op y ft C D ra IntelliVue MX40 Instructions for Use Release B.
Notice Proprietary Information This document contains proprietary information, which is protected by copyright. First Edition 2012 4535 643 15721 Copyright op y 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.
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.
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.
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 D ra ft C op y A Note contains additional information on the product's usage.
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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.
Inserting/Removing Batteries ------------------------------------------------Inserting Batteries---------------------------------------------------------------Removing the Batteries -------------------------------------------------------Battery Charge Status ---------------------------------------------------------Lithium-ion Rechargeable Battery Charge Status -------------------AA Battery Charge Status --------------------------------------------------- 4-16 4-17 4-19 4-20 4-20 4-21 Pouch Use -----------
ft C op y 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 ------------------------------------------
EASI ECG Monitoring -------------------------------------------------------- 6-36 6-36 6-37 6-37 6-38 6-38 6-38 6-39 6-39 6-40 6-40 6-41 ST Alarms -------------------------------------------------------------------------STE Alarms -----------------------------------------------------------------------QT Interval Monitoring--------------------------------------------------------------Intended Use ---------------------------------------------------------------------How the QT Analysis Algorithm Works -------
Understanding SpO2 Alarms --------------------------------------------------- 9-10 10.
op y AC Power Source ---------------------------------------------------------------Industrie Canada Compliance (Canada)----------------------------------Safety Standards ----------------------------------------------------------------Intended Use Statement ------------------------------------------------------Indications for Use --------------------------------------------------------------Intended Uses of MX40 -------------------------------------------------------Authorized EU Representative -----------
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.
op y ft C D ra 8 Contents
1. Introducing the IntelliVue MX40 This section introduces the IntelliVue MX40 wearable patient monitor. MX40 Features ........................................................................................... 1-2 MX40 Models ............................................................................................. 1-3 D ra ft C op y MX40 Release B.0 Compatibility .............................................................
MX40 Features MX40 Features Easy for clinicians to use and comfortable for patients to wear. 2.8" color, touch sensitive display. Smart, multi-measurement cable system available for use with reusable and single-patient use supplies. FAST SpO2 (continuous, automatic or manual measurement). Standard, EASI or Hexad ECG lead system selection. Impedance-based Respiration measurement.
MX40 Models MX40 Models D ra ft C op y The MX40 is available in three models (ECG only, ECG and FAST SpO2, or ECG and SpO2 Ready (for future upgrade).
MX40 Release B.0 Compatibility MX40 Release B.0 Compatibility The MX40 is compatible for use with IntelliVue Information Center Release N and IntelliVue Information Center iX Release A. Limited compatibility is offered when used with IntelliVue Information Center Release L or M. See the "Operating with Release L or M" chapter for more information. The MX40 is compatible for use with IntelliVue Patient Monitors Release G or later when wirelessly connected.
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. D ra ft C op y New Features and Enhancements ...........................................................
New Features and Enhancements New Features and Enhancements Compatibility The MX40 B.0 offers compatibility with the new IntelliVue Information Center iX Respiration The MX40 now offers a Respiration Rate measurement (available with the IntelliVue Information Center iX only).
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 D ra ft C op y Safety Symbols & Other Marks ...............................................................
General Safety General Safety Warnings The MX40 operates exclusively via a wireless network connection, thereforel, it should not be used for primary monitoring in applications where momentary loss of the ECG is unacceptable at the Information Center. It sends ECG and optionally pulse oximetry data to the Information Center, where the Information Center displays real-time patient data, provides alarm annunciation, data storage and review applications.
General Safety Do not use patient cables or accessory cables and sensors if prior visual inspection reveals cable damage or the presence of liquid, lint or dust inside. The system is not completely immune from radio interference although it is designed to minimize interference. Sources of interference that may be a problem include failing fluorescent lights and construction equipment. See "Electromagnetic Compatibility p. 15-8". The product should not be used next to or stacked with other equipment.
General Safety Short-range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, and DECT phones. Outside the frequency band and 5% above and below, i.e. the exclusion band according to IEC 60601-1-2, the short-range radio connection is immune up to 3V/m in the frequency range from 80MHz to 2.5 GHz. Depending on the strength and duration of the interference, the interruption may occur for an extended period.
Safety Symbols & Other Marks Safety Symbols & Other Marks The table below describes the safety symbols and other markings present on the MX40 and the lithium-ion battery.
Safety Symbols & Other Marks Label Definition Disposal Dispose of in accordance with the local country’s requirements. 2002/96/EC (Waste Electrical and Electronic Equipment). Follow operating instructions. op y Prescription Device CSA Mark for ft C Certified by CSA to the applicable Canadian and US standards.. Defibrillation Proof D ra Patient connections are protected against defibrillation (DEFIBRILLATION-PROOF) and are a TYPE CF APPLIED PART.
Safety Symbols & Other Marks Label Definition IPX Waterproof Rating Protected against the effects of temporary immersion in water. 2D Barcode UL Listed Device Listed by Underwriters Laboratories D ra ft C op y Attention! See Instructions for Use.
D ra ft C op y Safety Symbols & Other Marks 3-8 Product Safety
4. Basic Operation This section gives you an overview of the IntelliVue MX40 and its functions. It tells you how to perform tasks that are common to all measurements, such as turning a measurement on and off, adjusting wave size and information in preparation for use. op y 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 Controls, Indicators and Connectors This section describes the clinical controls of the IntelliVue MX40. These controls include buttons, display icons, visual and auditory indicators, ports, and safety labeling located on the front and back of the device. MX40 Controls and Indicators 1. Patient Cable 2. Patient Information Area 3. Active Alarms Area op y 4. INOP Area 5. Measurement Area 1 6. Measurement Area 2 7. Waveform 1 8. Waveform 2 D ra ft C 9.
Controls, Indicators and Connectors Multi-Function Button Button Function Depending on configuration at the Information Center: generates a Nurse Call; Initiates a Delayed Recording; Both, or; None Note — the Multi-Function Button does not operate when paired with an IntelliVue Patient Monitor via the short-range radio connection. Button op y Silence Alarm Button Function Initiates a local silence/acknowledgment of all active alarms when enabled (IIC).
Controls, Indicators and Connectors Main Screen Button Button Function Activates the Touch Display if touched for two seconds. Cycles through the display screens if touched repeatedly. Resumes from Standby. When pressed from a sub-menu, returns display to the Main Screen. SmartKeys op y The following table lists the SmartKeys available on the display of the MX40. Note—gray text on a SmartKey signifies that the item is unavailable. Function Start SpO2 Starts a manual SpO2 measurement.
Controls, Indicators and Connectors Function Standby Puts the device into Standby locally and at the Information Center. Displays purchased/enabled product options. To resume from Standby, touch the Main Screen button. Add/Remove Displays available monitors and IntelliVue Cableless Measurements to assign to via the short-range radio. Print Reports Prints the pre-configured report as designated at the Information Center. Vitals Trends View up to 24 hours of tabular trend data. One hour standard.
Controls, Indicators and Connectors Patient Information Area The Patient Information Area displays the following information: Bed Label Patient Name (up to 15 characters will display) Time Touching the Patient Information Area displays the Patient Demogr.
Controls, Indicators and Connectors Status Area D ra ft C op y 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.
Operating and Navigating Operating and Navigating The principle method of operating your MX40 is via the Touch Display. Almost every element on the display is interactive. Display elements include measurement numerics, information fields, alarm fields, waveforms, SmartKeys and menus. Power-On Self Test op y Once battery power is supplied, the MX40 performs a power-on self test to check operational status prior to start-up.
Operating and Navigating Locking the Display To provide additional protection against accidental patient access to the MX40, the display can be locked using the Lock SmartKey. When Lock is selected, the SmartKey menu automatically changes to the Main Screen. When Unlock is selected, you must close the SmartKey menu to return to the Main Screen.
Operating and Navigating Connecting/Disconnecting the Patient Cable op y The patient cable is connected to the MX40 as shown in the illustration below. ft C When connecting to the MX40, there is a slight clicking sound that signifies that the cable is securely connected. D ra Typically, the patient cable may be disconnected as shown below.
Operating and Navigating Caution op y 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. D ra ft C Never disconnect the patient cable by pulling on the leadwires, as this may damage wires over time.
Understanding Settings Understanding Settings Each aspect of how the MX40 works and looks is defined by a setting. There are a number of different categories of settings, including: Screen Settings - to define the selection and appearance of elements on each individual display screen. Measurement Settings - to define setting unique to each measurement, e.g. high and low alarm limits.
Understanding Settings Setting Description ECG Set ECG On/Off New Lead Setup When IntelliVue Patient Monitor lead sets are in use, select 3-wire, or 5-wire. Va Lead Shows position of Va, or C1, electrodes. Choices are V1-V9, v3R, V4R, V5R. Vb Lead Shows position of Vb, or C2, electrodes. Choices are V1-V9, v3R, V4R, V5R. Change Numeric Selects parameter numeric to display in place of current HR numeric.
Battery Information Battery Information Battery Safety Information Warnings The battery compartment door must be closed during defibrillation. Use the Philips Rechargeable Lithium-ion Battery or 3 Duracell Alkaline batteries, size AA, MN 1500, 1.5V, to ensure specified performance and correct battery gauge reporting. Outdated, mismatched, or poor-quality batteries can give unacceptable performance (e.g., insufficient Battery-Low warning time).
