Philips Medical Systems North America MX40SH1B4 INTELLIVUE MX40 1.4GHz PATIENT WORN DEVICE User Manual MX40 IFU Athens

Philips Medical Systems North America Co. INTELLIVUE MX40 1.4GHz PATIENT WORN DEVICE MX40 IFU Athens

USERS MANUAL

IntelliVue MX40 Instructions for Use Release B.0 Draft Copy

$ii Notice Proprietary Information This document contains proprietary information, which is protected by copyright. First Edition 2012 4535 643 15721 Copyright Copyright © 2012 Koninklijke Philips Electronics N.V. All rights reserved. Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder. Philips Medical Systems Nederland B.V. reserves the right to make changes in specifications and/or to discontinue any products at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. This product contains software licensed under an open source license. For acknowledgments, license texts and source code, please refer to the IntelliVue Information Center iX M3290B Software\References\README.pdf. Windows ® is a registered trademark of Microsoft Corporation in the United States and other countries. EASI is a trademark of Zymed Inc. OxiCliq ® and OxiMax ® are registered trademarks of Nellcor Incorporated. Duracell ® is a registered trademark of Procter & Gamble Incorporated. STERRAD ® is a registered trademark of Advanced Sterilization Products. GORE-TEX ® is a registered trademark of W.L. Gore & Assoc. Incorporated. Tone modulation is licensed under US patent 4,653,498 from Nellcor Puritan Bennett Incorporated. Manufacturer Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 (978) 687-1501 Printed in USA Document number Draft Copy$

iii 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 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 Protecting Personal Information 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. Draft Copy

iv 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 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. 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. First Edition February 2012 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. Draft Copy

v 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 A Note contains additional information on the product's usage. Draft Copy

Contents 1 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 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 Draft Copy

2 Contents Inserting/Removing Batteries ------------------------------------------------- 4-16 Inserting Batteries ---------------------------------------------------------------- 4-17 Removing the Batteries -------------------------------------------------------- 4-19 Battery Charge Status ---------------------------------------------------------- 4-20 Lithium-ion Rechargeable Battery Charge Status -------------------- 4-20 AA Battery Charge Status --------------------------------------------------- 4-21 Pouch Use ------------------------------------------------------------------------------ 4-22 Securing the Pouch-------------------------------------------------------------- 4-22 Showering -------------------------------------------------------------------------- 4-24 Telemetry Mode Use ---------------------------------------------------------------- 4-26 Monitoring Mode Use ---------------------------------------------------------------- 4-27 Briefing the Patient ------------------------------------------------------------------- 4-28 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 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 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 Draft Copy

Contents 3 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 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 Draft Copy

4 Contents EASI ECG Monitoring -------------------------------------------------------- 6-36 Initiating Arrhythmia Relearning Manually --------------------------------- 6-36 ST/AR ST Analysis Algorithm ----------------------------------------------------- 6-37 Introduction ------------------------------------------------------------------------ 6-37 The Measurements -------------------------------------------------------------- 6-38 Overview --------------------------------------------------------------------------- 6-38 Turning ST or STE On and Off ----------------------------------------------- 6-38 Displayed ST Data --------------------------------------------------------------- 6-39 ST Lead Groups ------------------------------------------------------------------ 6-39 Derived 12 Lead ECG ---------------------------------------------------------- 6-40 EASI ST Analysis -------------------------------------------------------------- 6-40 HEXAD ST Analysis ---------------------------------------------------------- 6-41 ST Alarms -------------------------------------------------------------------------- 6-41 STE Alarms ------------------------------------------------------------------------ 6-41 QT Interval Monitoring --------------------------------------------------------------- 6-42 Intended Use ---------------------------------------------------------------------- 6-43 How the QT Analysis Algorithm Works ------------------------------------- 6-43 Adjusting QT Settings -------------------------------------------------------- 6-44 Limitations for QT Monitoring ----------------------------------------------- 6-45 7. Monitoring Pulse Rate 7-1 Pulse Rate Measurement ------------------------------------------------------------ 7-2 Displaying the Pulse Rate Measurement at the MX40 ----------------------- 7-3 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 Draft Copy

Contents 5 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 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 12. Operating with Information Center Release L or M 12-1 Display ----------------------------------------------------------------------------------- 12-2 Alarms ------------------------------------------------------------------------------------ 12-3 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 Draft Copy

6 Contents AC Power Source ---------------------------------------------------------------- 15-2 Industrie Canada Compliance (Canada) ----------------------------------- 15-2 Safety Standards ----------------------------------------------------------------- 15-2 Intended Use Statement ------------------------------------------------------- 15-3 Indications for Use --------------------------------------------------------------- 15-3 Intended Uses of MX40 -------------------------------------------------------- 15-3 Authorized EU Representative ----------------------------------------------- 15-4 Patient Population --------------------------------------------------------------- 15-4 Rx ------------------------------------------------------------------------------------ 15-4 Essential Performance --------------------------------------------------------- 15-4 Risk Management Considerations ------------------------------------------ 15-5 Electromagnetic Compatibility ----------------------------------------------------- 15-8 Reducing Electromagnetic Interference ------------------------------------ 15-9 Restrictions for Use-------------------------------------------------------------- 15-9 Electromagnetic Compatibility (EMC) Specifications ------------------- 15-9 Accessories Compliant with EMC Standards -------------------------- 15-9 Electromagnetic Emissions --------------------------------------------------- 15-10 Electromagnetic Immunity ---------------------------------------------------- 15-10 Recommended Separation Distance -------------------------------------- 15-11 Electrosurgery Interference/Defibrillation/Electrostatic Discharge15-13 Restart Time ------------------------------------------------------------------- 15-13 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 Draft Copy

Contents 7 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. Sales and Support Offices C-1 Draft Copy

