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IntelliVue MX40
Instructions for Use

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Table of Contents

   Also See for Philips IntelliVue MX40

   Summary of Contents for Philips IntelliVue MX40

  • Page 1 IntelliVue MX40 Instructions for Use...
  • Page 2 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...
  • Page 3 (2) these devices must accept any interference received, including interference that may cause undesired operation. Changes and modifications not expressly approved by Philips Medical Systems can void your authority to operate this equipment under Federal Communications Commissions rules...
  • Page 4 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.
  • Page 5: Table Of Contents

    Contents 1. Introducing the IntelliVue MX40 MX40 Features -------------------------------------------------------------------------- 1-2 MX40 Models ---------------------------------------------------------------------------- 1-3 MX40 Compatibility -------------------------------------------------------------------- 1-4 2. Product Safety General Safety -------------------------------------------------------------------------- 2-2 Safety Symbols & Other Marks ----------------------------------------------------- 2-4 3. Basic Operation Controls, Indicators and Connectors ---------------------------------------------- 3-2...
  • Page 6 Pausing or Switching Off Alarms----------------------------------------------- 4-6 Alarm Limits ------------------------------------------------------------------------- 4-7 Reviewing Alarms ------------------------------------------------------------------ 4-8 Latching Alarms -------------------------------------------------------------------- 4-8 Alarm Latching Behavior --------------------------------------------------------- 4-9 Alarm Behavior at Power On ---------------------------------------------------- 4-9 Physiologic Alarms ------------------------------------------------------------------- 4-10 Technical Alarms (INOPs) --------------------------------------------------------- 4-14 5. ECG and Arrhythmia Monitoring ECG Safety Information--------------------------------------------------------------- 5-2 For Paced Patients ---------------------------------------------------------------- 5-3 Measuring ECG ------------------------------------------------------------------------- 5-5...
  • Page 7 EASI ST Analysis ----------------------------------------------------------------- 5-34 Turning ST Monitoring On/Off ------------------------------------------------- 5-34 QT Interval Monitoring --------------------------------------------------------------- 5-35 Intended Use ----------------------------------------------------------------------- 5-36 How the QT Analysis Algorithm Works ------------------------------------- 5-36 6. Monitoring Pulse Rate Pulse Rate Measurement ------------------------------------------------------------ 6-2 Displaying the Pulse Rate Measurement at the MX40 ----------------------- 6-3 7.
  • Page 8 12. Maintenance 12-1 Cleaning --------------------------------------------------------------------------------- 12-2 Cleaning Materials for the MX40 --------------------------------------------- 12-2 Label Assignment for Replacement MX40 ------------------------------------- 12-5 Re-assigning an Equipment Label ------------------------------------------ 12-5 Charging Lithium-ion Rechargeable Batteries -------------------------------- 12-7 Battery Power Indicators ------------------------------------------------------- 12-7 Battery Lifetime Management ------------------------------------------------ 12-8 Battery Disposal ------------------------------------------------------------------ 12-9 13.
  • Page 9 Miscellaneous ----------------------------------------------------------------------- A-2 ECG Accessories ----------------------------------------------------------------------- A-3 Electrodes --------------------------------------------------------------------------- A-3 Leadsets and Patient Cables --------------------------------------------------- A-3 Accessories ---------------------------------------------------------------------- A-5 Philips/Nellcor Disposable Sensors ------------------------------------------- A-5 Philips Reusable Sensors ------------------------------------------------------- A-5 Adapter Cables --------------------------------------------------------------------- A-6 B. Default Settings Alarm Default Settings ---------------------------------------------------------------- B-2...
  • Page 10 Contents - 6...
  • Page 11: Introducing The Intellivue Mx40

    Introducing the IntelliVue MX40 This section introduces the IntelliVue MX40 wearable monitor. MX40 Features ................... 1-2 MX40 Models ..................... 1-3 MX40 Compatibility .................. 1-4 Introducing the IntelliVue MX40...
  • Page 12: Mx40 Features

    Alarm suspend and resume from standby at device and Information Center. Pouch with clear front that closes securely. Note — Unlike a traditional bedside monitor which operates on AC power, the MX40 is powered by battery and provides time-limited screen display and local alarming. Introducing the IntelliVue MX40...
  • Page 13: Mx40 Models

    MX40 Models The MX40 is available in three models (ECG only, ECG and FAST SpO , or ECG and SpO Ready (for future upgrade). Introducing the IntelliVue MX40...
  • Page 14: Mx40 Compatibility

    The MX40 Patient Cable is compatible for use with IntelliVue Patient Monitor platforms MP2/X2, MP5/MP5T/MP5SC, MP20/30 with MMS or X2, MP40/50 with MMS or X2, MP60/70 with MMS or X2, MP80/90 with MMS or X2, and MX800/700/600 with MMS or X2. Introducing the IntelliVue MX40...
  • Page 15: Product Safety

    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 .................... 2-2 Safety Symbols &...
  • Page 16: General Safety

    General Safety Warnings The IntelliVue MX40 should not be used for primary monitoring in applications where the momentary loss of the ECG is unacceptable at the Information Center. For continued safe use of this equipment, it is necessary that the listed instructions are followed.
  • Page 17 Tele Disconnected INOP message on the IntelliVue Patient Monitor. Caution Philips recommends that when using a pouch to attach the MX40 to your patient that you consider your patient's condition and are careful about placement of the straps as the straps could present a strangulation hazard.
  • Page 18: Safety Symbols & Other Marks

    Safety Symbols & Other Marks The table below describes the safety symbols and other markings present on the MX40 and the lithium-ion battery. Label Definition FCC ID: Federal Communications Commission (FCC) ID Canadian ID Federal Communications Commission (FCC) Grant of Equipment Authorization CE Mark (MX40) Compliance to Council Directive...
  • Page 19 Patient connections are protected against defibrillation (DEFIBRILLATION-PROOF) and are a TYPE CF APPLIED PART. Product Number Serial Number Used to identify the equipment during a call to the Philips Healthcare (Service). MAC Address Date of Manufacture Battery Polarity IPX Waterproof Rating 2D Barcode...
  • Page 20 Label Definition Service Identification Number Used to identify the equipment during a call to the Philips Healthcare (Service). Attention! See Instructions for Use. Product Safety...
  • Page 21: Basic Operation