Battery Information Lithium-ion Rechargeable Battery Care Care of the rechargeable battery begins when you receive a new battery for use and continues throughout the life of the battery. The table below lists battery care activities and when they should be performed. When to Perform Perform a visual inspection. Before inserting a battery in the MX40. Charge the battery. Upon receipt, after use, or if a low battery state is indicated.
Battery Information Do not incinerate batteries or expose them to temperatures above 60oC (140oF). If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not: discontinue use. dispose of the battery in accordance with the disposal instructions. Lithium-ion Rechargeable Battery Storage When storing rechargeable batteries, make sure that the battery terminals do not come into contact with metallic objects or other conductive materials.
Battery Information The battery compartment is located on the back of the MX40, accessible by opening the compartment door from the bottom. It accommodates three AA 1.5V Alkaline batteries or the Philips Rechargeable Lithium-ion battery. Only these batteries should be used. Note— Lithium-ion batteries should be fully charged prior to first use. Important— Do not use other rechargeable batteries.
ft C op y Battery Information Close the battery compartment door. 4 Watch for the start-up screen on the front of the MX40 to illuminate briefly. D ra 3 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.
op y Battery Information Close the battery compartment door. 5 Watch for the start-up screen on the front of the MX40 to illuminate briefly. ft C 4 Removing the Batteries D ra Batteries should be removed when the MX40 is not in use or is being stored. To remove the batteries, open the battery compartment door and push from the opening at the bottom of the compartment to pop the batteries out. Device settings (patient cable type, SpO2 mode, volume, etc.) are retained when the batteries are removed.
Battery Information Disposal of Batteries When disposing of batteries, follow local laws for proper disposal. Dispose of batteries in approved containers. If local regulations require you to recycle batteries, recycle batteries in accordance with those regulations. Battery Charge Status The battery charge indicator displays in the Status Area and communicates the remaining battery charge time when using both AA batteries or the rechargeablelithium-ion battery.
Battery Information AA Battery Charge Status Approximate Time Remaining (ECG only) Approximate Functionality Battery Time Disabled Indicator Remaining LCD (ECG & Spo2 Segments Continuous) 100% ~ 24 hours ~ 9 hours None 5 Green 75% < 18 hours < 7 hours None 4 Green 50% < 12 hours < 5 hours None 3 Green 25% < 6 hours < 2 hours None 2 Green 10% < 2 hours < 1 hours None 1 Green Low battery level to replace/charge battery level < 30 minutes < 30 minutes SpO2 and short-range radio a
Pouch Use Pouch Use The MX40 is not intended for direct contact with the patient’s skin. During normal use, the MX40 should be worn over clothing, in a pocket or, preferably, in a pouch. The Waterproof Carry Pouch with clear front is an appropriate means for holding the MX40. See Appendix A, "Accessories" for ordering information. Securing the Pouch See the Carry Pouch, Waterproof, Instructions for Use, P/N 453564267571, for more information.
Pouch Use Seal the pouch. 4 Secure the pouch on the patient with the ties around the patient’s shoulder and under the arm. D ra ft C op y 3 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.
Pouch Use Showering Warning When the patient is showering, signal quality and leads off detection may be compromised due to significant movement. Appropriate clinical precautions must be taken. Caution Because the touchscreen display is sensitive to water impact, the display should be locked when showering. op y 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.
Pouch Use Accidental Liquid Exposure D ra ft C op y 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.
Telemetry Mode Use Telemetry Mode Use D ra ft C op y 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.
Monitoring Mode Use Monitoring Mode Use You may find the use of Monitoring Mode helpful when spending extended time directly with your patient, e.g. during transport, showering, dressing change. The display is always on for easy viewing and should an alarm condition occur, it will be announced locally at the MX40 and at the Information Center if networked connected. If the MX40 is not network connected, the alarm is only announced locally. To use Monitor Mode: Press the SmartKeys Button.
Briefing the Patient Briefing the Patient Warning Patients should be instructed not to interact with the display of the device and to not open the battery compartment while the MX40 is in use. Note — Pausing alarms at the Information Center activates the MX40 display. Patients should be notified that this is normal operation and not cause for any concern.
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 D ra ft C op y Technical Alarms (INOPs) .....................................................................
Alarms Overview Alarms Overview The MX40 has two different types of alarms: physiological alarms and INOPs. For MX40 devices operating with IntelliVue Information Center Release L and M, physiological alarms are not available locally on the MX40. INOPs are displayed as described here.
Alarms Overview The MX40 is designed to achieve visual alarm notification at a distance of up to one meter, which is consistent with its intended use model as a wearable monitor. Alarms are indicated after the alarm delay time. This is made up of the system delay time plus the trigger delay time for the individual measurement. For more information see ECG Performance Disclosure/Specifications p. 15-27 .
Alarms Overview Alarm Indicator An Alarm Indicator on the MX40 main display communicates alarm/INOP conditions that have not been acknowledged. The alarm indicator is divided into two sections and appears in the upper right hand corner normally occupied by the time display. The right section flashes for a physiological alarm, except for short yellow alarms where the indicator will light for approximately six seconds. The color is yellow or red corresponding to the highest priority alarm currently present.
Alarms Overview Audible Alarm Indicators when in Monitoring Mode The audible alarm indicators configured for your monitor depend on which alarm standard applies in your hospital. Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). Warning Do not rely exclusively on the audible alarm system for patient monitoring.
Alarms Overview Acknowledging Alarms To acknowledge all active physiological alarms and INOPs, touch the Silence Alarm button. This switches off the audible alarm indicators, if present, and alarm messages at the MX40 and at the IntelliVue Information Center iX. A check mark beside the alarm message indicates that the alarm has been acknowledged .
Alarms Overview While Alarms are Paused In the alarm field, the MX40 displays the message ALARMS PAUSED 1:28 or ALARMS OFF, together with the alarms paused symbol or the alarms off symbol. No alarms are sounded and no alarm messages are shown. INOP messages are shown but no INOP tones are sounded. The only exceptions are the INOPs CUFF NOT DEFLATED, NBP CUFF OVERPRESS and INOPs relating to empty, missing and malfunctioning batteries.
Alarms Overview Viewing Individual Alarm Limits You can see the alarm limits set for each measurement next to the measurement numeric on the main screen. Reviewing Alarms op y 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.
Alarms Overview Latching Alarms The alarm latching setting for your MX40 defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the monitor after the alarm condition ends. The indication lasts until you acknowledge the alarm by touching the Alarm Silence button.
Physiologic Alarms Physiologic Alarms Physiologic alarms indicate a life-threatening situation or a less urgent situation such as heart rate beyond limits. Warning Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.
Physiologic Alarms 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.
Physiologic Alarms Alarm Text Priority Condition Source */** HR High Yellow Heart Rate (yyy) greater than the upper Heart rate limit (xxx). ST/AR Basic & Enhanced Arrhythmia */** HR Low Yellow Heart Rate (yyy) lower than the lower Heart Rate limit (xxx). ST/AR Basic & Enhanced Arrhythmia */** IRREGULAR HR Yellow Consistently irregular rhythm (irregular R-R intervals). ST/AR Enhanced Arrhythmia Yellow No beat detected for 1.
Physiologic Alarms Alarm Text Priority Condition Source * R-ON-T PVCs Yellow For Heart Rate less than 100, a PVC with ST/AR R-R interval less than 1/3 the average Enhanced interval followed by a compensatory pause Arrhythmia of 1.25 x average R-R interval, or 2 such Vs without a compensatory pause occurring within 5 minutes of each other. (When Heart Rate is greater than 100, 1/3 R-R interval is too short for detection.) * RUN PVCs Yellow Run of PVCs greater than or equal to 2.
Technical Alarms (INOPs) Technical Alarms (INOPs) Technical Alarms, or INOPs (inoperative conditions), are sourced at the MX40, the ST/AR algorithm running at the Information Center, or the IntelliVue Patient Monitor. They identify inoperative conditions (that is conditions where the system is not operating properly and therefore cannot measure or detect alarm conditions reliably). There are four levels of Technical Alarms: Severe - Monitoring and alarm generation are disabled.
Technical Alarms (INOPs) Alarm Text Priority CHECK PAIRING Yellow Technical Alarm Source - MX40 cl NBP Batt Low Condition There is a problem with device pairing. When the MX40 is wirelessly paired with an X2 patient monitor (no label) docked with a larger networked MP series monitor, and the network connection is lost. What to do Check that the bedside monitor or cableless measurement device is correctly paired. Select the correct device to be paired. Hard CL NBP Pod weak battery condition.
Technical Alarms (INOPs) Alarm Text Priority Condition What to do ECG/ARRH ALARM(S) OFF Soft ECG is turned off. Turn on ECG. Source - MX40 ECG LEADS OFF Note This INOP may also be configured to display as a Red or Yellow Technical Alarm. Red or Yellow or Hard Technical Alarm Multiple leads are off. Re-attach ECG leads to patient.. Source - MX40 Hard Hard Source - MX40 Patient cable has been unplugged from the MX40. LOCAL AUDIO OFF Re-attach the patient cable. Replace the leadset.
Technical Alarms (INOPs) Alarm Text Priority NBP EQUIP MALF Hard Return the MX40 to the coverage area. Patient Sector at the Information Center is in Standby. Select Resume at the Information Center. The paired MX40/bedside monitor is out of short-range radio range or there is excessive radio interference. The MX40 is outside the coverage area, or ft C Hard, Latched No batteries in the MX40, or Note — When operating with IIC iX, the INOP will display as NO DATA PWM. The MX40 has failed.