Introducing the IntelliVue MX40 1-1 1. Introducing the IntelliVue MX40 This section introduces the IntelliVue MX40 wearable patient monitor. MX40 Features ........................................................................................... 1-2 MX40 Models ............................................................................................. 1-3 MX40 Release B.0 Compatibility ............................................................. 1-4 Draft Copy

MX40 Features 1-2 Introducing the IntelliVue MX40 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. 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). 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). 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. Draft Copy

MX40 Models Introducing the IntelliVue MX40 1-3 MX40 Models The MX40 is available in three models (ECG only, ECG and FAST SpO2, or ECG and SpO2 Ready (for future upgrade). Draft Copy

MX40 Release B.0 Compatibility 1-4 Introducing the IntelliVue MX40 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. The MX40 is compatible for use with Access Point Controller 862147, Release B.00.19 and Access Point Controller 865346, Release C.00.04. 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. Draft Copy

What's New? 2-1 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. New Features and Enhancements ........................................................... 2-2 Draft Copy

New Features and Enhancements 2-2 What's New? 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 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). Numeric Only Display A new display orientation is available showing six numerics only. No waveforms are shown (available with IntelliVue Information Center iX). ECG Waveform Size Adjustment The size of the ECG waveform can now be adjusted by touching the waveform on the display. Wireless LAN Availability 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). Draft Copy

Product Safety 3-1 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 Safety Symbols & Other Marks ............................................................... 3-5 Draft Copy

General Safety 3-2 Product 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. 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. 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. Draft Copy

General Safety Product Safety 3-3 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. 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. 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. 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. Draft Copy

General Safety 3-4 Product 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 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. Draft Copy

Safety Symbols & Other Marks Product Safety 3-5 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: IC: Federal Communications Commission (FCC) ID Industry Canada Number GMDN: Global Medical Device Nomenclature Federal Communications Commission (FCC) 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. Draft Copy

Safety Symbols & Other Marks 3-6 Product Safety Label Definition Disposal Dispose of in accordance with the local country’s requirements. 2002/96/EC (Waste Electrical and Electronic Equipment). Follow operating instructions. Prescription Device CSA Mark for Certified by CSA to the applicable Canadian and US standards.. Defibrillation Proof 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 Draft Copy

Safety Symbols & Other Marks Product Safety 3-7 Label Definition IPX Waterproof Rating Protected against the effects of temporary immersion in water. 2D Barcode UL Listed Device Listed by Underwriters Laboratories Attention! See Instructions for Use. Draft Copy

Safety Symbols & Other Marks 3-8 Product Safety Draft Copy

Basic Operation 4-1 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. 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 Battery Information ................................................................................. 4-14 Pouch Use ................................................................................................. 4-22 Telemetry Mode Use ............................................................................... 4-26 Monitoring Mode Use ............................................................................. 4-27 Briefing the Patient .................................................................................. 4-28 Draft Copy

Controls, Indicators and Connectors 4-2 Basic Operation 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 4. INOP Area 5. Measurement Area 1 6. Measurement Area 2 7. Waveform 1 8. Waveform 2 9. Radio/Network/Battery Status Area 10. Leads Off Status Area 11. Silence Alarms Button 12. SmartKeys Button 13. Main Screen Button 14. Multi-Function Button Draft Copy

Controls, Indicators and Connectors Basic Operation 4-3 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. Silence Alarm Button Button Function Initiates a local silence/acknowledgment of all active alarms when enabled (IIC). Initiates a global silence/acknowledgment of all active alarms when enabled (IIC iX). Silences the "Find Device" sound. 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. Draft Copy

Controls, Indicators and Connectors 4-4 Basic Operation 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 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. SmartKey Function Start SpO2 Note — This SmartKey is unavailable when SpO2 mode is continuous. Starts a manual SpO2 measurement. 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 / Mode: Monitor Toggles between modes. In Telemetry Mode, display and audio are off; in Monitor Mode, display and audio are always on. Draft Copy

Controls, Indicators and Connectors Basic Operation 4-5 SmartKey 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. Lock/Unlock Locks/Unlocks the display. Op Mode Selects either Monitoring, Demo, Config or Service modes. Alarms Area 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.. Draft Copy

Controls, Indicators and Connectors 4-6 Basic Operation 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 Paced Mode Height Weight Date of Birth Gender Note — If you use an alternative ID, it will display at the Information Center and on printed reports. It will not display at the MX40. 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. Draft Copy

Controls, Indicators and Connectors Basic Operation 4-7 Status Area 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. Draft Copy

Operating and Navigating 4-8 Basic Operation 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 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. 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. 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. Draft Copy

Operating and Navigating Basic Operation 4-9 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. The display automatically locks when there is no interaction for the configured time period (1-30 minutes with a default of 5 minutes). Function 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 Measurement Area 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 Draft Copy

Operating and Navigating 4-10 Basic Operation Connecting/Disconnecting the Patient Cable The patient cable is connected to the MX40 as shown in the illustration below. When connecting to the MX40, there is a slight clicking sound that signifies that the cable is securely connected. Typically, the patient cable may be disconnected as shown below. Draft Copy

Operating and Navigating Basic Operation 4-11 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. Caution Never disconnect the patient cable by pulling on the leadwires, as this may damage wires over time. Draft Copy

Understanding Settings 4-12 Basic Operation 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. 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. 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 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) (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 II is the default. 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 (Set at IIC Release N or IIC iX) On, Off 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 Draft Copy

Understanding Settings Basic Operation 4-13 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. Waveform Settings at the MX40 Setting Description Wave 1 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. Wave 2 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. Draft Copy

Battery Information 4-14 Basic Operation 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. 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. 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. 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. Draft Copy

Battery Information Basic Operation 4-15 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. Activity 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. 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 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 . 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. Draft Copy

Battery Information 4-16 Basic Operation 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. 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. 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. 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. Draft Copy