    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.
  • Page 22: 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.
  • Page 23 Multi-Function Button Button Function Depending on configuration at the Information Center: generates a Nurse Call; Initiates a Delayed Recording; Both, or; None Note — the Multi-Function Button does not operate when paired with an IntelliVue Patient Monitor via the short-range radio connection. Silence Alarm Button Button Function...
  • Page 24 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. SmartKeys The following table lists the SmartKeys available on the display of the MX40. Note—gray text on a SmartKey signifies that the item is unavailable. SmartKey Function Start SpO...
  • Page 25 SmartKey Function Standby Puts the device into standby locally and at the Information Center. Displays purchased/enabled product options. 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.
  • Page 26 Patient Information Area Touching the Patient Information Area displays the following information: Bed Label Patient Name (up to 15 characters will display) Paced Status (see Paced Status below) Time Gender/Type (Male/Female and Adult/Pediatric) MRN (Lifetime ID, Encounter ID) Note — If you use an alternative ID, it will display at the Information Center and on printed reports.
  • Page 27: Operating And Navigating

    Operating and Navigating The principle method of operating your MX40 is via the Touch Display. Almost every element on the is interactive. Display elements include measurement numerics, information fields, alarm fields, waveforms, SmartKeys and menus. Power-On Self Test Once battery power is supplied, the MX40 performs a power-on self test to check operational status prior to start-up.
  • Page 28: Selecting Display Elements

    Selecting Display Elements Touch a display element to get to the actions linked to that element. For example, touch the Patient Information element to call up the Patient Info window, or touch the HR numeric to call up the Setup ECG menu. Touch the ECG waveform to call up the wave selection menu.
  • Page 29: Connecting/disconnecting The Patient Cable

    Portrait - Viewable Chest Diagram and two Numerics Connecting/Disconnecting the Patient Cable The patient cable is connected to the MX40 as shown in the illustration below. When connecting to the MX40, there is a slight clicking sound that signifies the the cable is securely connected. Disconnect the patient cable as shown below.
  • Page 30: 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.
  • Page 31: Waveform Settings At The Mx40

    Setting Description Set ECG On/Off New Lead Setup When IntelliVue Patient Monitor lead sets are in use, selects 3-wire, or 5-wire. Va Lead Shows position of Va, Vb or C1, C2 electrodes. Choices are V1-V9, v3R, V4R, V5R. Vb Lead Shows position of Va, Vb or C1, C2 electrodes.
  • Page 32: 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...
  • Page 33: Lithium-ion Rechargeable Battery Care

    Lithium-ion Rechargeable Battery Care Care of the rechargeable battery begins when you receive a new battery for use and continues throughout the life of the battery. The table below lists battery care activities and when they should be performed. Activity When to Perform Perform a visual inspection.
  • Page 34: Inserting/removing Batteries

    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.
  • Page 35: Inserting Batteries

    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.
  • Page 36: Removing The Batteries

    If using the rechargeable lithium-ion battery, remove the AA battery tray if present. Insert the battery pack so that the raised tab is aligned with the cutout in the base of the battery compartment. Close the battery compartment door. Watch for the start-up screen on the front of the MX40 to illuminate briefly.
  • Page 37: Battery Charge Status

    If you remove good AA batteries to turn off the MX40, keep them together as a set for later re-use so that all batteries will have the same level of power remaining. Important— Do not "store" disposable AA batteries by leaving them in the incorrect polarity position in the MX40.
  • Page 38 Approximate Approximate Approximate Functionality Battery Battery Life Time Time Disabled Indicator Remaining Remaining Remaining (ECG only) (ECG & Spo Segments Continuous) Low battery < 30 minutes < 30 minutes 1 Red level to short-range Red Battery replace/charg radio are Icon e battery level disabled.
  • Page 39: 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.
  • Page 40 Seal the pouch. Secure the pouch on the patient with the ties around the patient’s shoulder and under the arm. Check that the patient is comfortable wearing the pouch with the MX40. Warning To avoid the risk of strangulation, do not tie a pouch solely around the patient’s neck.
  • Page 41: Showering

    The MX40 can be used to monitor a patient in the shower, but only when placed inside a Philips carrying pouch and secured on the patient as described above. The combination of the MX40 and pouch will withstand showering for up to 10 minutes.
  • Page 42 Accidental Liquid Exposure If the MX40 is accidentally immersed in liquid, no damage to the device and no electrical safety issues for the patient will result. Remove the device, dry it off, and follow the procedure for cleaning/sterilization under "Cleaning and Sterilization" as needed. 3-22 Basic Operation...
  • Page 43: Telemetry Mode Use

    Telemetry Mode Use To minimize patient disruption, the MX40 operates in Telemetry Mode when connected to the Information Center. In Telemetry Mode, the local volume is set to zero and the display is off. You can activate the display at any time by touching the Main Screen button for two seconds.
  • Page 44: 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.
  • Page 45: Briefing The Patient

    Briefing the Patient Warning Patients should be instructed not to interact with the with 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.
  • Page 46 3-26 Basic Operation...
  • Page 47: Alarms

    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 ..................4-2 Physiologic Alarms ................. 4-10 Technical Alarms (INOPs) ..............4-14 Alarms...
  • Page 48: 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. For MX40 devices operating with IntelliVue Information Center Release N, physiological alarms are available locally on the MX40 when network connected to the Information Center, and as configured by the Information...
  • Page 49: Visual Alarm Indicators

    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.
  • Page 50 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.
  • Page 51: Audible Alarm Indicators When In Monitoring Mode