Technical Alarms (INOPs) Alarm Text Priority Condition What to do SOME ECG ALARMS OFF Soft Some ECG alarms have been turned off at the Information Center. For information only. SpO2T EQUIP MALF Hard Malfunction in the SpO2 equipment Contact Service. Hard Erratic SpO2 measurements, often due to a faulty sensor or invalid SpO2 measurements, or incorrect transducer position Repeat measurement, reposition sensor on patient, or finally, replace sensor.
Technical Alarms (INOPs) Alarm Text Priority Condition SpO2 POOR SIGNAL Soft Although a measurement may be possible, its accuracy may be reduced due to poor signal quality. Source - MX40 Soft The patient signal is analyzed, but a valid numeric is not available yet. Hard The algorithm has determined that a sensor is connected, but not properly applied to the patient. Source - MX40 SpO2T SENSOR OFF Note — The ability of the algorithm to detect this condition depends on the sensor type in use.
Technical Alarms (INOPs) Alarm Text Priority Condition What to do TELE MALFUNCTION Hard MX40 malfunction or self-test failure. Contact Service to replace the MX40. Hard, Latched The temperature of the o lithium-ion battery is >60 C and the battery must be removed. Replace the lithium-ion battery. The lithium-ion battery has exceeded the maximum charge cycle limit and reached the end of its useful life. Replace the lithium-ion battery.
6. ECG and Arrhythmia Monitoring This section covers the specifics of ECG measurement and the ST/AR Arrhythmia, ST, and QT algorithms used for arrhythmia monitoring. ECG Safety Information ........................................................................... 6-2 Measuring ECG ......................................................................................... 6-5 op y Connecting and Positioning ECG Electrodes ........................................
ECG Safety Information ECG Safety Information Warnings The MX40 operates exclusively via a wireless network connection, therefore, it should not be used for primary monitoring in applications where momentary loss of the ECG is unacceptable at the Information Center. It sends ECG and optionally pulse oximetry data to the Information Center, where the Information Center displays real-time patient data, provides alarm annunciation, data storage and review applications.
ECG Safety Information Caution To protect the MX40 from damage during defibrillation, to ensure accurate ECG information, and to provide protection against signal noise and other interference, use only ECG electrodes and cables specified by Philips. Philips recommends that you change the lead label only to reflect the physical placement of electrodes. This will ensure a match between the monitored lead and the label, and prevent any possible confusion.
ECG Safety Information For paced patients who exhibit only intrinsic rhythm, the monitor can erroneously count pace pulses as QRS complexes when the algorithm first encounters them, resulting in missed detection of cardiac arrest. The risk of missing cardiac arrest can be reduced by monitoring these patients with the low heart rate limit at or slightly above the basic/demand pacemaker rate. A low heart rate alarm notifies you when the patient begins pacing.
Measuring ECG Measuring ECG The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the MX40 and the Information Center as a waveform and a numeric. In order to compare measured ECG signals, the electrodes (or patient cables) are placed in standardized positions, forming "leads". To obtain ECG signals optimized for use in diagnosis and patient management in different care environments, different leadsets in varying lead placements are used.
Connecting and Positioning ECG Electrodes Connecting and Positioning ECG Electrodes Correct lead placement is always important for accurate diagnosis. Especially in the precordial leads, which are close the heart, QRS morphology can be greatly altered if an electrode is moved away from its correct location. Each electrode is color-coded. Use the placement diagrams available on the display of the MX40 and in this section for guidance.
Connecting and Positioning ECG Electrodes Use ECG skin preparation paper (abrasive) to remove dead skin cells and to improve the conductivity of the electrode site. 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. Place the electrodes on the patient according to the lead placement you have chosen (see the electrode placement diagrams following).
Selecting the Primary and Secondary ECG Leads Selecting the Primary and Secondary ECG Leads When multilead analysis is used, the MX40 uses the primary and secondary lead selected at the Information Center to compute HR and to analyze and detect cardiac arrhythmias. They are also available for recordings and for display on the Information Center. Only the primary lead is used if your device is configured for single lead arrhythmia analysis.
Checking Paced Status Checking Paced Status It is important to set the paced status correctly when you start monitoring ECG. Note — Paced status is set at the Information Center and can only be changed at the Information Center. When Paced is set to On: Pacer Algorithm is switched on. This means that pacemaker pulses are not counted as extra QRS complexes. The pacer spikes are shown in white. The paced symbol is displayed.
Understanding the ECG Display Understanding the ECG Display Your display may be configured to look slightly different. 4. Current heart rate 2. 1 mV calibration bar 5. Current heart rate alarm limits 3. Pacer spikes 6. EASI lead placement label (located here when active) op y 1. Lead label of the displayed wave 7. Paced status ft C ECG HR numeric: This is the heart rate derived from the monitored ECG. D ra Pacer Spikes: The pacer spikes are shown in white.
Monitoring Paced Patients Monitoring Paced Patients An ECG optimized for monitoring a paced patient should look like this: 1. Normal Beats 2. Pace Pulses/Beats Choose a lead as primary or secondary lead that has these characteristics: op y 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.
Changing the Size of the ECG Wave Changing the Size of the ECG Wave If any of the displayed ECG waves is too small or clipped, you can change the size of the ECG waves on the screen. Changing the adjustment factor only changes the visual appearance of the ECG wave on the MX40. It does not affect the ECG signal analyzed by the algorithm. Comparing the wave size to the 1 mV calibration bar on the ECG wave segment can help you get an idea of the true ECG signal strength.
Choosing EASI or Standard Lead Placement 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.
Derived 12-lead ECG Derived 12-lead ECG Hexad When operating with the IntelliVue Information Center iX, the optional Hexad algorithm generates a Mason-Likar 12-lead ECG from a 6-wire leadset (including four limb electrodes and two chest electrodes) placed according to the Mason-Likar 6-electrode placement.
ECG Configuration ECG Configuration The MX40 supports 3-, 5-, and 6-wire patient cables. The 5-wire patient cable can be used for either standard or EASI electrode configurations. The 6-wire patient cable can be used for either standard or Hexad electrode configurations. The MX40 detects the patient cable type attached and automatically determines the ECG measurement and transmitted leads. Note—The labels and colors of the ECG electrodes differ according to the standards that apply for your hospital.
ECG Leads Monitored ECG Leads Monitored Depending on the patient cable connected to the MX40, a different set of viewable leads are available at the MX40 and the Information Center. The MX40 can source up to four raw ECG waves to the Information Center. If you are using ... these leads can be selected at the MX40 and the Information Center 3-wire I, II, III Sourced (raw) waves are received as: Channel 1 = I, II, or III Factory Default is II.
ECG Leads Monitored If you are using ... 6-wire these leads can be selected at the MX40 and the Information Center I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R. Sourced (raw) waves are received as: Channel 1 = II Channel 2 = III Channel 3 = Va Channel 4 = Vb Factory Defaults are II, Va = V2, III, Vb = V5. The two chest leads, Va and Vb, can be placed on the patient in any of the V lead positions (V1 through V9, V3R, V4R, V5R).
Reconstructed Leads Reconstructed Leads Reconstruction of leads from the sourced wave is defined by the calculations in the following table.
Chest Electrode Placement Chest Electrode Placement V1 on the fourth intercostal space at the right sternal border V2 on the fourth intercostal space at the left sternal border V3 midway between the V2 and V4 electrode positions V4 on the fifth intercostal space at the left midclavicular line V5 on the left anterior axillary line, horizontal with the V4 electrode position V6 on the left midaxillary line, horizontal with the V4 electrode position V3R-V6R on the right side of the chest in positions correspon
3-Wire Placement 3-Wire Placement 1. RA - directly below the clavicle and near the right shoulder 2. LA -directly below the clavicle and near the left shoulder D ra ft C op y 3.
5-Wire Placement (Standard Mode) 5-Wire Placement (Standard Mode) 1. RA directly below the clavicle and near the right shoulder 2. LA directly below the clavicle and near the left shoulder 3. RL on the left lower abdomen 4. LL on the right lower abdomen 5. V on the chest, the position depends on your required lead selection.
5-Wire Placement (EASI Mode) 5-Wire Placement (EASI Mode) 1. E (V) on the lower sternum at the level of the fifth intercostal space 2. A (LL) on the left midaxillary line at the same level as the E electrode 3. S (LA) on the upper sternum 4. I (RA) on the right midaxillary line at the same level as the E electrode ft C op y 5.
6-Wire Placement 6-Wire Placement For a 6-lead placement use the positions from the 5-lead diagram above but with two chest leads. The two chest leads, Va and Vb, can be positioned at any two of the V1 to V6 positions shown in the chest electrode diagram below. The default position of Va - the brown lead - is at the V2 position. The default position for Vb - the brown/white lead - is at the V5 position. op y The lead placement for the Va and Vb lead labels must be appropriate.
6-Wire Placement (Hexad Mode) 6-Wire Placement (Hexad Mode) The diagram below shows the Mason-Likar Placement for 12-Lead ECG using 6 electrodes. 1. RA directly below the clavicle and near the right shoulder 2. LA directly below the clavicle and near the left shoulder 3. RL on the left lower abdomen 4. LL on the right lower abdomen 5. V on the chest, the position depends on your required lead selection. The typical position is V1, although this may vary according based on your hospital’s protocol.
