer Spike A = Artifact (noisy episode) op L = Learning patient's ECG ? = Insufficient information to classify beats I = Inoperative condition (e.g., LEADS OFF) ra ft M = Pause or missed beat 6-32 ECG and Arrhythmia Monitoring ST/AR Arrhythmia Monitoring Enhanced Arrhythmia Chain The diagram below shows the alarm condition priority chains for enhanced arrhythmia. The alarm conditions in each category are prioritized according to the level of seriousness. Red Alarms Chain Asystole ↓ V-FIB/TACH ↓ V-TACH ↓ Extreme Tachy/Extreme Brady PVC Alarms Chain Rate Alarms Chain SVT ↓ ↓ HR > xxx or HR < xxx ↓ Pair PVCs ↓ ↓ ra R-On-T PVCs Beat Detection Alarms Chain Afib/End Afib ↓ lHR/End IHR Pause ft Non Sustain VT/Vent Rhythm Run PVCs op Yellow Arrhythmia Alarms ↓ Pacer Not Capture/Pacer Not Pace/Missed Beat. First Level Timeout Period ---------------------------------------------------------------------------------------------------------------------------Second Level Timeout Period Vent Bigeminy ↓ Vent Trigeminy ↓ PVCs >xx/min ↓ Multiform PVCs ECG and Arrhythmia Monitoring 6-33 ST/AR Arrhythmia Monitoring Basic Arrhythmia Chain The diagram below shows the alarm condition priorities for basic arrhythmia and the timeout levels for yellow alarm conditions. Red Alarms Asystole ↓ V-FIB/TACH ↓ V-TACH ↓ Extreme Tachy/Extreme Brady op ↓ Yellow Arrhythmia Alarms Beat Detection Alarms Chain Rate Alarms Chain Pacer Not Capture/Pacer Not Pace HR > xxx or HR < xxx ft PVC Alarms Chain First Level Timeout Period ---------------------------------------------------------------------------------------------------------------------------------------------------------- PVCs >xx/min ra Second Level Timeout Period Learning The arrhythmia system’s goal is to learn the patient’s normal complexes so it can differentiate abnormal beats. This "learning" process uses the 15 first valid beats (for example, free from noise) encountered during the learning phase. While the system is learning the complex, the delayed arrhythmia wave displays the beat label "L". Learning Phase A learning phase involves the system learning the patient’s dominant complexes. During a learning phase: 6-34 ECG and Arrhythmia Monitoring ST/AR Arrhythmia Monitoring Alarm timeout periods are cleared. Stored arrhythmia templates are cleared. Asystole, Vfib, and HR alarms (when there are enough beats to compute the HR) are active. All other alarms are not active. Single Lead Analysis If single lead analysis is selected, the arrhythmia system begins learning whenever: ECG monitoring is initiated. op The Relearn Arrhy control is activated. See Initiating Arrhythmia Relearning Manually p. 6-36. The ECG Lead or Lead Label is changed manually, or when Fallback occurs. See Fallback. A "LEADS OFF" INOP condition (that has been active for >60 seconds) ends. ft When the MX40 re-associates with the Information Center. Multilead Analysis ra If multilead analysis is selected, the arrhythmia system begins a learning on both leads whenever: ECG monitoring is initiated. The Relearn Arrhy control is activated (see Initiating Arrhythmia Relearning Manually p. 6-36). There has been a Leads Off INOP condition (that has been active for >60 seconds) for both leads, and the condition ends in either lead. When the MX40 re-associates with the Information Center. Multilead Analysis With Changes in One Lead Since the arrhythmia system uses more than one lead for analysis, if there is a change in one lead, the system does a relearn only on the affected lead. This happens whenever: An ECG lead or label is changed. A Leads Off INOP condition (that has been active for >60 seconds) ends. ECG and Arrhythmia Monitoring 6-35 ST/AR Arrhythmia Monitoring Note — During this learning phase the system will continue monitoring using the operative lead. Therefore, the delayed arrhythmia wave is not labeled "L". In addition: Alarm timeout periods are maintained. Stored arrhythmia templates are maintained for the operative lead. All alarms turned on are active. EASI ECG Monitoring Whenever there is an INOP condition, the arrhythmia algorithm performs a Relearn, using the available lead. Warning op Since Relearn happens automatically, if 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. For this reason, you should: Respond to the INOP message (for example, re-connect the electrode(s). Ensure that the arrhythmia algorithm is labeling beats correctly. ft ra Initiating Arrhythmia Relearning Manually To initiate relearning manually, in the Setup ECG menu, select Relearn Arrhy. While the monitor is learning, if annotate arrhythmia is On, the delayed arrhythmia wave displays the beat label L. Next, the monitor determines the dominant rhythm. The beats are labeled N. After relearning is complete, you should check the delayed arrhythmia wave to ensure that the algorithm is labeling the beats correctly. See Arrhythmia Beat Labels p. 6-31. If beats are still not classified correctly, check that the ECG is optimized for arrhythmia monitoring. You may need to select a different lead or change the electrodes or electrode positions if there is excessive noise, unstable voltage, low amplitude, or large P- or T-waves. 6-36 ECG and Arrhythmia Monitoring ST/AR ST Analysis Algorithm ST/AR ST Analysis Algorithm Introduction The intended use of the ST/AR ST Analysis algorithm is to monitor an adult patient’s ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST Analysis algorithm is capable of monitoring paced and non-paced adult patients. The ST/AR ST algorithm monitors ST segment elevation or depression for each available telemetry ECG lead and produces events/alarms simultaneously. Warning op Note—The ST Analysis algorithm does not analyze ventricularly paced or ventricular ectopic beats. ft This device provides ST level change information; the clinical significance of the ST level change information needs to be determined by a physician. ST values update with every measurement period and enunciate, depending upon the severity of the change, events and alarms as they are detected. ra The ST/AR ST algorithm is approved for use only with adult non-paced and atrially-paced patients. Caution Some clinical conditions may make it difficult to achieve reliable ST monitoring, for example: if you are unable to select a lead this is not noisy if arrhythmias such as atrial fib/flutter are present, which may cause an irregular baseline if the patient is continuously ventricularly paced if the patient has left bundle branch block ECG and Arrhythmia Monitoring 6-37 ST/AR ST Analysis Algorithm The Measurements Overview The ST/STE measurement for each beat complex is the vertical difference between two measurement points. The isoelectric point provides the baseline for both measurements. The ST measurement uses the isoelectric point and the ST point. The ST point is positioned with reference to the J-point. The STE measurement uses the isoelectric point and the J point. 1. R-wave peak at 0 msec 2. J point op 3. Difference = ST value 4. ST measurement point. Default = J+60 msec 5. Isoelectric point. Default = -80 msec 6. P 7. Q ft 8. S 9. T ra You can manually adjust the ST/STE measurements on the Information Center's Measurements application. Turning ST or STE On and Off ST and STE analysis can be turned on and off independently. You would turn ST/STE monitoring off if: You are unable to get any lead that is not noisy. Arrhythmias such as atrial fib/flutter cause irregular baseline. The patient is continuously ventricularly paced. The patient has left bundle branch block. To turn all ST or STE monitoring on or off at the IntelliVue Information Center iX: 6-38 Select the Measurements ST page. Click the I/O ST or I/O STE Analysis button to toggle ST or STE Analysis on or off as appropriate. ECG and Arrhythmia Monitoring ST/AR ST Analysis Algorithm To turn ST monitoring on or off at the IntelliVue Information Center Release N: From the Patient Window, click the All Controls button. From the All Controls Window, click the ST Setup button. From the ST Setup Window, click ST On/Off as appropriate. Displayed ST Data Displayed STE Data op ST data displays as values in the Patient Sector and Patient Window at the Information Center. At the MX40, three ST values can be displayed below the ECG wave. A positive value indicates ST segment elevation; a negative value indicates ST segment depression. You can view ST data at the MX40 if ST is assigned to a numeric area. Up to 3 values can display in the assigned space. If more than three values area available, the last value will rotate. ft STE Data can only be displayed in the Measurements application STE page at the Information Center iX. Note — ST/STE data and alarms are only displayed at the MX40 when operating with IntelliVue Information Center iX. ra ST Lead Groups ECG Leads are clinically grouped as follows: ST Lead Group ECG Leads Inferior II, III, aVF Lateral I, aVL, V5, V6 Antero-lateral I, aVL, V4, V5, V6 Anterior V1, V2, V3, V4 Septal V1, V2, V3 Right V3R, V4R, V5R Posterior V7, V8, V9 You can change the group displayed using the ST Views menu. ECG and Arrhythmia Monitoring 6-39 ST/AR ST Analysis Algorithm Derived 12 Lead ECG Caution op In view of the high degree of redundancy among the standard 12-lead ECG leads, it is quite conceivable that a more practical leadset with a smaller number of judiciously chosen leads can be used to reconstruct the missing leads. For Hexad derived 12-lead the-6 electrode configuration is the feasibility of deriving additional chest leads if the two chest electrodes are placed in several pre-specified standard precordial locations. Using a standard 5-electrode set in EASI lead placement you can monitor up to 12 standard ECG leads simultaneously and continuously at the bedside. EASI provides a monitoring method for trending ST segment changes that can provide an early indication of ischemia. Derived ECG and their measurements are approximations to the standard ECG, and should not be used for diagnostic interpretation. ft EASI ST Analysis With EASI monitoring, ST analysis is performed on up to 12 leads, and an additional value of ST index is calculated and displayed. Assessment of EASI-derived 12-lead ST measurement is recommended for adult patients that meet the following parameters: ra Ages: 33-82 years Heights: 147 to 185 cm (58 to 73 in) Weights: 53 to 118 kg (117 to 261 lbs) Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) For additional information on ST monitoring, refer to the ST Segment Monitoring Application Note, Part Number 452296278611. ST values are presented in the patient sector and Patient Window for EASI derived leads along with STindx (ST Index). STindx is a summation of three ST segment measurements, using the leads that can indicate ST segment changes in the different locations of the heart: anterior lead V2 lateral lead V5 inferior lead aVF 6-40 ECG and Arrhythmia Monitoring ST/AR ST Analysis Algorithm HEXAD ST Analysis When operating with the IntelliVue Information Center iX, the optional Hexad algorithm generates a Mason-Likar 12-lead ECG from a 6-wire leadset (including four limb electrodes and two chest electrodes) placed according to the Mason-Likar 6-electrode placement. ST Alarms op To generate a derived 12-lead ECG using this configuration, 8 out of the 12 leads are directly acquired (I, II, III, aVR, aVL, aVF and the two directly-recorded V leads) and only 4 precordial leads need to be derived. This means that 8 of 12 are identical to the 12 leads acquired using a full set of 10-wire standard ECG lead set. For more information refer to the 12 Lead ECG Monitoring Using a Reduced Lead Set Application Note, Part Number 452296278591. ft ST Alarms are yellow alarms. They are announced after exceeding alarm limits for one minute. ST Alarm Limits can only be set at the Information Center. Each ST lead has its own alarm limit. ST alarms are triggered when an ST value exceeds its limit for more than one minute. Turning ST Alarms off turns off alarms for all ST leads. STE Alarms ra The STE Alarm is a yellow alarm. It is announced after exceeding alarm limits for one minute. It can be turned on and off at the Information Center, however its limits are not adjustable. The STE alarm limits are gender specific and can be set individually for limb leads, V2/V3 leads, and V1/V4/V5/V6 leads. The default values, for example on V2 and V3 1.5 mm for females and 2.0 mm for males, are based on the recommendations from the American Heart Association and American College of Cardiology. The ST Elevation measurements with automated J-point determination generate ST Elevation alarms, in addition to the ST measurements at the user-defined ST point (J+offset), which may be useful for ST depression alarms. When ST and STE analysis are both in use, this may result in redundant alarms for ST elevations. Because of the different measurement points, there may be different values obtained. Thus there could be an ST alarm and an STE alarm but the STE alarm may announce sooner based upon the values obtained. ECG and Arrhythmia Monitoring 6-41 QT Interval Monitoring QT Interval Monitoring Of special concern for QT monitoring is the administration of QT prolonging drugs to patients identified with risk factors for Torsade de Pointe. Females, older patients and patients with bradycardia, impaired left ventricular function (ischemia, left ventricular hypertrophy), hypokalemia and hypomagnesemia are in this increased risk category. ra ft op QT interval monitoring can assist in the detection of prolonged QT interval syndrome. The QT interval in an ECG lead is the time interval from the onset of the earliest deflection in the QRS complex to the end of the T wave. For patients being monitored by the MX40, the Information Center measures the QT interval once every minute during startup, during the learning phase and on lead mode change. After that the Information Center updates the QT values every five minutes. The QT interval has an inverse relationship to heart rate. Faster heart rates shorten the QT interval and slower heart rates prolong the QT interval. To correct the QT interval for heart rate the Information Center uses the Bazett correction formula by default. Your system, however, may be set up to use the Fridericia correction formula as an alternative. The heart rate corrected QT interval is abbreviated as QTc. Note — When operating with the IntelliVue Information Center Release N or earlier, QT Data is not displayed at the MX40 6-42 ECG and Arrhythmia Monitoring QT Interval Monitoring Intended Use The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements. Additional information regarding QT monitoring can be found in the QT Interval Monitoring Application Note, Part Number 452296278601. Warning op The device provides QT and QTc interval change information; the clinical significance of the QT and QTc interval change information should be determined by a clinician. ft How the QT Analysis Algorithm Works ra The Information Center measures the QT values once every minute during startup. Subsequently, the Information Center updates the QT values every five minutes. Normal or atrial paced beats and beats with a similar morphology are averaged to form a representative waveform for further processing. Normal beats followed by a premature QRS will be excluded from the measurements to prevent the premature beat from obscuring the end of the T-wave. If the algorithm cannot form a representative waveform, for example because the morphology of the beats is too varied, the Information Center generates a Cannot Analyze QT INOP when it detects two consecutive invalid 5 minute values. This is also the case if normal beats have been falsely labeled so that the algorithm does not have enough valid beats to make QT measurements. No QT value is calculated if the QT-HR is >150 bpm (Adult) or >180 bpm (Pediatric). Because of the different algorithm approaches, a QT/QTc measurement from a diagnostic 12-lead program may differ from the realtime measurement. For QT interval monitoring to be effective, basic or enhanced arrhythmia monitoring must be on. ECG and Arrhythmia Monitoring 6-43 QT Interval Monitoring Adjusting QT Settings For patients being monitored by the MX40, you can turn QT Monitoring on/off and adjust QT settings at the IntelliVue Information Center. To turn QT Monitoring on/off at the IntelliVue Information Center Release N: From the Patient Window, click the All Controls button. From the All Controls Window, click the QT Setup button. From QT Setup, click the QT Analysis On checkbox. op QT analysis is on when a checkmark displays in the check box. When the QT measurement is on, a QT status message is displayed in the QT Setup window, along with the current values for QT, QTc, dQTc and QT-HR. The lead labels indicating the leads used to calculate the baseline and current values also appear. ft To turn QT Monitoring on/off at the IntelliVue Information Center iX: Select the Measurements button from the Main Setup Window. From the Measurements Window, select QT. Click the I/O QT Analysis button to toggle on or off as appropriate. ra The table below provides descriptions for each of the QT measurement descriptions. Measurement Definition QT QT interval in milliseconds. The QT interval is the time between the beginning of the Q-wave and the end of the Twave. QTc QTc represents the heart rate corrected QT interval. By default, the Information Center uses the Bazett correction formula to correct the QT interval for heart rate. Your system, however, may be set up to use the Fridericia correction formula. dQTc The difference between the current QTc value and the QTc baseline value. QT-HR The heart rate used to calculate QTc Note—Turning QT analysis off does not clear the baseline value. This allows you to turn QT analysis off during prolonged arrhythmias, such as bigeminy, without losing the baseline. 