Battery Information Basic Operation 4-17 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 Inserting Batteries  Insert the rechargeable lithium-ion battery using the following procedure: Open the battery compartment by lifting up on both bottom sides of the compartment door. 1 Remove the AA battery tray if present. 2 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. Draft Copy

Battery Information 4-18 Basic Operation 3 Close the battery compartment door. 4 Watch for the start-up screen on the front of the MX40 to illuminate briefly.  Insert AA batteries into the MX40 using the following procedure: 1 Open the battery compartment by lifting up on both bottom sides of the compartment door. 2 Insert the AA battery tray if not already present. 3 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. Draft Copy

Battery Information Basic Operation 4-19 4 Close the battery compartment door. 5 Watch for the start-up screen on the front of the MX40 to illuminate briefly. Removing the Batteries 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. Draft Copy

Battery Information 4-20 Basic Operation 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. 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. Lithium-ion Rechargeable Battery Charge Status Approximate Battery Life Remaining Approximate Time Remaining (ECG only) Approximate Time Remaining (ECG & Spo2 Continuous) Functionality Disabled Battery Indicator LCD Segments 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 Draft Copy

Battery Information Basic Operation 4-21 AA Battery Charge Status Approximate Battery Life Remaining Approximate Time Remaining (ECG only) Approximate Time Remaining (ECG & Spo2 Continuous) Functionality Disabled Battery Indicator LCD Segments 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 < 10 minutes Device shutdown 1 Red Red Battery Icon Draft Copy

Pouch Use 4-22 Basic Operation 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 1 See the Carry Pouch, Waterproof, Instructions for Use, P/N 453564267571, for more information. 2 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. Draft Copy

Pouch Use Basic Operation 4-23 3 Seal the pouch. 4 Secure the pouch on the patient with the ties around the patient’s shoulder and under the arm. 5 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. Draft Copy

Pouch Use 4-24 Basic Operation 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. 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 After showering, perform the following steps to continue monitoring: 1 Remove the battery. 2 Pat dry the patient cable connections at the electrodes. 3 Wipe the lead wires with care. 4 If wet, dry the outside of the MX40 with a non-lint producing cloth. 5 If wet, wipe dry the inside of the battery compartment. Dry the batteries. 6 If wet, disconnect the patient cable and shake out any water. Dry the connector pin area with a cotton swab. 7 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. Draft Copy

Pouch Use Basic Operation 4-25 Accidental Liquid Exposure 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. Draft Copy

Telemetry Mode Use 4-26 Basic Operation Telemetry Mode Use 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. Draft Copy

Monitoring Mode Use Basic Operation 4-27 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: 1 Press the SmartKeys Button. 2 Press the Mode: Telemetry / Mode: Monitor SmartKey and choose Mode: Monitor. Draft Copy

Briefing the Patient 4-28 Basic Operation 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. 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. 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. Draft Copy

Alarms 5-1 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 Technical Alarms (INOPs) ..................................................................... 5-14 Draft Copy

Alarms Overview 5-2 Alarms 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. 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. Physiological Alarms 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). INOPs 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. Draft Copy

Alarms Overview Alarms 5-3 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. Visual Alarm Indicators Warning 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. 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. Draft Copy

Alarms Overview 5-4 Alarms 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. An unacknowledged physiological alarm and INOP appears as (portrait view): An acknowledged physiological alarm and INOP with an additional unacknowledged physiological alarm appears as (landscape view): 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. Draft Copy

Alarms Overview Alarms 5-5 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. 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. 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. Draft Copy

Alarms Overview 5-6 Alarms 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 . 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. Switching off the alarms for the measurement in alarm, or switching off the measurement itself, also stops alarm indication. Pausing or Switching Off Alarms 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. Draft Copy

Alarms Overview Alarms 5-7 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. 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. Warning 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. 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. Draft Copy

Alarms Overview 5-8 Alarms 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 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. 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 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. Draft Copy

Alarms Overview Alarms 5-9 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 Red & Yellow Measurement Alarms Non-latching Alarms Visual and Audible Latching Alarm has not been acknowledged. Alarm condition still present. 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 has been acknowledged. 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. 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. Draft Copy

Physiologic Alarms 5-10 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. 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. 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. 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 yyy<xxx". Alarm Text Priority Condition Source *** APNEA Note — Only available with IIC iX. Red Respiration has stopped for longer than the preset apnea time. RESP *** ASYSTOLE Red Asystole. No QRS for 4 consecutive seconds ST/AR Basic & Enhanced Arrhythmia *** EXTREME BRADY Red Extreme Bradycardia. Heart Rate (yyy) less than Extreme Brady limit (xxx) ST/AR Basic & Enhanced Arrhythmia *** DESAT Red Very Low SpO2 Saturation. SpO2 value below Desaturation limit Note— Desat limit is set 10 points below low limit with IIC Release N. It is configurable with IIC iX. SpO2 Draft Copy

Physiologic Alarms Alarms 5-11 Alarm Text Priority Condition Source ***EXTREME TACHY Red Extreme Tachycardia. Heart Rate (yyy) greater than Extreme Tachy limit ST/AR Basic & Enhanced Arrhythmia *** VENT FIB/TACH Red Ventricular Fibrillation. Fibrillatory wave (sinusoidal wave between 2-10 Hz) for 4 consecutive seconds ST/AR Basic & Enhanced Arrhythmia *** V-TACH Red Ventricular Tachycardia. Consecutive PVCs greater than or equal to V-Tach Run limit and Heart Rate greater than V-Tach limit (xxx) ST/AR Basic & Enhanced Arrhythmia ** dQTc Yellow dQTC value has exceeded the dQTC high limit for > 5 minutes for 2 consecutive time periods. ECG/QT ** MULTI ST Yellow Two contiguous ST leads have values exceeding elevation or depression alarm limits for > 60 sec. ECG/ST ** NBP High Yellow High limit has been exceeded for high pressure limit. NBP ** NBP Low Yellow Low limit has been exceeded for low pressure limit. NBP ** QTc High Yellow QTc value has exceeded the QTc high limit for > 5 minute for2 consecutive time periods. ECG/QT ** RR HIGH Note — Only available with IIC iX. Yellow The respiration rate has exceeded the high alarm limit. RESP ** RR LOW Note — Only available with IIC iX. 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 value (yyy) less than low SpO2 limit (xxx). SpO2 ** 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 Draft Copy