Monitoring during Leads Off Monitoring during Leads Off ECG Fallback and Extended monitoring states are supported for the MX40 when the primary and/or secondary leads are in a "Leads Off" INOP condition. Both of these states are entered into after 10 seconds of "Leads Off" in an attempt to maintain monitoring and arrhythmia analysis. ECG Fallback ECG Fallback occurs when the primary lead is in "Leads Off" for 10 seconds and a secondary lead is available.
Monitoring during Leads Off Warning Since Relearn happens automatically, if learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib. For this reason, you should: Respond promptly to any technical alarm. 2 Ensure that the arrhythmia algorithm is labeling beats correctly.
ST/AR Arrhythmia Monitoring ST/AR Arrhythmia Monitoring ST/AR Arrhythmia Algorithm Indications for Use The ST/AR Arrhythmia Algorithm is indicated for use in instances where the clinician decides to monitor cardiac arrhythmias of adult and pediatric patients and/or the ST segment of adult patients to gain information for treatment, monitor the adequacy of treatment, or to exclude causes of symptoms.
ST/AR Arrhythmia Monitoring For additional information on the ST/AR Algorithm, refer to the Arrhythmia Monitoring ST/AR Algorithm Application Note. Aberrantly-Conducted Beats Atrial Fibrillation Alarm op y 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.
ST/AR Arrhythmia Monitoring Intermittent Bundle Branch Block Bundle branch and the other fascicular blocks create a challenge for the arrhythmia algorithm. If the QRS during the block changes considerably from the learned normal, the blocked beat may be incorrectly classified as ventricular, causing false PVC alarms. You should always select a lead where the bundle branch block beats have an R-wave that is as narrow as possible to minimize incorrect calls.
ST/AR Arrhythmia Monitoring Note — When operating with the IntelliVue Information Center Release N or earlier, the ST/AR Arrhythmia Algorithm operates and generates alarms independently at both the MX40 and the Information Center. Therefore, you may see slight differences between the two, even though the alarm settings and limits are the same.
ST/AR Arrhythmia Monitoring Yellow Arrhythmia Alarms Yellow arrhythmia alarms are short yellow alarms specific to arrhythmia-related patient conditions. Depending on your Information Center configuration, they may be shown with one or two stars. The heart rate alarms (High HR and Low HR) can be configured as short yellow or standard yellow alarms. When they are standard yellow alarms they exist independently of the other arrhythmia alarms and no timeout periods apply.
ST/AR Arrhythmia Monitoring Arrhythmia Beat Labels Arrhythmia beat labels tell you how the monitor is classifying beats. N = Normal V = Ventricular Ectopic S = Supra-ventricular Premature P = Paced ' = Pacer spike " = Biventricular Pacer Spike A = Artifact (noisy episode) op y L = Learning patient's ECG ? = Insufficient information to classify beats I = Inoperative condition (e.g.
ST/AR Arrhythmia Monitoring Enhanced Arrhythmia Chain The diagram below shows the alarm condition priority chains for enhanced arrhythmia. The alarm conditions in each category are prioritized according to the level of seriousness.
ST/AR Arrhythmia Monitoring Basic Arrhythmia Chain The diagram below shows the alarm condition priorities for basic arrhythmia and the timeout levels for yellow alarm conditions.
ST/AR Arrhythmia Monitoring Alarm timeout periods are cleared. Stored arrhythmia templates are cleared. Asystole, Vfib, and HR alarms (when there are enough beats to compute the HR) are active. All other alarms are not active. Single Lead Analysis If single lead analysis is selected, the arrhythmia system begins learning whenever: ECG monitoring is initiated. op y The Relearn Arrhy control is activated. See Initiating Arrhythmia Relearning Manually p. 6-36.
ST/AR Arrhythmia Monitoring Note — During this learning phase the system will continue monitoring using the operative lead. Therefore, the delayed arrhythmia wave is not labeled "L". In addition: Alarm timeout periods are maintained. Stored arrhythmia templates are maintained for the operative lead. All alarms turned on are active. EASI ECG Monitoring Whenever there is an INOP condition, the arrhythmia algorithm performs a Relearn, using the available lead.
ST/AR ST Analysis Algorithm ST/AR ST Analysis Algorithm Introduction The intended use of the ST/AR ST Analysis algorithm is to monitor an adult patient’s ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST Analysis algorithm is capable of monitoring paced and non-paced adult patients. The ST/AR ST algorithm monitors ST segment elevation or depression for each available telemetry ECG lead and produces events/alarms simultaneously.
ST/AR ST Analysis Algorithm The Measurements Overview The ST/STE measurement for each beat complex is the vertical difference between two measurement points. The isoelectric point provides the baseline for both measurements. The ST measurement uses the isoelectric point and the ST point. The ST point is positioned with reference to the J-point. The STE measurement uses the isoelectric point and the J point. 1. R-wave peak at 0 msec 2. J point op y 3. Difference = ST value 4. ST measurement point.
ST/AR ST Analysis Algorithm 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 Displayed STE Data op y 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.
ST/AR ST Analysis Algorithm Derived 12 Lead ECG Caution op y 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.
ST/AR ST Analysis Algorithm HEXAD ST Analysis When operating with the IntelliVue Information Center iX, the optional Hexad algorithm generates a Mason-Likar 12-lead ECG from a 6-wire leadset (including four limb electrodes and two chest electrodes) placed according to the Mason-Likar 6-electrode placement.
QT Interval Monitoring QT Interval Monitoring Of special concern for QT monitoring is the administration of QT prolonging drugs to patients identified with risk factors for Torsade de Pointe. Females, older patients and patients with bradycardia, impaired left ventricular function (ischemia, left ventricular hypertrophy), hypokalemia and hypomagnesemia are in this increased risk category. D ra ft C op y QT interval monitoring can assist in the detection of prolonged QT interval syndrome.
QT Interval Monitoring Intended Use The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.
QT Interval Monitoring Adjusting QT Settings For patients being monitored by the MX40, you can turn QT Monitoring on/off and adjust QT settings at the IntelliVue Information Center. To turn QT Monitoring on/off at the IntelliVue Information Center Release N: 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. op y QT analysis is on when a checkmark displays in the check box.
QT Interval Monitoring Limitations for QT Monitoring Some conditions may make it difficult to achieve reliable QT monitoring. When this occurs the CANNOT ANALYZE QT INOP message displays at the Information Center, along with a QT STATUS message. Some conditions that may make reliable QT monitoring difficult include: T-Wave Detection Limitations. QRS Changes op y Flat T-wave, atrial Fibrillation or atrial Flutter and prominent U-waves can make QT monitoring difficult.
D ra ft C op y QT Interval Monitoring 6-46 ECG and Arrhythmia Monitoring
7. Monitoring Pulse Rate This section provides an introduction to the Pulse measurement and its application. Pulse Rate Measurement .......................................................................... 7-2 D ra ft C op y Displaying the Pulse Rate Measurement at the MX40 .........................
Pulse Rate Measurement Pulse Rate Measurement The pulse rate measurement counts the arterial pulsations that result from the mechanical activity of the heart in beats per minute (bpm). The pulse rate is derived from the SpO2 measurement. Displayed results can range from 30 to 300 bpm. There is no alarm function for pulse rate. D ra ft C op y The pulse numeric is displayed at the Information Center only when SpO2 is being measured continuously.
Displaying the Pulse Rate Measurement at the MX40 Displaying the Pulse Rate Measurement at the MX40 To display the pulse rate measurement at the MX40: If not already selected, press the Main Screen button and select the 1 waveform with 4 numerics display. 2 If pulse is not already displayed, touch a numeric. 3 Select Change Numeric. 4 Select Pulse.
D ra ft C op y Displaying the Pulse Rate Measurement at the MX40 7-4 Monitoring Pulse Rate
8. Monitoring Respiration Rate (Resp) This section provides an introduction to the Respiration Rate measurement and its application. Note — Resp is only available with theIntelliVue Information Center iX. op y Respiration Rate Measurement ............................................................... 8-2 Resp Safety Information ........................................................................... 8-3 Lead Placement for Monitoring Resp .....................................................
Respiration Rate Measurement Respiration Rate Measurement For the respiratory measurement (Resp), the MX40 measures the thoracic impedance between two ECG electrodes on the patient's chest. Changes in the impedance due to thoracic movement produce the Resp waveform on the display. The MX40 counts the waveform cycles to calculate the respiration rate (RR).The waveform size can be set using the Setup Resp menu which is displayed when you touch the Resp measurement area.
Resp Safety Information Resp Safety Information Warning Apnea The respiration measurement does not recognize obstructive and mixed apneas. It only indicates an alarm when a pre-adjusted time has elapsed since the last detected breath. Resp Accessories To monitor respiration, use only non-OR ECG accessories as listed in the Accessories Appendix.
Lead Placement for Monitoring Resp Lead Placement for Monitoring Resp Correct patient skin preparation techniques for electrode placement are important for Resp measurement. See Connecting and Positioning ECG Electrodes p. 6-6. The Resp measurement uses the standard MX40 patient cable. You can use 3-wire, 5-wire, or 6-wire leadsets, using either Standard or EASI placement.
Displaying Resp on the MX40 Displaying Resp on the MX40 To display the Resp waveform and/or numeric: At the IntelliVue Information Center iX, select the Measurements button from the Main Window. 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.
D ra ft C op y Displaying Resp on the MX40 8-6 Monitoring Respiration Rate (Resp)
9. SpO2 Monitoring This section provides an introduction to the SpO2 measurement and its application. SpO2 Safety Information ........................................................................... 9-2 D ra ft C op y Pulse Oximetry Measurement .................................................................