    Telemetry Mode. Audible alarm indicators become active as soon as the MX40 is no longer connected to the Information Center. Traditional Audible Alarms (HP/Agilent/Philips/Carenet) Red alarms and red INOPs: A high pitched sound is repeated once a second.
  • Page 52: Acknowledging Alarms

    Acknowledging Alarms To acknowledge all active alarms and INOPs, touch the Silence Alarm button. This switches off the audible alarm indicators, if present, and alarm messages. A check mark beside the alarm message indicates that the alarm has been acknowledged . If the condition that triggered the alarm is still present after the alarm has been acknowledged, the alarm message stays on the screen with a check mark symbol beside it, except for NBP alarms and alarms from other...
  • Page 53: Alarm Limits

    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.
  • Page 54: Reviewing Alarms

    Changing Alarm Limits  To change individual measurement alarm limits using the measurement's Setup Menu: In the measurement's setup menu, select the alarm limit you want to change. This calls up a list of available values for the alarm limit. Select a value from the list to adjust the alarm limit.
  • Page 55: Alarm Latching Behavior

    Alarm Latching Behavior Red & Yellow Measurement Alarms Non-latching Visual and Alarms Audible Latching Alarm has not been Alarm condition still Alarm tone on. Alarm Alarm tone on. acknowledged. present. message. Flashing Alarm message. numerics. Flashing numerics. Alarm condition no All audible and visual Alarm tone on.
  • Page 56: 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.
  • Page 57 Alarm Text Priority Condition Source *** TACHY yyy > xxx Extreme Tachycardia. ST/AR Heart Rate (yyy) greater than Extreme Basic & Enhanced Tachy limit Arrhythmia *** V-FIB/TACH Ventricular Fibrillation. ST/AR Fibrillatory wave (sinusoidal wave Basic & between 2-10 Hz) for 4 consecutive Enhanced seconds Arrhythmia...
  • Page 58 Alarm Text Priority Condition Source * MULTIFORM PVCs Yellow The occurrence of two differently ST/AR shaped Vs, each occurring at least Enhanced twice within the last 300 beats as well Arrhythmia as each occurring at least once within the last 60 beats. * NON-SUSTAIN VT Yellow A run of Vs having a ventricular Heart...
  • Page 59 Alarm Text Priority Condition Source * SVT Yellow Run of SVPBs greater than or equal ST/AR to SVT Run limit and with SVT Heart Enhanced Rate greater than the SVT Heart Rate Arrhythmia limit. * VENT BIGEMINY Yellow A dominant rhythm of N, V, N, V ST/AR (where N= supraventricular beat, Enhanced...
  • Page 60: 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).
  • Page 61 Alarm Text Priority Condition What to do CANNOT ANALYZE Hard Arrhythmia algorithm Assess the lead selections, cannot reliably analyze initiate relearn, and validate the ECG data on any analyzed rhythm. Check monitored leads. other INOPs for possible Source - MX40 and source of problem.
  • Page 62 Alarm Text Priority Condition What to do cl NBP DISCONNECT Hard CL NBP Pod is not Resolve interference connected with the condition. MX40. Source - Cableless Reduce range between Measurement Device CL NBP Pod and MX40. cl SpO Batt Low Hard CL SpO Pod weak...
  • Page 63 Alarm Text Priority Condition What to do LEADSET UNPLUGGED Hard Leadset has been Re-attach the ECG leadset. unplugged from the MX40. Source - MX40 LOCAL AUDIO OFF Soft There is no alarm Change to Monitor Mode. audio notification when operating in Telemetry Source - MX40 Mode.
  • Page 64 Alarm Text Priority Condition What to do NO SIGNAL Hard, The MX40 is outside Make sure that the MX40 (appears at the Latched the coverage area, is within the coverage Information Center only) area and has good batteries. No batteries in the Source - Information MX40, or Replace the MX40 if...
  • Page 65 Alarm Text Priority Condition What to do %SpO Hard Level of ambient light Reduce ambient light to or level of electrical sensor or electrical noise INTERFERENCE interference are so sources. high that the SpO Source - MX40 sensor cannot measure and pulse rate.
  • Page 66 Alarm Text Priority Condition What to do TELE BATT EMPTY Hard, Lithium-ion battery Insert a charged lithium-ion level is critically low. A Latched battery pack. Note — This INOP may 10-minute countdown also be configured to begins. The MX40 will display as a Red or shutdown if the Yellow Technical Alarm.
  • Page 67 Alarm Text Priority Condition What to do TELE REMOVE BATT Hard, The temperature of the Replace the lithium-ion lithium-ion battery is Latched battery. Source - Monitor >60 C and the battery must be removed. Note — Information Center Release L or M, this INOP will appear as "REPLACE BATTERY T".
  • Page 68 4-22 Alarms...
  • Page 69: Ecg And Arrhythmia Monitoring

    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 ................5-2 Measuring ECG ..................5-5 Connecting and Positioning ECG Electrodes ........5-6 Selecting the Primary and Secondary ECG Leads ........
  • Page 70: Ecg Safety Information

    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.
  • Page 71: For Paced Patients

    Note— When switching from EASI to standard monitoring, there is a momentary loss of data. For Paced Patients Warnings The output power of the MX40 and other sources of radio frequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker performance.
  • Page 72 Note— During defibrillation, monitoring may be temporarily interrupted or distorted. It may take several seconds for the ECG trace to reappear on the screen. After defibrillation, the device will continue to monitor as before; the device settings will not be affected. ECG and Arrhythmia Monitoring...
  • Page 73: 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.
  • Page 74: Connecting And Positioning Ecg Electrodes

    Clip or shave hair from the site as necessary. Wash site with soap and water, leaving no soap residue. Note— Philips does not recommend using ether or pure alcohol, because they dry the skin and increase the resistance. Dry thoroughly.
  • Page 75: Selecting The Primary And Secondary Ecg Leads

    Selecting the Primary and Secondary ECG Leads 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. The secondary lead is used if your device is configured for multi-lead (instead of single-lead) arrhythmia analysis.
  • Page 76: Checking Paced Status