Physiologic Alarms 5-12 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 * MISSED BEAT Yellow No beat detected for 1.75 x average R-R interval for Heart Rate greater than 120, or no beat for 1 second with Heart Rate greater than 120 (non-paced patient only). ST/AR Enhanced Arrhythmia * MULTIFORM PVCs Yellow The occurrence of two differently shaped Vs, each occurring at least twice within the last 300 beats as well as each occurring at least once within the last 60 beats. ST/AR Enhanced Arrhythmia * 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. ST/AR Enhanced Arrhythmia *Nurse Call Yellow The patient has pressed the Multi-Function Button on the MX40. * PACER NOT CAPTURE Yellow No QRS for 1.75 x the average R-R interval with Pace Pulse (paced patient only). ST/AR Basic & Enhanced Arrhythmia * PACER NOT PACING Yellow No QRS and Pace Pulse for 1.75 x the average R-R interval (paced patient only). ST/AR Basic & Enhanced Arrhythmia * PAIR PVCs Yellow 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 Draft Copy

Physiologic Alarms Alarms 5-13 Alarm Text Priority Condition Source * R-ON-T PVCs Yellow For Heart Rate less than 100, a PVC with R-R interval less than 1/3 the average interval followed by a compensatory pause 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.) ST/AR Enhanced Arrhythmia * RUN PVCs Yellow Run of PVCs greater than or equal to 2. ST/AR Enhanced Arrhythmia * SVT 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 Arrhythmia * VENT RHYTHM Yellow A dominant rhythm of adjacent Vs greater than Vent Rhythm limit and ventricular Heart Rate less than V-Tach limit. ST/AR Enhanced Arrhythmia * VENT TRIGEMINY Yellow A dominant rhythm of N, N, V, N, N, V (where N=supraventricular beat, V=ventricular beat). ST/AR Enhanced Arrhythmia Draft Copy

Technical Alarms (INOPs) 5-14 Alarms 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. 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. 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. In the following table, technical alarms are listed alphabetically. Alarm Text Priority Condition What to do BATTERY LOW T Source - MX40 Soft There is less than 15 minutes of monitoring time remaining (AA batteries). Lithium-ion battery level is < 10% or has <30 minutes remaining time. Replace batteries promptly to avoid shutdown and cessation of monitoring. Insert a charged lithium-ion battery pack. CANNOT ANALYZE ECG Source - MX40 (IIC iX only) and Information Center Hard 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. Draft Copy

Technical Alarms (INOPs) Alarms 5-15 Alarm Text Priority Condition What to do CHECK PAIRING Source - MX40 Yellow Technical Alarm 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. Check that the bedside monitor or cableless measurement device is correctly paired. Select the correct device to be paired. cl NBP Batt Low Source - Cableless Measurement Device Hard CL NBP Pod weak battery condition. Charge CL NBP Pod. cl NBP Batt Empty Source - Cableless Measurement Device Severe CL NBP Pod empty battery condition. Monitoring is not possible. Replace CL NBP Pod. Recharge depleted CL NBP Pod. cl NBP DISCONNECT Source - Cableless Measurement Device Hard CL NBP Pod is not connected with the MX40. Resolve interference condition. Reduce range between CL NBP Pod and MX40. cl SpO2 Batt Low Source - Cableless Measurement Device Hard CL SpO2 Pod weak battery condition. Charge CL SpO2 Pod. cl SpO2 Batt Empty Source - Cableless Measurement Device Severe CL SpO2 Pod empty battery condition. Monitoring is not possible. Replace CL SpO2 Pod. Recharge depleted SpO2 Pod. cl SpO2 DISCONNECT Source - Cableless Measurement Device Hard CL SpO2 Pod is not connected with the MX40. Resolve interference condition. Reduce range between CL SpO2 Pod and MX40. !!!/!! CUFF NOT DEFLATED Source - Cableless Measurement Device Severe Cuff pressure has exceeded the specified safety limit. Remove cuff and tubing and expel air. !!!/!! CUFF OVERPRESS Source - Cableless Measurement Device Severe Cuff pressure has increased above overpressure safety limits. Remove cuff and tubing and expel air. Draft Copy

Technical Alarms (INOPs) 5-16 Alarms Alarm Text Priority Condition What to do ECG/ARRH ALARM(S) OFF Source - MX40 Soft ECG is turned off. Turn on ECG. ECG LEADS OFF Note This INOP may also be configured to display as a Red or Yellow Technical Alarm. Source - MX40 Red or Yellow or Hard Technical Alarm Multiple leads are off. Re-attach ECG leads to patient.. <electrode> LEAD OFF Source - MX40 Hard Single lead is off. If primary lead is MCL, lead will be identified as V/C in INOP text. Re-attach ECG leads to patient. LEADSET UNPLUGGED Source - MX40 Hard Patient cable has been unplugged from the MX40. Incompatible leadset attached to patient cable. Re-attach the patient cable. Replace the leadset. LEADSET LIFE Soft The single-patient use leadset has exceeded its limit of 25 cycles. Replace with new leadset. LOCAL AUDIO OFF Source - MX40 Note — This is normal operation in Telemetry Mode. Soft There is no alarm audio notification when operating in Telemetry Mode. Change to Monitor Mode. NBP INTERRUPTED Source - Cableless Measurement Device Hard The preset maximum time for the total measurement has been exceeded. Reduce patient movement and avoid interaction with the cuff and tubing. NBP MEASURE FAILED Source - Cableless Measurement Device Hard Measurement values cannot be derived. Attach cuff to new location on patient. Replace cuff. Draft Copy