SpO2 Safety Information SpO2 Safety Information Warnings Always confirm monitor observations with clinical observation of the patient before administering interventions. op y 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.
SpO2 Safety Information At elevated ambient temperatures, be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41o C on the skin if the initial skin temperature does not exceed 37o C. Avoid placing the sensor on extremities with an arterial catheter or intravascular venous infusion line. Sensors connected to the MX40 but not applied to the patient, can produce an error measurement.
SpO2 Safety Information A 10 second averaging filter is used in the calculation of the result. Displayed results are typically updated every second, but the update period can be automatically delayed by up to 30 seconds in the presence of noise. Note — The averaging filter time period is configurable at the IntelliVue Information Center iX (default = 10 seconds). op y Physiological SpO2 alarm signals will be generated.
Pulse Oximetry Measurement Pulse Oximetry Measurement The MX40 supports an SpO2 sensor connection using Fourier Artifact Suppression Technology (FAST). The FAST algorithm overcomes many of the issues associated with traditional pulse oximetry such as sensitivity to patient movement and intense ambient light. The algorithm offers improved motion artifact rejection as well as performance improvements for patients with low perfusion.
Pulse Oximetry Measurement SpO2 Sensors Familiarize yourself with the instructions for use supplied with your sensor before using it. In particular, check that the sensor being used is appropriate for your patient category and application site. See Appendix A, Accessories, for a complete listing of supported sensors for the MX40. Selecting an SpO2 Sensor Warning op y Use only Philips-approved accessories. Use of product accessories (patient cables, SpO2 sensors, etc.
Pulse Oximetry Measurement Sensor Type When to Use Reusable You can use reusable sensors on different patients after cleaning and disinfecting them. For care and cleaning instructions, see the instructions accompanying the sensors. Reusable sensors should be changed to another site every four hours or in accordance with your clinical practice guidelines. See the Directions for Use supplied by Nellcor® Incorporated for instructions on preparation and application of reusable sensors.
Pulse Oximetry Measurement Ambient Temperature: Never apply an SpO2 sensor at ambient temperatures above 37 oC (99 oF) because this can cause severe burns after prolonged application. Extremities to Avoid: Avoid sites distal to NBP cuff, intra-arterial line, or intravascular venous infusion line. Applying the Sensor Follow the SpO2 sensor's Instructions for Use, adhering to all warnings and cautions. 2 If necessary, remove colored nail polish from the application site.
Pulse Oximetry Measurement Measuring SpO2 Warning Removal of the SpO2 sensor from the MX40 patient cable during Continuous SpO2 monitoring results in a "No Sensor" technical alarm. Silencing this alarm turns the SpO2 measurement off, however the SpO2 module is still operating in the background and consuming battery power. If you do not intend to resume continuous SpO2 monitoring, change to Manual mode. There is no technical alarm for a "No Sensor" condition in Manual mode.
Pulse Oximetry Measurement Understanding SpO2 Alarms SpO2 monitoring offers high and low limit alarms, and a high priority (red level) oxygen desaturation alarm. For adult patients, the SpO2 low limit can be set between 50 and 99% inclusive, in 1% increments. For pediatric patients, the SpO2 low limit can be set between 30 and 99% inclusive, in 1% increments. You cannot set the low limit below the desaturation limit.
10. Monitoring with other Assigned Devices This section provides information about the use of the MX40 when it is assigned to other monitoring devices. The MX40 can be assigned to IntelliVue Patient Monitors or IntelliVue Cableless Measurements for SpO2 and NBP. The connection to these other devices is done by pairing networked devices or using the integrated short-range radio of the MX40.
Pulse Oximetry Measurement Assigning Devices ...................................................................................10-3 Controls Available when Assigned to IntelliVue Cableless Measurements ..........................................................................................10-6 Controls Available when Assigned to IntelliVue Patient Monitors .10-7 Networked Device Synchronized Settings...........................................
Assigning Devices Assigning Devices Device Assignment at the Information Center You can assign an MX40 to a patient monitor at the Information Center. The data from the MX40 automatically displays as a permanent overview session in the Telemetry Data window on the patient monitor. At the Information Center the MX40 data and the patient monitor data are integrated in the patient sector. Warning op y All data presented in the Telemetry Data window are delayed for several seconds.
Assigning Devices When connected the or earlier. icon appears at the Information Center, Release N The MX40 is assigned to the monitor. A "Tele Device Assigned" message appears on the monitor. If the ECG wave now appears on the monitor, the signal from the MX40 is successfully transmitting to the monitor. To confirm that the correct MX40 has been assigned, open the ECG Setup menu by touching the ECG waveform or HR numeric. The title of the menu contains the equipment label of the MX40.
Assigning Devices D ra ft C op y When the devices are networked, all data is sent to the Information Center. When non-networked, only the additional parameters measured at the patient monitor (NBP, SpO2, and predictive temperature) are sent to the Information Center. The Telemetry Data window is not displayed when devices are non-networked.
Controls Available when Assigned to IntelliVue Cableless Measurements Controls Available when Assigned to IntelliVue Cableless Measurements Action At the MX40 At the Cableless Measurement Device At the IIC At the IIC iX Start SpO2 Yes Yes Yes Yes Change SpO2 Mode Yes Yes Yes Yes Select SpO2 Repetition Time No Yes No Yes Assign SpO2 Pod Yes Yes No No Remove SpO2 Pod Yes Yes Yes No Change Alarm Limits No No Yes Yes Place Device in Standby No No No No Alarm Silence Yes
Controls Available when Assigned to IntelliVue Patient Monitors Controls Available when Assigned to IntelliVue Patient Monitors Action At the MX40 (N/A) At the Patient Monitor At the IIC At the IIC iX Start SpO2 Yes Yes Yes Change SpO2 Mode Yes Yes Yes Select SpO2 Repetition Time Yes No Yes Assign SpO2 Pod Yes No No Remove SpO2 Pod Yes Yes No Yes Yes Yes No No Yes Yes Yes Yes Yes No Yes Change Alarm Limits Place Device in Standby Alarm Silence NBP ft C Alarm Off/Paus
Networked Device Synchronized Settings Networked Device Synchronized Settings If the patient’s ECG is initially being measured with a patient monitor, and then the patient is connected to the MX40 for monitoring, the Information Center will use the patient monitor settings for the MX40. When the initial ECG source is the MX40, and then the patient is connected to the monitor, the Information Center uses its Telemetry Setup settings.
MX40 Display when Wirelessly Connected to a Patient Monitor MX40 Display when Wirelessly Connected to a Patient Monitor D ra ft C op y When the MX40 is wirelessly connected to a patient monitor via the short-range radio, its display is primarily inactive. There is no viewable patient data on the display, however, battery status information is available if the display is turned on.
D ra ft C op y MX40 Display when Wirelessly Connected to a Patient Monitor 10-10 Monitoring with other Assigned Devices
11. Monitoring with the MX40 at the Information Center op y This section describes the behavior of the MX40 as it relates to what is displayed at the Information Center. What is displayed depends on which version of the Information Center is in use, IntelliVue Information Center Release N or earlier (referred to here as IIC), or IntelliVue Information Center iX (referred here to as IIC iX). MX40 Connection to the Information Center ......................................
MX40 Connection to the Information Center MX40 Connection to the Information Center Once the MX40 has been assigned to a sector at the Information Center, the settings (alarms, arrhythmia and configured Unit settings) are synchronized with the MX40. You may see a "Settings sync'd" message in the Status Area on connection, re-connection, and anytime the settings are updated at the Information Center. Arrhythmia Learning/Relearn occurs on connection and re-connection to the IIC.
MX40 Controls in the Patient Window (IIC) MX40 Controls in the Patient Window (IIC) The Patient Window at the Information Center (accessed from the Patient Window control in the Patient Sector) includes controls for a number of MX40 operations. For detailed instructions on these operations, see the IntelliVue Information Center Instructions for Use or the Online Help. To View ECG or SpO2 Alarm Limits 1 Move the cursor over the HR or SpO2 label to display the current high and low alarm limits.
MX40 Controls in the Patient Window (IIC) Important — Do not set the primary and secondary channels to the same lead. To Initiate a Spot Check (Manual) Spo2 Measurement Move the cursor over the SpO2 label. 2 Click on the Spot Check (Manual) icon. op y 1 D ra ft C .
MX40 Controls in the Patient Window (IIC iX) MX40 Controls in the Patient Window (IIC iX) The Patient Window at the Information Center iX includes controls for a number of MX40 operations. For detailed instructions on these operations, see the IntelliVue Information Center iX Instructions for Use or the Online Help. To View ECG, Resp, NBP or SpO2 Alarm Limits 1 Click on the HR or SpO2 label in the Patient Window to display the current high and low alarm limits.
MX40 Controls in the Patient Window (IIC iX) 2 Select ECG from the menu on the left. 3 Select Va or Vb from the ECG menu on the right and select from the list. To Initiate a Manual SpO2 Measurement Click the Measurements Application button. 2 Select SpO2 from the menu on the left. 3 Select Start from the SpO2 menu on the right.
Locating the MX40 (Find Device) Locating the MX40 (Find Device) The Find Device feature enables you to generate an alternating pitch repeated tone at the MX40 to assist in locating a missing device. Find Device requires that the MX40 has sufficient battery power and is within the coverage area. To locate an MX40 (IIC): 1 From the Patient Window, select Telemetry Setup. 2 Select Find Device to generate a repeated tone at the MX40. To silence this tone, touch the silence key on the MX40.