    Checking Paced Status It is important to set the paced status correctly when you start monitoring ECG. When Paced is set to Yes: Pacer Algorithm is switched on. This means that pacemaker pulses are not counted as extra QRS complexes. The pacer spikes are shown in white.
  • Page 77: Understanding The Ecg Display

    Understanding the ECG Display Your display may be configured to look slightly different. 1. Lead label of the displayed wave 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) ECG HR numeric: This is the heart rate derived from the monitored ECG.
  • Page 78: 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 You should choose a lead as primary or secondary lead that has these characteristics: the normal QRS complex should be either completely above or below the baseline and it should not be biphasic.
  • Page 79: 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.
  • Page 80: Selecting Positions Of Va And Vb Chest Leads

    Selecting Positions of Va and Vb Chest Leads The two chest leads for the 6-lead placement can be positioned at any two of the V1 to V9 and V3R, V4R and V5R positions. Select the positions you have used in the Patient Window at the Information Center, so that the chest leads will be correctly labeled.
  • Page 81: Choosing Easi Or Standard Lead Placement

    Choosing EASI or Standard Lead Placement Choose either standard lead placement or EASI lead placement: In the Setup ECG menu, select Lead Placement to toggle between Standard or EASI. Select Standard or EASI. Note — When changing lead placement, the patient cable must be attached to the MX40.
  • Page 82: 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 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.
  • Page 83: 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. these leads can be selected at the MX40 If you are using ...
  • Page 84 these leads can be selected at the MX40 If you are using ... and the Information Center 6-wire I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R. Sourced (raw) waves are received as: Channel 1 = II Channel 2 = III Channel 3 = Va...
  • Page 85: Reconstructed Leads

    Reconstructed Leads Reconstruction of leads from the sourced wave is defined by the calculations in the following table. EASI reconstructed leads are a linear combination of all three raw EASI leads ECG Lead Clinical Calculations in terms of electrodes 3-wire 5-wire 6-wire Standard...
  • Page 86: 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 3. LL - on the left lower abdomen 5-18 ECG and Arrhythmia Monitoring...
  • Page 87: 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.
  • Page 88: 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.
  • Page 89: 6-wire Placement

    6-Wire Placement 6-lead placement uses the same positions from as the 5-lead standard placement described above , along with two precordial leads - referred to as Va and Vb. 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.
  • Page 90: 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...
  • Page 91: 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"...
  • Page 92 Ensure that the arrhythmia algorithm is labeling beats correctly. 5-24 ECG and Arrhythmia Monitoring...
  • Page 93: 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.
  • Page 94: Ecg And Arrhythmia Alarm Overview

    Aberrantly-Conducted Beats As P-waves are not analyzed, it is difficult and sometimes impossible for the monitor to distinguish between an aberrantly-conducted supraventricular beat and a ventricular beat. If the aberrant beat resembles a ventricular beat, it is classified as ventricular. You should always select a lead where the aberrantly-conducted beats have an R-wave that is as narrow as possible to minimize incorrect calls.
  • Page 95: Using Ecg Alarms

    Alarms with Basic Arrhythmia Additional Alarms with Enhanced Option Arrhythmia Option ***Ventricular Tachycardia **Irregular HR **High heart rate **Ventricular Rhythm **Low heart rate **Run PVCs High **Pacer Not Capture (if Pacing **Pair PVCs set to Yes) **Pacer Not Pacing (If Pacing set **R-on-T PVCs to Yes) **PVCs/min HIGH (PVC >...
  • Page 96 Arrhythmia Alarm Settings Some arrhythmia alarms can be turned off at the Information Center. They are: Non-Sustain, Vent Rhythm, Run PVCs, Pair PVCs, R-On-T PVCs, V.Bigeminy, V.Trigeminy, Multif.PVCs, Pause, SVT, Irregular HR, Missed Beat, PVCs/min and Afib. It is also possible to turn all yellow arrhythmia alarms off at the Information Center.
  • Page 97: Learning

     To return to the normal ECG primary lead display: Select Annotate Arrhy. Change to Off. Exit from the Setup ECG menu. 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...
  • Page 98 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 alearning whenever: ECG monitoring is initiated. The Relearn key is activated (see Initiating Arrhythmia Relearning Manually p.
  • Page 99: Initiating Arrhythmia Relearning Manually

    EASI ECG Monitoring Whenever there is an INOP condition, the arrhythmia algorithm performs a Relearn, using the available lead. Warning Since Relearn happens automatically, if learning takes place during ventricular rhythm, the ectopics may be incorrectly learned as the normal QRS complex.
  • Page 100: St/ar St Analysis Algorithm

    ST/AR ST Analysis Algorithm Intended Use 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.
  • Page 101: The Measurement

    The Measurement The ST measurement for each beat complex is the vertical difference between two measurement points. The isoelectric point provides the baseline for the measurement and the ST point provides the other measurement point. It is positioned with reference to the J-point. Algorithm Processing ST analysis analyzes ECG signals to classify the heart beats.
  • Page 102: Displayed St Data

    Displayed ST Data ST data displays as values in the Patient Sector and Patient Window at the Information Center. A positive value indicates ST segment elevation; a negative value indicates ST segment depression. You can view ST data in ST Review, Trend Review, and Event Review windows. Note —...
  • Page 103: 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.
  • Page 104: Intended Use

    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.
  • Page 105 Adjusting QT Settings For patients being monitored by the MX40, you can adjust QT settings in the QT Setup window at the Information Center. Turn QT analysis on by clicking in the QT Analysis On check box. QT analysis is on when a checkmark displays in the check box. When the QT measurement is on, a QT status message is displayed in the QT Setup window, along with the current values for QT, QTc, dQTc and QT-HR.
  • Page 106 5-38 ECG and Arrhythmia Monitoring...
  • Page 107: Monitoring Pulse Rate