6-44 ECG and Arrhythmia Monitoring QT Interval Monitoring Limitations for QT Monitoring Some conditions may make it difficult to achieve reliable QT monitoring. When this occurs the CANNOT ANALYZE QT INOP message displays at the Information Center, along with a QT STATUS message. Some conditions that may make reliable QT monitoring difficult include: T-Wave Detection Limitations. QRS Changes op Flat T-wave, atrial Fibrillation or atrial Flutter and prominent U-waves can make QT monitoring difficult. For these cases you should select All as the QT Lead on the QT window. The Information Center will use the lead or leads that have a T-wave with sufficient amplitude and can be detected. Alternatively select a single lead with a good T- wave amplitude and no visible flutter activity and without a predominant U-wave or P-wave. QRS changes such as widened QRS can affect QT monitoring. If a long QTc is observed verify that is not caused by QRS widening. Rhythm and Rate Limitations ra ft Rhythm and rate limitations such as high heart rate (> 150 beats/min for adults patients or > 180 beats/min for pediatric or neonatal patients), paced rhythm and bigeminy rhythm can make reliable QT monitoring difficult. If rhythm is sustained you may want to consider turning QT interval monitoring off. ECG and Arrhythmia Monitoring 6-45 D ra ft op QT Interval Monitoring 6-46 ECG and Arrhythmia Monitoring 7. Monitoring Pulse Rate This section provides an introduction to the Pulse measurement and its application. Pulse Rate Measurement .......................................................................... 7-2 ra ft op Displaying the Pulse Rate Measurement at the MX40 ......................... 7-3 Monitoring Pulse Rate 7-1 Pulse Rate Measurement Pulse Rate Measurement The pulse rate measurement counts the arterial pulsations that result from the mechanical activity of the heart in beats per minute (bpm). The pulse rate is derived from the SpO2 measurement. Displayed results can range from 30 to 300 bpm. There is no alarm function for pulse rate. ra ft op The pulse numeric is displayed at the Information Center only when SpO2 is being measured continuously. Manual measurements are displayed at the MX40 with a time stamp. There are no alarms associated with the pulse measurement. Pulse is turned on in the Telemetry Setup window at the IntelliVue Information Center Release N or earlier and using the Measurements/SpO2 page at the IntelliVue Information Center iX. 7-2 Monitoring Pulse Rate Displaying the Pulse Rate Measurement at the MX40 Displaying the Pulse Rate Measurement at the MX40 To display the pulse rate measurement at the MX40: If not already selected, press the Main Screen button and select the 1 waveform with 4 numerics display. If pulse is not already displayed, touch a numeric. Select Change Numeric. Select Pulse. ra ft op Monitoring Pulse Rate 7-3 D ra ft op Displaying the Pulse Rate Measurement at the MX40 7-4 Monitoring Pulse Rate 8. Monitoring Respiration Rate (Resp) This section provides an introduction to the Respiration Rate measurement and its application. Note — Resp is only available with theIntelliVue Information Center iX. op Respiration Rate Measurement ............................................................... 8-2 Resp Safety Information ........................................................................... 8-3 Lead Placement for Monitoring Resp ..................................................... 8-4 ra ft Displaying Resp on the MX40 ................................................................. 8-5 Monitoring Respiration Rate (Resp) 8-1 Respiration Rate Measurement Respiration Rate Measurement For the respiratory measurement (Resp), the MX40 measures the thoracic impedance between two ECG electrodes on the patient's chest. Changes in the impedance due to thoracic movement produce the Resp waveform on the display. The MX40 counts the waveform cycles to calculate the respiration rate (RR).The waveform size can be set using the Setup Resp menu which is displayed when you touch the Resp measurement area. Settings for Resp On/Off, alarms, alarm limits and apnea time are defined at the Information Center. When the ECG measurement is turned off, the Resp measurement is also turned off. ra ft op Note — The Resp measurement is not available when the MX40 is wirelessly connected to MP5T, MP2, or X2 patient monitors. When not connected wirelessly to a monitor and Resp is being measured, the message SRR Unavail w/ Resp is displayed on the MX40. 8-2 Monitoring Respiration Rate (Resp) Resp Safety Information Resp Safety Information Warning Apnea The respiration measurement does not recognize obstructive and mixed apneas. It only indicates an alarm when a pre-adjusted time has elapsed since the last detected breath. Resp Accessories To monitor respiration, use only non-OR ECG accessories as listed in the Accessories Appendix. ra ft op Rate Adaptive Pacemakers Implanted pacemakers which can adapt to the Minute Ventilation rate may occasionally react on the Impedance measurement used by devices for the determination of the Resp value and execute pacing with the maximum programmed rate. Turning off the Resp measurement can prevent this. Monitoring Respiration Rate (Resp) 8-3 Lead Placement for Monitoring Resp Lead Placement for Monitoring Resp Correct patient skin preparation techniques for electrode placement are important for Resp measurement. See Connecting and Positioning ECG Electrodes p. 6-6. The Resp measurement uses the standard MX40 patient cable. You can use 3-wire, 5-wire, or 6-wire leadsets, using either Standard or EASI placement. Optimizing Lead Placement for Resp Cardiac Overlay op If you want to measure Resp and you are already measuring ECG, you may need to optimize placement of the two electrodes between which Resp will be measured. Repositioning ECG electrodes from standard positions, especially when you are using EASI placement, results in changes in the ECG waveform and may influence ST and arrhythmia interpretation. ft Cardiac activity that affects the Resp waveform is called cardiac overlay. Cardiac overlay happens when the Resp electrodes pick up impedance changes caused by the rhythmic blood flow. Correct electrode placement can help to reduce cardiac overlay. Avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes. ra Abdominal Breathing Some patients with restricted chest movement breathe mainly abdominally. In these cases, you may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory wave. 8-4 Monitoring Respiration Rate (Resp) Displaying Resp on the MX40 Displaying Resp on the MX40 To display the Resp waveform and/or numeric: At the IntelliVue Information Center iX, select the Measurements button from the Main Window. From the Measurements Window, select Resp. Click the I/O Resp button to toggle on or off as appropriate. At the MX40, select a waveform area to display the Resp waveform. The Change Wave menu is displayed. From the Change Wave menu, select Resp. Select any measurement numeric to change to display the Resp numeric. Select Change Numeric (it may be necessary to scroll down). op From the Change Numeric menu, select Resp. ra ft Note — The Change Wave menu is also used to adjust the Resp waveform size at the MX40 and at the IntelliVue Information Center iX.) Monitoring Respiration Rate (Resp) 8-5 D ra ft op Displaying Resp on the MX40 8-6 Monitoring Respiration Rate (Resp) 9. SpO2 Monitoring This section provides an introduction to the SpO2 measurement and its application. SpO2 Safety Information ........................................................................... 9-2 ra ft op Pulse Oximetry Measurement ................................................................. 9-5 SpO2 Monitoring 9-1 SpO2 Safety Information SpO2 Safety Information Warnings Always confirm monitor observations with clinical observation of the patient before administering interventions. op Prolonged, continuous monitoring can increase the risk of changes in skin characteristics, such as irritation, reddening, blistering or pressure necrosis, particularly on patients with impaired perfusion and varying or immature skin morphology. Specific attention must be given to sensor site inspection for changes in skin quality, proper optical path alignment and attachment. Check the application site at regular intervals and change the site if any compromise in skin quality should occur. More frequent checking can be required due to an individual patient's condition. Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin can lead to inaccurate (over-estimated) measurements. ft Interference leading to inaccurate measurements can be caused by: High levels of ambient light (Hint: cover application site with opaque material) Electromagnetic interference ra Excessive patient movement and vibration. This equipment is not suitable for use in the presence of a flammable anesthetic mixture or oxygen concentrations greater than 25% (or partial pressures greater than 27,5 kPa /206.27 mmHg). Disposable SpO2 sensors can be damaged and lead to patient harm if they become wet. Wet sensors must be replaced immediately. To avoid venous pulsation, obstructed circulation, pressure marks, pressure necrosis, artifacts and inaccurate measurements, make sure that the sensor is not too tight. If the sensor is too tight, because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxia and tissue malnutrition. Inspect the sensor application site every 2 to 3 hours to ensure skin integrity, correct optical alignment, and circulation distal to the sensor site. Move the sensor application site every four hours, or more often if circulation or skin integrity is compromised. 9-2 SpO2 Monitoring SpO2 Safety Information At elevated ambient temperatures, be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41o C on the skin if the initial skin temperature does not exceed 37o C. Avoid placing the sensor on extremities with an arterial catheter or intravascular venous infusion line. Sensors connected to the MX40 but not applied to the patient, can produce an error measurement. To avoid misdiagnosis, ensure the sensor is properly applied to the patient. Cautions op If you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 INOP (SpO2T NO PULSE) can occur. If the monitor is configured to suppress this alarm, there may be a delay of up to 60 seconds in indicating critical patient status, such as sudden pulse loss or hypoxia. ft Do not use OxiCliq disposable sensors in a high humidity environment, such as an incubator, or in the presence of fluids, which may contaminate sensor and electrical connections causing unreliable or intermittent measurements. Do not use disposable sensors on patients who have allergic reactions to the adhesive. ra When the MX40 is connected to a patient monitor using the MX40 / IntelliVue Patient Monitor Adapter Cable, (p/n 989803172211), the SpO2 sensor must be directly connected to the patient monitor to monitor SpO2. Do not use more than one extension cable (M1941A). See Appendix A, Accessories, for information on which sensors cannot be used with an extension cable. Position the sensor cable away from power cables to avoid electrical interference. SpO2 Information for the User The pulse oximeter is calibrated to indicate functional oxygen saturation (fractional oxyhemoglobin), and displayed results can range from 0 to 100%. SpO2 Monitoring 9-3 SpO2 Safety Information A 10 second averaging filter is used in the calculation of the result. Displayed results are typically updated every second, but the update period can be automatically delayed by up to 30 seconds in the presence of noise. Note — The averaging filter time period is configurable at the IntelliVue Information Center iX (default = 10 seconds). op Physiological SpO2 alarm signals will be generated. For adult patients, the SpO2 low limit can be set between 50 and 99% inclusive, in 1% increments, and the SpO2 high alarm limit can be set between 51 and 100% inclusive, in 1% increments. For pediatric patients, the SpO2 low limit can be set between 30 and 99% inclusive, in 1% increments, and the high alarm limit can be set between 31 and 100% inclusive, in 1% increments. The maximum delay between the physiological alarm condition and alarm signal generation is 25 seconds. Pulse rate is also derived from the pulsatile SpO2 measurement, and displayed results can range from 30 to 300 bpm. There is no alarm function for pulse rate. ra ft The pleth wave is auto-scaled to maximum display size. It decreases only when the signal quality becomes marginal. Pleth wave size is NOT directly proportional to the pulse volume. 9-4 SpO2 Monitoring Pulse Oximetry Measurement Pulse Oximetry Measurement The MX40 supports an SpO2 sensor connection using Fourier Artifact Suppression Technology (FAST). The FAST algorithm overcomes many of the issues associated with traditional pulse oximetry such as sensitivity to patient movement and intense ambient light. The algorithm offers improved motion artifact rejection as well as performance improvements for patients with low perfusion. SpO2 can be measured continuously, where a value is sent to the Information Center every second, or as a single, individual Manual measurement. The Manual measurement will be removed from the Information Center display after 1 hour. op The SpO2 parameter measures the arterial oxygen saturation, that is, the percentage of oxygenated hemoglobin in relation to the total hemoglobin. ft If, for example, a total of 97% of the hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has an oxygen saturation of 97%. The SpO2 numeric that appears on the monitor will read 97%. The SpO2 numeric indicates the percentage of hemoglobin molecules which have combined with oxygen molecules to form oxyhemoglobin. ra The oxygen saturation is measured using the pulse oximetry method. This is a noninvasive method of measuring the arterial hemoglobin oxygen saturation. It measures how much light, sent from light sources on one side of the sensor, travels through patient tissue (such as a finger or an ear), to a receiver on the other side of the sensor. The amount of light passing through depends on many factors, most of which are constant, such as tissue or venous blood. However one of the factors, the blood flow in the arterioles, varies with time because it is pulsatile. This measurement principle is used to derive the SpO2 measurement. The numeric that is displayed is the oxygen saturation of the arterial blood - the measurement of light absorption during a pulsation. Correct placement of the sensor is essential for accurate measurements. Note—Because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oximeter equipment measurements can be expected to fall with ± Arms of the value measured by a CO-oximeter. SpO2 Monitoring 9-5 Pulse Oximetry Measurement SpO2 Sensors Familiarize yourself with the instructions for use supplied with your sensor before using it. In particular, check that the sensor being used is appropriate for your patient category and application site. See Appendix A, Accessories, for a complete listing of supported sensors for the MX40. Selecting an SpO2 Sensor Warning op Use only Philips-approved accessories. Use of product accessories (patient cables, SpO2 sensors, etc.) other than those specified in this manual may lead to patient injury or result in increased electromagnetic emissions or decreased immunity of the product. Reuse: Never reuse disposable sensors, accessories and so forth that are intended for single use, or single patient use only. Packaging: Do not use a sterilized accessory if the packaging is damaged. ft Do not use disposable sensors on patients who exhibit allergic reactions to the adhesive. ra When the specified Nellcor® sensors are used, the application must be consistent with the sensor manufacturer's own guidelines. Philips reusable sensors in adult, pediatric and infant (an alternative for use on adult patients only) models can be used, as well as Philips and Nellcor® disposable sensors. Caution Do not use OxiCliq disposable sensors in a high humidity environment, or in the presence of fluids. These can contaminate sensor and electrical connections, and thereby cause unreliable or intermittent measurements. The following table will help you in selecting the correct sensor type. 9-6 SpO2 Monitoring Pulse Oximetry Measurement Sensor Type When to Use Reusable You can use reusable sensors on different patients after cleaning and disinfecting them. For care and cleaning instructions, see the instructions accompanying the sensors. Reusable sensors should be changed to another site every four hours or in accordance with your clinical practice guidelines. See the Directions for Use supplied by Nellcor® Incorporated for instructions on preparation and application of reusable sensors. Disposable Use disposable sensors only once and then discard. However, you can relocate them to a different patient-site if the first location does not give the desired results. Do not reuse disposable sensors on different patients. op Note — See the Instructions for Use supplied ft by Nellcor® Incorporated for instructions on preparation and application of disposable sensors. Sensor Application Safety Information Warning ra Failure to apply a sensor properly can reduce the accuracy of the SpO2 measurement. Loose/Tight sensor: If a sensor is too loose, it can compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure can be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxia and tissue malnutrition. Skin irritations or ulcerations can occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and ulcerations, inspect the sensor application site every 2-3 hours, and change the application site at least every 4 hours or according to clinical practice guidelines. Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation, which can severely obstruct circulation and lead to inaccurate measurements. SpO2 Monitoring 9-7 Pulse Oximetry Measurement Ambient Temperature: Never apply an SpO2 sensor at ambient temperatures above 37 oC (99 oF) because this can cause severe burns after prolonged application. Extremities to Avoid: Avoid sites distal to NBP cuff, intra-arterial line, or intravascular venous infusion line. Applying the Sensor Follow the SpO2 sensor's Instructions for Use, adhering to all warnings and cautions. If necessary, remove colored nail polish from the application site. Apply the sensor to the patient. The application site should match the sensor size so that the sensor can neither fall off, nor apply excessive pressure. Check that the light emitter and the photodetector are directly opposite each other. All light from the emitter must pass through the patient's tissue. ft op Connecting SpO2 Cables ra The sensor cable is either directly connected to the blue SpO2 connector on the MX40 patient cable or is connected to an adapter cable that is then connected to the MX40 SpO2 connector. Tone Modulation Indication The pulse signal tone is controlled by the setting in the SpO2 Tone Modulation menu. Note — Tone Modulation Indication is only available when operating in Continuous mode. It is not available when operating in Manual or Auto mode. Signal Quality Indicator The SpO2 numeric is displayed together with a signal quality indicator which gives an indication of the reliability of the current values. The level to which the triangle is filled shows the quality of the signal. The signal quality is at a maximum when the triangle is completely filled. 9-8 SpO2 Monitoring Pulse Oximetry Measurement Measuring SpO2 Warning Removal of the SpO2 sensor from the MX40 patient cable during Continuous SpO2 monitoring results in a "No Sensor" technical alarm. Silencing this alarm turns the SpO2 measurement off, however the SpO2 module is still operating in the background and consuming battery power. If you do not intend to resume continuous SpO2 monitoring, change to Manual mode. There is no technical alarm for a "No Sensor" condition in Manual mode. op If you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 technical alarm can occur. If the monitor is configured to suppress this alarm, there can be a delay of up to 60 seconds in indicating critical patient status, such as hypoxia. ra ft SpO2 measurements can be made manually on an as-needed basis in Manual mode, continuously in Continuous mode, or automatically in Auto mode (IntelliVue Information Center iX only), depending on your MX40 configuration. While operating in Continuous mode, you can also measure pulse, and display the pleth wave on the MX40 and at the Information Center. The SpO2 parameter is turned on/off at the MX40 or by a control from the Information Center. SpO2 monitoring consumes considerable electrical energy. The battery power must be at least 10% full in order to make SpO2 measurements. To resume the SpO2 measurement after it has been turned off, touch the blank measurement area and select SpO2 to turn it back on. Note — Before disabling SpO2 at the Information Center, acknowledge any active alarms at the MX40. Setting the SpO2 mode can be done at the Information Center or at the MX40. To select the measurement mode at the MX40: In SpO2 Setup, select Mode. Select Continuous, Manual or Auto mode. SpO2 Monitoring 9-9 Pulse Oximetry Measurement Understanding SpO2 Alarms SpO2 monitoring offers high and low limit alarms, and a high priority (red level) oxygen desaturation alarm. For adult patients, the SpO2 low limit can be set between 50 and 99% inclusive, in 1% increments. For pediatric patients, the SpO2 low limit can be set between 30 and 99% inclusive, in 1% increments. You cannot set the low limit below the desaturation limit. The SpO2 high alarm limit can be set between 51 and 100% inclusive, in 1% increments for adult patients and set for pediatric patients between 31 and 100% inclusive, in 1% increments. op The delay between the physiologic alarm condition and alarm annunciation at the MX40 is <16 seconds. This means that the MX40 will generate an alarm if the averaged numeric value on the display exists beyond the alarm limit for more than a maximum of 16 seconds. Setting the high SpO2 alarm limit to 100% is equivalent to switching off the high alarm. Therefore the upper alarm limit for oxygen saturation must be carefully selected in accordance with accepted clinical practices. ra ft The default setting for SpO2 yellow alarms is latched. That is, when an SpO2 limit is exceeded, you will need to acknowledge it at the Information Center. The sound will be silenced but the message will remain on the display until the condition is resolved. 9-10 SpO2 Monitoring 10. Monitoring with other Assigned Devices This section provides information about the use of the MX40 when it is assigned to other monitoring devices. The MX40 can be assigned to IntelliVue Patient Monitors or IntelliVue Cableless Measurements for SpO2 and NBP. The connection to these other devices is done by pairing networked devices or using the integrated short-range radio of the MX40. Warning op For additional information on IntelliVue Patient Monitor or IntelliVue Cableless Measurements operation, consult the Instructions for Use that accompanied the device. ft Assignment of the MX40 to IntelliVue Patient Monitors is only supported when the patient monitor (MP5,MP5T,MP5SC, MP2 or X2 only) is equipped with a short-range radio. Monitors that have this equipment will display the short-range radio symbol on the label. ra Caution When the MX40 is connected to a patient monitor using the MX40 / IntelliVue Patient Monitor Adapter Cable, (p/n 989803172211), the SpO2 sensor must be directly connected to the patient monitor to monitor SpO2. Note — Assignment of the MX40 to IntelliVue Patient Monitors is not available with patient monitors connected to the M3140 Information Center. Note — The MP5T and MP5SC are non-networked devices as they does not support a connection to the Information Center. Monitoring with other Assigned Devices 10-1 Pulse Oximetry Measurement Assigning Devices ...................................................................................10-3 Controls Available when Assigned to IntelliVue Cableless Measurements ..........................................................................................10-6 Controls Available when Assigned to IntelliVue Patient Monitors .10-7 Networked Device Synchronized Settings...........................................10-8 ra ft op MX40 Display when Wirelessly Connected to a Patient Monitor ....10-9 10-2 Monitoring with other Assigned Devices Assigning Devices Assigning Devices Device Assignment at the Information Center You can assign an MX40 to a patient monitor at the Information Center. The data from the MX40 automatically displays as a permanent overview session in the Telemetry Data window on the patient monitor. At the Information Center the MX40 data and the patient monitor data are integrated in the patient sector. Warning op All data presented in the Telemetry Data window are delayed for several seconds. If you need realtime data, e.g. for defibrillation, always use the ECG from the patient monitor. Device Assignment at the MX40 ft To assign an MX40 to an IntelliVue Cableless Measurement device: Press the SmartKey button. Press the Add/Remove SmartKey. From the Add to menu, select the desired device and press Confirm. ra The MX40 will attempt to complete the assignment for a 2-minute period. If assignment fails or the MX40 is no longer in range of the other device, the short-range radio turns off to save battery power. Repeat the procedure above to retry or resume the assignment. You may also need to restart the short-range radio at the cableless measurement device if it has entered its power save mode. Touch and hold the left button on the device to restart the short-range radio. To assign an MX40 to an IntelliVue Patient Monitor: Press the SmartKey button. Press the Add/Remove SmartKey. The measurement selection key on the monitor will change to show the "add cableless" icon In the Add Cableless menu, select the correct equipment label for the device. Monitoring with other Assigned Devices 10-3 Assigning Devices When connected the or earlier. icon appears at the Information Center, Release N The MX40 is assigned to the monitor. A "Tele Device Assigned" message appears on the monitor. If the ECG wave now appears on the monitor, the signal from the MX40 is successfully transmitting to the monitor. To confirm that the correct MX40 has been assigned, open the ECG Setup menu by touching the ECG waveform or HR numeric. The title of the menu contains the equipment label of the MX40. Check that this is the correct label. op When assigned to the monitor, the display of the MX40 appears as shown below: The display is primarily inactive, and there is no viewable patient data displayed, however, battery status information is available. ft If a monitor is already paired to another device, you cannot assign an MX40 to that monitor. ra If the MX40 goes out-of-range or loses the short-range radio connection, it will switch over to standard telemetry transmission to the Information Center. In this case, the telemetry data is displayed in the Telemetry Data Window. If the devices are unassigned, the short-range radio connection is ended To remove an assigned device from the MX40: Press the SmartKey button. Press the Add/Remove SmartKey. From the Remove from menu, select the desired device and press Confirm. Device Assignment at the Patient Monitor At the patient monitor, you can assign an MX40 to the patient monitor using the Telemetry menu on the patient monitor. 10-4 Monitoring with other Assigned Devices Assigning Devices ra ft op When the devices are networked, all data is sent to the Information Center. When non-networked, only the additional parameters measured at the patient monitor (NBP, SpO2, and predictive temperature) are sent to the Information Center. The Telemetry Data window is not displayed when devices are non-networked. Monitoring with other Assigned Devices 10-5 Controls Available when Assigned to IntelliVue Cableless Measurements Controls Available when Assigned to IntelliVue Cableless Measurements Action At the MX40 At the Cableless Measurement Device At the IIC At the IIC iX Start SpO2 Yes Yes Yes Yes Change SpO2 Mode Yes Yes Yes Yes Select SpO2 Repetition Time No Yes No Yes Assign SpO2 Pod Yes Yes No No Remove SpO2 Pod Yes Yes Yes No Change Alarm Limits No No Yes Yes Place Device in Standby No No No No Alarm Silence Yes (local only) No Yes Yes ft Alarm Off/Pause Yes (if enabled) No Yes Yes Yes Yes Yes Yes Yes Yes No No Change NBP Repetition Time No Yes No No Change Alarm Limits No No Yes Yes Assign NBP Pod Yes Yes No No Remove NBP Pod Yes Yes Yes No Place Device in Standby No No No No Alarm Silence Yes (local only) No Yes Yes Alarm Off/Pause Yes (if enabled) No Yes Yes NBP Start/Stop/Stat NBP ra Change NBP Mode 10-6 op SpO2 Monitoring with other Assigned Devices Controls Available when Assigned to IntelliVue Patient Monitors Controls Available when Assigned to IntelliVue Patient Monitors Action At the MX40 (N/A) At the Patient Monitor At the IIC At the IIC iX Start SpO2 Yes Yes Yes Change SpO2 Mode Yes Yes Yes Select SpO2 Repetition Time Yes No Yes Assign SpO2 Pod Yes No No Remove SpO2 Pod Yes Yes No Yes Yes Yes No No Yes Yes Yes Yes Yes No Yes Change Alarm Limits Place Device in Standby Alarm Silence NBP ft Alarm Off/Pause op SpO2 Yes Yes Yes Change NBP Mode Yes No No Change NBP Repetition Time Yes No Yes Change Alarm Limits Yes Yes Yes Assign NBP Pod Yes No No Remove NBP Pod Yes Yes No Place Device in Standby No No Yes Alarm Silence Yes Yes Yes Alarm Off/Pause Yes No Yes ra Start/Stop/Stat NBP Monitoring with other Assigned Devices 10-7 Networked Device Synchronized Settings Networked Device Synchronized Settings If the patient’s ECG is initially being measured with a patient monitor, and then the patient is connected to the MX40 for monitoring, the Information Center will use the patient monitor settings for the MX40. When the initial ECG source is the MX40, and then the patient is connected to the monitor, the Information Center uses its Telemetry Setup settings. The following settings will be synchronized: HR/Pulse Alarm On/Off, Heart Rate High/Low Limit ECG Primary Lead, Secondary Lead, Va Lead, Vb Lead Arrhythmia On/Unlocked, On/Locked, Off/Unlocked, Off/Locked, Off/Not Available, Analysis Mode, Asystole Threshold, Pause Threshold, VTach HR, VTach Run, PVCs/min, Vent. Rhythm, SVT HR, SVT Run, PVCs/min On/Off, Pacer not Capture On/Off, Pacer not Pace On/Off, Non-sustain On/Off, Vent. Rhythm On/Off, Run PVCs On/Off, Pair PVCs On/Off, Missed Beat On/Off, Pause On/Off, R-on-T On/Off, Vent. Bigeminy On/Off, Vent. Trigeminy On/Off, Multiform PVCs On/Off, Irregular HR On/Off, SVT On/Off, Afib On/Off, End Afib Time, Afib Remind Time ft op Heart Rate ST Analysis On/Off, ST Alarm On/Off, ISO point, J point, ST point, ST Priority List, Single ST Alarm Limit, Multi ST Alarm Limit, ST Auto/Manual STE STE Analysis On/Off, STE Alarm On/Off ra ST 10-8 QT QT Analysis On/Off, QTc High On/Off, QTc High Alarm Limit, dQTc High On/Off, dQTc High Alarm Limit, QT Lead, QTc Correction Formula, QT Baseline SpO2T SpO2 Alarms On/Off, SpO2 Alarm Limits, NBP Alarm Suppression On/Off, Pulse (SpO2) On/Off, Desat Limit, SpO2 Averaging Time Monitoring with other Assigned Devices MX40 Display when Wirelessly Connected to a Patient Monitor MX40 Display when Wirelessly Connected to a Patient Monitor ra ft op When the MX40 is wirelessly connected to a patient monitor via the short-range radio, its display is primarily inactive. There is no viewable patient data on the display, however, battery status information is available if the display is turned on. Monitoring with other Assigned Devices 10-9 D ra ft op MX40 Display when Wirelessly Connected to a Patient Monitor 10-10 Monitoring with other Assigned Devices 11. Monitoring with the MX40 at the Information Center op This section describes the behavior of the MX40 as it relates to what is displayed at the Information Center. What is displayed depends on which version of the Information Center is in use, IntelliVue Information Center Release N or earlier (referred to here as IIC), or IntelliVue Information Center iX (referred here to as IIC iX). MX40 Connection to the Information Center ...................................... 