Viewing Device Location and Location History (optional) Viewing Device Location and Location History (optional) MX40 Device Location information is identified in the Patient Window by a compass icon followed by the location name of the access point that the MX40 is currently connected to. If the location of the device changes, the Patient Window is updated within 5 seconds of the location change.
Using the Device Location Client (optional - IIC only) Using the Device Location Client (optional - IIC only) The Device Location Client application is an optional software application that allows you to display and locate devices visually, using Floor Plans associated with your hospital’s layout. Device location history is also available. The application is accessible using a separate PC’s web browser. For additional installation information, see the IntelliVue Device Location Installation Guide.
Patient Configurable Settings in Telemetry Setup Patient Configurable Settings in Telemetry Setup The Telemetry Setup window enables you to configure the MX40 for patient-specific settings. All patient-specific settings will be reset to the unit defaults upon patient discharge. To access the window, from the Patient Window click Telemetry Setup.
Patient Configurable Settings in Telemetry Setup Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Telemetry/ Multi-Function Button Determines the Information Center response when the Multi-Function Button is pressed. Nurse Call - generate nurse call alarm that can be retrieved from Alarm Review for later use.
Patient Configurable Settings in Telemetry Setup Patient-Configurable Settings in Telemetry Setup Control Function Setting Choices Factory Default Suppress SpO2 INOPs with NBP Enable/disable the SpO2 algorithm to suppress sending technical alarms from the MX40 during an NBP measurement for 60 seconds. enable enable disable Warning ft C Enable/disable the transmission of the Pleth wave (and its subsequent display) to the Information Center. For Continuous SpO2 mode only.
Unit Configurable Settings Unit Configurable Settings Unit Settings provide access to clinical configuration items that affect all patients on an Information Center. Changes in unit settings take effect upon discharge, except for Standby duration and SpO2 mode, which take effect immediately. D ra ft C op y Access to unit settings requires a password, and the displays are in English. Telemetry specific settings are accessed through All Controls -> Unit Settings -> Telemetry Setup.
Unit Configurable Settings Unit Settings - Telemetry Setup Control Function Settings Factory Default Patient Type Set patient type used for SpO2 alarm limits. Adult Adult Determine the Information Center response when Telemetry Button is pressed. Nurse Call - generate nurse call alarm that can be retrieved from Alarm Review for later use.
Unit Configurable Settings Unit Settings - Telemetry Setup Control Function Settings RF Auto Shutoff Enable/disable RF operation during an extended situation of all leads off for more than 10 minutes and the SpO2 is not being measured continuously. enable Autopair Enable/disable the autopairing of the MX40 and the IntelliVue Patient Monitor at the Information Center.
Unit Configurable Settings Unit Settings - Telemetry Setup Factory Default Control Function Settings SpO2 Mode Determine the MX40 SpO2 measurement behavior. Spot Check (Manual)Spot Check Provides manual (Manual) measurements so the clinician can check as needed. Measurement can be initiated from the SmartKeys menu, the SpO2 Setup menu or by selecting the Spot Check SpO2 icon in the Patient Window. Note — Pulse Rate and Pleth Wave are not available in Spot Check (Manual) mode.
Unit Configurable Settings Unit Settings - Telemetry Setup Control Function Settings Pleth Wave Enable/disable the transmission of the Pleth wave and its subsequent display to the Information Center. For Continuous mode only. enable Enable/disable the transmission of the Pulse rate and its subsequent display to the Information Center. For Continuous mode only. enable Turn SpO2 alarms on/off at the Information Center. enable (on) SpO2 Limits High disable disable (Pulse rate is not displayed.
Unit Configurable Settings Unit Settings - Default Leads Function Settings Factory Default 3-wire Set the unit default lead. I, II, III II 5-wire, ECG1 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V II 5-wire, ECG2 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V V 5-wire, ECG3 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V III I, II, III, AVR, AVL, AVF, V1, V2, V3, V4, V5, V6 II 5-wire EASI, Set the unit default lead.
Unit Configurable Settings Unit Settings - NBP Setup Control Function Settings Factory Default Patient Type Set patient type used for NBP alarm limits. Adult Adult NBP Alarm Set NBP alarm notification. Systolic or Diastolic Pediatric Systolic Systolic or Diastolic Diastolic Mean op y Off Increment/decrement NBP high alarm limit by 5. Limit Maximum is 260 Limit Minimum is 10 160 Adult Systolic Low Increment/decrement NBP low alarm limit by 5.
Unit Configurable Settings Unit Settings - Alarms Control Function Settings Factory Default ECG Leads Off Adjust the severity level of this technical alarm (INOP). Cyan Cyan Adjust the severity level of this technical alarm (INOP). Cyan Set latched/non-latched status for SpO2, ST, and other non-arrhythmia yellow alarms. Latched Yellow Reminders Red Cyan Yellow Red Latched Non-latched op y Replace Battery Yellow Enables alarm reminders.
12. Operating with Information Center Release L or M This section covers performance differences when operating the MX40 with previous releases of the Information Center (Release L or M). Display ...................................................................................................... 12-2 D ra ft C op y Alarms .......................................................................................................
Display Display D ra ft C op y An MX40 operating with either Release L or M of the Information Center has two screens showing either one measurement waveform and four numeric parameter values or the ECG lead placement chest diagram along with two numeric parameter values, depending on configuration.
Alarms Alarms An MX40 operating with Release L or M of the Information Center does not have physiological alarm capability locally at the device (networked or non-networked). A No Alarm Display message is present along with the Alarms Paused icon. Cautions When operating with Information Center Release L or M, the alarm pause time of the MX40 is not configurable. The alarm pause time for the MX40 is always two minutes.
D ra ft C op y Alarms 12-4 Operating with Information Center Release L or M
13. Trends op y This section covers the Trend functionality of the MX40. Trends are patient data collected over time and displayed in tabular form to give you a picture of how your patient's condition is developing. Trend information is stored in the MX40 for continuously-monitored measurements, such as ECG, as well as for aperiodically-measured parameters, such as SpO2. One hour of Trend information is standard on the MX40, with the option available for 24 hours.
Viewing Vital Trend Information Viewing Vital Trend Information To view Vital Trend information: 1 Touch the SmartKeys button. 2 From the SmartKeys menu, select Vitals Trend. To change the time columns: Touch the time column. 2 Select a different time period.
14. Maintenance This section provides procedures for maintaining the MX40 after installation, including equipment label assignment, cleaning and battery care. Cleaning .................................................................................................... 14-2 Disposing of the MX40 ........................................................................... 14-5 Label Assignment for Replacement MX40...........................................
Cleaning Cleaning The procedure in this section keeps the MX40 and its accompanying patient cable clean and provides protection against infectious agents and bloodborne pathogens. Both the outside and the inside of the MX40 battery compartment and the patient cable must be kept free of dirt, dust, and debris. Note — Single-Patient-Use leadsets are intended to be disposed of when use is complete. They are not to be re-used and are not designed to be cleaned using any of the materials listed below.
Cleaning Cleaning Materials for the MX40 Caution Use of abrasive cleaning materials, or disinfectants or cleaning agents not listed herein, on any part or component of the MX40 may damage the components. The Gore-tex patch in the battery compartment of the MX40 can be damaged by the use of glutaraldehyde and anti-bacterial soap. Sharp or pointed instruments should not be used to remove soil from recessed areas on the MX40.
Cleaning Cleaner Active Ingredient Sanicloth Plus Quaternary ammonium (0.25%) 2-Butoxyethol (1-4%) Isopropyl alcohol (14.85%) Super Sanicloth Quaternary ammonium (<1%) Isopropyl alcohol (55%) Sanicloth Bleach Germicidal Disposable Wipes Sodium Hypochlorite (0.
Disposing of the MX40 Disposing of the MX40 Warning To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the MX40 appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories where not otherwise specified, follow local regulations regarding disposal of hospital waste.
Label Assignment for Replacement MX40 Label Assignment for Replacement MX40 During installation, an equipment label is assigned to each MX40 in a clinical unit so that the device can be identified during operation within the wireless system. If an MX40 is lost, the Assign Label function at the Information Center enables you to unassign the label from a lost device, and re-assign its label to a replacement device. Labels are limited to those available in an individual clinical unit.
Label Assignment for Replacement MX40 10 Wait for the new_device label to change to the selected equipment label. 11 In Sector Setup, select the Bed Label and Equipment Label and then press OK. Re-assigning an Equipment Label at the IntelliVue Information Center iX To re-assign an equipment label to a replacement device: Enter the Manage Unit application (scroll down if necessary). 2 Select Label Assignment.
Charging Lithium-ion Rechargeable Batteries Charging Lithium-ion Rechargeable Batteries The li-ion rechargeable battery is recharged using the IntelliVue CL Charging Station. To charge a battery, place it onto a charger slot on the charging station. The battery power indicators will supply information about the charge status. Warning Always use the supplied power cord with the grounded mains plug to connect the charging station to a grounded AC mains socket.
Charging Lithium-ion Rechargeable Batteries If a battery is put on a charging station slot, the corresponding LED will flash yellow until the battery's current state has been identified. Then a beep is issued and the LED reflects the battery status as described in the table below.
Charging Lithium-ion Rechargeable Batteries The age of a li-ion battery begins at the date of manufacture. The date of manufacture is listed on the side of the battery. Battery Disposal D ra ft C op y Discharge the battery and insulate the terminals with tape before disposal. Dispose of used batteries promptly and in accordance with local recycling regulations.