    Monitoring Pulse Rate This section provides an introduction to the Pulse measurement and its application. Pulse Rate Measurement ................6-2 Displaying the Pulse Rate Measurement at the MX40 ......6-3 Monitoring Pulse Rate...
  • Page 108: 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 SpO measurement. Displayed results can range from 30 to 300 bpm. There is no alarm function for pulse rate. The pulse numeric is displayed at the Information Center only when SpO is being measured continuously.
  • Page 109: Displaying The Pulse Rate Measurement At The Mx40

    Displaying the Pulse Rate Measurement at the MX40  To display the pulse rate measurement at the MX40: If not already selected, press the Main Screen button and select the 1 waveform with 4 numerics display. If pulse is not already displayed, touch a numeric. Select Change Numeric.
  • Page 110 Monitoring Pulse Rate...
  • Page 111: Spo Monitoring

    Monitoring This section provides an introduction to the SpO measurement and its application. Safety Information ................7-2 Pulse Oximetry Measurement ..............7-5 SpO2 Monitoring...
  • Page 112: Spo 2 Safety Information

    Safety Information Warnings Always confirm monitor observations with clinical observation of the patient before administering interventions. Prolonged, continuous monitoring can increase the risk of changes in skin characteristics, such as irritation, reddening, blistering or pressure necrosis, particularly on patients with impaired perfusion and varying or immature skin morphology.
  • Page 113: Spo 2 Information For The User

    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 41 C on the skin if the initial skin temperature does not exceed 37 Avoid placing the sensor on extremities with an arterial catheter or intravascular venous infusion line.
  • Page 114 Physiological SpO alarm signals will be generated. For adult patients, the low limit can be set between 50 and 99% inclusive, in 1% increments, and the SpO high alarm limit can be set between 51 and 100% inclusive, in 1% increments. For pediatric patients, the SpO low limit can be set between 30 and 99% inclusive, in 1% increments, and the high alarm limit can be set between 31 and 100% inclusive, in 1% increments.
  • Page 115: Pulse Oximetry Measurement

    Pulse Oximetry Measurement The MX40 supports an SpO 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.
  • Page 116: Spo 2 Sensors

    When the specified Nellcor® sensors are used, the application must be consistent with the sensor manufacturer's own guidelines. Philips reusable sensors in adult, pediatric and infant models can be used, as well as Philips and Nellcor® disposable sensors. Caution Do not use OxiCliq disposable sensors in a high humidity environment, or in the presence of fluids.
  • Page 117: Sensor Application Safety Information

    Sensor Type When to Use You can use reusable sensors on different Reusable 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.
  • Page 118: Applying The Sensor

    Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation, which can severely obstruct circulation and lead to inaccurate measurements. Ambient Temperature: Never apply an SpO sensor at ambient temperatures above 37 C (99 F) because this can cause severe burns after prolonged application.
  • Page 119: Measuring Spo

    The level to which the triangle is filled shows the quality of the signal. The signal quality is at a maximum when the triangle is completely filled. Measuring SpO Warning Removal of the SpO sensor from the MX40 patient cable during Continuous SpO monitoring results in a "No Sensor"...
  • Page 120: Understanding Spo 2 Alarms

    Understanding SpO Alarms monitoring offers high and low limit alarms, and a high priority (red level) oxygen desaturation alarm. For adult patients, the SpO low limit can be set between 50 and 99% inclusive, in 1% increments. For pediatric patients, the SpO low limit can be set between 30 and 99% inclusive, in 1% increments.
  • Page 121: Monitoring With Other Assigned Devices

    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 SpO and NBP. The connection to these other devices is done by pairing networked devices or using the integrated short-range radio of the MX40.
  • Page 122: 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.
  • Page 123: Device Assignment At The Patient Monitor

    When connected the icon appears at the Information Center. 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.
  • Page 124 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, SpO , and predictive temperature) are sent to the Information Center. The Telemetry Data window is not displayed when devices are non-networked.
  • Page 125: Controls Available When Assigned To Intellivue Cableless Measurements8-5

    Controls Available when Assigned to IntelliVue Cableless Measurements Action At the At the IntelliVue At the IIC MX40 Cableless Measurement Device Start SpO Change SpO Mode Select SpO Repetition Time Assign SpO Remove SpO Change Alarm Limits Place Device in Standby Alarm Silence (local only) Alarm Off/Pause...
  • Page 126: Controls Available When Assigned To Intellivue Patient Monitors

    Controls Available when Assigned to IntelliVue Patient Monitors Action At the At the IntelliVue At the IIC MX40 Patient Monitor Start SpO Change SpO Mode Select SpO Repetition Time Assign SpO Remove SpO Change Alarm Limits Place Device in Standby Alarm Silence (local only) Alarm Off/Pause...
  • Page 127: Mx40 Display When Wirelessly Connected To A Patient Monitor

    MX40 Display when Wirelessly Connected to a Patient Monitor 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.
  • Page 128 Monitoring with other Assigned Devices...
  • Page 129: Monitoring With The Mx40 At The Information Center

    Monitoring with the MX40 at the Information Center This section describes the behavior of the MX40 as it relates to what is displayed at the Information Center. MX40 Controls in the Patient Window ..........9-2 Locating the MX40 (Find Device) ............9-4 Viewing Device Location and Location History (optional) ....
  • Page 130: Mx40 Controls In The Patient Window

    MX40 Controls in the Patient Window 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. ...
  • Page 131 Important — Do not set the primary and secondary channels to the same lead.  To Initiate a Spot Check (Manual) Spo Measurement Move the cursor over the SpO label. Click on the Spot Check (Manual) icon. Monitoring with the MX40 at the Information Center...
  • Page 132: 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. This function is initiated in the Telemetry Setup Window. Find Device requires that the MX40 has sufficient battery power and is within the coverage area.
  • Page 133: Viewing Device Location And Location History (optional)

    Viewing Device Location and Location History (optional) You can see the location of an MX40 in the Patient Window. The 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.
  • Page 134: Using The Device Location Client (optional)