11-2 MX40 Controls in the Patient Window (IIC) ....................................... 11-3 MX40 Controls in the Patient Window (IIC iX) .................................. 11-5 Locating the MX40 (Find Device) .......................................................... 11-7 ft Viewing Device Location and Location History (optional)............... 11-8 Using the Device Location Client (optional - IIC only) ...................... 11-9 Patient Configurable Settings in Telemetry Setup ............................ 11-10 ra Unit Configurable Settings ................................................................... 11-13 Monitoring with the MX40 at the Information Center 11-1 MX40 Connection to the Information Center MX40 Connection to the Information Center Once the MX40 has been assigned to a sector at the Information Center, the settings (alarms, arrhythmia and configured Unit settings) are synchronized with the MX40. You may see a "Settings sync'd" message in the Status Area on connection, re-connection, and anytime the settings are updated at the Information Center. Arrhythmia Learning/Relearn occurs on connection and re-connection to the IIC. Warning op Since Relearn happens automatically at the IIC, if learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib. For this reason, you should: Respond promptly to any technical alarm. Ensure that the arrhythmia algorithm is labeling beats correctly. ft Upon loss of connection to the Information Center the MX40: turns on its display displays the "NO CENTRAL MONIT" INOP uses the last known settings from the Information Center. ra new physiological alarms are announced locally only. Active alarms that occurred prior to the loss of connection can be viewed in the Alarm List. When a loss of battery power occurs while not connected to the Information Center, the MX40 retains the last known alarm limits and vitals trends data but this is not sent to the Information Center at re-connection. Patient name is restored at re-connection. When operating wirelessly via a Short-range Radio connection to an IntelliVue Patient Monitor, changes made to patient name are updated at the Information Center and the patient monitor, however, they are not reflected in the Patient Information Area on the MX40. The update occurs when network connection is restored. 11-2 Monitoring with the MX40 at the Information Center MX40 Controls in the Patient Window (IIC) MX40 Controls in the Patient Window (IIC) The Patient Window at the Information Center (accessed from the Patient Window control in the Patient Sector) includes controls for a number of MX40 operations. For detailed instructions on these operations, see the IntelliVue Information Center Instructions for Use or the Online Help. To View ECG or SpO2 Alarm Limits Move the cursor over the HR or SpO2 label to display the current high and low alarm limits. To Change ECG or SpO2 Alarm Limits Move the cursor over the High or Low numeric to display up/down arrow controls for adjusting the limit. After adjusting the limit, move the cursor away from the area to dismiss the limit controls. op To Change ECG Waveform Size Move the cursor over the ECG waveform to display the ECG Waveform Size control. Select the desired size from the list. ft ra To Select Lead Move the cursor over the ECG waveform to display the Lead Selection control. Select the desired lead from the list. Important — Do not set the primary and secondary channels to the same lead. To Change Va and Vb Default Lead Settings (6-lead only) Move the cursor over the ECG waveform to display the Lead Selection popup. Select the label from the label list. For Va or Vb, select Va or Vb, then select the lead to be assigned. Assignment of the same V lead to both Va and Vb is not allowed. Monitoring with the MX40 at the Information Center 11-3 MX40 Controls in the Patient Window (IIC) Important — Do not set the primary and secondary channels to the same lead. To Initiate a Spot Check (Manual) Spo2 Measurement Move the cursor over the SpO2 label. Click on the Spot Check (Manual) icon. op ra ft 11-4 Monitoring with the MX40 at the Information Center MX40 Controls in the Patient Window (IIC iX) MX40 Controls in the Patient Window (IIC iX) The Patient Window at the Information Center iX includes controls for a number of MX40 operations. For detailed instructions on these operations, see the IntelliVue Information Center iX Instructions for Use or the Online Help. To View ECG, Resp, NBP or SpO2 Alarm Limits Click on the HR or SpO2 label in the Patient Window to display the current high and low alarm limits. To Change ECG, Resp, NBP or SpO2 Alarm Limits Click on the HR or SpO2 label in the Patient Window. Click on High Limit or Low Limit and select the new value from the list. op To Change Paced Status Click on the HR label in the Patient Window. Click on Paced Mode. Click on Off or On to select the status. ft Warning ra At admission/discharge, always check that paced status is correct for the patient. To Change ECG Waveform Size Click on the appropriate waveform. Select Size Up or Size Down. To Select Lead Click the appropriate waveform. Select the desired lead label from the list. Important — Do not set the primary and secondary channels to the same lead. To Change Va and Vb Default Lead Settings (6-lead only) Click the Measurements Application button. Monitoring with the MX40 at the Information Center 11-5 MX40 Controls in the Patient Window (IIC iX) Select ECG from the menu on the left. Select Va or Vb from the ECG menu on the right and select from the list. To Initiate a Manual SpO2 Measurement Click the Measurements Application button. Select SpO2 from the menu on the left. Select Start from the SpO2 menu on the right. ra ft op 11-6 Monitoring with the MX40 at the Information Center Locating the MX40 (Find Device) Locating the MX40 (Find Device) The Find Device feature enables you to generate an alternating pitch repeated tone at the MX40 to assist in locating a missing device. Find Device requires that the MX40 has sufficient battery power and is within the coverage area. To locate an MX40 (IIC): From the Patient Window, select Telemetry Setup. Select Find Device to generate a repeated tone at the MX40. To silence this tone, touch the silence key on the MX40. op To locate an MX40 (IIC iX): Click the Measurements application button. Select Telemetry Setup. Select Find. ra ft To silence this tone, touch the silence key on the MX40. Monitoring with the MX40 at the Information Center 11-7 Viewing Device Location and Location History (optional) Viewing Device Location and Location History (optional) MX40 Device Location information is identified in the Patient Window by a compass icon followed by the location name of the access point that the MX40 is currently connected to. If the location of the device changes, the Patient Window is updated within 5 seconds of the location change. Location History (IIC) Location History (IIC iX) op You can view the location history for a particular MX40 in the Device Location History field in the Telemetry Setup window. The field displays the five most recent Device Location descriptions in ascending order. The total timespan of the log is 60 minutes. Warning ft You can view the location history for a particular MX40 by clicking on the compass icon in the Patient Window. The location and time-stamped history is displayed for each equipment label. ra Because the coverage range of Access Points can sometimes overlap, including different floor levels, the IntelliVue Device Location feature is not intended for use when attempting to locate a patient. Note — If there is a change in location while viewing the history in the Telemetry Setup window, you must re-enter Telemetry Setup to see the change, as it does not update automatically. Note — The IntelliVue Device Location feature is not supported for use with the MX40 WLAN device, Part Number 865352. 11-8 Monitoring with the MX40 at the Information Center Using the Device Location Client (optional - IIC only) Using the Device Location Client (optional - IIC only) The Device Location Client application is an optional software application that allows you to display and locate devices visually, using Floor Plans associated with your hospital’s layout. Device location history is also available. The application is accessible using a separate PC’s web browser. For additional installation information, see the IntelliVue Device Location Installation Guide. Warning op Because the coverage range of Access Points can sometimes overlap, including different floor levels, the IntelliVue Device Location feature is not intended for use when attempting to locate a patient. Displaying and Locating Devices ft The left side of the Client display screen contains a list of clinical units associated with the current Floor Plan. Each unit contains a list of bed labels. You view the beds listed within a unit by clicking on the plus sign next to the unit name. Note — The beds listed are only those equipped with traditional IntelliVue telemetry devices or the MX40. ra To identify and locate the device associated with the bed, simply click on the desired bed label. The floor plan and the status bar above the floor plan image now display the location of the device. Additionally, the status bar lists the Access Point the device is currently associated with. Viewing Device Location History The location history of a particular device is also available. Select a device from the Device List box and then click on the down arrow in the status bar. The last five known locations of the device are displayed. Monitoring with the MX40 at the Information Center 11-9 Patient Configurable Settings in Telemetry Setup Patient Configurable Settings in Telemetry Setup The Telemetry Setup window enables you to configure the MX40 for patient-specific settings. All patient-specific settings will be reset to the unit defaults upon patient discharge. To access the window, from the Patient Window click Telemetry Setup. ra ft op The following settings can be adjusted in this window: 11-10 Monitoring with the MX40 at the Information Center Patient Configurable Settings in Telemetry Setup Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Telemetry/ Multi-Function Button Determines the Information Center response when the Multi-Function Button is pressed. Nurse Call - generate nurse call alarm that can be retrieved from Alarm Review for later use. Factory Default Nurse Call Record - generate a recording strip Nurse Call and Record - generate nurse call alarm and recording strip None SpO2 Mode enable Enable/disable the SpO2 measurement at the Information Center and the MX40. enable Determine the MX40 SpO2 measurement behavior. Spot Check (Manual)- Provides manual measurements so the clinician can check as needed. Measurement can be initiated at the MX40 from the SmartKeys menu or the SpO2 Setup menu and at the Information Center by selecting the Spot Check SpO2 icon in the Patient Window. op SpO2 Enabled Sets the appearance of the pacer spikes to a fixed size as they appear in the patient window. Note — Pulse Rate ra and Pleth Wave are not available in Spot Check (Manual) mode. disable disable Note — this does not affect the appearance of the pacer spikes on the MX40. enable disable ft Fixed Pacer Amplitude Spot Check (Manual) Continuous - Sends an SpO2 parameter value to the Information Center every second. If selected, Pulse Rate and Pleth Wave may also be sent. Monitoring with the MX40 at the Information Center 11-11 Patient Configurable Settings in Telemetry Setup Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Factory Default Suppress SpO2 INOPs with NBP Enable/disable the SpO2 algorithm to suppress sending technical alarms from the MX40 during an NBP measurement for 60 seconds. enable enable disable Warning ft Enable/disable the transmission of the Pleth wave (and its subsequent display) to the Information Center. For Continuous SpO2 mode only. enable disable disable (Pleth is not displayed.) Note — When enabled, the Pleth wave replaces the Vb wave in the Patient Window during 6-lead monitoring. ra Pleth Wave op If you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 technical alarm can occur. If the monitor is configured to suppress this alarm, there can be a delay of up to 60 seconds in indicating critical patient status, such as sudden pulse loss or hypoxia. enable Enable/disable display of the Pulse rate at the disable Information Center. For Continuous SpO2 mode only. disable (Pulse rate is not displayed.) SpO2 Alarm enable (on) Turn SpO2 alarms on/off at the Information disable (off) Center and the MX40. enable Unit Settings Change current settings (none) back to last saved clinical unit settings. Pulse 11-12 Monitoring with the MX40 at the Information Center Unit Configurable Settings Unit Configurable Settings Unit Settings provide access to clinical configuration items that affect all patients on an Information Center. Changes in unit settings take effect upon discharge, except for Standby duration and SpO2 mode, which take effect immediately. ra ft op Access to unit settings requires a password, and the displays are in English. Telemetry specific settings are accessed through All Controls -> Unit Settings -> Telemetry Setup. The setting for telemetry non-arrhythmia yellow alarms and INOP severity is located in All Controls -> Unit Settings -> Alarms. For all other information on unit settings, see IntelliVue Information Center Instructions for Use. Monitoring with the MX40 at the Information Center 11-13 Unit Configurable Settings Unit Settings - Telemetry Setup Control Function Settings Factory Default Patient Type Set patient type used for SpO2 alarm limits. Adult Adult Determine the Information Center response when Telemetry Button is pressed. Nurse Call - generate nurse call alarm that can be retrieved from Alarm Review for later use. Telemetry/ Multi-Function Button Pediatric Nurse Call Record - generate a recording strip Both - generate nurse call alarm and recording strip Standby Duration op None Sets the standby duration on the MX40 when Standby is initiated from the Information Center. Infinite Note — When Standby 30 minutes Infinite 10 minutes 20 minutes ft is initiated from the MX40, 1 hour the duration is always 2 hours Infinite. 3 hours 4 hours Enable Remote Enable/disable alarm pause/suspend at the Suspend ra MX40. enable disable disable Suspend Duration Sets the alarm suspend duration time for each assigned device on the Information Center. 1, 2, or 3 minutes 2 minutes Battery Gauge on Information Center Display/disable a battery gauge for each assigned device on the Information Center. enable enable (battery gauge is displayed) disable Note — the battery gauge is always displayed on the MX40. 11-14 Monitoring with the MX40 at the Information Center Unit Configurable Settings Unit Settings - Telemetry Setup Control Function Settings RF Auto Shutoff Enable/disable RF operation during an extended situation of all leads off for more than 10 minutes and the SpO2 is not being measured continuously. enable Autopair Enable/disable the autopairing of the MX40 and the IntelliVue Patient Monitor at the Information Center. enable Enable Cableless Measurements Enable/disable the use of IntelliVue Cableless Measurements for SpO2 and NBP enable SRR Fast Transition Reduce the delay time when fast switching between the MX40 and the patient monitor. enable Sets the appearance of the pacer spikes at the Information Center to a fixed size as they appear in the patient window. enable Enable/disable the SpO2 measurement at the Information Center. enable Enable SpO2 enable (MX40 will shut off after 10 minutes of Leads Off condition and SpO2 is not being measured continuously. Reconnect the patient cable to resume monitoring.) enable op disable disable disable ft ra Fixed Pacer Amplitude disable Factory Default enable disable disable disable enable disable Monitoring with the MX40 at the Information Center 11-15 Unit Configurable Settings Unit Settings - Telemetry Setup Factory Default Control Function Settings SpO2 Mode Determine the MX40 SpO2 measurement behavior. Spot Check (Manual)Spot Check Provides manual (Manual) measurements so the clinician can check as needed. Measurement can be initiated from the SmartKeys menu, the SpO2 Setup menu or by selecting the Spot Check SpO2 icon in the Patient Window. Note — Pulse Rate and Pleth Wave are not available in Spot Check (Manual) mode. ft op Continuous - Sends an SpO2 parameter value to the Information Center every second. If selected, Pulse Rate and Pleth Wave may also be sent. Suppress SpO2 Enable/disable the SpO2 Inops with NBP algorithm to detect NBP disable ra running and suppress sending technical alarms from the MX40 for 60 seconds. enable Warning If you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 technical alarm can occur. If the monitor is configured to suppress this alarm, there can be a delay of up to 60 seconds in indicating critical patient status, such as sudden hypoxia. 