Technical Alarms (INOPs) Alarms 5-17 Alarm Text Priority Condition What to do NBP EQUIP MALF Source - Cableless Measurement Device Hard Tubing may be obstructed or kinked. Hardware malfunction. Check tubing. If condition persists, contact Service. NO ALARM DISPLAY Source - MX40 Soft When operating with Information Center Release L Or M, there is no local alarming at the MX40, networked or non-networked. Condition is not present when operating with Information Center Release N or later (unless specifically configured to operate in this way). NO CENTRAL MONITOR (appears at MX40 only) Source - MX40 Hard The MX40 is out of range of the network. Patient Sector at the Information Center is in Standby. Return the MX40 to the coverage area. Select Resume at the Information Center. NO HOST MONITOR Source - MX40 Hard The paired MX40/bedside monitor is out of short-range radio range or there is excessive radio interference. Reduce the distance between the devices. Identify and remove interference source. NO SIGNAL (appears at the Information Center only) Note — When operating with IIC iX, the INOP will display as NO DATA PWM. Source - Information Center Hard, Latched The MX40 is outside the coverage area, or No batteries in the MX40, or The MX40 has failed. 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 BATTERY T Source - MX40 Note — This INOP may also be configured to display as a Red or Yellow Technical Alarm. Red or Yellow or Hard Technical Alarm, Latched Dead battery. No monitoring is occurring. Replace batteries. RESP EQUIP MALF Source - MX40 Hard Malfunction in the Resp equipment. MX40 requires calibration. Contact Service. RESP LEAD OFF Note — OR leadsets cannot be used to monitor Resp with the MX40. Source - MX40 Hard Resp lead off. Re-attach lead to patient. Draft Copy

Technical Alarms (INOPs) 5-18 Alarms 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 Source - MX40 Hard Malfunction in the SpO2 equipment Contact Service. SpO2T ERRATIC Source - MX40 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. SpO2T EXTD UPDATE Numeric is replaced by a -?-. Source - MX40 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. SpO2T LOW PERF Source - Monitor 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 INTERFERENCE Source - MX40 Hard Level of ambient light or level of electrical interference are so high that the SpO2 sensor cannot measure SpO2 and pulse rate. Reduce ambient light to sensor or electrical noise sources. SpO2T NO SENSOR Note — Silencing this technical alarm turns off the SpO2 measurement on the MX40 and at the Information Center. Source - MX40 Hard No sensor attached to SpO2 device. Attach SpO2 sensor. %SpO2T NOISY SIGN Source - MX40 Hard Excessive patient movements or electrical interference are causing irregular pulse patterns Reduce movement or electrical noise sources. SpO2T NO PULSE Source - MX40 Note — When paired directly with an IntelliVue MP5 Patient Monitor, the INOP will display as SpO2T SENSOR OFF. 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. Draft Copy

Technical Alarms (INOPs) Alarms 5-19 Alarm Text Priority Condition What to do SpO2 POOR SIGNAL Source - MX40 Soft Although a measurement may be possible, its accuracy may be reduced due to poor signal quality. Apply the sensor according to the manufacturer's instructions. Relocate the sensor to a different site on the patient. SpO2T SEARCHING Source - MX40 Soft The patient signal is analyzed, but a valid numeric is not available yet. Wait for the measurement to complete. SpO2T SENSOR OFF Note — The ability of the algorithm to detect this condition depends on the sensor type in use. Hard The algorithm has determined that a sensor is connected, but not properly applied to the patient. Apply the sensor according to the manufacturer's instructions. If the condition persists, relocate the sensor to a different site on the patient. SpO2T SENSOR MALF Source - MX40 Hard Malfunction of the SpO2 sensor/adapter cable Replace sensor. SpO2 UNKN SENSOR Source - MX40 Hard The connected SpO2 sensor and/or adapter cable is not supported by the hardware version. Use specified sensor and/or adapter cable. SpO2T UPGRADE Source - MX40 Soft SpO2 hardware is in upgrade process. Monitoring is not possible. Wait for the upgrade process to complete. TELE BATT EMPTY Note — This INOP may 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". 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. TELE BATTERY TEMP Source - MX40 Note — For Information Center Release L or M, this INOP will appear as "REPLACE BATTERY T" Hard The temperature of the lithium-ion battery is above 55o C or below -5o C. Replace the lithium-ion battery. TELE CHECK BATT Source - MX40 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. Draft Copy

Technical Alarms (INOPs) 5-20 Alarms Alarm Text Priority Condition What to do TELE MALFUNCTION Source - MX40 Hard MX40 malfunction or self-test failure. Contact Service to replace the MX40. TELE REMOVE BATT Source - MX40 Note — For Information Center Release L or M, this INOP will appear as "REPLACE BATTERY T". Hard, Latched The temperature of the lithium-ion battery is >60o C and the battery must be removed. Replace the lithium-ion battery. Dispose of old battery properly. TELE SERVICE BATT Source - MX40 Hard The lithium-ion battery has exceeded the maximum charge cycle limit and reached the end of its useful life. Replace the lithium-ion battery. Dispose of old battery properly. TELE WEAK SIGNAL Source - MX40 Soft Patient is at outer range of the radio coverage area. The MX40 is receiving a weak signal with high data loss from the AP. Condition exists for multiple devices in a specific area 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 TRANSMITTER OFF Source - MX40 Hard RF Auto Shutoff after 10 minutes of all leads off and no SpO2 sensor connected. Reattach ECG leads to patient. Reattach SpO2 sensor. UNSUPPORTED LAN Source - MX40 Hard The MX40 (WLAN) is connected to the Access Point, but cannot obtain an IP address. Correct the IP address issue. WIFI OUT OF RANGE Source - MX40 Hard The MX40 (WLAN) is out of range of an access point. Correct the RF coverage issue. Draft Copy