    Using the Device Location Client (optional) 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.
  • Page 135: 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. The following settings can be adjusted in this window: Monitoring with the MX40 at the Information Center...
  • Page 136 Patient-Configurable Settings in Telemetry Setup Factory Control Function Setting Choices Default Determines the Nurse Call - generate nurse call Nurse Call Telemetry/ Information Center alarm that can be retrieved from Multi-Function response when the Alarm Review for later use. Button Multi-Function Button is Record - generate a recording pressed.
  • Page 137 Patient-Configurable Settings in Telemetry Setup Factory Control Function Setting Choices Default Enable/disable the enable Suppress enable algorithm to INOPs disable suppress sending with NBP technical alarms from the MX40 during an NBP measurement for 60 seconds. Warning If you measure SpO on a limb that has an inflated NBP cuff, a non-pulsatile SpO...
  • Page 138 9-10 Monitoring with the MX40 at the Information Center...
  • Page 139: 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 SpO mode, which take effect immediately. Access to unit settings requires a password, and the displays are in English. Telemetry specific settings are accessed through All Controls ->...
  • Page 140 Unit Settings - Telemetry Setup Factory Control Function Settings Default Set patient type used for Adult Patient Type Adult and NBP alarm Pediatric limits. Determine the Information Nurse Call - generate nurse Nurse Call Telemetry/ Center response when call alarm that can be Multi-Function Telemetry Button is retrieved from Alarm Review...
  • Page 141 Unit Settings - Telemetry Setup Factory Control Function Settings Default Enable/disable RF enable RF Auto enable operation during an (MX40 will Shutoff disable extended situation of all shut off after leads off for more than 10 10 minutes minutes and the SpO of Leads Off not being measured condition...
  • Page 142 Unit Settings - Telemetry Setup Factory Control Function Settings Default Determine the MX40 SpO Spot Check Mode Spot Check (Manual)- measurement behavior. Provides manual (Manual) measurements so the clinician Note — Pulse Rate and can check as needed. Pleth Wave are not Measurement can be initiated available in Spot Check from the SmartKeys menu, the...
  • Page 143 Unit Settings - Telemetry Setup Factory Control Function Settings Default Enable/disable the disable Pleth Wave enable transmission of the Pleth (Pleth wave disable wave and its subsequent is not Note — When enabled, display to the Information displayed.) during 6-lead monitoring, the Center.
  • Page 144 Unit Settings - Default Leads Factory Control Function Settings Default Set the unit default lead. 3-wire I, II, III 5-wire, ECG1 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V 5-wire, ECG2 Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V 5-wire, ECG3 Set the unit default lead.
  • Page 145 Unit Settings - NBP Setup Factory Control Function Settings Default Set patient type used for NBP Adult Patient Type Adult alarm limits. Pediatric Set NBP alarm notification. Systolic or NBP Alarm Systolic or Diastolic Diastolic Systolic Diastolic Mean Systolic High Increment/decrement NBP 160 Adult Limit Maximum is 260 high alarm limit by 1.
  • Page 146 Unit Settings - Alarms Control Function Settings Factory Default Set latched/non-latched Latched Non-arrhythmia Latched status for SpO , ST, and Yellow Alarms Non-latched other non-arrhythmia yellow alarms. Adjust the severity level Cyan Leads Off Cyan of this technical alarm Yellow (INOP).
  • Page 147: Operating With Information Center Release L Or M

    10. 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 ...................... 10-2 Alarms ....................... 10-3 Operating with Information Center Release L or M 10-1...
  • Page 148: Display

    Display An MX40 operating with either Release L or M of the Information Center has a fixed display 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. 10-2 Operating with Information Center Release L or M...
  • Page 149: 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. Technical alarms (INOPs) are communicated and can be silenced using the Alarm Silence button.
  • Page 150 10-4 Operating with Information Center Release L or M...
  • Page 151: Trends (optional)

    11. Trends (Optional) 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 SpO Viewing Vital Trend Information ............
  • Page 152: Viewing Vital Trend Information

    Viewing Vital Trend Information  To view Vital Trend information: Touch the SmartKeys button. From the SmartKeys menu, select Vitals Trend.  To change the time columns: Touch the time column. Select a different time period. 11-2 Trends (Optional)
  • Page 153: 12. Maintenance

    12. Maintenance This section provides procedures for maintaining the MX40 after installation, including equipment label assignment, cleaning, and troubleshooting information for common problems. Cleaning ....................12-2 Label Assignment for Replacement MX40 ........... 12-5 Charging Lithium-ion Rechargeable Batteries ........12-7 Maintenance 12-1...
  • Page 154: 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.
  • Page 155 Sharp or pointed instruments should not be used to remove soil from recessed areas on the MX40. Approved Cleaners Cleaner Active Ingredient Isopropyl Alcohol Isopropyl Alcohol (>70%) based Hydrogen Peroxide Hydrogen Peroxide (3%) Chlorine Bleach Sodium Hypochlorite (1:10 concentration, mixed < 24 hours) Caltech Dispatch Sodium hydroxide (<0.2%) 5200 Wipes...
  • Page 156 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%) Carpe Diem TM/ MC Hydrogen peroxide (0.5%) Tb Wipes Benzyl alcohol (3.1%) Note —The cleaners listed above are also suitable for cleaning the patient cable and the lithium-ion battery.
  • Page 157: 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.
  • Page 158 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. 12-6 Maintenance...
  • Page 159: 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.
  • Page 160: Battery Lifetime Management

    Status no battery on charger slot battery put on charger slot flashing yellow battery not properly recognized, cyan error battery recognized, battery yellow charging battery recognized, battery full green (>90%) The AC Power / Error LED is green when the charging station is connected to AC power cyan during startup or to indicate a general charging station error Note —...
  • Page 161: Battery Disposal

     To check the number of charge-discharge cycles: Touch the battery gauge on the display. The number of cycles is listed as xx/500 on the Device Status menu. Battery Disposal Discharge the battery and insulate the terminals with tape before disposal. Dispose of used batteries promptly and in accordance with local recycling regulations.
  • Page 162 12-10 Maintenance...
  • Page 163: Safety Standards & Specifications