11-16 Monitoring with the MX40 at the Information Center enable Unit Configurable Settings Unit Settings - Telemetry Setup Control Function Settings Pleth Wave Enable/disable the transmission of the Pleth wave and its subsequent display to the Information Center. For Continuous mode only. enable Enable/disable the transmission of the Pulse rate and its subsequent display to the Information Center. For Continuous mode only. enable Turn SpO2 alarms on/off at the Information Center. enable (on) SpO2 Limits High disable disable (Pulse rate is not displayed.) enable disable (off) Increment/decrement Limit maximum is 100. Limit SpO2 high alarm limit by 1 minimum is 51 (adult) or 31 (in %). (pediatric). High and low limit must be at least 1% apart. 100 (adult, pediatric) Increment/decrement SpO2 low alarm limit by 1 (in %). 90 (adult, pediatric) ra SpO2 Limits Low disable (Pleth wave is not displayed.) during 6-lead monitoring, the Pleth wave will replace the Vb wave in the Patient Window. op SpO2 Alarm Note — When enabled, ft Pulse disable Factory Default Limit maximum is 99. Limit minimum is 50 (adult) or 30 (pediatric). High and low limit must be at least 1% apart. Monitoring with the MX40 at the Information Center 11-17 Unit Configurable Settings Unit Settings - Default Leads Function Settings Factory Default 3-wire Set the unit default lead. I, II, III II 5-wire, ECG1 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, II 5-wire, ECG2 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, 5-wire, ECG3 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, III I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6 II 5-wire EASI, Set the unit default lead. ECG1 5-wire EASI, Set the unit default lead. ECG2 5-wire EASI, Set the unit default lead. ECG3 I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6 V2 I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6 III I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6 V5 ft 5-wire EASI, Set the unit default lead. ECG4 op Control Set the unit default lead V1, V2, V3, V4, V5, ,V6, V7, V8, V9, V3R, V4R, V5R V2 6-wire, Vb Set the unit default lead V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R V5 ra 6-wire, Va 6-wire, ECG1 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R II 6-wire, ECG2 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R V2; V lead choice is determined by Va and Vb settings 6-wire, ECG3 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R III 6-wire, ECG4 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R V5; V lead choice is determined by Va and Vb settings 11-18 Monitoring with the MX40 at the Information Center Unit Configurable Settings Unit Settings - NBP Setup Control Function Settings Factory Default Patient Type Set patient type used for NBP alarm limits. Adult Adult NBP Alarm Set NBP alarm notification. Systolic or Diastolic Pediatric Systolic Systolic or Diastolic Diastolic Mean op Off Increment/decrement NBP high alarm limit by 5. Limit Maximum is 260 Limit Minimum is 10 160 Adult Systolic Low Increment/decrement NBP low alarm limit by 5. Limit Maximum is 260 Limit Minimum is 10 90 Adult Diastolic High Increment/decrement NBP high alarm limit by5. Limit Maximum is 260 Limit Minimum is 10 90 Adult Diastolic Low Increment/decrement NBP low alarm limit by 5. Limit Maximum is 260 Limit Minimum is 10 50 Adult Mean High Increment/decrement NBP high alarm limit by 5. Limit Maximum is 260 Limit Minimum is 10 110 Adult Increment/decrement NBP low alarm limit by 5. Limit Maximum is 260 Limit Minimum is 10 60 Adult ra ft Systolic High Mean Low 120 Pediatric 70 Pediatric 70 Pediatric 40 Pediatric 90 Pediatric 50 Pediatric Monitoring with the MX40 at the Information Center 11-19 Unit Configurable Settings Unit Settings - Alarms Control Function Settings Factory Default ECG Leads Off Adjust the severity level of this technical alarm (INOP). Cyan Cyan Adjust the severity level of this technical alarm (INOP). Cyan Set latched/non-latched status for SpO2, ST, and other non-arrhythmia yellow alarms. Latched Yellow Reminders Red Cyan Yellow Red Latched Non-latched op Replace Battery Yellow Enables alarm reminders. Enable ra ft Disable 11-20 Monitoring with the MX40 at the Information Center Enable 12. Operating with Information Center Release L or M This section covers performance differences when operating the MX40 with previous releases of the Information Center (Release L or M). Display ...................................................................................................... 12-2 ra ft op Alarms ....................................................................................................... 12-3 Operating with Information Center Release L or M 12-1 Display Display ra ft op An MX40 operating with either Release L or M of the Information Center has two screens showing either one measurement waveform and four numeric parameter values or the ECG lead placement chest diagram along with two numeric parameter values, depending on configuration. 12-2 Operating with Information Center Release L or M Alarms Alarms An MX40 operating with Release L or M of the Information Center does not have physiological alarm capability locally at the device (networked or non-networked). A No Alarm Display message is present along with the Alarms Paused icon. Cautions When operating with Information Center Release L or M, the alarm pause time of the MX40 is not configurable. The alarm pause time for the MX40 is always two minutes. op When operating with Information Center Release L or M, if alarms are paused at the Information Center, the "Alarms Paused" message is only displayed at the Information Center. Technical alarms (INOPs) are communicated and can be silenced using the Alarm Silence button. ft Technical alarms can be reviewed using the Alarms SmartKey. Note — Not all rechargeable battery technical alarms are communicated via the Alert Data Integration paging system. The following alarms are not communicated: TELE CHECK BATT ra TELE SERVICE BATT TELE BATTERY TEMP However, these technical alarms are still transmitted to the Information Center. Operating with Information Center Release L or M 12-3 D ra ft op Alarms 12-4 Operating with Information Center Release L or M 13. Trends op This section covers the Trend functionality of the MX40. Trends are patient data collected over time and displayed in tabular form to give you a picture of how your patient's condition is developing. Trend information is stored in the MX40 for continuously-monitored measurements, such as ECG, as well as for aperiodically-measured parameters, such as SpO2. One hour of Trend information is standard on the MX40, with the option available for 24 hours. ra ft Viewing Vital Trend Information ......................................................... 13-2 Trends 13-1 Viewing Vital Trend Information Viewing Vital Trend Information To view Vital Trend information: Touch the SmartKeys button. From the SmartKeys menu, select Vitals Trend. To change the time columns: Touch the time column. Select a different time period. ra ft op 13-2 Trends 14. Maintenance This section provides procedures for maintaining the MX40 after installation, including equipment label assignment, cleaning and battery care. Cleaning .................................................................................................... 14-2 Disposing of the MX40 ........................................................................... 14-5 Label Assignment for Replacement MX40........................................... 14-6 ra ft op Charging Lithium-ion Rechargeable Batteries .................................... 14-8 Maintenance 14-1 Cleaning Cleaning The procedure in this section keeps the MX40 and its accompanying patient cable clean and provides protection against infectious agents and bloodborne pathogens. Both the outside and the inside of the MX40 battery compartment and the patient cable must be kept free of dirt, dust, and debris. Note — Single-Patient-Use leadsets are intended to be disposed of when use is complete. They are not to be re-used and are not designed to be cleaned using any of the materials listed below. op Important — After exposure, the MX40 and the patient cable must be cleaned as per the instructions contained herein. Sterilization of the MX40 has been qualified using the STERRAD 100NX System. For more information and instruction on sterilizing the MX40, contact your service personnel. The alternative Steris V-pro process using hydrogen peroxide vapor is also acceptable. ft Perform the following steps to clean the MX40 and the patient cable of visible surface contamination. Note — when cleaning, the use of protective gloves is encouraged. Remove the batteries and disconnect the patient cable. If using disposable AA batteries, remove the battery tray and clean separately. ra 14-2 Wipe the MX40 and the patient cable clean by using a cloth dampened modestly with one of the approved cleaning agents listed in the table below. Follow the manufacturer's instructions with regard to application duration. Wipe the M40 and inside the patient cable housing with distilled water or alcohol to prevent residue build-up. Allow to air-dry, or dry with a non-lint producing cloth. Maintenance Cleaning Cleaning Materials for the MX40 Caution Use of abrasive cleaning materials, or disinfectants or cleaning agents not listed herein, on any part or component of the MX40 may damage the components. The Gore-tex patch in the battery compartment of the MX40 can be damaged by the use of glutaraldehyde and anti-bacterial soap. Sharp or pointed instruments should not be used to remove soil from recessed areas on the MX40. Approved Cleaners Active Ingredient op Cleaner Isopropyl Alcohol (>70%) Hydrogen Peroxide Hydrogen Peroxide (3%) Chlorine Bleach Sodium Hypochlorite (1:10 concentration, mixed < 24 hours) Metrex CaviWipes Isopropyl alcohol (15-18%) ft Isopropyl Alcohol based Sodium hydroxide (0.1%) 2-butoxyethanol (1-5%) ra Viraguard Resert XL HLD Isopropanol (70%) Hydrogen peroxide (1.4-2-3%) 2-Fumic Acid (<2.5%) Sporox II Sterilizing & Disinfection Solution Hydrogen peroxide (7.5%) Sanicloth Plus Germicidal Cloths Isopropyl alcohol (55%) WipesPlus Disinfecting Wipes Phenylphenol (0.28%), TechSpray General Purpose Cleaner Isopropyl alcohol (70%) Oxivir Tb Cleaner Disinfectant Hydrogen peroxide (2.5-3.5%) Oxivir Tb Wipes Hydrogen peroxide (3%) Sanicloth HB Quaternary ammonium (1%) Phosphoric acid (0.85%) Quaternary ammonium (0.5%) Benzyl-p-chlorophenol (0.03%) Maintenance 14-3 Cleaning Cleaner Active Ingredient Sanicloth Plus Quaternary ammonium (0.25%) 2-Butoxyethol (1-4%) Isopropyl alcohol (14.85%) Super Sanicloth Quaternary ammonium (<1%) Isopropyl alcohol (55%) Sanicloth Bleach Germicidal Disposable Wipes Sodium Hypochlorite (0.6%) Bacillol 25 Ethanol (100 mg/g g) Propane-2-ol (90 mg/g) Propane-1-ol (60 mg/g) Bacillol AF Propane-1-ol (450 mg/g) op Propane-2-ol (250 mg/g) Ethanol (47 mg/g) Hydrogen Peroxide Meliseptol Hydrogen peroxide (5%) Propane-1-ol, (50 g) Glyoxal (0.08 g / 100 g) ra ft Note —The cleaners listed above are also suitable for cleaning the patient cable and the lithium-ion battery. 14-4 Maintenance Disposing of the MX40 Disposing of the MX40 Warning To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the MX40 appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories where not otherwise specified, follow local regulations regarding disposal of hospital waste. You will find detailed disposal information on the following web page: op http://www.healthcare.philips.com/main/about/Sustainability/Recycling/p m.wpd ft The Recycling Passports located there contain information on the material content of the equipment, including potentially dangerous materials which must be removed before recycling (for example, batteries and parts containing mercury or magnesium). ra Do not dispose of waste electrical and electronic equipment as unsorted municipal waste. Collect it separately, so that it can be safely and properly reused, treated, recycled, or recovered. Maintenance 14-5 Label Assignment for Replacement MX40 Label Assignment for Replacement MX40 During installation, an equipment label is assigned to each MX40 in a clinical unit so that the device can be identified during operation within the wireless system. If an MX40 is lost, the Assign Label function at the Information Center enables you to unassign the label from a lost device, and re-assign its label to a replacement device. Labels are limited to those available in an individual clinical unit. Re-assigning an Equipment Label at the IntelliVue Information Center op To re-assign an equipment label to a replacement device: At the Information Center, clear the sector that the original equipment label was assigned to (Patient Window -> Sector Setup -> Clear Sector -> OK). ft Note — Before clearing the sector, ensure that the equipment label of the lost device is not actively assigned to a patient being monitored. Select All Controls -> Label Assignment. Enter password. ra Note — The remaining screens will be in English only. Insert battery power into the MX40 and if attached, disconnect the patient cable. Select Refresh. Select the MAC address of the replacement device from the New Devices list. If the address does not appear, remove battery power and re-insert. Select Refresh. Note — The MAC address appears on the rear label of the MX40. 14-6 Select the equipment label that was assigned to the previous device from the Equipment Label list. Select Assign Label to initiate programming of the equipment label into the replacement MX40. When prompted, press Confirm on the MX40 to accept the assignment. The confirmation must occur within 30 seconds of the prompt. Maintenance Label Assignment for Replacement MX40 10 Wait for the new_device label to change to the selected equipment label. 11 In Sector Setup, select the Bed Label and Equipment Label and then press OK. Re-assigning an Equipment Label at the IntelliVue Information Center iX To re-assign an equipment label to a replacement device: Enter the Manage Unit application (scroll down if necessary). Select Label Assignment. Select the entry for both the previously assigned device (on the left) and the entry for the available device (on the right). Select Replace. At the MX40, select Confirm. At the Information Center iX, select OK. Select Refresh to confirm that the device now appears in the Assigned Devices column. Confirm that the Equipment Label is now displayed on the MX40. ra ft op Maintenance 14-7 Charging Lithium-ion Rechargeable Batteries Charging Lithium-ion Rechargeable Batteries The li-ion rechargeable battery is recharged using the IntelliVue CL Charging Station. To charge a battery, place it onto a charger slot on the charging station. The battery power indicators will supply information about the charge status. Warning Always use the supplied power cord with the grounded mains plug to connect the charging station to a grounded AC mains socket. Never adapt the mains plug from the power supply to fit an ungrounded AC mains socket. op Do not use AC mains extension cords or multiple socket outlets. If a multiple portable socket outlet without an approved isolation transformer is used, the interruption of its protective grounding may result in leakage currents equal to the sum of the individual ground leakage currents, so exceeding allowable limits. ft Do not connect any devices that are not supported as part of the system. Battery Power Indicators ra There are various indications which help you keep track of the battery power status. LEDs on the charging station slots battery status information on both the MX40 and the charging station's display INOP messages The indicators always show the remaining capacity in relation to the battery's actual maximum capacity which may lessen as the battery ages. Charging Station LEDs The nine charger slot LEDs show the battery status of the device in their slot and are switched off if no battery is inserted. 