15. Safety Standards & Specifications This section describes the regulatory standards that the IntelliVue MX40 complies with, along with product and measurement specifications. Regulatory Information .......................................................................... 15-2 Electromagnetic Compatibility .............................................................. 15-8 op y Battery Specifications ............................................................................
Regulatory Information Regulatory Information Software Hazard Prevention Potential hazards arising from errors in the software program have been identified. Mitigations applied to reduce the associated risk of such hazards are included as part of the Risk Management, Clinical Evaluation, and Verification and Validation phases of the product’s development. AC Power Source op y The system is not intended for connection to the public mains as defined in CISPR-11.
Regulatory Information IEC 60601-1-2:2001 Electromagnetic Compliance IEC 60601-1-4:1999 +A1 Requirements for Programmable Electrical Medical Systems IEC 60601-1-6:2006 General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-8:2006 General Requirements for Safety for Alarm Systems IEC 60601-2-49:2001 Particular Requirements for Safety for Patient Monitoring Equipment IEC 60601-2-27:2005 Particular Requirements for Safety for Electrocardiograph Monitoring E
Regulatory Information The MX40 can provide time-limited local monitoring when it is not connected to the wireless network. Unlike a traditional bedside monitor which operates on AC power, the MX40 is powered by battery and cannot provide continuous monitoring. Authorized EU Representative Patient Population op y Philips Medizin Systeme Deutschland Hewlett-Packard-Strasse 2 D 71034, Boeblingen Germany This device is not for use with infant or neonatal patients.
Regulatory Information The IntelliVue MX40 protects the patient from unacceptable immediate clinical risk by generating specific Physiological Alarms when appropriate. If the system cannot generate Physiological Alarms, then relevant Severe or Hard-Level Technical Alarms (Inops) are created.
Regulatory Information Problem Cause Remedy Dropouts Low signal strength See "Signal Strength" below. RF interference See "Radio Frequency Interference" below. Monitoring Considerations Patient should be restricted to the designated coverage area. Monitoring performance will degrade if patients go outside the radius of coverage of the receiving wireless network. op y A patient location strategy is critical to a telemetry system.
Regulatory Information D ra ft C op y If the MX40 experiences loss of network connectivity, technical alerts at the Information Center ("No Signal") and at the MX40 ("No Central Monitor") will occur. The MX40 will also automatically revert to local monitor mode which activates display of patient data on the MX40 – however, when in this state, battery life will be shortened.
Electromagnetic Compatibility Electromagnetic Compatibility Medical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC 60601-1-2:2001, the international standard for EMC for medical electrical equipment. This IEC standard has been adopted in the European Union as the European Norm, EN 60601-1-2:2001.
Electromagnetic Compatibility Reducing Electromagnetic Interference The MX40 and associated accessories can be susceptible to interference from other RF energy sources and continuous, repetitive, power line bursts. Examples of other sources of RF interference are other medical electrical devices, cellular products, information technology equipment, and radio/television transmission.
Electromagnetic Compatibility Warning Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitoring equipment. Electromagnetic Emissions Compliance Avoiding Electromagnetic Interference Radio Frequency (RF) emissions Group 1 TheMX40 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Electromagnetic Compatibility Recommended Separation Distance Warning The MX40, equipped with a wireless network interface, intentionally receives RF electromagnetic energy for the purpose of its operation. Therefore, other equipment may cause interference, even if that other equipment complies with CISPR emission requirements.
Electromagnetic Compatibility Field strengths from fixed transmitters, such as base stations for radio (cellular, cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Electromagnetic Compatibility Electrosurgery Interference/Defibrillation/Electrostatic Discharge The equipment returns to the previous operating mode within 10 seconds without loss of any stored data. Measurement accuracy may be temporarily decreased while performing defibrillation. This does not affect patient or equipment safety. Do not expose the equipment to x-ray or strong magnetic fields (MRI). The MX40 is not for use during electrosurgery.
Battery Specifications Battery Specifications Battery Life The battery life specifications listed below are based on the use of three Duracell MN 1500 batteries. Battery life for other brands may differ. Telemetry Mode Networked (Display Off) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) 24.9 hours 24.7 hours ECG/SpO2 Continuous (using legacy SpO2 cable/sensors. Only one radio active.) 11.2 hours 8.
Battery Specifications Monitor Mode Non-networked (Display On) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. The battery life specifications listed below are based on the use of the Philips Rechargeable Lithium-ion battery. Battery Life (1.4GHz p/n 865350) Battery Life (2.
Battery Specifications Monitor Mode Non-networked (Display On) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) Battery Life (WLAN p/n 865352) ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. Note — Use of the Short-range radio can reduce battery life by 25%. Note — The battery capacity of re-chargeable batteries degrades over time and number of recharge cycles.
Lithium-ion Battery Charge Time Lithium-ion Battery Charge Time Charging Method Charge Time Battery pack charge time from 90% depletion state The Lithium-ion Battery Pack is charged on 6.5 hours a separate external charging station. It must be removed from the MX40 to charge.
Physical Specifications Physical Specifications Parameter Specification Height 126.8 mm (4.99 in) Width 69.9 mm (2.75 in) Depth 31.5 mm (1.24 in) Weight Without batteries, includes SpO2 and Short-range radio 1.4 GHz - 240 g (8.5 oz) 2.4 GHz - 215 g (7.6 oz) WLAN - 206 g (7.3 oz) 1.4 GHz - 324 g (11.4 oz) 2.4 GHz - 298 g (10.5 oz) WLAN - 292 g (10.3 oz) op y With 3 AA batteries, includes SpO2 and Short-range radio 1.4 GHz - 314 g (11.1 oz) 2.4 GHz - 289 g (10.
MX40 1.4 GHz Smart-Hopping Radio MX40 1.4 GHz Smart-Hopping Radio Parameter Specification Frequency Ranges Bands: 1395-1400 MHz and 1427-1432 MHz Channel Spacing: 1.6 MHz 8 dBm +2/-1.5 dB (4.
MX40 2.4 GHz Smart-Hopping Radio MX40 2.4 GHz Smart-Hopping Radio Parameter Specification Frequency Range ISM Band: 2400 - 2483.5 MHz Channel Assignment 48 radio channels assigned from 2401.056 MHz - 2482.272 MHz Channel Spacing: 1.728 MHz RF Output Power FCC: Channels 0-46 -17 dBm +/- 1 dB (40 mW to 63 mW, nominal 50 mW), into antenna load. Channel 47 only - 15 dBm +/- 1 dB. ETSI: 12 dBm +/- 1 dB (13 mW to 20 mW, nominal 16 mW), into antenna load op y ARIB: 13.
MX40 2.4 GHz Smart-Hopping Radio The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC (Radio Equipment and Telecommunications Terminal Equipment Directive). Class 2 radio equipment. Member states may apply restrictions on putting this device into service or placing it on the market. This product is intended to be connected to the Publicly Available Interfaces (PAI) and used throughout the EEA.
MX40 Short-Range Radio MX40 Short-Range Radio Specification Frequency Ranges ISM Band: 2400-2483.5MHz Radio Channel assignment 16 Radio Channel assigned, Fc= 2405 +5*(k-11)MHz, k=11,12,…,26 Frequency Control Configured via the bedside monitor or the Information Center depending on use model. RF Output Power -1.5 to -4.5 dBm +2/-3dB (0.7 mW to 0.3 mW), into Antenna load.
MX40 2.4GHz WLAN Radio MX40 2.4GHz WLAN Radio The MX40 2.4GHz/5.6GHz WLAN Radio conforms to the 802.11 a/b/g standard operating in the 2.4GHz and 5.6GHz ISM bands. Note — For the MX40 WLAN device, Part Number 865352, use of the MX40's Short-range Radio is only supported when operating with 802.11a (5.6GHz band). The Radio characteristics are defined below. WLAN Radio RF Specs Specification 802.11b IEEE 802.11 b Frequency Range 2.4 to 2.
MX40 2.4GHz WLAN Radio WLAN Radio RF Specs Specification Frequency Bands (802.11a) FCC, RS210: 5.15 ~ 5.25Ghz, 5.25 ~ 5.35Ghz, 5.42 ~ 5.725Ghz, 5.725 ~ 5.825Ghz (excluding 5.6 ~5.65GH ETSI, AU/NZ: 5.15~ 5.35Ghz, 5.47 ~ 5.725Ghz Japan, ARIB: 5.150 – 5.250GHz, 5.25 – 5.35GHz, 5.470 – 5.725GHz, China: 5.725 ~5.825Ghz Out of Band Emissions (802.
Environmental Specifications Environmental Specifications Parameter Specification Temperature Operating 0 to 37o C (32 to 99o F) Storage -30o C to 50o C (-22o F to 122o F) without batteries o o o o 12 C to 35 C (53.6 F to 95 F) with Single-Patient-Use leadsets Humidity Operating < 95% RH at 37o C (98.
Measurement Specifications Measurement Specifications ECG Parameter Specification ECG channel transmitted Leads Channel #1 = I, II, or III 5 electrodes Channel #1 = II Channel #2 = III Channel #3 = MCL 5 electrodes, EASI Channel #1 = Va-i Channel #2 = Va-s Channel #3 = Ve-s 6 electrodes Channel #1= II Channel #2 = III Channel #3 = MCLa Channel #4 = MCLb 5 V ft C Resolution op y 3 electrodes Differential, defibrillator protected against 360 joules discharge into a 100 ohm load Input Impedance
Measurement Specifications Parameter Specification Pacer Rejection Performance Positive pacers (Pace pulses with no tails). 1 Amplitude Width +2 to +700 mV 0.1, 0.2, 0.5 and 1.0 ms +2 to +500 mV 1.5 ms +2 to +400 mV Negative pacers 2 ms 1 Amplitude Width -2 to -700 mV 0.1, 0.2, 0.5 and 1.0 ms -2 to -500 mV 1.5 ms -2 to -400 mV 2 ms 1 op y Philips does not claim, verify, or validate support for all available pacemakers. EMC Performance Limits, Meets Essential Performance.