    13. Safety Standards & Specifications This section describes the regulatory standards that the IntelliVue MX40 complies with, along with product and measurement specifications. Regulatory Information ................13-2 Electromagnetic Compatibility .............. 13-6 Battery Specifications ................13-12 Lithium-ion Battery Charge Time ............13-14 Physical Specifications ................
  • Page 164: 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 The system is not intended for connection to the public mains as defined in CISPR-11.
  • Page 165: Intended Use Statement

    EN ISO 9919:2005 Pulse Oximeters 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...
  • Page 166: Intended Uses Of Mx40

    Unlike a traditional bedside monitor which operates on AC power, the MX40 is powered by battery and cannot provide continuous monitoring. Authorized EU Representative Philips Medizin Systeme Deutschland Hewlett-Packard-Strasse 2 D 71034, Boeblingen Germany Patient Population This device is not for use with infant or neonatal patients.
  • Page 167: Essential Performance

    Essential Performance The IntelliVue MX40 provides Essential Performance (EP) under normal operating conditions (includes EMC exposure) only as a complete Medical Electrical System, consisting of the MX40, MPx companion monitor (Optional), IntelliVue CL SpO and NBP Cableless Measurement devices(Optional), IntelliVue Telemetry Network Infrastructure, and the M3290 Information Center Software.
  • Page 168: 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.
  • Page 169: Reducing Electromagnetic Interference

    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.
  • Page 170: Electromagnetic Emissions

    Warning Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitoring equipment. Electromagnetic Emissions Emissions Test Compliance Avoiding Electromagnetic Interference Radio Frequency Group 1 TheMX40 uses RF energy only for (RF) emissions its internal function.
  • Page 171: Recommended Separation Distance

    Immunity Test IEC 60601-1-2 Test Compliance Level Electromagnetic Level Environment Guidance Power frequency 3 A/m 3 A/m Power frequency magnetic (50/60 Hz) magnetic fields should be a t levels characteristic of a typical field location in a typical IEC 61000-4-8 commercial and/or hospital environment Recommended Separation Distance...
  • Page 172 Immunity Test IEC 60601-1-2 Test Compliance Level Electromagnetic Level Environment Guidance Radiated RF IEC 3 V/m 3 V/m Recommended separation distance: 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 800 MHz d = 1.2√P 800 MHz to 2.5 GHz d = 2.3√P Field strengths from fixed transmitters, such as base stations for radio (cellular, cordless) telephones and land mobile radios, amateur radio, AM...
  • Page 173 Frequency of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz Transmitter 10 W 3.8 m 3.8 m 7.3 m 100 W 12.0 m 12.0 m 23.0 m Electrosurgery Interference/Defibrillation/Electrostatic Discharge The equipment returns to the previous operating mode within 10 seconds without loss of any stored data.
  • Page 174: Battery Specifications

    Continuous 4.6 hours (using legacy SpO cable/sensors. Only one radio active.) The battery life specifications listed below are based on the use of the Philips Rechargeable Lithium-ion battery. Telemetry Mode Battery Life Networked ECG Only (only one 25.1 hours radio active)
  • Page 175 Monitor Mode Battery Life Non-networked ECG Only (only one 8.6 hours radio active) ECG/SpO Continuous 7.0 hours (using legacy SpO cable/sensors. Only one radio active.) ECG/SpO Manual In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO Continuous battery life.
  • Page 176: Lithium-ion Battery Charge Time

    Lithium-ion Battery Charge Time Definition Charging Method Charge Time Battery pack The Lithium-ion Battery Pack is 6.5 hours charge time from charged on a separate external 90% depletion charging station. It must be removed state from the MX40 to charge. 13-14 Safety Standards &...
  • Page 177: 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 1.4 GHz - 240 g (8.5 oz) and Short-range 2.4 GHz - 215 g (7.6 oz) radio 1.4 GHz - 298 g (10.5 oz) With 3 AA batteries, includes SpO...
  • Page 178: Mx40 1.4 Ghz Radio

    MX40 1.4 GHz Radio Parameter Specification Frequency Ranges Bands: 1395-1400 MHz and 1427-1432 Channel Spacing: 1.6 MHz RF Output Power 8 dBm +2/-1.5 dB (4.5 mW to 10 mW), into (existing systems) antenna load MX40 Frequency <+60/-100 KHz relative to channel Accuracy during normal frequency, includes temperature operation...
  • Page 179: Mx40 2.4 Ghz Radio

    Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment. Safety Standards & Specifications...
  • Page 180 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.
  • Page 181: Mx40 Short-range Radio

    MX40 Short-Range Radio Parameter Specification Frequency Ranges ISM Band: 2400-2483.5MHz Radio Channel 16 Radio Channel assigned, Fc= 2405 assignment +5*(k-11)MHz, k=11,12,…,26 Frequency Control Configured via the bedside monitor. RF Output Power 1.5 to 4.5 dBm +0/-3dB (0.7 mW to 0.3 mW), into Antenna load.
  • Page 182: Environmental Specifications

    Environmental Specifications Parameter Specification Temperature Operating 0 to 37 C (32 to 99 Storage C to 50 C (-22 F to 122 F) without batteries Humidity Operating < 95% RH at 37 C (98.6 F) non-condensing Storage < 90% RH at 50 C (112 F) without batteries Altitude...
  • Page 183: Measurement Specifications

    Measurement Specifications Parameter Specification ECG channel transmitted Leads 3 electrodes 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...
  • Page 184: Ecg Performance Disclosure/specifications

    -2 to -700 mV 0.1, 0.2, 0.5 and 1.0 -2 to -500 mV 1.5 ms -2 to -400 mV 2 ms Philips does not claim, verify, or validate support for all available pacemakers. EMC Performance Meets Essential Performance. Limits, radiated immunity...
  • Page 185 Characteristic Performance Disclosure/Specification (in italics) Heart Rate Meter Accuracy and Provides correct heart rates (80, 60, 120, 90 b/min) Response to Irregular Rhythm using test waveforms as indicated in ANSI/AAMI EC13 Sec. 3. 1. 2. 1 (5). Response Time of Heart Rate Meter to For a rate increase, the average time to reach the Change in Heart Rate specified heart rate using test waveforms as indicated in...
  • Page 186: Fast Spo