14-8 Maintenance Charging Lithium-ion Rechargeable Batteries If a battery is put on a charging station slot, the corresponding LED will flash yellow until the battery's current state has been identified. Then a beep is issued and the LED reflects the battery status as described in the table below. Status LED no battery on charger slot off battery put on charger slot flashing yellow battery not properly recognized, error cyan battery recognized, battery charging yellow battery recognized, battery full (>90%) green The AC Power / Error LED is op green when the charging station is connected to AC power cyan during startup or to indicate a general charging station error ft Note — Wiping of battery contacts with an alcohol solution after cleaning is recommended. Battery Status on the Charging Station Display ra The IntelliVue CL Charging Station display provides a quick overview of all the connected devices and their battery status. The screen is arranged in the same layout as the charger slots. Battery Lifetime Management The lifetime of a li-ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 4 years or 500 complete charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. We therefore strongly recommend that li-ion batteries be replaced after 2 years or 500 complete charge-discharge cycles. Maintenance 14-9 Charging Lithium-ion Rechargeable Batteries The age of a li-ion battery begins at the date of manufacture. The date of manufacture is listed on the side of the battery. Battery Disposal ra ft op Discharge the battery and insulate the terminals with tape before disposal. Dispose of used batteries promptly and in accordance with local recycling regulations. 14-10 Maintenance 15. Safety Standards & Specifications This section describes the regulatory standards that the IntelliVue MX40 complies with, along with product and measurement specifications. Regulatory Information .......................................................................... 15-2 Electromagnetic Compatibility .............................................................. 15-8 op Battery Specifications ............................................................................ 15-14 Lithium-ion Battery Charge Time ....................................................... 15-17 Physical Specifications .......................................................................... 15-18 MX40 1.4 GHz Smart-Hopping Radio ................................................ 15-19 ft MX40 2.4 GHz Smart-Hopping Radio ................................................ 15-20 MX40 Short-Range Radio ..................................................................... 15-22 MX40 2.4GHz WLAN Radio ................................................................ 15-23 Environmental Specifications .............................................................. 15-25 ra Measurement Specifications ................................................................ 15-26 Safety Standards & Specifications 15-1 Regulatory Information Regulatory Information Software Hazard Prevention Potential hazards arising from errors in the software program have been identified. Mitigations applied to reduce the associated risk of such hazards are included as part of the Risk Management, Clinical Evaluation, and Verification and Validation phases of the product’s development. AC Power Source op The system is not intended for connection to the public mains as defined in CISPR-11. Industrie Canada Compliance (Canada) This Class B ISM device complies with Canadian ICES-001. ft Cet ISM de la classe B est conforme à la norme NMB-001 du Canada. Safety Standards The device complies with the following safety requirements for medical electrical equipment: ra EN 60601-1:1990 + A1:1993 + A2:1995 +A11:1993 +A12:1993 + A13:1996 General Requirements for Safety (with worldwide deviations, including U.S. deviations) CSA C22.2 #601.1:1992 Medical Electrical Equipment - General Safety UL 60601-1 Medical Electrical Equipment - General Safety UL 2054 Standards for Household and Commercial Batteries EN 60601-1-1:2006 System Requirements EN 60601-1-4:2000 Safety Requirements for Programmable Electronic Medical Systems EN 50371:2005 Low Power Electronic and Electronic Apparatus Electromagnetic Exposure EN ISO 9919:2005 Requirements for SpO2 Pulse Oximeters EN ISO 10993-1:2003 Biocompatibility EN ISO 10993-1:2003 Biocompatibility (for leadwires and pouch) EN ISO 9919:2005 Pulse Oximeters 15-2 Safety Standards & Specifications Regulatory Information IEC 60601-1-2:2001 Electromagnetic Compliance IEC 60601-1-4:1999 +A1 Requirements for Programmable Electrical Medical Systems IEC 60601-1-6:2006 General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-8:2006 General Requirements for Safety for Alarm Systems IEC 60601-2-49:2001 Particular Requirements for Safety for Patient Monitoring Equipment IEC 60601-2-27:2005 Particular Requirements for Safety for Electrocardiograph Monitoring Equipment op IEC 62133:2002 Safety Requirements for Portable Sealed Secondary Cells (alkaline, lithium-ion) AAMI EC 13:2007 Performance Standard, Cardiac Monitors AAMI EC 53:1995 (R) 2001 ECG Cables/Leadwires (excluding 4.2.1) ft Intended Use Statement ra Intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals. Indications for Use Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. Intended Uses of MX40 The MX40 is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center. Safety Standards & Specifications 15-3 Regulatory Information The MX40 can provide time-limited local monitoring when it is not connected to the wireless network. Unlike a traditional bedside monitor which operates on AC power, the MX40 is powered by battery and cannot provide continuous monitoring. Authorized EU Representative Patient Population op Philips Medizin Systeme Deutschland Hewlett-Packard-Strasse 2 D 71034, Boeblingen Germany This device is not for use with infant or neonatal patients. Use of the device is restricted to one patient at a time. ra ft The components/accessories which come into contact with the patient’s skin are in compliance with the relevant requirements of EN ISO 10993-1 for Biocompatibility. The device is not designed for direct contact with the patient’s skin. The accompanying pouch is the appropriate means for holding the device. Rx Federal Law restricts this device to sale by or on the order of a physician. Essential Performance The IntelliVue MX40 provides Essential Performance (EP) under normal operating conditions (includes EMC exposure) only as a complete Medical Electrical System, consisting of the MX40, MPx companion monitor (Optional), IntelliVue CL SpO2 and NBP Cableless Measurement devices(Optional), IntelliVue Telemetry Network Infrastructure, and the Information Center. The System achieves its Essential Performance exclusively through alarm generation at the IntelliVue Information Center and locally at the MX40, based on configuration. 15-4 Safety Standards & Specifications Regulatory Information The IntelliVue MX40 protects the patient from unacceptable immediate clinical risk by generating specific Physiological Alarms when appropriate. If the system cannot generate Physiological Alarms, then relevant Severe or Hard-Level Technical Alarms (Inops) are created. Risk Management Considerations Warning op The MX40 operates exclusively via a wireless network connection, therefore, it should not be used for primary monitoring in applications where momentary loss of the ECG is unacceptable at the Information Center. It sends ECG and optionally pulse oximetry data to the Information Center, where the Information Center displays real-time patient data, provides alarm annunciation, data storage and review applications. The ECG waveform data, alarms and optionally SpO2 can always be viewed on the MX40 regardless of the connection to the Information Center. ra ft Smart Hopping technology alleviates most of the problems associated with legacy telemetry technologies. Reception problems are less frequent, because Smart Hopping avoids interference and moves to a different access point if the signal strength is too low. The level of radio frequency activity is always fluctuating in the environment. If the level becomes high enough to significantly interfere with transceiver operation, the system responds by moving to another "cleaner" area where there is less activity. Dropouts Because the MX40 operates exclusively via a wireless network connection, under certain frequency conditions dropouts can occur. Dropouts result from a weak signal or RF interference, and appear on the waveform when the signal "drops" to the bottom of the channel for a minimum of 200 ms. If dropouts are frequent enough to affect the heart rate count, the "Cannot Analyze ECG" or "Cannot Analyze ST" technical alarm occurs. If there are enough dropouts to cause disassociation/reassociation with the Information Center, events in the Clinical Review application can reflect loss of data for up to 1 minute in the worst case. Safety Standards & Specifications 15-5 Regulatory Information Problem Cause Remedy Dropouts Low signal strength See "Signal Strength" below. RF interference See "Radio Frequency Interference" below. Monitoring Considerations Patient should be restricted to the designated coverage area. Monitoring performance will degrade if patients go outside the radius of coverage of the receiving wireless network. op A patient location strategy is critical to a telemetry system. If a life-threatening event occurs, the clinician must be able to locate the patient quickly. The importance of this increases as the coverage area increases. ra Caution ft Frequency management is the responsibility of the hospital. Philips Healthcare has no control over the RF environment in the hospital. If interference exists at the operating frequencies of the telemetry equipment, telemetry performance will be affected. Careful selection of frequencies for all wireless devices used within a facility (transceivers, other wireless medical devices, etc.) is important to prevent interference between them. IEC/ANSI/AAMI 80001-1:2010 Philips recognizes the importance of a safe and effective network that meets both the business needs of a healthcare facility, IT networking requirements, and the clinical functionality. Philips supports the IEC 80001-1 standard in regards to working as a partner with a healthcare organization in the design, implementation, and management of the Medical IT-Network to properly provision and support not only Philips devices, but all the devices using the network. Applying the principles of risk management to hospital frameworks is highly encouraged. When operating the MX40 on a Customer Supplied Clinical Network, Philips strongly encourages our customers to perform risk management of their Medical IT-Network infrastructure in accordance with IEC 80001. 15-6 Safety Standards & Specifications Regulatory Information ra ft op If the MX40 experiences loss of network connectivity, technical alerts at the Information Center ("No Signal") and at the MX40 ("No Central Monitor") will occur. The MX40 will also automatically revert to local monitor mode which activates display of patient data on the MX40 – however, when in this state, battery life will be shortened. Safety Standards & Specifications 15-7 Electromagnetic Compatibility Electromagnetic Compatibility Medical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC 60601-1-2:2001, the international standard for EMC for medical electrical equipment. This IEC standard has been adopted in the European Union as the European Norm, EN 60601-1-2:2001. Radio frequency (RF) interference from nearby transmitting devices can degrade performance of the product. Electromagnetic compatibility with surrounding devices should be assessed prior to using the product. op Fixed, portable, and mobile radio frequency communications equipment can also affect the performance of medical equipment. See your service provider for assistance with the minimum recommended separation distance between RF communications equipment and the product. Warnings ft The cables, sensors/transducers, and other accessories for which compliance is claimed are listed in the Service and User documentation accompanying the product. ra The use of accessories, transducers and cables other than those specified in the product service and user documentation can result in increased electromagnetic emissions or decreased immunity of the product. Short-range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, and DECT phones. Outside the frequency band and 5% above and below, i.e. the exclusion band according to IEC 60601-1-2, the short-range radio connection is immune up to 3V/m in the frequency range from 80MHz to 2.5 GHz. Depending on the strength and duration of the interference, the interruption may occur for an extended period. Any interruption of the signal due to interference, moving out of range, or for other reasons is indicated with a Tele Disconnected INOP message. The product should not be used next to or stacked with other equipment. If you must stack the product, you must check that normal operation is possible in the necessary configuration before the product is used on patients. 15-8 Safety Standards & Specifications Electromagnetic Compatibility Reducing Electromagnetic Interference The MX40 and associated accessories can be susceptible to interference from other RF energy sources and continuous, repetitive, power line bursts. Examples of other sources of RF interference are other medical electrical devices, cellular products, information technology equipment, and radio/television transmission. If interference is encountered, as demonstrated by artifact on the ECG or dramatic variations in physiological parameter measurement values, attempt to locate the source. Assess the following: Is the interference due to misplaced or poorly applied electrodes or sensors? If so, re-apply electrodes and sensors correctly according to directions in Chapter 6. op Is the interference intermittent or constant? Does the interference occur only in certain locations? Does the interference occur only when in close proximity to certain medical electrical equipment? ft Once the source is located, attempt to attenuate the interference by distancing the MX40 from the source as much as possible. If assistance is needed, contact your local service representative. Restrictions for Use ra Artifact on ECG and other physiological waveforms caused by electromagnetic interference should be evaluated by a physician or physician authorized personnel to determine if it will negatively impact patient diagnosis or treatment. Electromagnetic Compatibility (EMC) Specifications Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment. You must operate your monitoring equipment according to the EMC information provided in this book. Portable and mobile radiofrequency (RF) communications equipment can affect medical electrical equipment. Accessories Compliant with EMC Standards All accessories listed in the accessories section comply, in combination with the MX40, with the requirements of IEC 60601-1-2:2001 + A1:2004. Safety Standards & Specifications 15-9 Electromagnetic Compatibility Warning Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitoring equipment. Electromagnetic Emissions Compliance Avoiding Electromagnetic Interference Radio Frequency (RF) emissions Group 1 TheMX40 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 B op Emissions Test Harmonized emissions Not Applicable Device is battery powered only Not Applicable ft Voltage fluctuations/Flicker emissions IEC 61000-3-3 The MX40 is suitable for use in all establishments. ra Electromagnetic Immunity The MX40 is suitable for use in the specified electromagnetic environment. The user must ensure that it is used in the appropriate environment as described below. Immunity Test Electrostatic discharge (ESD) IEC 61000-4-2 Power frequency (50/60 Hz) magnetic field IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment Guidance ±6 kV contact ±6 kV contact ±8 kV air ±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%. 