ECG and Arrhythmia Monitoring 6-1 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 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 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 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 Draft Copy

ECG Safety Information 6-2 ECG and Arrhythmia Monitoring 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. 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. Every lead must be secured to an electrode on the patient. Conductive parts of electrodes must not contact earth or other conductive parts. 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. Draft Copy

ECG Safety Information ECG and Arrhythmia Monitoring 6-3 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. Note— When switching from EASI to standard monitoring, there is a momentary loss of data. For Paced Patients Warnings 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. 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. Draft Copy

ECG Safety Information 6-4 ECG and Arrhythmia Monitoring 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. 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. Draft Copy

Measuring ECG ECG and Arrhythmia Monitoring 6-5 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. 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. Draft Copy

Connecting and Positioning ECG Electrodes 6-6 ECG and Arrhythmia Monitoring 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. 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. Problems with the ECG signal stem from two main sources: 1 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 2 Frequency-related sources resulting in dropouts from signal disturbances and loss of signal. See Risk Management Considerations p. 15-5. 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. 1 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. Draft Copy

Connecting and Positioning ECG Electrodes ECG and Arrhythmia Monitoring 6-7 Use ECG skin preparation paper (abrasive) to remove dead skin cells and to improve the conductivity of the electrode site. 2 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. 3 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. 4 Attach the patient cable to the MX40. An ECG waveform and numeric appear on the monitor display. Draft Copy

Selecting the Primary and Secondary ECG Leads 6-8 ECG and Arrhythmia Monitoring 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 the QRS complex should be tall and narrow the P-waves and T-waves should be less than 0.2 mV Draft Copy

Checking Paced Status ECG and Arrhythmia Monitoring 6-9 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. 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. 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. 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. Draft Copy

Understanding the ECG Display 6-10 ECG and Arrhythmia Monitoring Understanding the ECG Display Your display may be configured to look slightly different. 1. Lead label of the displayed wave 2. 1 mV calibration bar 3. Pacer spikes 4. Current heart rate 5. Current heart rate alarm limits 6. EASI lead placement label (located here when active) 7. Paced status ECG HR numeric: This is the heart rate derived from the monitored ECG. Pacer Spikes: The pacer spikes are shown in white. Draft Copy

Monitoring Paced Patients ECG and Arrhythmia Monitoring 6-11 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: 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. 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. 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 Draft Copy

Changing the Size of the ECG Wave 6-12 ECG and Arrhythmia Monitoring 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: 1 Touch the HR parameter. 2 In the Setup ECG menu, scroll to the second page and select Adjust Size. 3 Select the required adjustment factor from the list. Size X1/2 to halve the wave size Size X1 to display the wave without zoom Size X2 to double the wave size Size X4 to multiply the wave size by four or 4 Touch the ECG wave and enter the size from the Change Wave menu. 5 Select the required adjustment factor from the list. Draft Copy

Choosing EASI or Standard Lead Placement ECG and Arrhythmia Monitoring 6-13 Choosing EASI or Standard Lead Placement Choose either standard lead placement or EASI lead placement: 1 In the Setup ECG menu, select Lead Placement to toggle between Standard or EASI. 2 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. See the sections on Lead Placement for electrode placement diagrams. Draft Copy

Derived 12-lead ECG 6-14 ECG and Arrhythmia Monitoring 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. 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 Hexad derived ECG and their measurements are approximations to the standard ECG, and should not be used for diagnostic interpretation. EASI 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. Draft Copy

ECG Configuration ECG and Arrhythmia Monitoring 6-15 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 IEC AAMI IEC RA I R White Red LA S L Black Yellow LL A F Red Green RL N N Green Black V/Va E C/Ca Brown White Vb Cb Brown/White White/Blue 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). Draft Copy

ECG Leads Monitored 6-16 ECG and Arrhythmia Monitoring 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 Sourced (raw) waves are received as: Channel 1 = II Channel 2 = III Channel 3 = MCL Factory Defaults are II, V, III. 5-wire (EASI mode) I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 In EASI mode, the sourced (raw) waves are received as: Channel 1 = Vector 1 (A-I) Channel 2 = Vector 2 (A-S) Channel 3 = Vector 3 (E-S) 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. Draft Copy

ECG Leads Monitored ECG and Arrhythmia Monitoring 6-17 If you are using ... these leads can be selected at the MX40 and the Information Center 6-wire 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 be selected for Va even though Vb does not appear to be used. 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 Derived leads are labeled, e.g. dV3. Draft Copy

Reconstructed Leads 6-18 ECG and Arrhythmia Monitoring 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 Clinical Calculations in terms of electrodes 3-wire 5-wire Standard 6-wire I I I LA-RA II (default) II (default) II (default) LL-RA III III (default) III (default) LL-LA - MCL V-LA, where V=C - aVR aVR RA-(LA+LL)/2 - aVL aVL LA-(RA+LL)/2 - aVF aVF LL-(LA+RA)/2 - V (default) 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 Draft Copy

Chest Electrode Placement ECG and Arrhythmia Monitoring 6-19 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 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 For accurate chest electrode placement and measurement, it is important to locate the fourth intercostal space.  To locate the fourth intercostal space: 1 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. 2 Palpate and count down the chest until you locate the fourth intercostal space. Draft Copy

3-Wire Placement 6-20 ECG and Arrhythmia Monitoring 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 3. LL - on the left lower abdomen Draft Copy

5-Wire Placement (Standard Mode) ECG and Arrhythmia Monitoring 6-21 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 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 Draft Copy

5-Wire Placement (EASI Mode) 6-22 ECG and Arrhythmia Monitoring 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 5. N (Reference) can be anywhere, usually below the sixth rib on the right hip Make sure that the S and E electrodes line up vertically on the sternum, and that the I, E and A electrodes align horizontally. Draft Copy