    Characteristic Performance Disclosure/Specification (in italics) 40 mm. Meets the ANSI/AAMI EC13 Section 3.2.9.7(a) Channel Width standard: minimum = 30mm. Trace Width 0.3 mm. Meets the ANSI/AAMI EC13 Section 3.2.9.7(b) standard: maximum = 1.0mm. Aspect Ratio 0.4s/mV. Meets the ANSI/AAMI EC13 Section 3.2.9.7(f) standard: 0.4s/mV.
  • Page 187 Parameter Specification Numerics - 5 - 20 seconds (default = 10 seconds) Averaging The update rate for the SpO pulse Note— oximetry value and pulse rate is typically 1 second. This can be extended to a max. 60 s when NBP is measured on the same limb, with a corresponding INOP message after a max.
  • Page 188: Spo 2 Sensor Accuracy

    Sensor Accuracy Type Description Model Number Accuracy % (70-100% Range) Reusable Sensors Adult Finger, 2m cable M1191B Adult Finger, 3m cable M1191BL Adult Finger, 0.45m cable M1191T Pediatric, Small Adult Finger, 1.5m M1192A cable Pediatric, Small Adult Finger, 0.45m M1192T cable Adult &Pediatric Ear Clip, 1.5m cable M1194A...
  • Page 189 Type Description Model Number Accuracy % (70-100% Range) Single Patient Use Sensors Adult Finger, > 40kg M1901B Pediatric 3-20kg M11902B Pediatric Finger, 10-50kg M1903B Adult Finger, >30kg M1904B Adult, Pediatric > 20kg M1131A Adult Finger, > 30kg Nellcor OxiMax Max-A Adult Finger, >...
  • Page 190 13-28 Safety Standards & Specifications...
  • Page 191: Accessories

    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.
  • Page 192: Mx40 Accessories

    MX40 Accessories Pouches Order Number Description 989803174141 Carry Pouch, Waterproof, box of 989803174151 Carry Pouch, Waterproof, box of 9300-0768-050 Disp tele pouch w/snaps, 50/box 9300-0768-200 Disp tele pouch w/snaps, 200/box Miscellaneous Order Number Description 989803176501 Protective caps, adapter cable, MX40 989803176491 Protective caps, Reusable leads, MX40...
  • Page 193: Ecg Accessories

    ECG Accessories Electrodes Order Number Description M4612A Solid gel ECG electrode 5/pouch 300/case M4613A Solid gel ECG electrode 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...
  • Page 194 Order Number Description 989803171841 ECG 5 lead snap AAMI + SpO .85m (35") 989803171831 ECG 5 lead grabber AAMI .85m (35") 989803171851 ECG 5 lead grabber AAMI + SpO .85m (35") 989803171861 ECG 6 lead grabber AAMI .85m (35") 989803171871 ECG 6 lead grabber AAMI + SpO .85m (35") MX40 Extender Cable, including Bed Sheet Clip, p/n 989803172241...
  • Page 195: Spo 2 Accessories

    989801190970 (B) Nellcor OxiMax N-25, <3 kg, >40 kg Require M1943A/AL cable to connect to MX40. Sold in packages of 24. (A) Only available from Philips in Europe and (B) Only avialable from Philips in Japan. Philips Reusable Sensors Order Number...
  • Page 196: Adapter Cables

    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 Order Number Description 989803105691...
  • Page 197: Default Settings

    Default Settings 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.
  • Page 198: Alarm Default Settings

    Alarm Default Settings Alarm Setting Factory Default Alarm Volume On Network: 0 Off Network: 10 QRS Volume Tone Modulation Alarm Sound Traditional Alarm Pause Time 2 min. Alarm Reminder (Red, Yellow) Alarm Reminder (INOP) Reminder Time 3 min. ECG Leads Off - Severity Cyan Replace Battery - Severity Cyan...
  • Page 199: Ecg, Arrhythmia, St And Qt Default Settings

    ECG, Arrhythmia, ST and QT Default Settings ECG Settings Factory Defaults Adult Pedi Primary Lead Secondary Lead 6-lead: V2 5-lead (Standard): V 5-lead (EASI): V2 Default ECG Size Lead Placement Standard Leadset Type AAMI Analysis Mode Multi-lead High Limit 120 bpm 160 bpm Low Limit 50 bpm...
  • Page 200 Arrhythmia Settings Factory Defaults Adult Pedi R-On-T PVCs V.Bigeminy V.Trigeminy PVCs/min Multif. PVCs Pacer N. Cap Pacer N. Pac Pause Missed Beat Afib Irregular HR Default Settings...
  • Page 201: Configuration Default Settings At The Mx40

    Configuration Default Settings at the MX40 Setting Factory Default 0 - 10 Touch Tone Volme 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 Unit Defaults...
  • Page 202 Default Settings...
  • Page 203: Mx40 2.4ghz Wlan Radio

    Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment. MX40 2.4GHz WLAN Radio...
  • Page 204 MX40 2.4GHz WLAN Radio...
  • Page 205: Sales And Support Offices

    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 Via email healthcare@philips.com...
  • Page 206 Sales and Support Offices...
  • Page 207 Index Accessories ECG • A-3 MX40 • A-2 SpO2 • A-5 Charging Lithium-ion Rechargeable Batteries • 3-13 Default Settings • B-1 alarms • B-2 ecg, arrhythmia, ST and QT • B-3 ECG Fallback • 5-30 ECG Performance Disclosure/Specifications • 4-3 Electromagnetic Compatibility •...
  • Page 210 Part Number 453 564 242 441 Printed in USA June 2011 First Edition 453 564 242 441...

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