3 A/m 3 A/m IEC 61000-4-8 15-10 Safety Standards & Specifications Power frequency magnetic fields should be a t levels characteristic of a typical location in a typical commercial and/or hospital environment Electromagnetic Compatibility Recommended Separation Distance Warning The MX40, equipped with a wireless network interface, intentionally receives RF electromagnetic energy for the purpose of its operation. Therefore, other equipment may cause interference, even if that other equipment complies with CISPR emission requirements. In the following table, 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). op Portable and mobile RF communications equipment should be used no closer to any part of the MX40, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. ft Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with this ra symbol: Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF 3 Vrms 3 VRMS Recommended separation distance: IEC 61000-4-6 Radiated RF IEC 61000-4-3 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz d = 1.2√P 3 V/m Recommended separation distance: 80 MHz to 800 MHz d = 1.2√P 800 MHz to 2.5 GHz d = 2.3√P Safety Standards & Specifications 15-11 Electromagnetic Compatibility 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 monitor is used exceeds the applicable RF compliance level above, the MX40 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the monitor. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. ft op The MX40 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the monitor as recommended below, according to the maximum output power of the communications equipment. In the following table, 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). Equation 150 kHz to 80 MHz 80 MHz to 800 MHz ra Frequency of Transmitter 800 MHz to 2.5 GHz d = 1.2√P d = 1.2√P d = 2.3√P Separation distance Separation distance Separation distance 0.1 m 0.1 m 0.2 m 0.4 m 0.4 m 0.7 m 1W 1.2 m 1.3 m 2.3 m 10 W 3.8 m 3.8 m 7.3 m 100 W 12.0 m 12.0 m 23.0 m Rated max. output power of transmitter 0.01 W 0.1 W 15-12 Safety Standards & Specifications Electromagnetic Compatibility Electrosurgery Interference/Defibrillation/Electrostatic Discharge The equipment returns to the previous operating mode within 10 seconds without loss of any stored data. Measurement accuracy may be temporarily decreased while performing defibrillation. This does not affect patient or equipment safety. Do not expose the equipment to x-ray or strong magnetic fields (MRI). The MX40 is not for use during electrosurgery. Restart Time ra ft op After power interruption, an ECG wave will be shown on the display after 30 seconds maximum. Safety Standards & Specifications 15-13 Battery Specifications Battery Specifications Battery Life The battery life specifications listed below are based on the use of three Duracell MN 1500 batteries. Battery life for other brands may differ. Telemetry Mode Networked (Display Off) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) 24.9 hours 24.7 hours ECG/SpO2 Continuous (using legacy SpO2 cable/sensors. Only one radio active.) 11.2 hours 8.9 hours ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. ft op ECG Only (only one radio active) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) ECG Only (only one radio active) 11 hours 7.7 hours ECG/SpO2 Continuous (using legacy SpO2 cable/sensors. Only one radio active.) 5.3 hours 2.9 hours ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. Monitor Mode Non-networked (Display On) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) ECG Only (only one radio active) 6.8 hours 7.3 hours ECG/SpO2 Continuous (using legacy SpO2 cable/sensors. Only one radio active.) 4.7 hours 4.6 hours ra Monitor Mode Networked (Display On) 15-14 Safety Standards & Specifications Battery Specifications Monitor Mode Non-networked (Display On) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. The battery life specifications listed below are based on the use of the Philips Rechargeable Lithium-ion battery. Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) Battery Life (WLAN p/n 865352) ECG Only (only one radio active) 26.1 hours 25.1 25 hours ECG/SpO2 Continuous (using legacy SpO2 cable/sensors. Only one radio active.) 15.6 hours 14.1 15 hours ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. ft op Telemetry Mode Networked (Display Off) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) Battery Life (WLAN p/n 865352) ECG Only (only one radio active) 11 hours 10.4 hours 11 hours ECG/SpO2 Continuous (using legacy SpO2 cable/sensors. Only one radio active.) 8 hours 7.8 hours 8 hours ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. ra Monitor Mode Networked (Display On) Monitor Mode Non-networked (Display On) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) Battery Life (WLAN p/n 865352) ECG Only (only one radio active) 13 hours 10.4 hours 12 hours ECG/SpO2 Continuous (using legacy SpO2 cable/sensors. Only one radio active.) 8.8 hours 7.8 hours 8.5 hours Safety Standards & Specifications 15-15 Battery Specifications Monitor Mode Non-networked (Display On) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) Battery Life (WLAN p/n 865352) ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. Note — Use of the Short-range radio can reduce battery life by 25%. Note — The battery capacity of re-chargeable batteries degrades over time and number of recharge cycles. Toward the end of its useful life, the battery capacity may be reduced by 25-30%. If this reduced battery life is unacceptable based on your use model, Philips recommends replacing the rechargeable battery sooner. op Nominal Current Nominal Current (p/n 865351) Nominal Current (p/n 865352) ECG Only (Display inactive) 67 mA @ 3.6V 67 mA @ 3.6V 70 mA @ 3.6V ECG/SpO2 Continuous (Display inactive) 136 mA @ 3.6V 136 mA @ 3.6V 140 mA @ 3.6V ra ft Nominal Current (p/n 865350) Operating Mode 15-16 Safety Standards & Specifications Lithium-ion Battery Charge Time Lithium-ion Battery Charge Time Charging Method Charge Time Battery pack charge time from 90% depletion state The Lithium-ion Battery Pack is charged on 6.5 hours a separate external charging station. It must be removed from the MX40 to charge. ra ft op Definition Safety Standards & Specifications 15-17 Physical Specifications Physical Specifications Parameter Specification Height 126.8 mm (4.99 in) Width 69.9 mm (2.75 in) Depth 31.5 mm (1.24 in) Weight Without batteries, includes SpO2 and Short-range radio 1.4 GHz - 240 g (8.5 oz) 2.4 GHz - 215 g (7.6 oz) WLAN - 206 g (7.3 oz) 1.4 GHz - 324 g (11.4 oz) 2.4 GHz - 298 g (10.5 oz) WLAN - 292 g (10.3 oz) op With 3 AA batteries, includes SpO2 and Short-range radio 1.4 GHz - 314 g (11.1 oz) 2.4 GHz - 289 g (10.2 oz) With lithium-ion battery, includes SpO2 and Short -range WLAN - 274 g (9.7 oz) radio ft Display Type 2.8" QVGA Color LCD View Area 43.2mm x 57.6 mm (1.70" x 2.26") Resolution 240 x 320 Backlight White LED ECG Display Sector Size (height) 13.5mm (portrait), 9.9mm (landscape) 10mm/s with 4.32 sec of viewable ecg data (portrait), 10mm/s with 5.76 sec of viewable ecg data (landscape) Resp Display Sweep Speed 2.5mm/s with 17.28 sec of viewable resp data (portrait) 2.5mm/s with 23.04 sec of viewable resp data (landscape). ra ECG Display Sweep Speed Alarm Signal Sound Pressure Level 15-18 Safety Standards & Specifications 40dB(A) - 70dB(A) MX40 1.4 GHz Smart-Hopping Radio MX40 1.4 GHz Smart-Hopping Radio Parameter Specification Frequency Ranges Bands: 1395-1400 MHz and 1427-1432 MHz Channel Spacing: 1.6 MHz 8 dBm +2/-1.5 dB (4.5 mW to 10 mW), into antenna load Radio Frequency Accuracy during normal operation <+60/-100 KHz relative to channel frequency, includes temperature compensation and aging effects Modulation Type GFSK (1M40Q7D) op RF Output Power (existing systems) Out of Band Spurious Emission Levels: <-41 dBm in 1 MHz bandwidth for FCC limit <= 1394 MHz, >= 1401 MHz ft <= 1428 MHz, >= 1433 MHz Occupied bandwidth as defined by power in 99% BW < +/- 800 KHz ra 1.4GHz WMTS (US only) This device complies with Part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. Safety Standards & Specifications 15-19 MX40 2.4 GHz Smart-Hopping Radio MX40 2.4 GHz Smart-Hopping Radio Parameter Specification Frequency Range ISM Band: 2400 - 2483.5 MHz Channel Assignment 48 radio channels assigned from 2401.056 MHz - 2482.272 MHz Channel Spacing: 1.728 MHz RF Output Power FCC: Channels 0-46 -17 dBm +/- 1 dB (40 mW to 63 mW, nominal 50 mW), into antenna load. Channel 47 only - 15 dBm +/- 1 dB. ETSI: 12 dBm +/- 1 dB (13 mW to 20 mW, nominal 16 mW), into antenna load op ARIB: 13.5 dBm +/- 1 dB (18 mW to 28 mW, nominal 22 mW), into antenna load <+ 60 /- 100 KHz relative to channel frequency, includes temperature compensation and aging effects ft Radio Frequency Accuracy during normal operation GFSK, Gaussian Frequency Shift keying (1M40Q7D) Modulation Bandwidth Typically 1.4 MHz (20 dB Bandwidth) ra Modulation Type Out of Band Spurious Emission Levels Typically 980 KHz (6 dB Bandwidth) Meets ETSI, RS210, FCC, ARIB standards 2.4 GHz ISM FCC and Industry Canada Radio Compliance: This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment. 15-20 Safety Standards & Specifications MX40 2.4 GHz Smart-Hopping Radio The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC (Radio Equipment and Telecommunications Terminal Equipment Directive). Class 2 radio equipment. Member states may apply restrictions on putting this device into service or placing it on the market. This product is intended to be connected to the Publicly Available Interfaces (PAI) and used throughout the EEA. ra ft op This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme a la norme NMB-001 du Canada. Safety Standards & Specifications 15-21 MX40 Short-Range Radio MX40 Short-Range Radio Specification Frequency Ranges ISM Band: 2400-2483.5MHz Radio Channel assignment 16 Radio Channel assigned, Fc= 2405 +5*(k-11)MHz, k=11,12,…,26 Frequency Control Configured via the bedside monitor or the Information Center depending on use model. RF Output Power -1.5 to -4.5 dBm +2/-3dB (0.7 mW to 0.3 mW), into Antenna load. MX40 Frequency Accuracy during normal operation <+/-40ppm, includes temperature compensation & aging effects Modulation Type Modulation Bandwidth op Parameter Direct Sequence Spread Spectrum (DSSS), O-QPSK with half sine pulse shaping modulation (1M40Q7D) >500KHz, typically +/-950KHz (6dB Bandwidth), ra ft typically +/-1.4MHz (20dB Bandwidth) 15-22 Safety Standards & Specifications MX40 2.4GHz WLAN Radio MX40 2.4GHz WLAN Radio The MX40 2.4GHz/5.6GHz WLAN Radio conforms to the 802.11 a/b/g standard operating in the 2.4GHz and 5.6GHz ISM bands. Note — For the MX40 WLAN device, Part Number 865352, use of the MX40's Short-range Radio is only supported when operating with 802.11a (5.6GHz band). The Radio characteristics are defined below. WLAN Radio RF Specs Specification 802.11b IEEE 802.11 b Frequency Range 2.4 to 2.4835GHz Transmitter Power Modulation op Technology Occupied Bandwidth, 99% 802.11g ft Technology 14 to 17 dBm into antenna load (RMS power) CCK (Complementary Code Keying) <-22 MHz IEEE 802.11 g 2.4 to 2.4835GHz Transmitter Power 12 to 15 dBm into antenna load (RMS power) Occupied Bandwidth, 99% <-22 MHz Modulation Type OFDM (Orthogonal Frequency Division Multiplex) Frequency Bands (802.11 b/g) FCC, RS210, ETSI Japan{ARIB},China, AU/NZ: 2.400 – 2.4835GHz Out of Band Emissions (802.11 b/g) Meets ETSI, RS210, FCC, ARIB, AU/NZ standards ra Frequency Range 802.11a Technology IEEE 802.11 a Frequency Power 5.15 to 5.825GHz Transmitter Power 12 to 14 dBm into Antenna load (RMS power) Occupied Bandwidth ≤ 18 MHz Modulation DSSS : OFDM (Orthogonal Frequency Division Multiplex) Safety Standards & Specifications 15-23 MX40 2.4GHz WLAN Radio WLAN Radio RF Specs Specification Frequency Bands (802.11a) FCC, RS210: 5.15 ~ 5.25Ghz, 5.25 ~ 5.35Ghz, 5.42 ~ 5.725Ghz, 5.725 ~ 5.825Ghz (excluding 5.6 ~5.65GH ETSI, AU/NZ: 5.15~ 5.35Ghz, 5.47 ~ 5.725Ghz Japan, ARIB: 5.150 – 5.250GHz, 5.25 – 5.35GHz, 5.470 – 5.725GHz, China: 5.725 ~5.825Ghz Out of Band Emissions (802.11a) Meets ETSI, RS210, FCC, ARIB, AU/NZ standards FCC and Industry Canada Radio Compliance op This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment. ft The maximum antenna gain permitted (for devices in the 5250-5350 MHz and 5470-5725 MHz bands) complies with the e.i.r.p. limits as stated in RSS-210. The maximum antenna gain permitted (for devices in the 5725-5825 MHz bands) complies with the e.i.r.p. limits specified for point-to-point operation as stated in RSS-210. ra The device for band 5150-5250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. Caution High power radars are allocated as primary users of 5250-5350 MHz and 5650-5850 MHz. These radars could cause interference and/or damage to LE-LAN devices. 15-24 Safety Standards & Specifications Environmental Specifications Environmental Specifications Parameter Specification Temperature Operating 0 to 37o C (32 to 99o F) Storage -30o C to 50o C (-22o F to 122o F) without batteries 12 C to 35 C (53.6 F to 95 F) with Single-Patient-Use leadsets Humidity Operating < 95% RH at 37o C (98.6o F) non-condensing Storage < 90% RH at 50o C (122o F) without batteries Altitude op Operating & 3,000 m (9,842 ft) Non-operating ra ft Barometric 72kPa (537 mmHg) Pressure Safety Standards & Specifications 15-25 Measurement Specifications Measurement Specifications ECG Parameter Specification ECG channel transmitted Leads Channel #1 = I, II, or III 5 electrodes Channel #1 = II Channel #2 = III Channel #3 = MCL 5 electrodes, EASI Channel #1 = Va-i Channel #2 = Va-s Channel #3 = Ve-s 6 electrodes Channel #1= II Channel #2 = III Channel #3 = MCLa Channel #4 = MCLb 5 V ft Resolution op 3 electrodes Differential, defibrillator protected against 360 joules discharge into a 100 ohm load Input Impedance > 5 megohms (@ 10 Hz Input Dynamic Range +/- 9 mV DC Offset Range +/- 320 mV CMRR > 90 dB @ 50, 60 Hz Bandwidth +/- 3 dB 0.05 to 40 Hz Gain Accuracy +/- 5% at 25 C (77 F) Noise Referred to ECG Input (Peak-to-Peak) AAMI: 30 V (as per AAMI EC 13) Lead Wires 3, 5 or 6-wire patient cable compatible with IntelliVue Patient Monitor, AAMI/IEC color codes ra ECG Input Time to baseline recovery AAMI: 5 s max (until ECG wave is on display but from Defibrillator not yet centered, monitoring bandwidth) 15-26 Safety Standards & Specifications Measurement Specifications Parameter Specification Pacer Rejection Performance Positive pacers (Pace pulses with no tails). Amplitude Width +2 to +700 mV 0.1, 0.2, 0.5 and 1.0 ms +2 to +500 mV 1.5 ms +2 to +400 mV Negative pacers 2 ms Amplitude Width -2 to -700 mV 0.1, 0.2, 0.5 and 1.0 ms -2 to -500 mV 1.5 ms -2 to -400 mV 2 ms op Philips does not claim, verify, or validate support for all available pacemakers. EMC Performance Limits, Meets Essential Performance. radiated immunity All ECG connections are patient safe within 750 msec of patient cable removal, with patient leakage current <10 Exception: Leadset detection pins are protected mechanically to prevent patient contact. ft ECG Patient Cable Disconnection Safety ra ECG Performance Disclosure/Specifications Characteristic Performance Disclosure/Specification (in italics) Heart Rate Averaging Method Two different methods are used: Normally, heart rate is computed by averaging the 12 most recent RR intervals. If each of 3 consecutive RR intervals are greater than 1200 milliseconds (i.e. rate less than 50 b/min) for adult and pediatric patients, then the 4 most recent RR intervals are averaged to compute the HR. Heart Rate Meter Accuracy and Response to Irregular Rhythm Provides correct heart rates (80, 60, 120, 90 b/min) using test waveforms as indicated in ANSI/AAMI EC13 Sec. 4. 1. 2. 1 (e). Response Time of Heart Rate Meter to Change in Heart Rate For a rate increase, the average time to reach the specified heart rate using test waveforms as indicated in ANSI/AAMI EC13 Sec. 4. 1. 2. 1 (f) is 10 seconds. For a rate drop, the average time is 7 seconds. Safety Standards & Specifications 15-27 Measurement Specifications Performance Disclosure/Specification (in italics) Characteristic Time to Alarm for Tachycardia The ranges of time to alarm using test waveforms as indicated in ANSI/AAMI EC13 Sec. 4 1. 2. 1 (g) are 4 to 5 seconds. Pacemaker Pulse Rejection Capability Rejects pace pulses using test waveforms as indicated in ANSI/AAMI EC13 Sec. 4. 1. 