6-Wire Placement ECG and Arrhythmia Monitoring 6-23 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. 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 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. Draft Copy

6-Wire Placement (Hexad Mode) 6-24 ECG and Arrhythmia Monitoring 6-Wire Placement (Hexad Mode) The diagram below shows the Mason-Likar Placement for 12-Lead ECG using 6 electrodes. Note — In Hexad mode, V leads are chosen in pairs at the IntelliVue Information Center iX. 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. 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 Draft Copy

Monitoring during Leads Off ECG and Arrhythmia Monitoring 6-25 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 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. 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 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. Draft Copy

Monitoring during Leads Off 6-26 ECG and Arrhythmia Monitoring 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: 1 Respond promptly to any technical alarm. 2 Ensure that the arrhythmia algorithm is labeling beats correctly. Draft Copy

ST/AR Arrhythmia Monitoring ECG and Arrhythmia Monitoring 6-27 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. 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: 1 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. 2 Beat detection to locate the QRS complexes for further analysis. 3 Feature measurement such as R-wave height, width, and timing. 4 Beat classification. Templates are created and are matched to incoming beats, and the appropriate beat label is determined. 5 Atrial Fibrillation Detection. Analyzes the RR intervals and P waves. 6 Ventricular Fibrillation Detection. Looks for a flutter or sinusoidal wave pattern in both ECG channels 7 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. Draft Copy

ST/AR Arrhythmia Monitoring 6-28 ECG and Arrhythmia Monitoring For additional information on the ST/AR Algorithm, refer to the Arrhythmia Monitoring ST/AR Algorithm Application Note. Aberrantly-Conducted Beats 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. Atrial Fibrillation Alarm 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 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 Draft Copy

ST/AR Arrhythmia Monitoring ECG and Arrhythmia Monitoring 6-29 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. 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. 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. To check your enabled settings, view the Standby screen. Cardiotach Alarms Additional Alarms with Basic Arrhythmia Option Additional Alarms with Enhanced Arrhythmia Option ***Asystole ***Ventricualr Fibrillation/ Tachycardia ***Extreme Bradycardia ***Extreme Tachycardia */**High heart rate */**Low heart rate ***Ventricular Tachycardia *Pacer Not Capture *Pacer Not Pacing *PVCs/min HIGH (PVC > limit/min) *Afib *End Afib *Supraventricular Tach *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 Draft Copy

ST/AR Arrhythmia Monitoring 6-30 ECG and 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. 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. 1. Extreme Brady Limit 2. Low Limit 3. High Limit 4. Extreme Tachy Limit 5. Extreme Brady (D value) 6. Extreme Tachy (D value) 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. Draft Copy

ST/AR Arrhythmia Monitoring ECG and Arrhythmia Monitoring 6-31 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 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. Viewing Arrhythmia Waves  To view arrhythmia beat labels: 1 Go to the Setup ECG menu. 2 Select Arrhythmia. 3 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: 1 Select Annotate Arrhy. 2 Change to Off. 3 Exit from the Setup ECG menu. Draft Copy

ST/AR Arrhythmia Monitoring 6-32 ECG and 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 L = Learning patient's ECG A = Artifact (noisy episode) ? = Insufficient information to classify beats I = Inoperative condition (e.g., LEADS OFF) M = Pause or missed beat Draft Copy

ST/AR Arrhythmia Monitoring ECG and Arrhythmia Monitoring 6-33 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 Yellow Arrhythmia Alarms PVC Alarms Chain Rate Alarms Chain Beat Detection Alarms Chain Afib/End Afib ↓ lHR/End IHR Non Sustain VT/Vent Rhythm ↓ Run PVCs ↓ Pair PVCs ↓ R-On-T PVCs ↓ SVT ↓ HR > xxx or HR < xxx Pause ↓ 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 Draft Copy

ST/AR Arrhythmia Monitoring 6-34 ECG and 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 ↓ Yellow Arrhythmia Alarms PVC Alarms Chain Beat Detection Alarms Chain Rate Alarms Chain Pacer Not Capture/Pacer Not Pace HR > xxx or HR < xxx First Level Timeout Period ---------------------------------------------------------------------------------------------------------------------------------------------------------- Second Level Timeout Period PVCs >xx/min 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: Draft Copy

ST/AR Arrhythmia Monitoring ECG and Arrhythmia Monitoring 6-35 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. 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. When the MX40 re-associates with the Information Center. Multilead Analysis 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. Draft Copy

ST/AR Arrhythmia Monitoring 6-36 ECG and 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 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: 1 Respond to the INOP message (for example, re-connect the electrode(s). 2 Ensure that the arrhythmia algorithm is labeling beats correctly. 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. Draft Copy

ST/AR ST Analysis Algorithm ECG and Arrhythmia Monitoring 6-37 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. Note—The ST Analysis algorithm does not analyze ventricularly paced or ventricular ectopic beats. Warning 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. 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 Draft Copy

ST/AR ST Analysis Algorithm 6-38 ECG and Arrhythmia Monitoring 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 3. Difference = ST value 4. ST measurement point. Default = J+60 msec 5. Isoelectric point. Default = -80 msec 6. P 7. Q 8. S 9. T 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: 1 Select the Measurements ST page. 2 Click the I/O ST or I/O STE Analysis button to toggle ST or STE Analysis on or off as appropriate. Draft Copy

ST/AR ST Analysis Algorithm ECG and Arrhythmia Monitoring 6-39  To turn ST monitoring on or off at the IntelliVue Information Center Release N: 1 From the Patient Window, click the All Controls button. 2 From the All Controls Window, click the ST Setup button. 3 From the ST Setup Window, click ST On/Off as appropriate. Displayed ST Data 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. Displayed STE Data 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. 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. Draft Copy