Measurement Specifications Performance Disclosure/Specification (in italics) Characteristic Time to Alarm for Tachycardia The ranges of time to alarm using test waveforms as indicated in ANSI/AAMI EC13 Sec. 4 1. 2. 1 (g) are 4 to 5 seconds. Pacemaker Pulse Rejection Capability Rejects pace pulses using test waveforms as indicated in ANSI/AAMI EC13 Sec. 4. 1. 4.1 (with amplitude from +/- 2 to +/- 700 mV, width from 0.1 to 2.0 ms).
Measurement Specifications Performance Disclosure/Specification (in italics) Characteristic Frequency Response: Triangular Meets the ANSI/AAMI EC13 Section 4.2.9.8(b) standard: 0 to 25% reduction. Impulse Response: Meets the ANSI/AAMI EC13 Section 4.2.9.8(c) standard: displacement maximum = 0.1 mV; slope (for waves marked with ST bandwidth) maximum = 0.30 mV/s. Pacemaker Pulse Display Capability Meets the ANSI/AAMI EC13 Section 4.2.9. 12 standard: minimum = 0.2 mV RTI.
Measurement Specifications FAST SpO2 Parameter Specification SpO2 Measurement Range (Calibration and Display) 0 to 100% SpO2 Accuracy See table following. SpO2 Resolution 1% SpO2 Numerics Averaging 5 - 20 seconds (default = 10 seconds) Note—The update rate for the SpO2 pulse oximetry value and pulse rate is op y typically 1 second. This can be extended to a max. 60 s when NBP is measured on the same limb, with a corresponding INOP message after a max.
Measurement Specifications Parameter Specification Display of SpO2 numerics SpO2 values are displayed as xxx % SpO2 to meet ISO 9919. Emitted Light Energy < 15 mW SpO2 Sensor Accuracy Description Reusable Sensors Model Number op y Type M1191B 2.0 Adult Finger, 3m cable M1191BL 2.0 Adult Finger, 0.45m cable M1191T 3.0 M1192A 2.0 Pediatric, Small Adult Finger, 0.45m cable M1192T 3.0 Adult &Pediatric Ear Clip, 1.5m cable M1194A 3.0 Adult Finger Clip, 3m cable M1196A 3.
Measurement Specifications Description Model Number Accuracy % A rms (70-100% Range) Adult Finger, > 40kg M1901B 3.0 Pediatric 3-20kg M1902B 3.0 Pediatric Finger, 10-50kg M1903B 3.0 Adult Finger, >30kg M1904B 3.0 Adult, Pediatric > 20kg M1131A 3.0 Adult Finger, > 30kg Nellcor OxiMax Max-A 3.0 Adult Finger, > 30kg Nellcor OxiMax Max-AL 3.0 Adult Finger > 40kg Nellcor OxiMax Max-N 3.0 Nellcor OxiMax Max-P 3.0 Nellcor OxiMax Max-I 3.
Measurement Specifications Description Model Number Accuracy % A rms (70-100% Range) Adult Adhesive Masimo LNCS Neo-3 2.
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A. Accessories This section lists the accessories for use with the MX40. Accessories are subject to change. Some accessories are not supplied by Philips. You can order parts and accessories from Philips at www.medical.philips.com or consult your local Philips representative for details. Warning op y Use only Philips-approved accessories. Use of product accessories (patient cables, SpO2 sensors, etc.
MX40 Accessories Pouches Description 989803174141 Carry Pouch, Waterproof, box of 50 989803174151 Carry Pouch, Waterproof, box of 200 9300-0768-050 Disp tele pouch w/snaps, 50/box 9300-0768-200 Disp tele pouch w/snaps, 200/box Miscellaneous Order Number 989803176501 989803176491 ft C 989803174131 op y Order Number Protective caps, adapter cable, MX40 Protective caps, Reusable leads, MX40 MX40 Lithium-ion battery, pkg 3 989803176201 MX40 Lithium-ion battery, pkg 1 989803174891 MX40 AA Batte
ECG Accessories Electrodes Description M4612A Solid gel ECG electrode disp. 5/pouch 300/case M4613A Solid gel ECG electrode disp. 30/pouch 300/case 40489E Adult paper tape ECG electrode, disp. 300/case 40493D Adult foam ECG electrode, disp. 300/case 40493E Adult foam ECG electrode, disp. 300/case M1935A Disposable EEG/ECG snap electrode 100/case 989803148801 Small adult solid gel snap electrode 1500/case 13941E Adult cloth ECG electrode, disp.
Order Number Description 989803171871 ECG 6 lead grabber AAMI + SpO2 .85m (35") MX40 Extender Cable, including Bed Sheet Clip, p/n 989803172241 MX40 Single-Paitent-Use Cables Order Number Description 989803172031 ECG 5 lead grabber AAMI .85m (35") 989803172051 ECG 5 lead grabber + SpO2 AAMI .85m (35") 989803172131 ECG 5 lead grabber IEC 85m (35") 989803172151 ECG 5 lead grabber + SpO2 IEC .
SpO2 Accessories Philips/Nellcor Disposable Sensors Description 989803105481 (A) M1904B Adult Finger, >30 kg 989803128551 M1133A Neo/Infant/Adult, <3, 10-20 kg, >40 kg 989803164921 M1134A Adh.
Order Number Description All sold as one piece each. A - Sensors plug directly into MX40. B - Supports use of M1941A extension cable. C - Not for use with M1941A extension cable. D - Requires M1943A/AL adapter cable. Adapter Cables Description 989803105691 M1943A Adapter Cable, 1. m 989803128651** M1943AL Adapter Cable, 3 m 989803105681** M11941A Extension Cable, 2 m M1020-61100** 989803148221** op y Order Number Massimo Adapter Cable for LNOP sensors,3.
B. Default Settings D ra ft C op y This section documents the most important default settings of your MX40 as it is delivered from the factory. For a comprehensive list and explanation of default settings, see the IntelliVue Information Center Release N Configuration Guide. The MX40's configuration settings can be changed permanently in Configuration Mode.
Alarm Default Settings Alarm Setting Factory Default Alarm Volume On Network: 0 Off Network: 10 QRS Volume 0 Tone Modulation On Alarm Sound Traditional Alarm Pause Time 2 min. Note — The Alarm Pause Time when operating with Information Center Release L or M is not configurable. It is always 2 min. Alarm Reminder (INOP) Reminder Time On 3 min.
ECG, Arrhythmia, ST and QT Default Settings ECG Settings Factory Defaults Adult On Primary Lead II Secondary Lead 6-lead: III 5-lead (Standard): III 5-lead (EASI): III Default ECG Size x1 Lead Placement Standard Leadset Type AAMI Analysis Mode High Limit Low Limit op y ECG Multi-lead 120 bpm 160 bpm 50 bpm 75 bpm 4.0 sec ft C Asystole Threshold Arrhythmia Settings Factory Defaults Adult D ra Arrhythmia Pedi Pedi On Pause Threshold 2.
Arrhythmia Settings Factory Defaults Adult On V.Trigeminy On PVCs/min On Multif. PVCs On Pacer N. Cap On Pacer N. Pac On Pause On Missed Beat On SVT On Afib op y V.
Configuration Default Settings at the MX40 Setting Factory Default Touch Tone Volume 0 - 10 Default Screen 1 Wave (Portrait) 2 Waves (Portrait) 2 Waves (Landscape) Chest Diagram Screen Color Blue Gray Green Pink* Purple* Yellow* (*only display in Standby Mode) Alarm Sounds Traditional ISO op y 4 Confirm to restore to unit default settings D ra ft C Unit Defaults Default Settings B-5
op y ft C D ra B-6 Default Settings
C. Sales and Support Offices Please call your local Philips Healthcare sales office listed in your telephone directory or a Philips Healthcare regional office listed below for the location of your nearest sales office. On the web www.healthcare.philips.com By fax +31 40 27 64 887 op y Via email healthcare@philips.com ft C By postal service Philips Healthcare Global Information Center P.O.
op y ft C D ra C-2 Sales and Support Offices
ECG Performance Disclosure/Specifications • 5-3 Electromagnetic Compatibility • 3-3 Index A I Accessories ECG • A-3 MX40 • A-2 SpO2 • A-5 Initiating Arrhythmia Relearning Manually • 6-35 IntelliVue Information Center • 11-1 Alarms • 5-1 L Pausing • 5-6 Physiologic • 5-10 Reviewing • 5-8 Technical • 5-14 Label Assignment • 14-6 Lock • 4-6 M Main Screen Button • 4-4 Multi Function Button • 4-3 op y Arrhythmia Beat Labels • 6-36 B P Battery • 4-14 Charge Status • 4-19 Safety • 4-14 ft C C Cable
Status Area • 4-7 Symbols • 3-5 T D ra ft C op y Telemetry Setup • 11-10 2 Index
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op y ft C D ra Part Number 4535 643 15721 Printed in USA February 2012 First Edition 4535 643 15721