4.1 (with amplitude from +/- 2 to +/- 700 mV, width from 0.1 to 2.0 ms). Range and Accuracy of Heart Rate Meter Meets the ANSI/AAMI EC13 Section 4.2.7 recommended minimum range and accuracy. Heart rate range is 15 - 300 b/min for adults patients and 15-350 b/min for pediatric patients with accuracy of 1% of the range. (Note: for rates equal to or less than 15, the displayed heart rate is 0). Meets the ANSI/AAMI EC13 Section 4.2.8.1 standard. Lower alarm limit is 15 -295. Upper alarm limit is 20 - 300. Resolution of Alarm Limit Settings Meets the ANSI/AAMI EC13 Section 4.2.8.2 standard. The resolution is 5 b/min. Alarm Limit Accuracy Meets the ANSI/AAMI EC13 Section 4.2.8.3 standard. op Alarm Limit Range Error less than ± 10% or ± 5b/min Meets the ANSI/AAMI EC13 Section 4.2.8.4 standard: maximum alarm time <10 seconds, using the test waveforms as indicated. Time to Alarm for Low Heart Rate Meets the ANSI/AAMI EC13 Section 4.2.8.5 standard: maximum alarm time <10 seconds, using the test waveforms as indicated. Time to Alarm for High Heart Rate Meets the ANSI/AAMI EC13 Section 4.2.8.6 standard: maximum alarm time <10 seconds, using the test waveforms as indicated. Alarm Silencing The time required for reactivation of a latched, silenced alarm is 3 minutes ECG Waveform Display Time Base Accuracy Meets the ANSI/AAMI EC13 Section 4.2.9.6 standard: maximum error = +/-10%. Channel Width Meets the ANSI/AAMI EC13 Section 4.2.9.7(a) standard: minimum = 30mm. Trace Width Meets the ANSI/AAMI EC13 Section 4.2.9.7(b) standard: maximum = 1.0mm. Aspect Ratio Meets the ANSI/AAMI EC13 Section 4.2.9.7(f) standard: 0.4 + 0.08 s/mV. Input Signal Reproduction Accuracy: Meets the ANSI/AAMI EC13 Section 4.2.9.8(a) standard: maximum = +/- 20%. ra ft Time to Alarm for Cardiac Standstill Overall Error Frequency Response: Sinusoidal Meets the ANSI/AAMI EC13 Section 4.2.9.8(b) standard: 0.67 to 40 Hz (3 db down). 15-28 Safety Standards & Specifications Measurement Specifications Performance Disclosure/Specification (in italics) Characteristic Frequency Response: Triangular Meets the ANSI/AAMI EC13 Section 4.2.9.8(b) standard: 0 to 25% reduction. Impulse Response: Meets the ANSI/AAMI EC13 Section 4.2.9.8(c) standard: displacement maximum = 0.1 mV; slope (for waves marked with ST bandwidth) maximum = 0.30 mV/s. Pacemaker Pulse Display Capability Meets the ANSI/AAMI EC13 Section 4.2.9. 12 standard: minimum = 0.2 mV RTI. Tall T-Wave Rejection Capability Meets AAMI standard: 0.5 – 40 BW: HR of 80bpm at all T-wave amplitudes Respiration Parameter op 0.05 – 40 BW: HR of 80bpm at all T-wave amplitudes Specification RA, LL (standard) or I, A (EASI) Range Adult/Pedi: 0 to 120 rpm Bandwidth 0.3Hz to 2.5Hz (-6dB) Noise Less than 25 mOhm (rms) referred to the input Calibration Signal Signal: 1 Ohm p-p; Accuracy: +/- 20% Respiration Rate Resolution 1 rpm Respiration Accuracy +/- 1 rpm for 0-120 rmp Auxiliary Current, Respiration Excitation Signal < 470 uA rms @48KHz, sinusoidal waveform ra ft Leads Used for Measurement Respiration Alarm Alarm Range Delay High Adult/Pediatric: 10 to 100 rpm ≤ 15 seconds Low Adult/Pediatric: 0 to 95 rpm for limits from 0 to 20 rpm: max. 4 seconds for limits above 20 rpm: max. 15 seconds Apnea Alarm 10 to 40 seconds Incremental delay 5 seconds max. Safety Standards & Specifications 15-29 Measurement Specifications FAST SpO2 Parameter Specification SpO2 Measurement Range (Calibration and Display) 0 to 100% SpO2 Accuracy See table following. SpO2 Resolution 1% SpO2 Numerics Averaging 5 - 20 seconds (default = 10 seconds) Note—The update rate for the SpO2 pulse oximetry value and pulse rate is op typically 1 second. This can be extended to a max. 60 s when NBP is measured on the same limb, with a corresponding INOP message after a max. of 30 s, indicating that the displayed values are not current values. ft The effect of SpO2 pulse oximetry on data averaging is internally controllable by the patient worn monitorMX40, with no user controls. ra SpO2 & Pulse Numerics - Transmitted once per second. Update Rate Note—The update rate for the SpO2 pulse oximetry value and pulse rate is typically 1 second. This can be extended to a max. 60 s when NBP is measured on the same limb, with a corresponding INOP message after a max. of 30 s, indicating that the displayed values are not current values. Pleth Wave- Sampling Rate 125 sps Technical Alarms (INOPs) Triggered if the sensor is disconnected, if a pulse is not detected, if the signal is noisy, if light interference is detected, if the sensor is defective, if the measurement is erratic, or if the module is malfunctioning Wavelength Range 500 to 1000 nm Note—Information about wavelength range can be especially useful to clinicians (e.g., clinicians performing photodynamic therapy). Pulse Rate Measurement Range: 30 to 300 bpm (available only with Continuous SpO2) Accuracy: +/- 2% Resolution: 1 bpm 15-30 Safety Standards & Specifications Measurement Specifications Parameter Specification Display of SpO2 numerics SpO2 values are displayed as xxx % SpO2 to meet ISO 9919. Emitted Light Energy < 15 mW SpO2 Sensor Accuracy Description Reusable Sensors Model Number op Type M1191B 2.0 Adult Finger, 3m cable M1191BL 2.0 Adult Finger, 0.45m cable M1191T 3.0 M1192A 2.0 Pediatric, Small Adult Finger, 0.45m cable M1192T 3.0 Adult &Pediatric Ear Clip, 1.5m cable M1194A 3.0 Adult Finger Clip, 3m cable M1196A 3.0 Adult Finger Clip, 2m cable M1196S 3.0 Adult Finger Clip, 0.9m cable M1196T 3.0 LNCS Adult Reusable Sensor Masimo LNCS DC-I 2.0 LNCS Pediatric Reusable Sensor Masimo LNCS DC-IP 2.0 LNCS Tip-Clip Ear Reusable Sensor Masimo LNCS TC-I 3.5 LNOP Adult Reusable Sensor Masimo LNOP-DC-I 2.0 LNOP Pediatric Reusable Sensor Masimo LNOP DC-IP 2.0 LNOP Tip-Clip Reusable Sensor Masimo LNOP TC-I Description Model Number ft Adult Finger, 2m cable ra Pediatric, Small Adult Finger, 1.5m cable Type Accuracy % rms (70-100% Range) 3.5 Accuracy % rms (70-100% Range) Single Patient Use Sensors Safety Standards & Specifications 15-31 Measurement Specifications Description Model Number Accuracy % rms (70-100% Range) Adult Finger, > 40kg M1901B 3.0 Pediatric 3-20kg M1902B 3.0 Pediatric Finger, 10-50kg M1903B 3.0 Adult Finger, >30kg M1904B 3.0 Adult, Pediatric > 20kg M1131A 3.0 Adult Finger, > 30kg Nellcor OxiMax Max-A 3.0 Adult Finger, > 30kg Nellcor OxiMax Max-AL 3.0 Adult Finger > 40kg Nellcor OxiMax Max-N 3.0 Nellcor OxiMax Max-P 3.0 Nellcor OxiMax Max-I 3.0 Adult Finger > 30kg Nellcor Oxisensor II D-25 3.0 Adult Finger > 40kg Nellcor Oxisensor II N-25 3.0 Pediatric Finger 10-50kg Nellcor Oxisensor II D-20 3.0 Adult Finger Nellcor OxiCliq A 3.0 Pediatric Finger Nellcor OxiCliq P 3.0 Pediatric Nellcor OxiCliq I 3.0 Adult Finger > 40kg Nellcor OxiCliq N 3.0 Pediatric Adhesive Masimo LNOP PDT 2.0 Pediatric Adhesive Masimo LNOP PDTx 2.0 Adult Adhesive Masimo LNOP ADT 2.0 Adult Adhesive Masimo LNOP ADTx 2.0 Adult Adhesive Masimo LNCS ADTx 2.0 Pediatric Adhesive Masimo LNCS PDTx 2.0 Pediatric ra ft Pediatric op Type 15-32 Safety Standards & Specifications Measurement Specifications Description Model Number Accuracy % rms (70-100% Range) Adult Adhesive Masimo LNCS Neo-3 2.0 ra ft op Type Safety Standards & Specifications 15-33 D ra op ft A. Accessories This section lists the accessories for use with the MX40. Accessories are subject to change. Some accessories are not supplied by Philips. You can order parts and accessories from Philips at www.medical.philips.com or consult your local Philips representative for details. Warning op Use only Philips-approved accessories. Use of product accessories (patient cables, SpO2 sensors, etc.) other than those specified in this manual may lead to patient injury or result in increased electromagnetic emissions or decreased immunity of the product. ft Reuse: Never reuse disposable transducers, sensors, accessories, etc. that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard. Philips' approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance and cause a potential hazard. ra Packaging: Do not use a sterilized accessory if its packaging is damaged. Accessories A-1 MX40 Accessories Pouches Description 989803174141 Carry Pouch, Waterproof, box of 50 989803174151 Carry Pouch, Waterproof, box of 200 9300-0768-050 Disp tele pouch w/snaps, 50/box 9300-0768-200 Disp tele pouch w/snaps, 200/box Miscellaneous Order Number 989803176501 989803176491 ft 989803174131 op Order Number Protective caps, adapter cable, MX40 Protective caps, Reusable leads, MX40 MX40 Lithium-ion battery, pkg 3 989803176201 MX40 Lithium-ion battery, pkg 1 989803174891 MX40 AA Battery adapter, pkg 3 989803134771 Skin Preparation Sheets, 10 preps/sheet, pkg 10 ra A-2 Accessories Description ECG Accessories Electrodes Description M4612A Solid gel ECG electrode disp. 5/pouch 300/case M4613A Solid gel ECG electrode disp. 30/pouch 300/case 40489E Adult paper tape ECG electrode, disp. 300/case 40493D Adult foam ECG electrode, disp. 300/case 40493E Adult foam ECG electrode, disp. 300/case M1935A Disposable EEG/ECG snap electrode 100/case 989803148801 Small adult solid gel snap electrode 1500/case 13941E Adult cloth ECG electrode, disp. 300/case 13942E Adult plastic tape ECG electrode, disp. 300/case 13950B Pediatric cloth ECG electrode, disp. 300/case 13951C Neo/Pediatric solid gel electrode, disp. 300/case ra ft op Order Number 13955C Neo/Pedi snap electrode, square, disp.300/case Leadsets and Patient Cables MX40 Reusable Patient Cables Order Number Description 989803171801 ECG 3 lead grabber AAMI .85m (35") 989803171811 ECG 3 lead grabber AAMI + SpO2 .85m (35") 989803171821 ECG 5 lead snap AAMI .85m (35") 989803171841 ECG 5 lead snap AAMI + SpO2 .85m (35") 989803171831 ECG 5 lead grabber AAMI .85m (35") 989803171851 ECG 5 lead grabber AAMI + SpO2 .85m (35") 989803171861 ECG 6 lead grabber AAMI .85m (35") Accessories A-3 Order Number Description 989803171871 ECG 6 lead grabber AAMI + SpO2 .85m (35") MX40 Extender Cable, including Bed Sheet Clip, p/n 989803172241 MX40 Single-Paitent-Use Cables Order Number Description 989803172031 ECG 5 lead grabber AAMI .85m (35") 989803172051 ECG 5 lead grabber + SpO2 AAMI .85m (35") 989803172131 ECG 5 lead grabber IEC 85m (35") 989803172151 ECG 5 lead grabber + SpO2 IEC .85m (35") op Reusable Leadsets for Use with IntelliVue Patient Monitors Order Number Description ECG 3 lead snap, gray, AAMI .85m (35") 989803151971 ECG 3 lead grabber, gray, AAMI .85m (35") 989803152071 ECG 5 lead snap, multi AAMI .85m (35") 989803152051 ECG 5 lead grabber, multi AAMI .85m (35") 989803152001 ECG 3 lead snap, gray IEC .85m (35") 989803151981 ECG 3 lead grabber, gray IEC .85m (35") 989803152081 ECG 5 lead snap, multi IEC .85m (35") 989803152061 ECG 5 lead grabber, multi IEC .85m (35") ft 989803151991 ra All above leadsets require the MX40 to IntelliVue Adapter Cable, p/n 989803172211 and the use of the 3 lead and 5 lead Detachable Shield when showering. A-4 Accessories SpO2 Accessories Philips/Nellcor Disposable Sensors Description 989803105481 (A) M1904B Adult Finger, >30 kg 989803128551 M1133A Neo/Infant/Adult, <3, 10-20 kg, >40 kg 989803164921 M1134A Adh.-free Neo/Infant/Adult, >40 kg 989803128531 M1131A Adult/Pedi, >20 kg 989803111561(A) M1903B Pedi Finger, 10-50 kg 989803105471(A) M1902B Infant, 3-20 kg 989803105461(A) M1901B Neonatal (adult application only), <3 kg, >40 kg op Order Number 989801190969 (B) NellCor OxiMax Max-1, 3-20 kg 989801190966 (B) Nellcor Oxisensor II D-20, 10-50 kg 989801190967 (B) Nellcor OxiMax D-25, >30 kg Nellcor OxiMax N-25, <3 kg, >40 kg ft 989801190970 (B) Require M1943A/AL cable to connect to MX40. Sold in packages of 24. (A) Only available from Philips in Europe and (B) Only available from Philips in Japan. ra Philips Reusable Sensors Order Number Description 989803144371 A, B M1191B Adult Finger, >50 kg 989803103231 A, B M1192APedi/Sm. Adult 1.5 m, 15-50 kg 989803103251 A, B M1194A Adult/Pedi Ear 1.5m, >40 kg 989803144381 M1191BL Adult Finger 3 m, >50 kg 989803128631 M1196A Adult Finger 3 m, >40 kg 989803128591 C, D M1191T Adult Finger .45 m, >50 kg 989803128611 C, D M1192T Pedi/Sm. Adults .45 m, 15-50 kg 989803128641 C, D M1196T Adult Finger .9 m, >40 kg 989803174381 A, B M1196S Adult Finger 2m, >40 kg Accessories A-5 Order Number Description All sold as one piece each. A - Sensors plug directly into MX40. B - Supports use of M1941A extension cable. C - Not for use with M1941A extension cable. D - Requires M1943A/AL adapter cable. Adapter Cables Description 989803105691 M1943A Adapter Cable, 1. m 989803128651** M1943AL Adapter Cable, 3 m 989803105681** M11941A Extension Cable, 2 m M1020-61100** 989803148221** op Order Number Massimo Adapter Cable for LNOP sensors,3.6 m Massimo Adapter Cable for LNCS sensors, 3 m ra ft **Not to be used with the MX40 extender cable, p/n 989803172241 A-6 Accessories B. Default Settings ra ft op This section documents the most important default settings of your MX40 as it is delivered from the factory. For a comprehensive list and explanation of default settings, see the IntelliVue Information Center Release N Configuration Guide. The MX40's configuration settings can be changed permanently in Configuration Mode. Default Settings B-1 Alarm Default Settings Alarm Setting Factory Default Alarm Volume On Network: 0 Off Network: 10 QRS Volume Tone Modulation On Alarm Sound Traditional Alarm Pause Time 2 min. Note — The Alarm Pause Time when operating with Information Center Release L or M is not configurable. It is always 2 min. Alarm Reminder (INOP) Reminder Time On 3 min. ECG Leads Off - Severity Cyan Cyan ft Replace Battery - Severity Alarms On On op Alarm Reminder (Red, Yellow) Information Center Release L/M: Disabled ra Information Center Release N: Enabled B-2 Default Settings ECG, Arrhythmia, ST and QT Default Settings ECG Settings Factory Defaults Adult On Primary Lead II Secondary Lead 6-lead: III 5-lead (Standard): III 5-lead (EASI): III Default ECG Size x1 Lead Placement Standard Leadset Type AAMI Analysis Mode High Limit Low Limit op ECG Multi-lead 120 bpm 160 bpm 50 bpm 75 bpm 4.0 sec ft Asystole Threshold Arrhythmia Settings Factory Defaults Adult ra Arrhythmia Pedi Pedi On Pause Threshold 2.0 sec VTach HR 100 bpm VTach Run Vent Rhythm 14 SVT HR 180 bpm SVT Run PVCs/min 10 Non-Sustained VT On Run PVCs On Pair PVCs On R-On-T PVCs On 120 bpm 200 Default Settings B-3 Arrhythmia Settings Factory Defaults Adult On V.Trigeminy On PVCs/min On Multif. PVCs On Pacer N. Cap On Pacer N. Pac On Pause On Missed Beat On SVT On Afib op V.Bigeminy On On ra ft Irregular HR B-4 Default Settings Pedi Configuration Default Settings at the MX40 Setting Factory Default Touch Tone Volume 0 - 10 Default Screen 1 Wave (Portrait) 2 Waves (Portrait) 2 Waves (Landscape) Chest Diagram Screen Color Blue Gray Green Pink* Purple* Yellow* (*only display in Standby Mode) Alarm Sounds Traditional ISO op Confirm to restore to unit default settings ra ft Unit Defaults Default Settings B-5 op ft ra B-6 Default Settings C. Sales and Support Offices Please call your local Philips Healthcare sales office listed in your telephone directory or a Philips Healthcare regional office listed below for the location of your nearest sales office. On the web www.healthcare.philips.com By fax +31 40 27 64 887 op Via email healthcare@philips.com ft By postal service Philips Healthcare Global Information Center P.O. Box 1168 5602 BD Eindhoven The Netherlands Asia Tel: +842 2821 5888 ra Europe, Middle East, Africa Tel: +31 40 27 63005 Latin America Tel: +55 11 2125 0764 North America Tel: +1 800 229 6417 Sales and Support Offices C-1 op ft ra C-2 Sales and Support Offices ECG Performance Disclosure/Specifications • 5-3 Electromagnetic Compatibility • 3-3 Index Accessories ECG • A-3 MX40 • A-2 SpO2 • A-5 Initiating Arrhythmia Relearning Manually • 6-35 IntelliVue Information Center • 11-1 Alarms • 5-1 Pausing • 5-6 Physiologic • 5-10 Reviewing • 5-8 Technical • 5-14 Label Assignment • 14-6 Lock • 4-6 Main Screen Button • 4-4 Multi Function Button • 4-3 op Arrhythmia Beat Labels • 6-36 Battery • 4-14 Charge Status • 4-19 Safety • 4-14 ft Cableless Measurements • 10-1 Charging Lithium-ion Rechargeable Batteries • 4-15 Cleaning • 14-2 ra Materials • 14-3 Paced Status • 4-6 Patient Configurable Settings in Telemetry Setup • 4-28 Patient Information Area • 4-6 Pouch Use • 4-22 Pulse • 7-1 QT • 6-42 Connecting and Positioning ECG Electrodes • 8-4 Default Settings • B-1 RF Auto Shutoff • 11-13 RF Interference • 15-9 Risk Management Considerations • 6-6 alarms • B-2 ecg, arrhythmia, ST and QT • B-3 ECG • 6-5 Accessories • A-3 Fallback • 6-25 Relearn • 6-25 Safety • 6-2 Silence Alarms Button • 4-3 SmartKeys • 4-4 SmartKeys Button • 4-3 SpO2 • 9-9 Safety • 9-2 Sensor Type • 9-6 Index 1 Status Area • 4-7 Symbols • 3-5 ra ft op Telemetry Setup • 11-10 2 Index D ra op ft op ft ra Part Number 4535 643 15721 Printed in USA February 2012 First Edition 4535 643 15721
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