ST/AR ST Analysis Algorithm 6-40 ECG and Arrhythmia Monitoring Derived 12 Lead ECG 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. Caution Derived ECG and their measurements are approximations to the standard ECG, and should not be used for diagnostic interpretation. 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: 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 Draft Copy

ST/AR ST Analysis Algorithm ECG and Arrhythmia Monitoring 6-41 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. 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. ST Alarms 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 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. Draft Copy

QT Interval Monitoring 6-42 ECG and Arrhythmia 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. 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 Draft Copy

QT Interval Monitoring ECG and Arrhythmia Monitoring 6-43 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 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. How the QT Analysis Algorithm Works 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. Draft Copy

QT Interval Monitoring 6-44 ECG and Arrhythmia 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: 1 From the Patient Window, click the All Controls button. 2 From the All Controls Window, click the QT Setup button. 3 From QT Setup, click the QT Analysis On checkbox. 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.  To turn QT Monitoring on/off at the IntelliVue Information Center iX: 1 Select the Measurements button from the Main Setup Window. 2 From the Measurements Window, select QT. 3 Click the I/O QT Analysis button to toggle on or off as appropriate. 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. Draft Copy

QT Interval Monitoring ECG and Arrhythmia Monitoring 6-45 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. 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 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 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. Draft Copy

QT Interval Monitoring 6-46 ECG and Arrhythmia Monitoring Draft Copy

Monitoring Pulse Rate 7-1 7. Monitoring Pulse Rate This section provides an introduction to the Pulse measurement and its application. Pulse Rate Measurement .......................................................................... 7-2 Displaying the Pulse Rate Measurement at the MX40 ......................... 7-3 Draft Copy

Pulse Rate Measurement 7-2 Monitoring Pulse Rate 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. 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. Draft Copy

Displaying the Pulse Rate Measurement at the MX40 Monitoring Pulse Rate 7-3 Displaying the Pulse Rate Measurement at the MX40  To display the pulse rate measurement at the MX40: 1 If not already selected, press the Main Screen button and select the 1 waveform with 4 numerics display. 2 If pulse is not already displayed, touch a numeric. 3 Select Change Numeric. 4 Select Pulse. Draft Copy

Displaying the Pulse Rate Measurement at the MX40 7-4 Monitoring Pulse Rate Draft Copy

Monitoring Respiration Rate (Resp) 8-1 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. Respiration Rate Measurement ............................................................... 8-2 Resp Safety Information ........................................................................... 8-3 Lead Placement for Monitoring Resp ..................................................... 8-4 Displaying Resp on the MX40 ................................................................. 8-5 Draft Copy

Respiration Rate Measurement 8-2 Monitoring Respiration Rate (Resp) 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. 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. Draft Copy

Resp Safety Information Monitoring Respiration Rate (Resp) 8-3 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. 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. Draft Copy

Lead Placement for Monitoring Resp 8-4 Monitoring Respiration Rate (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 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. Cardiac Overlay 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. 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. Draft Copy

Displaying Resp on the MX40 Monitoring Respiration Rate (Resp) 8-5 Displaying Resp on the MX40  To display the Resp waveform and/or numeric: 1 At the IntelliVue Information Center iX, select the Measurements button from the Main Window. 2 From the Measurements Window, select Resp. 3 Click the I/O Resp button to toggle on or off as appropriate. 4 At the MX40, select a waveform area to display the Resp waveform. 5 The Change Wave menu is displayed. 6 From the Change Wave menu, select Resp. 7 Select any measurement numeric to change to display the Resp numeric. 8 Select Change Numeric (it may be necessary to scroll down). Note — The Change Wave menu is also used to adjust the Resp waveform size at the MX40 and at the IntelliVue Information Center iX.) 9 From the Change Numeric menu, select Resp. Draft Copy

Displaying Resp on the MX40 8-6 Monitoring Respiration Rate (Resp) Draft Copy

SpO2 Monitoring 9-1 9. SpO2 Monitoring This section provides an introduction to the SpO2 measurement and its application. SpO2 Safety Information ........................................................................... 9-2 Pulse Oximetry Measurement ................................................................. 9-5 Draft Copy

SpO2 Safety Information 9-2 SpO2 Monitoring SpO2 Safety Information Warnings Always confirm monitor observations with clinical observation of the patient before administering interventions. 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. Interference leading to inaccurate measurements can be caused by: High levels of ambient light (Hint: cover application site with opaque material) Electromagnetic interference 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. Draft Copy

$SpO2 Safety Information SpO2 Monitoring 9-3 At elevated ambient temperatures, be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41o C on the skin if the initial skin temperature does not exceed 37o C. Avoid placing the sensor on extremities with an arterial catheter or intravascular venous infusion line. Sensors connected to the MX40 but not applied to the patient, can produce an error measurement. To avoid misdiagnosis, ensure the sensor is properly applied to the patient. Cautions If you measure SpO2 on a limb that has an inflated NBP cuff, a non-pulsatile SpO2 INOP (SpO2T NO PULSE) can occur. If the monitor is configured to suppress this alarm, there may be a delay of up to 60 seconds in indicating critical patient status, such as sudden pulse loss or hypoxia. Do not use OxiCliq disposable sensors in a high humidity environment, such as an incubator, or in the presence of fluids, which may contaminate sensor and electrical connections causing unreliable or intermittent measurements. Do not use disposable sensors on patients who have allergic reactions to the adhesive. When the MX40 is connected to a patient monitor using the MX40 / IntelliVue Patient Monitor Adapter Cable, (p/n 989803172211), the SpO2 sensor must be directly connected to the patient monitor to monitor SpO2. Do not use more than one extension cable (M1941A). See Appendix A, Accessories, for information on which sensors cannot be used with an extension cable. Position the sensor cable away from power cables to avoid electrical interference. SpO2 Information for the User The pulse oximeter is calibrated to indicate functional oxygen saturation (fractional oxyhemoglobin), and displayed results can range from 0 to 100%. Draft Copy$